Canton, MA, March 4, 2019 – Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced that a new case series published in Plastic and Reconstructive Surgery – Global Open suggests PuraPly® Antimicrobial (PuraPly AM) positively affects the course of healing in a variety of complex, chronic wounds that were previously unresponsive to treatment.
The case series, “Use of Native Type I Collagen Matrix Plus Polyhexamethylene Biguanide for Chronic Wound Treatment” was conducted by Alisha R. Oropallo, MD, FACS, APWCA, et al, of Northwell Health Department of Surgery in Lake Success, New York. Dr. Oropallo tested the efficacy of PuraPly AM – referred to as PCMP in the study – in managing pressure ulcers, surgical wounds, venous ulcers, diabetic ulcers, and other types of wounds.
“The purpose of this case series was to assess the extent to which PuraPly AM helped meet wound-specific treatment goals on wounds that had not responded to conventional therapies, likely due to bioburden,” said Dr. Oropallo. “Our findings show that Puraply AM indeed appears to positively impact the course of healing across a variety of complex chronic wounds, resulting in a wound environment that is conducive to wound area reduction and complete wound closure. We shared results of two subsets of wounds in this study at the 2018 Symposium on Advanced Wound Care.”
Of the 41 wounds studied, 73% demonstrated a reduction in wound area at 12 weeks. Thirty-seven percent of the wounds studied achieved complete wound closure, with a mean time of 6.7 weeks to complete closure.
“This case series confirms what many clinicians already know firsthand: PuraPly AM is an innovative and important technology in the fight against non-healing wounds,” said Gary S. Gillheeney, Sr., President and CEO of Organogenesis. “Given the tremendous burden these wounds impose on patients and the healthcare system, we are proud to offer a product that helps clinicians address a critical barrier to wound healing.”
“An increasing body of clinical evidence demonstrates that appropriate use of PuraPly AM can lead to improved wound healing outcomes, which should allow patients to achieve a better quality of life in a shorter time frame,” said Shabnam Vaezzadeh, MD, MPA, Vice President of Global Medical & Clinical Affairs for Organogenesis. “We are pleased that so many respected clinicians are conducting research on PuraPly AM and sharing their clinical outcomes with the wider medical community.”
Organogenesis Holdings Inc. sponsored the case series.
About PuraPly Antimicrobial
PuraPly AM is an FDA 510(k)-cleared Class II medical device indicated for acute and chronic wound management across a wide variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, and venous and diabetic ulcers. It is available in a range of sizes to meet the needs of a variety of wound types.
PuraPly AM utilizes a novel technology—purified native collagen matrix embedded with polyhexamethylene biguanide, or PHMB, a broad-spectrum antimicrobial. This unique combination of native collagen and PHMB helps manage the reformation of biofilm while supporting healing across a wide variety of wound types, regardless of severity or duration.
About Organogenesis Holdings Inc.
Organogenesis Holdings Inc. is a leading regenerative medicine company offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis’s comprehensive portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts for future events and include statements regarding the potential effectiveness of PuraPly AM. 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,” 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. Although they 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.