OTC: PETV

Business
Description

The
Company is primarily engaged in the business of commercializing and licensing products in the veterinary market to treat and/or manage
afflictions of companion animals such as cats, dogs and horses. Most of our technology was developed for human biomedical applications,
and we intend to leverage the investments already expended in their development to commercialize treatments for horses and companion
animals in a capital and time-efficient way.

3

Many
of the Company’s products are derived from proprietary biomaterials that simulate a body’s cellular tissue by virtue of their
reliance upon natural protein and carbohydrate compositions which incorporate such “tissue building blocks” as collagen,
elastin, and proteoglycans such as heparin. Since these are naturally-occurring in the body, we believe they have an enhanced biocompatibility
with living tissues compared to synthetic biomaterials such as those based upon alpha-hydroxy polymers (e.g PLA, PLGA, and the like),
polyacrylamides, and other “natural” biomaterials that may lack the multiple proteins incorporated into our biomaterials.
These proprietary protein-based biomaterials that are similar to the body’s tissue thus allowing integration and tissue repair
in long-term implantation in certain applications.

Our
initial product, Spryng® is a veterinary medical device designed and engineered to provide a bio-integrative scaffold
in the affected joint, promoting restoration of proper joint mechanics. Spryng® is an intra-articular injectable product
of biocompatible and insoluble particles that are slippery, wet-permeable, durable, and resilient to enhance the force cushioning function
of the synovial fluid and cartilage. The particles mimic natural cartilage in composition, structure, and hydration. Multiple joints
can be treated simultaneously. Our particles are comprised of naturally derived collagen, elastin, and a glycosaminoglycan (i.e. heparin);
such particles mimic the composition and mechanical properties of extracellular matrix and natural cartilage. Spryng®
assists in promoting a constructive restoration of diseased synovial tissue to improve the biomechanics and mechanical homeostasis of
the joint. Furthermore, these particles are designed and engineered to provide a bio-integrative scaffold in the affected joint, promoting
restoration of proper joint mechanics.

Osteoarthritis,
a common inflammatory joint disease in both dogs and horses, is a chronic, progressive, degenerative joint disease that is caused by
a loss of synovial fluid and/or the deterioration of joint cartilage. Osteoarthritis affects approximately 14 million dogs and 1 million
horses in the $11 billion companion animal veterinary care and product sales market.

Despite
the market size, veterinary clinics and hospitals have very few treatments and/or drugs for use in treating osteoarthritis in dogs, horses,
and other pets. As there is no cure for osteoarthritis, current solutions treat symptoms, but do not manage the cause. The current treatment
for osteoarthritis in dogs generally consists of the use of nonsteroidal anti-inflammatory drugs (or “NSAIDs”) which are
approved to alleviate pain and inflammation but present the potential for side effects relating to gastrointestinal, kidney, and liver
damage and do not halt or slow joint degeneration. The Company offers an alternative to traditional treatments that only address the
symptoms of the affliction. our Spryng® product addresses the affliction, loss of synovial fluid and/or the deterioration
of joint cartilage, rather than treating just the symptoms and, to the best of our knowledge, has elicited minimal adverse side effects
in dogs and horses. Spryng®-treated dogs and horses have shown an increase in activity even after they no longer are receiving pain
medication or other treatments. Other treatments for osteoarthritis include steroid and/or hyaluronic acid injections, which are used
for treating pain, inflammation and/or joint lubrication, but can be slow acting and/or short lasting.

We
believe Spryng® is an optimal solution to safely improve joint function in animals for several reasons:

●
Spryng®
addresses the underlying problems which relate to deterioration of cartilage causing pain and inflammation. Spryng®
mimics the composition and mechanical properties of extracellular matrix and assists in promoting a constructive restoration of diseased
synovial tissue to improve the biomechanics and mechanical homeostasis of the joint.

●
Spryng®
is easily administered with the standard intra-articular injection technique. Multiple joints can be treated simultaneously.

●
Case
studies indicate many dogs and horses have long-lasting multi-month improvement in lameness after having been treated with Spryng®

●
After
receiving a Spryng® injection, many canines are able to discontinue the use of NSAID’s, eliminating the risk
of negative side effects.

●
Spryng®
is an effective and economical solution for treating osteoarthritis. A single injection of Spryng® is approximately
$600 to $900 per joint and typically lasts for at least 12 months.

Historically,
drug sales represent up to 30% of revenues at a typical veterinary practice (Veterinary Practice News). Revenues and margins at veterinary
practices are being eroded because online, big-box, and traditional pharmacies have recently started filling veterinary prescriptions.
Veterinary practices are looking for ways to replace lost prescription revenues with safe and effective products. Spryng®
is a veterinarian-administered medical device that should expand practice revenues and margins. We believe that the increased revenues
and margins provided by Spryng® will accelerate its adoption rate and propel it forward as the standard of care for canine
and equine lameness related to or due to synovial joint issues.

