Biomerix, a developer of implantable medical devices, has received the FDA 510k clearance to market Revive.
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Constructed using the Biomerix Biomaterial, Revive acts as a tissue scaffold facilitating rapid tissue ingrowth and can be utilized in a variety of soft tissue repair procedures, including the repair of inguinal hernias, the company said.
The company has initiated a market launch of Revive in the US through a small direct sales force and plans to expand the group over time as additional products are brought to market.
Kenneth Hayes, president and CEO of Biomerix, said: “The company plans to launch numerous products across a range of therapeutic areas by capitalizing on its novel Biomerix Biomaterial platform technology. Revive is specifically designed to support tissue remodeling by enhancing the soft tissue wound healing process and thereby improves clinical outcomes.”
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