NASDAQ: MOVE
Corvex, Inc.CIK 0001734750 · Computer Processing & Data Preparation
On March 19, 2026, we consummated and completed the Merger pursuant to the Merger Agreement, as further described below. Following the closing of the Merger, the Company will conduct its operations through two primary business divisions. Our AI cloud computing business specializes in… About this business →
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About Corvex, Inc.
Source: Item 1 (Business) from the 10-K filed March 31, 2026. Description as filed by the company with the SEC.
Item 1.
Business
Overview
On March 19, 2026, we consummated and completed the Merger pursuant
to the Merger Agreement, as further described below. Following the closing of the Merger, the Company will conduct its operations
through two primary business divisions. Our AI cloud computing business specializes in GPU-accelerated infrastructure for AI workloads
and our healthcare business consists of our wellness ring (formerly referred to as the Evie Ring) (the “Wellness Ring”), a
wearable designed specifically for women that was launched in November 2023.
The
descriptions of the two business divisions, their corresponding products, and business models
are detailed below.
Merger
On
March 19, 2026, Corvex, Inc. (formerly known as Movano Inc.), acquired Corvex Legacy Holdings, Inc. (formerly known as Corvex, Inc.)
(“Corvex OpCo”), in accordance with the terms of the Amended and Restated Agreement and Plan of Merger, dated March 19,
2026 (the “Merger Agreement”), by and among Corvex, Thor Merger Sub Inc., a Delaware corporation and a wholly-owned subsidiary
of the Company (“Merger Sub”), and Corvex OpCo. Pursuant to the Merger Agreement, Merger Sub merged with and into Corvex
OpCo, pursuant to which Corvex OpCo was the surviving corporation and became a wholly owned subsidiary of the Company (the “Merger”).
The Merger Agreement amended and restated in its entirety the prior merger agreement between the parties which was entered into and announced
on November 6, 2025.
Under the terms of the Merger Agreement, at the
closing of the Merger (the “Closing”), the Company issued to the prior securityholders of Corvex OpCo (i) 240.562 shares of
Series B Convertible Preferred Stock, par value $0.0001 per share (the “Series B Preferred Stock”), which such shares of Series
B Preferred Stock, on an as-converted basis, represented no more than 19.9% of the outstanding shares of the Company’s common stock,
par value $0.0001 per share (the “Common Stock” or the “common stock”) immediately prior to the Closing, (ii)
23,551.5195 shares of Series C Non-Voting Convertible Preferred Stock, par value $0.0001 per share (the “Series C Preferred Stock”)
and (iii) 30,227.0524 shares of Series D Non-Voting Convertible Preferred Stock, par value $0.0001 per share (the “Series D Preferred
Stock”).
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Each
share of Series B Preferred Stock will automatically convert into 1,000 shares of Common
Stock on March 31, 2026, which is one day following the March 30, 2026 record date
of the stock dividend payable to holders of the Company’s Common Stock and Series A
Preferred Stock pursuant to the Merger Agreement. Subject to and contingent upon the affirmative
vote of a majority of the shares of common stock present or represented and entitled to vote
at a meeting of stockholders of Company to approve, for purposes of the Nasdaq Listing Rules,
the issuance of shares of Common Stock to the stockholders of Corvex upon conversion, (1)
each share of Series C Preferred Stock will automatically convert into 1,000 shares of Common
Stock and (2) each share of Series D Preferred Stock will be convertible into 1,000 shares
of Common Stock.
1
AI Cloud Computing Business
Our engineering-led, AI computing platform
specializes in GPU-accelerated infrastructure for AI workloads. Our mission is to become the trusted infrastructure partner for AI
model training and inference.
Our
platform allows organizations to leverage the advantage of AI by providing secure, scalable, and cost-efficient computational resources.
Our infrastructure leverages advanced GPU-accelerated compute clusters, high-throughput storage systems and layered architecture
to provide enhanced security, consistent performance and efficiency at scale.
We provide a range of capabilities, including:
●
AI Factories and GPU Clusters. Our integrated computing and data-center platform is designed to deliver artificial intelligence workloads at scale by combining high-performance AI accelerators, networking, power, cooling, and systems software to support reliable and cost-efficient production AI training and inference. Deployments may be delivered using managed Kubernetes or as bare metal, and operated on-premise or in multi-tenant or single-tenant configurations that are compliant with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and SOC 2 Type II (“SOC 2”).
