Healthcare Industry News: demineralized bone matrix
News Release - May 17, 2016
MiMedx Files Lawsuit Against Osiris For False And Misleading RepresentationsMARIETTA, Ga., May 17, 2016 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today that it has filed a lawsuit under the Lanham Act against Osiris Therapeutics, Inc. for permanent injunctive relief and damages.
The lawsuit asserts that in Osiris' press release of May 2, 2016, Osiris knowingly and willfully made false and misleading representations about a retrospective database analysis review. The lawsuit further asserts that Osiris 1) deliberately used inadequate clinical study standards to produce a biased and contrived report; 2) knew that its review did not meet any of the accepted clinical standards of a comparative effectiveness study; and 3) conspired with the physician responsible for the study to retrospectively select unmatched, uncontrolled, and subjective variables, as well as nonrandomized, noncomparable, and highly variable study groups to create a report that intentionally misleads the public. The suit was filed in the United States District Court for the Southern District of New York.
Parker "Pete" H. Petit, Chairman and CEO of MiMedx, stated, "The press release that Osiris published on their retrospective review was an absolute disservice to advanced wound care, the patients, the professionals who serve these patients and the payer community. This type of pseudoscience serves no one."
"MiMedx invests millions of dollars annually on rigorous scientific and clinical studies. These studies document the clinical and cost effectiveness of our allografts and are published in numerous clinical and scientific peer-reviewed journals," added Bill Taylor, President and COO.
Petit added, "Unfortunately, this press release is yet another item on the growing list of issues that Osiris has had of late. Osiris also publicly disclosed that it is under investigation by the Securities and Exchange Commission related to its historical accounting practices, which impact financial reporting to the public. Additionally, over the last several years, Osiris has had three different Chief Executive Officers, two different Chief Financial Officers, two different Chief Medical Officers, and three different outside Auditors. Further, Osiris had a Sales Executive who pled guilty to Department of Justice charges of conspiracy to commit criminal conflicts of interest, bribery and health care fraud during his tenure with another company."
"This type of behavior needs to be discredited or it will continue. The filing of our lawsuit is essential to stop this egregious behavior. I would encourage all participants in this sector of healthcare to reject this type of misinformation. Patients who are so much in need of advanced therapies and their attending physicians should not be deceived. Organizations that conduct themselves with honesty and integrity always eventually prevail," stated Petit.
MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues and human skin and bone. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies are AmnioFix®, EpiFix®, OrthoFlo, Physio®, AlloBurn™, and CollaFix™. AmnioFix and EpiFix are our tissue technologies processed from human amniotic membrane derived from donated placentas. Elected in advance of delivery through our donor program, a mother delivering a healthy baby via scheduled full-term Caesarean section birth may donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 600,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. We recently introduced OrthoFlo, an amniotic fluid derived allograft for homologous use. Amniotic fluid is donated by a consenting mother delivering a full-term healthy baby by scheduled Caesarean section. Through the recent acquisition of Stability Biologics, our newest proprietary platforms include Physio, a unique bone grafting material comprised of 100% bone tissue with no added carrier, thus maximizing bone forming potential, a demineralized bone matrix (DBM) to complement our product portfolio offerings within the Orthopedic market and AlloBurn, a skin product for burns. CollaFix, our next technology platform we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair. CollaFix is the only biological, biodegradable, biomimetic technology that matches human tendon in strength and stiffness. The Company's wholly-owned subsidiary, Stability Biologics, LLC, is accredited by the American Association of Tissue Banks (AATB) and registered with the FDA. The Company distinguishes its revenue in two primary regenerative medicine specialties of "Wound Care" and "SSO." The Company defines SSO as surgical, sports medicine and orthopedics with spinal procedures included in orthopedics and abdominal, and lower pelvic procedures included in surgical.
Safe Harbor Statement
This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, that the filing of this lawsuit is essential to stopping the offending behavior. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the lawsuit may not be successful or may not otherwise stop the offending behavior, the normal risks of litigation, and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2015. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.
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