MINNEAPOLIS, MN / ACCESSWIRE / August 19th, 2014 / PetVivo Holdings, Inc. (OTCPINK:PETV) an emerging biomedical device company focused on the licensing and commercialization of innovative medical devices for pets, or pet therapeutics is pleased to announce the commercial launch schedule for their first three veterinary devices.
PetVivo’s lead product, Kush(tm) Canine, for the treatment of canine osteoarthritis, is scheduled for commercial launch in Q1 2015, followed shortly thereafter by Kush(tm) Equine for the treatment of lameness in horses in Q4 of 2015. The Kush(tm) Digital Cushion lameness treatment, for the repair and regeneration of equine and bovine digital cushions, is scheduled to launch in 2016.
Each of the Kush devices are similar and contain the same-patented biomaterial, thereby facilitating an expedited product roll out. This versatile biomaterial has an extensive safety and efficacy profile, including a successful human trial as an injected particulate. The Kush particles are classified as a veterinary medical device and no FDA clearance is required for veterinary medical devices.
--------------------------------------------------------------------------------------- |Indication |Species |Device |Commercial Launch| --------------------------------------------------------------------------------------- |Canine Osteoarthritis |Canine |KushTM Canine |Q1 2015 | --------------------------------------------------------------------------------------- |Equine Osteoarthritis |Equine |KushTM Equine |Q4 2015 | --------------------------------------------------------------------------------------- |Digital Cushion Lameness|Equine & Bovine |KushTM Digital Cushion|2016 | ---------------------------------------------------------------------------------------
The initial veterinary therapeutic market sectors being targeted by PetVivo are very large and growing. Our market research indicates that osteoarthritis and lameness currently impacts twenty million dogs and one million horses in the United States and Europe. Lameness also impacts the dairy industry, affecting 20% to 40% of dairy cattle.
PetVivo’s solutions for the treatment of osteoarthritis are the Kush Canine and Kush Equine devices. “Kush joint injections for osteoarthritis have the ability to provide a superior treatment to improve synovial joint function,” noted Gel-Del Technologies CEO Dr. David Masters, “Our rabbit, dog and horse studies show that our particles work safely in the joint, and can help to reduce pain and stiffness. The lubricious, cushioning and long-lasting particles used in the Kush devices can also help to allow natural healing by reducing the joint’s mechanical stress. The spongy protein-based particles are fabricated to mimic the wet composition and protective function of cartilage to provide a slippery cushion.”
Dr. Masters further explained, “Osteoarthritis is a condition with degenerating cartilage, creating joint stiffness from mechanical stress resulting in inflammation and pain. Because osteoarthritis joint stiffness and lameness worsens with time from gradual cartilage degeneration, there is an ongoing loss of protective cushion and lubricity. Our Kush particles will immediately replace the missing slippery padding in the joint. Non-steroidal anti-inflammatory drugs, NSAIDS, are used to alleviate the pain and inflammation caused by osteoarthritis, but long-term NSAIDS can cause severe gastric problems and really do not halt or slow the progression of the osteoarthritis condition. We believe our particles can provide the missing cartilage function to alleviate the pain, halt the progression of further damage, and allow native reparative healing to occur.”
The particles used to make the Kush devices are part of a large pipeline of patented animal and human therapeutics developed and manufactured by Gel-Del Technologies. PetVivo previously announced that PetVivo and Gel-Del have entered into a binding term sheet for a merger. Under the agreed upon terms Gel-Del will merge with PetVivo Holdings and upon satisfaction of certain conditions, a definitive agreement would govern the merger.
About Gel-Del Technologies, Inc:
Gel-Del Technologies (http://www.gel-del.com/) is a biomaterial and medical device manufacturing company based in St. Paul, Minnesota. The company successfully completed a pivotal clinical trial using their novel thermoplastic biomaterial as an injected dermal filler for human facial contour applications (clinicaltrials.gov NCT00414544).
Gel-Del’s core competencies include the development and manufacturing of medical devices containing its proprietary biomaterials with or without pharmaceuticals. Using its patented thermoplastic and/or compression manufacturing technologies, purified proteins and carbohydrates are accurately self-assembled and fabricated into cell supporting and tissue compatible biomaterial scaffolds. These "made from scratch" biological scaffolds have the hydrophilic biomimetic structure of the body's non-cellular tissue allowing in vivo biochemical interaction, cellular integration, neovascularization, tissue repair, and regeneration as a temporary or permanent implant. These non-soluble biomaterials are produced using a patented and reproducible-scalable process that is FDA-validated for human clinical trial production. The inherent properties of these biomaterials allow thermoplastic or liquid coating techniques to manufacture implantable devices of all shapes and sizes, including particles for injection and as drug delivery devices at any pharmaceutical dose.
About PetVivo, Inc:
PetVivo, Inc. is a wholly owned subsidiary of PetVivo Holdings, Inc. (OTCPINK:PETV) based in Minneapolis, Minnesota. PetVivo is an emerging biomedical device company focused on the licensing and commercialization of innovative medical devices and other therapeutics for pets.
PetVivo believes that it can leverage the investments in the human biomaterials and medical device industries to commercialize therapeutics to pets in a capital and time efficient way. PetVivo's strategy is to in-license proprietary products from human medical device companies specifically for use in pets. A key component of this strategy is the accelerated timeline to revenues for veterinary medical devices, which enter the market much earlier than the more stringently regulated pharmaceuticals.
Forward-Looking Statements:
The foregoing material may contain forward-looking statements. We caution that such statements may be subject to uncertainties and that actual results could differ materially from the forward-looking statements. Readers accordingly should not place undue reliance on these forward-looking statements, which do not reflect unknown or unanticipated events or circumstances occurring after the date of these forward-looking statements.
CONTACT:
John Lai
Chief Executive Officer
PetVivo Holdings, Inc.
Email: [email protected]
Phone: 612-296-7305
Source: PetVivo Holdings, Inc.