●
Confidential Computing. Confidential computing is designed to protect customers’ valuable intellectual property and enhance compliance with data security mandates. Our patent-pending Corvex Secure Model Weights product enables AI model builders and security-conscious enterprises to safely deploy inference workloads on third-party GPU infrastructure without exposing their model weights via the integration of Trusted Execution Environments, post-quantum key exchange, and remote attestation.
●Token Factory. Currently in
development, Token Factory is expected to provide access to premium open-source AI models through simplified API integration and a
performance-optimized inference engine operating on automatically scaling infrastructure. The platform is designed to improve
performance and reduce per-token inference costs relative to certain alternatives by leveraging a proprietary inference engine and custom orchestration logic intended to maximize compute resource
utilization when serving multiple models concurrently. We intend for Token Factory to achieve SOC 2 Type II certification and to support
HIPAA-compliant deployments.
Our capabilities are designed to capture the accelerating demand for
AI infrastructure driven by global digital transformation, the proliferation of AI applications and the increasing complexity of enterprise
workloads. Modern
AI models require far more compute, faster networking and more power than what general-purpose cloud infrastructures can support. Such
demand is accelerating the shift toward purpose-built AI infrastructure designed for high-density GPUs, fast interconnects and predictable
performance at scale. Our platform provides purpose-built solutions optimized for AI workloads focused on creating competitive differentiation
around performance, cost efficiency and flexibility as well as security and reliability.
2
Our
technology stack combines high-density GPU Clusters, fast networking, and software to deliver reliable model training and inference at
up to AI Factory scale, without customers having to build or operate the underlying infrastructure. The system is organized in layers
that handle hardware, orchestration, and certain security functions to enable more predictable performance, security and operational
control at scale.
The
infrastructure services layer provides the core hardware and facility environment needed
to operate high-density computing clusters. A core component of our infrastructure is our
GPU-accelerated compute clusters, which are optimized for both training and inference of
AI models. These clusters leverage the latest generation of GPUs, including NVIDIA’s
B200 GPU, and are often interconnected through high-bandwidth, low-latency networking to
ensure optimal performance for distributed workloads. High-bandwidth networking is engineered
to move data quickly between nodes, which keeps distributed training efficient. In addition
to compute services, we provide high-throughput storage solutions positioned close to compute
in order to reduce delays during data loading, checkpointing and model serving. These capabilities
are important for organizations engaged in training large language models, conducting real-time
analytics or processing high-resolution imaging data. Further, our current tier III-designed
facility provides redundant power, cooling, and other forms of resiliency to support reliable
AI workloads.
The
managed software services layer handles how jobs work on the hardware and gives customers flexibility in how they use the platform. Our
technology platform supports bare metal and managed Kubernetes, allowing clients to manage complex workloads with flexibility and efficiency.
Security
and compliance are integral to our operations. We adhere to rigorous compliance standards, including SOC 2 and HIPAA, and employs advanced
encryption protocols for data in transit and at rest. Optional confidential computing protects information as it is being processed.
We also conduct regular penetration testing and vulnerability assessments to identify and remediate potential risks.
The
platform services and operations layer is designed to keep the overall environment stable, secure, and integrated with customer systems.
As part of every product and service offering, we provide ongoing hands-on support, including provisioning, monitoring and maintenance
of infrastructure to help customers maximize the value of their reservations. These services include strategic consulting to align infrastructure
investments with business objectives, migration support to ensure a smooth transition from legacy environments, and workload optimization
to enhance performance and cost efficiency. Our team of experts works closely with customers to design tailored solutions that address
specific technical and operational challenges, leveraging deep domain expertise in AI infrastructure to deliver measurable outcomes.
Our
infrastructure roadmap includes ongoing investments in next-generation GPUs, high-speed interconnects and advanced orchestration capabilities
to support emerging workloads and maintain a competitive edge in the rapidly evolving AI ecosystem.
3
Strategic
Partnerships
We
have entered into several strategic partnerships to strengthen our ability to deliver secure, high-performance AI infrastructure at scale.
