OTC: RBOT
Vicarious Surgical Inc.CIK 0001812173 · Orthopedic & Prosthetic Supplies
The following discussion reflects the business of Vicarious Surgical, as currently embodied by Vicarious Surgical. Unless the context otherwise requires, all references in this section to the “Company”, “we”, “us” and “our” generally refer to Vicarious Surgical in the present tense or Vicarious… About this business →
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About Vicarious Surgical Inc.
Source: Item 1 (Business) from the 10-K filed March 9, 2026. Description as filed by the company with the SEC.
ITEM 1. BUSINESS.
The following discussion reflects the business
of Vicarious Surgical, as currently embodied by Vicarious Surgical. Unless the context otherwise requires, all references in this section
to the “Company”, “we”, “us” and “our” generally refer to Vicarious Surgical in the present
tense or Vicarious Surgical from and after the Business Combination.
Overview
We are combining advanced miniaturized robotics,
computer science, sensing and 3D visualization to build a new category of intelligent and affordable single-port surgical robots that
virtually transport surgeons inside the patient to perform minimally invasive surgery. With our next-generation robotics technology, which
is being designed with proprietary human-like motion, we are seeking to improve surgical precision, ergonomics, and procedural efficiency,
with the goal of improving patient outcomes and the cost and efficacy of surgical procedures over time. Led by a visionary team of engineers
from MIT, we intend to deliver the next generation in robotic surgery, designed to solve the shortcomings of both open surgery, as well
as current manual and robot-assisted minimally invasive surgery.
Our single-port surgical robot, called the
Vicarious Surgical System, is designed to address certain deficiencies that have limited broad adoption of robot-assisted minimally invasive
surgery to date. By fundamentally engineering a better solution, we believe we have designed a surgical robot with capabilities intended
to address limitations of systems currently available on the market, and if authorized by the FDA, the Vicarious Surgical System will
offer surgeons the ability to perform surgical procedures with greater dexterity and greater access across the abdomen, with better visibility
and sensor-based feedback, through a small single incision in the abdomen. The Vicarious Surgical System features proprietary “de-coupled”
actuators, which are intended to enable a cascade of benefits, including improved robotic mobility, reduced size, improved functionality
and lower materials costs. If authorized by the FDA, the Vicarious Surgical System is designed to enable surgeons to perform procedures
inside the abdomen with human-equivalent motion, with a full nine degrees of freedom per robotic arm, providing an experience that is
more natural, and more akin to the surgeon’s own upper body movements. In surgical procedures conducted on cadavers, the Vicarious
Surgical System has demonstrated expanded reach within the abdomen, and if authorized by the FDA, it will enable the surgeon to enter
the abdomen from a wide range of angles and directions, without having to triangulate to the surgical area from multiple incisions or
to operate only within the limited area directly in front of a single incision. The Vicarious Surgical System is designed to provide exceptional
visualization, with a high-performance, stereoscopic camera that rotates in three degrees of freedom (yaw, pitch, and roll) to provide
the surgeon with stereoscopic imaging of a broad range of surfaces in the abdomen. The Vicarious Surgical System also contains 28 sensors
per instrument arm, which allows the system to provide real-time feedback to the surgeon on force, motion and other data that are intended
to enhance surgical procedures and patient outcomes.
Read full description ↓
The Vicarious Surgical System is being
developed to provide attractive advantages to hospitals and ambulatory surgical centers, or ASCs, which we believe will drive rapid
and widespread adoption. Unlike many legacy surgical robotic systems with larger physical footprints that may require dedicated
operating room configurations, the Vicarious Surgical System is designed to be smaller and mobile, supporting flexibility of use
across multiple operating rooms within a medical facility. We anticipate that, if authorized by the FDA, the smaller size and
advanced engineering of the Vicarious Surgical System and related disposable instruments is expected to be offered at a
cost-effective price point compared to existing legacy robotic systems. Hospitals and ASCs would not be required to dedicate
permanent space and would reduce expenses relating to sterilization and operating room turnover. We believe that, if authorized by
the FDA, adoption of the Vicarious Surgical System could be facilitated by a streamlined training regimen, where surgeons may be
able to develop proficiency much more quickly than for legacy robotic systems. This is due to the design features of the Vicarious
Surgical System, such as the ease of use and more natural, human-equivalent motion of the Vicarious Surgical System, the reduced
surgeon burden during setup, and the fact that the Vicarious Surgical System would not be confined to a dedicated operating suite
and therefore could have more availability for training purposes. In addition, with its increased capability and dexterity, the
Vicarious Surgical System is designed to enable many procedures to be performed more efficiently and effectively, with the potential
to reduce procedural burden and overall healthcare costs. Because the Vicarious Surgical System has not yet been authorized by the
FDA or commercialized, the intended advantages of the Vicarious Surgical System have not yet been realized and are dependent upon
the successful development of the Vicarious Surgical System and a timely authorization by the FDA.
1
We estimate that there are 45 million
soft tissue abdominal and gynecological surgical procedures performed annually worldwide that could potentially be addressed with the
Vicarious Surgical System, including use for ventral hernia, other types of hernia, hysterectomy, cholecystectomy (gall bladder) and certain
other gastrointestinal procedures. We intend for use in ventral hernia procedures to be the first clinical application for the Vicarious
Surgical System, of which there are estimated to be 3.9 million cases worldwide and 0.9 million in the U.S. annually. We
then intend to seek FDA clearance or authorization to enable the expansion into the other applications addressable by the Vicarious Surgical
System.
Industry Background
Despite the advancements in manual and robot-assisted
minimally invasive surgery over the last 40 years, of the estimated 45 million annual worldwide procedures addressable by the
Vicarious Surgical System, it is estimated that a significant portion are currently performed by open surgery and a relatively small percentage
are performed by existing robot-assisted minimally invasive surgery technologies. The large incisions required for open surgery, while
allowing the surgeon to see with their own eyes and operate with their own hands, create significant trauma to the patient, resulting
in long hospitalization and recovery times, high hospitalization costs, as well as pain and suffering. Open surgical procedures are associated
with a meaningful risk of post-operative complications, including incisional hernias, which in some cases may require additional corrective
surgery. Although there have been significant improvements in minimally invasive surgery procedures over open surgery, the following limitations
associated with minimally invasive surgery still exist:
●Laparoscopic surgery results in improved patient outcomes,
but it presents significant challenges for surgeons, primarily associated with using long, rigid instruments through multiple incisions
across the abdominal wall, which introduces the “fulcrum effect” requiring the surgeon to adjust for the inversion and scaling
of movements. These laparoscopic instruments can be difficult to manipulate, have limited degrees of freedom, limited reach and reduced
depth-perception and visibility, which can require significant coordination among the surgical team to perform the procedure.
●Multi-port robotic systems introduced in the early 2000s have
managed to overcome some of the challenges associated with laparoscopy, but they require multiple incisions. While the wristed robotic
instruments provide more dexterity than the long, rigid instruments used in laparoscopy, these robotic systems still require multiple
system components and place responsibility on the surgeon to define the workspace and kinematic motion profile of the robotic system
for every procedure, based on where they create the incisions and where they intend to operate. Additionally, these systems are expensive
and often involve a steep learning-curve for surgeons. In addition, these systems are often underutilized because they have large footprints,
limited portability and require extensive setup and longer operating room turnover time.
●More recently, single-port surgical robots have been developed,
but these systems are limited in that they rely on legacy robotic architecture, and thus require a much larger incision than multi-port
robotic systems, have limited motion, strength, and visualization, and can only operate in a small procedural area. Given the relatively
large size of the trocar incision required to be made by the surgeon to accommodate existing single-port robotic systems, among other
limitations, these existing single-port robots have faced adoption challenges due to these architectural and functional limitations,
which may constrain surgeon performance in certain procedures. For all these reasons, legacy single-port robotic solutions, much like
multi-port manual and robotic minimally invasive surgery, have received limited adoption to date.
We believe this slow adoption of robot-assisted
surgery has occurred because of several factors, including the following:
●Significant Capital Investment. Legacy
robotic systems require high upfront acquisition costs and burdensome annual service contracts that are often prohibitively expensive,
especially in outpatient settings. Based on discussion with industry sources, we estimate these capital costs to be up to $2.0 million
or more per system upfront, plus an additional 10% to 20% annually for maintenance and service contracts.
●Low Utilization. In addition to the significant
acquisition costs, existing robotic systems create inefficiencies and increase costs to medical facilities considering adoption. Due
to their large size and limited portability, existing robotic systems often require dedicated operating room configurations, occupying
valuable real estate within the hospital. Once in place, these robotic systems require extensive set-up and operating room turnover times,
which limits the number of procedures that can be performed with the robotic system.
2
●Limited Capabilities. Existing robotic
systems have limited capabilities and are ill-suited for many outpatient procedures. Due to their limited degrees of freedom inside the
abdomen, they depend on significant, complicated, robotic motion outside the body, and they have limited ability to operate in multiple
quadrants, difficulty operating on the “ceiling” of the abdomen, create collisions inside and outside of the patient’s
abdomen, and restrict overall access of the operating team to the patient.
●Difficult to Use. Existing robotic systems
require the surgeon to develop an extensive procedure plan in advance to determine appropriate incision sites and angles for each procedure,
in order to avoid collisions inside and outside of the patient’s abdomen. Surgeons must develop this plan with fewer degrees of
freedom than they would employ using open surgery, restricting their natural movements. Becoming proficient at manipulating these legacy
robotic systems to perform the procedures they otherwise were trained to perform via open surgery requires extensive training and several
dozen procedures on live patients. As these systems are maintained in dedicated, expensive, operating rooms, obtaining access to train
on the system becomes a significant impediment to adoption, which may contribute to continued reliance on open surgeries.
