Conference Calendar

March 14-18 - American Association of Orthopaedic Medicine Annual Meeting 2017

March 14-December 31 - Canaccord Genuity Musculoskeletal Conference

Complete Calendar »

Earnings Calendar

No Upcoming Events Scheduled
Complete Calendar »

Read our research via:
email art

Weekly Email

rss art

RSS



app icon

iPhone

app store icon

Kindle



Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 11-Jun-15 BY ANDREW VAHRADIAN, JUNE 11, 2015

M&A
Integra LifeSciences announced the spin-off of its Spine business to Integra shareholders on a tax-free basis, creating a new publicly traded spinal hardware and orthobiologics company called "SeaSpine Holdings Corporation" (SeaSpine). Under the terms of the separation, Integra stockholders will receive one share of SeaSpine common stock for every three shares of Integra common stock held by such holders. The SeaSpine stock will be listed on the Nasdaq Global Market (NasdaqGM) under the ticker symbol "SPNE". Neither Integra nor SeaSpine will have any ownership interest in the other company. Keith Valentine, former Chief Operating Officer of NuVasive was appointed as SeaSpine's Chief Executive Officer.

REGULATORY
The House of Representatives' Ways & Means Committee voted 25-14 in favor of new legislation to repeal the 2.3% medical device excise tax. The new bill was developed by Rep. Erik Paulsen (R-MN) and it aims to repeal the tax on all sales of pacemakers, artificial joints and other devices. Unlike previous proposed bills, Paulsen's bill does not provide a way to make up for revenue that would be lost from repealing the tax, now estimated at $26 billion. The next stage for the new bill is the House floor, and if it receives approval, it will move on to the Senate. Representative Ron Kind (D-WI) was the only Democrat to support the bill.

St. Jude received CE Mark certification approval for its Invisible Trial app-based wireless neuromodulation system, which leverages Apple's iOS devices, specifically an iPod touch for the patient and an iPad mini for the treating physician. The Invisible Trial system utilizes an external pulse generator for power, which uses Bluetooth to communicate between the iOS device controllers and the stimulator, allowing the system to be worn under clothing and controlled externally. The system can deliver both traditional and burst stimulation modes.

Vericel Corporation is planning to submit a Biologics License Application (BLA) to the FDA by the end of 2015 for its MACI (matrix-applied characterized autologous cultured chondrocytes) implant, intended for the treatment of focal chondral cartilage defects in the knee. MACI is a third-generation autologous chondrocyte implantation (ACI) product.

PRODUCT INTRODUCTION & UPDATE
Blue Belt Technologies, a medical device company specializing in technology solutions for orthopedic surgery, announces 1,000 cases utilizing the company’s proprietary implant, the STRIDE Unicondylar Knee System. STRIDE has been commercially available since October 2013. The STRIDE implant is used in surgical treatment of early to mid-stage osteoarthritis that affects either the medial or lateral compartment of the knee. STRIDE offers patients an advanced implant for partial knee replacement that has been optimized for robotic-assistance with the Navio Surgical System.

Expanding Orthopedics (EOI) announced the 100th surgical implantation of its FLXfit system, an in-situ articulating with lordosis correctional spinal cage, intended to restore disc height, segmental lordosis and overall sagittal balance of the spine. FLXfit is an alternative for TLIF (Transforaminal Lumbar Interbody Fusion) procedures and offers an articulated, self-guided design with large, anterior type, footprint coupled with a unique expansion mechanism to restore lordosis angle and tight anatomical fit.

joimax launched its iLESSYS Delta system, intended for the dorsal and dorso lateral treatment of central spinal canal stenosis. The system enables a large area to be decompressed by means of the interlaminar access, guided by endoscopic-assisted vision. The system's instrument set includes specially developed tools that enables tissue-sparing decompression.

RESEARCH
The University of Massachusetts at Lowell, launched "The Innovation Hub", a medtech development incubator. The facilities occupy two floors of a reconstituted mill totaling 22,000 sq ft. Furthermore, the Massachusetts Device Development Center has also been expanded by the university. Sponsors include Smith & Nephew and Boston Scientific.

DISTRIBUTION
aap Implantate signed the first eight contracts for the distribution of its LOQTEQ products with non-stocking distributors in the U.S. market. On the basis of these agreements these distributors will cover different regions in the federal states California, Texas, Ohio, Tennessee, Oklahoma and Utah. aap will be utilizing a hybrid distribution model, planning to sell LOQTEQ products locally via both stocking (distributor buys the products) and non-stocking distributors (distributor is supplied with the products and pays after usage). The company anticipates initial sales in the U.S. market in 3Q:15.

OPERATIONS
Algostim, LLC, a subsidiary of Greatbatch's QiG Group, announced that it will now do business as "Nuvectra". Greatbatch recently announced a proposed tax-free spin-off of the subsidiary, which is expected to be completed by the end of 2015. The company is commercializing the Algovita Spinal Cord Stimulation (SCS) system, intended to treat chronic intractable pain of the trunk and/or limbs. The system has been submitted to the FDA and the company anticipates approval in 2Q:15.

Email this to a colleague: