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CardioMEMS, Inc. Wins Frost & Sullivan 2006 Product Innovation of the Year Award

March 31, 2006 – CardioMEMS, Inc. announced today they are the recipients of the Frost & Sullivan 2006 Product Innovation of the Year Award in the medical monitoring market for the company’s breakthrough EndoSure™ Wireless AAA Pressure Measurement System. CardioMEMS, Inc. is the leading developer of innovative wireless medical pressure sensors for the management of Abdominal Aortic Aneurysm (AAA) and Heart Failure (HF) disease. The EndoSure sensor is the first MEMS-based wireless permanently implantable pressure device to become commercially available in the United States.

The Frost & Sullivan Award for Product Innovation of the Year is presented each year to the company that has demonstrated excellence in new products and technologies within their industry. The recipient company must show innovation by launching a broad line of emerging products and technologies.

David Stern, President and CEO of CardioMEMS, commented “We sincerely appreciate that Frost & Sullivan has recognized the innovative nature of our product. The successful commericialization of the EndoSure Wireless Sensor required a significant effort on the part of many talented and hard-working individuals and was the product of a strong collaboration between engineers and physicians. We believe that this sensor will be the first of many unique and innovative applications of our core MEMS and wireless technologies.”


According to Frost & Sullivan:
Despite vast advances in scientific research and technology development in past decades, there are few companies that are able to effectively take a revolutionary technology from the lab to the market. CardioMEMS is one such company. Headquartered in Atlanta, Georgia, CardioMEMS is a cutting-edge technology development firm with ties to the Georgia Institute of Technology. Focused on developing microelectromechanical systems (MEMS) technology for medical applications, CardioMEMS has achieved FDA 510(k) clearance for the first permanent implanted pressure monitor that is both wireless and un-powered. Designed to measure pressure within an aneurysm sac, the device provides an unprecedented level of patient monitoring for those patients undergoing endovascular aortic repair surgery. With one product now successfully launched and several others under development, CardioMEMS is successfully driving the industry towards unprecedented patient monitoring potential.


Approved to Ensure Patient Safety
With the EndoSure Wireless AAA Pressure Measurement System, the power and benefit of MEMS pressure sensing technology has been brought from an external sensor to an implant for the first time in order to dramatically improve the quality of patient care. The specific application that received 510(k) clearance is for pressure monitoring during endovascular aortic repair surgery. The sensor is inserted during the procedure to repair an aortic aneurysm with a stent graft. The sensor then measures the pressure in the aneurysm sac, which enables physicians to verify the success of the implant by simply holding the company’s antenna over the patient’s chest.


The World’s First MEMS Implant
The CardioMEMS breakthrough is its adaptation of MEMS pressure sensing technology for use as an implant. For decades, MEMS technology has been implemented for cost-effective, disposable blood pressure sensors for use with IV lines. Through small deflections of a micro machined diaphragm, the conductive properties of the sensor would change according to the surrounding fluid pressure. While this application revolutionized invasive blood pressure measurements, the need for electrical conduction prohibited using the sensor as an implant. CardioMEMS solved this issue by creating a passive MEMS sensor composed of conducting plates that respond to specific radiofrequency (RF) wave emissions from an external electrical device. The resultant resonance emitted by the MEMS sensor corresponds to the local fluid pressure. Finally, by designing the sensor with biocompatible materials, CardioMEMS created the first long-term MEMS sensor suitable for human implantation.


Setting the Pace for New Medical Frontiers
While the CardioMEMS Wireless AAA Measurement System has clearly enhanced the possible quality of care following endovascular aortic repair surgery, the company also recognizes that the potential applications of their technology may be far greater. While currently being studied for use following thoracic aneurysm repair, the company also plans to study the benefit for monitoring heart failure patients more closely in order to prevent recurring hospitalizations and optimize medication dosing. Beyond these plans, the success of the EndoSure system is a tremendous step towards a medical frontier where implanted chips can cost-effectively monitor critically ill patient populations without the imposition of bulky non-invasive devices or the risk of infection with invasive needles. CardioMEMS has now set the precedent for all other MEMS developers on how to bring a breakthrough technology to market.

For the company’s outstanding achievement in product development and medical technology innovation, Frost & Sullivan is proud to present CardioMEMS with the 2006 Product Innovation of the Year Award in the medical pressure sensing market.


About CardioMEMS, Inc.
CardioMEMS, Inc. is a privately held medical device company located in Atlanta, GA, which is focused on the design, manufacture and sale of implantable wireless pressure sensors. The company was founded by Jay Yadav, M.D. of the Cleveland Clinic Foundation and Mark Allen, Ph.D., Professor of Electrical and Computer Engineering at The Georgia Institute of Technology.

Now available for sale in the United States, the EndoSure Wireless AAA Pressure Measurement System consists of a sterile sensor packaged in its delivery system and a separate electronics cart. The cart contains a 15” touchscreen monitor and lightweight, ergonomically designed antenna. The proprietary EndoSure software is simple to use.

The technology used for the EndoSure AAA Pressure Measurement System is also being studied for use in other clinical applications. The company plans to initiate clinical studies that will assess the use of the sensor in thoracic aneurysms and in post-procedure surveillance. The technology used for the EndoSure Sensor is also being assessed for use in the management of patients with HF (heart failure). A clinical study will assess how the HF sensor can help patients with HF avoid hospitalizations by providing early detection of clinical decomposition. The company expects that pressure data provided by the sensor will allow adjustment of medications to alleviate symptoms before they are severe enough to warrant hospitalization.
©2008 CardioMEMS Inc.