Company: PETVW
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001641172-25-018617
Chunk: 4

Company: PetVivo Holdings, Inc.
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 4
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 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