Seven Poster Abstracts Highlight MiMedx Allografts at the 10th Annual Desert
STUDIES DEMONSTRATE STRONG HEALING RESULTS OF EPIFIX® AND AMNIOFIX®
MARIETTA, Ga., Nov. 26, 2013
MARIETTA, Ga., Nov. 26, 2013 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ:
MDXG), an integrated developer, manufacturer and marketer of patent protected
regenerative biomaterials and bioimplants processed from human amniotic
membrane, announced today the summaries of a selection of the seven posters
highlighting MiMedx allografts presented at the recent 10^th Annual Desert
Foot High Risk Diabetic Foot Conference in Phoenix, Arizona.
The posters chronicled the clinical effectiveness of the MiMedx dehydrated
human amnion/chorion membrane ("dHACM") allografts and detailed a wide range
of wounds and injuries with varying degrees of etiologies. A sampling of the
posters presenting dHACM cases and studies, along with a summary of the
respective study results and conclusions are as follows:
oEpiFix Utilization for Advanced Wound Therapy in an Evidence Based
Approach to Treat Foot Ulcers.
oResults: 10 non-healing diabetic foot ulcers (DFUs) and 3 pressure
ulcers were treated with EpiFix®. 75% of the ulcers healed with
EpiFix® at an average healing time of 11.7 weeks after 3.5
applications. Complete healing occurred in 67% of the DFUs and 100%
of pressure ulcers. Of the 3 DFUs not healing 100%, 2 were
non-compliant and one had foot deformity issues prior to the study
causing discontinuation of the graft.
oConclusion: Multiple advantages were noted in using EpiFix® to treat
non-healing wounds in the VA clinic setting including ease of use and
availability of multiple graft sizes to minimize waste. With adequate
wound debridement and proper wound bed maintenance, a 75% healing
rate of non-healing foot ulcers was achieved with the utilization of
oDehydrated Human Amnion/Chorion Membrane for the Treatment of
Full-Thickness Plantar Burn in a Diabetic Patient: A Case Report.
oResults: Rapid healing of wound occurred with epithelialization
essentially complete 4 weeks after dHACM application.
oConclusion: This case report demonstrated that dHACM can be used as
an effective treatment for plantar burns in diabetics and deserves
oTreatment of Lower Extremity Chronic Wounds with Dehydrated Human
Amnion/Chorion Membrane (dHACM): A Vascular Compromised Cohort (ABI<.65).
oResults: Patients with wound chronicity and an abnormally low
ankle-brachial index (low blood flow to the limbs) were treated with
standard wound treatment prior to initiation of dHACM therapy. Wounds
were healed with an average weeks to closure of 7.42 and an average
of 4.4 applications.
oConclusion: dHACM is an extremely efficacious and cost effective
alternative in patients failing to achieve appropriate wound area
reduction in a timely manner. In this subset of patients, when
compared to the previously utilized advanced wound care modalities, a
75% cost savings was realized.
oDehydrated Human Amnion/Chorion Membrane Allograft for the Treatment of a
Post Surgical Amputation Wound in a Diabetic Patient.
oResults: Following sharp debridement period of August 13^th through
September 2^nd to prepare wound for advanced wound healing therapy
with EpiFix®, advanced wound healing with EpiFix® started on
September 3^rd and patient healed on October 15^th.
oConclusion: Post-surgical patients need aggressive antibiotic
treatment for an extended period of time. Aggressive chemical and
sharp debridement is necessary to prepare wound bed. Speed to
closure, cost effectiveness of multiple sizes and ease of use are
positive attributes for EpiFix®.
oExperience with dHACM for a Complicated Sternal and Abdominal Wound.
oResults: A total of 6 applications were used over 10 week period;
patient presented in week 12 with full closure and wound has
continued to be resolved to date.
oConclusion: dHACM is a very effective treatment for complicated
sternal and abdominal wounds as well as lower extremity ulcerations.
Parker H. "Pete" Petit, Chairman and CEO, said, "The independent study
abstracts presented at Desert Foot are further indications of the clinical and
cost effectiveness of our dHACM allografts. When a graft achieves wound
closure with these metrics, we believe we are best serving the clinical and
economic needs of our market. We continue to champion the cause of reducing
costs of wound closure, and these abstracts highlight those goals."
Bill Taylor, President and COO, stated, "In the collective body of work
forming the basis for the seven MiMedx poster abstracts, the EpiFix® data
involved the treatment of 55 patients. In the combined studies, an average
number of 3.5 EpiFix® applications were applied to achieve healed ulcers, and
the average number of weeks to achieve healing using the MiMedx allografts was
6.8 weeks. These results mirror the impressive results our dHACM allografts
have achieved in prior Randomized Controlled Trials, cross over trials and
follow-up studies. "
MiMedx® is an integrated developer, manufacturer and marketer of patent
protected regenerative biomaterial products and bioimplants processed from
human amniotic membrane. "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 include AmnioFix®
and EpiFix®, our tissue technologies processed from human amniotic membrane
that is derived from donated placentas. Through our donor program, mothers
delivering full-term Caesarean section births can elect in advance of delivery
to 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 200,000 allografts to date to
distributors and OEMs for application in the Wound Care, Surgical, Sports
Medicine, Ophthalmic and Dental sectors of healthcare.
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 the clinical and cost effectiveness of EpiFix® and AmnioFix®. These
statements are based on current information and belief, and are not guarantees
of future performance. Among the risks and uncertainties that could cause
actual results to differ materially from those indicated by such
forward-looking statements include the potential that EpiFix® and AmnioFix®
will not perform as expected or will not gain acceptance in the medical
community, 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, 2012, and
the Company's most recent Form 10-Q. 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
SOURCE MiMedx Group
Contact: Michael Senken, (770) 651-9100
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