Multicenter Randomized Controlled VLU Clinical Study Published in the International Wound Journal Demonstrates Significantly Higher Healing Rates of MiMedx EpiFix®

In the Company's earlier press release of August 31, 2017, MiMedx confirmed the impressive results of this study. The study results indicate that:

• Patients treated with EpiFix showed VLU healing rates of 60% within 12 weeks and 71% within 16 weeks. Healing rate in this context means the percentage of patients that achieved complete healing.
• EpiFix showed clinical superiority over Standard of Care (SOC) in the treatment of non-healing, full thickness VLUs. Wounds treated with EpiFix were 2.26 times more likely to heal within 12 weeks than wounds treated with standard care alone.
• Results of this study are vastly superior to VLU healing rates reported in studies of other advanced wound care products.
• In the 1998 randomized study of VLU healing rates with Apligraf® conducted by Falanga, et al., a healing rate of 63% was reported at 24 weeks, which, while a separate study, nevertheless corresponds to the week 12 healing rate of 60% with EpiFix reported in this study. The healing results observed with EpiFix within 12 weeks are even more remarkable given that Falanga, et al. reported a mean wound size of 1.33 ± 2.69 cm² for Apligraf treated subjects, and excluded patients with uncontrolled diabetes and other clinically significant medical conditions that could impair wound healing. In this EpiFix study, patients with these types of comorbidities were included and mean wound size was considerably larger at 7.6 ± 6.1 cm².

"When comparing individual 12-week VLU clinical trial results of Apligraf, the other biologically active product with next largest market share behind our EpiFix allograft, EpiFix shows by far the highest percentage of patients healed in 12 weeks. Compared to the superior 60% healing rate of EpiFix, it took Apligraf twice as long to heal 45% of wounds at 24 weeks. Additionally, in the Apligraf study, significantly smaller wounds were treated, and the study excluded patients with difficult medical conditions that were included in the EpiFix study," said Petit.   

Taylor added, "With only about 30% of the commercial plans that cover EpiFix for Diabetic Foot Ulcers (DFUs) also covering EpiFix for VLUs, we expect this study will dramatically increase that ratio. We look forward to working with those commercial health plans to gain EpiFix coverage for VLUs. Conservatively, we expect our incremental annual revenue opportunity based on patients presenting with VLUs not currently covered by our commercial insurance to be between approximately $75 million and $150 million."

Petit commented, "We have demonstrated in several peer-reviewed publications that our PURION® Processed dHACM recruits stem cells, promotes migration, and modulates stem cell activity in vitro and in vivo compared to appropriate controls. Numerous randomized controlled clinical trials have demonstrated that our PURION Processed dHACM is an effective therapy for treatment of chronic wounds and to promote soft tissue healing. In addition, MiMedx's dHACM allografts are now described in an official U.S. Pharmacopeia – National Formulary monograph with the publication of USP 40 - NF 35. We believe no other competitor can come close to this level of accomplishment, nor can their and products compare with the clinical and economic effectiveness of our dHACM allografts."

Apligraf® is federally registered trademark of Organogenesis Inc. Use of this marks in this press release does not imply any affiliation with or endorsement by the trademark holder.

About MiMedx

MiMedx is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION Process among other processes, to produce safe and effective allografts.   MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement

This press release includes forward-looking statements, including statements regarding EpiFix' expected healing rates, expected expanded insurance coverage, and the expected incremental revenue opportunity.  These statements also may be identified by words such as "believe," "except," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that actual healing rates may be less than those obtained in the study, expected favorable insurance coverage decisions are delayed or do not occur, and that the market for EpiFix is less than expected.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

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SOURCE MiMedx Group, Inc.