Organogenesis Announces FDA Clearance for PuraPly MZ

Regenerative medicine company Organogenesis announced on August 15 that PuraPly MZ , an extension of the brand’s PuraPly portfolio, has received 510k Clearance from the US Food and Drug Administration (FDA). The new product leverages the properties of the company’s PuraPly technology in a micronized (powdered) form, giving surgeons an innovative option for dealing with complex surgical wounds. 

The native structured collagen in PuraPly MZ is crafted for maximum coverage and ideal contact with wound surfaces to promote healing and can be used for a range of wounds, including partial- and full-thickness wounds, venous, diabetic, and chronic vascular ulcers, surgical wounds, trauma wounds, and partial-thickness burns. According to the press release, “Of the 40 to 50 million surgeries in the United States each year, up to 28% of surgical sites must be left open to heal. To support clinicians and patients with these complex post-surgical wounds, Organogenesis developed PuraPly MZ, a powder that is designed to support wound healing in deep, tunneling, and complex wounds.”

Gary S. Gillheeney, Sr, President and chief executive officer of Organogenesis, noted, “Securing FDA Clearance for PuraPly MZ is a significant milestone for the company as we continue to expand into the surgical and sports medicine market,” adding that the new solution represents the company’s “commitment to delivering innovative advanced technologies that improve surgical outcomes and patient experience.”