A Medical Device Daily

IsoRay Medical, a subsidiary of IsoRay (Redmond, Washington), has signed a letter of intent with International Brachytherapy (IBt; Seneffe, Belgium) to form a global strategic alliance focusing on worldwide sales of brachytherapy solutions in the treatment of prostate cancer and other malignant-tissue cancers.

IsoRay is a medical isotope company focused on brachytherapy solutions for prostate cancer and other malignant tissue cancers through use of its proprietary Cesium-131 radioisotope, marketed under the name Proxcelan. The company said Cesium-131 is “the most significant scientific advancement in prostate cancer brachytherapy in more than 20 years.”

Major elements of the proposed alliance include the future marketing of IsoRay’s Proxcelan Cesium-131 brachytherapy seeds and Iodine-125 brachytherapy seeds in Russia. It includes planned distribution in 19 European countries using IBt’s established distribution channels.

IsoRay said it will continue to develop a new generation of Cesium-131 brachytherapy sources using IBt’s polymer seed technology and automated manufacturing processes, which it said “should further differentiate Cesium-131 in the cancer therapy market.”

“This letter of intent represents another major step in the strategic business plan for IsoRay as we continue to grow the domestic market for Proxcelan and begin taking advantage of growth opportunities and demand worldwide,” said Roger Girard, CEO and chairman of IsoRay.

Girard said the increasing awareness of brachytherapy and particularly Cesium-131 as a treatment option in the U.S. and other parts of the world was a key factor in the entry into the letter of intent with IBt.

“Through this joint effort, we will have access to new channels to distribute Cesium-131 technology to the growing European market and other emerging markets,” he said. “By obtaining access to IBt’s expertise and existing distribution channels, we will be in a position to meet the increasing demand for the latest technology by patients and physicians abroad who understand the therapeutic and quality of life benefits of using brachytherapy.”

IsoRay said the alliance will form the basis of a collaboration between the two companies in the areas of R&D and sales and marketing.

IsoRay said it intends to collaborate with IBt to complete the research and development process to design and build new-generation Cesium-131 brachytherapy sources using IBt’s polymer seed technology and advanced automated manufacturing processes.

IsoRay and IBt said they will collaborate on efforts to optimize manufacturing processes and locations based on economic conditions and access to specific markets. IsoRay said it will collaborate with IBt to develop new technologies, which may include bio-absorbable polymer technology, for use in multiple cancer indications.

IsoRay and IBt will negotiate a five-year exclusive performance-based distribution agreement for IBt to sell Proxcelan Cesium-131 brachytherapy seeds in Europe, with rights for other parts of the world to be determined.

IBt said it will grant IsoRay the exclusive right to market the future polymer Cesium-131 seed and the polymer Iodine-125 seed in North America and South America.

Enrollment grows in TRIAS stent trial

Enrollment in the randomized TRIAS (TRI-stent Adjudication Study) trial of OrbusNeich’s (Hong Kong/Hoevelaken, the Netherlands) Genous Bio-engineered R stent has reached 110 patients since the initiation of the trial in April, according to Robbert de Winter, MD, PhD, principal investigator and director of the cath lab at the Academic Medical Center (Amsterdam, the Netherlands).

The trial, involving about 50 centers throughout Europe, consists of two arms: high-risk for restenosis (HR) and low-risk for restenosis (LR). The primary endpoint in both is target vessel failure within 12 months, with clinical follow-up extending to five years.

In the HR arm, about 1,250 patients will be enrolled for a non-inferiority study of Genous vs. Taxus or Cypher drug-eluting stent (DES). In the TRIAS LR arm, about the same number of patients will be enrolled for a superiority study of Genous vs. bare metal stents (BMS).

“With the interventional cardiology community’s concerns with the long-term safety of drug-eluting stents, we must look to new technologies that are as effective in terms of restenosis while minimizing the concern about long- term thrombosis,” de Winter said. “The dual antiplatelet therapy requirement for Genous is only 30 days. Drug-eluting stents require a minimum of six months of dual antiplatelet therapy, which gives rise to many patient compliance and cost issues.”

All TRIAS participants will receive one week of statin therapy pre-procedure. Patients treated with a Genous or BMS will receive 30 days of clopidogrel post-procedure, while patients treated with a Taxus or Cypher DES will receive at least six months of clopidogrel post-procedure.

For TRIAS, high risk of restenosis is defined as patients who have diabetes mellitus and/or small vessels (less than 2.8 mm) and/or long lesions (greater than 20 mm). Target vessel failure is defined as cardiac death, myocardial infarction or repeat vascularization of a treated vessel.

The Genous stent is coated with an antibody to capture a patient’s endothelial progenitor cells, and, therefore, accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. The company said that when attracted to the surface of the Genous stent, EPCs can form an endothelial layer over the stent to provide protection against thrombus and minimize restenosis.

CE mark for Occlutech’s occluder line

Occlutech (Jenna, Germany), a developer of cardiac occlusion devices, said it has received CE mark approval for its line of atrial septal defects (ASD) and patent foramen ovale (PFO) occluders under the Occlutech Figulla N brand.

The company said the fact that its ASD and PFO occluders are not clamped gives them “distinct advantages” such as increased flexibility and a reduction of the amount of material implanted.

Occlusion devices are used to treat structural heart disease, including structural heart defects and abnormalities, such as ASD or PFO, in a minimally invasive, non-surgical way.

Occlutech said the market for these devices, the PFO occluder in particular, “is expected to expand significantly over the next few years.”