4

We
commenced sales of Spryng® in the second quarter of fiscal 2022 and plan to increase our commercialization efforts of
Spryng® in the United States through the use of sales reps, clinical studies and market awareness to educate and inform
key opinion leaders on the benefits of Spryng®.

We
entered into a Distribution Services Agreement (“Distribution Agreement”) with MWI on June 17, 2022. Pursuant to the Agreement,
we appointed MWI to distribute, advertise, promote, market, supply, and sell the Company’s lead product, Spryng®
on an exclusive basis for two (2) years within the United States (the “Territory”), transitioning to a non-exclusive basis
thereafter; provided however that the Company shall extend the exclusivity for an additional one (1) year if MWI achieves certain performance
targets agreed upon by the parties. The Company can continue to sell Spryng® within the Territory to established accounts,
which include: (a) customers who have purchased Spryng® from the Company prior to the date of the Agreement, (b) customers
who require that they deal directly with the Company, (c) governmental agencies, and (d) customers that order via the internet who are
not directly solicited by MWI to purchase Spryng®. All customers must be licensed veterinary practices.

In
December 2023, the Company and MWI agreed to change the Distribution Agreement from an exclusive distribution agreement to a non-exclusive
distribution agreement, effective as of January 1, 2024. This is consistent with the Company’s strategy to create multiple sales
channels for its products. In March 2025, the Company mutually terminated its non-exclusive distribution agreement with MWI. In December
2023, the Company entered into a non-exclusive distribution agreement with Covetrus North America, LLC (“Covetrus Distribution
Agreement”), to market, distribute and sell the Company’s products in the United States, including the District of Colombia.
The Covetrus Distribution Agreement had an initial term of one year, which was not automatically renewed. The Company mutually terminated
its non-exclusive distribution agreement with Covetrus North America, LLC in February 2025.

In
December 2024, we entered into new wholesale distribution partnerships with Vedco Inc. (“Vedco”) and Clipper Distributing,
LLC (“Clipper”), both leaders in logistical solutions and supply of products to veterinarians through the channel-of-distribution
for veterinarians. Both MWI and Covetrus have the capability to purchase directly from Vedco and/or Clipper.

Spryng®
is classified as a veterinary medical device under the United States Food and Drug Administration (“FDA”) rules and pre-market
approval is not required by the FDA. Spryng® completed a safety and efficacy study in rabbits in 2007. Since that time,
more than 2,000 horses and dogs have been treated with Spryng®. We entered into a clinical trial services agreement with
Colorado State University on November 5, 2020. This university clinical study was completed in March 2024. Additionally, the Company
successfully completed an equine tolerance study in March 2022 and began a two canine clinical study with Ethos Veterinary Health, the
first beginning in May of 2022 which was completed in October 2023, and the second began in June of 2023 with an expected completion
in October 2024. We anticipate these and other studies that we plan to initiate will be primarily used to expand our distribution outlets
since the large international and national distributors generally require a third-party university study and other third-party studies
prior to including a product in their catalog of products.

We
manufacture our products in an ISO 7 certified clean room manufacturing facility in Minneapolis using our patented and scalable self-assembly
production process, which minimizes the infrastructure requirements and manufacturing risks to deliver a consistent, high-quality product
while being responsive to volume requirements. A second ISO cleanroom facility is expected to be operational later this year. We believe
that having two manufacturing facilities will help us minimize supply risks, allow for continued scaling or our production capacity,
and expand our research and development facilities.

We
also have a pipeline that includes 17 therapeutic devices for both veterinary and human clinical applications. Some such devices may
be regulated by the FDA or other equivalent regulatory agencies, including but not limited to the Center for Veterinary Medicine (“CVM”).
We anticipate growing our product pipeline through the acquisition or in-licensing of additional proprietary products from human medical
device companies specifically for use in pets. In addition to commercializing our own products in strategic market sectors and in view
of the Company’s vast proprietary product pipeline, the Company may establish strategic out-licensing partnerships to provide secondary
revenues.

5

In
February 2025, the Company signed an exclusive licensing agreement with VetStem, Inc. to market and sell their Precise PRP (Platelet-Rich
Plasma) product for both canine and equine. Revenues are expected in fiscal year 2026.

Product
Pipeline: Other Potential Biocoacervate and Protein Based Products

Below
is a listing of applications of our technology that we plan to commercialize or out-license to strategic partners:

Dermal
Filler

Our
biomaterials are constructed from purified water, protein, and carbohydrate, tailored to simulate different body tissues that biologically
integrate (bio-integration). Our biomaterials can be manufactured and used as a dermal filler for wrinkle treatment by injection. These
formed, gel particles fill, integrate and rejuvenate dermal skin tissue to remove the wrinkle. This product was taken through an FDA
clinical trial under the name CosmetaLife®, see the results here: www.clinicaltrials.gov (NCT00414544).

