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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 17-May-12 BY LAUREN UZDIENSKI, MAY 17, 2012

Earnings
aap Implantate reported 1Q:12 sales of EUR 9.9 million ($13.2 million), up 51% from the year-ago period. The company attributed sales growth to product sales, which increased by 18% to EUR 7.7 million ($10.3 million), and to revenue from the conclusion of an exclusive license agreement. EBITDA increased to EUR 2.1 million ($2.8 million) from EUR 0.8 million ($1.1 million) in 1Q:11.

Corin announced that sales for four months of 2012 (ended April 30th) were up 24% at constant currency rates. This was attributed partially to stocking orders to MAKO Surgical, and excluding these stocking orders, constant currency sales growth was 10%. Overall, revenue growth was led by sales of the company's new hip products. Knee sales were flat during the period.

Mazor Robotics reported 1Q:12 revenue of NIS 9.2 million ($2.5 million), up 45% over the year-ago period, which included the sale of three Renaissance robotic systems. The company launched the Renaissance system, which is used for minimally invasive and complex spine surgeries, in the U.S. in 4Q:11.

TiGenix reported that 1Q:12 sales of their ChondroCelect product increased by 123% to EUR 0.7 million ($0.9 million) compared to 1Q:11. Sales rose by 62% from 4Q:11.

M&A
SurgLine International acquired Eden Surgical Technologies, a distributor of trauma products. The transaction was structured as a share exchange agreement whereby Eden Surgical received 50 million shares of restricted common stock of SGLN.

Funding
Regenerative Sciences secured a $2.0 million investment from John C. Malone, PhD, chairman of Liberty Media Corporation. Funds will be used to advance Regenerative Sciences' clinical and lab-based stem cell research as well as support the national expansion of the Regenexx Physician Network. Regenexx is described as an autologous stem cell therapy that can be used to treat a number of conditions, including cartilage lesions, torn ligaments and tendons, osteoarthritis and bulging spinal discs.

Israeli company Regentis Biomaterials raised $10 million from new investors Royal DSM (which just acquired Kensey Nash) and Crossroad Fund, as well as from existing investors Medica Venture Partners, SCPVitalife and the Technion Investment Opportunities Fund. Regentis is developing GelrinC, a biodegradable hydrogel that can be used to treat articular cartilage lesions. Regentis is currently conducting a multi-center pilot study in Europe and Israel to evaluate the safety and performance of GelrinC, with the latest round of financing to be used to "establish Regentis's European presence and expand its ongoing clinical efforts of GelrinC."

Zyga Technology raised $25.0 million in a series C financing led by new investor Versant Ventures, who were joined by existing investors Split Rock Partners, Domain Associates, and MB Venture Partners. In conjunction with the funding, Kirk Nielsen, Managing Director at Versant Ventures, will join the board of directors of Zyga. Funds will support sales, marketing, and clinical efforts to commercialize the SImmetry Sacroiliac Joint Fusion System and the GLYDER facet resurfacing product.

Regulatory
AxioMed received CE mark certification for its Freedom Cervical Disc, an elastomeric total spinal disc replacement device. AxioMed's first product was the Freedom Lumbar Disc, which received the CE mark in 2009.

Product Introduction & Update
OMNIlife science announced completion of 1,000 knee replacements using its APEX robotic surgical navigation technology (called A.R.T.), which automates positioning of a bone cutting guide.

The Orthopaedic Implant Company launched its Pedicle Screw System, which they say "can save hospitals and surgery centers up to $3,000 per fusion level."

Legal
Medtronic announced that the DOJ has closed their investigation of InFuse. The government first subpoenaed documents from Medtronic in October 2008.

A German District Court in Mannheim dismissed Synthes' patent infringement claims against Spinal Kinetics. Synthes had claimed that Spinal Kinetics' M6-C cervical and M6-L lumbar artificial discs, which feature an artificial nucleus and annulus, violated Synthes patents.

Clinical
Histogenics reported intermediate-term data from 29 subjects pooled from previously-completed, company-sponsored phase I and II multi-center clinical trials of Neocart. Results "supported the clinical efficacy" of NeoCart at a median of 48 months of follow-up, as evidenced by significant improvement on the International Knee Documentation Committee, Short Form Health Survey, all five domains of the Knee injury and Osteoarthritis Outcome Score and VAS measures. NeoCart is an autologous treatment option that uses the patient's own cartilage cells, which are cultured ex-vivo then re-implanted to treat chondral lesions.

Piramal highlighted phase III data for their cartilage defect treatment BST-CarGel, noting that the product achieved "statistical significance over microfracture in the degree of filling treated lesions and the quality of the new tissue." Piramal added that cartilage repair structural outcomes resulting from BST-CarGel treatment were "superior at 12 months to microfracture" which may "translate to longer durability and sustained clinical benefit."

Spinal Restoration provided an update on its 260-subject, 20-center, phase III, randomized, placebo-controlled study evaluating its BIOSTAT BIOLOGX Fibrin Sealant for the treatment of chronic discogenic low back pain. The study is more than 85% enrolled, and data will be used to support a Biologic License Application to the FDA.

Distribution
SurgLine International signed a distribution agreement with Castlegate Holdings, which provides product, product financing and AR management to rural hospitals, ambulatory surgical centers and orthopedic and neurosurgical groups. Castlegate projects that it will utilize SurgLine's products for approximately 20 surgical spine cases per month. The agreement has a three-year term, and sales are estimated to be $100,000 per month.

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