Anika Therapeutics Announces Monovisc PMA News
<0> Anika Therapeutics, Inc.Charles H. Sherwood, Ph.D., 781-457-9000CEOorKevin W. Quinlan, 781-457-9000CFO </0>
Anika Therapeutics, Inc. (Nasdaq: ANIK) announced today 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 FDA’s appeal process to continue to discuss the Monovisc PMA with the FDA.
The company plans to schedule a meeting with the FDA as soon as possible to determine the next steps concerning the Monovisc product.
Headquartered in Bedford, Mass., develops, manufactures and commercializes therapeutic products for tissue protection, healing, and repair. These products are based on , a naturally occurring, biocompatible polymer found throughout the body. Anika’s products range from orthopedic/joint health solutions led by , a treatment for osteoarthritis of the knee, to surgical aids in the and fields. The company also offers for the correction of facial wrinkles. Anika’s Italian subsidiary, Anika S.r.l., provides complementary HA products in orthopedic/joint health and anti-adhesion, as well as therapeutics in new areas such as advanced wound treatment and ear, nose and throat care. Anika S.r.l.’s regenerative tissue technology advances Anika’s vision to offer therapeutic products that go beyond pain relief to protect and restore damaged tissue.