Clinicians at EACTS to Highlight Prospective Randomized Clinical Trial Data Indicating Reduced Complications With On-X Heart Valve

On-X^® Life Technologies, Inc. (On-X LTI) announced today that recent interim results from the PROACT (Prospective Randomized On-X Anticoagulation Clinical Trial) study indicate that patients with the On-X® Plus 1.5™ Aortic Heart Valve may be safely managed at lower INR rates with statistically significant reductions in bleeding events and no increase in thromboembolic events (TE), even in higher TE risk patients.

PROACT Principal Investigator John D. Puskas, M.D., FACS, FACC, Professor of Cardiothoracic Surgery, Icahn School of Medicine at Mount Sinai, and Chairman, Department of CT Surgery, Mount Sinai Beth Israel New York, New York, will present recently updated data that provide compelling support for the adoption of a lower level of anticoagulation with the On-X® Plus 1.5™ Aortic Heart Valve. Dr. Puskas’ presentation will take place during the “New Nuggets from Late-Breaking Clinical Trials” session, at the 28^th annual meeting of the European Association of Cardio-Thoracic Surgeons (EACTS) in Milan, Italy this week.

“The major concern with the use of anticoagulants such as warfarin has been bleeding risk,” said Dr. Puskas. “The interim PROACT trial results show that On-X aortic heart valve recipients can be safely maintained at much lower INR levels than have been used for other mechanical heart valves, thereby significantly reducing the risk of bleeding complications.”

The level of anticoagulation activity is measured as international normalized ratio (INR) that is used to determine the clotting tendency of blood. INR in the absence of anticoagulation therapy is normally 0.8-1.2. A patient’s target range for INR in anticoagulant use (e.g. warfarin) varies, depending upon indication for therapy. Professional societies have recommended that patients with mechanical aortic heart valves in the absence of thromboembolic risk factors be maintained at 2.0-3.0 INR.

However, the PROACT trial for the On-X aortic valve studied an INR range of 1.5-2.0 INR for aortic valve patients who were at higher than normal risk of thromboembolism. According to Dr. Puskas, the lower target INR in the PROACT trial resulted in a statistically significant reduction of 65% in bleeding events for the test patients without an increase in thromboembolic events.

The interim PROACT trial results have provided the basis for the recent submission of a revised, reduced anticoagulation guideline for the On-X valve Instructions for Use (IFU). The revised IFU may permit patients with On-X aortic valves to be managed at an INR (International Normalized Ratio) level of 1.5 to 2.0, which is closer to an unmedicated INR. CE approval was obtained for this reduced anticoagulation in January 2014, and U.S. FDA approval is pending.

“These results showing reduced bleeding events for patients who receive the On-X aortic valve, should be extremely meaningful for those who are in the process of choosing a prosthetic valve,” said Clyde Baker, On-X Life Technologies CEO. “We expect the pending FDA clearance of the revised IFU will give younger aortic heart valve replacement patients — particularly those 65 years and under — a safer and more permanent solution for their aortic valve disease. The On-X aortic valve not only represents reduced risk of bleeding complications, but its proven clinical durability eliminates the trauma associated with future cardiac reoperations needed to replace failing animal tissue valves.”

On-X LTI also will sponsor a lunchtime symposium during EACTS on Monday October 13, 2014. Marc Gerdisch, M.D., FACS FACC, Chief of Cardiovascular and Thoracic Surgery at Franciscan St. Francis Heart Center of Indianapolis, Indiana, USA, and Jose L. Pomar, M.D., Ph.D. of University Hospital Barcelona, Spain will present additional interim PROACT data on anticoagulation rates, and a review of long-term clinical event rates with the On-X bileaflet mechanical heart valve.

About the On-X Prosthetic Heart Valve

The On-X® Plus 1.5™ Aortic Heart Valve is the result of a breakthrough in medical grade carbon technology—On-X^® pure pyrolytic carbon. In addition to providing a more thromboresistant surface, the comparatively high strength of pure On-X® carbon enabled On-X LTI to make significant valve design changes that result in a prosthesis that acts more like a natural valve in its treatment of blood. It is well documented that the On-X valve does not produce the turbulence and blood damage commonly produced by other mechanical heart valve prostheses and therefore significantly reduces the potential for life-threatening blood clots.

About On-X LTI

On-X^® LTI develops heart valve replacements that significantly improve the quality of life of patients. Jack Bokros, Ph.D., and his associates founded On-X LTI in 1994 to further advance prosthetic heart valve technology by capitalizing on their new form of pyrolytic carbon. The company has FDA, CE and Japanese approval for sale of the On-X^® valve. On-X LTI also provides contract-manufacturing services utilizing its patented pyrolytic carbon to manufacturers of other medical products, including orthopedic joint and spine prostheses. Headquartered in Austin, Texas, On-X LTI is a privately held company. To learn more about the On-X heart valve and On-X Life Technologies, visit www.onxlti.com and the company’s Healthcare Blog.

On-X is a registered trademark of On-X Life Technologies, Inc. All other trademarks mentioned herein belong to their respective companies.

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