On-X Life Technologies Enters License and Development Agreement with Cleveland Clinic for Surgical System to Repair Mitral Valve Chordae
System is intended to improve mitral valve repair and simplify procedure for cardiac surgeons

AUSTIN, TX (December 8, 2009) – Austin-based On-X® Life Technologies, Inc. (On-X LTI), manufacturers of the On-X® Prosthetic Heart Valve announced today that it has entered into an exclusive worldwide license with the Cleveland Clinic for a system of products intended to improve and simplify the replacement of damaged or severed mitral valve chordae. The system is the creation of co-inventors A. Marc Gillinov, M.D., a staff cardiac surgeon at Cleveland Clinic, and Michael K. Banbury, M. D., of Christiana Care’s Center for Heart and Vascular Health, and will be co-developed with the On-X LTI New Product Development team.

Surgical repair of the mitral valve includes the insertion of a cloth-covered ring around the valve to bring the leaflets into contact with each other (annuloplasty), removal of redundant/loose segments of the leaflets and re-suspension of the leaflets with artificial cords (chordal replacement). Replacement of diseased mitral valve chordae with expanded polytetrafluoroethylene (ePTFE) sutures is an established technique with good long-term results. Various techniques have been described to assist the surgeon to establish the correct replacement chordal length.

“For the past three decades, there has been great focus on the roles of leaflet resection and annuloplasty for mitral valve repair in patients with mitral valve prolapse. More recently, surgeons have recognized the value of using artificial chordae to correct prolapse,” said Dr. Gillinov. “With current techniques, chordal replacement is technically challenging. The hope is to assist cardiac surgeons by providing a simple method for chordal replacement.”

“The surgical approach to mitral valve repair appears to be a method by which a long-term satisfactory outcome can be achieved,” said Dr. Banbury. “It is our expectation that the surgical tools we will develop with On-X LTI will further enable the surgical approach and enhance the consistency of surgical outcomes, providing patients with the best opportunity for a solution to their mitral incompetence.”

Approximately 50,000 mitral valve repair procedures are performed annually in the United States. Mitral valve repair is one of the fastest growing procedures in cardiac surgery due to the excellent long-term outcome. In a minority of cases the mitral valve may not be surgically repaired and must be replaced with a prosthetic valve.

“Cleveland Clinic, and Drs. Gillinov and Banbury are recognized leaders in the delivery of excellent heart surgery results,” said Clyde Baker, On-X LTI president and CEO. “The opportunity for On-X LTI to work with them and to develop this important new surgical system not only enhances the future product offerings of On-X Life Technologies, but also provides us with new insight into the future of heart valve treatment. We are extremely pleased to enter into this relationship and expect that surgeons and patients will receive meaningful value from the delivery of these innovative products.”

About On-X Life Technologies, Inc.

On-X LTI develops heart valve replacements that significantly improve the quality of life for patients. The On-X valve design was awarded a 2002 Medical Device Excellence Award in the Implant and Tissue-Replacement Products category. The company also provides OEM services utilizing its patented On-X carbon to manufacturers of other medical products, including orthopedic joint and spine implant devices. On-X LTI was founded in 1994 by a team of heart valve material and design scientists and engineers led by pioneer Jack Bokros, PhD. Capitalizing on more than 30 years of heart valve design experience the team developed and continues to manufacture the On-X Prosthetic Heart Valve. The valve is approved for use within the US and throughout the world. On-X LTI is headquartered in Austin, Texas. More information is located at www.onxlti.com.

Media Contacts:

Clyde Baker
President & CEO On-X Life Technologies, Inc.
512-339-8000 ext. 269
cbaker@onxlti.com

On-X® Prosthetic Heart Valve and On-X® carbon are trademarks of On-X LTI, registered in the US Patent and Trademark Office and corresponding foreign filings. All other trademarks mentioned herein belong to their respective companies.

On-X Life Technologies Completes Enrollment in High-Risk Patient Group of Low-Anticoagulation Trial
Data from the PROACT Trial may provide evidence that the On-X valve may be appropriately maintained at lower levels of anticoagulation

AUSTIN, TX (October 20, 2009) – Austin-based On-X® Life Technologies, Inc. (On-X LTI), manufacturers of the On-X® Prosthetic Heart Valve and On-X® carbon products for orthopedic implants, announced today that enrollment in the High-Risk Patient Group of the landmark PROACT (Prospective Randomized On-X Anticoagulation Clinical Trial) is complete. While data is still to be analyzed, it is a positive indication that the trial has reached full enrollment of the High-Risk Aortic Valve Replacement Patient Group without an adverse incident that would lead the study’s Data Safety Committee to conclude the study prematurely.

Based upon existing clinical data, The U.S. Food and Drug Administration approved the PROACT trial in January 2006. The study is being conducted in 40 world-class clinical sites in the U.S.

The patient groups in the study include low-risk aortic valve replacement patients, higher risk aortic valve replacement patients and mitral valve replacement patients. Higher risk patients include those with heart rhythm problems, left ventricular dysfunction, previous thrombo-embolism and condition of hypercoagulability. It is within the higher-risk aortic patient group where enrollment is complete.

“This is the first FDA trial to explore lower anticoagulation with a mechanical heart valve,” said Professor John D. Puskas, M.D., associate chief, Division of Cardiothoracic Surgery at Emory University School of Medicine in Atlanta, Georgia, the study’s Principle Investigator.

“Although we must wait until the clinical data are analyzed, the completion of enrollment of the high-risk aortic patient group without a significant number of patient events provides optimism toward an eventual good result,” said Dr. Puskas. “The exciting thing about this trial is the opportunity it may provide patients to choose a durable mechanical valve for life with complications similar to those of less durable tissue valves – meaning they may not have to face either an increased risk of bleeding or valve failure,” notes Dr Puskas.

“This is a significant achievement for On-X LTI and the On-X heart valve,” said Clyde Baker, president and CEO of On-X Life Technologies, Inc. “But more importantly, when the data are available and we have sufficient evidence of efficacy, we will apply to authorities to modify our product labeling significantly to permit modification of anticoagulation protocols with the On-X valve, a change that will provide an immediate clinical benefit to patients.”

“We are extremely appreciative to the patients involved in this study, to the leadership of Dr. Puskas and the many surgeons and coordinators within these 40 institutions for conducting the trial thus far, and we look forward to the data analysis and completion of enrollment in the other patient groups within the PROACT trial,” notes Baker.

More about the On-X Prosthetic Heart Valve

The On-X valve is the result of a breakthrough in medical grade carbon technology: On-X pure pyrolytic carbon. In addition to providing a more thrombo-resistant surface, the comparatively high strength of pure On-X carbon enabled On-X LTI to make significant valve design changes that resulted in a prosthetic 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.

First implanted in 1996, recent clinical evidence suggests that patients implanted with the On-X heart valve may be able to reduce the dosages of anticoagulation therapy traditionally required by mechanical heart valve recipients.

The FDA approved the On-X aortic and mitral valves for commercial use in the United States on May 30, 2001, and March 6, 2002, respectively. More than 70,000 On-X valves have been implanted since 1996.

About On-X Life Technologies, Inc.

On-X LTI develops heart valve replacements that significantly improve the quality of life for patients. The On-X valve design was awarded a 2002 Medical Device Excellence Award in the Implant and Tissue-Replacement Products category. The company also provides OEM services utilizing its patented On-X carbon to manufacturers of other medical products, including orthopedic joint and spine implant devices. On-X LTI was founded in 1994 by a team of heart valve material and design scientists and engineers led by pioneer Jack Bokros, PhD. Capitalizing on more than 30 years of heart valve design experience the team developed and continues to manufacture the On-X Prosthetic Heart Valve. The valve is approved for use within the US and throughout the world. On-X LTI is headquartered in Austin, Texas. More information is located at www.onxlti.com.

Media Contacts:

Clyde Baker
President & CEO On-X Life Technologies, Inc.
512-339-8000 ext. 269
cbaker@onxlti.com

On-X® Prosthetic Heart Valve and On-X® carbon are trademarks of On-X LTI, registered in the US Patent and Trademark Office and corresponding foreign filings. All other trademarks mentioned herein belong to their respective companies.

