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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 29-Sept-16 BY BLAKE MOSSY, SEPTEMBER 29, 2016

M&A
Amplitude Surgical exercised the company's call option to acquire the remaining (40%) minority interests in its Brazilian subsidiary, Unimplant, for approximately €4.1 million ($4.6 million). Management expects this transaction will help the company continue to exhibit a robust growth profile in Brazil and take advantage of meaningful strategic opportunities in the market.

Stryker entered into an agreement to acquire the assets of Restore Surgical LLC, which conducts business as Instratek. Instratek's product portfolio consists of staple and hammertoe implants and minimally invasive soft tissue recession instrumentation for foot, ankle and upper extremity procedures. The acquired assets complement Stryker's existing extremities portfolio, provides the company with immediate access into the minimally invasive soft tissue recession market, and strengthens Stryker's position in the forefoot segment.

Zimmer Biomet entered into an agreement to acquire Clinical Graphics, B.V., a Dutch imaging company that specializes in 3-D range-of-motion simulation technology to help surgeons make treatment decisions for common hip conditions requiring early intervention. Clinical Graphics develops 3-D interactive range-of-motion simulation reports for common hip conditions such as femoroacetabular impingement and dysplasia, and surgical practitioners. The transaction provides Zimmer with novel imaging technology that they integrate with and enhance their hip preservation portfolio.

REGULATORY
AxioMed received approval from the Therapeutic Goods Administration (TGA) of Australia for its cervical and lumbar Freedom Viscoelastic Disc Replacement devices. Freedom is the company's next-generation disc replacement indicated for the restoration of natural disc height, motion and stability in the spine.

Phygen received Notice of Allowance for its Leucadia AutoLok Fixation Screw Assembly, indicated to address the stabilization and repair of spinal trauma and disease. AutoLoc was originally introduced in 2011, and taken off the market after an asset sale in 2012. The company has re-acquired full ownership of the technology.

Regentis Biomaterials received Investigational Device Exemption (IDE) approval from the FDA to initiate a Phase III clinical study of its GelrinC procedure for damaged articular knee cartilage. The minimally-invasive procedure administers GelrinC as a liquid into any size or shape lesion and exposes it to ultra-violet light that converts it into a solid implant filling in the lesion. Over a 6-12 month period, the implant grades and replaced by natural cartilage. The study will evaluate the safety and efficacy of the implant compared to traditional microfracture knee surgery using a control arm.

SI BONE announced that Blue Cross Blue (BCBS) will provide coverage, under an updated medical policy for its iFuse Implant System, a minimally invasive sacroiliac joint fusion system. The coverage makes the device available to BCBS members in Nebraska who suffer from chronic SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.

PRODUCT INTRODUCTION & UPDATE
Amendia launched its Syzygy Stabilization System, a titanium implant comprised of cannulated and non-cannulated screws with self-tapping threads for maximum cortical bone. Syzygy is a spondyloisthesis reduction system designed to provide immobilization of spinal segments as an adjunct to fusion for the treatment of specific acute and chronic instabilities or deformities of the thoracic, lumbar or sacral spine.

Spineology launched an assortment of transforaminal lumbar interbody fusion (TLIF) technologies as part of its Anatomy Conserving Medial Lumbar Interbody Fusion (ACT MediaLIF) platform, allowing for TLIF placement of interbody using a direct posterior, or ACT MediaLIF, approach. The additional of TLIF technologies allows surgeons to reduce incision size, muscle trauma and amount of bony removal to place the cage during the procedure, which maximizes lordosis restoration.

ulrich medical launched its uCerv titanium spinal implants as an addition to the company's uCerv PEEK OPTIMA Interbody System indicated for anterior cervical discectomy and fusion (ACDF) surgical procedures. The titanium implants provide a reliable structure for bone growth and are available in parallel and lordotic configurations and large and small footprints.

CLINICAL
Rotation Medical published clinical results from a seven-patient, retrospective study supporting its collagen-based bioinductive implant and its ability to facilitate the growth of new connective tissue as a rotator cuff repair system and an alternative to traditional surgical repair. The study results show that the implant can biologically augment torn tendons and potentially reduce re-tear and revision rates.

DISTRIBUTION
Spineology expanded its agreement with the tissue bank, Musculoskeletal Transplant Foundation (MTF) be the sole tissue provider for Spineology's allograft product lines, including the recently-launched Incite Cortical Fibers bone grafting solution. The system is comprised of ultra-thin, entangled cortical fibers that cover significant surface area to stimulate bone growth and an osteconductive matrix for cellular attachment and proliferation.


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