A Medical Device Daily

Replication Medical (Cranbury, New Jersey), a developer of proprietary, hydrogel-based products for the spine and other surgical applications, reported that it has received a CE mark for its GelFix Posterior Spinal Distraction implant.

The GelFix device is a one-piece posterior spinal implant made from HPAN, a biocompatible hydrogel which exhibits desirable mechanical properties including compressive resistance with a dynamic response. The GelFix distraction implant is used as a spacer between the spinous processes to provide separation and prevent nerve pinching. The product is available in three sizes to fit the typical range of spinal stenosis patients.

The CE mark for this implant follows the approval the company received last year from the FDA to market its EnGuard Vessel Guard. The EnGuard device is indicated for use as a protective cover for blood vessels following anterior spine surgery and is composed of the same biocompatible polymer.

Commenting on these developments, Ann Prewett, president/CEO, said, “The GelFix implant provides a unique, minimally invasive solution for treating spinal stenosis, a leading cause of back pain.“ The GelFix device acts as a dynamic spacer, compressing under load yet maintaining separation of the interspinous space. In this manner, some of the complications associated with rigid spacers such as breakage of the bones of the spinous process or subsidence may be avoided.

mtm launches cervical cancer screening assay

mtm laboratories (Heidelberg, Germany), a privately held diagnostics company, reported the launch of Cintec PLUS, the company's next generation cervical cancer screening product with unmatched accuracy for the screening and management for cervical cancer. Cintec PLUS will be launched with claims direct in Germany, Italy, Spain, France and the UK, and will also be available in other parts of the world via mtm's nominated distributors.

Cintec PLUS combines the p16 biomarker, widely validated for diagnostic purposes, with the proliferation marker Ki-67. By combining these two markers in a single diagnostic test, CintecPLUS provides both high sensitivity and high specificity for detecting high-grade cervical disease. The performance of this test for highly accurate detection of pre-cancerous cervical lesions has been demonstrated in three clinical trials conducted in over 30,000 women across Europe. In these studies, Cintec PLUS was demonstrated to have significant clinical utility across a wide range of applications in cervical cancer screening and management.

Cintec PLUS is the newest in a line of diagnostic and screening tests using the p16 biomarker that have been developed by mtm laboratories. Cintec Histology and Cintec Cytology are already marketed in Europe and were launched in 2007.

ExonHit, bioMerieux end one collaboration plan

ExonHit Therapeutics (Paris) and bioMérieux (Marcy, l'Etoile, France) have decided not to pursue their collaboration in colon cancer, following a recent review of data by their scientific committee. Both say they will continue to collaborate in the field of prostate cancer.

“ExonHit's technology was able to produce a robust and reproducible test however, the final results from the colon cancer program did not reach the level of performance we were aiming to achieve. Therefore, we have decided together with bioMérieux to focus our efforts on the prostate cancer program,“ commented Loïc Maurel, MD, president of the management board of ExonHit Therapeutics.

“Biomarker discovery is a strategic focus of innovation research for bioMerieux, but is a challenging scientific, medical and business endeavor. We made the decision to stop this Colon cancer screening Research program with ExonHit after reviewing the results of the clinical data. Our teams have learned a lot about this important disease“, said Stéphane Bancel, CEO of bioMérieux. “We look forward to continuing our collaboration together in the area of prostate cancer.“