On-X Life Technologies Doubles Manufacturing Space in Austin –
Increasing demand for On-X Prosthetic Heart Valve and orthopedic implant products make capacity expansion necessary
- Friday March 20, 2009 at 08:00

AUSTIN, TX (March 20, 2009) – Austin-based On-X Life Technologies, Inc. (On-X LTI), manufacturers of the On-X Prosthetic Heart Valve and On-X carbon products for orthopedic implants, announced today that it is doubling the size of its manufacturing space in Austin. The expansion is a result of increased demand for On-X LTI products in both the cardiac surgery and orthopedic markets. The company has signed a lease for a 40,405 square foot building at 1300 East Anderson Lane, Austin, Texas, that was previously used by Sorin Carbomedics. On-X LTI will begin a 19-month transition from its present site at 8200 Cameron Road to the larger facility this week.

“We continue to experience increasing acceptance of the On-X heart valve in the US and around the world,” said Clyde Baker, On-X LTI president and CEO. “The relocation of our operation to this larger facility will permit us to expand our manufacturing capacity to meet this demand. Although some renovation will be required, it is extremely fortuitous that a facility that previously housed a heart valve manufacturing operation was available for occupation. Moving into this building, rather than constructing a new facility to meet the special requirements of our operation, will save the company several million dollars. In addition to the building, we’re also benefiting from the relocation of the Sorin Carbomedics business from Austin to Italy by gaining several pieces of vitally needed equipment and a number of key employees.”

On-X LTI also renewed its supply agreement with Ascension Orthopedic Inc. (AOI) in December 2008. The Austin-based medical device company uses On-X pure carbon in the manufacture of joint replacement, trauma and tissue regeneration surgical implants for use in upper and lower extremities to help patients suffering from pain and dysfunction. Ascension currently markets nine different joint reconstruction implants made of On-X carbon and is actively developing new uses for On-X carbon in joint reconstruction.

“The long-term supply agreement with AOI in combination with the ongoing growth of our cardiac surgery business provides On-X LTI with the assurance of increasing demand for our products and a growing base of operation for the company in Austin,” said Baker.

The demand for the On-X valve is being driven by the benefits patients are receiving from its breakthrough design and material technology. The On-X valve received approval from the US Food and Drug Administration in 2006 to test whether it may become the first mechanical valve able to maintain certain recipients without Warfarin. The study is being conducted in 40 clinical sites comprised primarily of university-based medical institutions in the United States.

More about the On-X Prosthetic Heart Valve
The On-X valve is the result of a breakthrough in medical grade carbon technology: On-X pure pyrolytic carbon. In addition to providing a more thrombo-resistant surface, the comparatively high strength of pure On-X carbon enabled On-X LTI to make significant valve design changes that resulted in a prosthetic 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.

First implanted in 1996, recent clinical evidence suggests that patients implanted with the On-X heart valve may be able to reduce the dosages of anticoagulation therapy traditionally required by mechanical heart valve recipients.

The FDA approved the On-X aortic and mitral valves for commercial use in the United States on May 30, 2001, and March 6, 2002, respectively. More than 70,000 On-X valves have been implanted since 1996.

About On-X Life Technologies, Inc.
On-X LTI develops heart valve replacements that significantly improve the quality of life for patients. The On-X valve design was awarded a 2002 Medical Device Excellence Award in the Implant and Tissue-Replacement Products category. The company also provides OEM services utilizing its patented On-X carbon to manufacturers of other medical products, including orthopedic joint and spine implant devices. On-X LTI was founded in 1994 by a team of heart valve material and design scientists and engineers led by pioneer Jack Bokros, PhD. Capitalizing on more than 30 years of heart valve design experience the team developed and continues to manufacture the On-X Prosthetic Heart Valve. The valve is approved for use within the US and throughout the world. On-X LTI is headquartered in Austin, Texas. More information is located at www.onxlti.com.

Media Contacts:
Clyde Baker
President and CEO On-X Life Technologies
512-339-8000 ext. 269
cbaker@onxlti.com

On-X® Prosthetic Heart Valve and On-X® carbon are trademarks of On-X LTI, registered in the US Patent and Trademark Office and corresponding foreign filings. All other trademarks mentioned herein belong to their respective companies.

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