These partnerships allow us to expand our reach, accelerate deployment timelines and provide customers with integrated solutions that
combine hardware, software and professional services. Our partnership with NVIDIA, as an NVIDIA Certified Cloud Partner, and other leading
manufacturers and software vendors allow us to expand our reach, accelerate deployment timelines and provide
customers with integrated solutions that combine hardware, software and professional services. In addition, we lease data-center capacity to obtain
the physical infrastructure necessary to supply power, cooling and network connectivity required to run large GPU Clusters and support
capacity expansion. We also use redundant telecommunications network providers to maintain low-latency interconnectivity between major
networks.
Customers
We
serve a broad spectrum of industries that require running mission-critical AI workloads with predictable performance, security and scale.
The versatility of our platform enables organizations to deploy workloads that range from AI model training to real-time analytics, supporting
mission-critical applications across diverse sectors.
Technology
companies represent a significant portion of our customer base. These organizations utilize
our GPU Clusters for training and deploying generative AI models, including large language
models and diffusion-based architectures. Our HIPAA and SOC 2 compliance certifications and
our emerging security capabilities position us to serve healthcare organizations, financial
institutions, and government agencies in the future.
Our
ability to serve a wide range of industries reflects our commitment to delivering solutions that combine high performance scalability
and security. By enabling customers to access advanced compute resources without the need for significant upfront investment, we empower
organizations to innovate faster and compete more effectively in an increasingly data-driven economy.
Sales
Infrastructure and Go-to-Market Strategies
Our
go-to-market strategy is designed to position us as a trusted partner for organizations seeking reliable, secure and scalable infrastructure
for AI workloads. We employ a direct sales model supported by a network of strategic partnerships with resellers, brokers, technology
providers and system integrators. Our sales strategy focuses primarily on annual or multi-year commitments for customers that demand
performance, security and operational reliability to support GPU infrastructure and capabilities.
4
We
invest in direct engagement through account teams and solutions engineers supporting customers through cluster design, deployment and
ongoing operations. In addition, we focus on workload expansion over time to support the growth of customer usage as training scales
and inference workloads shift into production. Our sales team consists of experienced account executives and engineers skilled in solution
design, delivery and operations who work collaboratively to deliver tailored solutions that meet the unique needs of each client. This
high-touch model matches the technical depth and evaluation cycles of the targeted AI deployments.
Our
pricing strategy is designed to offer flexibility and scalability. We provide reserved capacity agreements that align with customer requirements
and budget constraints. This approach helps customers to optimize costs while ensuring access to the compute resources necessary for
mission-critical workloads.
We
also prioritize customer retention and long-term relationships through account management and post-sales support. We offer onboarding
assistance and related services and success motions to ensure that customers derive maximum value from their investment in our infrastructure.
Customer feedback is incorporated into product development cycles, which enables continuous improvement and innovation.
We plan to expand our sales infrastructure by
increasing our presence, hiring additional sales and technical personnel, marketing personnel, and other types of roles as well as systems
to enhance pipeline visibility and forecasting accuracy. We intend to continue to refine our go-to-market strategy to address emerging
opportunities in AI, confidential computing and other deployments, while maintaining our focus on security, scalability and cost efficiency
as core differentiators.
Data
Center Footprint
We
operate our platform in a Tier III data center facility located in Delaware. Clusters use current-generation NVIDIA H200-class and
B200 systems to support the dense, predictable compute required for training and inference required by our customers. We intend to add
data center capacity in various domestic and foreign geographies based on customer demand and to engineer greater geographic diversity
and operational resilience.
Our
data center is designed to meet stringent reliability and security standards, incorporating redundant power supplies, backup generators
and uninterruptible power systems to maintain continuous availability. Networking infrastructure within these facilities includes high-speed
fiber connections and advanced routing technologies to support low-latency communication between clusters and external networks. The
facilities are designed to provide redundant power infrastructure beyond the minimum required to support the normal load (“N”),
including N+N power paths, N+1 uninterruptible power supply and generators, N+1 cooling, and redundant network and storage delivery,
as well as complying with applicable fire-protection standards for data centers.
Competition
The
market for AI infrastructure and high-performance computing services is highly competitive and characterized by rapid technological change,
evolving customer requirements and significant capital investment. We compete with a broad range of providers that offer varying degrees
of scale, geographic reach, and service integration, and many possess substantial financial resources and established customer relationships.