Cardiovascular
Devices

Our
blood-compatible biomaterial, which allows blood contact and bio-integrative processes to occur without clotting, platelet attachment,
or thrombogenesis, is used to repair cardiovascular tissue. VasoGraft®, a blood vessel graft made from VasoCover™
material, is designed to mimic natural blood vessel tissue in almost every respect, including the components used.

Drug
Delivery

Unique
fabrication techniques allow us to homogeneously distribute the drug in milligram to nanogram amounts, resulting in optimum performance
and manufacturing capabilities for a variety of delivery methods, such as coatings, injectables, implantables, or transmucosal delivery.
The first planned transmucosal product has been optimized and tested with peptide drugs with better efficacy than oral dosing via swallowing.

6

Orthopedic
Devices

Another
of our materials can be used in a variety of shapes for orthopedic and dental applications. The first products, OrthoGelic™ and
OrthoMetic™, will be aimed at difficult-to-heal, non-union broken bones, by using particles to fill the empty space. The orthopedic
biomaterial, made to mimic the structural components of bone, can allow integration and healing to fill in the break and exclude non-bone
tissue infiltration.

Intellectual
Property

Our
intellectual property portfolio is comprised of patents, patent applications, trademarks, and trade secrets. We have six patents issued
and 2 patent applications pending in the United States. In addition to the United States patent portfolio, we also have four patents
granted in key markets around the world including Canada and countries within the European Union.

We
believe we have developed a broad and deep patent portfolio around our biomaterials and manufacturing processes in addition to the application
of these biomaterials for use as medical devices, medical device coatings, and pharmaceutical delivery devices. The Company secures other
technological know-how by trade secret law and also possesses several trademarks that are either registered or protected pursuant to
trademark common law.

United
States Patents:

●11,890,371
– Biocompatible Protein-Based Particles and Methods Thereof

●11,975,121
– Protein Biomaterials and Bioacervates and Methods of Making and Using Thereof

●10,744,236
- Protein Biomaterial and Biocoacervate Vessel Graft Systems and Methods of Making and Using
Thereof

●10,016,534
– Protein Biomaterial and Biocoacervate Vessel Graft Systems and Methods of Making
and Using Thereof

●8,623,393
– Biomatrix Structural Containment and Fixation Systems and Methods of Use Thereof

●8,529,939
– Mucoadhesive Drug Delivery Devices and Methods of Making and Using Thereof

To
maximize the strength and value of our patent portfolio, many of the claims use the transitional term “comprising”, which
is synonymous with “including,” This use of transitional language is inclusive or open-ended and does not exclude additional,
unrecited elements or method steps. Our patents also include method claims covering many of the applications and uses of the biomaterials
as medical devices and drug delivery systems. We believe our intellectual property portfolio strongly protects our proprietary technology,
including the composition of raw elements used to produce our formulations, the fabricated biomaterials, and their application in end
products, thereby making our material and devices much more attractive to industry partners.

Furthermore,
we rely on proprietary trade secrets and confidential know-how to protect various aspects of its product formulations and manufacturing
processes. The Company has six documented trade secrets that include, but are not limited to, unique ingredient compositions, specialized
blending and production techniques, quality control procedures, and process efficiencies that have been developed and refined through
years of internal research and development. These proprietary methods are central to the performance, stability, and scalability of the
products currently commercialized by the Company. To safeguard this intellectual property, the Company maintains strict internal controls,
including non-disclosure agreements, restricted access protocols, and employee confidentiality and invention assignment agreements. Although
trade secrets do not offer the same legal protections as patents, the Company believes that its robust internal policies and the technical
complexity of its formulations and processes provide significant competitive advantage and barriers to entry.

We
will seek to protect our products and technologies through a combination of patents, regulatory exclusivity, and proprietary know-how.
Our goal is to obtain, maintain and enforce patent protection for our products, formulations, processes, methods, and other proprietary
technologies, preserve our trade secrets, and operate without infringing on the proprietary rights of other parties, both in the United
States and in other countries. Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection
possible for our current compounds and any future compounds developed. We also strenuously protect our proprietary information and proprietary
technology through a combination of contractual arrangements, trade secrets, and patents, both in the United States and abroad. However,
even patent protection may not always afford us with complete protection against competitors who seek to circumvent our patents.

7

We
depend upon the skills, knowledge, and experience of our scientific and technical personnel, including those of our company, as well
as that of our advisors, consultants, and other contractors, none of which is patentable. To help protect our proprietary know-how, which
may not be patentable, and inventions for which patents may be difficult to obtain or enforce, we rely on trade secret protection and
confidentiality agreements to protect our interests. To this end, we generally require all of our employees, consultants, advisors, and
other contractors to enter into confidentiality agreements that prohibit disclosure of confidential information and, where applicable,
require disclosure and assignment of ownership to us the ideas, developments, discoveries, and inventions important to our business.

