510(k) Clearance for Wound Dressing

NovaBone Products Receives 510(k) Clearance for Wound Dressing for the Advanced Wound Market

NovaBone’s Wound Matrix is a fully resorbable, sterile, single-use device intended for the management of partial and full-thickness wounds; pressure, venous, diabetic and chronic vascular ulcers; and tunneled, surgical, trauma and draining wounds.

“We are thrilled to obtain FDA clearance for Wound Matrix. This is our first product in the Advanced Wound Care market. Our core technology platforms of Bioactive glass and collagen combined with our manufacturing capability, uniquely position us to provide this differentiated product in the wound care space,” said Sameer Paranjpe, VP R&D and Operations at NovaBone.

NovaBone’s Wound Matrix is an advanced wound care device comprised of Type I bovine tendon collagen and bioactive glass. It is provided as a porous scaffold that can imbibe fluids, making it easy to combine with saline or water. The bioactive glass serves as a structural reinforcement to facilitate handling of the device. Once hydrated, the Wound Matrix device becomes compressible while providing a highly conformable three dimensional porous matrix for placement into the surgical site. Wound Matrix resorbs over time and can be replaced as needed by qualified clinicians.

NovaBone is currently looking for commercial partners for distribution of its Wound Matrix.

Learn more at Novabone.com.

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