Traditional hyperscale cloud platforms, such as Amazon (Amazon Web Services), Google (Google Cloud Platform) and Microsoft (Azure), represent
the most significant competitive threat due to their extensive infrastructure, global presence and ability to bundle AI compute services
with complementary offerings such as storage, networking and software. These providers benefit from economies of scale and can exert
pricing pressure across multiple service categories. However, their platforms are generally designed for broad, general-purpose workloads
rather than optimized for the unique performance requirements of reliable model AI training and inference, sometimes resulting in slow
provisioning, inconsistent performance at scale and higher per-GPU costs. Neoclouds and specialized providers, such as CoreWeave, Inc.
and Nebius Group N.V., focus on GPU-optimized infrastructure with flexible provisioning and competitive pricing. Across the neocloud
segment, competitors vary in maturity and operational depth. Some customers deploy and manage their own GPU resources and develop internal
AI infrastructures, which may allow for better control of data and latency, but requires significant capital, engineering talent and
operational discipline to scale clusters, maintain a consistent supply of GPUs and upkeep infrastructure at the level required for production.
5
Competition
is expected to intensify as demand for AI compute resources accelerates and new technologies
gain traction. Our strategy to maintain and strengthen our competitive position includes
continuous innovation in our product offerings and technology platforms, expansion of our
infrastructure capacity, and development of strategic partnerships. We believe that our ability
to deliver secure, high-throughput infrastructure at scale, tailored to the needs of customers,
will enable it to compete effectively against both general-purpose cloud providers and specialized
competitors.
Healthcare Business Overview
Prior to the Merger on May 15, 2025, Movano Inc. announced that
it had initiated a process to explore strategic alternatives to maximize shareholder value. In order to conserve cash, it reduced its
operations and turned its primary focus to consummating a strategic transaction with the goal of maximizing shareholder value, which resulted
in the Merger described above. While we expect to ultimately dispose of the assets related to our legacy healthcare business, as of the
date of this filing we are continuing to operate this business in a reduced capacity as we explore available opportunities.
Our commercial product was the wellness ring (formerly
referred to as the Evie Ring) (the “Wellness Ring”), a wearable designed specifically for women that was launched in November
2023. We launched the Wellness Ring as a general wellness device without any FDA premarket clearances. All revenues from the sale of the
Wellness Ring were generated in the United States. Following a final order by the Trademark Trial and Appeal Board (“TTAB”)
of the United States Patent and Trademark Office sustaining Allora Health, Inc. d/b/a EVVY’s (“EVVY”) opposition to
the Company’s registration of its EVIE mark for two of the three classes of products challenged by EVVY and receipt from EVVY of
a cease and desist letter relating to our use of the EVIE mark, we currently have paused all commercial sales of the Wellness Ring (See
Note 16 Subsequent Events in our consolidated financial statements for further discussions).
The Wellness Ring combines health and wellness
metrics to give a full picture of one’s health, which include resting heart rate, heart rate variability, blood oxygen saturation,
respiration rate, skin temperature variability, period and ovulation tracking, menstrual symptom tracking, activity profile, including
steps, active minutes and calories burned, sleep stages and duration, and mood tracking. The device provides women with continuous health
data distilled down to simple, yet meaningful, insights to help them make manageable lifestyle changes and take a more proactive approach
that could mitigate the risks of chronic disease.
Separately, in November 2024, the Company received
FDA 510(k) clearance for the pulse oximetry feature in its Medical Ring, making it a medical device. The clearance enables the Company
to pursue health solutions needed for applications such as clinical trials, post-clinical trial management, and remote patient spot check
monitoring for both healthcare providers and payors. The Company believes the Medical Ring is one of the first patient wearables with
FDA clearance on the entire system, both hardware and software, differing from its competition that sometimes gets FDA clearance on an
individual algorithm under “Software as a Medical Device” guidance. The FDA clearance of these metrics, including pulse rate
and blood oxygen saturation, will be sold via prescription, and will help to ensure clinical-level confidence in the Medical Ring’s
monitoring capabilities and make the device attractive to clinicians and to facilities engaged in clinical trials for at-home and/or long-term
patient monitoring. This unique competitive advantage is not only a key pillar in building brand trust and loyalty but will also redefine
the expectations of wearable devices.
