Claret Medical is just two years old, but the Santa Rosa med-tech startup already is finding success with a new device for preventing strokes in heart patients.
It's the latest example of innovation in Sonoma County's medical technology sector, which has weathered the recession better than other parts of the economy.
Medical technology has the potential to succeed telecommunications as a powerful job engine in Sonoma County, said Saeid Rahimi, dean emeritus at Sonoma State University's School of Science and Technology.
"I'd call it the second wave after telecom," he said. "I have great hope for it."
Today, Sonoma County has 10 medical technology companies with about 1,200 workers. The industry's growth is driven by an aging population and the need for cost-effective, less-risky medical procedures, said Steve Weiss, a Healdsburg biotech entrepreneur and investor.
"A lot of these technologies are replacing older, invasive hospital procedures," he said. "If you can move a patient from a high-cost hospital setting, you're improving safety and saving the system huge dollars."
Venture funding for medical technology startups has held steady, despite an overall slump in private equity deals, said Weiss, co-founder of North Bay Angels, a Sonoma County group that invests in early-stage tech companies.
Claret reached a milestone last week when it received regulatory approval to market its Montage filtration system in Europe.
The Montage device is used in Transcatheter Aortic Valve Intervention (TAVI), a next-generation technology for replacing damaged heart valves without risky open-heart surgery.
The TAVI technique lets a doctor deliver an artificial heart valve through a patient's femoral artery, located near the groin, using a tube-and-wire catheter system.
While the procedure is safer than open-heart surgery, it can dislodge particles that travel to the brain, causing stroke in a small percentage of patients.
Claret's new device is designed to reduce stroke risk during the procedure. With Montage, a physician uses a small catheter to insert two small filters into the carotid arteries, catching debris before it can reach the brain.
European approval was based on Claret's successful clinical trials outside the United States.
"We're catching debris in almost all of the filters," said Randy Lashinski, the startup's founder and CEO. "It gives physicians and patients an option for reducing embolic events in interventional procedures."
Lashinski is a Sonoma County med-tech veteran who led research and development at Santa Rosa's Arterial Vascular Engineering. That business was sold to Medtronic in 1999 for $3.7 billion.
He also worked for Medtronic before co-founding Direct Flow Medical, a Santa Rosa startup that is developing a transcatheter heart valve.
Lashinski got the idea for Claret after leaving Direct Flow in 2008. A German physician, Dr. Eberhard Grube, approached him about the need to reduce stroke risk in vascular intervention procedures such as TAVI.
Two years of research, development and clinical testing led to Claret's European approval. Investors have put a little less than $5 million into the startup.
"The Montage system is an exciting new step forward to potentially reduce stroke rates in TAVI and other vascular procedures," said Grube, who heads the structural heart program at University Hospital in Bonn. "It has the potential to change the way physicians view TAVI in their practice."
Claret has about a dozen workers in Santa Rosa and is adding employees as it gears up for commercialization outside the U.S. Its next goal is U.S. market approval, but it hasn't set a timeline.
The global market for TAVI could reach $5 billion by 2020, according to UBS Research, part of the Swiss financial services firm.
About 300,000 U.S. patients suffer from deterioration of the aortic valve, which can lead to heart failure and death. But many of those patients are too sick for open-heart surgery.
"We believe TAVI will become the dominant therapy among patients of medium to high surgical risk," UBS said.
Medtronic and Edwards Lifesciences are the world leaders in transcatheter aortic valves, and Edwards' Sapien device became the first to win market approval from the U.S. Food and Drug Administration last week.
Medtronic's CoreValve device has been implanted in more than 20,000 patients outside the U.S. after getting European approval in 2007. Medtronic's Santa Rosa-based vascular division reported $2.13 billion in worldwide sales last year.
Sonoma County's other medical technology companies also are making strides.
Last week, the FDA approved TriVascular's Ovation stent graft system for certain patients with abdominal aortic aneurysms. It was the first U.S. approval for the Santa Rosa company, which has been in the European market since January.
Physicians use the Ovation device to repair the aneurysms, weak spots or bulges in part of the aorta that runs through the abdomen. They can rupture, causing internal bleeding and death.
"This represents an important step in expanding access to minimally invasive treatment for patients with aortic disease," said Michael Chobotov, TriVascular's CEO.
Ovation was approved only for U.S. patients with small arteries, but it will help pave the way for TriVascular to enter the broader U.S. market, said Weiss, an investor in the company.
"It allows them to introduce the product," he said.
TriVascular hopes to get full U.S. market approval by the end of next year.
Sonoma State has launched a master's degree program in bioengineering to support the medical technology sector, Rahimi said.
"It's going to supply the local need for talent," he said.
The business is challenging, Weiss said. It takes years of costly research, development and testing to get regulatory approval for a new device, he said.
Competition is fierce, and not all companies get through the process. Medlogics, a Santa Rosa device company that received European approval for a bare-metal stent in 2008, has since closed its doors.
But the sector is here to stay, Weiss said.
"People always want better health care," he said. "Medical technology is going to be a growth area for Sonoma County."
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