The leading edge of innovation in medical devices is often concentrated on nifty implantable tools that a doctor can insert without a scalpel, as a less-invasive alternative to surgery. But now we’re seeing more startups, like Bothell, WA-based QuantumCor, designing devices to fix what’s broken in the body without even leaving any sort of implant behind at all.
QuantumCor’s vision is to change the way a common type of heart failure is treated, called mitral valve regurgitation. The idea is to allow doctors to heat up and tighten the loose, leaky tissue around the mitral valve that makes it hard for the heart to vigorously pump blood. CEO Vern Dahl told me about this plan, and how the company has secured the lead investor in a $10 million Series B financing, when we met the other day near the Xconomy office on Seattle’s First Hill.
The problem QuantumCor is trying to solve is the same as Kirkland, WA-based Cardiac Dimensions, so that sets up some friendly cross-town competition. Dahl insists there’s plenty of room for new contenders in this space. An estimated 3 million people in the U.S. have a loose mitral valve that allows blood to backflow into the heart. It’s a chronic condition that makes people tired and short of breath, making it hard to climb stairs, but rarely rises to the level of requiring open heart surgery.
Because the problem is so widespread, startups like Cardiac Dimensions have long sought ways to create a minimally invasive alternative like an implantable clamp or cinching device around the valve to make it pump correctly. None of these devices are currently available in the U.S., but the market for such alternatives could exceed $1.6 billion in the U.S. by 2016, according to the Millennium Research Group. While minimally invasive has traditionally been defined as catheter-guided tools like stents that prop open clogged arteries, or the Cardiac Dimensions’ wire clamp, QuantumCor wants to leapfrog ahead by shrinking tissue without implanting anything. This is the same concept driving a couple other device companies that have raised capital this year, Seattle-based Uptake Medical, and Redmond, WA-based CoAptus Medical.
“Anytime you can do a procedure and not leave something behind, it’s a plus,” Dahl says.
QuantumCor hasn’t started clinical trials of its device yet, and it still needs to raise more money to pursue its plan, so this isn’t going to appear in a hospital catheterization lab near you anytime soon. The company was formed in 2002 around some patents for using radio-frequency energy (RF), loaded on the tip of a catheter, which is aimed at the collagen tissue around the mitral valve. By using radio-frequency energy to heat up this collagen, the idea is that it will naturally shrink, causing the valve to seal properly and prevent blood from flowing back into the heart, Dahl says.
By naturally shrinking the tissue and not implanting anything, the QuantumCor device won’t create future complications for a doctor who might want to do surgery, it won’t get in the way of other devices, and it leaves open the possibility of future re-treatment, Dahl says.
Dahl has had a long career on the business side of big medical device players like Cordis before it was acquired by Johnson & Johnson, Cardiac Pacemakers (a forerunner of Guidant, which is now part of Boston Scientific), and as a CEO entrepreneur at CardioMetrix, VascuSense, and others. He joined QuantumCor about a year and a half ago. “The company needed someone to take a great idea, and some part-time engineers, and make it into a real company,” Dahl says.
QuantumCor has raised about $3 million so far, and with that, it has assembled some preliminary evidence that gives it enough confidence to take its device into clinical trials. The company performed a study in 16 sheep, and found consistent shrinkage of the tissue near the mitral valve in all of them, with an average tissue reduction of 21.7 percent. When seven of the animals were followed for six months, the tissue shrinkage appeared to plateau after 90 days, and the average shrinkage by the end of the study was 26 percent, Dahl says.
Of course, sheep aren’t the same as people. So QuantumCor also did a small study with its technology on 11 human cadaver hearts. It found the same shrinkage consistently in that cadaver study, with little variation among older, diseased hearts, and younger, healthier hearts, Dahl says.
If this kind of result can be repeated in clinical trials, it should translate into the kind of treatment goals that U.S. and European regulators want to see with a new treatment for mitral valve regurgitation, Dahl says. He’s hopeful he’ll have a compelling business case to make to doctors and insurers as well. The QuantumCor technology requires an outpatient procedure that takes 60 to 90 minutes in the hospital catheterization lab, one to two days of patient recovery time, and will cost $20,000 to $25,000, Dahl estimates. The current surgery typically requires more than six days in the hospital and costs can exceed $100,000, he says.
It will take more venture capital for QuantumCor to assemble the evidence it needs to get this device closer to the marketplace. Dahl is currently on the fundraising trail for the $10 million Series B venture round. So far, he has received a commitment from Seattle-based Denny Hill Capital to lead the round, and Dahl is looking for other investors to fill out the syndicate, he says.
Scoring that kind of venture capital will be no small task in this very rough year for medical devices, which I outlined a few weeks ago based on a new industry report from Ernst & Young. And it’s hard to ask too many specifics about realistic timelines for clinical trial results before the company has deposited the capital in the bank.
If QuantumCor gets the money, the endgame, like with many medical device companies, will be to get acquired by a bigger device company. Dahl was quick to point to a couple of deals from this year that he considered benchmarks for what QuantumCor can achieve—Medtronic’s $700 million acquisition of Irvine, CA-based CoreValve, and Abbott Laboratories’ acquisition of Menlo Park, CA-based Evalve for $410 million. If such a deal happens, QuantumCor’s investors will be rewarded, and it will be the bigger company’s job to carry the baton the rest of the way to the ultimate goal of bringing the technology to the market.
“My vision is to develop technology that works for patients much earlier in the disease, before they get really sick,” Dahl says.
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