A Medical Device Daily

HemoSense (San Jose, California) reported that Beckman Coulter (BC; Fullerton, California) has filed a complaint in the United States District Court for the Northern District of California, alleging that HemoSense is infringing a patent held by BC, relating to the HemoSense INRatio® system. BC is seeking injunctive relief as well as unspecified damages. HemoSense believes it has meritorious defenses against the claims raised by Beckman and intends to defend itself vigorously.

HemoSense is a point-of-care diagnostic healthcare company that has developed, handheld blood coagulation systems for monitoring patients taking warfarin. The HemoSense INRatio®system consists of a small monitor and disposable test strips. It provides measurement of blood clotting time, or PT/INR values. Routine measurements of PT/INR are necessary for the safe and effective management of the patient’s warfarin dosing. HemoSense is awaiting word on a proposed $165 million buyout bid by Inverness Medical Innovations (IMI; Waltham, Massachusetts (Medical Device Daily, Aug. 8, 2007).

BC and IMI traded buyout offers for Biosite (San Diego), a medical testing company, for six weeks during the spring.

BC eventually bowed out after Biosite sided with a $1.6 billion bid from IMI.

Cardium Therapeutics (San Diego) and its subsidiary InnerCool Therapies (also San Diego) have entered into a license agreement with the University ofTexas Health Science Center (Houston) for the clinical research, development and commercialization of Caffeinol as a potential therapeutic for use in acute ischemic stroke patients.

One of the objectives of the exclusive licensing agreement is to evaluate the safety and efficacy of treating stroke patients with Caffeinol, administered by intravenous infusion (IV), in combination with InnerCool’s endovascular hypothermia technology. A study has been proposed to the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH).

James Grotta, MD, director of the stroke program and professor of neurology at the University of Texas Medical School, described the need for an effective stroke therapy and the potential of the new technology. “Within hours of an ischemic stroke, neurotoxic events are triggered in the ischemic brain that result in tissue damage even after blood flow has been restored, which leads to negative outcomes for stroke patients. Caffeinol and hypothermia have both been shown to be beneficial in reducing damage to brain tissue following stroke, and our data suggest that combining these neuroprotective therapies can substantially reduce neurotoxic events triggered by ischemia and allow for better tissue viability and ultimate function. We look forward to working with Cardium and InnerCool in furthering these promising new therapeutic approaches to stroke.”

InnerCool will be providing endovascular temperature modulation systems and catheters in support of a proposed prospective, randomized, controlled, multi-center Phase 2a Treatment Selection Study of Intravenous Thrombolysis, Hypothermia, and Caffeinol for Acute Treatment of Ischemic Stroke (ICTuS-C study), which is proposed to be sponsored by the NINDS.

The ICTuS-C study is designed to assess the safety and efficacy of induced hypothermia and Caffeinol, both individually and in combination, in an estimated 400 patients presenting within three hours of an acute stroke. All patient groups would also receive tPA, a widely used clot-dissolving agent. Preclinical data in animal models of stroke suggest that Caffeinol and hypothermia have both individual and additive neuroprotective effects in decreasing tissue damage and improving functional outcome. Experimental data implies improved neuroprotection with the combination of Caffeinol and hypothermia, even when administered an hour following the onset of ischemia. In addition, by effectively cooling patients from within their body, InnerCool’s temperature modulation systems can rapidly cool patients to 33 degrees Celsius without having to place them under general anesthesia, which is particularly advantageous in the context of stroke and other severe neurologic conditions.

Cardium is focused on the development of biologic therapeutics and medical devices for cardiovascular and ischemic disease.