Major milestone for PolyNovo for FDA clearance of wound care innovation

Latest News

The US FDA has granted 510(k) clearance for PolyNovo's (ASX:PNV) NovoSorb MTX which provides soft tissue regeneration for the management of complex wounds.

PolyNovo said MTX leverages the technology platform underpinning the clinical success of its BTM, but without a sealing membrane.

The product was developed to satisfy clinician demand for a product for use in indications where the sealing membrane is not required, it said, adding MTX is complimentary to BTM and expands its advanced wound care portfolio for the treatment of soft tissue deficits.

With MTX, a wound can be closed either with a skin graft or allowed to heal by contraction and formation of an epithelial layer. PolyNovo said this can simplify wound management and presents wider applications for common wound healing problems.

MTX is indicated for use in partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic and vascular ulcers, diabetic ulcers, and surgical and trauma wounds, offering clinicians greater versatility in wound management.

PolyNovo said the MTX product portfolio expands its addressable market in the US by an estimated $500 million.

According to plastic surgeon Associate Professor Marcus Wagstaff, who is PolyNovo's medical director, “MTX is a synthetic dermal substitute comprised of NovoSorb foam providing a scaffold for wound healing across deep, complex structures such as bone and tendon.

"For wounds that do not require temporising or protection from contraction, there is a clear clinical need for MTX. It is best suited in cases where wound contraction and reduced time to healing are preferred, such as diabetic and venous ulcers, and smaller traumatic or postsurgical wounds (for example after excision of skin cancer). MTX promises clinicians ease of use and simplicity as a one-step procedure.”

CEO Swami Raote added, “The creation of MTX is an exciting example of surgeon-led product development that opens a significant new market for us. We are proud to bring MTX to US surgeons and patients, and believe a product specifically designed for use in a single-stage procedure will leverage and expand our penetration of the advanced wound care space. We expect clinicians to carry BTM and MTX and provide them a richer tool kit for patient care. We aim to quickly put MTX in the hands of Key Opinion Leader surgeons.”