Agreement With PLC Medical Systems to MakeLaser Technology More Widely Available in U.S.
IRVINE, Calif., Jan. 9, 2001 -- Edwards Lifesciences Corporation (NYSE: EW) announced today that it has entered into an exclusive, multi-year agreement with PLC Medical Systems Inc. (Amex: PLC) to distribute the company's next-generation carbon-dioxide (CO2) TMR Heart Laser system. TMR, or transmyocardial revascularization, is a therapeutic option for treating severe angina, a condition in which the heart muscle does not receive sufficient blood, resulting in chest pain. During a TMR procedure, PLC's CO2 Heart Laser is used to create a series of precise channels on the heart's surface to encourage improved bloodflow and subsequent reduction in angina pain. PLC's next-generation TMR system, which is currently awaiting FDA approval, is substantially smaller and more mobile than the currently available system.
"The CO2 TMR Heart Laser has demonstrated excellent long-term clinical results and improved the quality of life for thousands of patients suffering from debilitating angina," said Michael A. Mussallem, Edwards' chairman and CEO. "In addition to being developed specifically to perform TMR, and the first to be approved by the U.S. Food and Drug Administration, we believe the CO2 Heart Laser has the most positive and sustained clinical benefits of any laser system for performing TMR."
Under terms of the agreement, Edwards will distribute PLC's next-generation CO2 TMR Heart Laser system and all associated disposable components to cardiovascular clinicians and institutions throughout the United States. Edwards also will market and distribute disposable components to PLC's existing U.S. customer base. In conjunction with this agreement, Edwards will make a $4 million equity investment in PLC and will receive warrants to purchase 3 million additional shares. The agreement with PLC, which is subject to customary closing conditions, is not expected to materially change Edwards' net income and earnings per share expectations for fiscal years 2000 and 2001, and management remains comfortable with current analyst consensus estimates for those periods.
Edwards, the leader in technologies and services to treat late-stage cardiovascular disease, is known for its strong working relationships with the clinical community and for its long-standing commitment to clinical education, factors which Mussallem sees as important in encouraging adoption of innovative therapies such as TMR.
"The significant peer-reviewed data, the recent establishment of Medicare reimbursement, and PLC's plans to launch a new, smaller laser configuration will encourage more widespread adoption of TMR as a standard of care," Mussallem said. "By combining these advantages with Edwards' highly skilled, focused cardiovascular organization, we will help more clinicians appreciate and embrace the therapeutic potential of CO2 TMR."
"Edwards' investment in PLC and commitment to CO2 TMR reaffirms the clinical leadership position of PLC's technology in TMR laser revascularization," said Mark R. Tauscher, president and CEO of PLC Medical Systems, the Franklin, Mass.-based leader in the development of products for performing CO2 TMR. "We believe Edwards' substantial sales and marketing resources, combined with PLC's technological leadership, will establish CO2 TMR as the standard of care in laser-powered heart revascularization."
Clinical Data Affirm CO2 TMR's Long-Term Success
Data from cases performed with the CO2 TMR Heart Laser system presented at the American Heart Association's annual scientific session in November 2000 showed that 68 percent of patients who underwent TMR using the CO2 Heart Laser system experienced clinical improvement and relief from debilitating angina pain up to five years following the procedure.
"The landmark data presented at the American Heart Association meeting reinforced our conviction that carbon-dioxide TMR can be a standard of care for patients who require improved revascularization, particularly those with extensive smaller vessel disease, which has been largely untreatable with other modalities," Mussallem said. "In fact, we were so convinced of the long-term viability and patient benefit offered by carbon-dioxide TMR, that we postponed work on our own excimer-laser TMR program to focus all of our resources on the CO2 TMR Heart Laser system."
Millions Suffer From Angina
Angina often is caused by atherosclerosis, the accumulation of fatty deposits within the coronary arteries that restricts bloodflow. According to the American Heart Association, an estimated 6.3 million Americans currently suffer from angina, and 350,000 new cases are diagnosed each year.
Angina often strikes when the body is undergoing some level of physical exertion. The severity of angina pain is classified against a standardized measurement system; patients suffering from higher angina classes find their activity levels becoming increasingly restricted, and many often become physically debilitated or bedridden. Symptomatic patients may undergo a balloon angioplasty or coronary artery bypass graft (CABG) surgery, but in many cases, these methods alone do not adequately relieve angina. TMR provides an additional therapeutic option for these patients.
Edwards Lifesciences designs, develops and markets a comprehensive line of products and services to treat late-stage cardiovascular disease. Headquartered in Irvine, Calif., Edwards focuses on cardiac surgery, critical care, vascular systems and perfusion products and services, and is the world leader in tissue replacement heart valves and heart valve repair products. With pro forma sales of more than $800 million in 1999, the company has strong international presence in more than 80 countries and generates more than 35 percent of its sales outside of the United States. Additional information about Edwards Lifesciences can be found at www.edwards.com.
This news release includes forward-looking statements that involve risks and uncertainties, including those related to the market's acceptance and adoption of PLC's CO2 TMR Heart Laser system and claims of technological leadership and clinical effectiveness, Edwards' targeted net income and earnings per share expectations for fiscal years 2000 and 2001, and more generally, timing or results of pending or future clinical trials, actions by the U.S. Food and Drug Administration and European Union, technological advances in the medical field, product demand and market acceptance, the effect of changing economic conditions, and other risks detailed in the company's filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.
Edwards Lifesciences and Edwards are trademarks of Edwards Lifesciences Corporation. Heart Laser is a trademark of PLC Systems Inc.
Contact Information :
Media, Scott Nelson, +1-949-250-5070, or Investors, David K. Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation