About PetVivo Holdings

PetVivo Holdings, Inc. operates as a veterinary biotech and biomedical device company that focuses on the licensing and commercialization of medical devices and therapeutics for pets. The company primarily engages in the business of translating or adapting human biotech and medical technology into products for commercialization in the veterinary market to treat companion animals, such as dogs, horses, cats, and other animals suffering from osteoarthritis and other afflictions. The company’s initial product, Kush, is an intra-articular injection consisted of patented, gel-like biomaterials that is being commercialized for companion animal osteoarthritis. Kush is a veterinarian-administered joint injection for the treatment of osteoarthritis and lameness in dogs and horses. The Kush device is made from natural components that are lubricious and cushioning to perform like cartilage for the treatment of pain and inflammation associated with osteoarthritis. The company plans to commercialize its products in the United States through distribution relationships supported by regional and national distributors and complemented by the use of digital marketing to educate and inform pet owners; and in Europe and the rest of the world through commercial partners. The company plans to have its product distribution leverage the existing supply chain and veterinary clinic and clinician relationships already established by these large distributors. It plans to support this distribution channel with regional sales representatives. The company’s representatives will support its distributors alongside the veterinary clinics and hospitals. It will also target pet owners with product education and treatment awareness campaigns utilizing a variety of digital marketing tools. The company’s biomaterials have been through a human clinical trial and have been classified as a medical device for use as a dermal filler. Its pipeline includes 17 therapeutic devices for both veterinary and human clinical applications. Product Pipeline Below is a listing of applications of the company’s technology that it plans to commercialize or out-license to strategic partners: Dermal Filler The company’s biomaterials are constructed from purified water, protein, and carbohydrate, tailored to simulate different body tissues that biologically integrate (bio-integration). Its 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. Cardiovascular Devices The company’s 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 the company to homogeneously distribute 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 efficacy than oral dosing via swallowing. Orthopedic Devices Another of the company’s 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. Strategy A key component of the company’s strategy is the potential for an accelerated timeline to revenues for veterinary medical devices, which can enter the market earlier than the more stringently regulated veterinary pharmaceuticals or human therapeutics. Intellectual Property The company has nine issued United States Patents. In addition to the United States patent portfolio, it has twelve patents granted in key markets around the world, including Canada, Australia, and the European Union. The company has an additional application pending in the European Union. The company has developed a patent portfolio around its 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’s United States Patents include 10,016,534 – Protein Biomaterial and Biocoacervate Vessel Graft Systems and Methods of Making and Using Thereof; 9,999,705 – Protein Biomaterials and Bioacervates and Methods of Making and Using Thereof; 9,107,937 – Wound Treatments with Crosslinked Protein Amorphous Biomaterials; 8,871,267 – Protein Matrix Materials, Devices 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; 8,465,537 – Encapsulated or Coated Stent Systems; 8,153,591 – Protein Biomaterials and Biocoacervates and Methods of Making and Using Thereof; and 7,662,409 – Protein Matrix Materials, Devises and Methods of Making and Using Thereof. The company has granted and allowed 12 foreign patents. It also has 17 pending patent apps (the U.S. and Foreign). The company’s patents also include method claims covering many of the applications and uses of the biomaterials as medical devices and drug delivery systems. Its intellectual property portfolio protects its proprietary technology, including the composition of raw elements used to produce its formulations, the fabricated biomaterials and their application in end products, thereby making its material and devices much more attractive to industry partners. Research and Development For the year ended March 31, 2021, the company’s research and development expenses were $98,230. Regulation A number of the medical devices that the company manufactures for veterinary applications, and plans to manufacture for human applications, are subject to regulation by numerous regulatory bodies, including the Food and Drug Administration (FDA) and comparable international regulatory agencies. In Europe, the company’s devices are classified as Class IIa or IIb, and will need to conform to the Medical Devices Directive. 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, and various state Attorneys General) monitor the manner in which the company promotes and advertises its 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, the company is prohibited from promoting products for such ‘off-label’ uses and can only market its products for cleared or approved uses. Pertaining to the company’s Kush device (offered for veterinary use only), in the U.S., the FDA does not require submission of a 510(k), pre-market approval, or any pre-market approval for devices used in veterinary medicine.