The Vicarious Surgical System
The single-port Vicarious Surgical System
with advanced, miniaturized robotics and exceptional visualization is designed to address certain limitations of open surgery and existing
single- and multi-port robotic surgical approaches, with the goal of improving surgical workflow and supporting adoption by hospitals
and other medical facilities. The Vicarious Surgical System is designed with a fundamentally different architecture, and proprietary “de-coupled
actuators,” intended to address limitations of open surgery and existing robot-assisted surgical procedures with a minimally invasive
robotic system. This architecture is designed to enable a high degree of dexterity inside the abdomen through an ultra-thin support tube,
which we believe may offer advantages relative to existing robotic systems and support minimally invasive surgical approaches. The Vicarious
Surgical System has not yet been authorized by the FDA. We have conducted pre-submission meetings with the FDA to align on our regulatory
strategy and plan to file a De Novo classification request for use in ventral hernia procedures as our first indication.
(1)The Vicarious Surgical System is capable of incision sizes
as low as 1.8cm.
3
The Vicarious Surgical System consists of
the following components:
●Camera and Instrument Arms. The Vicarious
Surgical System incorporates a high-performance stereoscopic camera that, when combined with robotic motion, is designed to provide a
broad range of viewing angles and is being developed to continuously map the depth of the abdominal cavity. Based on cadaver studies,
the camera and instrument arms are designed to support operation across a wide range of direction within the abdomen, including the ability
to rotate and operate around the trocar incision point. Each surgical instrument arm is designed with nine degrees of movement, intended
to approximate the range of motion of the surgeon’s wrists, elbows and shoulders, and to support a more natural range of motion
during surgical procedures. While existing robotic systems are often constrained to operating primarily in front of the rigid instrument,
the Vicarious Surgical System is designed to support operation across a broader working envelope within the abdomen, which we believe
may enhance surgical flexibility while supporting minimally invasive approaches. The camera and both instrument arms are being developed
to enter the abdomen through a single, 1.8 centimeter trocar, which is within the size range of conventional minimally invasive surgery
trocars. If authorized by the FDA, the Vicarious Surgical System is designed to provide enhanced sensing capability relative to existing
systems due to its increased number of joints and sensors. The system features 28 sensors per instrument arm, to provide real-time feedback
to the surgeon on force, motion and other data, and to generate intraoperative data intended to support continued refinement of system
performance and surgeon capabilities over time.
●Surgeon Console. The Vicarious Surgical
System surgeon console is designed for an immersive operating environment that allows the surgeon to visualize the surgical field and
control robotic motion. If authorized by the FDA, the surgeon console is intended to support precise control and situational awareness
during procedures. The console includes a peer-in stereoscopic vision screen that enables surgeons to operate in a three-dimensional
environment without the use of 3D glasses, while maintaining awareness and line of sight to the operating room.
●Patient Cart. The Vicarious Surgical System
patient cart is designed to support maneuverability within hospitals, outpatient clinics, and ambulatory surgical centers, including
the ability to pass through standard doorways. Unlike many existing robotic systems, the Vicarious Surgical System, if authorized by
the FDA, is designed to support use across multiple operating rooms without requiring permanent room dedication. The system is intended
to be wheeled into and out of operating rooms and stored when not in use, similar to other mobile medical devices.
Because the majority of the robotic
motion occurs inside the abdomen through a single port, the Vicarious Surgical System is designed without multiple large robotic
arms operating outside the patient’s body. We believe that architectural approach, together with the potential use of advanced
manufacturing processes, may enable the Vicarious Surgical System to be manufactured at a lower cost than certain existing robotic
systems, based on publicly available information.
4
Vicarious Surgical System Advantages
We believe that addressing the factors that
have limited broad adoption of robot-assisted minimally invasive surgery to date including cost, system size, capability, ease of use,
setup time, throughput, and training requirements, requires a solution that considers these challenges. The Vicarious Surgical System
incorporates advanced engineering and proprietary “de-coupled actuators,” which are designed to support a differentiated approach
to surgical robotic system architecture and may help address certain factors that have historically limited broader adoption of robot-assisted
minimally invasive surgery. Based on this design, the Vicarious Surgical System is intended to provide increased degrees of freedom and
dexterity to support more natural surgical motion, as well as enhanced visibility, sensing and functionality for the surgeon, all through
a small, single port minimally invasive approach. We believe these design features may address certain limitations associated with existing
single- and multi-port surgical modalities and support improved surgical workflow and system utilization.
●Decoupled Actuators. Robotic arms are controlled
by actuators located at each joint. In many existing robotic systems, these actuators are mechanically “coupled,” such that
movement at one joint results in corresponding movement at subsequent or prior joints. In legacy robotic systems, software is used to
coordinate joint motion and compensate for this coupling in order to reduce unintended movement. However, this approach does not eliminate
the accumulation of forces across multiple joints that can arise from coupled mechanical architectures. As a result, such systems often
require larger and more robust cables, pulleys, and structural components, which can increase system size and cost and constrain overall
mobility.
The Vicarious Surgical System is designed with a decoupled
actuator architecture intended to reduce mechanical interdependence between joints. We believe this approach may enable greater integration
of components and materials, and support improvements in system flexibility, strength, and form factor. These design features are intended
to provide benefits for surgeons, hospitals, and ambulatory surgical centers by supporting enhanced system capability and more efficient
use within the operating environment. Because the Vicarious Surgical System has not yet been authorized by the FDA or commercialized,
the intended benefits of this architecture have not yet been realized and are dependent on successful development and regulatory authorization.
Because the Vicarious Surgical System has
not yet been authorized by the FDA or commercialized, the intended advantages of the Vicarious Surgical System have not yet been realized
and are dependent upon the successful development of the Vicarious Surgical System and timely authorization by the FDA.
Surgeon Experience
●Human Equivalent Motion — Nine Degrees
of Freedom. The Vicarious Surgical System is designed to provide nine degrees of freedom per instrument arm, intended to
approximate the range of motion of a surgeon’s wrists, elbows and shoulders. Based on data from cadaver studies, this design is
intended to support a broader range of motion than that available with many existing single- or multi-port robotic systems, which often
require surgeons to adapt their movements to the constraints of the robotic architecture. We believe this approach may provide a more
natural operating experience by allowing surgeons to work in a manner that is more consistent with their training in open surgery, while
performing procedures through a minimally invasive approach.
5
●Expanded Reach Inside the Abdomen. With
nine degrees of freedom per instrument arm, the Vicarious Surgical System is designed to support operation across a wide range of angles
and directions within the abdomen through a single incision. This design is intended to reduce the need for triangulation and the limitations
associated with operating only within a narrow working area directly in front of the incision, which is common in manual and robotic
minimally invasive surgery. The system architecture is designed to allow the surgeon to reposition and pivot the instruments within the
abdominal cavity, including operating in proximity to the incision site, in order to support procedural flexibility.
●Sensing, Visualization and Future AI. The
surgeon utilizes a peer-in stereoscopic display on the console for visualization of the surgical field. The Vicarious Surgical System
incorporates a high-performance stereoscopic camera that is designed to support a broad range of viewing operations and is being developed
to provide three-dimensional spatial mapping of the surgical environment. The system includes more than two dozen sensors per instrument
arm that are designed to provide real-time feedback to the surgeon on force, motion and other data. These data are also intended for
to support future software and analytics development, including potential artificial intelligence-enabled capabilities, which may be
used to enhance surgical workflow and to explore relationships between intraoperative data and procedural outcomes over time.
Hospital and Ambulatory Surgical
Center (ASC) Advantages
●System Size and Mobility. Unlike many legacy
robotic systems that often require dedicated operating room configurations or physical modifications to accommodate their size, the Vicarious
Surgical System is designed with a smaller footprint intended to allow it to pass through standard hospital and operating room doorways.
This design is intended to support system mobility within a medical facility and may help reduce set-up and break-down time, enabling
use across multiple operating rooms rather than permanent room dedication.
●Training and Accessibility. The Vicarious
Surgical System is designed to support more natural surgical motion and, due to its mobility, is not intended to be confined to a dedicated
operating suite. We believe this design may increase system availability for surgeon training and practice. As a result, surgeons may
be able to develop proficiency more efficiently compared to certain existing robotic systems, which could support surgeon adoption and
improve utilization for hospitals and ASCs.
●Economics and System Cost. If authorized
by the FDA, we intend to offer the Vicarious Surgical System, along with maintenance and service support, at more pricing we believe
may be more attractive relative to certain existing robotic systems. In addition, the system’s design is intended to support efficient
procedural workflow, which may enable procedures to be performed more efficiently and could contribute to reductions in overall operating
room time and associated costs.
●Disposable Instruments and Accessories. The
Vicarious Surgical System’s instruments and accessories are designed for single use and are intended to be offered at pricing that
supports disposability. We believe this approach may reduce the need for hospitals and ASCs to dedicate space, equipment, and personnel
to instrument reprocessing and sterilization, potentially simplifying logistics and reducing associated operational costs.
Patient Outcomes
●Enhanced Surgical Capability. The Vicarious
Surgical System is designed to provide enhanced visualization, dexterity, and access within the abdomen to support precise surgical technique.
If authorized by the FDA, these design features are intended to allow surgeons to perform advanced minimally advanced techniques that
are already established in clinical practice. We believe that supporting such techniques may contribute to improved procedural
execution and patient outcomes when compared to open surgical approaches.
6
●Minimally Invasive Access and Trocar Size Considerations. Clinical
experience with minimally invasive surgery has demonstrated that smaller incisions are generally associated with reduced tissue disruption
and lower rates of incision-related complications when compared to open surgical procedures. Existing minimally invasive approaches typically
utilize smaller trocar sizes than those required for open surgery, which may reduce the risk of wound-related complications.
