Stent Maker OrbusNeich To Hire up to 200 Employees

OrbusNeich plans to hire dozens of people in Fort Lauderdale, FL as it ramps up clinical trials for its heart stents.

The Hong Kong, China-based company, which conducts research and development in Fort Lauderdale, uses technology developed by a Miami, FL cardiologist. The company plans to boost its sales force and clinical team in Fort Lauderdale as it seeks approval for its stent, known as the Blazer where it’s available overseas.

Johnson & Johnson’s Cordis and Boston Scientific have facilities in Miami that concentrate on drug-eluting stents. OrbusNeich said it offers an upgraded version of bare metal stents.

Drug-eluting stents quickly conquered the US market after their introduction several years ago, but questions about their safety and effectiveness have caused sales to drop off. Cordis blamed declining sales on layoffs in Miami.

David L. Camp Jr., OrbusNeich VP of corporate development, said some of those workers could find a home at his company. It plans to hire 150 to 200 people in the United Stattes over the next two years – with half of them in Fort Lauderdale. It has 40 employees there now.

OrbusNeich needs to build a workforce to manage the clinical trials, deal with regulatory issues and set sales strategy.

The clinical trial would follow about 350 patients in centers nationwide for nine months, Camp said. Results should come in 2010.

OrbusNeich’s stents have been implanted in more than 10,000 patients in more than 60 countries, mostly in Europe, Camp said. They are also approved in parts of the Middle East, South America and Asia. The company has held off on the U.S. until now because clinical trials are so expensive.

Camp said the bare metal stent trial should cost from $5 million to $10 million.

The device should sell for about the same as current bare metal stents, which run about $1,000 each, he added.

The OrbusNeich stent is about 3 millimeters in diameter and nine to 33 millimeters long. The flexible wiring is made from cobalt chromium, which Camp said is less likely to cause an allergic reaction than materials used for other stents. Another plus is its improved ability to open holes in the side of the stent so an intersecting artery can continue flowing into the damaged passage, he said.

“It’s a timely product because of the lack of innovation in bare metal stents currently on the market,” Camp said.

Stephen Dunn, director of research at Boca Raton, FL-based Dawson James Securities, said the health concerns raised about drug-eluting stents in clinical trials has opened the door for bare metal stents to grab a larger piece of the market. Bare metal stents also cost less, making them preferred by the insurance industry and government health programs, Dunn added.

But OrbusNeich isn’t a one-trick pony. Its Genous Bio-engineered R stent, which is coated with antibodies designed to repair damaged arteries, is undergoing clinical trials in Europe. No other available stent uses such technology in the U.S., the company said. Results are expected in 2010.

“That trial should give us the answers we need to know if it’s the right product to pull a $50 million trigger in the United States,” said David Kujawa, OrbusNeich director of strategic marketing, referring to the cost of a potential clinical trial for Genous.

OrbusNeich is also working on a hybrid stent. It would have the antibodies on the inside and a drug coating outside. That one is in development in Fort Lauderdale.

In order to fund a US clinical trial for the Genous or the hybrid stent, OrbusNeich is considering a public offering in the United States, Camp said. Other options include a private equity investment or a partnership with a larger corporation.

With the IPO market in decline, one of the latter two options would be more viable for a medical device company, Dunn said.

SOURCE: South Florida Business Journal