CardioMEMS (Atlanta, GA) anticipates seeking FDA approval for its 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 heart failure and aneurysms. Miniature wireless sensors can be implanted using minimally invasive techniques and transmit cardiac output, blood pressure, and heart rate data that are critical to the management of patients. In the U.S. alone, there are approximately 5.5 million heart failure patients.
Due to their small size, durability, and lack of wires and batteries, these sensors are designed to be permanently implanted into the cardiovascular system, using radiofrequency to transmit real-time data to an external electronics module. CardioMEMS’s first commercial device, the EndoSure® Wireless AAA Pressure Measurement System, is comprised of an implanted sensor and an external electronics module. More than 2,000 patients have been treated with the EndoSure® system to date. CardioMEMS, a user of the Georgia Tech MiRC since they were founded in 2000, currently employs 120 people, 11 of whom use the Georgia Tech facility.
In August, 2009, CardioMEMS raised $22.1M financing. The financing provides the company with additional capital to fund the company’s CHAMPION clinical trial. Initiated in September 2007, the CHAMPION trial is evaluating the safety and effectiveness of CardioMEMS’ heart failure (HF) pressure measurement system in patients with heart failure.
The CardioMEMS wireless HF sensor is an innovative miniature device which is implanted into the patient’s pulmonary artery using a simple, catheter-based procedure. The pulmonary artery pressure is then measured and displayed using the CardioMEMS proprietary electronic monitoring system. Following the procedure, patients perform wireless measurements of their pulmonary artery pressure from home. The pressure data is immediately transmitted to a secure database and is available for review by the implanting physician on the CardioMEMS website.
The CHAMPION clinical trial is being conducted in over 65 leading heart centers in the U.S. The co-principal investigators of the trial are Philip Adamson, MD, Director of the Heart Failure Institute, Oklahoma Heart Institute and William Abraham, MD, Director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center.
Jay Yadav, MD, Chairman and CEO of CardioMEMS and an interventional cardiologist, said at the time, “We are excited about our heart failure technology and the potential benefits that are available to patients who have this serious condition. This is a very exciting time for CardioMEMS and we are looking forward to the great opportunities in front of us in 2010.”
Commenting on the financing, Dan Bauer, CardioMEMS CFO stated, “We are pleased with the continued support of Arcapita Ventures, Boston Millennium, Foundation Medical and our other existing investors. We look forward to the successful completion of the CHAMPION trial as well as pursuing other opportunities where our technology can be beneficial.”
Aortic aneurysms affect approximately 2.7 million Americans and are the 13th leading cause of death in the United States. Treatment of an aneurysm requires either traditional open surgery to remove the aneurysm or the increasingly popular and less invasive endovascular surgery. Endovascular repair of the aneurysm means that a stent graft is placed inside the aneurysm sac. A stent graft is a tube-like device that allows blood to flow through it instead of through the aneurysm, similar to a straw in a drinking glass. Blood flows through the stent graft (straw) instead of into the aneurysm sac (glass) and reduces the pressure in the aneurysm to keep it from bursting. The stent graft is inserted into an artery in the groin and advanced into the aneurysm sac. The EndoSure® Wireless AAA Pressure Sensor is indicated for use during endovascular aneurysm repair.
Aortic aneurysms affect approximately 2.7 million Americans and are the 13th leading cause of death in the United States. Treatment of an aneurysm requires either traditional open surgery to remove the aneurysm or the increasingly popular and less invasive endovascular surgery. Endovascular repair of the aneurysm means that a stent graft is placed inside the aneurysm sac. A stent graft is a tube-like device that allows blood to flow through it instead of through the aneurysm, similar to a straw in a drinking glass. Blood flows through the stent graft (straw) instead of into the aneurysm sac (glass) and reduces the pressure in the aneurysm to keep it from bursting. The stent graft is inserted into an artery in the groin and advanced into the aneurysm sac. The EndoSure® Wireless AAA Pressure Sensor is indicated for use during endovascular aneurysm repair.
Contact: Daniel H. Bauer, CFO, 678-651-2376
