Stem cell researchers have a lot of big dreams, and one is to someday regenerate damaged hearts. That is still many years away from becoming a commercial reality, if ever, but a few University of Washington scientists have formed a new company that hopes to make cells that can replace pacemakers, and someday rebuild damaged heart tissue that people are left with after heart attacks.
The company, Bellevue, WA-based Beat BioTherapeutics, is the brainchild of Chuck Murry and Michael Laflamme, a pair of UW stem cell researchers, and UW bioengineering professor Buddy Ratner. It has roots in about a decade of research, with $20 million of funding from the National Institutes of Health, Ratner says. No venture capitalists have chipped in to carry this work forward through the early phases of development, although the fledgling company has found another way forward through a partnership with the Bellevue, WA-based Hope Heart Institute, that will provide it with services and support, says CEO Stephen Quinn.
The basic concept of BeatBio, as it’s known for short, is a marriage of stem cell biology and biomedical engineering. Murry and Laflamme’s work has at least partly paved the way for the company to reprogram adult skin cells, to give them vast potential to become other types of cells, like those of the heart. BeatBio specifically wants to direct these cells to become cardiac pacemaker cells, and also cardiomyocytes, the cells that make up heart ventricles. Importantly, scientists have shown the cells can be kept proliferating over time in live animals, Ratner says.
Then comes the engineering part. Normally, when these proliferating cells are injected into the heart, they squirt right out before they can rebuild tissue, Ratner says. BeatBio plans to deliver them via catheter, with a type of bioengineered scaffolding material mounted on the tip. BeatBio hopes that doctors will be able to thread the catheter into the right place in the heart, implant the cells, and use the scaffold as a shield that will keep them in place and alive long enough so they can embed in the heart tissue. Eventually, the new proliferating heart cells will draw support from blood vessels, and thrive on their own, Ratner says.
The market for products that control heart rhythm is worth $10 billion a year, and about 1 million patients worldwide get implanted pacemakers each year, according to Minneapolis-based Medtronic, a leading maker of pacemakers. BeatBio says the market opportunity could be even bigger for an effective new treatment for congestive heart failure. That’s a condition in which the heart enlarges and loses its pumping power, usually after a heart attack causes buildup of scar tissue. About 5.7 million Americans have heart failure, and 670,000 new cases are diagnosed each year, according to the American Heart Association. Plenty of pharmaceutical companies have tried and failed to tap this huge market, but BeatBio insists it sees potential.
“Somebody’s got to be crazy enough to take stem cell therapies to the market,” Quinn says.
So many things could go wrong with this plan, it’s hard to even know where to start. 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: 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.
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