Wound Management Technologies Gets FDA Clearance for Resorbable Bone Wax

Addison, Texas-based Wound Management Technologies Inc.’s Resorbable Orthopedic Products (ROP) subsidiary has received FDA 510(k) clearance for Hemaquell resorbable bone wax.

Hemaquell is a water soluble material that is used as a tamponade to control bleeding from bone surfaces. It is based on the multi-faceted patent that the company acquired in 2009. Hemaquell will be delivered in a unique patent-pending applicator that allows surgeons to directly apply the waxy product on bleeding bones. Unlike other non-resorbable “bone wax” hemostats, which can interfere with bone healing, the Hemaquell bone hemostasis material is completely resorbed between 2 and 7 days and does not delay healing of bone injury.

“We are extremely pleased to have this approval for Hemaquell,” said Deborah Hutchinson, president of Wound Management Technologies. “This project was headed by Barry Constantine, our director of research and development and co-inventor of the related patent. Our surgical sales team has been looking forward to the introduction of this product and we have several surgeons lined up to begin evaluation cases. This is a nice companion product for our CellerateRX Surgical powder. Hemaquell will generate additional sales opportunities for our company in the operating room.”

“This product will be valuable to control bleeding in bones during surgery,” commented Blaine Farless, M.D., medical director of Resorbable Orthopedic Products. “I look forward to working with our surgical group on the market launch and introduction of this revolutionary product.”

Wound Management Technologies’ primary focus is the distribution of its Wound Care Innovations subsidiary’s patented collagen product line CellerateRX, which is FDA-cleared for all wound types except 3rd degree burns.