Charles River Laboratories International (Wilmington, Massachusetts) has acquired River Valley Farms (Minneapolis, Minnesota), a privately held medical device contract research business. Terms were not disclosed. River Valley Farms provides preclinical evaluation services to the medical device industry, offering its expertise in veterinary medicine that is required to support medical device companies in the development of new technologies for human health applications, particularly minimally-invasive cardiovascular devices such as drug-eluting stents. River Valley Farms says it has established relationships with a number of companies in the industry, including the five leading cardiovascular device companies. Employing about 65 veterinary surgeons and technicians, River Valley Farms' service offerings include interventional cardiology procedures such as studies conducted on drug-eluting stents and cardiac surgery procedures in support of suture and congestive heart failure devices. Studies can be performed under both Good Laboratory Practices (GLP) and non-GLP standards. Charles River Laboratories operates 82 facilities in 16 countries.
Recom Managed Systems (Los Angeles, California) reported that it would acquire from TZ Medical (Portland, Oregon) the over-the-counter (OTC) Cardio Sentry heart event recorder, a device, it said, believed to be among the first to have received OTC clearance from the FDA. Terms of the purchase were not disclosed. Recom also will acquire an exclusive license on TZ's Cardio Sentry RX and explore the use of TZ's manufacturing facilities and monitoring centers during Recom's initial product rollout later this year. The Cardio Sentry, about the size of a credit card, is termed by Recom a "starter platform" for evaluating EKG signals on a single lead. This single-lead device could augment Recom's 12-lead device, which has been submitted for FDA approval. Recom said it believes that the market for Cardio Sentry "could greatly expand if Recom's patented amplification technologies could be added to the Cardio Sentry." Marvin Fink, Recom's chief executive officer, said that the tech combination could provide for a "whole new market for Recom by expanding our product areas to encompass early- to late-stage EKG evaluation for users of varying ages and pathologies." In September 2002, Recom completed a technology acquisition for developing and commercializing heart-monitoring devices. Although the company has submitted its first FDA application, Recom said it "intends for the foreseeable future to remain a development-stage company."
Biophan Technologies (Rochester, New York), a developer and marketer of advanced biomedical technology, has secured additional technology rights expanding its exclusive license for use of nanomagnetic particle and other technology. The technology rights are granted under an expanded license agreement executed on Jan. 15 with Nanoset (East Rochester, New York) that increases Biophan's rights to technology that may be applied to medical devices and other uses. The expanded rights include the exclusive right to any technology that affects magnetic resonance imaging (MRI) safety or image compatibility or involves an implantable power system. Under the license agreement, Biophan currently has rights to two U.S. patents and 12 pending U.S. patent applications. In addition, Nanoset has received an indication from the U.S. Patent and Trademark Office of allowablity for many of the claims of a patent application that relates to the Nanoview technology previously announced. Nanoset, a developer of nanomagnetic particle coatings, and Biophan are jointly developing technologies for the medical device industry. Biophan develops technologies used to make biomedical devices such as cardiac pacemakers, surgical and diagnostic tools safe and compatible with MRI equipment and other sources of powerful magnetism or radiofrequency signals.
Cardiac Science (Irvine, California), a manufacturer of automated defibrillators (AEDs), said it has been awarded multi-year contracts by several of the world's largest pharmaceutical manufacturers, including AstraZeneca (London), Schering-Plough (Kenilworth, New Jersey) and Wyeth (Madison, New Jersey) to supply Powerheart AEDs and provide comprehensive training and program management services for facilities in various locations throughout the U.S. and Puerto Rico. In aggregate, the total value of the contracts signed with all three companies exceeded $725,000.
GenVec (Gaithersburg, Maryland) said it has entered into a research collaboration with Cordis' (Miami Lakes, Florida) Cardiology division to study the clinical benefit of Biobypass in a procedure involving guided delivery of the angiogenic agent directly into targeted regions of the heart in patients with severe coronary artery disease using the Cordis Nogastar Mapping Catheter and Myostar Injection Catheter. The purpose of the collaboration is to conduct a randomized, double-blind, placebo controlled study of GenVec's cardiovascular product candidate, Biopbypass. The multi-center study will be conducted in Europe and is expected to enroll up to 125 patients with heart disease.