A Medical Device Daily

AxoGen (Alachua, Florida) reported an agreement with orthopedics powerhouse Stryker (Kalamazoo, Michigan) to provide distribution and co-marketing services for the new Avance Nerve Graft.

Stryker will be responsible for Avance Nerve Graft distribution services for nerve repairs in the upper extremities, lower extremities and brachial plexus. AxoGen will provide distribution services within the head, neck and torso.

Avance is intended for use in the repair of damaged and diseased peripheral nerves. According to the companies, it is the only product available that gives surgeons the option to repair damaged peripheral nerves with human allograft nerves while eliminating a second donor site surgery.

“AxoGen is pleased to be partnering with Stryker to bring hope of restoration of nerve function to more patients suffering from peripheral nerve damage and disease. This partnership represents a milestone achievement for our organization,” said John Engels, VP for AxoGen.

In other agreements:

• Clinical Data (Newton, Massachusetts) and Affymetrix (Santa Clara, California) reported a marketing agreement for a new drug metabolism service using the Affymetrix Drug Metabolizing Enzymes and Transporter (DMET) Early Access solution. Cogenics and Epidauros Biotechnologie, both subsidiaries of Clinical Data, will offer the DMET services on a global basis, with limited exclusivity in Europe.

The service is intended to enable pharmaceutical customers to generate comprehensive genetic profiles of a patient’s metabolic status to gain a better understanding of pharmacokinetic drug response.

Affymetrix has been working closely with Cogenics to develop the DMET technology, which directly assays 1,069 total biomarkers in 160 Absorption, Distribution, Metabolism and Excretion (ADME) genes. The kit includes cytochrome p450 enzymes and drug transporters like MDR1 genetic biomarkers, the company said.

• StemCells (Palo Alto, California) said it has entered into a research collaboration with the Oregon Health & Science University (OHSU; Portland) Casey Eye Institute to evaluate the company’s HuCNS-SC product candidate (purified human neural stem cells) as a potential treatment for retinal degeneration, a leading cause of blindness.

The retina is a thin layer of neural cells that lines the back of the eye and is responsible for converting external light into neural signals. Thus, the loss of function in retinal cells leads to an impairment or loss of vision, the company noted. The most common forms of retinal degeneration are age-related macular degeneration and retinitis pigmentosa. In the U.S., age-related macular degeneration affects more than 1.5 million people in the over-65 population and is the leading cause of blindness in that group, the company said. The macula, one of the most critical parts of the retina, is responsible for processing detailed vision. Retinitis pigmentosa is a class of hereditary diseases that also leads to progressive degeneration of retinal cells. In the U.S., the most common types of retinitis pigmentosa affect about 65,000 people. For both age-related macular degeneration and retinitis pigmentosa, preventative measures are generally not available and current treatments have only limited effects, according to StemCells.

StemCells develops cell-based therapeutics to treat diseases of the nervous system and the liver. It recently completed enrollment in a Phase I trial to evaluate the safety and preliminary efficacy of its HuCNS-SC product candidate as a treatment for infantile and late infantile neuronal ceroid lipofuscinosis, a fatal neurodegenerative disease often referred to as Batten Disease.

• St. Jude Medical (St. Paul Minnesota) reported that it has renewed its complete line of product agreements with HealthTrust Purchasing Group (Brentwood, Tennessee). The renewal will extend through December 2010 all existing purchasing agreements between the parties, which cover St. Jude Medical’s complete line of Cardiac Rhythm Management, Atrial Fibrillation, Cardiac Surgery and Cardiology products.

HealthTrust also reported signing a three-year supplier agreement with Masimo (Irvine, California). The agreement provides HealthTrust members access to Masimo SET pulse oximetry and Masimo Rainbow SET monitoring technologies. Masimo said that the addition of HealthTrust expands its GPO contracts to include all 10 of the nation’s top GPOs, allowing hospitals and other care providers access to Masimo SET and Masimo Rainbow SET technologies.

HealthTrust reports supporting over 3,800 not-for-profit and for-profit facilities including acute care hospitals, ambulatory surgery centers, physician practices, and alternate care sites.