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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 3-March-17 BY BLAKE MOSSY, MARCH 3, 2017

FINANCIALS
Anika Therapeutics reported financial results for 4Q:16. Total revenue was $28.3 million in 4Q:16, beating consensus estimates by 3% and representing an increase of 11% compared to $25.6 million in 4Q:15. Product gross margin increased to 73.4% in 4Q:16 from 75.4% in 4Q:15. The company's segments grew by: Orthobiologics +13%, Surgical +17%, Dermal (2%) and Other (23%) in 4Q:16 respectively. The company grew geographically: Domestic +12%, European +10% and ROW +3% in 4Q:16. All growth rates are on a reported basis.

M&A
Shoulder Options sought out a divestiture of its proximal humerus plate devices. The plating systems are designed for the treatment of proximal humerous fractures and for rotator cuff repair, are 510(k) approved by the FDA, and have been granted patents by the USPTO. The devices include the AFT Proximal Humerus Fracture Plate, the AFT Greater Tuberosity Fracture Plate, and the CRP Cuff Repair Plate.

REGULATORY
Amend Surgical received 510(k) clearance from the FDA for its NanoFUSE BA, a bone graft extender for spine and orthopedic applications. Bioactive glass facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogensis, creating a favorable environment for bone fusion as it remodels into the recipient's skeletal system.

joinmax received full product registration from the Thai Food & Drug Administration (FDA) for its systems and training methods for endoscopic minimally invasive spinal surgery. The company also has approvals in South Korea, China, Singapore, Indonesia, Hong Kong and Vietnam. joinmax systems for endoscopic minimally invasive spinal surgery include TESSYs transforaminal, iLESSYS interlaminar and CESSYS cervical for decompression procedures, MultiXZYTE SI for SI joint therapy and EndoLIF and Percusys for endoscopic minimally-invasive assisted stabilization.

Synergy Biomedical received CE Mark clearance in the European Union for its BIOSPHERE PUTTY synthetic bone graft product. The system utilizes a form of bioactive glass in combination with a moldable phospholipid carrier to fill bony voids or gaps in the skeletal system. The product including an application in interbody and posterolateral fusion and general bone defect filling in the extremities and pelvis. BIOSPHERE may be used alone or in combination with autograft or allograft.

PRODUCT INTRODUCTION & UPDATE
Alphatec Spine launched its Arsenal Deformity Adolescent Idiopathic Scoliosis (AIS) System and has successfully completed initial patient cases. The system is designed to give surgeons a sloution to address complex deformity pathologies, including unique uniplanar screws, which enable easier screw positioning and rod placement, while restricting motion in the medial/lateral plane for derotation correction.

CLINICAL
Centric Medical completed initial cases with its Hammertoe Correction System, designed with dual treading, the system is inserted between the proximal and middle phalanges so that opposing threads fixate on the phalangeal canal of the toe and compress the joint.

INTELLECTUAL PROPERTY
IMPLANET received a patent from the French patent office for its JAZZ Lock implant in France. The implant is designed from the treatment of degenerative spine disorders and aims to allow surgeons to shorten and simplify the surgical procedure by removing multiple steps and implants used in traditional systems.

APPOINTMENTS
OrthAlign appointed Eric Timko company its Chief Executive Officer (CEO) and Chairman of the Board. Mr. Timko will succeed William Maya. Prior to OrthAlign, Mr. Timko served as president and CEO of Blue Belt Technologies. Before Blue Belt Technologies, he served as president and CEO of NeuroVasx, president of Carl Zeiss Surgical and as vice president of Siemens Medical Systems. Mr. Timko has over 25 years of experience in the healthcare industry and has served on OrthoAlign's Board of Directors since July 2016.

RESEARCH
The American Action Forum (AAF) estimates that the medtech industry could recover the 28,000 jobs that were terminated during the implementation of the the Affordable Care Act's 2.3% medical device excise tax by 2021 if Congress permanently repeals the tax this year. The tax went into effect in January 2013 and pertained to domestic medical device sales. In December 2015, Congress passed the Omnibus Appropriations Act, a $1.1 trillion funding bill that negated another government "shut down" and kept the U.S. federal government functioning until September 30, 2016. The AAF also noted that if the tax was to be reinstated as opposed to being permanently repealed, such an action could result in a loss of an incremental 25,000 jobs within the industry by 2021.


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