Company Recently Announced European CE Mark Approval for SYNERGY

CircuLite®, Inc. today announced that the latest data from patients enrolled in the Company’s CE Mark trial of the SYNERGY® Circulatory Support System were presented on Monday, September 10 in a “Late-breaking News” podium presentation at the Heart Failure Society of America Annual Scientific Meeting. The presented data focused on results from the most recently implanted patients who received the optimized version of the system. Results from these patients strengthened prior findings indicating that implantation with SYNERGY resulted in significant, sustained improvements in hemodynamics and exercise tolerance. SYNERGY, which recently received CE Mark approval in Europe, is a micro-pump designed to halt the progression of heart failure and to improve symptoms and exercise tolerance. By working with the heart’s native pumping capacity, the SYNERGY System is specifically targeted for treatment of ambulatory heart failure patients (INTERMACS 4,5,6 / NYHA III and early IV) who remain symptomatic despite standard medical management.

“Beyond the hemodynamic and quality of life improvements that we have seen, we have also observed that the simple, off-pump mini-thoracotomy procedure used to implant SYNERGY allows for potentially quick recovery, with patients often being extubated within hours post-implant and typically ambulatory within one to two days post-implant,” said Daniel Burkhoff, M.D., Ph.D., Medical Director of CircuLite and Adjunct Associate Professor of Medicine at Columbia University. “The data continue to support the belief that SYNERGY holds significant potential to benefit ambulatory heart failure patients who are symptomatic but not sick enough to justify the risks associated with more invasive assist devices.”

Dr. Robert L. Kormos, M.D., Director of the Artificial Heart Program and Co-Director of Heart Transplantation at the Heart and Vascular Institute at the University of Pittsburgh Medical Center, who moderated the session, said, “Dr. Burkhoff emphasized the improved results achieved with the latest, optimized version of this unique, minimally invasive support system for the treatment of congestive heart failure. The trial results suggest lower rates of adverse events such as bleeding, infection and right heart failure can be achieved with smaller, less invasive systems such as SYNERGY.”

“We continue to gain clinical validation for the SYNERGY System following our recent receipt of CE Marking approval in Europe,” said Paul Southworth, President and CEO of CircuLite. “We believe that SYNERGY’s clinical benefits, combined with the potential cost benefits that may result from the minimally invasive procedure and rapid patient recovery, will contribute greatly to its commercial potential as we begin a controlled European launch later this year and plan a U.S. IDE trial to begin in late 2012 or early 2013.”

Dr. Burkhoff presented the abstract titled “Current Clinical Experience with the CircuLite Synergy System in Chronic Ambulatory Heart Failure” during the late-breaking news session. A total of 59 patients at nine clinical trial sites in Europe have been implanted with the SYNERGY System to-date; however, the presented findings focused on the 20 most recently implanted patients, who received the optimized version of the system. Hemodynamic improvements were significant and sustained, as measured by cardiac output (3.9±0.9 to 4.8±0.9 L/min) and capillary wedge pressure (28±8.0 to 15.1±5.0 mmHg) a median of 3 months after implant. Additionally, results demonstrated improved exercise tolerance, as measured by peak VO2 (10.6±2.9 to 12.6±2.4 ml O2/kg/min) and six-minute walk (301±146 to 439±63.6 meters). Patients implanted with SYNERGY also demonstrated improvements in quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire (71±5.0 to 38±23.0). These improvements were accompanied by an adverse event rate during the first 30 days post-implant that was relatively lower than reported for standard full support VADs.

CircuLite will also provide additional data related to SYNERGY at the meeting in the following presentations:

• “Contractility Modulation or Smaller Assist Devices for Earlier Use?” to be presented by Dr. Burkhoff on Tuesday, September 11 at 8:30 a.m. PDT in the How Should We Improve Pump Function symposium
• “Can the Seattle Heart Failure Score (SHFS) be Used to Select Non-Inotrope Dependent Severe Heart Failure Patients with Appropriate Risk for Mechanical Circulatory Support?” to be presented on Tuesday, September 11 during a poster session
• “CircuLite® Synergy® System Experience in Circulatory Support for Elderly Chronic Heart Failure Patients” to be presented on Tuesday, September 11 during a poster session
• “Destination Therapy with Miniaturized Percutaneous VADs” to be presented by Dr. Burkhoff on Wednesday, September 12 at 11:20 a.m. PDT in the Envisioning Therapy in Heart Failure symposium

Source: CircuLite®, Inc.