• BSD Medical (Salt Lake City) reported the installation of the first BSD-500 hyperthermia cancer therapy system in Switzerland at the Department of Radiation Oncology of Kantonsspital Aarau. The BSD-500 will be used to increase the department's cancer therapy technology, particularly in treating advanced and recurrent cancer patients. It delivers hyperthermia through the use of microwave energy, helping to address the limitations of radiation therapy. "Control for locally advanced or recurrent neoplasm (tumors) continues to be a significant problem in clinical oncology. We look forward to coupling hyperthermia with ionizing radiation to enhance the effect on certain types of cancer. The BSD-500 provides superficial hyperthermia, which is used to non-invasively treat cancerous tumors located within a few centimeters of the surface of the body such as melanoma and recurrent breast cancer. It is also able to deliver interstitial hyperthermia to treat certain other tumors," said Stefan Bodis, MD, head of the department of radiation oncology and associate professor of radiotherapy at the University Medical School in Zurich, Switzerland. The department of radiation oncology of Kantonsspital Aarau, with more than 20,000 treatment sessions per year, is among the most important radiation treatment centers in Switzerland and offers virtually all cancer treatment modalities.
  • Delcath Systems (New York) said the FDA has notified it that patient enrollment may resume in the Phase III and Phase II clinical trials of the Delcath System. Current and prospective clinical investigation sites have been notified that study accrual can be resumed immediately. This decision follows Delcath's meeting with representatives of the FDA, along with the principal investigator at the National Cancer Institute. Resumption of study accrual follows a voluntary enrollment deferral reported by the company on Oct. 23 in response to an FDA inquiry into certain gastrointestinal adverse events observed in four patients enrolled in the studies of the Delcath System prior to protocol changes enacted earlier this year. During the meeting at the FDA, the principal investigator presented an analysis of the previously reported gastrointestinal toxicities and of the changes incorporated into the trial protocols to prevent a recurrence of (GI) toxicities. These changes had been previously approved by the NCI Institutional Review Board and were subsequently approved by the Data Safety Monitoring Board for the Phase III trial. Delcath is a developmental-stage company testing its percutaneous perfusion technology for the isolated-organ and region-specific delivery of therapeutic and chemotherapeutic agents.
  • EarlySense (Ramat-Gan, Israel) said it has received FDA clearance for its ES-16 system. The ES-16 system, cleared by the FDA, monitors heart and respiratory rates in both children and adults. The technology developed by EarlySense uses a contact-free sensor, meaning that it is not physically connected to the body of the patient. The ES-16 System eliminates patient discomfort and enables the cost-effective monitoring of patients in settings such as homes, hospitals and other clinic settings such as long term care facilities. The system is currently being evaluated at several clinical settings on patients suffering from chronic diseases, such as asthma, COPD and CHF, as well as at acute-care facilities, on critical-care patients and patients hospitalized for various medical and post-operative conditions. "Hospitals and other healthcare providers are facing a growing challenge in treating older and sicker patients. Such providers are looking for technological solutions that allow them to increase the quality of care and improve patient safety without adding to already stretched budgets and manpower. We have addressed this need with a smart monitoring solution that facilitates the improvement of patient safety and nursing efficiencies," said EarlySense CEO Avner Halperin. EarlySense intends to start selling its new product, to be named EverOn, in 2008, following a number of beta-site evaluations in both Israel and the U.S. EarlySense makes "smart systems" for monitoring changes in a patient's clinical condition.