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PetVivo Holdings, Inc. Begins Process to Pursue Approval of Biomatrix Particulate Technology for Initial Human Indication

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PetVivo Holdings receives initial regulatory assessment for its Biomatrix Particulate Technology, paving the way for regulatory approval of various indications for human products.
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  • PetVivo Holdings has received an initial regulatory assessment for its Biomatrix Particulate Technology, which could lead to the approval of human products such as dermal fillers, tendon and ligament repair devices, and dental biomaterials. This opens up new market sectors for the company.
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MINNEAPOLIS, June 21, 2023 (GLOBE NEWSWIRE) -- PetVivo Holdings, Inc. (NASDAQ: PETV & PETVW) ("PetVivo" or the “Company) an emerging biomedical device company focused on the commercialization of innovative medical devices and therapeutics for companion animals and equine announced today it has received an initial regulatory assessment from a Contract Research Organization outlining pathways to regulatory approval of various indications for its proprietary Biomatrix Particulate Technology. The regulatory assessment will assist the Company in better understanding the regulatory pathway to approval of one or more human products such as dermal fillers, tendon and ligament repair, intraarticular injectable devices, urinary incontinence bulking agents and dental – soft tissue augmentation biomaterials.

The Company’s first product that implemented the Biomatrix Particulate Technology, SPRYNG with OsteoCushion Technology, is an intra-articular injectable veterinary medical device consisting of sterilized, extra-cellular matrix microparticles; SPRYNG microparticles perform in the joint as wet, slippery micro-cushions used in the management of lameness and other joint related afflictions, such as osteoarthritis.

“As a result of our successes demonstrated by administering SPRYNG in a large number of companion animals and horses, we are highly encouraged by the prospect of enhancing the lives of people suffering from a variety of medical afflictions, such as osteoarthritis,” said John Lai PetVivo’s Chief Executive Officer. “We are looking forward to moving one or more products through the regulatory process as quickly as possible so that we can begin commercialization in a number of very large market sectors.”

The Company’s management team in cooperation with its human advisory task force anticipates regulatory plans to be completed for new human products implementing the Biomatrix Particulate Technology in the first part of calendar year 2024. The products for human use will be manufactured by PetVivo in its state-of-the-art manufacturing facility in Edina, Minnesota, which is anticipated to be opened in the fourth quarter of 2023.

For more information about PetVivo Holdings, Inc. and its innovative product, Spryng, please contact info1@petvivo.com or visit https://petvivo.com/ and https://sprynghealth.com/.

About PetVivo Holdings, Inc.

PetVivo Holdings Inc. (NASDAQ: PETV & PETVW) is an emerging biomedical device company currently focused on the manufacturing, commercialization and licensing of innovative medical devices and therapeutics for companion animals. The Company's strategy is to leverage human therapies for the treatment of companion animals in a capital and time efficient way. A key component of this strategy is the accelerated timeline to revenues for veterinary medical devices, which enter the market much earlier than more stringently regulated pharmaceuticals and biologics.

PetVivo has a pipeline of seventeen products for the treatment of animals and people. A portfolio of nineteen patents protects the Company's biomaterials, products, production processes and methods of use. The Company’s lead product SPRYNG, a veterinarian-administered, intraarticular injection for the treatment of lameness and other joint related afflictions, including osteoarthritis, in dogs and horses, is currently available for commercial sale to veterinarians.

CONTACT:

John Lai, CEO
PetVivo Holdings, Inc.
Email: info1@petvivo.com
(952) 405-6216

Forward-Looking commercial Statements:

The foregoing material may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation the Company’s proposed development and commercial timelines, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements, including the potential listing of the Company’s common stock on Nasdaq, are based on information currently available the Company and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning the Company’s business are described in detail in the Company’s Annual Report on Form 10-K for the year ended March 31, 2022 and other periodic and current reports filed with the Securities and Exchange Commission. The Company is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.


FAQ

What is PetVivo Holdings focused on?

PetVivo Holdings is an emerging biomedical device company focused on the commercialization of medical devices and therapeutics for companion animals and equine.

What is the Biomatrix Particulate Technology?

The Biomatrix Particulate Technology is a proprietary technology developed by PetVivo Holdings. It is used in the company's products for veterinary and potentially human use.

What is SPRYNG™ with OsteoCushion™ Technology?

SPRYNG™ with OsteoCushion™ Technology is an intra-articular injectable veterinary medical device developed by PetVivo Holdings. It uses the Biomatrix Particulate Technology to manage joint-related afflictions in companion animals and horses.

When will PetVivo Holdings complete regulatory plans for new human products?

PetVivo Holdings anticipates completing regulatory plans for new human products implementing the Biomatrix Particulate Technology in the first part of calendar year 2024.

Where will the human products be manufactured?

The human products will be manufactured by PetVivo Holdings in its state-of-the-art facility in Edina, Minnesota, which is expected to open in the fourth quarter of 2023.

How can I get more information about PetVivo Holdings and its products?

For more information about PetVivo Holdings and its innovative product, Spryng, you can contact info1@petvivo.com or visit their official websites.

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Medical Devices
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United States of America
Edina