Company: PETVW
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001493152-25-023398
Chunk: 61

Company: PetVivo Holdings, Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Part I, Item 2
Chunk 61
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 with infectious
disease screening, donors are tested for blood type and plasma antibody to red blood cells, providing a low risk of transfusion reaction.
At the request of the FDA, two randomized placebo-controlled safety studies were conducted in dogs and horses. There
were no treatment-related adverse events reported in dogs or horses after treatment with PrecisePRP™.

“This
is a game changer for veterinarians and their ability to treat their patients with PRP”, said Mike Eldred, PetVivo Board Member.
“This innovative, and FDA reviewed product, will be a great addition to Spryng® with OsteoCushion® technology,
and supports our strategy to be the leader in veterinary medical devices and regenerative medicine.”

Distributors

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.

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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