MIMEDX EPIFIX® Receives Reimbursement Approval in Japan
12 Setembro 2022 - 05:30PM
MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a
transformational placental biologics company, today announced that
the Japanese Ministry of Health, Labour and Welfare (JMHLW)
approved reimbursement of EPIFIX® to treat refractory or
hard-to-heal lower extremity diabetic and venous ulcers. The
Company is in the last stages of preparing for full product launch,
anticipated in the fourth quarter. The Company estimates the
Japanese total addressable market associated with the scope of the
JMHLW reimbursement decision to be approximately $500 million based
on a recently completed third party market study. The study
estimated that there are more than 400,000 hard-to-heal wounds that
present each year in Japan that can be treated by EPIFIX and which
qualify for reimbursement under the JMHLW’s decision.
“Achieving reimbursement was a key pre-requisite
to launch EPIFIX in Japan, and we think the awarded rate of 35,100
Yen/cm2 will be very favorable in supporting market adoption,” said
Rohit Kashyap, Ph.D., MIMEDX President, Wound Care & Surgical.
“We view the Japanese market as a meaningful new stream of future
revenue. With this positive reimbursement decision now secured, we
are moving quickly to finalize our launch sequence, which includes
completing distributor agreements and training, gaining local
patient experience, and building market awareness. We have been
very encouraged by early physician interest and are well positioned
to penetrate the market leveraging the strength of our clinical and
economic data, established Key Opinion Leader relationships, and
strong local society support.”
Dr. Hiroto Terashi, Chief Professor in the
Department of Plastic Surgery at Kobe University, Chairman of the
Japanese Society for Foot Care and Podiatric Medicine and Chairman
of the Japan Society for Surgical Wound Care, said, “Physicians
need products that are clinically effective in wound closure and
that can prevent complications such as infection, wound recurrence,
surgical intervention, and amputation. I am very excited to have
reimbursement acceptance for EPIFIX in Japan, and I believe many
patients and physicians will benefit from having a new treatment
option for chronic wounds caused by lower extremity diabetic and
venous ulcers. The clinical and scientific data that I have seen
for EPIFIX shows strong support for use in difficult to heal
wounds.”
Takanori Kuramoto, MIMEDX’s recently-appointed
General Manager, Japan, added, “We are grateful for the involvement
and collaboration of the Japanese Society for Foot Care and
Podiatric Medicine and other societies to increase awareness of the
proper use of EPIFIX within their physician communities. With over
250 physicians now trained, we will be efficient in making EPIFIX
available to treat patients in need of the clinical outcomes that
the product has been shown to deliver. Ongoing medical training and
education will be a hallmark of our launch activity, and we
appreciate the strong level of interest by local physicians and
hospital staff for this new treatment option. The Japanese Society
for Foot Care and Podiatric Medicine plans to conduct three
additional EPIFIX training events for its members over the next six
months.”
About EPIFIXEPIFIX is a PURION®
processed placental tissue allograft that supports the healing
cascade by providing a protective barrier over wounds. EPIFIX is
classified as a Class IV Medical Device and “Specified Biological
Product” under JMHLW guidelines, and approved for the treatment of
refractory ulcers, such as diabetic foot ulcers (DFUs) and venous
leg ulcers (VLUs) that do not respond to conventional therapy. It
is the first and only amniotic tissue product approved for use in
Japan.
About MIMEDXMIMEDX is a
transformational placental biologics company, developing and
distributing placental tissue allografts with patent-protected,
proprietary processes for multiple sectors of healthcare. As a
pioneer in placental tissue engineering, we have both a commercial
business, focused on addressing the needs of patients with acute
and chronic non-healing wounds, and a promising late-stage pipeline
targeted at decreasing pain and improving function for patients
with degenerative musculoskeletal conditions. We derive our
products from human placental tissues and process these tissues
using our proprietary methods, including the PURION® process. We
employ Current Good Tissue Practices, Current Good Manufacturing
Practices, and terminal sterilization to produce our allografts.
MIMEDX has supplied over two million allografts, through both
direct and consignment shipments. For additional information,
please visit www.mimedx.com.
ContactsInvestors:Jack
HowarthInvestor Relations404.360.5681jhowarth@mimedx.com
Media:Hilary DixonCorporate & Strategic
Communications404.323.4779hdixon@mimedx.com
MiMedx (NASDAQ:MDXG)
Gráfico Histórico do Ativo
De Fev 2024 até Mar 2024
MiMedx (NASDAQ:MDXG)
Gráfico Histórico do Ativo
De Mar 2023 até Mar 2024