The burning question of the biopharma industry over the last several years is “where are the new drugs?” With blockbusters going off patent and investigational drugs failing in clinical trial after clinical trial, there has been a dearth of important new medications, and venture capital financing in life sciences startups has dropped like a stone. A cardiologist and an engineer believe they have found a better way, however, to move life sciences forward—with innovations that treat or cure diseases without new drugs.
Mark Gelfand and Howard Levin, co-founders of New York-based technology incubator Coridea, believe that now is a golden age, not for drugs, but for medical devices. “Drugs are shotguns that hit a lot of targets, and create a lot of side effects as a result,” says Levin, the cardiologist. “Medical devices tend to be snipers. A [heart] valve replacement fixes one specific problem, and that’s it. No worries about side effects.” Plus, he says, unlike many drugs that must be taken for life, devices can often cure diseases, making them much more appealing to patients, and to payers.
So far, Levin’s and Gelfand’s emphasis on devices is playing out according to plan. Working out of a small suite of offices on a gritty block of Manhattan’s Flatiron district, the two have launched six medical device companies since founding Coridea in 2003. Just last month they raised $10 million in Series A financing for their newest creation, Cibiem. As my colleague Luke Timmerman writes in this week’s BioBeat column, Cibiem is in a elite group of only 28 companies in North America and Britain to pull in at least $5 million in first time financing so far this year. The startup is developing a novel catheter-based system that targets the carotid body, a chemosensor at the base of the neck, where the carotid artery forks, that may be implicated in a broad range of diseases, including heart failure, hypertension, and diabetes.
Coridea’s most successful launch to date is Ardian, a Mountain View, CA-based developer of a catheter-based system to treat hypertension. It was acquired by Medtronic for $800 million in January 2011, with the potential for as much as $500 million in additional milestone payments. Ardian grabbed the pharma industry’s attention in 2010 when it reported that its device was able to bring down high blood pressure in hypertensive patients who were taking up to five drugs a day without success.
“Ten years ago people laughed at us when we tried to sell them on the idea of a device to treat hypertension,” says Levin. “It was just brutal to try and raise money.” That all changed, he says, when the Ardian clinical trial data was presented. “All of sudden people realized you could replace drugs with a device, and it would be much more cost effective.”
Levin started his career as a cardiologist at Johns Hopkins, treating heart disease with surgery or medicines that to him seemed far too crude a solution. As an investigator on clinical trials for one of the first left-ventricular assist devices, he began working with Gelfand, a senior research engineer in the cardiology division at Johns Hopkins Medical School.
The two decided to go out on their own, and spent about two years trying, and failing, to raise money, says Levin. In 2004 they were finally able to obtain about $1.5 million in financing from The Foundry, a medical device incubator near San Francisco—“money they had set aside for some other crazy project,” says Gelfand. The pair used the money to develop the Ardian device, but both men say they never had any interest in actually running a company.
“We know what we do well, and that is generating ideas. There are a lot of people who are much better than us at executing,” says Gelfand, who was born and trained in Russia before emigrating to the U.S. in 1987. “We know how to take these brilliant ideas and decide which can become a viable commercial opportunity.”
They have generated a lot of ideas. Levin and Gelfand can lay claim to 67 issued U.S. patents and 95 pending applications between them. Among the companies they have created are CHF Solutions, to develop a device they invented for removing fluid overload from patients, acquired by Sweden’s Gambro in 2010, and Respicardia (formerly Cardiac Concepts), of Minnetonka, MN, to develop their sleep apnea device. Respicardia was spun out of Coridea in 2010, after raising $30 million to take their device into clinical trials.
The two men believe their success rate rests on their completely different backgrounds in medicine and engineering. “We challenge each other all the time, and we each know that we don’t know everything,” says Levin. “We’ve been working together since 1987. At this point, it’s like we’re an old married couple.” Next up for this marriage—the two will continue to search for devices for diseases that they believe are not well served by drugs, such as asthma and diabetes.