A Diagnostics & Imaging Week
Biological Signal Processing (BSP; Tel Aviv, Israel), a start-up company that develops what it terms “innovative, simple and cost-effective systems for early stage, non-invasive diagnosis and monitoring of ischemic heart disease,” said it has received a letter of intent from Schiller (Baar, Switzerland) indicating that firm’s interest in incorporating BSP’s HyperQ technology into Schiller’s products.
BSP said that after reviewing the technological and clinical evidence regarding the HyperQ technology, Schiller expressed interest in integrating the HyperQ technology, as a first step, into its stress ECG systems.
BSP said negotiations will take place regarding licensing of the stress HyperQ technology, with the intention of signing an agreement during 1Q08. The letter of understnding is non-binding, and BSP said Schiller is aware that the Israeli company is negotiating with other parties without limitations.
Dr. Amir Beker, founder and CEO of BSP, said, “We are pleased with the signed letter of intent and perceive it as a declaration of confidence in our HyperQ technology and products. This is a ... significant step, accelerating the deployment of the HyperQ technology and products into world markets.” He added: “The incorporation of the HyperQ technology into the products of a world-leading medical device manufacturer such as Schiller will pave the way for the integration of the HyperQ technology into further applications such as rest ECG systems, implantable devices, homecare monitors and more.” BSP is dedicated to developing risk-free and reliable solutions for the diagnosis and monitoring of ischemic heart disease. The HyperQ System for Stress Tests, BSP’s first product, has received FDA 510(k) approval and obtained the CE mark.
BSP was founded in 2000 by Beker, a graduate of the Israeli IDF Talpiot program and a researcher in the field of biomedical signal analysis in academia and industry, and Ariel Landau, formerly executive VP of Elbit Systems and Elscint. The company completed a successful IPO in mid-2006 and is traded on the Tel Aviv Stock Exchange.
More than 3,500 patients in Israel, Europe and the U.S. have been examined by the HyperQ System in controlled clinical studies, in a clinical pilot program and in routine operation. In addition to its headquarters in Tel Aviv, the company has U.S. offices in Rockville, Maryland.
CE mark won for iRenalGuard
PLC Systems (Franklin, Massachusetts) reported receipt of the CE mark for its RenalGuard System, clearing the way for the company to begin its initial launch of the product in the European Union.
PLC said it expects to initiate a limited launch of RenalGuard in 1Q08 in Italy, “targeting early adopters who recognize the benefits of utilizing the unique fluid-balancing capabilities of the RenalGuard System in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of contrast-induced nephropathy (CIN).”
RenalGuard is an automated, real-time, matched-fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. It is based on existing pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects.
Mark Tauscher, president/CEO of PLC, said, “Receiving the CE mark for RenalGuard is an important milestone for PLC in the development of our new-product initiative. We are very enthusiastic about the potential opportunity for the RenalGuard System in Europe and look forward to working with leading practitioners there to introduce it to the market.”
Tauscher said that the initial launch in Italy will be supported by the company’s previously announced planned clinical trial at the Centro Cardiologico Monzino (CCM-University of Milan), led by Drs. Antonio Bartorelli and Giancarlo Marenzi, global experts in the prevention of CIN.
“We anticipate that this study will receive final approval by the ethics committee at CCM and will greatly increase the visibility of our RenalGuard System and that the data gathered from the study will enable us to seek expanded claims in order to market RenalGuard as a CIN-prevention device throughout the European Union,” Tauscher said.
With CE-mark approval, PLC said it expects to conclude negotiations with an Italian distribution partner “shortly” and that finalization of a distribution agreement is expected to include an initial stocking order of product from the distributor to support the initial sales launch of RenalGuard at select hospital sites throughout Italy.
Studies indicate that between 15% and 20% of all patients undergoing image-guided cardiology and radiology procedures are at risk of developing CIN, PLC said, with estimated mortality rate for those acquiring CIN as high as 35%.
1st Parkinson’s blood test is study goal
DiaGenic (Oslo, Norway) reported that the Michael J. Fox Foundation for Parkinson’s Research (MJFF; New York) is funding a DiaGenic study with Clemens Scherzer, MD, assistant professor of neurology at Brigham and Women’s Hospital (Boston) and Harvard Medical School (Boston), to develop the first-ever blood test for Parkinson’s disease.
The gene expression signature test for the early detection of Parkinson’s involves the identification and independent validation of a unique gene expression signature for Parkinson’s using peripheral blood, DiaGenic said.
Over the past three years, Scherzer and colleagues have established the Harvard PD Biomarker Study, funded by MJFF, designed for discovery and validation of blood tests for Parkinson’s disease. Because blood samples already have been collected, the company says it can immediately start on the analytical and bioinformatics studies. This will ensure the “rapid development of a prototype blood test followed by an approved diagnostic test for early detection of Parkinson’s disease,” DiaGenic said.
Erik Christiansen, CEO of DiaGenic, said that the study would be based on results from the company’s pilot study on Parkinson’s.
Support from MJFF will secure the initial funding of the project, which involves analyzing samples from the Harvard PD Biomarker Study U.S. cohort to find a common gene expression signature. This signature is then incorporated into a test on a standard platform, combined with DiaGenic’s analysis software.
Parkinson’s will now form the third disease in the portfolio, the company noted, along with Alzheimer’s disease and breast cancer.