A piece of Cold War-era technology is being modernized by a Laguna Beach startup to stop irregular heartbeats.
Advanced Cardiac Therapeutics Inc. is under way on a European safety trial of its Tempasure catheter with plans to start selling it overseas by the end of 2011.
“European regulatory authorities only require (you) to show the technology is safe to use in patients, and that’s exactly what we’re doing,” said Peter van der Sluis, Advanced Cardiac’s cofounder and chief executive.
Tempasure is manually placed in a patient’s heart to selectively ablate, or kill off, certain areas of tissue. The catheter prevents the spread of electrical signals that cause an irregular heartbeat, known as atrial fibrillation.
Tempasure uses what’s called microwave radiometry to help it sense temperature—131 degrees is required to kill tissue—by measuring microwave emissions off a heat source.
Microwave radiometry was developed by Kenneth Carr, a scientist and cofounder of Advanced. The company holds the rights to develop it for medical use.
Carr’s invention originally was used as a surveillance tool by the military during the Cold War to spy on the Soviet Union’s agricultural crop from outer space.
Temperature control is critical because levels lower than 131 degrees are ineffective in killing tissue, while higher temperatures could result in complications.
“We sense temperature from within the tissue, which is unique,” van der Sluis said. “No other catheter can do that today.”
European Clearance
• Headquarters: Laguna Beach
• Business: medical devices
• Founded: 2007
• Key product: Tempasure heart catheter
• Status: safety trials in Europe
• Funding: $12 million from various investors
• Earnings: pre-profit
• Employees: 12
Advanced, which has 12 workers, plans to get European regulatory clearance and begin selling overseas by the end of this year. The company is planning a U.S. clinical trial for Tempasure, he said.
The catheter is “probably a good two years away” from an introduction here, according to van der Sluis.
Competitors include Biosense Webster Inc., a Johnson & Johnson unit just across the county line in Diamond Bar. Biosense Webster has about 40% of the market, according to van der Sluis.
The ablation catheter market is estimated at $800 million to $900 million a year, with a 23% annual growth rate.
About 2.3 million people in the country are affected by atrial fibrillation, which is the most frequently diagnosed form of irregular heartbeat.
Last year, Advanced raised $5 million in a second round of funding led by NBGI Ventures of London. Advanced, which doesn’t have any sales or profits yet, plans to use the investment to bring Tempasure to market in Europe.
The company plans to use direct salespeople and distributors to sell Tempasure, which will be aimed at cardiac electrophysiologists.
Cardiac electrophysiologists diagnose and treat the heart’s electrical activities.
NBCI partner Gerard Harper said in a release his firm was “delighted” to support Advanced’s device in the growing cardiac catheter ablation market.
Advanced, established in 2007, has raised a total of $12 million.
Besides NBGI, the company also received funds from angel investors, including Palo Alto-based Life Science Angels.
The company received an undisclosed investment in 2009 from Hansen Medical Inc., a Bay Area medical device maker.
Hansen invested in Advanced in order to secure rights to some of its patents for robotic applications.
Hansen “specializes in using robots to steer the catheters,” van der Sluis said. “We will be using this in the manually steerable market.”
Van der Sluis said he isn’t thinking about the prospects of Advanced being acquired or going public.
He acknowledged the Tempasure catheter is attracting “a great deal of interest by all of the major players.”
Van der Sluis, a biochemist by training, previously worked at San Clemente’s Cameron Health Inc., a defibrillator maker.
