CardioMEMS Gains $14 Million to Commercialize Wireless Medical Devices Based on Georgia Tech Technology

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The funding was led by Boston Millennia Partners with co-investors Foundation Medical Partners, Arboretum Ventures, Guidant Corp. and Johnson & Johnson Development Corp.

Atlanta-based CardioMEMS is using microelectromechanical systems (MEMS) technology to create a new generation of medical devices. The company's first products will enable doctors to more easily monitor heart patients with tiny, wireless sensors inside the human body.

The sensors operate without batteries: Radio waves activate the devices, which internally measure heart and blood pressure, then transfer the information to an external receiver.

"This represents a milestone in monitoring and safety," says David Stern, CEO of CardioMEMS. "Instead of having to go to the hospital for invasive surgical tests or expensive CT scans, people can be monitored in their doctor's office - or even their own homes. This will significantly lower costs, provide more information for doctors and make life a lot easier for patients."

MEMS technology, which originated in the late '80s in the integrated-circuit industry, allows engineers to build electrical and mechanical devices at the micron scale (one millionth of a meter).

CardioMEMS co-founders Dr. Jay Yadav and Mark Allen met in 2000 when Yadav, a cardiologist and director of peripheral and carotid intervention at the Cleveland Clinic Foundation, was exploring ways to use MEMS technology for healthcare innovations. Allen, a professor of electrical and computer engineering at Georgia Tech, had already been working with MEMS to measure pressure inside turbine engines.

Allen's microsensors were designed specifically for military drone aircraft, however, he and Yadav believed that they could adapt the technology to monitor heart and blood pressure in people.

"Although the human body is nothing like a jet engine, they both create a very hostile environment for devices like ours," Stern explains. "It's difficult to gain internal access to the body, and it doesn't welcome foreign materials. Implantable devices must be both biocompatible and durable because you can't go back and make modifications or replace a battery."

In early 2001, CardioMEMS raised $2.5 million in seed capital and licensed key patents from Georgia Tech related to Allen's research. Although Allen had already worked out the engineering process, the researchers needed to develop new materials that the human body would accept and be stable enough for long-term implantation. CardioMEMS is initially developing two products with its wireless pressure-sensing technology:

* The heart sensor measures intra-cardiac pressure in patients with congestive heart failure, a condition in which the heart is not pumping properly due to clogged arteries, high blood pressure or other medical conditions.

* The AAA sensor measures blood pressure in people who have been treated for an abdominal aortic aneurysm, which is a weakening in the lower aorta that can cause it to expand and rupture.

CardioMEMS microsensors will be implanted using a minor surgical procedure. Once these sensors are in place, doctors can regularly audit their patients and collect information that can't be obtained in an isolated test, making it easier to spot trends and changes in patients' condition.

"Our sensors serve as an early-warning system," Stern says. What's more, the AAA sensor provides richer information than current tests, he adds, explaining that CT scanners only reveal the size of an abdominal aortic aneurysm - not pressure, which can be a more reliable indicator of whether a stent graft (used to treat an abdominal aortic aneurysm) is functioning properly.

Nearly 5 million people in the United States have congestive heart disease, which makes the market for the heart sensor significant. Although the market for the AAA sensor is smaller - currently about 50,000 stent-graft procedures are done each year to repair abdominal aortic aneurysms - it remains an attractive niche because CardioMEMS faces less competition.


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