Finally,
we rely on a combination of registered and unregistered intellectual property to protect our brand and products. As of the date of this
filing, we own two United States federally registered trademarks: Spryng® and OsteoCushion®, both of which are actively used
in commerce in connection with our core products and services. In addition, we assert common law trademark rights in PetVivo™,
which has been used continuously in the marketplace in association with our business since approximately 2014. We also own various copyrights
that protect our original works of authorship, including proprietary product documentation, website content, marketing materials, clinical
publications and other creative and technical content developed internally or acquired through business operations. These trademarks
and copyrights are important assets that support our brand identity, help safeguard the unique elements of our products, differentiate
our offerings, enhance our user experience and contribute to our competitive position. We actively monitor and enforce our trademark
and copyright rights to protect against infringement or misuse.

Companion
Animal Market

Over
the last several decades, we believe the animal health market and industry has a strong component in the overall U.S. economy and is
more resistant to economic cycles. The veterinary sector is an attractive area to participate in the growth of the broader healthcare
industry without reimbursement risk. The American Pet Products Association (APPA) 2021-2022 National Pet Owners Survey indicates that
$123.6 billion was spent on pets in the U. S. in 2021. Vet Care and product sales constitute about $34.3 billion of the market. The growth
in the U.S. companion animal market has been continuing to increase due to the increase in the number of pet-owning households.

The
APPA 2021-2022 National Pet Owners Survey indicates U.S. pet ownership reached record levels in 2022. Specifically, 70% of all U.S. households
owned a pet in 2022. That’s 90.5 million pet-owning households, up from 84.6 million in 2018. In 2022, dogs and cats were the most
popular pet species, owned by 69% and 45% of U.S. households, respectively. APPA also reported that there were 69.0 million dogs and
45.3 million cats in the U.S. APPA reported that 3.5% of U.S. households owned horses in 2022. According to the American Horse Council,
the total number of horses owned by U.S. households was 7.2 million.

Osteoarthritis
Market

Osteoarthritis,
the most common inflammatory joint disease in both dogs and horses, is a progressive condition that is caused by a deterioration of joint
cartilage. Over time, the joint cartilage deterioration creates joint stiffness from mechanical stress resulting in inflammation, pain,
and loss of range of motion, which may be referred to as lameness. Osteoarthritis joint stiffness and lameness worsen with time from
gradual cartilage degeneration and an ongoing loss of protective cushion and lubricity (i.e., loss of slippery padding). As there is
no cure for osteoarthritis, the various treatment methods are focused on managing the related symptoms of pain and inflammation. Veterinarians
recommend several treatments depending on the severity of the disease, including a combination of rest, weight loss, physical rehabilitation,
and a regimen of pain and anti-inflammatory drugs (NSAIDs). Non-steroidal anti-inflammatory drugs (NSAIDs) are used to alleviate the
pain and inflammation caused by OA, but long-term NSAIDs cause gastric problems. Moreover, NSAIDs do not treat the cartilage degeneration
issue to halt or slow progression of the OA condition.

The
Morris Animal Foundation estimates that OA affects approximately 14 million adult dogs in the U.S. and owners consistently report it
as a top concern.

8

Horse
Osteoarthritis (Lameness)

Equine
osteoarthritis is the most common cause of lameness in horses. Equine OA is expensive to manage,
with estimated annual costs as high as $10,000-15,000 per horse to diagnose, treat, and medicate, researchers found in one study as referenced
in the Horse – Equine Monthly.

As
noted previously, the American Horse Council reported the total number of horses owned by U.S. households was 7.2 million. According
to an annual National Equine Health Survey conducted in collaboration with the British Equine Veterinary Association in 2016, 26% of
horses suffered from lameness. As referenced in the Horse–Equine Monthly, studies show 60% of all lameness issues are related to
OA. Based on the above assumptions we calculate that there are approximately 1.1 million horses suffering from OA.

Distribution

Most
U.S. veterinarians buy a majority of their equipment and supplies from a preferred distributor. More than 75% of veterinarians name Covetrus
North America/Butler Schein Animal Health, Inc., Patterson Veterinary, MWI, Midwest Veterinary Supply, Inc., or Victor Medical Company
as their preferred distributor. Combined, these top-tier distributors sell more than 85%, by revenue, of the products sold to companion
animal veterinarians in the U.S. Covetrus, Patterson, and MWI are recognized by manufacturers, distributors, and veterinarians as the
pre-eminent national companion animal veterinary supply distributors in the US. There are no other distributors that provide equivalent
levels of service to manufacturers and regularly visit veterinarians in as wide a geographic area as Covetrus, Patterson or MWI. Midwest
and Victor are large, regional distributors. The above data in this paragraph was sourced from File No. 101 0023 at the U.S. Federal
Trade Commission.

We
commenced sales of Spryng® in the second quarter of fiscal 2022 and plan to increase our commercialization efforts of
Spryng® in the United States through our distribution relationship with MWI Veterinary Supply Co. (“Distributor”
or “MWI”) and the use of sales reps, clinical studies, and market awareness to educate and inform key opinion leaders on
the benefits of Spryng®.

