MIMEDX Receives Regulatory Approval to Commercialize EPIFIX® in Japan

What Kind of Equipment is Used to Analyze DNA?

Below are some of a few basic processes followed throughout DNA testing. The general procedure entails:  • Isolating DNA from a sample containing the needed...

mJOULE Launches in the United Kingdom Reports Sciton

"Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide." says Lacee J. Naik, Vice President of Marketing and Public Relations.

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

MIMEDX Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, today announced successful regulatory approval by the Japanese Ministry of Health, Labour and Welfare (JMHLW) to market EPIFIX® in Japan.

EPIFIX – a bioabsorbable, human amniotic membrane allograft, is applied to affected areas for wound healing. The product uses proprietary methods, including the PURION® process, to provide a semi-permeable, protective barrier that supports the healing cascade. EPIFIX protects the wound bed to aid in the development of granulation tissue and delivers a human biocompatible extracellular matrix that retains 300+ regulatory proteins.

MIMEDX submitted a Shonin (pre-market approval) to the JMHLW, Japan’s primary regulatory body for creating and implementing safety standards for drugs and medical devices, and the Pharmaceutical and Medical Device Agency (PMDA), an independent administrative agency that works with JMHLW to ensure the safety and quality of drugs and medical devices, in mid-2020. EPIFIX was approved for hard-to-heal chronic wounds, such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), which do not respond to conventional therapy. EPIFIX will be classified as a Class IV Medical Device and “Specified Biological Product” under JMHLW guidelines.

Dr. Hiroto Terashi, Chief Professor in Department of Plastic Surgery at Kobe University, Chairman of the Japanese Society for Foot Care and Podiatric Medicine (JFCPM), and Chairman of the Japan Society for Surgical Wound Care (JSSWC) said, “As a plastic surgeon and wound care physician for my entire career, I am delighted with EPIFIX’s approval in Japan. EPIFIX will greatly expand treatment options for chronic wounds caused by lower extremity venous and diabetic ulcers in patients in Japan, providing opportunities for increased limb salvage.”

“Diabetic foot ulcers and venous leg ulcers that are unable to heal on their own pose a serious long-term health risk to people around the world. Our vision is to provide access to EPIFIX technology that can change people’s lives, no matter where they live,” said Stan Micek, MIMEDX Senior Vice President, Business Development and International. “We are extremely pleased with JMHLW’s decision to grant Shonin approval for EPIFIX, and we are glad to be one step closer to bringing EPIFIX to market in Japan. Our focus will now shift toward obtaining appropriate reimbursement and establishing logistical and distribution networks for commercialization, which we hope will result in full availability of EPIFIX in the Japanese market in early 2022.”

The Company is currently working with JMHLW to establish reimbursement pricing, a process expected to take up to six months. Once a reimbursement pricing policy is approved and the reimbursement rate is listed, the Company can begin offering EPIFIX to patients and providers in Japan.

Timothy R. Wright, MIMEDX Chief Executive Officer, commented, “EPIFIX can only benefit patients with hard-to-heal wounds if they can access its life-improving properties, and regulatory approval is a significant milestone in addressing unmet need for people in Japan. With today’s announcement, EPIFIX now has the potential to reach as many as 100,000 additional patients each year. This critical step helps us fulfil our mission of bringing advanced regenerative medicine to suffering patient populations and is important in the Company’s global expansion.”

spot_img

DON'T MISS

Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles