News Releases Details

Scientific Advisory Board Adds Multi-disciplinary Clinical and Scientific Expertise to Support Acceleration of the Company’s mdHACM Placental Biologics Pipeline

MARIETTA, Ga., July 27, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a transformational placental biologics company, today announced the formation of a Regenerative Medicine Scientific Advisory Board (RMSAB) to provide guidance on the Company’s regenerative medicine clinical pipeline initiatives and support its focus on placental biologics innovation. The RMSAB, comprised of renowned industry and academic experts across the fields of tissue engineering, osteoarthritis, orthobiologics, musculoskeletal diseases, and regenerative medicine, will provide external scientific and clinical perspectives and high-level counsel on the Company’s micronized dehydrated Human Amnion Chorion Membrane (mdHACM) injectable pipeline in Knee Osteoarthritis (KOA), as well as other important indications that could benefit from regenerative medicine therapeutics.

Timothy R. Wright, MIMEDX Chief Executive Officer, said, “The prestigious group of thought leaders we have assembled to contribute on our Scientific Advisory Board will provide MIMEDX with extensive and recognized expertise as we work to advance a deep and diversified pipeline of a new category of medicine – placental biologics. Working in collaboration with these industry and academic pioneers strengthens our ability to rapidly accelerate scientific innovation, expand our therapeutic potential across multiple indications, and further our vision to advance regenerative science and innovative biologics that restore quality of life for patients in need of safe and effective treatment options.”

Robert B. Stein, M.D., Ph.D., MIMEDX President, Regenerative Medicine and Biologics Innovation, added, “We are pleased to bring together this distinguished group of advisors to help us optimize the clinical applicability, scientific rigor, and overall value of our placental biologics pipeline. These individuals have pioneered significant clinical and scientific contributions in their respective fields. Together, I believe we can accelerate our path forward to registering and developing best-in-class treatment options for patients suffering from osteoarthritis and other debilitating conditions.”

The founding members of the MIMEDX Regenerative Medicine Scientific Advisory Board include:

• Kris Alden, MD, PhD, Orthopaedic Surgeon, Hip, Knee & Shoulder Reconstruction
• Anthony Atala, MD, G. Link Professor and Director of the Wake Forest Institute for Regenerative Medicine, and the W.H. Boyce Professor and Chair of Urology
• Asger Bihlet, M.Sc., Pharmacy, Chief Scientific Officer, Nordic Bioscience Clinical Development A/S
• Eric Carson, MD, Chair of Orthopaedics, U.S. Veteran’s Hospital, Washington University School of Medicine
• Constance Chu, MD, Professor and Vice Chair Research, Orthopedic Surgery at Stanford University; Director of the Joint Preservation Center and Chief of Sports Medicine at the VA Palo Alto
• Philip Conaghan, MBBS, PhD, FRACP, FRCP, Professor of Musculoskeletal Medicine; Director of the Leeds Institute of Rheumatic and Musculoskeletal Medicine
• Robert Guldberg, PhD, Vice President and Leona DeArmond Executive Director of the Knight Campus for Accelerating Scientific Impact, University of Oregon
• Olga Kubassova, PhD, Chief Executive Officer, Image Analysis Group
• Regis O’Keefe, MD, PhD, Chair of Orthopaedic Surgery, Washington University School of Medicine
• Scott Rodeo, MD, Orthopedic Surgeon and Clinician-Scientist at Hospital for Special Surgery; Professor of Orthopedic Surgery at Weill Cornell Medical College
• Vibeke Strand, MD, Adjunct Clinical Professor, Division of Immunology and Rheumatology, Stanford University School of Medicine
  