Our Strategy
We seek to expand access to robot-assisted
minimally invasive surgery through the development of a surgical robotic platform designed to be capable, flexible, and accessible across
a range of care settings. Our objective is to establish the Vicarious Surgical System as a differentiated robotic platforms for soft tissue
surgery. The execution of our strategy is dependent upon the successful development of the Vicarious Surgical System and receipt of FDA
authorization:
●Initial Focus on Ventral Hernia Procedures. We
plan to initially focus commercialization efforts on ventral hernia procedures, targeting surgeons, hospitals and ambulatory surgical
centers that perform general surgery procedures which may benefit from a single-incision robotic approach. We believe ventral hernia
repair represents an attractive initial indication due to procedure volume, clinical need, and the opportunity to apply minimally invasive
techniques. As part of this strategy, we intend to engage with experienced surgeons and clinical advisors to gather feedback that may
inform product development, clinical protocols, and surgeon training.
●Expansion of Indications. The Vicarious Surgical
System is designed to provide broad access within the abdomen, which we believe may support use across additional surgical procedures
over time. Subject to regulatory authorization, we plan to pursue expanded indications that may include inguinal and hiatal hernia repair,
hysterectomy, cholecystectomy (gallbladder), colorectal and other gastrointestinal procedures. We estimate that 39 million of these
procedures are performed annually worldwide today.
●Recurring Revenue Model. Following initial system
placement, we intend to focus on increasing system utilization by supporting efficient procedural workflow and repeat use. Increased
utilization may enable hospitals and ASCs to perform a greater number of procedures using the Vicarious Surgical System, which could
drive recurring revenue through the sale of single-use and disposable components, including robotic arms, camera and instrument tips.
●Demonstration of Clinical and Economic Value. A
significant portion of ventral hernia procedures are currently performed as open surgical procedures in hospital settings. We believe
there is an ongoing trend toward shifting appropriate procedures from hospitals to ASCs, driven by cost, efficiency, and patient preference.
Subject to regulatory authorization, we believe the Vicarious Surgical System may support the performance of more complex minimally invasive
hernia procedures in ASC settings. Because ASCs often have limited capital and infrastructure budgets, our value proposition is designed
to address considerations related to system cost, footprint, and operating room flexibility.
●Expansion of Product Capabilities. We believe
that advancements in software, data analytics, and automation may further enhance robotic-assisted surgery over time. We plan to evaluate
and develop additional features for future generations of the Vicarious Surgical System, which may include enhanced visualization, data-driven
insights, and automation-enabled functionality, subject to technical feasibility and regulatory requirements.
●International Commercialization. If the Vicarious
Surgical System receives FDA authorization for commercialization in the U.S., we intend to pursue applicable regulatory clearances or
approvals in additional markets, including Asia, Europe and other international regions, in order to support global commercialization
of the system.
7
Historical Development of the Vicarious
Surgical System
The foundational technology underlying the
Vicarious Surgical System was developed by the Vicarious Legacy founders Adam Sachs, Sammy Khalifa, and Barry Greene. The founding team
conducted extensive prototyping and experimentation focused on robotic arm architecture and motion control. Through this work, they developed
and patented a cable pathway design intended to de-couple motion within the robotic arm, reducing mechanical interdependence between joints.
This approach supported the development of an early robotic arm prototype designed to approximate aspects of natural human arm motion.
Following the development of this initial
prototype, the founding team expanded the design into a more complete robotic system. Early versions of the device were constructed using
internally machined components and were funded by the founders. The system was subsequently integrated with internally developed software
and a surgeon input tracking system to support coordinated robotic motion. After achieving a fully functioning prototype, the company
raised outside capital and expanded the engineering and development team to continue advancing the system.
We have conducted, and continue to conduct,
synthetic cadaver and cadaver studies with the Vicarious Surgical System being developed, as part of our iterative development process.
The primary objective of these studies has been to evaluate system design, refine performance characteristics, and inform ongoing product
development. In these studies, surgeons have used the system to perform a range of procedures, including ventral hernia repair, hysterectomy,
and cholecystectomy. Surgeons have also evaluated multiple ventral hernia repair techniques, including robotic transabdominal preperitoneal
(rTAPP), retrorectus, and intraperitoneal onlay mesh repair (IPOM) plus. Insights gathered from these cadaver studies have informed design
considerations across multiple aspects of the system, including:
●Instrument length requirements for ventral hernia repair procedures;
●Camera field of view and depth perception;
●User interface elements, including foot pedals and digital
controls;
●Responsiveness and quality of robotic end-effector motion
relative to surgeon input;
●Instrument and camera insertion and extraction workflow; and
●Reliability and durability of the robotic instruments and
camera.
These development activities have been conducted
to support the continued refinement of the Vicarious Surgical System and to inform our regulatory strategy. The system has not yet been
authorized by the FDA, and further development, testing, and regulatory review and authorization will be required prior to any potential
commercialization.
8
Regulatory History and Pathway
In November 2019, the FDA granted Breakthrough
Device designation to a prior prototype version of the Vicarious Surgical System for a proposed indication for use in ventral hernia repair
procedures. We anticipate that after FDA authorization, the Vicarious Surgical System will be classified as a Class II medical device.
We have held multiple pre-submission meetings with the FDA to align on our regulatory strategy and currently plan to pursue a De Novo
classification request with the FDA for use in ventral hernia procedures as our initial indication.
In December 2021, we conducted a
preliminary meeting with the FDA to discuss two technology changes made to the Vicarious Surgical System design that had received
Breakthrough Device designation in November 2019. Based on these changes, the FDA determined that the current Vicarious Surgical
System design planned for our initial limited launch differs from the prior design that received Breakthrough Device designation. As
a result, the FDA stated that the Breakthrough Device designation remains applicable only to the prior device design. In the future,
we may seek to reincorporate elements of the prior design to potentially leverage the previously granted Breakthrough Device
designation. However, medical device development is inherently uncertain and there can be no assurance that Breakthrough Device
designation would be granted to a different device design, and if granted, that such designation would accelerate the timeline for
authorization or increase the likelihood of FDA authorization.
In February 2022, we held an additional pre-submission
meeting with the FDA focused on the current Vicarious Surgical System design. During this meeting, the FDA emphasized that each robotic-assisted
surgical system is highly complex and that differences in system architecture, kinetics, software, data transmission, interfaces, and
user interaction create unique safety and effectiveness considerations. The FDA indicated that these system-level differences may raise
questions of safety or effectiveness that are not applicable to predicate devices and that robotic-assisted surgical systems are generally
not sufficiently similar to permit meaningful comparison for purposes of a traditional 510(k) submission. Based on FDA feedback, the evaluation
of the Vicarious Surgical System is expected to require a holistic assessment incorporating software verification and validation, bench
testing, animal studies, human factors and usability testing, and clinical data, among other verification and validation data. The FDA
indicated that, due to the unique technological characteristics and clinical implementation of the system, an independent evaluation of
safety and effectiveness would be required. As a result, the FDA advised that a 510(k) submission would likely be found not substantially
equivalent to a predicate robotic-assisted surgical system. In accordance with this FDA feedback, we revised our regulatory pathway to
pursue a De Novo classification.
In February 2024, we submitted an application
to the FDA seeking acceptance into its Safer Technologies Program (“the STeP Program”). The FDA accepted our robotic system,
intended to assist in visualization and control of endoscopic instruments during ventral hernia repair procedures in adults, into the
STeP Program. This acceptance means the device meets STeP eligibility criteria, but it does not change requirements for granting Investigational
Device Exemption (“IDE”) or marketing authorization, nor does it guarantee future authorization. Through the STeP Program,
we can utilize available feedback mechanisms that prioritize interactive and timely communications with the FDA, as resources permit.
The goal of the STeP Program is to expedite the development of devices and offers program-specific feedback mechanisms, including early
engagement on Data Development Plans (“DDPs”) for aligning on necessary safety evidence, “sprint discussions”
with FDA experts to address development challenges, and potential senior management engagement for discussing high-level strategic issues.
In addition, general FDA feedback mechanisms like the Q-Submission Program (including Pre-Submissions and Informational Meetings) continue
to be available to us.
9
Regulatory Roadmap for Market Authorization
Based on the outcome of the pre-submission
meeting with the FDA in February 2022, the FDA determined that there is no legally marketed predicate device. Therefore, we will plan
to file a De Novo classification request for the proposed initial indication for use in ventral hernia repair procedures as a regulatory
pathway to classify the Vicarious Surgical System. Devices that are classified into Class I or Class II through a De Novo classification
request may be marketed and used as predicates for future premarket notification (or 510(k)) submissions, when applicable. Accordingly,
we believe that the 510(k) pathway will be available as a regulatory pathway for the Vicarious Surgical System with respect to future
indications or other significant modifications to the device system.
We plan to conduct a prospective human pivotal
clinical investigation under an FDA IDE to evaluate the safety, effectiveness, and performance of the Vicarious Surgical System to support
a De Novo classification request and obtain U.S. marketing authorization for the proposed indication for use in ventral hernia repair
procedures. In addition to conducting a human pivotal clinical investigation, we plan to conduct non-clinical testing activities to verify
and validate the safety, performance, effectiveness, functionality, usability and reliability characteristics of the Vicarious Surgical
System with respect to the intended use and defined requirements. A verification and validation process is expected to provide the necessary
data to submit to the FDA for IDE approval.
