MARIETTA, Ga., Sept. 25, 2018 /PRNewswire/ -- MiMedx Group,
Inc. (NASDAQ: MDXG), a leading developer and marketer of
regenerative and therapeutic biologics, today announced that a new
clinical study has been published in the peer-reviewed
International Wound Journal, which evaluated the safety and
efficacy of using dehydrated human umbilical cord (dHUC - EpiCord)
for chronic diabetic foot ulcers (DFUs).
The paper is entitled "A multicentre prospective randomised
controlled comparative parallel study of dehydrated human umbilical
cord (EpiCord) allograft for the treatment of diabetic foot
ulcers" and was co-authored by: William
Tettelbach, MD; Shawn
Cazzell, DPM; Felix Sigal,
DPM; Joseph M. Caporusso, DPM;
Patrick S. Agnew, DPM; Jason Hanft, DPM; and Cyaandi Dove, DPM. The
published article in the International Wound Journal can be
found at
https://onlinelibrary.wiley.com/doi/full/10.1111/iwj.13001.
This multicenter randomized and controlled trial was conducted
at 11 centers in the United States
and was led by William Tettelbach,
MD, principal investigator and former Executive System Medical
Director of Wound Care and Hyperbaric Medicine Services for
Intermountain Healthcare. Dr. Tettelbach later became Associate
Chief Medical Officer for MiMedx, a position that postdated the
completion of the study.
Clinical Study Design and Results
This is the first published clinical study of dHUC tissue. The
objective of the study was to determine the safety and
effectiveness of dHUC as compared to standardized therapy with
alginate wound dressings for chronic, non-healing DFUs.
The primary efficacy endpoint was the incidence of complete
wound closure over a 12-week period. Data from 155 patients were
analyzed in the Intent-to-Treat (ITT) cohort. Patients were
randomized in a 2:1 ratio to receive weekly application of dHUC
(n=101) or standardized therapy with alginate dressings (n=54). A
total of 134 patients completed the study Per-Protocol
(Per-Protocol cohort).
ITT analysis includes patients even if they did not fully adhere
to the protocol. In comparison, in a Per-Protocol analysis, only
patients who completed the entire clinical trial according to the
protocol are included in the final analysis.
In the current study on an ITT basis, 70% of patients who
received weekly dHUC had complete healing by 12 weeks versus 48% of
patients only receiving weekly standardized therapy (p=0.0089).
For patients completing the study Per-Protocol, 81% of those who
received weekly dHUC achieved complete healing by 12 weeks. In
comparison, 54% of patients had complete healing in 12 weeks after
receiving weekly standardized therapy (p=0.0013).
About dHUC
dHUC is a thick membrane derived from umbilical cord, the
structure that protects the arteries and vein that carry essential
nourishment and oxygenated blood to and from mother and fetus. dHUC
is a minimally manipulated, dehydrated, non-viable cellular
umbilical cord allograft intended for homologous use that provides
a protective environment for the healing process.
Umbilical cord consists of amniotic epithelium and Wharton's
jelly containing an extracellular matrix composed of collagen,
proteoglycans and hyaluronic acid. MiMedx processes dHUC using the
PURION® Plus process, an approach that provides an easy-to-use
allograft stored at ambient conditions.
MiMedx currently markets dHUC as a Human Cellular and
Tissue-based Product (HCT/P) under Section 361 of Food and Drug
Administration regulations under the brand names EpiCord® and
AmnioCord®. MiMedx manufactures its products according to current
Good Tissue Practices (cGTP) standards, pursuant to 21 CFR 1271, an
FDA regulation. The Company is also in compliance with the AATB's
(American Association of Tissue Banks) 14th standard, of which
MiMedx is a fully accredited member in good standing.
About MiMedx
MiMedx® is a leading biopharmaceutical company developing and
marketing regenerative and therapeutic biologics utilizing human
placental tissue allografts with patent-protected processes for
multiple sectors of healthcare. "Innovations in Regenerative
Medicine" is the framework behind the Company's mission to provide
physicians products to help the body heal itself. The Company
processes the human placental tissue utilizing its proprietary
PURION® process methodology, among other processes, to produce
allografts by employing aseptic processing techniques in addition
to terminal sterilization. MiMedx has supplied over 1.3 million
allografts to date for application in the Wound Care, Burn,
Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and
Dental sectors of healthcare. For additional information, please
visit www.mimedx.com.
Safe Harbor Statement
This press release includes forward-looking statements.
Statements regarding the safety and efficacy of MiMedx dHUC for
diabetic foot ulcers are forward-looking statements. Additional
forward-looking statements may be identified by words such as
"believe," "expect," "may," "plan," "potential," "will,"
"preliminary," and similar expressions, and are based on
management's current beliefs and expectations. Forward-looking
statements are subject to risks and uncertainties, and the Company
cautions investors against placing undue reliance on such
statements.
Actual results may differ materially from those set forth in the
forward-looking statements. For more detailed information on the
risks and uncertainties, please review the Risk Factors section of
the Company's most recent annual report or quarterly report filed
with the Securities and Exchange Commission. Any
forward-looking statements speak only as of the date of this press
release and the Company assumes no obligation to update any
forward-looking statement.
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SOURCE MiMedx Group, Inc.