April 17, 2018, 2am ET from Solsys Medical, LLC
NEWPORT NEWS, VIRGINIA, April 17, 2018 – Solsys Medical, LLC (“Solsys”) (formerly known and doing business as Soluble Systems, LLC) (“Soluble Systems”), which markets TheraSkin®, a cellular and tissue based product for regenerative wound healing, announced today that it has filed a lawsuit against Organogenesis, Inc. (“Organogenesis”) to stop Organogenesis from continuing to make false and misleading representations in the wound care market that have been misleading Solsys’ current and potential customers. The suit was filed in the United States District Court for the Eastern District of Virginia (Newport News Division).
TheraSkin is a minimally-manipulated human tissue product that contains the relevant human biological components needed to treat slow-healing or chronic wounds. Post-market studies of TheraSkin have confirmed that the product safely and effectively treats diabetic foot ulcers (“DFUs”) and venous leg ulcers (“VLUs”). For example, a retrospective study of 188 patients treated at the Inova Wound Center in Mount Vernon, Virginia found that approximately 60% of DFUs and VLUs had closed by 12 weeks of treatment with TheraSkin, and roughly 75% of DFUs and VLUs had closed after 20 weeks of treatment with TheraSkin.
Organogenesis manufactures Apligraf®, a competing product for regenerative wound healing, that comprises both human and bovine tissue and cellular components and that is indicated for use in the treatment of certain DFUs and VLUs. The Complaint alleges that Organogenesis has been engaging in false and misleading advertising of Apligraf in the wound care market in violation of the federal Lanham Act and the Virginia Code. The Complaint challenges the underlying Organogenesis-funded retrospective study on which these claims are based. Specifically, the Complaint alleges that the study, whose authors are all current or former Organogenesis representatives, contains numerous methodological errors and omissions that call into question the validity of the study’s findings. Solsys CEO Allan Staley explained that the Company “filed this false advertising lawsuit to stop Organogenesis from intentionally and improperly trying to mislead our current and potential customers.” According to Mr. Staley, “TheraSkin provides a value-based model in advanced wound care and provides healing speed and wound closure with few applications. Solsys has invested significant time and money into marketing TheraSkin, and we will pursue all appropriate legal avenues to protect our brand from false and misleading statements, and unfair competition.”
Mr. Staley added that pursuing legal action against Organogenesis “is consistent with our brand commitment to our customers to provide honest and ethical clinical evidence to facilitate decisions that are in the best interests of patients. Our Company will not tolerate false and misleading marketing claims by any company that serve only to undermine the trust of health care professionals and payors and interfere with their ability to make informed treatment, coverage and payment decisions, particularly those premised on a biased, false and misleading study.”
Solsys Medical, LLC is represented by E. John Steren and Gail Javitt of Epstein Becker & Green, P.C.
About Solsys Medical, LLC: Solsys Medical, LLC™ (formerly known and doing business as Soluble Systems, LLC) markets a regenerative medical product under the brand name TheraSkin®, designed to help healthcare professionals treat difficult to heal and chronic wounds.
About TheraSkin: TheraSkin is a clinically proven, minimally manipulated, cryopreserved
human skin allograft containing the relevant human biological components needed to treat
difficult to heal and chronic wounds.
For more information on TheraSkin and Solsys Medical, LLC, visit www.solsysmedical.com