We expect that non-clinical verification
and validation testing will be conducted to verify and validate that the Vicarious Surgical System meets all design specifications
for its intended use. These tests will include in vitro, simulated clinical bench testing and cadaver studies, as well as in vivo
animal studies to support and demonstrate the safety, performance, effectiveness, functionality, usability, and reliability
characteristics of the Vicarious Surgical System with respect to the intended use and defined requirements. Cadaver studies,
representing realistic dimensions and contours of the human abdominal space, will be used primarily to verify and validate system
functionality, performance, and safety relevant to patient anatomy and contexts of use with respect to insertion, access and
movement within the abdominal cavity, visualization, manipulating tissue, cutting, and suturing as needed during a simulated ventral
hernia repair procedure. Animal studies will be used primarily to demonstrate performance, safety, effectiveness, and usability of
the system as relevant to a live model with respect to insertion, access and movement within the abdominal cavity, visualization,
manipulating tissue, cutting, coagulating, and suturing, during a simulated ventral hernia repair procedure. This testing may also
be used to demonstrate that applicable risk mitigation features, including software alarms, alerts, extraction of multi-jointed
instrumentation in case of system failure, misuse, or other errors are adequate and perform to specifications. Summative usability
testing will be conducted by surgeons, nurses and technicians in a simulated operating room environment to provide objective
evidence that the Vicarious Surgical System can be used safely and effectively by end users for its intended uses, the device
functions as expected and intended, and all risk mitigations implemented are safe and effective. In addition, we plan to conduct
simulated bench-top testing on transparent anatomical models to evaluate, among other things, how the Vicarious Surgical System
performs in “worst case” scenarios to verify and validate safe anatomical access, instrument/camera angulation and
movement at the extremes of various surgical procedures with respect to patient anatomy and dimensions that cannot be readily
controlled for when using live animal and human cadaver models.
Future Indications
We plan to expand upon our claims and/or indication
for use to address additional unmet clinical needs in different anatomical areas as well as therapeutic procedures. Following the initial
authorization for use in ventral hernia repair procedures under a De Novo classification, if obtained by the FDA, we plan to submit 510(k)
premarket notifications for other indications for use, using the Vicarious Surgical System’s first De Novo authorization as a predicate,
along with other predicate devices with similar cleared indications for use. We may also include a predetermined change control plan in
our De Novo classification, or future premarket notification submissions, which if authorized by the FDA, would allow us to implement
the modifications to the Vicarious Surgical System described in the plan without submitting a new application for marketing authorization.
We have identified several potential future indications and procedures that align well with the Vicarious Surgical System’s ability
to access and visualize the abdominal cavity. Possible future indications may include but not be limited to inguinal and hiatal hernias,
hysterectomy, cholecystectomy (gallbladder), colorectal and other gastrointestinal procedures. We will perform an assessment to determine
the appropriate regulatory strategy required to expand claims and obtain applicable regulatory clearances in the United States and in
other global markets.
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Intellectual Property
We strive to protect and enhance the proprietary
technology, inventions and improvements that are important to our business by seeking, maintaining and defending our intellectual property,
all of which has been developed internally and not in-licensed from third parties. We also rely on trade secrets, know-how, continuing
technological innovation and in-licensing opportunities to develop, strengthen and maintain our proprietary position in the field of surgical
robotics. Additionally, we intend to rely on regulatory protection afforded through data exclusivity and market exclusivity as well as
patent term extensions, where available.
We currently do not rely heavily on technologies
from third parties. However, in the future, we may need to rely or be dependent on patented or proprietary technologies that we may license
from third parties.
We maintain a patent portfolio that includes
issued U.S. and foreign patents as well as pending U.S. and foreign patent applications, which include claims directed towards
our proprietary technology. We intend to pursue additional intellectual property protection to the extent we believe it would be beneficial
and cost-effective. As of February 9, 2026, we owned approximately twenty (20) issued U.S. utility patents, one (1) issues U.S.
design patent and approximately thirty-one (31) issued utility patents in foreign jurisdictions, including one (1) in Canada, five
(5) in China, eleven (11) in Japan, and thirteen (13) in European jurisdictions, and three (3) Hong Kong patents. We also had
approximately 115 pending utility patent applications in the U.S. and foreign jurisdictions, including in Canada, China, Europe,
Japan, and Hong Kong. These issued utility patents and pending utility patent applications (if they were to issue as patents) have expected
expiration dates ranging between 2039 and 2045. Our patents and patent applications are directed to, among other things, our core technology.
This includes the surgical robotic and camera system; sensing capabilities, controls and visualization interfaces; the surgical tools
suite; and related technologies.
The term of individual patents may vary based
on the countries in which they are obtained. Generally, patents issued for applications filed in the United States are effective
for 20 years from the earliest effective non-provisional filing date. In addition, in certain instances, a patent term can be extended
to recapture a portion of the term effectively lost as a result of the FDA regulatory review period. The restoration period cannot be
longer than five years and the total patent term, including the restoration period, must not exceed 14 years following FDA approval.
The duration of patents outside of the United States varies in accordance with provisions of applicable local law, but typically
is also 20 years from the earliest effective filing date.
In addition to patents and patent applications,
we rely on trade secrets and know-how to develop and maintain our competitive position. However, trade secrets can be difficult to protect.
We seek to protect our proprietary technology and processes, and obtain and maintain ownership of certain technologies, in part, through
confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and commercial
partners. We also seek to preserve the integrity and confidentiality of our data, trade secrets and know-how, including by implementing
measures intended to maintain the physical security of our premises and the physical and electronic security of our information technology
systems.
Our future commercial success depends, in
part, on our ability to obtain and maintain patent and other proprietary protection for commercially important technology, inventions
and know-how related to our business; defend and enforce our patents; preserve the confidentiality of our trade secrets; and operate without
infringing the valid enforceable patents and proprietary rights of third parties. Our ability to stop third parties from making, using,
selling, offering to sell or importing our product candidates will depend on the extent to which we have rights under valid and enforceable
patents or trade secrets that cover these activities. Moreover, we may be unable to obtain patent protection for the Vicarious Surgical
System generally, as well as with respect to certain surgical indications. See the section entitled “Risk Factors — Risks
Related to Our Intellectual Property” for a more comprehensive description of risks related to our intellectual property.
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Research and Development
Our research and development programs are
generally pursued by our engineering, scientific and technical personnel employed by us in our offices in Massachusetts on a full-time
basis or as consultants, or through partnerships with industry leaders in manufacturing and design and with researchers in academia. We
are also working with subcontractors in developing specific components of our technologies.
The primary objectives of our research and
development efforts are to continue to introduce incremental enhancements to the capabilities of the Vicarious Surgical System and to
advance development.
For the fiscal years ended December 31,
2025 and 2024, we incurred research and development expenses of $33.6 million and $40.2 million, respectively.
Manufacturing
We have manufacturing capabilities within
our headquarters in Waltham, Massachusetts. We currently rely and expect to expand on third parties for the manufacturing of certain products
for preclinical and clinical testing, as well as for commercial manufacturing.
We purchase both custom and off-the-shelf
components from a large number of suppliers and subject them to stringent quality specifications and processes. Some of the components
necessary for the assembly of the Vicarious Surgical System are currently provided to us by sole-sourced suppliers or single-sourced suppliers.
We are committed to developing an ethical,
safe and sustainable supply chain. This extends to our supplier base as well, so we are seeking partnerships with suppliers who share
our commitment to strong ethics and full compliance with all applicable laws.
We promote the following basic principles
in our supply chain:
●Business practices that respect human rights that align with
international standards of responsible business conduct;
●Compliance with conflict mineral laws;
●Business integrity;
●Environmental responsibility and sustainability;
●Protection of confidential information.
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Competition
We face competition in the forms of existing
open surgery, conventional minimally invasive surgery, drug therapies, radiation treatment, and emerging interventional surgical approaches.
Our success depends on continued clinical and technical innovation, quality and reliability, as well as educating hospitals, surgeons,
and patients on the results associated with robotic-assisted surgery using the Vicarious Surgical System and our value proposition relative
to other techniques. We also face competition from several companies that have introduced or are developing new approaches and products
for the minimally invasive surgery market. We believe that the entrance or emergence of competition validates robotic-assisted surgery.
We face competition from larger and well-established
companies. The companies that have introduced products in the field of robotic-assisted surgery or have made explicit statements about
their efforts to enter the field, include, but are not limited to: Intuitive Surgical, Inc.; Johnson & Johnson (including their
wholly-owned subsidiaries Ethicon Endo-Surgery, Inc., Auris Health, Inc. and Verb Surgical Inc.); Medtronic plc (including their wholly-owned
subsidiary Covidien LP); Virtual Incision Corporation; Stryker Corporation; and CMR Surgical Ltd. Other companies with substantial
experience in industrial robotics could potentially expand into the field of surgical robotics and become a competitor. In addition, research
efforts utilizing computers and robotics in surgery are underway at various companies and research institutions. Our ability to generate
future revenue may be adversely impacted as competitors announce their intent to enter these markets and as our potential customers anticipate
the availability of competing products.
Commercialization
We have not yet established a sales or product
distribution infrastructure for the Vicarious Surgical System. We plan to access the U.S. market with the Vicarious Surgical System
through strategic partnerships and also develop our own focused, specialized sales force or distribution channels once we have commercialized
the Vicarious Surgical System.
Government Regulation
Our operations are subject to comprehensive
federal, state, and local laws and regulations in the jurisdictions in which we or our research and development partners or affiliates
do business. The laws and regulations governing our business and interpretations of those laws and regulations are subject to frequent
change. Our ability to operate profitably will depend in part upon our ability, and that of our research and development partners and
affiliates, to operate in compliance with applicable laws and regulations. The laws and regulations relating to medical products and healthcare
services that apply to our business and that of our partners and affiliates continue to evolve, and we must, therefore, devote significant
resources to monitoring developments in legislation, enforcement, and regulation in such areas. As the applicable laws and regulations
change, we are likely to make conforming modifications in our business processes from time to time. We cannot provide assurance that a
review of our business by courts or regulatory authorities will not result in determinations that could adversely affect our operations
or that the regulatory environment will not change in a way that restricts our operations.
