A Medical Device Daily

Valor Medical (San Diego) reported that the first human implant of Neucrylate AN for treatment of cerebral aneurysms was performed by Dr. Sean Pakbaz at the University of Tehran in Iran.

The treatment was under the guidance of a clinical protocol that had been approved by the university's Internal Ethics Committee.

Pakbaz said that the patient's aneurysm was of a type and location that is very difficult to treat. However, he said the insertion of the Neucrylate AN was "very smooth,” and the total procedure time was "significantly less” than if the procedure had been done with a stent and coils.

"The procedure went very well,” he said. "The many practice implants I performed at Valor's simulated anatomical training lab prepared me for this trial.”

He added: "Valor's technology will make a major impact on how cerebral aneurysms are treated.”

Valor Medical's Neucrylate AN is injected into the cerebral aneurysm through a micro-infusion catheter that is first inserted in the femoral artery. It is a liquid that, when it comes in contact with blood, changes into a solid spongy material.

The company noted that the liquid "enables the surgeon to totally fill the aneurysm regardless of shape, a property that is not found with implantable coils.”

Valor noted that with a cerebral aneurysm, as the swelling of an artery in the brain increases, the blood vessel wall weakens and can rupture, causing bleeding and death.

It said it is estimated that more 30,000 patients in the U.S. are diagnosed with cerebral aneurysms each year, and about 5 million persons are walking around in the U.S. with undiagnosed cerebral aneurysms.

InnerCool Therapies in distribution accord

Cardium Therapeutics (San Diego) and its operating unit, InnerCool Therapies, reported that InnerCool has entered into a distribution agreement with Lifehealthcare Pty Ltd. (Artarmon, Australia), described as "one of Australia's leading medical device distributors and healthcare service providers.”

Under terms of the agreement, Lifehealthcare will have exclusive marketing, sales and distribution rights in Australia and New Zealand for InnerCool's portfolio of temperature modulation systems.

The accord covers InnerCool's CoolBlue, which it describes as "a nurse-friendly and cost-effective surface-cooling temperature modulation system,” which was launched in the U.S. market during 4Q07, as well as its, premium-priced, high-performance RapidBlue endovascular cooling system, which is expected to be launched in the U.S. market in the 2Q08.

RapidBlue is expected to be available for the Australia and New Zealand markets in 3Q08.

"We are pleased to have this distribution agreement with Lifehealthcare. The company is establishing one of the finest medical equipment distribution networks in Australia and New Zealand, and their sales force already has experience in selling temperature modulation products,” said Christopher Reinhard, chairman/CEO of Cardium Therapeutics and InnerCool Therapies. "Partnering with an experienced regional distributor is designed to accelerate the growth of InnerCool's temperature modulation business without the costs associated with developing our own international direct sales team.”

The CoolBlue surface temperature modulation system, which includes a console and a disposable CoolBlue vest with upper thigh pads, is designed to provide a tool for use in clinical settings best suited to prolonged temperature management. The system is designed to cool or warm patients from outside of their bodies and is intended for use in less-acute settings such as in-hospital fever management.

The next-generation RapidBlue system for high-performance endovascular temperature modulation is expected to initially have the same clearance as the company's current Celsius Control System. The RapidBlue system powers InnerCool's Accutrol catheter, which has a flexible metallic temperature control element and a built-in temperature feedback sensor to provide fast and precise patient temperature control.

U.S. cancer center in Korean collaboration

Fred Hutchinson Cancer Research Center (Seattle) and NSB Postech (NSB; Pohang, South Korea) have signed a collaboration agreement to coordinate their efforts and to determine the efficacy of the NSB's NanoCones surface technology in creating high-quality proteomic microarrays to be used in the study of human diseases.

NSB is a biotech company that possesses a proprietary microarray technology and what the U.S. center terms "a great deal of expertise in nano-scale controlled surface chemistry.”

NSB has agreed to fund the collaboration, which will involve a comparison of slides created with NSB's newly developed NanoCones surface technology and the current industry standard.

"This is the first time a Korean biotech company has had an opportunity to collaborate with a major U.S.-based cancer research center. We are ... thrilled to be working with scientists at the Hutchinson Center,” said Dr. Joon Won Park, president of NSB and one of the inventors of the NanoCones technology.

Dr. Paul Lampe of the Hutchinson Center's Public Health Sciences Division and associate program head of molecular diagnostics, said, "We are excited about the preliminary data that has been generated when antibodies were arrayed using the NanoCones technology. We hope this will make our antibody arrays more sensitive and accurate.”

Antibody microarrays can be used to simultaneously determine the level of each antibody's specific binding partner in complex mixtures such as blood so thousands of different assays can be performed with small amounts of sample.

Hitachi, bioMérieux in partnership

bioMérieux (Paris), a developer of in vitro diagnostics, reported it has entered into a long-term partnership with Hitachi High-Technologies (Japan) to develop new microbiology and molecular diagnostic systems.

bioMérieux and Hitachi will work together to identify and develop new systems. The new instruments developed under this partnership will be manufactured by Hitachi and distributed through bioMérieux's worldwide commercial network.