RMSAB Member Credentials and Qualifications

• Kris Alden, MD, PhD, Orthopaedic Surgeon, Hip, Knee & Shoulder Reconstruction is a board-certified orthopaedic surgeon who is fellowship trained in hip and knee reconstruction. He completed a dual degree program in which he received his M.D. and Ph.D. concurrently at the University of Illinois at Chicago. His Ph.D. thesis in biophysics garnered the Outstanding Thesis Award for research excellence upon his graduation. He was additionally awarded the Kate and Michael Barany Award for outstanding research and scholarship. He is also affiliated with the American Academy of Orthopaedic Surgeons and American Association of Hip and Knee Surgeons. Dr. Alden completed his residency in orthopaedic surgery at the Johns Hopkins Hospital in Baltimore, Maryland, before undertaking his fellowship in adult hip and knee reconstruction at the Mayo Clinic in Rochester, Minnesota. While there, he trained in the latest approaches to hip and knee replacement, minimally invasive surgery, and complex revision joint replacement. With a particular interest in using innovative techniques, Dr. Alden strives to achieve the best results for active patients with hip and knee arthritis, offering both non-surgical and surgical treatment of arthritis and related conditions. In addition, he has a special interest in complex revision surgeries including direct anterior hip revision surgery, distal femur replacement, and total femur replacement for the treatment of orthopaedic related conditions. He is active in orthopaedic education and clinical research and has trained surgeons in novel techniques for primary and revision hip and knee replacement surgeries throughout North America and Europe.
  
• Anthony Atala, MD, is the G. Link Professor and Director of the Wake Forest Institute for Regenerative Medicine, and the W.H. Boyce Professor and Chair of Urology. Dr. Atala is a practicing surgeon and a researcher in the area of regenerative medicine. Dr. Atala is editor of three journals, 25 books, and has published over 800 journal articles, having received over 250 national and international patents. He was elected to the Institute of Medicine of the National Academies of Sciences, to the National Academy of Inventors as a Charter Fellow, and to the American Institute for Medical and Biological Engineering. Dr. Atala is a recipient of several awards, including the U.S. Congress funded Christopher Columbus Foundation Award, the World Technology Award in Health and Medicine, the Edison Science/Medical Award for innovation, the R&D Innovator of the Year Award, and the Smithsonian Ingenuity Award for Bioprinting Tissue and Organs. Dr. Atala’s work was listed twice as Time Magazine’s Top 10 medical breakthroughs of the year, and once as one of five discoveries that will change the future of organ transplants. Other accolades include being named one of the world’s most influential people in biotechnology by Scientific American, and one of 14 pioneers of Medical Progress in the 21^st Century by U.S. News & World Report. Dr. Atala has led or served several national professional and government committees, including the National Institutes of Health working group on Cells and Developmental Biology, the National Institutes of Health Bioengineering Consortium, and the National Cancer Institute’s Advisory Board. He is a founding member of the Tissue Engineering Society, Regenerative Medicine Foundation, Regenerative Medicine Manufacturing Innovation Consortium, Regenerative Medicine Development Organization, and Regenerative Medicine Manufacturing Society.
  
• Asger Bihlet, M.Sc., Pharmacy, Chief Scientific Officer, Nordic Bioscience Clinical Development A/S is an internationally renowned expert in osteoarthritis (OA) drug development, OA pain, and clinical trial design. After receiving his MSc. in pharmaceutical sciences from the University of Copenhagen, Mr. Bihlet has held several leading positions in pharma and clinical research organizations within regulatory affairs, medical affairs, and clinical science. He has published more than 25 peer-reviewed papers on OA science in high-ranking journals and has been cited more than 1,000 times. Mr. Bihlet has played key roles in the design and conduct of landmark osteoarthritis trials, including the sprifermin FORWARD trial published in JAMA in 2019, and is a frequent speaker at OARSI, EULAR, and ACR conferences, where more than 50 original abstracts have been presented, in addition to invited speaker sessions on OA trial design and placebo response mitigation. As Chief Scientific Officer, he currently leads the scientific affairs activities of Sanos Group and the subsidiary of NBCD A/S, a Contract Research Organization specializing in OA clinical trials. As chief scientist, he was the person primarily responsible for the design and conduct of three global phase III, 15 phase II and five phase I trials totaling approximately 10,000 study participants evaluating experimental treatments primarily within knee osteoarthritis. Mr. Bihlet is actively researching in the fields of osteoarthritis with a particular focus on optimizing clinical methodology and outcome.
  
