A Medical Device Daily

BSD Medical (Salt Lake City) said a newly published study conducted in Berlin involving 137 patients with advanced rectal cancer has shown that the addition of cancer treatments with the company's BSD-2000 system to radiation and chemotherapy treatments did not result in any statistically significant adverse effect on patient quality of life compared to patients who received radiation and chemotherapy without the added treatment.

The company said it was “highly pleased” with the findings, “especially in light of the substantial reduction of patient quality of life that can accompany other cancer therapies.”

BSD is a developer of cancer treatment technology designed to make cancer treatment more effective without adversely impacting the quality of life for patients during treatments.

The study was conducted using the Gastrointestinal Quality-of-Life Index (GIQLI), an instrument validated and tested for its reproducibility and sensitivity in measuring quality of life for patients suffering from malignant and benign diseases of the gastrointestinal tract.

The GIQLI contains 19 questions pertaining to symptoms of disease, five questions relating to emotional well-being, seven questions regarding physical function, four questions that assess social function and six questions that measure the perception of the medical treatment. Of the 137 patients in the Berlin study, 68 (49.6%) received treatments with radiation, chemotherapy and the BSD-2000 and 69 (50.4%) were treated with radiation and chemotherapy alone.

BSC said the global GIQLI scores showed no significant differences at any time pertaining to quality of life for the two groups.

BSC's systems deliver precision-focused microwave/RF energy to heat diseased sites in the body, raising them to therapeutic temperatures as required for a variety of medical treatments.

Its cancer treatment systems were developed and have been tested in clinical trials as an additive therapy to radiation and/or chemotherapy, used to kill cancer with mild heat and create conditions in tumors that enable these companion therapies to more effectively destroy cancer.

PillCam gets push to French reimbursement

Given Imaging (Yoqnam, Israel) reported that the French National Authority for Health (HAS) has completed the first step in advancing reimbursement for PillCam SB capsule endoscopy for more than 60 million French citizens.

Given said that the HAS which advises the French government on medical reimbursement decisions – last month published a report that highly recommends the use of PillCam SB in patients with obscure gastrointestinal bleeding and Crohn's disease following inconclusive first-line tests. Its report, “Examination of the Lumen of the Digestive Tract by Ingested Video Capsule,” was based on an analysis of existing clinical data and physician opinions, concluding that capsule endoscopy provides additional medical benefit and, as a result, recommends including capsule endoscopy in the list of reimbursable procedures, using two previously assigned codes.

Given said that such a recommendation is considered the pivotal step toward achieving universal reimbursement for PillCam SB in France.

The next step will be for the Union Nationale des Caisses Assurances Maladies to set a monetary value for the code, expected in 2007.

Homi Shamir, president/CEO of Given, said, “We expect other national health systems to follow France's lead and allow physicians to use PillCam capsule endoscopy to detect and monitor patients with small bowel illnesses.”

The PillCam SB capsule is a naturally ingested method for visualization of the small intestine, currently marketed in the U.S. and in more than 50 other countries.

Principal investigator signed for trial

CardioTech International (Wilmington, Massachusetts) reported signing an agreement with a principal investigator for the European clinical trial of its CardioPass synthetic coronary artery bypass graft.

CardoTech's newly named CEO Michael Adams, who also is responsible for regulatory affairs and business development, said the unnamed investigator “has participated in a wide range of cardiovascular clinical trials. This decision, [which] fits within our planned timeline, is an important benchmark in the commencement and completion of the trial.”

CardioTech previously has hired a European-based contract research organization to assist in the organization, execution and completion of the clinical trial in the European Union. As reported earlier, CardioTech is moving forward with its approved protocol to conduct a clinical trial of 10 patients with a post-operative follow up period of 90 days.

“With the selection of a principal investigator, we can now apply for ethics committee and Ministry of Health approvals, which are needed before import licenses and other administrative paperwork can be completed. Patient enrollment for the trial is expected to begin by year-end,” Adams said.

CardioTech International develops products for the treatment of cardiovascular, orthopedic, oncology and other diseases. CardioPass the company's synthetic coronary artery bypass graft.

BioMachines adds SameSpots to analysis offering

Nonlinear Dynamics (Newcastle upon Tyne, UK), a global provider of bioinformatics solutions, said that BioMachines (Research Triangle Park, North Carolina) has selected the company's SameSpots product as the 2-D analysis solution to support its new protein analysis service

BioMachines says that its Applied Proteomics Services Division offers an integrated technology platform, giving advantages in data quality and throughput. The approach of Nonlinear's SameSpots solution is a key component for delivering the service offering.

SameSpots offers proteomics researchers a breakthrough in the analysis of 2-D single stain and DIGE images by means of a faster 2-D workflow, largely through the elimination of post-analysis editing on the majority of experiments.

The SameSpots approach also guarantees 100% matching across an experiment and no missing values, allowing increased statistical power and new possibilities for 2D based proteomics research, according to Nonlinear Dynamics.

Tom Larrichio, CEO of BioMachines, said, “We implemented the SameSpots approach in our 2-D image analysis workflow as we recognize the significant time savings it offers on what is a labor-intensive process. Applying SameSpots to the aligned images vastly reduces, and even removes in some cases, the need for post-analysis editing – the time-consuming part of 2-D image analysis.”