GNBT - FDA Approval
Wound Conforming Gel Matrix with Three Dosage Options
Plans Commercial Launch of three dosing options for Excellagen in pre-filled syringes
The 0.5 cc and 0.8 cc and 3.0 cc doses provide optimal wound coverage while reducing waste and costs
3 cc dose has utility in surgical applications for the treatment of larger wounds and surgical incisions
In negotiations with major surgical wound care networks for treatment of diabetic foot ulcers, venous stasis ulcers, and difficult to heal wounds
Nationally Renowned Wound Care Thought Leader, Dr. Peter A. Blume of Yale School of Medicine, provides insight
January 11, 2019 09:00 AM Eastern Standard Time
MIRAMAR, Fla.--(BUSINESS WIRE)--Generex Biotechnology Corporation (OTCQB:GNBT) is pleased to announce that Olaregen Therapeutix Inc., a subsidiary of Generex Biotechnology will launch three doses of FDA 510K-Cleared Excellagen, the company’s wound conforming gel matrix that is designated as a Cellular & Tissue Based Product or CTP for wound healing. The 0.5 cc and a 0.8 cc syringes will be utilized to treat smaller wounds such as diabetic foot ulcers, venous stasis ulcers, and pressure ulcers, and in patients who have undergone MOHs surgery for removal of cancerous tissue. The 3 cc syringe has been developed for larger wounds that are most frequently seen in emergency departments, operating rooms, and surgical suites. Excellagen has a designated reimbursement code in the Healthcare Common Procedure Coding System, with a unique Q Code designation 4149 referred to as a skin substitute.
“We’ve heard time and again about the issue of waste, or the need for multiple applications per a single procedure because the existing products don’t necessarily accommodate the size of the wound. This is not only time consuming for the doctor but is cost inefficient”