FDA Regulation
Medical devices are strictly regulated
by the FDA in the United States. Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), a medical device is defined as
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,
including a component, part or accessory which is, among other things: intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or intended to affect the
structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through
chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement
of any of its primary intended purposes.” This definition provides a clear distinction between a medical device and other FDA
regulated products such as drugs. If the primary intended use of a medical product is achieved through chemical action or by being
metabolized by the body, the product is usually a drug or biologic. If not, it is generally a medical device.
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We are currently developing a robotic-assisted
surgical system, which is regulated by the FDA as a medical device under the FDCA, as implemented and enforced by the FDA. The FDA regulates,
among other things, the development, testing, manufacturing, labeling, packaging, storage, installation, servicing, advertising, promotion,
marketing, distribution, import, export, and post-market surveillance of medical devices. The Vicarious Surgical System is not yet authorized
for commercialization in the United States.
Device Premarket Regulatory Requirements
Before being introduced into the U.S. market,
each medical device must obtain marketing clearance, authorization, or approval from the FDA through the premarket notification (510(k))
process, the De Novo classification process, or the premarket approval (“PMA”) process, unless they are determined to be exempt
from premarket review by the FDA. Under the FDCA, medical devices are classified into one of three classes — Class I, Class II or
Class III — depending on the degree of risk associated with each medical device and the extent of control needed to provide reasonable
assurance of safety and effectiveness. Classification of a device is important because the class to which a device is assigned determines,
in part, among other things, the necessity and type of FDA review required prior to marketing the device. Class I devices are those for
which reasonable assurance of safety and effectiveness can be maintained through adherence to general controls that include compliance
with the applicable portions of the FDA’s Quality Management System Regulation (“QMSR”), as well as regulations requiring
establishment registration and device listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling
and promotional materials.
Class II devices are those for which general
controls alone are insufficient to provide reasonable assurance of safety and effectiveness and there is sufficient information to establish
“special controls.” These special controls can include performance standards, post-market surveillance requirements, patient
registries and FDA guidance documents describing device-specific special controls. While most Class I devices are exempt from the 510(k)
premarket notification requirement, most Class II devices require a clearance of a 510(k) premarket notification prior to commercialization
in the United States; however, the FDA has the authority to exempt Class II devices from the premarket notification requirement under
certain circumstances. As a result, manufacturers of most Class II devices must submit 510(k) premarket notifications to the FDA in order
to obtain the necessary clearance to market or commercially distribute such devices. To obtain 510(k) clearance, manufacturers must submit
to the FDA adequate information demonstrating that the proposed device is “substantially equivalent” to a “predicate
device” that is already on the market. A predicate device is a legally marketed device that is not subject to PMA, meaning, (i)
a device that was legally marketed prior to May 28, 1976 (“preamendments device”) and for which a PMA is not required, (ii)
a device that has been reclassified from Class III to Class II or I, or (iii) a device that was found substantially equivalent through
the 510(k) process. If the FDA agrees that the device is substantially equivalent to the predicate device identified by the applicant
in a premarket notification submission, the FDA will grant 510(k) clearance for the new device, permitting the applicant to commercialize
the device. Premarket notifications are subject to user fees, unless a specific exemption applies.
After a medical device receives 510(k) clearance,
any modification that could significantly affect the device’s safety or effectiveness, or that would constitute a major change in
its intended use, requires a new 510(k) submission or could require a De Novo classification request or PMA application. The FDA requires
each manufacturer to make the determination of whether a device modification requires a new 510(k), De Novo, or PMA in the first instance,
but the FDA may review any such decision. If the FDA disagrees with a manufacturer’s decision not to seek a new 510(k) clearance,
De Novo authorization, or PMA for a particular change, the FDA may retroactively require the manufacturer to submit a 510(k), De Novo,
or PMA application. The FDA may also require the manufacturer to cease its marketing activities for the modified device in the United
States and/or recall the device until the appropriate marketing authorization for the modification is obtained.
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If there is no adequate predicate to which
a manufacturer can compare its proposed device, the proposed device is automatically classified as a Class III device. In such cases,
a device manufacturer must then fulfill the more rigorous PMA requirements or can request a risk-based classification determination for
its device in accordance with the De Novo classification process.
Devices that are intended to be life sustaining
or life supporting, devices that are implantable, devices that present a potential unreasonable risk of harm or are of substantial importance
in preventing impairment of health, and devices that are not substantially equivalent to a predicate device and for which safety and effectiveness
cannot be assured solely by the general controls and special controls are placed in Class III. Such devices generally require FDA approval
through the PMA process, unless the device is a novel or preamendments device not yet subject to a regulation requiring premarket approval.
The PMA process is more demanding than the 510(k) process. For a PMA, the manufacturer must demonstrate through extensive data, including
data from preclinical studies and one or more clinical trials, that there is a reasonable assurance that the device is safe and effective
for its proposed indication. The PMA application must also contain a full description of the device and its components, a full description
of the methods, facilities and controls used for manufacturing, and proposed labeling. Following receipt of a PMA submission, the FDA
determines whether the application is sufficiently complete to permit a substantive review. If the FDA accepts the application for review,
it has 180 days under the FDCA to complete its review and determine whether the proposed device can be approved for commercialization,
although in practice, PMA submission reviews often take significantly longer, and it can take up to several years for the FDA to issue
a final decision. Before granting a PMA, the FDA generally also performs an on-site inspection of manufacturing facilities for the product
to ensure compliance with the QMSR.
The FDA may refer any PMA application, including
applications for novel device candidates or device candidates that present difficult questions of safety or effectiveness, to an advisory
committee for review. Typically, an advisory committee is a panel of independent experts, including clinicians and other scientific experts,
that reviews, evaluates and provides a recommendation as to whether the application should be approved and, if so, under what conditions.
The FDA is not bound by the recommendation of an advisory committee, but it considers such recommendations when making final decisions
on approval.
If the FDA’s evaluation of the PMA application
and inspection of the manufacturing facility is favorable, the FDA may issue an approval order authorizing commercial marketing of the
device, or an “approvable letter,” which usually contains a number of conditions that must be met in order to secure final
approval of the PMA. When and if those conditions have been met to the satisfaction of the FDA, the agency will issue a PMA approval order,
subject to the conditions of approval and the limitations established in the approval order. If the FDA’s evaluation of a PMA application
or manufacturing facility is not favorable, the FDA will deny approval of the PMA or issue a “not approvable letter.” The
FDA may also determine that additional studies are necessary, in which case the PMA may be delayed for several months or years while such
additional studies are conducted and data is submitted in an amendment to the PMA. The PMA process can be expensive, uncertain and lengthy,
and each PMA submission is subject to a substantial user fee unless a specific exemption applies. The FDA may also grant a PMA subject
to post-approval requirements, such as the need for additional patient follow-up or requirements to conduct additional clinical trials.
New PMA applications or PMA supplements may
be required for any modifications to the manufacturing process, labeling, device specifications, materials or design of a device that
is approved through the PMA process. PMA supplements often require submission of the same type of information as an initial PMA application,
except that the supplements are limited to information needed to support any changes from the device covered by the approved PMA application
and may or may not require as extensive clinical data or the convening of an advisory committee.
The De Novo classification process
allows a manufacturer whose novel device is automatically classified into Class III to request down-classification of its device to
Class I or Class II, on the basis that the device presents low or moderate risk, as an alternative to following the typical Class
III device pathway requiring the submission and approval of a PMA application. Under the Food and Drug Administration Safety and
Innovation Act of 2012, the FDA is required to classify a device within 120 days following receipt of the De Novo classification
request from an applicant; however, the most recent FDA premarket review goals state that the agency will attempt to issue a
decision within 150 days of receipt on 70% of all De Novo classification requests received during each fiscal year. If the
manufacturer seeks reclassification into Class II, the classification request must include a draft proposal for special controls
that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device. The FDA may reject the
classification request if it identifies a legally marketed predicate device that would be appropriate for a 510(k) notification or
determines that the device is not low to moderate risk or that general controls would be inadequate to control the risks and special
controls cannot be developed. If a De Novo classification request results in the classification of the novel device into Class II,
the device may be used as a predicate for future 510(k) premarket notifications for other similar devices with the same intended
uses. De Novo classification requests are subject to user fees, unless a specific exemption applies.
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As with the 510(k) premarket notification
process described above, any modification to a device authorized through the De Novo process that could significantly affect the safety
or effectiveness of such device, or that would constitute a major change in its intended use, requires a new 510(k) clearance or could
require the submission of a new De Novo classification request or PMA application.
Predetermined Change Control Plans for
Medical Devices
As part of the Consolidated Appropriations
Act for 2023, Congress amended the FDCA to give FDA the authority to authorize certain potential, future changes to a medical device in
a predetermined change control plan (“PCCP”) as part of a PMA application or 510(k) premarket notification for a medical device,
including a device that incorporates artificial intelligence or machine learning technology. In practice, FDA will also allow for inclusion
of a PCCP in a De Novo. A PCCP must describe the specific proposed modifications and provide sufficient information to demonstrate that
the device will remain safe and effective for its intended use, and in the case of a 510(k) cleared device that the device will remain
substantially equivalent to the predicate device, if the applicant implements the proposed modifications to the device as described in
the PCCP. If FDA authorizes a PCCP for a device, any modification to the device within the authorized scope of the PCCP will not require
the submission and authorization of a new PMA application, PMA supplement, or new 510(k) premarket notification. However, modifications
to a previously authorized PCCP will generally require submission of a PMA supplement or new 510(k) premarket notification, depending
on the original authorization pathway for the device, with the modified PCCP.
