Derma Sciences announces Veterans Administration adds AMNIOEXCEL® to its Federal Supply Schedule
22 July 2014 - 11:02PM
Business Wire
Marks Derma Sciences’ official launch with
its expanded US sales force to sell AMNIOEXCEL into VA and military
medical centers, outpatient clinics and community living centers
across the U.S.
Derma Sciences, Inc. (Nasdaq:DSCI), a tissue regeneration
company focused on advanced wound care, announces that AMNIOEXCEL®,
its novel human amniotic membrane allograft, has been approved by
the Veterans Administration (VA) for inclusion in its Federal
Supply Schedule V797P-2000D. The announcement marks Derma Sciences’
official launch with its expanded U.S. sales force to sell
AMNIOEXCEL into VA and military medical centers, outpatient clinics
and community living centers across the U.S. AMNIOEXCEL has been
rapidly adopted by clinicians in several test facilities for use in
patient care and a 10-patient case series has been submitted for
publication in a peer-reviewed journal. In addition, Derma Sciences
expects to begin a randomized clinical trial with AMNIOEXCEL in
August to further support marketing into additional channels.
“Inclusion in the Federal Supply Schedule is an important
milestone for our newly acquired AMNIO product line as we continue
to position Derma Sciences as a leading wound care company
specializing in tissue regeneration,” said Edward J. Quilty, chief
executive officer of Derma Sciences. “Amniotic tissue technology
facilitates excellent clinical outcomes with difficult, non-healing
wounds and we are delighted that active military personnel and
veterans will benefit from access to another of our advanced
products. Based on the early clinical evaluations of AMNIOEXCEL in
certain VA hospitals, we are confident that our product will offer
clinicians a best-in-class product with a compelling combination of
clinical efficacy and ease-of-use.”
“In addition, AMNIOEXCEL meets Centers for Medicare &
Medicaid Services (CMS) guidelines for placement into the high cost
tier skin substitutes,” Mr. Quilty continued. “This product is
priced to be in line with the new CMS bundled payment initiative
for skin substitute guidelines that became effective January 1,
2014, thus ensuring cost savings. Given the positive clinical
results achieved following thorough product evaluations on
patients, prosthetics purchasing departments in many VA facilities
have acknowledged that the resultant savings from using AMNIOEXCEL
will allow them to help more veterans and active
military personnel with other important healthcare needs.”
Barry J. Wolfenson, group president of advanced wound care and
drug development at Derma Sciences, added, “With this approval, we
can now implement the next part of our business plan by achieving
more widespread utilization of AMNIOEXCEL in this $500 million
market. This will help us to develop an even broader base of key
opinion leaders, which will be critical as we work diligently to
secure coverage from the Medicare Administrative Contractors. We
look forward to announcing our progress in this area in the coming
months.”
About AMNIOEXCEL
AMNIOEXCEL® is a human amniotic membrane allograft used
on challenging and non-healing wounds. As a dehydrated human
amnion-derived tissue allograft, AMNIOEXCEL® maintains the
natural, inherent properties of the native tissue including an
intact extracellular matrix and growth factors. It provides a
structural tissue for the repair, replacement or reconstruction of
damaged skin. AMNIOEXCEL® is a natural alternative to synthetics
and xenografts, is flexible and conformable to the wound bed, and
is not side-specific in its application.
About Derma Sciences, Inc.
Derma Sciences is a tissue regeneration company focused on
advanced wound and burn care. It offers a line of products with
patented technologies to help better manage chronic and
hard-to-heal wounds, many of which result from diabetes and poor
vascular functioning. The company recently entered the $500 million
market for skin substitute products with its licensing of
AMNIOEXCEL® and AMNIOMATRIX® in the first quarter of 2014.
AMNIOEXCEL® was launched to customers in March 2014 and AMNIOMATRIX
® was launched in the second quarter. Its MEDIHONEY® product is the
leading brand of honey-based dressings for the management of wounds
and burns. The product has been shown in clinical studies to be
effective in a variety of indications. TCC-EZ® is its gold-standard
total contact casting system for diabetic foot ulcers. Other novel
products introduced into the $14 billion global wound care market
include XTRASORB® for better management of wound exudate, and
BIOGUARD® for barrier protection against microbes and other
contaminants. Its pharmaceutical wound care products include
DSC127, which is currently in Phase 3 clinical trials for the
healing of diabetic foot ulcers. The drug candidate is also part of
a BARDA grant program for the healing/prevention of tissue damage
due to ionizing radiation exposure. The patented API peptide used
in DSC127 is also in preclinical testing for scar
prevention/reduction. The company also offers a full product line
of traditional dressings.
For more information please visit www.dermasciences.com.
Forward-Looking Statements
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statements of historical fact may be deemed to be forward-looking
statements. Without limiting the generality of the foregoing, words
such as "may," "will," "expect," "believe," "anticipate," "intend,"
"could," "estimate" or "continue" are intended to identify
forward-looking statements. Readers are cautioned that certain
important factors may affect the company's actual results and could
cause such results to differ materially from any forward-looking
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otherwise made by or on behalf of the company. Factors that may
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differences between the company's actual results and
forward-looking statements include but are not limited to, those
discussed in the company's filings with the U.S. Securities and
Exchange Commission.
Derma Sciences, Inc.Barry
Wolfenson, 609-514-4744Group President, Advanced Wound Care and
Pharmaceutical
Developmentbwolfenson@dermasciences.comorLHAKim
Sutton Golodetz, 212-838-3777kgolodetz@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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