VasoTech gears up to go global

It would have been easy for Tim Wu, cardiologist and founder of VasoTech Inc., to give up on his vision for the next generation of drug-eluting stent. He didn’t.

Instead, he invested $50,000 of his own money to set up shop in his garage and build a better stent, wrapping three state-of-the-art elements — a cobalt chromium stent, a biodegradable polymer and a potent combination of two anti-restenosis drugs — into a single device he calls the PowerStent. And he’s counting on that power to take his fledgling company global.

The next generation

The problem with the stents now used to treat blocked or narrowed coronary arteries, Wu explains, is their potential to cause clotting, known as thrombosis, and restenosis, a re-narrowing of the artery.

It’s not the tube-shaped stent itself, but the glue-like polymer that binds anti-thrombosis and anti-restenosis drugs to the stents he’d like to compete with that cause the problem, he says.

{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/VasoTech_stent_100.jpg}”My stent, which is made of cobalt chromium because it’s stronger and more flexible than metal or stainless steel, addresses this problem. The cobalt stents being used now contain a polymer that is not biodegradable,” Wu says.

He’s betting the PowerStent will catapult him to the top of the worldwide drug-eluting stent market. Besides its cobalt chromium structure, the device’s innovations involve a biodegradable polymer that holds two powerful anti-restenosis drugs.

The first, paclitaxel, also used in several of Boston Scientific’s drug-eluting stents, was originally aimed at combating tumor growth.

“But two drugs are key,” Wu explains. “I also use what Johnson & Johnson is using in its stents, an immuno-suppressive drug called sirolimus. Together, these drugs create a synergy that makes my stent more effective against restenosis.”

Wu claims his biodegradable materials also give him an edge over his competitors. Companies such as Singapore’s Biosensors International and India’s Sahajanand Medical Technologies use polylactide in their stents. But PLA can irritate arteries as it degrades and has yet to be cleared by the Food and Drug Administration for use in biodegradable stents.

“It causes pain similar to the pain you feel in your muscles after you work out,” Wu notes.

Instead of PLA, he uses PLGA or poly(lactic-co-glycolic acid), which is already in use in FDA-approved therapeutic devices because of its biodegradability and biocompatibility. When PLGA degrades, it produces acids the body can effectively metabolize without pain.

Dr. Donald Cutlip, who heads Beth Israel Deaconess Medical Center’s interventional cardiology program, says Wu might be onto something by focusing on polymers.

{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Cutlip_Donald_100x100.jpg}”From an engineering standpoint, the polymer technology is the whole key here. The drug and stent are simple things, but the polymer is the key to success,” Cutlip says. “These drug-eluting stents are coated with a polymer on the outside and inside, and a certain drug is embedded within the polymer. The idea is to have the drugs released early and then keep going for about 30 days.”

The trick for folks like Wu, who hope to be the first to bring the next generation of stents to market, is determining exactly how long the devices need to persist in blood vessels to be most effective, Cutlip adds.

“There is a theory that a stent is only needed for a certain amount of time. This hasn’t been defined yet, but if a stent can stay in the artery for an ideal period of time to support the artery to heal, then you wouldn’t need the stent anymore. The stent could then dissolve and you wouldn’t have to worry about restenosis or clotting later on,” Cutlip explains.

Another trick lies in raising enough cash to shepherd a stent design through the rigors of the FDA approval process.

“The major problem with new drug-eluting stents, too, is the testing rigor that is appropriately required for FDA approval,” Cutlip notes. “It takes at least three to five years after a device is ready to enter trials before it can be considered for approval.”

Wu met the funding portion of the challenge in part through grants. VasoTech landed a $1.2 million Small Business Innovation Research grant from the National Institutes of Health last year, taking Wu out of his garage and into a 3,000-square-foot lab near Lowell’s historic mill district.

He then partnered with Harvard Medical School for clinical trials and teamed with the University of Massachusetts-Lowell’s Medical Device Development Center for additional funding and free lab space.

Now he’s seeking a half-million-dollar loan from the Massachusetts Life Sciences Center to develop a clean room to manufacture the device.

The road to China

As for the second, regulatory portion of the challenge, he’s pushing for domestic and international approval for the PowerStent, with a decided emphasis on the latter.

“There’s a huge market for cardiovascular devices,” he says. “The U.S. market is so hard right now, particularly with the current financial situation. It’s very hard to get investors to put money into this kind of technology.”

In the U.S., drug-eluting stents accounted for nearly 70 percent of the market last year, up from about 65 percent in 2007, at least according to Boston Scientific.

The worldwide coronary stent market was worth about $5 billion in 2007 and 2008, with drug-eluting stents accounting for about 80 percent of the total.

So Wu is turning to his homeland, where he sees enormous growth potential. China has more than 50 million coronary artery disease patients, he estimates, but very few receive angioplasties.

“I have the most advantage in the China market; it needs less money, about one-tenth the money in the U.S., and it’s relatively easy to get approval, only about three years to get China market approval,” he explains. “China is a huge market, but only about five percent of the patients get treated with this kind of technology, while in the U.S. it’s about 50 or 60 percent.”

China’s burgeoning middle class and steadily expanding prosperity could lead to a surge in the number of patients who receive the procedure.

“The Chinese market will continue to grow at 15 percent to 20 percent, which is why the potential is so huge. It’s the right time to jump in,” Wu says.

But before that can happen Wu needs to raise additional capital and complete clinical trials in Europe or China. If successful, he projects sales of $30 million to $50 million by 2011 in India and Europe.

“I’ll try to get a product over there and try to generate revenue from any local markets. Meanwhile, I’ll get more data for the FDA,” he explains, adding that he hopes to get FDA approval in 2012 or 2013.

He might be looking for success overseas, but Wu says he doesn’t plan on moving from Massachusetts any time soon.

{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Wu_Tim_100x100.jpg}”There are so many advantages to being in Massachusetts; it’s a good base for medical devices. Whatever kind of material you need you can find locally and the government invests a huge amount in biotech,” he says.

And, as another Chinese strategic thinker put it, it’s wise to keep your friends close and your enemies closer. For Wu, they could be one and the same.

“I want to be the next Boston Scientific,” he says with a smile. “You never know. Twenty years ago, Boston Scientific was like me, just a couple of people. … If Boston Scientific likes me and they want to buy me, that’s OK. If no one buys me, I’ll just continue to develop.”