Royer Biomedical Receives Approval to Test Polymer Delivery System
Royer Biomedical, Inc. (RBI) recently announced it 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.”
Royer Biomedical, Inc. is a mid-stage biotechnology enterprise targeting novel drug delivery systems. RBI has developed proprietary bioabsorbable polymer hydrogel technology for topical and internal controlled release of a wide variety of pharmaceuticals, including antibiotics, chemotherapeutic agents, and local anesthetics. The various polymer and calcium-based matrix formulations have extensive patent protection in the
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