MARIETTA, Ga., Dec. 23, 2015 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today that the most recent peer-reviewed comparative clinical study of MiMedx EpiFix® allografts compared to Organogenesis Apligraf®, has been published. The study, "Treatment of Chronic Diabetic Lower Extremity Ulcers with Advanced Therapies: a Prospective, Randomised, Controlled, Multi-Centre Comparative Study Examining Clinical Efficacy and Cost," was electronically published in the International Wound Journal.
The paper was authored by Charles M. Zelen, DPM FACFAS; Thomas E. Serena, MD FACS; Lisa Gould, MD PhD; Lam Le, MD; Marissa J. Carter, PhD, MA; Jennifer Keller, DPM; and William W. Li, MD. The publication is expected to follow in a future issue of the International Wound Journal. The Early View electronic publication of the study in the International Wound Journal is now available in the Wiley Online Library at http://onlinelibrary.wiley.com/doi/10.1111/iwj.12566/pdf.
The previously published "A Prospective, Randomized, Controlled, Multi-Centre Comparative Effectiveness Study of Healing Using Dehydrated Human Amnion/Chorion Membrane Allograft, Bioengineered Skin Substitute, or Standard of Care for Treatment of Chronic Diabetic Lower Extremity Ulcers," analyzed data from 60 patients enrolled in a prospective, randomised, controlled, parallel group, multi-center clinical trial1 and showed that MiMedx dehydrated human amnion/chorion membrane (dHACM) allograft, EpiFix, is superior to standard wound care (SWC) and Organogenesis, Inc.'s Apligraf in achieving complete wound closure within 4 and 6 weeks. Rates and time to closure at a longer time interval, and factors influencing outcomes remained unassessed; and therefore, the study was continued to achieve analysis of at least 100 patients.
Highlights of this new 100 patient, 12 week multicenter, randomized, controlled, comparative effectiveness trial include:
- Patients treated with EpiFix had superior rate of wound healing and significantly faster rate of wound closure than patients treated with Apligraf.
- 97% of wounds treated with EpiFix achieved complete wound closure within the 12-week study period, compared to 73% with Apligraf and 51% with SWC (adjusted P = 0⋅00019).
- Treatment with EpiFix resulted in a 51% faster mean time-to-heal within 12 weeks compared to Apligraf. EpiFix mean time-to-heal within 12 weeks was 23.6 days, compared to 47.9 days with Apligraf, and 57.4 days with SWC alone (adjusted P = 3⋅2 x 10−7).
- Median number of grafts used per healed wound was 2.5 for patients treated with EpiFix, compared to 6 for the Apligraf patients (adjusted P= 0.003).
- Wounds treated with EpiFix healed more rapidly and at a lower cost compared to wounds treated with Apligraf.
- Median graft cost was $1,517 per healed wound in the EpiFix group, compared to $8,918 per healed wound for the Apligraf group (P<0⋅0001).
- Level 1 published evidence supports the use of EpiFix dHACM for the treatment of chronic wounds.
Parker H. "Pete" Petit, Chairman and CEO, stated, "In this most recent published study, substantially fewer grafts were required to achieve complete closure in the EpiFix group resulting in an average reduction in cost of graft material of 68.3% compared with the Apligraf group. Patients treated with EpiFix had a superior rate of wound healing and a more rapid rate of wound closure than those treated with Apligraf while utilizing an average of 42.7% fewer grafts and 94.4% fewer square centimeters of graft material. These results are statistically significant which is very important as to how the chief medical officers of health plans view the relevance of the publication relative to reviewing new coverage decisions."
The proportion of wounds achieving complete closure within the 12-week study period was 97% for EpiFix, 73% for Apligraf and 51% for SWC, respectively. Patients treated with Apligraf were less likely to heal than those treated with EpiFix. Mean time-to-heal within 12 weeks were 47.9 days with Apligraf, 23.6 days with EpiFix, and 57.4 days with SWC alone. Median numbers of grafts used per healed wound were 6 and 2.5 for the Apligraf and EpiFix groups, respectively. Median graft cost was $8,918 per healed wound for the Apligraf group and $1,517 per healed wound in the EpiFix group. The results of this randomized controlled comparative effectiveness study provide further evidence of the clinical and resource utilization superiority of EpiFix compared to Apligraf for the treatment of lower extremity diabetic wounds. The prospective, randomized multi-center design of the current comparative effectiveness study eliminates many issues that can occur when data collected outside of a research setting are examined retrospectively, including potential selection bias, the inability to control for confounding factors, and irregular data quality. Clinicians depend upon high quality evidence collected in well-designed randomized controlled trials, such as this current study, to advance clinical practice and provide the best proven patient care.
Bill Taylor, President and COO, said, "In conclusion, patients treated with EpiFix dHACM exhibited the highest rates of complete healing and faster wound healing than those treated with Apligraf or SWC. EpiFix was significantly more cost effective than Apligraf in this study due to the fewer number of grafts required to achieve complete healing and the ability to use a graft which is closer in size to the wound being treated which leads to less wastage of graft material. The results of this comparative effectiveness study are useful in providing guidance to clinicians regarding expectations of clinical outcomes with the use of EpiFix compared to Apligraf and SWC. More rapid healing of chronic lower extremity ulcers in patients with diabetes reduces both direct and indirect costs. These data and study conclusions are important for administrators and payers in their evaluation of the cost effectiveness of advanced wound care products."
Apligraf® is a registered trademark of Organogenesis, Inc.
1 Zelen CM, Gould L, Serena TE, Carter MJ, Keller J, Li WW. A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers. Int Wound J. 2015 Dec;12(6):724-32. doi: 10.1111/iwj.12395. Epub 2014 Nov 26.
MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies are AmnioFix®, EpiFix®, CollaFix™ and OrthoFlo. AmnioFix and EpiFix are our tissue technologies processed from human amniotic membrane derived from donated placentas. Elected in advance of delivery through our donor program, a mother delivering a healthy baby via scheduled full-term Caesarean section birth may donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 500,000 allografts to date for application in the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. The Company has recently introduced OrthoFlo, an amniotic fluid derived allograft for homologous use. Amniotic fluid is donated by a consenting mother delivering a healthy baby by scheduled full-term Caesarean section births. CollaFix™, our next technology platform we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair. CollaFix™ is the only biological, biodegradable, biomimetic technology that matches human tendon in strength and stiffness. The Company distinguished its revenue in two primary regenerative medicine specialties of "Wound Care" and "SSO." The Company defines SSO as surgical, sports medicine and orthopedics with spinal procedures included in orthopedics and abdominal and lower pelvic procedures included in surgical.
Safe Harbor Statement
This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to the continuing clinical and cost benefits of EpiFix over Apligraf and standard wound care, the comparative quality of the design of this clinical study and the evidence collected, and that the results of this clinical study will impact new coverage decisions by health plans. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that that changes in the Apligraf product will close or eliminate the gap in clinical and cost effectiveness; these clinical study results may not have the desired impact on new coverage decisions by health plans or have any impact at all, other studies may be conducted with different design, different evidence, and/or different results, and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2014 and its most recent Form 10Q filing. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.
SOURCE MiMedx Group, Inc.