Medical Device Clinical Studies
Clinical trials are almost always required
to support PMAs and are sometimes required to support 510(k) and De Novo classification submissions. All clinical investigations of devices
to determine safety and effectiveness must be conducted in accordance with the FDA’s IDE regulations that govern investigational
device labeling, prohibit promotion of investigational devices, and specify recordkeeping, reporting and monitoring responsibilities of
study sponsors and study investigators. If the device presents a “significant risk,” as defined by the FDA, the FDA requires
the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials. The
IDE will automatically become effective 30 days after receipt by the FDA, unless the FDA denies the application or notifies us that the
investigation is on hold and may not begin until the sponsor provides supplemental information about the investigation that satisfies
the FDA’s concerns. If the FDA determines that there are deficiencies or other concerns with an IDE that require modification of
the study, the FDA may permit a clinical trial to proceed under a conditional approval. In addition, the study must be approved by, and
conducted under the oversight of, an institutional review board (or IRB) for each clinical site. If the device presents a non-significant
risk to the patient according to criteria established by the FDA as part of the IDE regulations, a sponsor may begin the clinical trial
after obtaining approval for the trial by one or more IRBs without separate authorization from the FDA, but must still comply with abbreviated
IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping
requirements.
As part of its clinical trial oversight
responsibilities, an IRB must review and approve, among other things, the trial protocol and informed consent information to be
provided to clinical trial subjects. An IRB must operate in compliance with FDA regulations. Information about certain clinical
studies, including details of the protocol and eventually trial results, also must be submitted within specific timeframes to the
National Institutes of Health (“NIH”) for public dissemination on the clinicaltrials.gov data registry. Information
related to the product, patient population, phase of investigation, trial sites and other aspects of the clinical trial are made
public as part of the trial registration. Sponsors are also obligated to disclose the results of their clinical studies after
completion. Disclosure of the results of these studies can be delayed in some cases for up to two years after the date of completion
of the trial. Failure to timely register a covered clinical study or to submit study results as provided for in the law can give
rise to civil monetary penalties and also prevent the non-compliant party from receiving future grant funds from the federal
government. The NIH Final Rule on clinicaltrials.gov registration and reporting requirements became effective in 2017, and the
government has brought enforcement actions against non-compliant clinical trial sponsors.
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Progress reports detailing the results of
the clinical studies must be submitted at least annually to the FDA and more frequently if unanticipated serious adverse events (“SAEs”)
occur. The FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research
subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical
trial at its institution if the clinical trial is not being conducted in accordance with the clinical protocol, GCP, or other IRB requirements
or if the investigational product has been associated with unexpected serious harm to patients.
In the Consolidated Appropriations Act for
2023, Congress amended the FDCA to require the sponsor of any pivotal clinical trial that will be used to demonstrate the safety and effectiveness
of a medical device marketing authorization submission to develop a diversity action plan for such trial, and if submission of an IDE
application is required, to submit such diversity action plan to the FDA. The action plan must include the sponsor’s diversity goals
for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them. The FDA may grant a waiver for
some or all of the requirements for a diversity action plan. It is unknown at this time how the diversity action plan may affect device
pivotal clinical trial planning and timing, but if FDA objects to a sponsor’s diversity action plan and requires the sponsor to
amend the plan or take other actions, it may delay trial initiation.
Post-Marketing Restrictions and Enforcement
After a device is placed on the market, numerous
regulatory requirements apply. These include, but are not limited to:
●submitting and updating establishment registration and device
listings with the FDA;
●compliance with the QMSR, which requires manufacturers to
follow stringent design, testing, risk management, control, documentation, record maintenance, including maintenance of complaint and
related investigation files, and other quality assurance controls during the manufacturing process;
●unannounced routine or for-cause device facility inspections
by the FDA, which may include our suppliers’ facilities;
●labeling regulations, which, among other things, prohibit
the promotion of products for uncleared, unauthorized, or unapproved (or “off-label”) uses and impose other restrictions
relating to promotional activities;
●corrections and removal reporting regulations, which require
that manufacturers report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy
a violation of the FDCA that may present a risk to health; and
●post-market surveillance regulations, which apply to certain
Class II or III devices when necessary to protect the public health or to provide additional safety and effectiveness data
for the device.
In addition, under the FDA medical device
reporting (“MDR”) regulations, medical device manufacturers and importers are required to report to the FDA and/or the manufacturer
information that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would
likely cause or contribute to death or serious injury if the malfunction of the device or a similar device of such manufacturer were to
recur. The decision to file an MDR involves a judgment by the manufacturer or importer. If the FDA disagrees with the manufacturer or
importer’s determination, the FDA can take enforcement action.
The medical device reporting requirements
also extend to health-care facilities that use medical devices in providing care to patients, or “device user facilities,”
which include hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, or outpatient treatment facilities,
but not physician offices. A device user facility must report any death caused or contributed to by a device to both the FDA and the device
manufacturer, or any serious injury caused or contributed to by a device to the manufacturer (or, if the manufacturer is unknown, to the
FDA) within 10 days of the event. Device user facilities are not required to report device malfunctions that would likely cause or contribute
to death or serious injury if the malfunction were to recur but may voluntarily report such malfunctions through MedWatch, the FDA’s
Safety Information and Adverse Event Reporting Program.
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The FDA also has the authority to require
the recall of commercialized medical device products. The authority to require a recall must be based on an FDA finding that there is
a reasonable probability that the device would cause serious adverse health consequences or death. Manufacturers may, under their own
initiative, recall a product if any distributed devices fail to meet established specifications, are otherwise misbranded or adulterated
under the FDCA, or if any other material deficiency is found. The FDA requires that certain classifications of recalls be reported to
the FDA within ten working days after the recall is initiated.
The failure to comply with applicable regulatory
requirements can result in enforcement action by the FDA, which may include any of the following sanctions:
●warning letters, fines, injunctions or civil penalties;
●recalls, detentions or seizures of products;
●operating restrictions;
●delays in the introduction of products into the market;
●total or partial suspension of production;
●delay or refusal of the FDA or other regulators to grant 510(k)
clearance, De Novo authorization, PMA approvals, or other marketing authorization to new products;
●withdrawals of marketing authorizations, clearances, or approvals;
or
●in the most serious cases, criminal prosecution.
To ensure compliance with regulatory requirements,
medical device manufacturers are subject to market surveillance and periodic, announced and unannounced inspections by the FDA, and these
inspections may include the manufacturing facilities of subcontractors.
Breakthrough Device Designation and
the Safer Technologies Program
The 21st Century Cures Act,
which was signed into law on December 13, 2016, established and directed FDA to implement the Breakthrough Devices Program. Under
the program, device manufacturers may voluntarily request breakthrough designation for devices that provide for more effective treatment
or diagnosis of life-threatening or irreversibly debilitating human disease or conditions over currently available technology and that
meet at least one of the following criteria:
●The device represents breakthrough technology;
●There are no approved or cleared alternatives for the device;
●The device offers significant advantages over existing approved
or cleared alternatives; or
●Availability of the device is in the best interest of patients.
The goal of the Breakthrough Devices Program
is to accelerate the timeline to market for novel devices that will likely provide a benefit to patients. A Breakthrough Device designation
offers multiple benefits to the device manufacturer, including priority review of the pre-market submission for the device, opportunities
to interact directly with FDA’s experts throughout the process, and engagement of FDA senior management, to the extent permitted
by the FDA’s resources.
In November 2019, the FDA granted Breakthrough
Device designation to a prior prototype version of the Vicarious Surgical System for a proposed indication for use in ventral hernia repair
procedures. We anticipate that after FDA authorization, the Vicarious Surgical System will be classified as a Class II medical device.
We have held multiple pre-submission meetings with the FDA to align on our regulatory strategy and currently plan to pursue a De Novo
classification request with the FDA for use in ventral hernia procedures as our initial indication.
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A preliminary meeting with the FDA was
conducted in December 2021 to discuss with the FDA our decision to make two technology changes to the Vicarious Surgical System
design that was granted Breakthrough Device designation in November 2019. Based on these changes, the FDA has determined that the
current Vicarious Surgical System design that is planned for the initial limited launch and was submitted to the FDA in the November
2021 FDA pre-submission meeting request is different from the device that was granted Breakthrough Device designation for the device
design filed in November 2019. The FDA stated that the Breakthrough Device designation remains active for the prior device design
granted Breakthrough Device designation in November 2019. In the future, we may attempt to reincorporate the technologies from such
prior device design to leverage the previously granted Breakthrough Device designation. The process of medical device development is
inherently uncertain and there is no guarantee that a Breakthrough Device designation will be granted to a different device design,
and if it were granted, there is no guarantee that such designation will accelerate the timeline for authorization or make it more
likely that the Vicarious Surgical System will be authorized.
Devices that may significantly improve the
safety of currently available medical products that target a disease or condition, but the morbidities or mortalities associated
with the disease or condition are less serious than those eligible for Breakthrough Device designation, may be eligible for the STeP Program.
The goal of acceptance into the STeP Program is to provide opportunities to interact with FDA experts, as resources permit, through various
program options to address design and development issues efficiently. In February 2024, we submitted a STeP Program application to the
FDA, and the agency subsequently accepted Vicarious Surgical’s robotic system into the program.
Federal Trade Commission Regulatory
Oversight
Our advertising for our products and services
is subject to federal truth-in-advertising laws enforced by the Federal Trade Commission (“FTC”), as well as comparable state
consumer protection laws. Under the Federal Trade Commission Act (the “FTC Act”), the FTC is empowered, among other things,
to (a) prevent unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce; (b) seek monetary redress
and other relief for conduct injurious to consumers; and (c) gather and compile information and conduct investigations relating to the
organization, business, practices, and management of entities engaged in commerce. The FTC has very broad enforcement authority, and failure
to abide by the substantive requirements of the FTC Act and other consumer protection laws can result in administrative or judicial penalties,
including civil penalties, injunctions affecting the manner in which we would be able to market services or products in the future, or
criminal prosecution.
