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Placental Allografts for Diabetic Foot Ulcers: Interview with Tim Wright, CEO of MiMedx                                              Published February 18, 2021

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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.

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.

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®.

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.

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.

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.

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...

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Placental Allografts for Diabetic Foot Ulcers: Interview with Tim Wright, CEO of MiMedx

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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.

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https://youtu.be/m5Ezqcrlsdw

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Placental Based Allografts: From Womb to Wound

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Created by MiMedx, a company based in Georgia, EpiFix is an allograft system that can be used to treat diabetic foot ulcers. Donated human placental tissues that are obtained from a consenting mother during a C-section are used for the allograft system. The tissues extracted are cleaned and can be store at room temperature long term.

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*Positivity - I am always looking at the bright side, keeping the mood light.  I will try to build a strong team relationship and make everyone comfortable.
*Strategic - I will help the team with backup plans so if something goes wrong, we know what to do.
*Learner - Always eager to learn something new and share it with my team.
*Empathy - This strength helps build trust with the rest of my team and I can always be understanding if an issue arises.
*Responsibility - My team can count on me to complete my work in a timely manner and motivate others to complete their work as well.

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Carter (Communication) - He is good with people and presenting, he can teach the team some tips to be confident in their own communication.

Carlee (Consistency) - She enjoys setting rules and expectations, which can help our team stay on track.

Amelia (Adaptability) - She is very flexible and can provide a good alternative to my responsibility.  We will balance each other out, creating a well thought out team.

Daniel (Discipline) - He enjoys having an order to things and will be sure to remind the team when to stay on track or if changes are needed.

Fernando (Focus) - He is able to complete a task all the way through with no interruptions. His ability to focus will suit our team well, so we can learn from him and he can keep us on task.

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What is so important about EpiFix? (Pros)

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What is so important about EpiFix? (Pros)

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The placenta is made up of cells, extra-cellular matrix and a complex of regulatory cytokines. These components promote cell proliferation, cell modulation and cytokine secretion which are all involved in wound healing! Studies performed have shown that these grafts are successful in healing an unresponsive, chronic diabetic foot ulcer. This is an amazing advancement for diabetic patients.

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Of course, there must be consenting mothers to obtain the placental samples.  This could lead to a variance in supply since some mother may say yes and others say no.  This type of wound healing is not yet common in the U.S. and not many people are educated on this.  However, other countries such as Indonesia have made this available commercially for many years. Indonesia has offered this since 1986.

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I had never heard of this before and think it is an amazing way to treat complicated diabetic foot ulcers as well as other wounds. This can be used for various wounds that are not responding to other treatments. I believe this is something that needs to be used as a last resort, seeing as the supply can vary so much. Educating the public on this and including expecting mothers could greatly expand the general populations knowledge about this intervention.

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Hastings, C. (2021, February 18). Placental Allografts for Diabetic Foot Ulcers: Interview with Tim Wright, CEO of MiMedx. MedGadget. https://www.medgadget.com/2021/02/human-placental-allografts-for-diabetic-foot-ulcers-interview-with-tim-wright-ceo-of-mimedx.html

Oesman, I., & Dhamar Hutami, W. (2020). Gamma-treated placental amniotic membrane allograft as the adjuvant treatment of unresponsive diabetic ulcer of the foot. International journal of surgery case reports, 66, 313–318. https://doi.org/10.1016/j.ijscr.2019.12.033