MiMedx, a medtech company based in Georgia, has developed EpiFix, an off-the-shelf allograft system for the treatment of diabetic foot ulcers. The grafts are made using donated human placental tissues that are obtained from consenting mothers during caesarean section procedures. The tissues then undergo a proprietary processing procedure to clean them and eventually produce a dehydrated graft that can be stored at room temperature long term.
Diabetic foot ulcers are relatively common in patients with diabetes, presenting in as many as 15% of such patients. These wounds are stubborn and typically resistant to treatment, with current treatment approaches meeting with mixed success. The ulcers often present with complications such as infection, which frequently result in hospitalization.
These issues have inspired a different approach in the form of a human tissue-derived off-the-shelf graft that can be applied to an ulcer. The idea behind EpiFix is that it protects the wound site and promotes the healing process, and several studies have shown that the technology can enhance wound closure compared with current treatment approaches.
Medgadget had the opportunity to speak with Tim Wright, MiMedx CEO, about the technology.
Conn Hastings, Medgadget: Please give us an overview of diabetic foot ulcers (DFUs) and their consequences for patients.
Tim Wright, MiMedx: A diabetic foot ulcer is an open sore or wound that occurs in approximately 15% of patients with diabetes and is commonly located on the bottom of the foot. DFUs develop from a combination of factors such as lack of feeling in the foot, poor circulation, irritation (such as friction or pressure), and duration of diabetes. Of those who develop a foot ulcer, more than 5% will be hospitalized due to infection or other ulcer-related complications.
DFUs continue to be a major problem, causing patient suffering, infections, and high mortality. The cost of DFU treatment was estimated at $1.3 trillion globally in 2015. Despite evolving advanced wound care technologies through the years, DFUs continue to be among the most challenging chronic wound types.
Medgadget: How is the condition treated at present?
Tim Wright: Current standard of care treatments for DFUs include offloading, or taking pressure off the wound, surgical debridement, dressings to facilitate a moist wound environment, vascular assessment, and infection and glycemic control. While there are many methods to address DFUs, advanced wound management techniques are gaining acceptance – namely, placental-based allografts such as EpiFix®.
Medgadget: Please give us an overview of EpiFix, and how it is made.
Tim Wright: EpiFix is a dehydrated human amnion-chorion membrane (dHACM) allograft derived from placental tissues and has broad reimbursement coverage. This includes coverage by the largest U.S. commercial payor as a proven and medically necessary option in the treatment of diabetic foot ulcers. EpiFix allografts provide a semi-permeable protective barrier that supports the healing cascade and protects the wound bed to aid in the development of granulation tissue in acute and chronic wounds.
The product is derived from donated placental tissues from consenting mothers following scheduled C-sections of live births in the U.S. During processing, the product undergoes active preservation of the extracellular matrix (ECM) and over 300 regulatory proteins, and removal of blood contaminants via a proprietary cleansing process called Purion®. The result is an easy-to-use product with a five year shelf-life, storable at room temperature conditions. For an additional level of safety, the product is terminally sterilized.
Medgadget: How is EpiFix used and how does it work?
Tim Wright: EpiFix is a durable allograft with natural barrier properties that, when applied to a wound, provides a protective environment to help promote wound closure. EpiFix is available in sheet, mesh, and particulate configurations and in a variety of sizes to reduce wastage. As a semi-permeable protective barrier, EpiFix supports the healing cascade, protects the wound bed to aid in the development of granulation tissue and provides a human biocompatible extracellular matrix.
Medgadget: What is the Purion process?
Tim Wright: Purion is a unique patented processing method for placental-based allografts that is in accordance with the American Association of Tissue Banks (AATB) standards and FDA regulations and guidance, and specifically designed to deliver a clinically effective and minimally manipulated allograft tissue. MiMedx’s proprietary Purion process safely and gently separates placental tissues, cleans, and reassembles layers, and then dehydrates the tissue. Importantly, the process removes blood components while protecting the delicate scaffold of the amniotic membrane, leaving an intact extracellular matrix. All placental tissues are recovered under sterile conditions from patients who have been screened for underlying infectious disease.
Medgadget: Is there clinical evidence supporting EpiFix for DFUs?
Tim Wright: Yes. There are several recent published, peer-reviewed studies comparing MiMedx placental-based allografts to standard of care that have demonstrated improved rates of wound closure. The Agency for Healthcare Research and Quality (AHRQ) recently published a technology assessment analyzing skin substitutes for treating chronic wounds, and of the 22 randomized, controlled trials (RCTs) that met the inclusion criteria, only 12 were assessed as low risk of bias of which 5 were MiMedx RCTs.
This important government assessment is intended to help health care decision makers — patients and clinicians, health system leaders, and policymakers, among others — make well-informed decisions and thereby improve the quality of health care services. Recognition in this third-party evidence report highlights our commitment to providing level 1 clinical evidence in advanced wound treatment.
Medgadget: What other applications is EpiFix used for?
Tim Wright: EpiFix has been used in various clinical applications such as:
- Venous leg ulcers (VLUs)
- Surgical or wound debridements
- Pressure or Decubitus ulcers
- Patients with complex wound defects, delayed wound healing, or healing complications as a result of other comorbidities
Product page: EpiFix…
Link: MiMedx homepage…