In 2000, David Masters, Ph.D., a biochemist and biomaterials expert with credentials from Rutgers and Harvard, left his position at the Mayo Clinic in Rochester, Minnesota to launch Gel-Del Technologies, Inc. in St. Paul, Minnesota.
Initial seed funding was provided by a grant from the National Institutes of Health to facilitate the development of our initial biomatrix materials that deliver local anesthetics to create sustained nerve block in the treatment of chronic pain.
Ready for Market
John Lai, President of PetVivo Holdings, Inc., gives an update on the commercial readiness of the Kush® System at the SNN conference in Jupiter, Florida.
What came next...
In the development of these long-term implants, Dr. Masters recognized the many advantages of matching the implants composition to the native tissue surrounding the implant site. Furthermore, Dr. Masters recognized that these biomatrix materials exhibited no adverse effects. Therefore, the Company, now a subsidiary of PetVivo, began pursuing the development of several new product lines that utilized the Company’s proprietary biomatrix materials. In an effort to scale manufacturing, the Company developed an improved manufacturing process in 2004, which also produced a superior biomaterial that inherently possessed thermoplastic properties.
Beginning in 2005 and continuing through 2013, the National Institutes of Health awarded the Company a series of grants totaling $7M for the development of vascular grafts and other devices. The work derived from the vascular graft grant produced the completion of pre-clinical testing required for a FDA small diameter vascular graft clinical trial.
The Company determined that the easiest path to validate the safety and efficacy of the Company’s new biomatrix implant material for human use was as a dermal filler. In 2006, the FDA approved the Company’s IDE to conduct a Randomized, Double-Blind, Multicenter Dermal Filler Clinical Trial. The Company’s CosmetaLife dermal filler was injected into one side of each trial participant’s face and Restylane (Control) was injected into the other side. The blinded participants scored each naso-labial fold using the Global Aesthetic Improvement Scale and preferred the Company’s product at all trial time points.
After eight years from the date of filing an application, the United States Patent and Trademark Office issued the Company US Patent 8,153,591, entitled “Protein “Biomaterials and Biocoacervates and Methods of Making and Using Thereof. Filed in 2004, this key patent included ninety-three claims focused on many aspects of our biomatrix materials, manufacturing processes and numerous methods of use.
To date, the Company has 20 issued U.S. and foreign patents and 16 pending patent applications. Moreover, the Company has developed a large pipeline of medical devices that contain our proprietary thermoplastic protein-based biomaterials. These therapeutic devices mimic the body’s tissue to allow integration, tissue repair, and regeneration for long-term implantation.
In 2017, PetVivo Holdings, Inc. completed a merger with Gel-Del Technologies, Inc., which is now a wholly owned subsidiary of the Company. Initially, we are commercializing our technology in the animal healthcare market for the treatment of osteoarthritis, but anticipate launching other veterinary and human products in the near-term.