We
entered into a Distribution Services Agreement (“Distribution Agreement”) with MWI on June 17, 2022. Pursuant to the Agreement,
we appointed MWI to distribute, advertise, promote, market, supply, and sell the Company’s lead product, Spryng®
on an exclusive basis for two (2) years within the United States (the “Territory”), transitioning to a non-exclusive basis
thereafter; provided however that the Company shall extend the exclusivity for an additional one (1) year if MWI achieves certain performance
targets agreed upon by the parties. The Company can continue to sell Spryng® within the Territory to established accounts,
which include: (a) customers who have purchased Spryng® from the Company prior to the date of the Agreement, (b) customers
who require that they deal directly with the Company, (c) governmental agencies, and (d) customers that order via the internet who are
not directly solicited by MWI to purchase Spryng®. All customers must be licensed veterinary practices. In March 2025,
we mutually terminated our non-exclusive distribution agreement with MWI.

We
entered into a Distribution Services Agreement (the “Agreement”) with Covetrus on December 18, 2023. Pursuant to the Agreement,
we appointed Covetrus to distribute, advertise, promote, market, supply, and sell the Company’s lead product, Spryng®
on an exclusive basis for two (2) years within the United States (the “Territory”), transitioning to a non-exclusive basis
thereafter; provided however that the Company shall extend the exclusivity for an additional one (1) year if MWI achieves certain performance
targets agreed upon by the parties. The Company can continue to sell Spryng® within the Territory to established accounts,
which include: (a) customers who have purchased Spryng® from the Company prior to the date of the Agreement, (b) customers
who require that they deal directly with the Company, (c) governmental agencies, and (d) customers that order via the internet who are
not directly solicited by MWI to purchase Spryng®. All customers must be licensed veterinary practices. In February 2025,
we mutually terminated our non-exclusive distribution agreement with Covetrus.

In
December 2024, the Company entered into new wholesale distribution partnerships with Vedco, Inc. (“Vedco”) and Clipper Distributing,
LLC (“Clipper”). A distribution service agreement was not signed with either distribution partner. Both MWI and Covetrus
have the capability to purchase directly from both distributors.

9

Orthopedic
Joint Treatments

A
treatment for joint pain, which is made of injected, protein-based, biocompatible particles. In vivo studies indicate that the biocompatible
particle device can easily be combined with synovial fluid in a rabbit knee to form a joint cushion, buffering the adjacent bones/cartilage
where no damage was caused to the cartilage from replacing the synovial fluid. The particles show an effectiveness to augment and reinforce
the tissue, cartilage, ligaments and/or bone and/or enhance the functionality of the joint (e.g. reinforce deteriorated components present
in the joint to provide cushion or shock-absorbing features to the joint and to provide joint lubricity).

AppTec
Laboratories accomplished a gel-particle rabbit study. In short, New Zealand white rabbits (6) were injected in both stifle joints (knees)
to fill but not extend the synovial space (~0.5 cc GDP/site). Rabbits were tested every other day for abnormal clinical signs including
range of motion and joint observations until sacrifice. Behavioral testing revealed no abnormal scores for range of motion, withdrawal
response, or joint observations (all animals were 100% normal). At one week and at four weeks the animals were sacrificed. AppTec pathologists
evaluated knee joint histology. The reported cartilage surfaces of the femoral and tibia condyles and the menisci were grossly and histologically
100% normal for all animals and test sites. The test particles were found in all of the injection sites.

The
test particle did not cause changes in the articular cartilage of the femur or tibia when injected into the stifle joint of rabbits.
The test article and control rabbit knees were not different for either 1 or 4-week time points for all histological measurements. In
conclusion, the particles do not cause inflammation or damage to knee joint and will stick to exposed tissues and biologically integrate
with those tissues. The particles were not found to stick to articular cartilage in any sample.

Regenerative
Characteristics

The
particle devices for joint injections have been extensively studied for a broad range of applications including the treatment of wrinkles
as dermal filler. Here is an overview of the pre-clinical and clinical studies completed for CosmetaLife, which is the name used for
the particle device when it was used as a dermal filler.

CosmetaLife
is an easy-to-inject, water-protein-based dermal filler that not only fills nasolabial wrinkle depressions but also helps rejuvenate
the dermal tissues, counteracting damage that causes wrinkles. The dermal cells are attracted to the CosmetaLife gel-particles, attach
to them, and then slowly replace them with natural dermal material (extracellular matrix). The natural biological replacement process
of CosmetaLife to collagen is estimated to take 6-12 months. CosmetaLife clinical trial on nasolabial folds supports this estimate.

CosmetaLife
injections allow the body to create a more natural dermal structure in and around every particle. Enhancing the natural process of dermal
tissue construction with CosmetaLife allows for long-term dermal contouring, corrections, and rejuvenation with little to no adverse
side effects noted in clinical trials.

