Hyalomatrix, a unique advanced wound care device based on hyaluronic
acid (HA) technology, is now eligible for reimbursement as a skin
substitute through the Centers for Medicare and Medicaid Services (CMS)
in 11 states and D.C. after receiving positive local coverage
determination (LCD) changes in Arkansas, Colorado, Delaware, Louisiana,
Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania,
Texas, and Washington D.C.
“Receiving CMS reimbursement coverage in these states is an important
milestone in the commercialization of Hyalomatrix,” said Dr. Charles H.
Sherwood, President and CEO of Anika
Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue
protection, healing, and repair based on HA technology. “We look forward
to continued progress as we expand our advanced wound care product
franchise with Medline and broaden our footprint for Hyalomatrix in the
United States.”
Hyalomatrix
is being commercialized in the United States by Medline
Industries, Inc. (Medline), the nation's largest privately held
manufacturer and distributor of quality medical supplies and services
across the continuum of care. The company is a leader in the advanced
wound care space with more than 100 specialists and clinicians dedicated
exclusively to its extensive wound and skin care portfolio.
Hyalomatrix, a hyaluronic acid-rich scaffold onto which the body’s own
cells reconstruct dermal tissue, has U.S. Food and Drug Administration
510(k) marketing clearance for the management of wounds including
partial and full-thickness wounds, second-degree burns, pressure ulcers,
venous ulcers, diabetic ulcers, chronic vascular ulcers,
tunneled/undetermined wounds, surgical wounds, trauma wounds, and
draining wounds. Medline worked closely with leading reimbursement
industry experts to expand Hyalomatrix’s clinical reach as Novitas
Solutions, Inc., a Medicare Administrative Contractor, published its new
policy change on skin substitutes and product coverage, now including
Hyalomatrix.
“Those dealing with slow-healing and chronic wounds now have a more
affordable option to deliver significant clinical outcomes,” said Sissi
Miao, Ph.D, MBA, Vice President of Advanced Wound Care, Medline. “When
medically necessary, this new access to skin substitutes like
Hyalomatrix helps empower physicians and practitioners.”
Learn more about Hyalomatrix by visiting http://www.medline.com/products/wound-and-skin-care/hyalomatrix.
About Medline
As the nation's largest privately held manufacturer and distributor of
quality medical supplies and clinical solutions, Medline is dedicated to
helping healthcare providers reduce costs and achieve better outcomes
across the continuum of care. Named one of the country’s “Best and
Brightest Companies to Work For,” the company is headquartered in
Mundelein, Ill. and has more than 1,200 dedicated sales representatives
to support its robust product portfolio and deliver outstanding customer
service. For more information about Medline, go to www.medline.com
or visit http://www.medline.com/social-media
to connect with Medline on a variety of social media channels.
About Anika Therapeutics, Inc.
Headquartered in Bedford, Mass., Anika
Therapeutics, Inc. develops, manufactures, and commercializes
therapeutic products for tissue protection, healing, and repair. These
products are based on hyaluronic
acid (HA), a naturally occurring, biocompatible polymer found
throughout the body. Anika's products range from orthopedic/joint health
solutions led by Orthovisc®
and Monovisc®,
treatments for osteoarthritis of the knee, to surgical aids in the anti-adhesion
and ophthalmic
fields. The Company also offers aesthetic
dermal fillers for the correction of facial wrinkles. Anika's
Italian subsidiary, Anika Therapeutics S.r.l., provides complementary HA
products in the orthopedic/joint health and anti-adhesion fields, as
well as therapeutics in areas such as advanced wound treatment and ear,
nose, and throat care. Its regenerative technology advances Anika's
vision to offer therapeutic products and medical solutions that go
beyond pain relief to protect and restore damaged tissue.
The statements made in this press release, which are not statements
of historical fact, are forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E
of the Securities Exchange Act of 1934, as amended. These statements
include, but are not limited to, the commercialization of Hyalomatrix,
and the expansion of the wound care product franchise in the United
States. These statements are based upon the current beliefs and
expectations of the Company's management and are subject to significant
risks, uncertainties, and other factors. The Company's actual
results could differ materially from any anticipated future results,
performance, or achievements described in these or other forward-looking
statements made by the Company as a result of a number of factors
including (i) the Company's ability to successfully commence and/or
complete clinical trials of its products on a timely basis or at all,
obtain pre-clinical or clinical data to support domestic and
international pre-market approval applications or 510(k) applications,
or timely file and receive FDA or other regulatory approvals or
clearances of its products, or that such approvals will not be obtained
in a timely manner or without the need for additional clinical trials,
other testing or regulatory submissions, as applicable; (ii) the
Company's research and product development efforts and their relative
success, including whether the Company has any meaningful sales of any
new products resulting from such efforts; (iii) the cost effectiveness
and efficiency of our clinical studies, including the associated
regulatory approval applications, our manufacturing operations and our
production planning; (iv) the strength of the economies in which the
Company operates or will be operating, as well as the political
stability of any of those geographic areas; (v) future determinations by
the Company to allocate resources to products and in directions not
presently contemplated; (vi) the Company’s ability to successfully
complete its commercialization plans for its products in the U.S. and
internationally; (vii) the Company’s ability to provide an adequate and
timely supply of its products to its customers; (viii) our ability to
continue to successfully manage Anika Therapeutics S.r.l.’s business and
product lines, including its wound care franchise; and (ix) the
Company’s ability to achieve its growth targets. Certain other factors
that might cause the Company's actual results to differ materially from
those in the forward-looking statements include those set forth under
the headings "Business," "Risk Factors," and "Management's Discussion
and Analysis of Financial Condition and Results of Operations" in the
Company's Annual Report on Form 10-K for the year ended December 31,
2014, as well as those described in the Company's other press releases
and SEC filings.
Copyright Business Wire 2015