FDA approves RBI’s AppliGel-G for human testing

Royer Biomedical, Inc. (RBI) received FDA approval to proceed with Human Testing of AppliGel-G (Gentamicin) in management of Diabetic Foot Ulcers (DFU). AppliGel is a patented proprietary dissolvable non-immunogenic Polymer Drug Delivery System Platform. It has demonstrated efficacy in biofilm and infection eradication, without significant systemic API levels.

"This represents an important milestone in the development of AppliGel," said William Wolf, MD, RBI's President and CEO. "We are excited at the prospect of helping diabetics and their Physicians in the management of this difficult and limb-threatening disorder. We look forward to gaining final approval for topical, injectable, and implantable drug delivery applications for antibiotics, chemotherapeutics, and analgesics to address DFU, Cancers, and other conditions requiring sustained medication in a dissolvable platform without immunogenic reaction or the need for removal. Our AppliGel polymer platform's shelf stability, ease of application, and ability to deliver pharmaceuticals without significant adverse effects has been well-demonstrated in the veterinary world, and the prospect of collaborating with Johns Hopkins University Hospital and Georgetown University Hospital to improve patient outcomes in Cancer and Diabetes is truly exciting."