Particle
Device Clinical Studies

The
Company has conducted several biocompatibility animal studies. In the implantation study, no abnormal clinical signs were noted for any
of the rabbits. The results of the sensitization study in guinea pigs showed a sensitization response equivalent to the negative controls.

A
Food and Drug Administration (FDA) IDE approved pivotal human clinical trial began with CosmetaLife late in 2006. The clinical trial
was a randomized, double-blind, parallel assignment, multi-center comparison of the safety and efficacy of CosmetaLife versus Restylane®
(Control) for the correction of nasolabial folds. One hundred seventy-one patients were skin tested and 145 were treated at six trial
sites. The number of study exits after treatment totaled four subjects. This clinical trial was reported and published at www.clinicaltrials.gov
(NCT00414544).

The
feedback from physician investigators has been positive with respect to CosmetaLife injection qualities, cosmetic appearance, and its
feel to the touch. During the first three to four months of the study, CosmetaLife showed no decrease in efficacy, as compared to Restylane
which showed an 11 percent decrease in efficacy. The FDA/IDE approved human clinical trial for the CosmetaLife product through twelve
months was found to be the same as compared to control hyaluronic acid product, Restylane (for each interval the consensus of the blinded
subjects tested preferred CosmetaLife or showed no preference at 3, 6, 9 and 12 months).

10

We
use existing, scalable processes to reduce the infrastructure requirements and manufacturing risks to deliver a consistent, high-quality
product while being responsive to volume requirements. We are able to scale the manufacturing process having made batches in up to 2.0-kilogram
quantities to near GMP (Good Manufacturing Practices) standards.

Particles
Safety Study

Patients
injected with CosmetaLife were found to have no or mild inflammatory, irritation, or immunogenic responses. These results suggest the
particles are biocompatible because it closely matches the skin structure, composition, and moisture content. The no-to-low immunogenic
responses are attributed to the tight cross-linking of the CosmetaLife matrix, which prevents immunogenic progenitor cells from producing
antibodies to the matrix.

In
the clinical trial, the incidence of possible reaction to a skin test was 2.55 percent, with only one subject showing a reaction to a
second test or 0.6%, (1 out of 171). We also have a study report by AppTec, Inc., our Contract Research Organization, that CosmetaLife
did not produce an antibody response during the clinical trial further supporting our belief that it is safe to use.

CosmetaLife
is composed of materials that approximately meet the Generally Regarded As Safe (GRAS) requirements of the FDA. CosmetaLife contains
materials from certified bovine and porcine tissue sources that do not harbor prion disease or BSE. Additionally, steps in the manufacturing
process have been validated for deactivating all viruses.

Extrusion
force testing and the Clinical Trial usage both demonstrate the consistent and easy injection of CosmetaLife. Twenty-five month stability
testing shows that CosmetaLife is stable at room temperature conditions. Moreover, CosmetaLife has been shown to be stable at 40 °C
(104 °F) conditions for at least 3 months.

Competition

The
development and commercialization of new animal health medicines is highly competitive, and we expect considerable competition from major
pharmaceutical, biotechnology, and specialty animal health medicines companies. As a result, there are, and likely will continue to be,
extensive research and substantial financial resources invested in the discovery and development of new animal health medicines. Our
potential competitors include large animal health companies, such as Zoetis, Inc.; Merck Animal Health, the animal health division of
Merck & Co., Inc.; Merial, the animal health division of Sanofi S.A.; Elanco, the animal health division of Eli Lilly and Company;
Bayer Animal Health, the animal health division of Bayer AG; NAH, the animal health division of Novartis AG; Boehringer Ingelheim Animal
Health, the animal health division of Boehringer Ingelheim GmbH; Virbac Group; Ceva Animal Health; Vetoquinol and Dechra Pharmaceuticals
PLC. We are also aware of several smaller early stage animal health companies, such as Kindred Bio, Aratana Therapeutics Inc. (recently
acquired by Elanco), NextVet and VetDC that are developing products for use in the pet therapeutics market.

Regulation
– Human and Veterinary Use

A
number of the medical devices that we manufacture for veterinary applications, and plan to manufacture for human applications, are subject
to regulation by numerous regulatory bodies, including the FDA and comparable international regulatory agencies. These agencies require
manufacturers of medical devices to comply with applicable laws and regulations governing the development, testing, manufacturing, labeling,
marketing, and distribution of medical devices. Medical devices are generally subject to varying levels of regulatory control, the most
comprehensive of which requires that a clinical evaluation program be conducted before a device receives approval for commercial distribution.

In
the EU, medical devices are required to comply with the Medical Devices Directive and obtain CE Mark certification in order to market
medical devices. The CE Mark certification, granted following approval from an independent Notified Body, is an international symbol
of adherence to quality assurance standards and compliance with applicable European Medical Devices Directives. Distributors of medical
devices may also be required to comply with other foreign regulations such as Ministry of Health Labor and Welfare approval in Japan.
The time required to obtain these foreign approvals to market our products may be longer or shorter than that required in the U.S., and
requirements for those approvals may differ from those required by the FDA. In Europe, our devices are classified as Class IIa or IIb,
and will need to conform to the Medical Devices Regulation.

