gel-e Receives US FDA Clearance To Expand Its Bandage Product Line For Rx And OTC Use
gel-e Inc., a privately held, clinical-stage medical device company, announces the 510(k) clearance of its adhesive bandage by the U.S. Food and Drug Administration (FDA) for prescription (Rx) and over-the-counter (OTC) use.
This new bandage clearance expands the Company's label to include the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision, this new adhesive bandage may be used for the management of pressure sores, diabetic ulcers, leg ulcers, donor sites and graft sites, surgical wounds, skin abrasions and lacerations, 1st and 2nd degree burns and traumatic wounds. No medical supervision is required for usage in the management of minor cuts, minor scalds and 1st degree burns, and minor abrasions and lacerations. This newly cleared bandage complements gel-e's existing vascular closure device cleared for the "management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes."
"This clearance is the next step in expanding our external wound product line, and will be a key component of gel-e's 21stCentury First Aid Kit™," said Elsa Abruzzo, Head of Regulatory at gel-e. "We are developing a tool kit for clinicians and caregivers that will provide the best possible options for all manner of chronic and acute wounds and injuries. This bandage represents just the first tool in the kit."
gel-e's technology platform harnesses the natural characteristics of an abundant and inexpensive natural polysaccharide. Through proprietary modifications, this advanced biopolymer is designed to be a durable, biocompatible, and highly functional tool for the treatment of human wounds and injuries.