• Eric Carson, MD, Chair of Orthopaedics, U.S. Veteran’s Hospital, Washington University School of Medicine earned his medical degree from the University of Illinois College of Medicine in Chicago. He completed a residency in Orthopaedic Surgery at Harvard University combined Orthopaedic Surgery Program in Boston, before joining the faculty at Harvard’s Brigham and Women’s Hospital as a Clinical Instructor and Chief Resident in Orthopaedic Trauma Surgery. He then completed his fellowship in Sports Medicine/Shoulder at Cornell University’s Hospital for Special Surgery in New York. During this time, he assisted in the orthopaedic care of the NFL New York Giants. Dr. Carson served as an Assistant Professor of Orthopaedic Surgery at Emory University in Atlanta, before accepting a position as an Associate Professor of Orthopaedic Surgery and Chief of Sports Medicine at LSU Medical Center in New Orleans. He later worked in private practice at a busy multi-specialty orthopaedic surgery practice in Atlanta, while serving as an adjunct Clinical Instructor with Emory University. Dr. Carson then served as an Associate Professor of Orthopaedic Surgery at the University of Virginia in Charlottesville, where he was a team physician for the University of Virginia Cavaliers. He currently is a full professor and Vice Chairman of Diversity, Equity, and Inclusion at Washington University School of Medicine in St. Louis, Missouri. He also serves as the Chief of Orthopaedic Surgery at the St. Louis John Cochran Veterans Administration Hospital. In addition to his accomplished background in orthopaedics, Dr. Carson served in the United States Army Reserve Medical Corp and was deployed three times during his service. Additionally, he serves as an Olympic team orthopaedic surgeon for the United States National Rowing Team. 
• Constance Chu, MD, Professor and Vice Chair Research, Orthopedic Surgery at Stanford University; Director of the Joint Preservation Center and Chief of Sports Medicine at the VA Palo Alto graduated from the U.S. Military Academy at West Point and earned her medical degree from Harvard Medical School. Her clinical practice focuses on the knee, primarily restoration and reconstruction of the ACL, menisci and cartilage. Previously, she was the Albert Ferguson Endowed Chair and Professor of Orthopaedic Surgery at the University of Pittsburgh where she was recognized as a Castle-Connelly/U.S. News and World Report “Top Doctor” in Orthopedic Surgery and on Becker’s list of Top Knee Surgeons in the United States. Dr. Chu is a leading surgeon-scientist who has had continuous federal funding for more than 20 years as principal investigator of projects funded by the National Institutes of Health, the Department of Defense, and the Veterans Administration for her work on joint and cartilage rejuvenation to transform the clinical care of osteoarthritis from palliation to prevention. Dr. Chu regularly holds leadership and committee positions in major professional organizations, including the American Association of Orthopedic Surgeons (AAOS) and the American Orthopedic Association (AOA). In her subspecialty of Orthopedic Sports Medicine, she is a past President of the Forum Sports Focus Group, a member of the Herodicus Society of leaders in Sports Medicine, past Chair of the American Orthopedic Society for Sports Medicine (AOSSM) and Co-Chair of the AOSSM Diversity Task Force.
  
• Philip Conaghan, MBBS, PhD, FRACP, FRCP, Professor of Musculoskeletal Medicine, is Director of the Leeds Institute of Rheumatic and Musculoskeletal Medicine (a EULAR Centre of Excellence) at the University of Leeds and Deputy Director of the NIHR Leeds Biomedical Research Centre. His research focuses on understanding pathogenesis and developing effective therapies for common arthritis and joint problems, especially osteoarthritis. He is an executive member of the international outcomes group, OMERACT. He previously chaired UK NICE osteoarthritis clinical guidance and was inaugural Chair of the EULAR Standing Committee on Musculoskeletal Imaging. He is co-editor of the Oxford Textbook of Rheumatology and has authored/co-authored over 650 publications as original research, reviews, and book chapters. He has received the international Carol Nachman award for Rheumatology and the OARSI Clinical Research award.
  