11

In
the U.S., specific permission from the FDA to distribute a new device is usually required (that is, other than in the case of very low-risk
devices), and we expect that some form of marketing authorization will be necessary for our devices. Marketing authorization is generally
sought and obtained in one of two ways. The first process requires that a pre-market notification (510(k) Submission) be made to the
FDA to demonstrate that the device is as safe and effective as, or “substantially equivalent” to, a legally-marketed device
that is not subject to pre-market approval (“PMA”). A legally-marketed device is a device that (i) was legally marketed prior
to May 28, 1976, (ii) has been reclassified from Class III to Class II or I, or (iii) has been found to be substantially equivalent to
another legally-marketed device following a 510(k) Submission. The legally-marketed device to which equivalence is drawn is known as
the “predicate” device. Applicants must submit descriptive data and, when necessary, performance data to establish that the
device is substantially equivalent to a predicate device. In some instances, data from human clinical studies must also be submitted
in support of a 510(k) Submission. If so, these data must be collected in a manner that conforms with specific requirements in accordance
with federal regulations including the Investigational Device Exemption (IDE) and human subjects protections or “Good Clinical
Practice” regulations. After the 510(k) application is submitted, the applicant cannot market the device unless FDA issues “510(k)
clearance” deeming the device substantially equivalent. After an applicant has obtained clearance, the changes to existing devices
covered by a 510(k) Submission that do not significantly affect safety or effectiveness can generally be made without additional 510(k)
Submissions, but evaluation of whether a new 510(k) is needed is a complex regulatory issue, and changes must be evaluated on an ongoing
basis to determine whether a proposed change triggers the need for a new 510(k), or even PMA. The 510(k) clearance pathway is not available
for all devices: whether it is a suitable path to market depends on several factors, including regulatory classifications, the intended
use of the device, and technical and risk-related issues for the device.

The
second, more rigorous, process requires that an application for PMA be made to the FDA to demonstrate that the device is safe and effective
for its intended use as manufactured. This approval process applies to most Class III devices. A PMA submission includes data regarding
design, materials, bench and animal testing, and human clinical data for the medical device. Again, clinical trials are subject to extensive
FDA regulation. Following completion of clinical trials and submission of a PMA, the FDA will authorize commercial distribution if it
determines there is reasonable assurance that the medical device is safe and effective for its intended purpose. This determination is
based on the benefit outweighing the risk for the population intended to be treated with the device. This process is much more detailed,
time-consuming, and expensive than the 510(k) process. Also, FDA may impose a variety of conditions on the approval of a PMA.

Both
before and after a device for the U.S. market is commercially released, we would have ongoing responsibilities under FDA regulations.
The FDA reviews design and manufacturing practices, labeling and record keeping, and manufacturers’ required reports of adverse
experiences and other information to identify potential problems with marketed medical devices. We would also be subject to periodic
inspection by the FDA for compliance with the FDA’s quality system regulations, which govern the methods used in, and the facilities
and controls used for, the design, manufacture, packaging, and servicing of all finished medical devices intended for human use. In addition,
the FDA and other U.S. regulatory bodies (including the Federal Trade Commission, the Office of the Inspector General of the Department
of Health and Human Services, the Department of Justice (DOJ), and various state Attorneys General) monitor the manner in which we promote
and advertise our products. Although physicians are permitted to use their medical judgment to employ medical devices for indications
other than those cleared or approved by the FDA, we are prohibited from promoting products for such “off-label” uses and
can only market our products for cleared or approved uses. If the FDA were to conclude that we are not in compliance with applicable
laws or regulations, or that any of our medical devices are ineffective or pose an unreasonable health risk, the FDA could require us
to notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health, order
a recall, repair, replacement, or refund of such devices, detain or seize adulterated or misbranded medical devices, or ban such medical
devices. The FDA may also impose operating restrictions, enjoin and/or restrain certain conduct resulting in violations of applicable
law pertaining to medical devices, including a hold on approving new devices until issues are resolved to its satisfaction, and assess
civil or criminal penalties against our officers, employees, or us. The FDA may also recommend prosecution to the DOJ. Conduct giving
rise to civil or criminal penalties may also form the basis for private civil litigation by third-party payers or other persons allegedly
harmed by our conduct.

12

The
delivery of our devices in the U.S. market would be subject to regulation by the U.S. Department of Health and Human Services and comparable
state agencies responsible for reimbursement and regulation of healthcare items and services. U.S. laws and regulations are imposed primarily
in connection with the Medicare and Medicaid programs, as well as the government’s interest in regulating the quality and cost
of health care.

