PolyRemedy Enhances Personalized Woundcare System with FDA Clearance of Antimicrobial Dressings

PolyRemedy, a provider of personalized wound care systems, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its antimicrobial dressings. The company also announced that, in a separate review, the Centers for Medicare and Medicaid Services (CMS) has confirmed reimbursement codes for custom-sized and custom-shaped wound dressings.

Customized dressings comprise the therapeutic portion of PolyRemedy’s integrated Personalized Woundcare SystemTM (PWS) which also includes expert, protocol-driven wound assessment and dressing selection tools, as well as real-time feedback and alert notification throughout the wound healing process. PWS allows clinicians and nurse managers to monitor patient progress, respond to clinical alerts and changes in wound trajectory, and communicate effectively with referring physicians and primary care physicians.

The PolyRemedy Personalized Woundcare System enhances the consistency of wound care by advancing expert clinical workflows and delivering the right therapy to the right patient at the right time.

Unlike dressings that deliver antibiotic agents, PolyRemedy’s PolyFIT™ antimicrobial dressings promote an enhanced wound-healing environment without causing resistance to specific bacteria for which they are targeted. Embedded with a 0.3% concentration of Polyhexamethylene Biguanide (PHMB), PolyFIT dressings are specifically designed for managing wound exudate and microbial proliferation within the dressing, while maintaining a moist wound environment. PHMB is uniquely bonded to proprietary PolyRemedy micro-fibers to ensure an optimal healing environment while reducing bioburden.

“In many healthcare environments, particularly home health care, dressings are left on wounds for extended periods of time,” according to Dr. Diane Cooper, Medical Director and Chief of Clinical Affairs at PolyRemedy. “PolyFIT dressings’ antimicrobial properties are important in preventing accumulating bacteria from replicating in the dressing and potentially reducing odor.”

“The PolyRemedy Personalized Woundcare System enhances the consistency of wound care by advancing expert clinical workflows and delivering the right therapy to the right patient at the right time,” said Mark Carbeau, President and CEO at PolyRemedy. “FDA approval and CMS confirmation mark significant milestones in our effort to bring advanced polymer science and wound care research directly to the point of care with an intuitive, easy-to-use application accessible via mobile devices.”