Healthcare Law and Regulation
If the Vicarious Surgical System or our other
product candidates are authorized in the United States, we will have to comply with various U.S. federal and state laws, rules
and regulations pertaining to healthcare fraud and abuse, including anti-kickback laws and physician self-referral laws, rules and regulations.
Violations of the fraud and abuse laws are punishable by criminal and civil sanctions, including, in some instances, exclusion from participation
in federal and state healthcare programs, including Medicare and Medicaid. These laws include the following:
●the federal Anti-Kickback Statute prohibits, among other things,
persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in
kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service,
for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid;
●the federal False Claims Act imposes civil penalties, and
provides for civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented,
to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal
an obligation to pay money to the federal government;
●the federal Health Insurance Portability and Accountability
Act of 1996 (“HIPAA”), imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit
program or making false statements relating to healthcare matters;
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●HIPAA, as amended by the Health Information Technology for
Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with
respect to safeguarding the privacy, security and transmission of individually identifiable health information;
●the federal false statements statute prohibits knowingly and
willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery
of or payment for healthcare benefits, items or services;
●the federal transparency requirements under the Physician
Payments Sunshine Act require manufacturers of FDA-cleared, authorized, or approved drugs, devices, biologics and medical supplies covered
by Medicare or Medicaid to report, on an annual basis, to the Department of Health and Human Services information related to payments
and other transfers of value to physicians, teaching hospitals, and certain advanced non-physician health-care practitioners and physician
ownership and investment interests; and
●analogous state and foreign laws and regulations, such as
state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services
reimbursed by nongovernmental third-party payors, including private insurers.
Some state laws require pharmaceutical or
medical device companies to comply with the relevant industry’s voluntary compliance guidelines and the relevant compliance guidance
promulgated by the federal government in addition to requiring drug and device manufacturers to report information related to payments
to physicians and other health-care providers or marketing expenditures.
State and foreign laws also govern the privacy
and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted
by HIPAA, thus complicating compliance efforts. We also may be subject to, or may in the future become subject to, U.S. federal and
state, and foreign laws and regulations imposing obligations on how we collect, use, disclose, store and process personal information.
Our actual or perceived failure to comply with such obligations could result in liability or reputational harm and could harm our business.
Ensuring compliance with such laws could also impair our efforts to maintain and expand our customer base and thereby decrease our future
revenues.
Third-Party Coverage and Reimbursement
In the United States, third-party payors,
including government health programs such as Medicare and Medicaid, commercial health insurers and managed care organizations, are responsible
for hospital and surgeon reimbursement for covered surgical procedures. Third-party payors generally reimburse hospitals and physicians
for surgery when the procedure is considered medically necessary. The Centers for Medicare and Medicaid Services, or CMS, manages the
Medicare program and administers the Medicaid program in conjunction with applicable state governments. Many commercial health insurers
model their reimbursement methodologies after the Medicare program. As the single largest payor, the Medicare program has a significant
impact on other third-party payors’ payment systems.
Generally, reimbursement for professional
services performed at a facility by physicians is reported under billing codes issued by the American Medical Association, or AMA, known
as Current Procedural Terminology, or CPT, codes. Physician reimbursement under Medicare generally is based on a fee schedule and determined
by the relative value of the professional service rendered. In addition, CMS and the National Center for Health Statistics are jointly
responsible for overseeing changes and modifications to billing codes used by hospitals to report inpatient procedures, known as ICD-10-PCS
codes. Under the Medicare program, CMS generally reimburses hospitals for services provided during an inpatient stay based on a prospective
payment system that is determined by a classification system known as Medicare-Severity Diagnostic Related Groupings, or MS-DRGs. MS-DRGs
are assigned using a number of factors, including the principal diagnosis, major procedures, discharged status, patient age, and complicating
secondary diagnoses, among other things. Hospital outpatient services, reported by CPT codes, are assigned to clinically relevant Ambulatory
Payment Classifications used to determine the payment amount for services provided.
Since October 1, 2015, a new family of
ICD-10-PCS codes can be used, in conjunction with other applicable procedure codes, to describe various robotic-assisted procedures. An
inpatient surgical procedure, completed with or without robotic assistance, continues to be assigned to the clinically relevant MS-DRG.
Third-party payors carefully review and increasingly
challenge the prices charged for medical products and surgical services. Reimbursement rates from commercial health insurers vary depending
on the procedure performed, the specific payor’s reimbursement policies, contract terms, and other factors. Because both hospitals
and physicians may receive the same reimbursement for a surgical procedure, whether it is performed with robotic assistance or not and
regardless of actual costs incurred in furnishing the patient care, including for the specific medical products or supplies used during
that procedure, hospitals and physicians may decide not to use our products if reimbursement amounts are insufficient to cover any additional
costs incurred when purchasing and using our products.
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For procedures that would involve assistance
from our robotic-assisted surgical system, U.S. health-care institutions typically bill various third-party payors, such as government
health programs (e.g., Medicare and Medicaid) and commercial health insurance plans, for the primary surgical procedure only. If our robotic-assisted
surgical system receives marketing authorization from the FDA, coverage and reimbursement by third-party payors will generally be determined
by the medical necessity of the primary surgical procedure. Government health programs and other third-party payors may also consider
additional factors when determining coverage and reimbursement, including the designation of the surgical procedure as a covered benefit,
the appropriateness of the procedure for the specific patient, guidelines for the procedure established by the relevant professional college
or medical society, and a payor determination that the procedure is neither experimental nor investigational. We believe that the procedures
we intend to pursue as indications for use for our robotic-assisted surgical system are established surgical procedures that are generally
already reimbursable by government health programs, commercial health insurers, and managed care organizations for appropriately selected
patients. If hospitals do not obtain sufficient reimbursement from third-party payors for procedures performed with our products, or if
government and commercial payors’ policies do not cover surgical procedures performed using our products, we may not be able to
generate the revenues necessary to support our business.
The process for determining whether a third-party
payor will provide coverage for a product or procedure may be separate from the process for establishing the reimbursement rate that such
a payor will pay for the product or procedure. A payor’s decision to provide coverage for a product or procedure does not imply
that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a product or procedure
does not assure that other payors will also provide coverage. Adequate third-party reimbursement may not be available to enable us to
maintain price levels sufficient to ensure profitability.
Healthcare Reform
The FDA’s and other regulatory authorities’
policies may change and future legislative and regulatory proposals may prevent, limit or delay regulatory authorization of our product
candidates or, more broadly, may materially impact the ability of the FDA and other regulatory agencies to operate as they have historically
operated. We cannot be sure whether additional legislative changes will be enacted, or whether any of the FDA’s regulations, guidances
or interpretations will be changed, or what the impact of such changes on the agency and its scientific review staff, if any, may be.
For example, the next FDA user fee reauthorization package entered stakeholder negotiations beginning in mid-2025, with any agreement
expected to be sent to Congress in early 2027 for purposes of initiating the legislative process. Reauthorization of the prescription
drug user fee program would need to be finalized by Congress by the end of September 2027 in order to avoid a disruption in FDA’s
review goals for 510(k), De Novo classification and PMA submissions and other activities supported by user fees assessed against industry.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not
able to maintain regulatory compliance, we may lose any marketing authorization that we otherwise may have obtained, and we may not achieve
or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.
In December 2022, the U.S. Congress enacted
the Consolidated Appropriations Act for 2023, an omnibus appropriations bill, which included amendments to the FDCA under the Food and
Drug Omnibus Reform Act of 2022 (“FDORA”). In addition to the requirement that sponsors of pivotal trials submit diversity
action plans for pivotal trials (see “—Government Regulation-Regulatory Landscape in the United States-Device Clinical
Studies”), FDORA included new requirements for cyber devices, defined as any medical device that is or includes software that
is validated, installed, or authorized by the manufacturer; can connect to the internet; and may be vulnerable to cybersecurity threats.
Under the FDORA amendments to the FDCA, any application for marketing authorization of a cyber device must include a software bill of
materials and a cybersecurity plan describing the methods by which the manufacturer will monitor, identify and address cybersecurity vulnerabilities.
Any failure by a cyber device manufacturer to comply with applicable cybersecurity requirements is considered a violation of the FDCA
and will subject the manufacturer to enforcement actions and possibly legal sanctions.
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In the United States, there have been,
and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system. In March 2010, the
Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, (collectively,
the “ACA”) was signed into law and substantially changed the way healthcare is financed by both governmental and private
insurers in the United States. The ACA contains a number of provisions, including those governing enrollment in federal healthcare
programs, reimbursement adjustments and fraud and abuse changes. Additionally, the ACA provided incentives to programs that increase
the federal government’s comparative effectiveness research and implemented payment system reforms including a national pilot
program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and
efficiency of certain healthcare services through bundled payment models.
Legislative and regulatory changes under the
ACA remain possible, although it is unknown what form any such changes or any law would take, and how or whether it may affect the medical
device industry as a whole or our business in the future. We expect that changes or additions to the ACA, the Medicare and Medicaid programs
and changes stemming from other healthcare reform measures, especially with regard to healthcare access, financing or other legislation
in individual states, could have a material adverse effect on the healthcare industry in the United States.
Moreover, there has recently been heightened
governmental scrutiny, including increasing legislative and enforcement interest, over the manner in which manufacturers set prices for
their marketed healthcare products, which has resulted in several Congressional inquiries and proposed and enacted legislation designed,
among other things, to bring more transparency to healthcare product pricing, review the relationship between pricing and manufacturer
patient programs and reform government program reimbursement methodologies for healthcare products. Individual states in the United States
have also become increasingly active in implementing regulations designed to control healthcare product pricing, including price or patient
reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures.