In addition to the Wellness Ring and Medical Ring,
the Company is developing one of the smallest ever patented and proprietary System-on-a-Chip (“SoC”) designed specifically
for blood pressure or CGM systems. The Company built the integrated sensor from the ground up with multiple antennas and a variety of
frequencies to achieve an unprecedented level of precision in health monitoring. The Company’s end goal is to bring a Class II FDA-cleared
wearable device to the market that includes CGM and cuffless blood pressure monitoring capabilities. Over time, the Company’s technology
could also enable the measurement and continuous monitoring of other health data.
Intellectual
Property
Our
intellectual property assets primarily consist of our proprietary software, system design
and operational expertise that drive our AI infrastructure platform. Our intellectual property
assets include proprietary inference engine and technologies, proprietary AI software ecosystem
and infrastructure management software, trade secrets, trademarks and contractual restrictions
such as confidentiality agreements, licenses and intellectual property assignment agreements,
that collectively form the foundation of our product offerings and technology platforms that
support the performance, security, and reliability requirements of AI workloads.
6
In
connection with our AI cloud computing business, as of December 31, 2025, we own two pending U.S. provisional patent applications.
In connection with our healthcare business, as of December 31, 2025, we own, jointly own, or have exclusive rights to 30 issued and
in-force patents (that cover one or more of our products or product candidates for method, system and device development) that
expire at various times between November 12, 2039 and December 18, 2040. Furthermore, as of December 31, 2025, we own, jointly own,
or have exclusive rights to two pending U.S. patent applications, and one pending foreign patent application.
Our
trade secrets, proprietary know-how and copyrights include our source code and confidential methodologies for our technology platforms
that are optimized for serving large AI models at scale, confidential computing that support secure execution of sensitive workloads
and GPU node integration technology that improves throughput, reliability and utilization. Corvex employs rigorous internal controls
to safeguard these trade secrets and proprietary know-how, including restricted access policies, encryption of sensitive documentation
and confidentiality agreements with employees and third-party partners to control access to and non-disclosure of our proprietary
information.
Our
intellectual property strategy is closely aligned with our product roadmap and growth objectives. We actively monitor emerging trends
in AI infrastructure to identify opportunities for innovation and patent protection. Our intellectual property portfolio and strategies
are the result of significant research and development focused on optimizing performance, security, and scalability for AI workloads,
and further supports our competitive advantage and increasingly differentiated product and service offerings relative to general-purpose
and specialized cloud infrastructure providers.
Government
Regulation
Our
operations are subject to an extensive and evolving framework of federal, state and international laws and regulations that govern AI,
data privacy, cybersecurity, export controls, environmental and other aspects of technology infrastructure and data centers. Compliance
with these regulations is critical to maintaining customer trust and ensuring uninterrupted service delivery.
We
actively monitor developments in emerging AI regulatory frameworks, including Regulation (EU) 2024/1689 of the European Parliament and
of the Council (the EU AI Act) and similar initiatives in the United States and other jurisdictions. New and evolving legislation
may impose additional requirements on companies deploying AI technologies or the responsible use of such AI technologies, which could
require us to implement new governance processes, conduct risk assessments and provide disclosures regarding the ethical use of AI. These
requirements may increase compliance costs and operational complexity. We also monitor our use and development of AI as regulated by
existing, technology-agnostic regulatory frameworks, including, for example, consumer protection, non-discrimination, and employment.
Such frameworks continue to apply to us, despite the use of novel technology, and we must ensure that our use and development of AI continue
to align with our existing obligations. These requirements may require updates to existing compliance frameworks to account for AI and
introduce additional operational complexity in enforcing internal policies. Export control regulations represent another significant
area of compliance for our operations. Our products and services incorporate advanced technology and encryption features that are subject
to the Export Administration Regulations (“EAR”) administered by the U.S. Department of Commerce. We must obtain appropriate
licenses for the export of controlled technologies and ensure that our operations do not involve prohibited end-users or destinations.
Failure to comply with these regulations could result in severe penalties, including fines, restrictions on export privileges and reputational
harm.