• Robert Guldberg, PhD, Vice President and Leona DeArmond Executive Director of the Knight Campus for Accelerating Scientific Impact, University of Oregon is a serial entrepreneur and internationally renowned bioengineer. Dr. Guldberg’s research focuses on musculoskeletal mechanobiology, regenerative medicine, and orthopaedic medical devices. In his 25+ year academic career, Dr. Guldberg has produced over 270 peer-reviewed publications, served as an advisor and board member for numerous biotechnology companies, and co-founded six start-ups. He was previously executive director of the Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Tech from 2009-2018 and, in 2018, was selected to lead the Knight Campus as its inaugural permanent Executive Director. At the national level, Dr. Guldberg is past Chair of the Americas Chapter of the Tissue Engineering and Regenerative Medicine International Society (TERMIS-AM). He currently serves on the Executive Leadership Council of the Wu Tsai Human Performance Alliance, a $220 million global initiative to promote wellness and peak performance through scientific discovery and innovation. Dr. Guldberg is an elected fellow of TERMIS, the American Society of Mechanical Engineers (ASME), the American Institute for Medical and Biological Engineering (AIMBE), the Orthopaedic Research Society (ORS), and the National Academy of Inventors (NAI).
  
• Olga Kubassova, PhD, Chief Executive Officer, Image Analysis Group (IAG) is a founder and a CEO at IAG, biotech investor and mathematician. She is author of 200+ publications focused on the use of radiological imaging, novel technologies, and Artificial Intelligence to aid drug development programs and precision medicine initiatives. Dr. Kubassova is an active contributor within the scientific community. She is a member of scientific advisory boards for blue-chip companies and start-ups, reviewer for international journals and scientific adviser to the UK government and EU funding bodies. She is a fellow of the Royal Society of Medicine and Royal Society of Engineering. Born in Kazakhstan, she received her Ph.D. in Computer Science in 2007 from University of Leeds, UK, Master’s in Mathematics from St. Petersburg State University, and her Master’s in IT from Lappeenranta University of Technology Finland. 
  
• Regis O’Keefe, MD, PhD, Chair of Orthopaedic Surgery, Washington University School of Medicine is an orthopaedic surgeon specializing in musculoskeletal oncology and adult reconstructive surgery of the hip and knee. Dr. O’Keefe received his medical degree from Harvard Medical School in 1985 and completed a surgical internship from Harvard Medical School/New England Deaconess Hospital in 1986. He served as an Instructor/Fellow of Research at the University of Rochester, School of Medicine and Dentistry until 1988, where he then went on to complete an orthopaedic surgery residency at the University of Rochester Medical Center in 1992. He then completed a Fellowship in Orthopaedic Oncology from the Massachusetts General Hospital in 1993. In 2000, he pursued a doctorate degree in biochemistry and biophysics from the University of Rochester, School of Medicine and Dentistry. Prior to arriving at Washington University School of Medicine, Dr. O’Keefe served as the Marjorie Strong Wehle Professor and the Chairman of the Department of Orthopaedics and Rehabilitation at the University of Rochester School of Medicine and Dentistry in Rochester, NY. Dr. O’Keefe is a member of the American Academy of Orthopaedic Surgeons, American Association for the Advancement of Science, American Board of Orthopaedic Surgeons, American Orthopaedic Association, American Society of Bone and Mineral Research, Association of American Physicians, Association of Osteobiology, Musculoskeletal Tumor Society, Orthopaedic Research Society, and Siteman Cancer Center.
  
