MARIETTA, GA, USA I August 2, 2017 I 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
SOURCE: MiMedx Group
Post Views: 24
MARIETTA, GA, USA I August 2, 2017 I 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
SOURCE: MiMedx Group
Post Views: 24
