TWC News Update

Organogenesis Launches PuraPly Products 

Organogenesis Inc., Canton, MA, has launched its new PuraPly™ wound management products, including the first purified collagen matrix with polyhexamethylene biguanide hydrochloride (PHMB) antimicrobial agent to be cleared by the Food and Drug Administration (FDA) — PuraPly Antimicrobial (PuraPly AM).

PuraPly and PuraPly AM are the latest additions to the company’s portfolio of advanced wound care products. Both products are FDA 510(k)-cleared Class II medical devices approved for acute and chronic wound management across a variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous ulcers, and diabetic ulcers.Both PuraPly and PuraPly AM have been approved for pass-through reimbursement in the hospital outpatient setting by the Centers for Medicare and Medicaid Services, according to Organogenesis officials.

“Organogenesis is excited to be advancing healing through new wound care technologies that serve unmet needs and are available across the spectrum of wound management and healing applications,” said Gary S. Gillheeney, Sr., president and chief executive officer of Organogenesis. “With the addition of the PuraPly wound management products to our portfolio, we now offer clinicians products to treat wounds immediately when they enter their wound centers. Importantly, with PuraPly Antimicrobial, physicians have a treatment option for wounds with a high degree of bioburden. The PuraPly products can be used on most wounds that clinicians see in their centers. For diabetic ulcer and venous leg ulcer wounds that are truly chronic and do not respond to wound management, Organogenesis offers our Apligraf® and Dermagraft® bioengineered living cell-based products, the only FDA-approved wound healing therapies in the ‘skin substitute’ class.”

When used within the first four weeks of treatment, PuraPly creates an optimal environment for wounds of varying depth, regardless of severity or duration, according to Organogenesis officials. PuraPly comprises layers of inherently strong, purified, and biocompatible natural collagen matrix. PuraPly AM is unique in that it combines purified collagen with PHMB, which provides broad antimicrobial coverage that protects against a variety of bacteria that colonize wounds and can progress to biofilm formation and infection. PuraPly AM can reduce the bacterial load in the wound bed, which, if not addressed, can negatively impact tissue repair and delay healing.  

For more information, visit www.organogenesis.com.