Press & Announcements
Organogenesis Announces Launch of PuraPly™ Antimicrobial Clinical Research Program
Multi-site, prospective studies, and a patient registry, commence across the country with a total of 440 patients to be enrolled
CANTON, Mass. ‐ March 27, 2017 - Organogenesis Inc., a global leader in advanced wound care innovations and technologies, today announced the launch of a PuraPly™ Antimicrobial (PuraPly™ AM) clinical research program which will comprise multiple studies and a nationwide patient registry.
The first studies, led by Drs. Harold Brem, Chief of Wound Healing & Regenerative Medicine and Scott Gorenstein, Clinical Director at the Wound Healing Center at Winthrop-University Hospital in Mineola, N.Y; and Dr. Alisha Oropallo, Director, Comprehensive Wound Healing Center and Hyperbarics at Northwell Health System in Lake Success, N.Y. will follow PuraPly AM treated patients for up to 12 weeks and have begun enrolling patients.
PuraPly™ AM is a class II medical device that has been 510(k) cleared by the US Food and Drug Administration (FDA), and is intended for the management of both acute and chronic wounds; and as an effective barrier to resist microbial colonization within the wound dressing and reduce microbes penetrating through the dressing. PuraPly Antimicrobial consists of a bi-layered purified Type I collagen sheet, coated with the broad spectrum antimicrobial agent polyhexamethylenebiguanide hydrochloride (PHMB).
The studies at Winthrop-University Hospital and Northwell Health System seek to better understand PuraPly AM’s utilization as an antimicrobial wound management product and subsequent healing outcomes across a variety of wound types. The two New York based studies will also assess PuraPly AM’s ability to meet wound-specific treatment goals, including management of bioburden, support of granulation tissue formation, and support of wound closure.
"Up until now, we’ve seen encouraging case studies showing individual patient results following treatment with PuraPly AM," stated Dr. Brem. "While those studies have yielded valuable information, the completion of this 100 patient prospective research program will provide wound care clinicians with important clinical data regarding how PuraPly AM is utilized in various wound types and the associated clinical outcomes."
"We are very excited to be at the forefront of this important research initiative to further our understanding of this unique product," stated Dr. Oropallo. "With biofilm being implicated in the majority of chronic wounds, a product like PuraPly AM holds great promise and we look forward to generating data to assess the clinical benefit."
In addition to these studies, a new patient registry, titled Real-World Effectiveness Study of PuraPly™ AM On Wounds (The RESPOND Registry), has begun patient enrollment. The registry will enroll 300 patients at up to 30 U.S. sites.
The prospective nationwide RESPOND Registry will examine and assess the use of PuraPly™ AM in real world clinical settings. Study objectives seek to evaluate the effectiveness of PuraPly™ AM as an antimicrobial wound management product as indicated by percent reduction in wound size, time to complete wound closure and improvements in wound bed condition as indicated by an increase in healthy granulation tissue, reduction in biofilm and readiness for advanced therapy applications such as FDA-approved Apligraf® or Dermagraft®. Patients will be followed for these outcomes for up to 24 weeks.
The RESPOND Registry will also collect patient reported pain and quality of life information before and after the use of PuraPly AM, as well as economic outcome information.
"Organogenesis is committed to developing and manufacturing innovative products backed by sound clinical research and scientific data, that serve our customers’ needs," noted Gary S. Gillheeney, Sr., President & CEO of Organogenesis. "We look forward to sharing the valuable findings of both the PuraPly Antimicrobial clinical research program and the RESPOND registry with the entire wound care community."
Massachusetts-based Organogenesis Inc. is a global leader in advanced wound care innovation and technologies, including bio-active wound healing and tissue regeneration. The company’s mission is to bring safe and effective wound care products to patients and to standardize their use in everyday medical care. Among Organogenesis’ suite of products are FDA-approved Apligraf® and Dermagraft®, the best-in-class products for bio-active wound healing, and recently introduced FDA-cleared PuraPly Antimicrobial™, which advances wound management for a wide variety of wound types. For more information, please visit www.organogenesis.com.