A Medical Device Daily

Misonix (Farmingdale, New York), a developer of ultrasonic technology for the treatment of cancer and other healthcare purposes, said that both the Sonablate 500 device used for the treatment of prostate cancer and its FS1000 Neuroaspirator for soft tissue removal, used primarily in neurosurgery, have received approval for sale within the Russian Federation.

“Approval by the Russian Federation is a very important and strategically significant milestone for Misonix,” said CEO Michael McManus Jr. “We are targeting international markets for continued growth. With the approval from the Russian Federation, we add to our international distribution of products with ultrasound technology that we believe is superior for the effective treatment for patients.”

The Sonablate 500 uses high intensity focused ultrasound to heat and ablate targeted prostate tissue non-invasively. Treatment with the device, which is manufactured by Focus Surgery (Indianapolis) and distributed by Misonix, offers a safe and effective alternative to more radical treatments such as invasive surgery or radiation. Misonix holds a minority ownership position in Focus.

The FS100 Neuroaspirator uses ultrasonic vibrations to fragment and aspirate tissue. The device is used in neurosurgery, general surgery and liver resection.

Igor Zolotarev, president of Eximex Russia Corp., the distributor of Misonix products to the Russian Federation, said, “There is a significant opportunity in the countries we serve for the types of medical devices that Misonix has brought to market. In particular, prostate cancer had the fourth-highest incidence rate of all cancers in males in the Russian Federation, according to the latest Globocan study.”

Zolotarev is the former deputy head of the Russian State Committee for the development and support of small- and medium-sized enterprises, as well as director of the Federal Fund for Support of Small Businesses.

Eximex is engaged in a full-scale promotional campaign, including seminars for physicians, educational trips to Russian regional hospitals, and medical journal advertisements. A new showroom at one of the most advanced hospitals in Moscow will showcase the Sonablate 500 and FS100 Neuroaspirator.

BD buys protein fractionation firm

BD Diagnostics (Sparks, Maryland) said that it has acquired the technology and other assets of FFE Weber (Munich, Germany), a privately held company that specializes in the separation and fractionation of complex proteins.

Financial terms were not disclosed.

BD Diagnostics, a unit of BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey), said FFE Weber’s technologies are targeted at the emerging field of proteomics, which is of growing importance in the academic research, pharmaceutical, biotechnology and clinical diagnostic markets.

Noting the need for new techniques for both clinical sample collection and processing, William Kozy, president of BD Diagnostics, said, “The complexity and dynamic range of proteins within a human plasma sample make it difficult to detect the very low abundance proteins that may prove indicative of a disease state.”

He said the protein separation technology acquired from FFE Weber “provides an important pre-analytical separation step that will help proteomics researchers to find, characterize and validate new classes of biomarkers.”

Located near the Max-Planck Institute in Munich, FFE Weber manufactures the Free Flow Electrophoresis protein separation system. The technology enables a pre-analytical protein separation step that, when used in combination with high-performance liquid chromatography (HPLC), 2-D gel and mass spectrometry-based protein analytical procedures, allows deeper interrogation into the plasma proteome than is possible with current methodologies, BD Diagnostics said.

The German company was founded by Dr. Gerhard Weber, who has functioned as owner and lead inventor for many years. Weber, who will continue to work closely with BD, said the U.S. company “has proven expertise in bringing important new technology platforms from pure research application into clinical utility.”

He said that although the current focus for his firm’s protein fractionation platform is academic protein analytics and biomarker discovery, “the clinical diagnostic potential for proteomics cannot be ignored. BD Diagnostics will ensure the proper application of this technology in the research segment and its potential evolution into clinical laboratory workflow.”

Edward Ludwig, BD’s chairman, president and CEO, said, “This acquisition represents an important step in [our] strategy to invest in emerging technologies which position the company in areas that hold promise for new diagnostic methods, such as the evolution of protein biomarker research into the clinical diagnostic lab of the future.”

Axya Systems acquired by Cerner

Cerner (Kansas City, Missouri) reported its acquisition of privately held Axya Systemes (Paris), a healthcare information technology (IT) company that specializes in financial, administrative and clinical solutions for hospitals.

The acquired company’s new name is Cerner France. Cerner said the transaction would expand its presence in France and bring “significant intellectual property and knowledge of the French healthcare market.”

Trace Devanny, Cerner president, said the two companies “have a shared mission to improve the quality and efficiency of healthcare around the world through information technology. Together we are better positioned to capitalize on the many opportunities available in all segments of the French healthcare market.”

He called Axya “an excellent fit within Cerner because of our common cultures, complementary solutions and similar views on the importance of unified architecture.”

Axya has a client base that includes academic, private and public hospitals in France, Switzerland and Morocco. Its founders, Anne-Veronique Dufresnoy and David Kalfon, will become part of the Cerner management team in France.

“The healthcare IT landscape in France is changing,” said Dufresnoy. “We believe that being a part of a global organization will be critical in addressing the significant opportunities developing in the market. We are now better positioned to accelerate our growth and respond to greater market demand.”

Cerner has more than 1,500 clients worldwide and is regarded as the leading supplier of healthcare IT products.