From the May 28, 2007, issue of "The Gray Sheet"
OrbusNeich hopes to lead a new wave of stent technology with its Genous Bio-engineered R-Stent, which the firm says is safer than existing drug-eluting stents because it has a natural antibody coating instead of a drug-eluting polymer.
David Camp, OrbusNeich's VP-strategic marketing and business development, spoke to "The Gray Sheet" about the device's potential May 23 from Barcelona, host of the EuroPCR conference May 22-25.
Genous was CE marked in August 2005 and is being evaluated in a number of studies in Europe. The Hong Kong firm met with FDA in March to discuss a pivotal trial to support U.S. approval of the device.
Meanwhile, sales of FDA-approved drug-eluting stents - Boston Scientific's Taxus and Johnson & Johnson/Cordis' Cypher - have slumped over the past year in response to new data suggesting the devices increase the risk of late stent thrombosis, or blood clots that develop months after implant, particularly if patients do not adhere to a rigorous drug regimen. Experts now recommend dual antiplatelet therapy for one year following stent placement.
The dual antiplatelet drug protocol for patients treated with Genous is only one month, and the firm believes its stent's mode of action will prove as effective in preventing restenosis as the drugs on drug-eluting stents.
"The physicians are looking at this technology saying, 'It's as effective as drug-eluting stents, but the safety profile is much broader,'" Camp explained. "That's what the interventional cardiology community is asking for today."
Genous Antibody Coating Promotes Healing
Restenosis is the overgrowth of smooth muscle tissue triggered by the injury to the vessel wall caused by the stent. Taxus and Cypher elute drugs - paclitaxel and sirolimus, respectively - that limit cell proliferation around the stent, but the drugs also affect the endothelial cells that are necessary to promote healing, Camp explained.
Genous accelerates natural healing by "capturing" endothelial progenitor cells out of the blood stream with its antibody coating, according to the company.
Instead of relying on a polymer, Genous directly bonds a layer of CD34 antibodies to an endothelial cell-friendly matrix on its stainless steel R-Stent.
OrbusNeich preserves the antibody layer on the stent in a dry format to stabilize it, and physicians rehydrate the device by soaking it in saline solution for 20-30 seconds prior to placement.
When endothelial progenitor cells attach to the antibody coating, they quickly form a protective endothelial layer over the stent that prevent thrombus formation while modulating smooth muscle cell growth to minimize restenosis. The creation of the endothelial layer is inhibited by drug-eluting stents, the company explains.
Camp says as far as he knows, OrbusNeich's bio-engineered approach is unique. Others in the stent market are trying to address thrombosis safety problems with new drugs or drug combinations or bioabsorbable stents that gradually dissolve in the body.
Firm Shows Favorable Thrombosis Rate At EuroPCR
Camp says enrollment in the physician initiated randomized TRIAS trial will begin soon in Europe. The trial is designed to show Genous is non-inferior to Taxus or Cypherin 650 high-risk patients. An additional 630 low-risk patients will be randomized to show Genous' superiority to bare-metal stents.
Meanwhile, OrbusNeich presented data from its ongoing 120-site e-HEALING Genous patient registry at EuroPCR on May 23.
According to Camp, the results are in line with rates of death, myocardial infarction and target lesion revascularization seen in Taxus and Cypher registries.
Genous thrombosis rates in the trial were especially encouraging, he said. At 30 days, data from 2,175 patients showed a sub-acute thrombosis rate of 0.37%. At six months, data from 1,039 patients showed a thrombosis rate of 0.88%. OrbusNeich plans to enroll 5,000 patients in the registry.
The firm also announced it has enrolled more than half of its 90-patient, 16-site HEALING IIB nonrandomized Genous trial since August. The trial is evaluating Genous in conjunction with statin therapy, which OrbusNeich believes may further enhance endothelial progenitor cell capture.
The studies are funded in part with sales from OrbusNeich's other CE marked interventional products, including its Avita and SafeCut angioplasty dilation catheters.
On May 21, the firm announced CE mark in Europe of its Blazer cobalt chromium stent, Sapphire dilation catheter and Lumina guiding catheter.
Genous, however, is the cornerstone of the firm's product portfolio, Camp says. He explained that the technology can be applied to any device that contacts blood. The firm is evaluating its application to heart valves and small diameter grafts for bypass surgery.
OrbusNeich is a private company and does not release sales figures, but it says it does business in over 60 countries with particularly strong performance in Europe and Asia, and it also has distributors in Latin America. According to Camp, the U.S. market is next on the horizon.
OrbusNeich Execs Draw On Past Experience
OrbusNeich in its current form was created with Neich Medical's acquisition of Orbus Medical Technologies in 2005. From the 1970s until its acquisition by Johnson & Johnson in 1996, Neich had represented Cordis in the Asia Pacific region. Neich reentered the interventional market in 1999 with agreements with Orbus, which was founded in 1996 and is responsible for developing Genous.
The majority of the company's executive management - including CEO Samuel Rasmussen, CFO and Vice Chairman Alfred Novak, the chief operating officer, the director of regulatory affairs, the VP-research and development, and Camp - have previously worked at Cordis.
In addition to the Hong Kong headquarters, OrbusNeich has an R&D facility in Fort Lauderdale, Fla., a production facility in China, and its global sales and marketing base in The Netherlands.
- Chloe Taft
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