• Scott Rodeo, MD, Orthopedic Surgeon and Clinician-Scientist at Hospital for Special Surgery; Professor of Orthopedic Surgery at Weill Cornell Medical College is an Attending Orthopedic Surgeon and Clinician-Scientist at HSS, with appointments in the Department of Orthopedic Surgery (Sports Medicine Institute) and the Research Department (Tissue Engineering, Repair, and Regeneration Program). He is Professor of Orthopedic Surgery at Weill Cornell Medical College and Co-Chief Emeritus of the Sports Medicine Institute at HSS. He specializes in sports medicine for injuries of the knee, shoulder, ankle, and elbow. He also performs arthritis surgery of the knee and shoulder, including joint replacement surgery, and has specific expertise in complex knee reconstruction, treatment of shoulder instability, and rotator cuff tendon repair. His research focuses on the basic biology of tendon and ligament healing, meniscal allograft transplantation, and rotator cuff repair. Dr. Rodeo cares for elite, professional, and everyday athletes. He was associate team physician of the New York Giants Football Team after 2000 and became head team physician after 2015. In 2004 and 2008 he served as Team Physician for USA Swimming and returned to this position for the London 2012 Olympic Games. As a former competitive swimmer himself, Dr. Rodeo works with USA Swimming and various swimming programs where he helps to promote injury prevention and treats injured swimmers of all ages.
• Vibeke Strand, MD, Adjunct Clinical Professor, Division of Immunology and Rheumatology, Stanford University School of Medicine has served as an adjunct clinical professor in the Division of Immunology and Rheumatology at Stanford University School of Medicine since 1993, previously at UCSF. Since 1991, she has led a consulting practice offering clinical research and regulatory strategy expertise to pharmaceutical and biotech companies for development of new therapies in rheumatic diseases. She has participated in the development of all the approved biologic agents and targeted synthetic DMARDs in RA, as well as new therapies for PsA, SpA, SLE, vasculitis, gout, biosimilars and symptomatic therapies in OA. She was previously a clinical investigator in subspecialty practice in San Francisco for six years, and senior director of clinical research at three pharmaceutical/biotech companies for six years. She has authored more than 490 publications, is a Fellow of the American College of Physicians (1982), Master of the American College of Rheumatology (2015) and member of the Cosmos Club (1994). She has been a member of the Executive Committee of the international Outcomes in Rheumatology Clinical Trials (OMERACT) consensus conferences since its inception in 1992; Steering Committee of Group for Research and Assessment of PsO and PsA (GRAPPA); and Board of International Dermatology Outcome Measures (IDEOM).
  

About MIMEDX

MIMEDX is a transformational placental biologics company, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare. As a pioneer in placental tissue engineering, we have both a commercial business, focused on addressing the needs of patients with acute and chronic non-healing wounds, and a promising late-stage pipeline targeted at decreasing pain and improving function for patients with degenerative musculoskeletal conditions. We derive our products from human placental tissues and process these tissues using our proprietary methods, including the PURION® process. We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts. MIMEDX has supplied over two million allografts, through both direct and consignment shipments. For additional information, please visit www.mimedx.com.

Important Cautionary Statement

This press release includes forward-looking statements, such as statements regarding our belief that, together with the members of our RMSAB, we can accelerate our path forward to registering and developing best-in-class treatment options for patients suffering from osteoarthritis and other debilitating conditions. Additional forward-looking statements may be identified by words such as "believe," "expect," "may," "plan," “goal,” “outlook,” "potential," "will," "preliminary," and similar expressions, and are based on management's current beliefs and expectations.

Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause actual results to differ from expectations include: (i) future sales are uncertain and are affected by competition, access to customers, patient access to healthcare providers, and many other factors; (ii) the status, timing, results, and expected results of the Company’s clinical trials, planned regulatory submissions and regulatory approvals, and our expectations regarding our ability to potentially accelerate the timing of any trial or regulatory submission, depend on a number of factors including favorable trial results, patient access, and our ability to manufacture in accordance with Current Good Manufacturing Practices (CGMP) and appropriate chemistry and manufacturing controls; (iii) the Company may change its plans due to unforeseen circumstances, or delays in analyzing and auditing results, and may delay or alter the timeline for future trials, analyses, or public announcements; (iv) our access to hospitals and health care provider facilities could be restricted as a result of the ongoing COVID-19 pandemic or other factors; (v) the results of scientific research are uncertain and may have little or no value; (vi) our ability to sell our products in other countries depends on a number of factors including adequate levels of reimbursement, regulatory approvals, market acceptance of novel therapies, and our ability to build and manage a direct sales force or third party distribution relationship; (vii) the effectiveness of amniotic tissue as a therapy for particular indications or conditions is the subject of further scientific and clinical studies; and (viii) we may alter the timing and amount of planned expenditures for research and development based on the results of clinical trials and other regulatory developments. The Company describes additional risks and uncertainties in the Risk Factors section of its most recent annual report and quarterly reports filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release, and the Company assumes no obligation to update any forward-looking statement.

Contacts

Investors:
Jack Howarth
Investor Relations
404-360-5681
jhowarth@mimedx.com

Media:
Hilary Dixon
Corporate & Strategic Communications
404-323-4779
hdixon@mimedx.com