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Musculoskeletal News Roundup 24-Feb-17

M&A
Wenzel Spine completed its acquisition of OsteoMed's PrimaLOK SP Interspinous Fusion System and PrimaLOK FF Facet Fixation System. The patented PrimaLOK SP and FF platforms include a polyaxial interspinous process device and percutaneous facet screw system which is designed for minimally invasive surgical treatments for lumbar spinal disorders. This transaction expands Wenzel Spine's product portfolio and will supplement the company's efforts to strengthen its development pipeline of minimally invasive surgical products.

PRODUCT INTRODUCTION & UPDATE
Corin Group launched its Humelock Reversed Shoulder System, a device used to treat patients with a massive rotator cuff tear and a severe form of shoulder arthritis, causing pain and reduced mobility in the arm and shoulder. The system received FDA clearance in January 2017 and is currently available in Europe and other international markets. The company holds a distribution agreement for the device in the United States, Germany and the United Kingdom.

GS Medical announced the launch of its AnyPlus Anterior Cervical Interbody Fusion (ACIF) implant and its AnyPlus Dual-Lead Pedicle Screw System. The company is seeking distributor partnership opportunities and is currently focused on spinal products spanning lumbar, thoracic and cervical applications.

Paragon 28 launched its Gorilla Medial Column Plating System for Charcot and midfoot reconstruction. The system offers 36 titanium plating options to address variations in patient anatomy and levels of deformity, and all plates accept both R3CON and TuffNeck screws.

Paragon 28 launched its PRESERVE HammerGraft System, aseptically-processed allograft implants for the treatment of hammertoe deformity. The system includes four allograft implants in 2.3 and 2.8mm straight and angled formats, harvested from the cortical rim of the tibia or femur. Aseptic processing is used to avoid the potential reduction of osteoinductivity and structural fatigue that may occur from bleaching. The system also includes dense cancellous spacers that are designed to fit over the HammerGraft.

CLINICAL
VEXIM completed enrollment in its international clinical trial to support FDA 510(k) submission for its SpineJack in the US. The multicenter, prospective and randomized study aims to compare the safety and efficacy of the SpineJack versus balloon kyphoplasty on 152 patients with osteoporotic vertebral compression fractures.

APPOINTMENTS
Active Implants appointed Ted David as company president Chief Executive Officer (CEO). Mr. Davis will succeed Henry Kylce, who will continue his role as chairman of the board. Prior to Active Implants, Mr. Davis served as CEO of MicroPort Orthopedics and president of its predecessor, Wright Medical Technology's global OrthoRecon division, from 2012 through 2015.

Xtant Medical appointed Carl O'Connell as its permanent Chief Executive Officer (CEO), effective February 17th, 2017. Mr. O'Connell previously served as president of Xtant since October of 2016 and was appointed as interim CEO on January 21st, 2017. Prior to Xtant, Mr. O'Connell served as Vice President Global Marketing- Extremities for Wright Medical.


Active Implants appoints Ted Davis as CEO

Active Implants appointed Ted David as company President Chief Executive Officer (CEO).

Mr. Davis will succeed Henry Kylce, who will continue his role as Chairman of the Board.

Prior to Active Implants, Mr. Davis served as CEO of MicroPort Orthopedics and President of its predecessor, Wright Medical Technology's global OrthoRecon division, from 2012 through 2015. Before joining Wright Medical, Mr. Davis served on the boards of multiple biotechnology and medical device companies.


Wenzel Spine Announces Aqcuistion of OsteoMed's Interspinous & Facet Fixation Product Platforms

Wenzel Spine completed its acquisition of OsteoMed's PrimaLOK SP Interspinous Fusion System and PrimaLOK FF Facet Fixation System.

The patented PrimaLOK SP and FF platforms include a polyaxial interspinous process device and percutaneous facet screw system which is designed for minimally invasive surgical treatments for lumbar spinal disorders. The systems are designed to provide surgeons an expanded MIS solution when used in with Wenzel Spine's Varilift-LX, a stand-alone, expandable fusion device.

This transaction expands Wenzel Spine's product portfolio and will supplement the company's efforts to strengthen its development pipeline of minimally invasive surgical products. The company has completed a limited US release of the PrimaLOK SP & FF Systems and plants to offer wide US release in the second quarter of 2017.


Musculoskeletal News Roundup 17-Feb-17

REGULATORY
Centric Medical received 510(k) approval from the FDA for its Metatarsal Hemi Implant System, indicated for the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint. The device is a single use implant intended to be used with bone cement or without bone cement. The company is the Foot and Ankle division of Life Spine, and has been established to treat disorders of distal extremities.

PRODUCT INTRODUCTION & UPDATE
DePuy Synthes and LifeNet Health launched its ViviGen Formable Celluar Bone Matrix, a second generation cellular allograft used to assist in the formation of bone during spinal fusion surgery. The system is comprised of osteoinductive, demineralized fibers that create a putty-like consistency. The fibers interconnnect to achieve the forable handling favored in open void cases such as posterolateral fusion, a type of spinal fusion surgery. DePuy Synthes has an exclusive worldwide agreement to market and promote ViviGen and ViviGen Formable products.

K2M launched its Balance ACS (BACS), a platform that applies 3-D solutions across the entire clinical care continuum to help drive quality outcomes for spine patients. The system aims to provide solutions focused on each anatomical vertebral segment with a 360-degree approach of the axial, coronal and sagittal planes. BACS includes insurance preauthorization tools, preoperative planning, 3-D anatomical modeling and postoperative reporting to facilitate quality outcomes. The company will also use predicitve analytics to aid in surgeon decision making and individualized care solutions for patients.

Nanovis launched its FortiCore PLIF, a pourous titanium scaffold interdigitated with a PEEK core, and announced implantation of the 2,000th FortiCore implant. ForiCore TLIF and PLIF implants are designed with deeply-porous titanium scaffolds to contract the endplate, with a radiolucent PEEK core injection-molded into the bottom of the scaffold. The systems are available with MIS or open instrumentation.

INTELLECTUALLY PROPERTY
Episurf received two patents from the State Intellectual Property Office in China for its technology platform's surgical tools. The Chinese patents covering the implant specific drill bit and the height adjustment drill guide are expected to be granted and issued next quarter. This is the company's first time to obtain patents in China.

APPOINTMENTS
Alphatec Holdings, Inc., the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced that its board of directors has appointed David H. Mowry as a member of the board of directors effective February 8, 2017. Mr. Mowry will be replacing Siri S. Marshall who notified the Company that she was resigning from the Board, effective as of February 8, 2017. Mr. Mowry is President and Chief Executive Officer of Vyaire Medical, recognized global leader in the respiratory diagnostics, ventilation, and anesthesia delivery and patient monitoring market segments.

RESEARCH
HealthpointCapital interviewed Dr. Michael Gelb on His New Book "GASP: Airway Health - The Hidden Path To Wellness". Dr. Michael Gelb is an innovator in airway, breathing, sleep, and painful TMJ disorders, and a pioneer in the Airway Centric method. He has studied early intervention for sleep disordered breathing (SDB), and he specializes in how SBD relates to Fatigue, focus, and pain, and how it can affect family health. Dr. Gelb received his D.D.S. degree from Columbia University School of Dental and Oral Surgery and his M.S. degree from SUNY at Buffalo School of Dental Medicine.



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