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SOURCE MiMedx Group, Inc.
MARIETTA, Ga., Sept. 24, 2013 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that Dr. Gary Stanziano has joined MiMedx as the Company's Vice President of Medical Affairs.
In his new role, Dr. Stanziano will focus primarily on interfacing with health plans to facilitate broader reimbursement for MiMedx products. "Dr. Stanziano is very knowledgeable in the navigation of the complex healthcare reimbursement system," said Parker H. "Pete" Petit, Chairman and CEO. "He brings a wealth of experience in working with health plans to collaborate on developing effective reimbursement policy and guidelines that ensure reimbursement for appropriate clinical indications and procedures. I have previously worked with Gary for nearly twenty years and have admired his professionalism, clinical expertise and business acumen."
Dr. Stanziano previously served as the Vice President of Medical Affairs at Matria Healthcare for twenty years, initially serving in that capacity with Matria's predecessor company, Healthdyne, Inc., and later serving in the same role with Alere, Inc., Matria's successor company. Dr. Stanziano was instrumental in establishing and sustaining Matria's on-going relationships with a large number of health plans that included nearly 1,000 commercial health plan contracts. Dr. Stanziano received his M.D. from the Medical College of Georgia School of Medicine in Augusta, Georgia. He earned a BS degree in Biology and a BS degree in Electrical Engineering from The Georgia Institute of Technology.
"Bringing Dr. Stanziano to our organization will allow Dr. Don Fetterolf, our Chief Medical Officer, to focus the majority of his attention on our clinical studies and clinical programs. As we have previously communicated, we have numerous studies that are in progress, just beginning, or in the planning stages. Dr. Fetterolf is an expert in the design, evaluation, reporting and analytics of clinical studies, and his expert focus on these matters will benefit us later in 2014 and 2015," added Bill Taylor, President and COO.
In addition to Dr. Fetterolf and Dr. Stanziano, the MiMedx team of Medical Directors consists of Dr. Christopher Clare, who serves as the Company's Consulting Medical Director for Neuroscience, and Dr. Paul Davis, III, who serves as the Company's Consulting Medical Director for Orthopedics. "MiMedx is fortunate to have an accomplished team of Medical Directors with in-depth experience in a wide-range of medical disciplines. Dr. Clare and Dr. Davis provide medical consultation and clinical study advice in their respective specialties, and are vital contributors to these two growth areas for the Company's products," commented Petit. "Each of our Consulting Medical Directors is well respected in his medical field of specialty, and together they provide MiMedx with insight and perspectives relating to two very important medical areas where our dehydrated human amnion/chorion membrane (dHACM) allografts can provide improved clinical and economic outcomes."
The contemplated clinical studies will support future reimbursement initiatives for our Section 361 allografts serving these specialties," said Taylor. "Also, as we have stated for over a year, we expect that some future tissue products may be regulated outside of the Section 361 regulatory pathway. These products may need approval via the FDA's Biologics License Applications (BLA) process, which also would require clinical studies."
Dr. Clare is a recognized thought leader and former practicing physician in the field of neurosurgery and the treatment of spinal injuries. He brings a comprehensive understanding of healthcare issues from the perspective of the practitioner, administrator and executive. Dr. Clare has retired as a practicing physician. His career includes a fellowship in Neurovascular Surgery at Barrow Neurologic Institute in Phoenix, Arizona. He practiced at Piedmont Hospital and St. Joseph's Hospital in Atlanta, Georgia and served as Chief of Neurosurgery at Shepherd Center in Atlanta, Georgia. Dr. Clare earned a Bachelor of Science degree in Biology from Colgate University and earned his M.D. degree from the Medical University of South Carolina with a specialty in Neurosurgery.
Dr. Davis is a practitioner in the field of orthopedics and brings a comprehensive understanding of population health, disease management and predictive health to his orthopedics specialty. Currently, Dr. Davis is CEO and Founder of North Star Health, Inc., an Atlanta, Georgia based health information technology company serving self-insured employers. He founded North Star Health in 2006. Prior to North Star Health, Dr. Davis served as principal executive and Orthopedic Surgeon of Peachtree Sports Medicine Center, a private clinic providing orthopedic medical services to injured athletes, which Dr. Davis founded in 1989. Dr. Davis earned a Bachelor of Science degree in Biology from Southern Methodist University, received his M.D. degree from Louisiana State University Medical Center, and earned a Master of Business Administration degree from Emory University Goizueta Business School.
MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. "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 include AmnioFix® and EpiFix®, our tissue technologies processed from human amniotic membrane that is derived from donated placentas. Through our donor program, mothers delivering full-term Caesarean section births can elect in advance of delivery to 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, effective and minimally manipulated implant for homologous use. MiMedx® is the leading supplier of amniotic tissue, having supplied over 170,000 allografts to date to distributors and OEMs for application in the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
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 the impact of Dr. Stanziano's and Dr. Fetterolf's respective focus on Company results and reimbursement for the Company's products, the impact of the medical consultation and clinical study advice from Drs. Clare and Davis, and the improved clinical and outcomes provided by the Company's dHACM allografts. 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 the potential that Dr. Stanziano's and Dr. Fetterolf's respective focus will not have the anticipated impact on the Company's results or reimbursement for the Company's products, the impact of the medical consultation and clinical study advise from Drs. Clare and Davis will not materialize as anticipated, and the clinical and economic outcomes resulting from the use of the Company's dHACM allografts will not be achieved, 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, 2012, and the Company's most recent Form 10-Q. 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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