A Medical Device Daily
EDAP TMS (Lyon, France), a developer of therapeutic ultrasound, reported that the French regulatory organization AFSSAPS has authorized a Phase I clinical study to evaluate high intensity focused ultrasound (HIFU) technology in patients with metastatic liver cancer. HIFU has the potential to assist with liver ablations and reduce bleeding during surgery.
Over the next six months, 20 patients are expected to receive treatment with a HIFU-based device designed to help destroy hepatic metastasis, or liver cancer tumors, while preserving surrounding tissues and organs. The objective is to expand the number of patients eligible for surgery and extend the survival rate. The device was jointly developed by EDAP in collaboration with Centre Leon Berard and INSERM 556 Unit (both Lyon, France) with the financial support from CLARA and OSEO, organizations respectively dedicated to supporting innovative cancer treatment initiatives and technological innovation.
Marc Oczachowski, EDAP's CEO, commented, "As a result of this successful cooperation among academic, clinical and industrial players, patients with liver cancer now have the potential to benefit from EDAP's HIFU technology. While EDAP maintains a focus on expanding our Ablatherm-HIFU business for patients with prostate cancer, our collaborators have clearly recognized the broader potential of our technology and the progress made by our R&D team in jointly developing a HIFU device to address liver cancer. Our collaboration in this early clinical study confirms EDAP's continuous leadership and expertise in HIFU and represents a preliminary step towards our long-term goal of positioning HIFU technology as a solution to improve existing treatment options across multiple pathologies."
EDAP makes Ablatherm, a HIFU treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment.
ResMed buys French-based Laboratoires Narval
ResMed (San Diego), a developer of sleep and respiratory medical equipment, reported that it has acquired Laboratoires Narval (Lyon, France), which makes the Narval O.R.M, a mandibular repositioning device (MRD) that offers a solution to patients for snoring and obstructive sleep apnea (OSA).
With this acquisition, ResMed said it adds another therapy to supplement its existing positive airway pressure-based solutions, providing a broader offering for this patient group. ResMed plans to commercialize this device in selected European markets.
"Obstructive sleep apnea is a serious disease that, left untreated, can have significant long-term impacts on the cardiovascular system, as well as impacts on other serious and chronic health issues," said Michael Farrell, senior VP of the Sleep Business Unit, ResMed. "The gold-standard therapy for obstructive sleep apnea is continuous positive airway pressure [CPAP] therapy. ResMed will now be able to provide an alternative solution for patients with mild obstructive sleep apnea as well as those with snoring. In addition, in France, there is reimbursement for MRD use as a second line treatment for severe OSA for those who are non-compliant on or refuse CPAP. We have found a good match in Narval as we both strive for clinical excellence and quality therapy solutions through market-leading innovation, education and service."
NOTE selected as supplier for Radi
NOTE (Stockholm, Sweden) said it has been appointed as a supplier of medical technology products to Radi Medical Systems (Uppsala, Sweden). A sophisticated wireless instrument used to measure blood pressure in the coronary artery will be developed and produced initially.
Radi is a St. Jude Medical (St. Paul, Minnesota) company that conducts applied research, development, production, marketing and sales of medtech products in the interventional cardiology segment. It conducts its business in close collaboration with physicians and other clinical staff to improve patient care.
This instrument the first wireless offering of its kind will be produced at NOTE's Torsby, Sweden facility. A web-based test database, enabling the customer to check quality levels directly from production, has been developed at the Norrt lje, Sweden plant.
"Our main priority was to find a supplier that satisfies all our quality standards," said Johnny Munther, Radi's Technical Purchasing Manager, "NOTE has the overall technology to cope with our products, plus good working methods that really allow us the necessary attention to maintain high quality. The fact that NOTE has a facility for volume production in China is also a plus."
DiagnoCure in distribution accord with Lab21
DiagnoCure (Quebec City, Ontario), a life sciences company commercializing cancer diagnostic tests and delivering laboratory services, said it has signed an exclusive agreement with a new partner, Lab21 (Cambridge, UK), a global provider of diagnostic products and services, for the promotion, marketing and selling of its Previstage GCC Colorectal Cancer Staging Test in the UK and Ireland. Lab21 will offer the Previstage GCC test as part of its oncology testing services, and patient samples will be processed in DiagnoCure's U.S. clinical laboratory. Terms of the agreement were not disclosed.
"This new partnership is a key initial step in reaching out to the European market. Lab21 is a leading provider of state-of-the-art diagnostics and world class customer service. This new avenue will support the global growth for our Previstage GCC Colorectal Cancer Staging Test," said John Schafer, president/CEO of DiagnoCure.