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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 01-July-15 BY MATTHEW JAFFE, JULY 1, 2015

ConforMIS priced its initial public offering (IPO), by offering 9.0 million shares of common stock at a price of $15 a share, raising total proceeds of $135 million. This equates to an enterprise value of approximately $632 million, valuing the company at 12.1x LTM revenues. The final terms came in at the midpoint of both the initial proposed price range of $14 to $16 and the offering range of $126 million and $144 million. The company intends to use the proceeds to expand the company's manufacturing capacity, sales, research and development, clinical activities, and to fund working capital and for general corporate purposes.

MEDICREA completed a €3.5 million ($3.9 million) private placement financing. The proceeds will be used to strengthen its U.S. market penetration, establish a marketing subsidiary in Germany, and to rebalanced the company's optimal capital structure.

DJO Global closed on the previously announced acquisition of assets, including the Biomet Cobalt Bone Cement, Optivac Cement Mixing Accessories, SoftPac Pouch and Discovery Elbow System from Zimmer Biomet Holdings, expanding DJO's product offering.

Integra LifeSciences entered into a definitive agreement to acquire all of the outstanding shares of TEI Biosciences and TEI Medical (TEI) for $312 million in cash, or 4.9x 2014 revenues, or approximately 19.7x 2014 EBITDA. TEI is a biomedical company that offers regenerative technology-based products for soft tissue repair and regeneration applications including dura, hernia, tendon and abdominal wall repair and plastic and reconstructive surgery.

Centinel Spine received clearance from the FDA for its STALIF C and STALIF C-TI to be utilized in multilevel, cervical spine fusion procedures. This on-label clearance is the first granted by the FDA for a cervical multilevel indication for a Stand-Alone interbody device.

Exactech received 510(k) clearance from the FDA for its Optetrak Logic Constrained Condylar Prosthesis system, intended for revision knee arthoplasty cases or for patients undergoing surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. The company plans a limited launch in 2015 and full availability in 2016.

MX Orthopedics received 510(k) clearance from the FDA for its dynaMX Compression Staple, indicated for fracture and osteotomy fixation of the hand and foot, joint arthrodesis of the hand and foot, and fixation of proximal tibial metaphysis osteotomy. The dynaMX is engineered with superelastic legs and a malleable bridge that combined enable a surgeon to more closely match the patients anatomy.

SpineGuard received regulatory clearance from the CFDA commence sales in China of its PediGuard system, which is utilizes the varying conductivity differences of cortical bone, cancellous bone and of periosteum and blood to help guide surgical placement of pedicle screws.

Spine Wave launched its Leva Interbody Device System, intended for the restoration of spinal disc height. The Leva is constructed from titanium that is designed to expand vertically in-situ, with open architecture facilitating surgical bone graft placement of up to 68.5% of the total disc space.

Tyber Medical launched its Lateral Retractor System for use in lateral lumbar procedures, designed utilizing a three blade retractor body with controlled tissue and muscle retraction. Tyber is positioning its system to compete on both design and low cost.

RepliCel Life Sciences enrolled the first participants in its phase 1/2 clinical trial of its RCT-01 autologous cell therapy, for the treatment of chronic achilles tendinosis. The trial is a 28 participant randomized, double-blind, and placebo-controlled study. The participants each had a biopsy of hair follicles on their heads from which isolate non-bulbar dermal sheath cells, that are processed into RCT-01 prior to the intra-tendon injection. The patients will be monitored for six months while they participate in post-treatment physiotherapy.

Medtronic appointed Geoff Martha to serve as its Executive Vice President and President, of its Restorative Therapies Group (RTG), effective immediately. Mr. Martha currently serves as Sr. Vice President of Corporate Strategy & Business Development, Global Communications and Medtronic Philanthropy, and as Chief Integration Officer for the Covidien integration. Medtronic also appointed Bill Burke to serve as Chief Integration Officer (CIO) due to the recent acquisition of Covidien. Mr. Burke served as lead deputy to Geoff Martha, and as the Principal Operating Officer for the Integration Management Office.

OrthoFix elected Lilly Marks to its Board of Directors. Ms. Marks serves as the Vice President for Health Affairs for the University of Colorado, and is a also member of the Board of Directors of the University of Colorado Health System, Children’s Hospital Colorado, Federal Reserve Bank of Kansas City, and the Advisory Board for Clinical Research of the National Institutes of Health, in addition to others.

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