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

Wednesday, August 2, 2017   (0 Comments)
Posted by: Kristen Pappaterra
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MiMedx Reports Exceptional Results in Phase 2B Clinical Trial on the Use of AmnioFix® Injectable in the Treatment of Plantar Fasciitis

 

MARIETTA, Ga.Aug. 2, 2017 /PRNewswire/ -- 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.  

IND Phase 2B Study Interim (Efficacy) Top Line Results

Efficacy When Compared to Baseline

AmnioFix Injectable
Group

Placebo Group

P Value

Mean VAS Reduction at 3 months

77.5%

45.7%

p = 0.0001

Mean VAS Reduction at 6 months

85.9%

57.1%

p = 0.0005

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 syn­drome of the plantar fascia. The condition may be caused by repeated trauma or overuse creating micro-tears in the plan­tar fascia.  Plantar Fasciitis is one of the most common orthopedic com­plaints 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 million annual 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." 

Conference Call 
MiMedx previously announced that it will host a live broadcast on Monday, August 7, 2017 at 2:00 p.m. eastern time.  Additional information regarding this study and its interim results will also be included in that broadcast. A listen-only simulcast of the MiMedx conference call will be available online at the Company's website at www.mimedx.com.  A 30-day online replay will be available approximately one hour following the conclusion of the live broadcast.  The replay can also be found on the Company's website at www.mimedx.com.

About MiMedx 
MiMedx® is a biopharmaceutical company developing and marketing regenerative 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 900,000 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

*Reference: Riddle DL, Schappert SM, Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors, Foot Ankle Int. May 2004;25(5):303-10) and Millennium Report 2013

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. 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 unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, 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.


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