Organogenesis Receives FDA Clearance for Next Generation PuraPly Surgical Solution

Rhea-AI Summary

Organogenesis Receives FDA Clearance for PuraPly MZ

On August 15, 2022, Organogenesis announced the FDA clearance of PuraPly MZ, an innovative powdered product for complex surgical wounds. This marks a significant milestone as it expands their PuraPly portfolio into the surgical and sports medicine markets. PuraPly MZ utilizes native structured collagen to enhance healing in complex wounds, addressing a pressing need in the medical community, with estimates indicating that 28% of surgical sites in the U.S. require specific attention for effective healing.

Positive

• FDA clearance for PuraPly MZ expands product offerings in the surgical field.
• PuraPly MZ addresses a significant market need for complex surgical wound care.

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• None.

PuraPly MZ is an Innovative Product for Complex Surgical Wounds

CANTON, Mass., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Organogenesis, a leading regenerative medicine company, today announced it has received U.S. Food and Drug Administration (FDA) 510k Clearance for PuraPly MZ, a brand extension to the PuraPly product portfolio. PuraPly MZ leverages the innovative properties of our PuraPly technology engineered into a micronized (powdered) form to provide surgeons with an option for complex surgical wounds.

“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,” said Gary S. Gillheeney, Sr., President and chief executive officer of Organogenesis. “We are very pleased to provide surgeons addressing complex surgical wounds with access to this extension of our widely used PuraPly technology. This new solution demonstrates Organogenesis’s commitment to delivering innovative advanced technologies that improve surgical outcomes and patient experience.”

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. PuraPly MZ consists of native structured collagen that is designed to allow for maximum coverage and maintenance of optimal contact with the contours of the wound surface to support healing.

Organogenesis offers a variety of solutions for the advanced wound care and surgical and sports medicine markets. For information on all Organogenesis’s wound care solutions, visit Organogenesis.com.

About Organogenesis Holdings Inc.
Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding adoption by surgeons of PuraPlyMZ for the treatment of complex surgical wounds. These forward-looking statements relate to expectations or forecasts for future events. Forward-looking statements may be identified by the use of words such as "will," "forecast," "intend," "seek," "target," "anticipate," "believe," "expect," "estimate," "plan," "outlook," "extend," "continue" and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. Important factors that could cause actual outcomes to differ materially from those indicated by these forward-looking statements include (1) to be commercially successful, Organogenesis must convince physicians that our products are safe and effective alternatives to existing treatments and that our products should be used in their procedures and (2) other risks and uncertainties described in Organogenesis’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2021 and its subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.  

FAQ

What is PuraPly MZ and why is it important?

PuraPly MZ is a powdered product developed by Organogenesis for treating complex surgical wounds, leveraging innovative collagen technology.

When did Organogenesis receive FDA clearance for PuraPly MZ?

Organogenesis received FDA clearance for PuraPly MZ on August 15, 2022.

How does PuraPly MZ support wound healing?

PuraPly MZ is designed to maximize coverage and maintain optimal contact with complex wound surfaces, supporting healing.

What market does Organogenesis aim to penetrate with PuraPly MZ?

Organogenesis aims to expand into the surgical and sports medicine markets with PuraPly MZ.