We cannot predict the likelihood, nature or
extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States
or abroad. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit
the amounts that federal and state governments will pay for healthcare products and services. Moreover, if we are slow or unable to adapt
to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance,
our medical devices may lose any marketing authorization that may have been obtained and we may not achieve or sustain profitability,
which would adversely affect our business.
U.S. and Foreign Data Security and Data
Privacy Laws
HIPAA, as well as a number of other federal
and state privacy-related laws, extensively regulate the use and disclosure of individually identifiable health information, known as
“protected health information” or “PHI”.
HIPAA applies to health plans, healthcare
providers who engage in certain standard healthcare transactions electronically, such as electronic billing, and healthcare clearinghouses,
all of which are referred to as “covered entities” under HIPAA. State imposed health information privacy and security laws
typically apply based on licensure, for example, licensed providers or licensed entities are limited in their ability to use and share
health information.
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Additionally, all U.S. states have
enacted legislation protecting the privacy and security of “personal information”, such as identifiable financial or
health information, social security numbers, credit card information and other personally identifiable information. These laws
overlap and apply simultaneously with federal privacy and security requirements and regulated entities must comply with all of them.
The California Consumer Privacy Act (“CCPA”) went into effect January 1, 2020, and is one of the most restrictive state
privacy laws, protecting a wide variety of personal information and granting significant rights to California residents with respect
to their personal information. Regulations under CCPA have been modified several times, and continue to be modified. Additionally, a
new privacy law, the California Privacy Rights Act, (“CPRA”) was approved by California voters in the election of
November 3, 2020 and went into effect in January of 2023. The CPRA modified the CCPA significantly, and may result in further
uncertainty, additional costs and expenses stemming from efforts to comply with this law, and increases the potential for harm and
liability for failure to comply. Among other things, the CPRA established a new regulatory authority, the California Privacy
Protection Agency, which is enacting new regulations and has expanded enforcement authority. Other states in the U.S. are
considering privacy laws similar to CCPA. Colorado, Connecticut, Delaware, Florida, Indiana, Iowa, Montana, New Jersey, Oregon,
Tennessee, Texas Virginia, and Utah have enacted similar data protection laws to California and other U.S. states have proposals
under consideration, increasing our regulatory compliance risk. In dealing with health information for the development of our
technology or for commercial purposes, we will be indirectly affected by HIPAA and state-imposed health information privacy and
cybersecurity laws because these laws regulate the ability of our potential customers and research collaborators to share health
information with us. Additionally, we must identify and comply with all applicable state laws for the protection of personal
information with respect to personal information that we collect.
In the event we market outside of the United
States, we will be subject to foreign privacy and data security laws that vary by jurisdiction, differ from those in the United States,
and may require us to implement additional compliance measures or change our business practices related to the collection and use of personal
and patient data. For example, in the European Union (“EU”), we will be subject to the EU General Data Protection Regulation
(“GDPR”) that significantly regulates the possession, use, and disclosure of personal information. In particular, medical
or health data, genetic data and biometric data where the latter is used to uniquely identify an individual are all classified as “special
category” data under the GDPR and are afforded greater protection and require additional compliance obligations. Noncompliance could
result in the imposition of fines, penalties, or orders to stop noncompliant activities. We may be subject to GDPR if we undertake operations
or transact business in the EU, offer products or services to individuals in the EU or monitor the behavior of individuals within the
EU.
Disruptions to Information Technology
Systems and Cybersecurity Incidents
We rely, and will continue to rely on, information
technology systems to keep financial and employment records, facilitate our research and development initiatives, manage our operations,
maintain quality control, maintain corporate records, communicate with staff, provide our services and operate other critical functions.
Our information technology systems, and those of our vendors and partners, are potentially vulnerable to disruption due to breakdown,
malicious intrusion and computer viruses or other disruptive events, including, but not limited to, natural disasters and catastrophes.
Cyberattacks and other malicious internet-based activity continue to increase, and cloud-based platform providers of services have been
and are expected to continue to be targeted, especially in the health-care industry. Methods of attacks on information technology systems
and data security breaches change frequently, are increasingly complex and sophisticated, including deployment of harmful malware and
key loggers, ransomware, a malicious website, social engineering and phishing scams, and other means to affect the confidentiality, integrity
and availability of our technology systems and data, and can originate from a wide variety of sources. In addition to traditional computer
“hackers,” malicious code, such as viruses and worms, denial-of-service attacks and sophisticated nation-state and nation-state
supported actors present a constant threat, including advanced persistent threat intrusions. Cyberattacks may also be due to employee
error or malfeasance, power outages, hardware failures, telecommunication or utility failures, catastrophes or other unforeseen events,
and our system redundancy and other disaster recovery planning may be ineffective or inadequate in preventing or responding to any of
these circumstances. Techniques used in cybersecurity attacks to obtain unauthorized access, disable or sabotage information technology
systems are evolving rapidly with data breaches and other cybersecurity incidents becoming commonplace. We recognize the risk of cybersecurity
incidents and work to constantly evolve our incident response plans as the known threat vectors emerge. We vet and verify the cybersecurity
practices and compliance of our vendors to ensure they follow established guidelines, compliance requirements, and best practices related
to their industry. Internally, we utilize a cybersecurity maturity model based on the National Institute of Standards and Technology,
or NIST, standards to track and report on the current and future compliance and progress within the multiple areas of compliance and concern.
We intend to make steady measured improvements to our cybersecurity maturity along with investments in tools, and services that are aligned
with our growth and maturity. We intend to adhere to a baseline of best practices that include proper use of encryption of data and communications,
policies and procedures, and mitigation/validation practices that seek to ensure the approach is meeting or exceeding our commitment to
our plan. Despite our current or future efforts to protect against cybersecurity attacks and data security incidents, there is no guarantee
that our efforts are adequate to safeguard against all such attacks and incidents. Moreover, it is possible that we may not be able to
anticipate, detect, appropriately react and respond to, or implement effective preventative measures against, all cybersecurity incidents.
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Human Capital
As of March 9, 2026, we had 26 employees,
11 of whom were engaged directly in research, development, regulatory and clinical activities, 8 in manufacturing and quality assurance
and 7 in marketing, sales, and administrative activities.
Facilities
Our principal executive offices are currently
located at 78 Fourth Avenue, Waltham, Massachusetts 02451, consisting of approximately 42,000 square feet. On October 14, 2021, we entered
into a lease amendment pursuant to which we agreed to lease additional space consisting of approximately 30,000 square feet located at
62 Fourth Avenue Waltham, MA 02451. On October 17, 2025, we entered into a second lease amendment which eliminates the second building
at 62 Fourth Avenue commencing on December 23, 2025. The leased space at 78 Fourth Avenue will expire on March 31, 2032. We consider our
current office space adequate for our current operations.
Legal Proceedings
As of the date of this Annual Report on Form
10-K, to our knowledge, we are not party to and our property is not subject to any material pending legal proceedings. However, from time
to time, we may become involved in legal proceedings or subject to claims that arise in the ordinary course of our business activities.
Regardless of the outcome, such legal proceedings or claims could have an adverse impact on us because of defense and settlement costs,
diversion of management resources, negative publicity and reputational harm, and other factors.
NYSE Delisting Proceedings
On March 3, 2026, the NYSE notified us that
it had determined to (A) immediately suspend trading in our Class A common stock due to a determination that we had fallen below the NYSE’s
continued listing standard requiring listed companies to maintain an average global market capitalization over a consecutive 30 trading
day period of at least $15,000,000 pursuant to Section 802.01B of the NYSE Listed Company Manual, and (B) commence proceedings to delist
the Class A common stock. We will not appeal the delisting determination. The NYSE has indicated that it will apply to the Securities
and Exchange Commission to delist the Class A common stock by filing a Form 25.
We received approval of our application to
have the Class A common stock quoted on the OTCID market tier operated by OTC Markets. The Class A common stock commenced quotation on
the OTCID at the open of business on March 4, 2026 under the trading symbol of “RBOT.”
The OTCID is a significantly more limited
market than the NYSE, and quotation on any OTC market will result in a less liquid market for existing and potential holders of Class
A common stock to trade their shares and could further depress the trading price of the Class A common stock. We can provide no assurance
that the Class A common stock will continue to trade on this market, whether broker-dealers will provide and continue to provide public
quotes of the Class A common stock on this market, or whether the trading volume of the Class A common stock will be sufficient to provide
for an efficient trading market.
Information Available on the Internet
Our internet address is https://www.vicarioussurgical.com,
to which we regularly post copies of our press releases as well as additional information about us. We also maintain an Investor Relations
website as a routine channel for distribution of important information, including news releases, presentations, and financial statements
(https://investor.vicarioussurgical.com). We intend to use our Investor Relations website as a means of complying with our disclosure
obligations under Regulation FD. Accordingly, investors should monitor our Investor Relations website in addition to press releases, Securities
and Exchange Commission (the “SEC”) filings, and public conference calls and webcasts. Our annual reports on Form 10-K,
quarterly reports on Form 10-Q, current reports on Form 8-K, and all amendments to those reports, will be available to you free
of charge through the Investor Relations section of our website as soon as reasonably practicable after such materials have been electronically
filed with, or furnished to, the SEC. The SEC maintains an internet site (http://www.sec.gov) that contains reports, proxy and
information statements, and other information regarding issuers that file electronically with the SEC. We include our web site address
in this Annual Report on Form 10-K only as an inactive textual reference. Information contained in our website does not constitute a part
of this report or our other filings with the SEC.
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