As
a global company, we are subject to state, federal, and international laws, rules and regulations pertaining to privacy and
security, such as state omnibus privacy laws (e.g., the CCPA and similar state laws) and the GDPR. We may be required to undertake
additional compliance investment to evaluate the application of these laws to our business and to take steps to come into compliance
with these laws, which could include changing our business processes. In addition, our internal computer and information technology
systems, and those of our vendors and customers are vulnerable to attack, unauthorized access, unauthorized use, or other harm.
Cyberattacks are increasing in frequency and sophistication, and although we have invested in security for our product offerings and
technology platforms, there is no guarantee that such measures will be sufficient to protect against external or internal threats.
We could incur costs to comply with the laws and to address a security incident as well as penalties if we are not deemed to be in
compliance with these laws, which could have a material impact on our business.
7
In
addition to data privacy, cybersecurity and AI-specific regulations, we are subject to environmental and energy efficiency standards
applicable to data center operations. Certain jurisdictions mandate reporting of greenhouse gas emissions and adherence to sustainability
targets, which may require additional investment in renewable energy sources and energy-efficient cooling technologies. We are also required
to comply with occupational health and safety regulations governing our facilities and workforce.
Environmental
Regulations
The cost of compliance with federal, state, and
local provisions related to the protection of the environment has had no material effect on our business. There were no material
capital expenditures for environmental control facilities in the year ended December 31, 2025, and there are no material expenditures
planned for such purposes for the year ended December 31, 2026.
Healthcare Regulations
FDA
Regulation
While
the first iteration of the Wellness Ring is a general wellness device and therefore does not require FDA premarket clearance, the Medical
Ring is a medical device and required FDA clearance and over time we believe the execution of additional accuracy studies could lead
to additional FDA clearances on vital signs monitoring capabilities including respiration rate.
Before
and after approval or clearance in the U.S., any subsequent iterations of our planned solution will be subject to extensive regulation
by FDA under the Federal Food, Drug and Cosmetic Act (the “FD&C Act”) and/or the Public Health Service Act, as well as
by other regulatory bodies. FDA regulations govern, among other things, the development, testing, manufacturing, labeling, safety, storage,
record-keeping, market clearance or approval, advertising and promotion, import and export, marketing and sales, and distribution of
medical devices and pharmaceutical products. There may be certain commercial applications for our technology that require less regulatory
scrutiny than described below.
FDA
Approval or Clearance of Medical Devices
In
the U.S., medical devices are subject to varying degrees of regulatory control and are classified in one of three classes depending on
the extent of controls FDA determines are necessary to reasonably ensure their safety and efficacy:
●
Class
I: general controls, such as labeling, establishment registration, device listing, and, for some devices, adherence to quality system
regulations;
●
Class
II: the general controls plus certain special controls, FDA clearance via a premarket notification, or 510(k) submission, specific
controls such as performance standards, patient registries and post-market surveillance and additional controls such as labeling
and adherence to quality system regulations; and
●
Class
III: general and special controls and approval of a premarket approval (“PMA”) application.
8
To
request marketing authorization by means of a 510(k) clearance, we must submit a notification demonstrating that the proposed device
is substantially equivalent to another legally marketed medical device, a “predicate device,” has the same intended use,
and is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness than a legally
marketed device. 510(k) submissions generally include, among other things, a description of the device and its manufacturing, device
labeling, medical devices to which the device is substantially equivalent, safety and biocompatibility information and the results of
performance testing. In this case, the 510(k) submission will likely also include data from human clinical studies demonstrating performance
and other parameters. Marketing may commence only when FDA issues a clearance letter finding substantial equivalence. The typical duration
to receive a 510(k) clearance is approximately six to twelve months from the date of the initial 510(k) submission, although there is
no guarantee that the timing will not be longer.
In
some instances, the 510(k) pathway for product marketing may be used with only proof of substantial equivalence in technology for a given
indication with a predicate device. In other instances, FDA may require additional clinical work to prove efficacy in addition to technological
equivalence and basic safety. Whether clinical data is provided or not, FDA may decide to reject the substantial equivalence argument
we present. If that happens, the device is automatically designated as a Class III device. The device sponsor must then fulfill more
rigorous PMA requirements or can request a risk-based classification determination for the device in accordance with the “de novo”
process, which may determine that the new device is of low to moderate risk and that it can be appropriately regulated as a Class I or
II device. If a de novo request is granted, the device may be legally marketed, and a new classification is established. If the device
is classified as Class II, the device may serve as a predicate for future 510(k) submissions. If the device is not reclassified through
de novo review, then it must go through the standard PMA process for Class III devices.
