CardioMEMS Receives FDA Approval for Heart Failure Treatment

ATLANTA, GA -- Arcapita Ventures announced today that CardioMEMS, Inc. has received U.S. FDA (Food and Drug Administration) approval for its Heart Failure Management System. The approval is based upon the results of the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) clinical trial which demonstrated a 28% reduction in the primary efficacy endpoint of heart failure hospitalization rates at 6 months, and a 37% reduction in heart failure hospitalization rates at 15 months for heart failure patients whose treatment was guided by pulmonary artery pressures obtained through a miniature, wireless sensor compared to control patients receiving standard heart failure treatment. The CHAMPION Trial also met all of its safety and secondary efficacy endpoints. The CardioMEMS HF System already has inpatient reimbursement from CMS (Center for Medicare and Medicaid Services).

"We are delighted that this revolutionary treatment will be available to heart failure patients in America as well as around the world," said John Huntz, Arcapita Ventures and Chairman of CardioMEMS, Inc., "Arcapita is proud to have invested early in this novel technology which will help millions of patients."

Jay Yadav, M.D., Founder and CEO of CardioMEMS stated, "Hospitalizations are very traumatic for heart failure patients and costly to the health care system. With the availability of the CardioMEMS heart failure monitoring system, doctors and nurses can now deliver improved and more efficient care to their patients and produce meaningful reductions in their patients' heart failure related hospitalizations."

"The results from the CHAMPION study are very significant and the CardioMEMS system provides a valuable new tool in the battle against heart failure. Pulmonary artery pressure monitoring is the first major device breakthrough in heart failure since CRT therapy." said William Abraham, M.D., Director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center and co-principal investigator of the CHAMPION study.

Philip Adamson, M.D., Director of the Heart Failure Institute at the Oklahoma Heart Institute and co-principal investigator of the CHAMPION study, added, "The CHAMPION trial illustrates how close monitoring of patients with chronic heart failure can reduce the need for costly and dangerous hospitalization while improving quality of life. These results are the beginning of a new era of hope for patients suffering from chronic symptomatic heart failure complementing medical and device therapies. The 'Hemodynamic Era' is a major advancement with promise for profound long-term impact on heart failure morbidity."

Takao Ohki, M.D., Chief of Vascular Surgery, Jikei University, Tokyo said, "The ability to get physiologic information wirelessly from patients with heart failure is a great breakthrough and represents the culmination of many years of basic and clinical research." Yadav noted that the research in heart failure would not have been possible without Dr. Ohki's pioneering work with the CardioMEMS wireless technology in aortic aneurysms.

About CardioMEMS, Inc.

CardioMEMS is a medical device company that has developed and is commercializing proprietary wireless sensing and communication technology for the human body. Its technology platform is designed to improve the management of severe chronic cardiovascular diseases such as aneurysms, heart failure and hypertension. CardioMEMS miniature wireless sensors can be implanted using minimally-invasive techniques and transmit cardiac output, blood pressure and heart rate data which are critical to the management of patients. The sensors can be permanently implanted into the heart and blood vessels due to their small size, durability and lack of wires and batteries. Using radiofrequency (RF) energy, the sensors transmit real-time data to external electronic readers, which then communicate this information to the patient's physician.

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