Company: PETVW
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001641172-25-018617
Chunk: 14

Company: PetVivo Holdings, Inc.
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 14
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 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