Company: PETVW
Filing Date: 2025-02-14
Form Type: 10-Q
Source: 0001493152-25-006783
Chunk: 44

Company: PetVivo Holdings, Inc.
Filing Date: 2025-02-14
Form: 10-Q
Item: Part I, Item 1
Chunk 44
---
 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.

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. We expect this university clinical study to be completed in March 2024. Additionally, the Company successfully completed
an equine tolerance study in March 2022 and began two canine clinical studies with Ethos Veterinary Health, the first beginning in May
of 2022 with anticipated completion in October 2023, and the second beginning 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.

29

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 of our production capacity,
and expand our research and development facilities.

We
also have a pipeline of 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.

RESULTS
OF OPERATIONS