on the tip of a catheter that is threaded up from the femoral vein in the leg, into the heart, where it grasps the two sides of tissue, and essentially welds them together, Eichinger says.
CoAptus was founded in 2003, and had raised about $10 million prior to the latest financing, Eichinger says. It recently went through a reorganization, in which it briefly laid off its seven employees, while it converted some debt from Boston Scientific into an equity stake, he says. The company plans to use the new money for some more animal testing before it hopes to start a feasibility study in humans in late 2009. The first study should be in five to seven patients in Germany, he says.
“We have been attacking this problem vigorously under the Coaptus banner since 2003 and now feel optimistic that our RF tissue welding approach is the answer,” Auth says. “The recent funding is intended to show early success in humans now that we have had excellent results in animals.”
The competition for CoAptus in this space comes mainly from three companies—Boston-based NMT Medical; Plymouth, MN-based AGA Medical; and W.L. Gore Associates, which has a medical products division in Flagstaff, AZ. They all require an implant to be left behind, so CoAptus hopes to differentiate itself by sealing the wound without any implants, Eichinger says. Leaving the heart without any implants could be important for many patients, because the implants might prevent patients from being eligible for other procedures in the future.
“You don’t know 20 years from now what kind of medical valve procedures they might be doing,” Eichinger says.
Further in the future, CoAptus hopes to show that closing up these heart defects can have a benefits for migraine sufferers, Auth says. A prominent interventional cardiologist at Swedish Medical Center in Seattle, Mark Reisman, has told the company that patients who have had this procedure done have mentioned that they are greatly relieved to see their migraines go away.
Reisman has advised the company that it’s unlikely that physicians and the FDA would consider the risks of the procedure to be worth the benefit of reducing migraines. Yet this kind of potential side-benefit sounds to me like the sort of thing that might catch on via social networking websites as patients talk about the pros and cons of the procedure.