A Medical Device Daily

Arbios Systems (Waltham, Massachusetts) reported an agreement with NxStage Medical (Lawrence, Massachusetts) for NxStage to make its Sepet Liver Assist device for the treatment of liver failure.

Arbios said it is currently seeking permission from the FDA to begin a controlled pivotal clinical trial for the device.

NxStage will make the devices for the pivotal trial and subsequent product commercialization, pending FDA approval. The Sepet device will be comprised of commercially used NxStage components and will include a synthetic microporous fiber, supplied by Membrana (Wuppertal, Germany). Arbios reported a supply relationship with Membrana in September (Medical Device Daily, Sept. 25, 2007).

Arbios said it would buy all commercial requirements of the Sepet from NxStage and NxStage said it would not market a competing product for a specified time.

The Sepet is a sterile, disposable cartridge containing microporous hollow fibers with permeability characteristics. When a patient’s blood is passed through these fibers, blood plasma components of specific molecular weights are expressed through the micropores, thereby cleansing the blood of harmful impurities. These substances would otherwise progressively accumulate in the patient’s bloodstream during liver failure, causing hypotension, increasing risk of sepsis development and accelerating damage to the liver, lungs and other organs, including the brain and kidneys, and suppressing the function and regeneration of the liver. The device is designed for use with standard blood dialysis systems available in hospital intensive care units.

In addition to the Sepet, Arbios is developing the HepatAssist cell-based liver support system, a bio-artificial liver that combines blood detoxification with liver cell therapy to replace whole liver function in patients with the most severe forms of liver failure.

In other agreements:

• TomoTherapy (Madison, Wisconsin) reported a new software licensing, marketing and development agreement with RaySearch Laboratories (Stockholm, Sweden).

A suite of software products will be developed to facilitate the transfer of radiation therapy treatment plans between TomoTherapy Hi Art treatment systems and conventional linear accelerators, and to extend the Hi Art system’s treatment planning functionality, TomoTherapy said. According to the company, these developments will lead to improved workflow coordination, more efficient product utilization and increased patient treatment capacity.

RaySearch is developing advanced software solutions for improved radiation therapy of cancer.

TomoTherapy makes the Hi Art system for the treatment of a wide variety of cancers. The system combines integrated CT imaging with conformal radiation therapy to deliver radiation treatments with speed and precision while reducing radiation exposure to surrounding healthy tissue, according to the company. The company completed its initial public offering in May (MDD, May 10, 2007), raising more than $186 million. Earlier this month it priced another offer of 8.5 million shares at $22.25 a share, placing the value of the stock sale at more than $189.1 million (MDD, Oct. 12, 2007).

• XTend Medical (Sun Valley, California) reported a strategic alliance agreement with EvREst/MES-HPSI of the Southeast.

EvRest will work closely with the management of XTend to assist in their sales efforts of the Infopia telemedicine glucose meter and also aide in the financing of sales to managed care companies and other healthcare organizations.

In addition, XTend will have the opportunity to present their other telemedicine products to the long term care facilities currently under EvRest management and to develop a pharmacy operation through their partner, Boulevard Pharmacy, to potentially deliver medications to more than 6,000 long term care facilities throughout the U.S.

XTend sells healthcare and wellness products to hospitals, managed care companies, nursing homes, physician groups and individual patients.

• NeoStem (New York) reported an agreement with Stem Collect to open a Beverly Hills location.

Finalization of the site is underway and will be opened upon build-out and satisfaction of licensing requirements, the companies said.

Stem Collect is entitled to begin opening NeoStem-affiliated adult stem cell centers in five locations in California and to open the first in the Denver marketplace upon the signing of collection center agreements designating the specified territory, (MDD, Oct. 17, 2007).

NeoStem is a biotechnology services company developing a nationwide network of adult stem cell collection centers, enabling people to donate and store their own stem cells with NeoStem for personal use years or decades later in times of critical medical need.