After
a device receives 510(k) clearance, any product modification that could significantly affect the safety or effectiveness of the product,
or that would constitute a significant change in intended use, requires a new 510(k) clearance or, if the device would no longer be substantially
equivalent, a PMA.
A
PMA application must provide a demonstration of safety and effectiveness, which generally requires extensive pre-clinical and clinical
trial data. Information about the device and its components, device design, manufacturing, and labeling, among other information, must
also be included in the PMA. As part of the PMA review, FDA will inspect the manufacturer’s facilities for compliance with quality
system regulation requirements, which govern testing, control, documentation, and other aspects of quality assurance with respect to
manufacturing, testing, and storage of medical devices. If FDA determines the application or manufacturing facilities are not acceptable,
FDA may outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission
of any requested additional information, FDA ultimately may decide that the application does not satisfy the regulatory criteria for
approval. During the review period, an FDA advisory committee, typically a panel of clinicians and statisticians, may be convened to
review the application and recommend to FDA whether, or upon what conditions, the device should be approved. FDA is not bound by the
advisory panel decision. While FDA often follows the panel’s recommendation, there have been instances in which FDA has not. FDA
must find the information to be satisfactory to approve the PMA. The PMA approval can include post-approval conditions, including, among
other things, restrictions on labeling, promotion, sale and distribution, or requirements to do additional clinical studies after approval.
Even after approval of a PMA, a new PMA or PMA supplement is required to authorize certain modifications to the device, its labeling,
or its manufacturing process. Supplements to a PMA often require the submission of the same type of information required for an original
PMA, except that the supplement is generally limited to that information needed to support the proposed change from the product covered
by the original PMA. The typical duration to receive PMA approval is approximately two years from the date of submission of the initial
PMA application, although there is no guarantee that the timing will not be longer.
9
Clinical
Trials of Medical Devices
One
or more clinical trials are generally required to support a PMA application and are sometimes necessary to support a 510(k) submission.
Clinical studies of unapproved or uncleared medical devices or devices being studied for uses for which they are not approved or cleared
(investigational devices) must be conducted in compliance with FDA requirements. If an investigational device could pose a significant
risk to patients, the sponsor company must submit an investigational device exemption application to FDA prior to initiation of the clinical
study. If an institutional review board determines that a device study does not present a significant risk, an investigational device
exemption submission to FDA is not required. An investigational device exemption application must be supported by appropriate data, such
as animal and laboratory test results, showing that it is safe to test the device on humans and that the testing protocol is scientifically
sound. Except for studies involving certain banned devices, the investigational device exemption will automatically become effective
30 days after receipt by FDA unless FDA notifies the company that the investigation may not begin. Clinical studies of investigational
devices may not begin until an institutional review board has approved the study.
During
the study, the sponsor must comply with FDA’s investigational device exemption requirements. These requirements include investigator
selection, trial monitoring, adverse event reporting, and record keeping. The investigators must obtain patient informed consent, rigorously
follow the investigational plan and study protocol, control the disposition of investigational devices, and comply with reporting and
record keeping requirements. The sponsor, FDA, or the institutional review board at each institution at which a clinical trial is being
conducted may suspend a clinical trial at any time for various reasons, including a belief that the subjects are being exposed to an
unacceptable risk. During the approval or clearance process, FDA typically inspects the records relating to the conduct of one or more
investigational sites participating in the study supporting the application.
Post-Approval
Regulation of Medical Devices
After
a device is cleared or approved for marketing, numerous and pervasive regulatory requirements continue to apply. These include:
●
FDA
quality systems regulation, which governs, among other things, how manufacturers design, test, manufacture, exercise quality control
over, and document manufacturing of their products;
●
labeling
and claims regulations, which prohibit the promotion of products for unapproved or “off-label” uses and impose other
restrictions on labeling; and
●
the
Medical Device Reporting regulation, which requires reporting to FDA of certain adverse experiences associated with use of the product.
