Extremity wounds are debilitating and complex. When critical structures are not exposed, extremity wounds can be managed with conservative measures such as local wound care or skin grafting. However, exposure of bone and tendon precludes the use of conservative wound care and skin grafting. Without soft tissue reconstruction, osteomyelitis leads to amputation 50% of the time, and tendon rupture results in loss of function. For years, free flap reconstruction has been the gold standard for limb salvage. The high technical expertise required for consistent free flap limb salvage poses a barrier for patient access to care, and not all patients are suitable candidates. Additionally, microsurgical free flaps in the lower extremity have an 8% failure rate, 75% of which proceed to amputation. Reliable alternatives to free flap reconstruction that lead to stable wound closure are needed. Extremity wounds with exposed critical structures, including bone and tendon, are a major burden on the American health care system with limited treatment options.
The authors of the paper developed a novel limb salvage technique using dHACM to generate granulation tissue over critical structures with exposed bone and tendon, and then definitively closed the wounds with split-thickness skin grafts ("STSG"). During the case series period from November 5, 2014, through March 30, 2015, seven patients underwent dHACM plus STSG limb salvage. Patients ranged from 8 to 64 years of age. Wounds included two with exposed tendons, three with exposed bone, and two with exposed bone and tendon. One of the seven patients was lost in follow-up, and no outcome results could be collected and measured for that patient.
Highlights of this case series include:
- dHACM and STSG were successful in all six of the patients with data collected and measured;
- None developed infection during dHACM treatment, STSG, or in the postoperative phase, even in the cases where initial antibiotic treatment was inadequate due to bacterial resistance;
- All wounds remain stably closed;
- Authors conclude that dHACM plus STSG is a viable, low-cost alternative to free flap reconstruction;
- Authors note that additional advantages of this modality include:
- Potential decreased time of hospital stay;
- Avoiding immobility for the patient;
- Avoiding need for intensive care unit monitoring; and
- Decreased need of ancillary services including nursing and physical therapy.
Parker H. "Pete" Petit, Chairman and CEO commented, "We are always gratified when leading physicians and prominent institutions independently examine the clinical efficacy and economic advantages of our amniotic allografts in medical treatments. The authors have indicated that future studies will be conducted to include a randomized controlled trial ("RCT"), and will be aimed at timing of treatment and analyzing the cost utility of our allografts and STSG in comparison to free flap reconstruction."
Bill Taylor, President and COO, said, "We applaud the innovative approach this team of physicians has undertaken to develop novel techniques to bring about better clinical outcomes, while at the same time reducing the economic burden of these highly technical and complex procedures. Their philosophy is much aligned with ours, and we look forward to seeing the results of their follow-up studies."
"With the additional advantages to free flap reconstructions that the case series identified for this modality, such as a potential decreased time of hospital stay, avoiding immobility for the patient, reduced need for intensive care unit monitoring, and decreased need of ancillary services including nursing and physical therapy, we are pleased to have our dHACM allografts be a part of the next phase of this unique study," concluded Petit.
References for statistics and complication rates cited in this press release can be found in the full article at the web address listed in the body of this press release.
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 and human skin and bone. "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®, OrthoFlo, Physio®, AlloBurn™, and CollaFix™. 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 600,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. We recently introduced OrthoFlo, an amniotic fluid derived allograft for homologous use. Amniotic fluid is donated by a consenting mother delivering a full-term healthy baby by scheduled Caesarean section. Through the recent acquisition of Stability Biologics, our newest proprietary platforms include Physio, a unique bone grafting material comprised of 100% bone tissue with no added carrier, thus maximizing bone forming potential, a demineralized bone matrix (DBM) to complement our product portfolio offerings within the Orthopedic market and AlloBurn, a skin product for burns. 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's wholly-owned subsidiary, Stability Biologics, LLC, is accredited by the American Association of Tissue Banks (AATB) and registered with the FDA. The Company distinguishes 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 that the techniques used highlighted the clinical efficacy and economic advantages of MiMedx amniotic allografts in the particular treatment studied, and that additional studies will be conducted, including a randomized controlled trial, to further analyze the technique being studied. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the results for the patients in this case series may not always be replicated for other patients, the advantages identified may not be advantages for all patients, that medical professionals may not adopt the new techniques highlighted by the case series, future studies may not be conducted as planned or may not produce the anticipated 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, 2015, and its most recent 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.
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SOURCE MiMedx Group, Inc.