Stentys, a new Paris-based biomedical device company, has just opened its North American headquarters and R & D facility in Carnegie Center. The company is working on making a better stent for use in propping open clogged heart arteries. The research to date on improving stents has centered on coating them with drugs to keep the artery open. But Hikmat Hojeibane, Stentys’ chief technology officer, says that his company is going in a different direction. In addition to introducing novel elements to the life-saving device, Stentys is working on a stent design that will treat some of the more difficult artery blockages.
Stents, wire mesh tubes used to prop open an artery during angioplasty, have been used for years, greatly cutting down on the need for open heart surgery to replace sections of blocked arteries. A far less invasive way to treat heart disease than bypass surgery, angioplasty and the use of stents has spared many patients the pain and lengthy recovery time that goes along with that operation.
A stent works by being collapsed to a small diameter and put over a balloon catheter and then moved into the area of the artery where the blockage is located. When the balloon is inflated, the stent expands, locks in place and forms a scaffold. This holds the artery open. The stent stays in the artery permanently, holds it open, and improves blood flow to the heart muscle. Within a few weeks of the time the stent is placed, the inside lining of the artery grows over the surface of the stent.
Stents are used in more than 70 percent of coronary angioplasty procedures.
While stents are a huge step forward in the treatment of blocked arteries, they are not always a permanent solution. The stented artery can reclose. This problem has been alleviated in recent years by the development of the coated, or drug-eluting, stent. These stents are coated with drugs that are slowly released and that help keep the artery from reclosing. Stents that are not coated with drugs are called bare metal stents. The promise of drug-eluting stents was dulled by 2006 when cases of sudden death in patients in whom they had been implanted were reported, but many researchers have concluded that the risk-reward ratio still tips in favor of the drug-eluting stent.
Stentys’ early stents, which have been used in procedures in Europe, are bare metal stents, but Hojeibane says that the company’s plans include developing a drug-eluting stent. The stents, he says, will be a significant improvement over current stents, particularly in the most difficult cases.
“Our stents are different in two ways,” says Hojeibane. The first is that they are designed to treat blockages that occur in “bifurcations,” or areas where a large side branch originates from a main vessel. These bifurcation lesions are present in about 20 percent of patients undergoing angioplasty, he says, and can be difficult to detect before the procedures begin.
“It’s like an exit ramp on a highway,” he gives as an example of a bifurcation. “Or like a stream branching off from a river.” Standard stents cannot go around that corner easily. The Stentys stent addresses this problem through “disconnetivity.” At any point in the stent, the interventional cardiologist performing the procedure can use an inflated balloon to pull the stent into the side vessel, thereby propping open the blockage that spills over and away from the main vessel. The stent is designed so that its mesh will easily pull apart and stretch into an adjacent area.
The second difference, says Hojeibane, is the material his stent uses. “It’s made of nitinol,” he says. “It’s self-expanding. It conforms to the anatomy. It shapes to the anatomy.” Nitinol, a family of intermetallic materials that contain approximately equal amounts of titanium and nickel, are known for their superelasticity and shape memory.
Hojeibane, who has been with Stentys for just over a year, signed on after the company received its second round of funding — $18 million — in August 2008. A 1981 Rutgers graduate who holds 18 patents, he has spent nearly all of his career developing catheters and stents — mostly in the area of cardiology. After receiving his master’s degree in biomedical engineering, also from Rutgers, he went to work for a small South Jersey company that makes catheters, which, he recalls, “were not very popular then.” But he found the technology fascinating. “People want less and less surgery,” he says. “They want to walk out of the hospital.” These devices, inserted through a small slit, “not even a slit, a tiny hole,” he says, often make this possible.
Hojeibane went on to work for the largest pharmaceutical companies, including Johnson & Johnson, where he worked for both the Cordis and the Ethicon divisions, leaving as director of R & D for Ethicon. He also started a Montreal-based company, Cryocath.
He says that working at a start-up, but says that it is very different from working for an industry giant like Johnson & Johnson. “There are some things you miss,” he says, “and some things you don’t miss at all. Here you can quickly make decisions and be as efficient as possible. That was something I tried to change at Johnson & Johnson. It worked well in some ways, but not in others.”
Hojeibane was introduced to the CEO of Stentys, Gonzague Issenmann, through a mutual acquaintance, and says that he is enjoying working for a start-up again.
The Stentys device will aim for regulatory approval first in Europe, and then in the United States. “We hope to get some approvals this year,” Hojeibane says.
The company’s Carnegie Center office now has six employees, all of them working on research and development. But Hojeibane expects the company to grow substantially in the next few years.
The Princeton area location was chosen because of the concentration of pharmaceutical and medical device companies close by, and perhaps more importantly, because Hojeibane has lived in Princeton for some 20 years.
He first came to the area at age 16 when his family fled Lebanon’s civil war. His father, who is now deceased, had a gunsmith business. His mother is a recently retired French and science teacher. His parents stayed only briefly in the United States, soon returning to Lebanon to ride out the war. “I stayed on with relatives,” he says. “I took care of my own education.” Interested in both medicine and engineering, he says that biomedical engineering was an easy choice for him.
Hojeibane’s wife, Tammy, works for the UMDNJ Foundation. They have three school-age children, Zachary, Catelyn, and Alexander.
Hojeibane’s father died from heart disease. He says that he is frustrated that the science to save his father did not exist. “It hits home,” he says. “What you are doing is helping.”
Stentys, 103 Carnegie Center, Suite 102, Princeton 08540; 609-853-0110. Hikmat Hojeibane, chief technology officer. www.stentys.com.