Remedium Technologies, a medical device company and University of Maryland spin-out advancing the standard of care for treating uncontrolled hemorrhage, today announces the 510(k) clearance of its Hemogrip™ Patch by the U.S. Food and Drug Administration (FDA).
Hemogrip™ Patch, the company's lead product, is indicated for use at vascular access sites, where it rapidly controls bleeding that occurs when accessing veins or arteries for various medical treatments and applications.
"Hemogrip™ Patch is an important and cost-effective tool for hospitals to quickly halt hemorrhaging at the sites of vascular procedures, reduce treatment costs and minimize patient stays," said Matthew Dowling, Ph.D., CEO of Remedium Technologies.
The Hemogrip™ platform technology is based upon chitosan, an abundant and inexpensive natural biopolymer found in the exoskeleton of crustaceans. Chitosan is biocompatible, anti-microbial, and durable under a wide range of environmental conditions. When applied to wounds, Hemogrip™ creates a nano-scale, three-dimensional mesh, rapidly coagulating blood and staunching blood loss.
"This is a significant regulatory milestone for us," said Tim Askew, a Remedium Technologies investor and board member. "It shows that the FDA is comfortable with this new technology platform and opens the door for us to raise money, build out the product pipeline, and enter into distribution relationships."