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Santa Rosa’s Sapheon starting Europe trials; scouts space, sees growth

[caption id="attachment_27572" align="alignright" width="352" caption="Sapheon’s disposable three-part delivery system closes malfunctioning veins without surgery or burning"][/caption]

SANTA ROSA – Human trials begin this week on a device that could change the way a chronic, universal disease is treated.

A Santa Rosa medical device startup is targeting a huge global market for varicose veins, a painful but often untreated condition that affects 20 percent of the population.

Sapheon Inc. has developed a minimally invasive, disposable system that physicians and technicians worldwide could use in outpatient clinics to quickly close off the diseased vein without costly equipment.

“Traditional treatment requires surgical removal of the vein and a long recovery period,” said Sapheon CEO Don Crawford, who has held executive positions with Boston Scientific and Guidant.

“Newer treatments like laser surgery or radio frequency ablation are less painful, but the equipment can cost upwards of $50,000,” he said.

Varicose veins, or venous reflux disease, can result when the valves that keep blood pumping upward from the legs to the heart become weakened or enlarged, allowing blood to flow backwards and impairing the drainage of the veins.

Painful and unsightly at least, the condition can reduce mobility, send blood clots throughout the body and cause ulcers if untreated.

Repeated pregnancies put women at risk for varicose veins, as do obesity and aging. Studies show that 30 million people in the U.S. suffer from the condition.

Once damaged, the vein must be removed surgically or destroyed by burning or chemicals. There is no reversal of the symptoms, although in mild cases wearing elasticized stockings can reduce discomfort.

“In the U.S., non-surgical methods of treatment are gaining ground, although still only a fraction of patients opt for treatment because it’s painful and recovery is slow,” said Mr. Crawford.

Outside the U.S., where laser and other advanced treatments are less available, a much smaller percentage of the population seeks treatment.

“That’s our initial target market,” he said.

He and the Sapheon team, about 20 full-time and consulting employees, see a $3 billion to $5 billion potential market for the Sapheon system.

Three disposable components including a catheter deliver a biodegradable adhesive to the damaged vein, a procedure that takes about 20 minutes, compared with 90 minutes for laser surgery or RF ablation.

As with those two therapies, the body then destroys the closed-off vein and re-routes blood to other arteries.

Sapheon’s closure system requires fewer analgesics during the process, and the patient can usually walk from the office, he said. Recovery time for laser and RF therapies can take weeks, months for surgical removal.

Sapheon, named for the great saphenous vein in the leg, has two patent applications and a third provisional application on its closure system, including an embolic protection device (SapheGuard) and catheter. Both are single-use and disposable.

The company won a $244,479 Qualifying Therapeutic Discoveries Grant from the federal government, part of the stimulus funding package, to fund its 30-day European human trial, now taking place in Germany.

By gaining approval in Europe, Sapheon can market its device there and in most Asian and South American countries.

Once the products go into production, manufacture of the devices is likely to take place overseas, said Mr. Crawford, although the adhesive will be developed and produced in the U.S.

Headquarters will remain in Sonoma County, where Sapheon is scouting a 4,000-square-foot-space, perhaps near the Charles M. Schulz-Sonoma County Airport. Several medical device companies are already located there, including TriVascular, MedLogics and Direct Flow Medical.

“We’ll be adding to our staff, perhaps 10 new employees within the year,” said Mr. Crawford.

For more information visit www.sapheoninc.com.