• BG Medicine (Waltham, Massachusetts) reported signing a Cooperative Research and Development Agreement (CRADA) with the National Heart, Lung, and Blood Institute (NHLBI) and Boston University (BU). Under the agreement, the three parties will jointly conduct a series of biomarker discovery studies for heart disease and early detection of metabolic syndrome a combination of certain risk factors, including abdominal obesity, hypertension, and insulin resistance which are believed to increase the risk of developing cardiovascular disease and diabetes. BG Medicine's highly advanced technology, which can detect and validate subtle biological changes at the molecular level, will analyze biosamples obtained during years of collection by Framingham Heart Study researchers. The Framingham Heart Study is funded by NHLBI and conducted in collaboration with BU's School of Medicine and School of Public Health. The collaborative research aims to identify those at high risk of heart attack and stroke, two of the world's leading killers. The study Systems Approach to Biomarker Research in Cardiovascular Disease (SABRe CVD) may also aid pharmaceutical companies in developing novel medicines to prevent or treat these conditions. The collaboration is the first time in the Framingham Heart Study's 60-year history that it is partnering with a commercial company in a CRADA research project.

• Cardiovascular Systems (CSI; St. Paul, Minnesota), a company focused on developing interventional treatment systems for vascular disease, reported that it has successfully closed its previously reported merger with Replidyne (Louisville, Colorado). The transactions included the merger of CSI with a subsidiary of Replidyne. In connection with the merger, Replidyne changed its name to Cardiovascular Systems and its shares have been approved for trading on the Nasdaq Global Market under the symbol CSII. Through this transaction, an additional $37 million in net assets, primarily cash, is available to CSI's business. The company plans to use the proceeds to advance its medical products, including its Diamondback 360 Orbital Atherectomy System, and expand its sales and marketing organization. The merger was first disclosed last November. The company's total common shares outstanding are about 13.7 million, after giving effect to the 1-for-10 reverse stock split of Replidyne's stock immediately prior to the merger and assuming the conversion of all of the outstanding shares of CSI upon the terms of the merger. Under terms of the merger agreement, the former CSI and Replidyne shareholders are entitled to receive about 83% and 17% of the combined company respectively.

• Hansen Medical (Mountain View, California) reported an equity investment in Advanced Cardiac Therapeutics (ACT; Laguna Beach, California), and the securing of exclusive rights to certain ACT intellectual property for certain robotic applications. Details of the transaction were not disclosed. ACT, a privately held company, is developing a technology designed to accurately measure the temperature in a lesion during cardiac ablation procedures. Current manual technology used by physicians to control catheters in electrophysiology procedures can be limiting in several ways including, precise catheter control and stability, as well as the inability to accurately sense tissue temperature and its potential effect on lesion quality. The Sensei Robotic Catheter System from Hansen has helped to advance the control of electrophysiologic mapping catheters by using flexible medical robotics technology to provide stable and predictable control of catheter movement inside the heart, according to the company.

• Spectral Diagnostics (Toronto) reported that it has signed a license agreement with Toray Industries (Tokyo) granting Spectral the exclusive development and commercial rights in the U.S. for Toraymyxin, a therapeutic device for the treatment of sepsis that removes endotoxin from the bloodstream. Under the agreement, Spectral will seek FDA approval for Toraymyxin and intends to commercialize the product together with its Endotoxin Activity Assay (EAA), the only FDA cleared diagnostic for the measurement of endotoxin. "The finalization of this agreement, on schedule, is an important milestone for Spectral and demonstrates the significant progress we have made on our path to delivering an effective treatment for severe sepsis in the U.S.. Toraymyxin has been used on more than 70,000 patients to date, primarily in Europe and Japan, for the treatment of severe sepsis caused by endotoxemia," said Paul Walker, president/CEO of Spectral. The company plans to conduct a pre-investigational device exemption meeting with the U.S. FDA this quarter as a first step toward gaining clearance for its clinical strategy, with the objective of initiating clinical trials in the latter half of 2009.

• Zoll Medical (Chelmsford, Massachusetts) reported an agreement with Alsius (Irvine, California) to buy substantially all the assets constituting Alsius's intravascular temperature management device business for $12 million. The assets to be acquired include the intellectual property relating to the business, other intangibles, inventories and fixed assets. Zoll will, as part of this agreement, assume warranty obligations relating to Alsius's installed base of products. Zoll said it plans to consolidate the operations of the acquired business at its facilities in Sunnyvale, California. The closing of the transaction is subject to the approval of Alsius shareholders and to other customary closing conditions.

No Comments