MiMedx Reports Exceptional Results in Phase 2B Clinical Trial on the Use of AmnioFix® Injectable in the Treatment of Plantar Fasciitis

MiMedx Group, Inc. (NASDAQ: MDXG), 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, announced today that it has closed enrollment in the Company's Plantar Fasciitis Investigational New Drug (IND) Phase 2B trial in accordance with an amendment filed with the Food and Drug Administration (FDA).

Based on exceptional interim results, in late June, MiMedx submitted a summary results amendment along with a formal request to the FDA for closure and unblinding of its Plantar Fasciitis Phase 2B trial. The FDA has not requested any changes to the Company's amendment. It is important to note that the FDA had previously agreed to reduce the overall follow-up duration for the Phase 2B study from 24 months to 12 months and has now accepted a further reduction in the overall follow-up duration for the Phase 3 trial to 6 months, which underlines that the product is safe.

The IND Phase 2B trial was a prospective, single-blinded, randomized, controlled trial of micronized dehydrated human amnion/chorion membrane (dhacm) injection as compared to a 0.9% Sodium Chloride USP placebo injection in the treatment of Plantar Fasciitis. In all, 14 study sites across the U.S. participated and 147 study subjects were randomized.

The results from the two-sample t-test on paired differences indicated that the difference in the two groups was considered statistically significant at 3 months with a p-value equal to 0.0001 and at six months with a p-value of 0.0005. Analysis of the groups from the baseline visit through the six-month visit utilizing a linear mixed model indicated a statistically significant difference in VAS scores trending over time with a p-value of 0.0001. The IND Phase 2B study also included a blood collection cohort of at least 40 subjects for the testing of safety. At the time of the summary report, all patients from the blood collection cohort had reached the follow-up time point of 12 months, thereby making the immune compatibility testing complete. No immune response attributable to the treatment with AmnioFix was reported.

Parker H. "Pete" Petit, Chairman and CEO, stated, "We believe this study will be a landmark one in demonstrating the impact of our dhacm micronized allografts in the treatment of a common orthopedic complaint, Plantar Fasciitis. The clinical results are extremely impressive and indicate very high statistical significance in the efficacy of micronized AmnioFix. We are looking forward to the publication of the study paper, and we expect it to be accomplished by one of the leading peer-reviewed journals."

Bill Taylor, President and COO, said, "Plantar Fasciitis is a degenerative syn¬drome of the plantar fascia. The condition may be caused by repeated trauma or overuse creating micro-tears in the plan¬tar fascia. Plantar Fasciitis is one of the most common orthopedic com¬plaints relating to the foot, affecting approximately 9% of the U.S. population with approximately one million people per year seeking medical treatment.* We believe 60% of these patients could be potential candidates to receive an AmnioFix injection, which we estimate represents approximately a $450 millionannual market opportunity for the Company.

Taylor continued, "Many different companies are supplying physicians with potential solutions for Plantar Fasciitis with little therapeutic benefit, such as PRP, steroid injections, and dry needling. AmnioFix Injectable delivers a unique combination of benefits that other therapeutic agents cannot deliver to date for pain reduction and improvement in foot function with a simple-to-use micronized form for quick preparation with a saline injection."