Earnings
Medicrea reported record sales figures in the first half of 2010, including realizing sales of 4.5 million Euros in 2Q:10 and a 36% increase over 2Q:09. Medicrea cites its three subsidiaries -- Medicrea USA, Medicrea Europe Francophone, and Medicrea UK -- with these surges in revenue, with these groups contributing to 75% of their parent's sales. Denys Sournac, CEO, predicts sales growth will continue to rise in the latter half of 2010 due to the company's "distinctive" distribution model and new products coming to market.
M&A
Sparton Medical Systems Colorado LLC, a subsidiary of Sparton Corporation, has acquired Delphi Medical Systems contract manufacturing business for $8 million in cash. Denver-based Delphi manufactures OEM devices, including spinal surgery products. Sparton expects the acquisition to increase their western customer base, projecting annual revenue to increase to $32 million.
Funding
Biomimetics announced the pricing of a public offering of 5,000,000 shares priced at $8.50. Net proceeds are expected to be around $40 million. The company, working with JP Morgan as sole lead book-runner Canaccord Genuity and Wedbush PacGrow Life Sciences as co-managers, expects to close by July 20, 2010.
Regulatory
NuOrtho Surgical received 510(k) approval for Cerileau, an arthroscopical device that treats soft tissue damage with radio frequencies. The electrosurgical probe helps surgeons to precisely locate damaged tissue, with studies showing that the device allows for selective treatment of harmed areas while not damaging healthy tissue. NuOrtho has already undertaken plans to manufacture and distribute Cerileau, though a specific launch date has not been set.
Xylos received 510(k) clearance for its Xylos Vessel Guard, an implantable device to cover vessels during anterior vertebral surgery. Xylos' product platform is based on a proprietary biocellulose technology.
Product Introduction and Update
DePuy introduced its OMNISPAN Meniscal Repair System at the 2010 AOSSM 2010 Annual Meeting. The system is for all-inside meniscus repairs and implements a low-profile needle to allow for less invasive procedures, and proprietary sutures that mitigate tissue abrasion over time. Last week DePuy also announced it would commence European sales of its Sigma High Performance Partial Knee. Sigma is unique in that it allows for uni-compartmental, bi-compartmental or staged replacement of the joint, enabling surgeons to tailor treatment to each patient's needs and adjust or add parts as degradation continues. DePuy recently launched a related knee implant, Sigma CR-150 High-Flex Knee, in India. The CR-150 is part of their High Performance Instrument platform, which includes the Sigma Partial Knee now selling in Europe.
SANUWAVE Health is launching its orthoPACE product in Europe. Indicated for use in trauma and sports medicine, orthoPACE promotes the body's own healing process using electrohydraulic shock waves that activate revascularization and other angiogenic processes. The product, which replaces SANUWAVE's Ossatron device, will be used for tendinoplasties and acute and non-union fractures.
Clinical
A study in the UK will investigate the effectiveness of stem cell therapy in the treatment of osteoarthritis. The trial, part of a five-year research effort funded by Arthritis Research UK, involves mixing stem cells with chondrocytes and then injecting them into arthritic joints. 70 patients are participating, and the researchers hope to launch the study this year.
Histogenics Corp. commenced a 245-patient Phase III trial of NeoCart, an implant intended for knee cartilage repair through tissue regeneration. The device derives neocartilagenous tissue from the patient's own chondrocyte cells, and the tissue is then integrated into a collagen matrix. Histogenic's study will compare NeoCart to standard microfracture repair surgery.
Distribution
ETEX signed a non-exclusive distribution contract with Stryker to market and sell its two bone graft products, Bio MatrX Structure and Bio MatrX Generate. Both bone graft substitutes are comprised of ETEX's proprietary nanocrystalline calcium phosphate technology, and are approved by the FDA as bone fillers in the pelvis, extremities and posterolateral spine.
