A Medical Device Daily

Spirus Medical (Stoughton, Massachusetts) reported receiving the CE mark for its Endo-Ease Advantage and Endo-Ease Vista products for colonoscopy and said it is planning for the launch of the products in Europe.

The company said the two products leverage its Endoluminal Advancement System (EAS), used in conjunction with a conventional colonoscope to aid advancement through the colon with the ease of rotation. Spirus said the EAS system uses a soft spiral component fixed on an active, flexible overtube to facilitate a more efficient approach to colonoscopy.

The shorter Endo-Ease Advantage is designed to aid advancement of a colonoscope through the tortuous sigmoid colon, where physicians often experience the most difficulty. Once the sigmoid colon has been traversed, the scope is unlocked from the device. The Endo-Ease Advantage then remains in place to stabilize the sigmoid colon while the scope is advanced traditionally through the rest of the colon to complete the procedure.

The Endo-Ease Vista is a longer version designed to enable rotational advancement of the scope beyond the sigmoid colon. The Vista also provides a stable conduit through which a colonoscope can be passed to complete a colonoscopy.

“Both Endo-Ease Advantage and Vista have been extremely well-received by gastroenterologists and surgeons in the U.S., and we are now positioning ourselves to market the Endoluminal Advancement System across Europe,” said Steven Tallarida, president and CEO of Spirus Medical. “With the application of the CE mark on these two devices, Spirus is building a solid foundation for growth in the European Union.”

The company said the Endo-Ease products “attach easily onto a slim or pediatric colonoscope.” It added that Endo-Ease Advantage and Endo-Ease Vista can help move the colonoscope through the colon and also provide a conduit through which the scope can be advanced.”

Other products in the Spirus pipeline utilizing its platform technology include the Endo-Ease Discovery SB for small-bowel enteroscopy and the Uro-Ease family of products for urology.

Spirus Medical was incubated and founded in 2005 by STD Med, a Stoughton-based manufacturer of medical technologies.

Firms expand cancer-screening program

bioMerieux (Marcy L’Etoile, France) and ExonHit Therapeutics (Paris) have initiated their third program for the screening of cancer from blood. One of the goals is to assist physicians in deciding whether to proceed with surgery for prostate cancer.

The companies said such diagnostic tests should allow the detection of cancers from a blood sample.

The collaboration is based on the expertise and intellectual property of ExonHit in the analysis of genome expression, and the expertise of bioMerieux in the field of in vitro diagnostics. Its purpose is to create DNA biochips that will allow screening for the presence of cancer markers from blood samples.

DNA biochips are perfectly adapted tools to detect several dozens of nucleic acid markers, which in turn enable the characterization of multigenic pathologies such as cancers.

bioMerieux and ExonHit first launched a program for breast cancer screening from blood, for which a prospective study is ongoing, with a second program focused on the detection of colorectal cancers, which are considered to be the most common, regardless of sex.

The companies said they now are going to tackle prostate cancer, the most frequently diagnosed cancer in men. In France each year, prostate cancer affects 40,000 men and is the second-most-common cause of death by cancer. Its frequency increases with age.

The only existing way to detect the presence of prostate cancer with certainty and to determine its characteristics is through biopsies. The companies said a reliable blood test would constitute a major improvement for the screening of prostate cancer, by assisting physicians in deciding which treatment to apply to improve patient management.

“We are very happy to tackle such public health challenges with bioMerieux,” said Bruno Tocque, ExonHit chairman “We are confident we will rapidly provide bioMerieux with a new diagnostic panel in the market of molecular detection of cancers.”

Stephane Bancel, deputy general manager of bioMerieux, said, “A wide-scale use of a test of blood detection could reduce by 15% to 20% the mortality due to cancer of populations which are subject to detection, thereby giving them quicker access to a therapeutic treatment.”

ExonHit Therapeutic is a global leader in the analysis of alternative RNA splicing, a process that, when deregulated, plays a key role in the onset of various diseases.

The company already is generating revenue from “SpliceArrays,” which enable life science researchers to detect crucial disease-associated information. These products are marketed worldwide in conjunction with Agilent (Palo Alto, California) and Affymetrix (Santa Clara, California).

It also has a strategic partnership with Allergan (Irvine, California), to discover and develop new therapeutics in the areas of pain, neurological diseases and ophthalmology. This collaboration provides ongoing research funding to ExonHit.

In the field of diagnostics, its collaboration with bioMerieux to develop predictive blood-based cancer diagnostics could play an important role in improving the treatment of breast and other major cancers.

ExonHit also is developing its own therapeutic pipeline in neurodegenerative diseases and cancer.

New subsidiaries for mtm labs

mtm laboratories (Heidelberg, Germany) has opened new subsidiaries in Milan, Italy; Madrid, Spain; and Paris in order to commercialize its diagnostic products in Europe.

When combined with Germany, these additional markets represent roughly two-thirds of the total European cervical cancer-screening market.

CEO Peter Pack said, “Our commitment to expanding into France, Italy and Spain, along with our existing presence in Germany and the U.S., signals our intention to make mtm’s cervical cancer diagnostic products globally available.”

mtm’s products for cervical cancer are based on the detection of a highly specific biomarker, p16INK4a, which indicates the existence of pre-cancerous and cancerous cervical cells. The identification and clinical validation of this biomarker has enabled mtm to develop assays for use in population-wide screenings to detect and to diagnose cancer at an early stage when it is most treatable.