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December 4, 2012
17:05 EDTANIKAnika Therapeutics announces Monovisc PMA news
Anika Therapeutics announced that it has received correspondence from the Chief Scientific Officer of the Center for Devices and Radiological Health of the U.S. FDA upholding the non-approvable decision for the Monovisc PMA that was previously disclosed. The company had utilized the FDAs appeal process to continue to discuss the Monovisc PMA with the FDA.
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April 15, 2014
14:31 EDTANIKAnika Therapeutics announces first U.S. commercial sale of Monovisc
Anika Therapeutics announced the first U.S. commercial sale of Monovisc by its commercial partner, DePuy Synthes Mitek Sports Medicine, a leading orthopedic sports medicine company. Monovisc received marketing approval from the U.S. FDA in February. It is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics, such as acetaminophen. It is a sterile, non-pyrogenic, viscoelastic solution of hyaluronan, and is the first FDA-approved single-injection product with HA from a non-animal source. Anika has marketed Monovisc internationally since 2008, with total treatments exceeding 230,000 since inception. In addition to the United States, the product is currently sold in Canada, the United Kingdom and a growing number of countries in the Middle East, Europe and Asia. The U.S. commercial introduction of Monovisc took place in March 2014 at the annual meeting of the American Academy of Orthopedic Surgeons in New Orleans. As a result of the first commercial sale in the U.S., and under the terms of its license agreement with DePuy Synthes Mitek Sports Medicine, Anika will receive a $5M milestone payment. In addition to product transfer and royalty fees, the license agreement contains potential additional payments contingent on achieving certain performance and sales threshold milestones.

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