Hyalomatrix® Receives CMS Reimbursement Coverage in 11 States

BEDFORD, Mass.--(BUSINESS WIRE)-- 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.

Contacts:
Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., 781-457-9000
President and CEO
or
Sylvia Cheung, CFO, 781-457-9000
or
Medline Industries, Inc.
Vivika Panagiotakakos, 847-643-3311
Senior Manager, Public Relations

Source: Anika Therapeutics, Inc.

You May Also Be Interested In

• Fisker (FSR) files form 10-K, sees more job cuts, reiterates going concern doubts
• CSS Entertainment (CSSE) Receives Nasdaq Delinquency Letter
• Vincerx Pharma (VINC) Announces Proposed Share and Warrant Offering