There’s the political and religious opposition, the lack of investment support, and the scientific challenge of getting cells to differentiate into exactly the kind of cells you want, without side effects. No therapy derived from human embryonic stem cells has yet made it through FDA approval, and Menlo Park, CA-based Geron (NASDAQ: [[ticker:GERN]]) spent years jumping through hoops with the FDA before it got clearance to start the first-ever clinical trial for such a treatment back in February. A couple of other companies, Sunrise, FL-based Bioheart and Columbia, MD-based Osiris Therapeutics, are trying to turn adult stem cells into regenerative medicines for the heart, although neither has gotten FDA approval.
“What those guys are trying to do is quite different from us,” Quinn says.
Quinn is a former Microsoft test manager who has had a hand in incubating projects from the Ratner lab that later became companies, including Healionics, Inson Medical Systems, and Calcionics. BeatBio is also getting scientific consulting from Greg Mahairas, a technology scout for Arch Venture Partners and immunologist at the Fred Hutchinson Cancer Research Center.
The company’s early plans are to run a couple of animal experiments to test its ideas. The first, in guinea pigs, will be to see whether BeatBio can regenerate a pin-sized tissue on the heart called the sino atrial node, which performs the job of a pacemaker, keeping the heart beating in proper rhythm. The second study, in dogs, will look into whether the technique can regenerate heart muscle. That kind of data, which will cost about $2 million and take six to nine months to generate, ought to lay the groundwork for another pitch to the venture capital crowd, Quinn says.