This past summer, CircuLite Inc. (Hackensack, NJ) launched the clinical development program for its Synergy pocket circulatory assist device with the successful implantation in the first patient in a European feasibility trial. Synergy is a miniature implantable blood pump that can be implanted superficially in a pocket, similar to a pacemaker. The device is designed to provide long-term, partial circulatory support in patients with chronic heart failure. The primary objective of the first-in-man trial is to assess the safety of the device in patients with chronic heart failure who are waiting to receive heart transplants. "The commencement of this trial is an achievement that brings together more than 11 years of engineering and research and demonstrates our leadership position in this space," said Paul Southworth, president and CEO of CircuLite. "This trial will provide us with important data to support our additional planned studies, including a CE mark trial in Europe, as well as our investigational device exemption trials in the United States."
CryoCor Inc. (San Diego) announced that FDA has granted premarket approval (PMA) for its cardiac cryoablation system for the treatment of right atrial flutter. Based on this approval, CryoCor intends to begin selling its cryoablation system in the United States over the next several months. The company has targeted an initial installed base of 120 to 160 consoles by December 31, 2008, growing to about 300 consoles by 2010. "The approval of the PMA for the CryoCor cryoablation system for the treatment of right atrial flutter by FDA is a major milestone for the company," says Ed Brennan, PhD, president and CEO of CryoCor. "An important element of our strategy is to grow our installed base of consoles, which drives the use of disposables for the treatment of right atrial flutter." FDA's decision to approve CryoCor's PMA for right atrial flutter follows a June advisory panel meeting, at which the panel voted to recommend approval of CryoCor's PMA, with conditions. To comply with these conditions, CryoCor will implement a formal training program for clinical sites, as well as conduct a two-arm registry study of 650 patients, collecting safety and long-term effectiveness data on the use of its cryoablation system as compared to approved radiofrequency catheters in the treatment of right atrial flutter. In related news, shortly following the FDA advisory panel's recommended approval of CryoCor's PMA, Boston Scientific (Natick, MA) and CryoCor Inc. announced a strategic collaboration in the field of cryoablation. The collaboration involves the codevelopment of therapeutic solutions for atrial fibrillation.
TheraGenetics Ltd. (London), a personalized diagnostics company focused on central nervous system (CNS) disorders, announced the successful completion of a $6 million series A venture financing round. Swarraton Partners led the financing. As part of the transaction, Stephen Brooke, managing partner of Swarraton Partners, has joined TheraGenetics' board of directors. TheraGenetics has developed a series of proprietary technologies and methods in the field of personalized medicine, based upon pharmacogenetics. Under the umbrella of the Institute of Psychiatry at King's College London, the founding team translated 15 years of research into the development of the first pharmacogenetic test for response prediction in psychiatry. "This venture financing round will be used to expand our intellectual property position and expedite the development of our portfolio of pharmacogenetic diagnostic tests," said Richard P. Kivel, CEO of TheraGenetics. "Our tests will guide doctors in their treatment of patients suffering from CNS disorders such as schizophrenia, Alzheimer's disease, and mood disorders."
Thermo Fisher Scientific Inc. (Waltham, MA) has acquired all assets of the OptiCell product line from BioCrystal Ltd. (Westerville, OH). OptiCell employs gas-permeable polymer membranes to provide a cell culture growth surface enclosed within a sealed environment. The cell culture technology provides scientists with a device that reduces time and labor required for sequential experimental steps such as imaging, cell separation, transfection, cloning, shipping of live cells, short-term cryopreservation, and laboratory-scale antibody production. For the past year, the product line was marketed as the Nunc OptiCell system under an exclusive distribution agreement with BioCrystal. "We decided to purchase the product line because we had very positive customer feedback during its launch phase," said Steve Silverman, vice president and general manager of labware and specialty plastics at Thermo Fisher Scientific. "This acquisition helps us leverage and further develop OptiCell as a next-generation cell culture device."
The University Medical Center Hamburg-Eppendorf (UKE) and Royal Philips Electronics (Amsterdam, The Netherlands) have developed a computer-aided diagnosis system for neurodegenerative diseases to support clinicians in diagnosing the onset and type of disease as early as possible. The new diagnostic technique is about to undergo clinical evaluation at UKE. The evaluation will run the computer-aided diagnostic system alongside UKE's existing de-mentia diagnosis procedures with the aim of fine-tuning the system's ability to detect and differentiate the three most common types of neurodegenerative disease: Alzheimer's disease, Lewy-body dementia, and frontotemporal dementia. "Building on our expertise in multimodal diagnostic imaging, we've combined functional and structural brain-scan information into a fully integrated and easy-to-use system for diagnosing the principal neurodegenerative diseases that cause dementia," says Lothar Spies, PhD, head of the digital imaging department at Philips Research. "Ultimately, it will enable early treatment and highly personalized therapies."
Privately held Novian Health Inc. (Chicago) reports that it has developed an interstitial laser therapy device. In its initial application, the device, used to treat fibroadenomas of the breast with tumor sizes up to 20 mm, was granted FDA clearance in May. "We are extremely pleased to have received FDA clearance," said Chip Appelbaum, president and CEO of Novian Health. "This enables us to begin the commercialization phase of establishing and operating treatment sites, which will offer women an alternative to traditional surgery, as well as to expand our clinical development efforts in malignant tumors." Previously known as Kelsey Inc., the company is introducing Novian Health as its new name.
Roche Diagnostics (Indianapolis) has completed its previously announced acquisition of BioVeris (Gaithersburg, MD). The company reports that completion of the $600 million merger means that Roche Diagnostics now owns the patents for electrochemiluminescence (ECL) technology and can expand its immunochemistry business from the human diagnostics field into new market segments such as life sciences research, life sciences development, patient self-testing, veterinary testing, drug discovery, drug development, and clinical trials. "We are excited to be able to offer ECL technology to existing and new customers for these expanded uses," said Andy Thomson, senior vice president for centralized diagnostics at Roche Diagnostics.
ATS Medical Inc. (Minneapolis) and CryoCath Technologies Inc. (Montreal) have entered into definitive agreements under which ATS Medical will acquire the surgical cryoablation business of CryoCath Technologies. The assets being acquired include the SurgiFrost, FrostByte, and SurgiFrost XL family of products for which ATS Medical currently serves as Cryo-Cath's exclusive agent in the United States and distributor in certain international markets. Under the definitive agreements, ATS Medical will pay CryoCath $22 million upon closing of the transaction, $2 million upon the achievement of certain manufacturing transition milestones, $2 million two years after closing, and up to $4 million in contingent payments based on future sales of SurgiFrost XL, an FDA-cleared and CE-marked product planned for commercial release in the second half of 2007. "We are very excited about the benefits that owning the surgical cryoablation business will bring to ATS Medical," said Michael Dale, president and chief executive officer of ATS Medical. "This innovative technology enables us to dramatically leverage our current operating infrastructure and provides us with a technological road map to address the rapidly growing, $1.5 billion cardiac arrhythmia market in both the short and long term. Under our existing distribution agreement with CryoCath, we have been extremely successful in growing revenue and market share, realizing an annual revenue growth rate in our accounts in excess of 50% in 2006."