Around The Industry - Calypte Biomedical Corp. received certification - Brief Article

Health Industry Today, May, 2001

Calypte Biomedical Corp., Alameda, Calif., received ISO 9001, ERN 46001 and ISO 12385 certification for its manufacturing facility and will continue to pursue CE Mark certification that will allow it to market its products throughout the European Union.

ISO (International Organization for Standardization) certification recognizes best manufacturing practices for a wide variety of products, including medical devices, and represents national standards bodies from 130 countries.

Nancy Katz, president, CEO and CFO of Calypte, said ISO certification "paves the way for the expansion of Calypte's business throughout Europe."

CE Mark certification, she added, will allow the company to market its products throughout the European Union based on approval from a single regulatory body. CE Mark certification is a product-specific stamp of approval, allowing manufacturers and exporters to market products within the European Union and to their customers in other developing markets.

Calypte develops and commercializes diagnostic products and services.

* www. calypte.com

Cytomedix Inc., Deerfield, Ill., announced an exclusive licensing agreement with DePuy AcroMed Inc., a subsidiary of DePuy Inc., Warsaw, Ind., by which Cytomedix will license relevant patents from its intellectual property portfolio for use in the fields of spinal, neurosurgery and orthopedic surgeries.

James Cour, president and CEO of Cytomedix, said, "One of our major business goals is to derive additional revenue from the licensing of elements in our extensive intellectual property portfolio."

Cour said the company will pursue similar agreements with other companies in the future.

Cytomedix develops cellular therapy products to serve clinical needs. The company currently markets the Autologel[TM] Process and Procuren[R], two proprietary wound healing agents used to treat chronic wounds such as diabetic foot ulcers, venous stasis and pressure ulcers.

* www.cytomedix.com

www.depuy.com

Cardiologists at the Lenox Hill Heart and Vascular Institute of New York, New York City, have begun a nationwide study to assess the effectiveness of a stent coated with the immuno-suppressive drug Sirolimus in the treatment of clogged arteries.

As reported in the April 2001 issue of Health Industry Today, coated stents are being developed to reduce instances of restenosis, the re-narrowing of arteries treated by either balloon angioplasty or traditional stents. Thus far, paclitaxel and sirolimus are seen as the most promising agents for drug-delivery stents.

The Lenox Hill study will follow more than 1,000 patients in 55 medical centers around the country.

Dr. Jeffrey W. Moses, chief of interventional cardiology at Lenox Hill, said the study is "A pivotal clinical trial that could very well be the definitive study on stenting."

Lenox Hill says that approximately 750,000 American undergo balloon angioplasty annually, of which 75% include the insertion of a stent to prop open arteries. But recurring blockages occur in approximately 15% to 20% of patients, requiring additional treatment or surgery.

For the study, stents will be sprayed with a polymer that contains Sirolimus. The drug is then released over a four-week period in hopes of interrupting events that can lead to reblockage.

* www.lenoxhillhospital.org

Zimmer, Warsaw, Ind., the University of Notre Dame, Indiana University and Purdue University will collaborate on a research project to develop innovative approaches for repairing and strengthening the human spine, funded in part by the state of Indiana's 21st Century Research and Technology Fund.

The 21st Century Fund was created in 1999 to stimulate research and development investments within the state and to help build long-term research partnerships between Indiana universities and high technology, private sector companies.

Zimmer and its partners will develop three new implant technologies for the repair and strengthening of the human spine. The company says each of the techniques will rely on new materials, manufacturing methods and implant technology.

Development will focus on spinal fixation to achieve fusion between vertebrae combined with minimally invasive approaches to strength the spinal column.

Zimmer will provide more than $2.2 million in funding for the research efforts. The 21st Century Fund will contribute nearly $2 million.

The company and its university partners received support for two other research projects in 2000.

Zimmer president Ray Elliott said the collaboration keeps the project's R&D activity in the state of Indiana and "creates the potential for futures jobs and revenues that might not have existed were it not for the 21st Century Fund."

* www.zimmer.com

Masimo Corp., Irvine, Calif., won the 2001 Medical Design Excellence Award (MDEA) competition for Radical[TM], its recently released Signal Extraction Technology[TM] pulse oximeter.

MDEA is an awards program recognizing contributions and advancements in the design of medical products selected by a panel of third-party jurors. Winners were named in 10 medical product categories. Radical was selected as a winner in the critical care and emergency product division.