Wrong.. According to GNBT's Press release they were FDA Cleared
Generex Biotechnology Subsidiary Olaregen Therapeutix Inc. Plans Launch of FDA Cleared Excellagen® Wound Conforming Gel Matrix with Three Dosage Options
Press Release | 01/11/2019
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.