Good
Manufacturing Practices Requirements
Manufacturers
of most medical devices are required to comply with the good manufacturing practices set forth in the quality system regulation promulgated
under Section 520 of the FD&C Act. Current good manufacturing practices regulations require, among other things, quality control
and quality assurance as well as the corresponding maintenance of records and documentation. The manufacturing facility for an approved
product must be registered with FDA and meet current good manufacturing practices requirements to the satisfaction of FDA pursuant to
a pre-PMA approval inspection before the facility can be used. Manufacturers, including third party contract manufacturers, are also
subject to periodic inspections by FDA and other authorities to assess compliance with applicable regulations. Failure to comply with
statutory and regulatory requirements subjects a manufacturer to possible legal or regulatory action, including the seizure or recall
of products, injunctions, consent decrees placing significant restrictions on or suspending manufacturing operations, and civil and criminal
penalties. Adverse experiences with the product must be reported to FDA and could result in the imposition of marketing restrictions
through labeling changes or in product withdrawal. Product approvals may be withdrawn if compliance with regulatory requirements is not
maintained or if problems concerning safety or efficacy of the product occur following the approval.
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Federal
Communication Commission (“FCC”) Regulations
Our
RF-based technology involves the transmission of RF energy, and as such, will be subject to regulation by the FCC, including the FCC’s
equipment authorization regulations and its regulations governing human exposure to RF energy. In particular, we expect the planned solution
to be regulated under Part 18 of the FCC’s rules governing industrial, scientific, and medical (ISM) equipment, and to be classified
as consumer ISM equipment under that rule part. Based on the expected frequency and power of operation, we expect that the product will
comply with the Part 18 technical specifications for these types of devices, which we will be required to verify under FCC equipment
authorization procedures. We also expect, based on the device’s frequency and power of operation, that the product will comply
with the FCC’s requirements governing human exposure to RF energy.
The regulatory environment in which we operate
is dynamic and subject to frequent changes. New laws or amendments to existing regulations could impose additional obligations, result
in additional compliance costs or restrictions on our business practices. We constantly monitor regulatory developments and industry standards
and their impact on business, investments in ongoing compliance programs, and reviews and assesses the adequacy of our technical controls
to ensure compliance with all applicable laws and regulations. Failure to comply with applicable regulations could result in civil or
criminal penalties, contractual liabilities, and reputational damage, any of which could materially and adversely affect our business,
financial condition, and results of operations. See “Risk Factors — Risks Related to Legal and Regulatory Matters
of the Company — our business is subject to a wide range of laws and regulations, and our failure to comply with those
laws and regulations could harm our business.”
People,
Culture and Values
As of March 20, 2026, we employ approximately 38 full-time and
two part-time professionals across engineering, operations, product development, customer success and administrative functions. Our workforce
is predominantly technical, with highly skilled individuals with expertise in AI infrastructure and high-performance compute. We place
significant emphasis on recruiting top talent from leading technology firms, research institutions and academic programs to ensure that
our team remains at the forefront of innovation.
We
foster a culture of collaboration and continuous improvement, encouraging employees to contribute ideas that drive product development
and operational excellence. Employee development is a strategic priority for us.
Our
ability to attract, develop, and retain highly skilled professionals is critical to our success. We believe that our engineering-driven
culture, commitment to disciplined execution and competitive compensation practices help attract and retain skilled technical talent.
We expect headcount to increase as we expand our data-center footprint and broaden our product capabilities.
Available
Information
We were incorporated in the State of
Delaware in January 2018 under the name Maestro Sensors Inc. On August 3, 2018, we changed our name to Movano Inc. and on March 23,
2026 we changed our name to Corvex, Inc. following the Merger. Our principal executive offices are located at 3401 North Fairfax
Drive, Suite 3230, Arlington, VA 22226, and our telephone number is (866) GET-GPUS ((866) 438-4787). Our Internet website
address is www.corvex.ai. Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K,
including exhibits, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange
Act of 1934 are available free of charge through the investor relations page of our Internet website as soon as reasonably
practicable after we electronically file such material with, or furnish it to, the U.S. Securities and Exchange Commission (the
“SEC”). Our Internet website and the information contained therein or connected thereto are not intended to be
incorporated into this Annual Report on Form 10-K.
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