A Medical Device Daily

FzioMed (San Luis Obispo, California) reported that it has signed an agreement appointing Ethicon (Somerville, New Jersey) as the exclusive distributor of FzioMed’s Oxiplex/AP, a bioabsorbable product for use in adhesion prevention in abdominal and pelvic surgeries.

Oxiplex/AP is a synthetic, bioabsorbable gel applied during gynecologic and general surgery to reduce post-operative internal scarring, also known as postsurgical adhesions.

Under the agreement, Ethicon will have exclusive rights to sell Oxiplex/AP worldwide, with the exception of Japan, for use in adhesion prevention in pelvic and general/abdominal surgeries. FzioMed will manufacture and supply the product to Ethicon. Financial terms were not disclosed.

“Millions of people each year undergo surgery that can result in complications due to adhesions, and yet there is no adhesion barrier product available in the U.S. for laparoscopic use,” said Richard Berg, PhD, vice president of R&D for FzioMed. FzioMed is focused on developing synthetic, absorbable biomaterials, based on its Oxiplex technology, for the prevention of postsurgical adhesions, tissue augmentation and regeneration and the delivery of drugs. Oxiplex is a polymer technology with potential uses in a variety of specialties, including orthopedics, gynecology, general surgery, neurosurgery and aesthetic surgery.

Other FzioMed products are in various stages of development, and are directed towards high growth markets in the field of biosurgery materials.

In other agreements:

• Beckman Coulter (Fullerton, California) reported signing a licensing agreement with Nephromics (Chestnut Hill, Massachusetts), providing it access to all Nephromics’ patents, patent applications and biologics related to the detection, monitoring and risk assessment of pre-eclampsia, considered the second leading cause of maternal deaths in the developed world.

Currently, there are no specific in vitro diagnostic tests for pre-eclampsia, “even though the disease threatens the lives of thousands of women and their babies, and places a significant burden on healthcare systems worldwide,” said Mike Whelan, vice president of Beckman Coulter’s immunoassays and nucleic acid testing business center. “Through this licensing agreement, we plan to develop new immunoassay tests designed to improve the outcomes in certain at-risk pregnancies. It is a powerful example of our commitment to provide clinical laboratories highly differentiated products and a broad immunoassay test menu for improved disease state management.”

The Nephromics technology is based, in part, on reagents supplied by R&D Systems (Minneapolis). Beckman Coulter in 2003 entered into an agreement with R&D Systems to development and manufacture automated cytokine assays and assay components designed for Beckman Coulter’s Access family of immunoassay systems.

The new tests are being designed for use on Beckman Coulter’s Access family of immunoassay systems – including the UniCel DxI 800 analyzer and the Synchron LXi 725 chemistry-immunoassay system.