News
EU approves Santa Rosa startup's stent Medlogics' thin, bare metal COBRA stent is easier to implant in diseased arteries, company founder says
By KEVIN MCCALLUM
THE PRESS DEMOCRAT
February 2, 2008
A 6-year-old Santa Rosa biotech startup has received approval from European Union regulators to sell its first product, a thin, bare metal stent designed to go where others cannot. Medlogics Device Corp. announced Friday that its Cobra coronary stent system has been approved for sale in Western Europe. It will be the first device released by Medlogics, a 65-employee company founded in 2002 by Rick Klein.
The COBRA stent has an advantage over other devices because it is thinner and easier to implant in diseased arteries than its rivals, Klein said. "We consider this stent and delivery system to be the best in class as it hits the market," Klein said.
News of the approval was almost overshadowed Friday by the announcement that Medtronic, which has 1,200 employees in Santa Rosa, had won approval to begin selling its Endeavor drug-coated stent in the lucrative U.S. market.
But inside Medlogics, the decision by European regulators was greeted with jubilation by employees who have been working for years to develop a completely new stent and delivery system from the ground up. "It was huge day for us," said Kalei Hampson, marketing director for Medlogics. Not only does the approval allow the company to begin generating revenue for the first time, but it bodes well for the future versions of COBRA, Hampson said. Medlogics is now conducting clinical trials on a drug-coated version, which is designed to reduce problems associated with bare metal stents. "This is the platform that our drug-eluting stent is based on, and getting this approval is validation of that platform," he said.
The cobalt super alloy stent is about 15 percent thinner than its competition, allowing the device to fit into arteries too clogged for larger stents to enter and open, Klein said. But the advantage is greater for the drug-eluting version. The drug coating technology used by Medlogics is thinner than the polymer-based drug coatings of its rivals, Klein said. Taken together, the advances make the drug-coated version 20 to 30 percent thinner than rivals, Klein said. But the real promise of the drug-coated version is that it solves a major problem facing the stent industry -- blood clotting.
Klein, a veteran of Arterial Vascular Engineering before the Santa Rosa company was purchased by Medtronic in 1999, said he started Medlogics after he saw the potential problems with the polymer-based drug-coated stent technologies marketed early in the decade. Plenty of studies showed that the polymer coatings designed to prevent arteries from closing up around the stent had the side effect of increasing the rate of blood clotting compared with bare metal stents, Klein said.
The problem has vexed the industry in recent years and led to a dramatic reduction in sales of drug-coated stents. "Our timing is actually really good because in the last year and a half, the pendulum has swung away from drug-eluting stents," Hampton said.
Medlogics' drug-coated stent, by contrast, has a silica gel-based coating that is gradually absorbed by the body after it delivers the drug, reducing the risk of clotting and the time patients must take costly anti-clotting medications, Klein said. That product is a least a year away from becoming commercially available, Hampton said.
The company has received $22 million in venture capital and other private funding since it was founded.
You can reach Staff Writer Kevin McCallum at (707) 521-5207 or kevin.mccallum@pressdemocrat.com.