Federal
healthcare laws apply when we or customers submit claims for items or services that are reimbursed under Medicare, Medicaid, or other
federally-funded healthcare programs. The principal federal laws include: (1) the False Claims Act which prohibits the submission of
false or otherwise improper claims for payment to a federally-funded health care program; (2) the Anti-Kickback Statute which prohibits
offers to pay or receive remuneration of any kind for the purpose of inducing or rewarding referrals of items or services reimbursable
by a Federal health care program; (3) the Stark law which prohibits physicians from referring Medicare or Medicaid patients to a provider
that bills these programs for the provision of certain designated health services if the physician (or a member of the physician’s
immediate family) has a financial relationship with that provider; and (4) health care fraud statutes that prohibit false statements
and improper claims to any third-party payer. There are often similar state false claims, anti-kickback, and anti-self-referral and insurance
laws that apply to state-funded Medicaid and other health care programs and private third-party payers. In addition, the U.S. Foreign
Corrupt Practices Act can be used to prosecute companies in the U.S. for arrangements with physicians, or other parties outside the U.S.
if the physician or party is a government official of another country and the arrangement violates the law of that country.

The
laws applicable to us are subject to change, and subject to evolving interpretations. If a governmental authority were to conclude that
we are not in compliance with applicable laws and regulations, we and our officers and employees could be subject to severe criminal
and civil penalties including substantial fines and damages, and exclusion from participation as a supplier of product to beneficiaries
covered by Medicare or Medicaid.

The
process of obtaining clearance to market products is costly and time-consuming in virtually all of the major markets in which we expect
to sell products and may delay the marketing and sale of our products. Countries around the world have recently adopted more stringent
regulatory requirements, which are expected to add to the delays and uncertainties associated with new product releases, as well as the
clinical and regulatory costs of supporting those releases. No assurance can be given that any of our other medical devices will be approved
on a timely basis, if at all. In addition, regulations regarding the development, manufacture, and sale of medical devices are subject
to future change. We cannot predict what impact, if any, those changes might have on our business. Failure to comply with regulatory
requirements could have a material adverse effect on our business, financial condition, and results of operations.

Pertaining
to our Spryng® product (offered for veterinary use only), in the U.S., the FDA does not require submission of a 510(k), PMA, or any
pre-market approval for devices used in veterinary medicine. Device manufacturers who exclusively manufacture or distribute veterinary
devices are not required to register their establishments and list veterinary devices and are exempt from post-marketing reporting. The
FDA does have regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded
or adulterated. It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices
are safe, effective, and properly labeled.

Exported
devices are subject to the regulatory requirements of each country to which the device is exported. Some countries do not have medical
device regulations, but in most foreign countries medical devices are regulated. Frequently, medical device companies may choose to seek
and obtain regulatory approval of a device in a foreign country prior to application in the U.S. given the different regulatory requirements.
However, this does not ensure approval of a device in the U.S.

Research
and Development

The
Company is currently pursuing advancements in the composition, methods of manufacture and use for its proprietary biomaterials. It is
anticipated that within the next twelve months the Company will pursue additional third-party studies related to the use of Spryng®
for the treatment of osteoarthritis in canine and equine patients. The Company also anticipates that resources will be expended to advance
and improve the manufacturing systems for Spryn® that will increase product volume and overall efficiency. Finally, the
Company anticipates that research and testing will be conducted in the next eighteen months involving the existing Spryng®
formulation and other variations to identify and determine the next commercial product(s) that may be administered to the digital cushion
of horses for the treatment of navicular disease.

13

Employees
and Human Capital

As
of July 10, 2025, we have 24 employees. We also engage outside consultants to assist with research and development, clinical development
and regulatory matters, investor relations, operations, and other functions from time to time.

The
Company believes that its success depends on the ability to attract, develop, and retain key personnel. It also believes that the skills,
experience, and industry knowledge of its employees significantly benefit its operations and performance. The Company believes that it
offers competitive compensation and other means of attracting and retaining key personnel. None of our employees are represented by a
labor union and we believe that our relationships with our employees are good.

Insurance

We
currently maintain a “life science” commercial insurance policy with coverage in the amount of $2 million for our products
and operations. The policy has been designed for those engaged in the life science business. We may face claims in excess of the limits
of such insurance. As well, claims made against us may fall outside of our coverage. The policy is a “claims made” policy.
Thus, our coverage must be maintained at the time a claim is made for us to be entitled to seek coverage from the issuer of the policy
for such claims.

Available
Information

We
make available, free of charge and through our Internet website at www.petvivo.com, our Annual Reports on Form 10-K, Quarterly Reports
on Form 10-Q, Current Reports on Form 8-K, and any amendments to any such reports filed or furnished pursuant to Section 13(a) or 15(d)
of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file such material with,
or furnish it to, the Securities and Exchange Commission (“SEC”). Reports filed with the SEC also may be viewed at www.sec.gov.
We include our website throughout this report for reference only. The information contained on or connected to our website is not incorporated
by reference into this report.