A Medical Device Daily

mtm laboratories (Heidelberg, Germany), a privately held diagnostics company developing in vitro diagnostics for cervical cancer early detection and diagnosis, reported the signing for an additional tranche of €7 million to its Series C funding. This addition is a formal expansion of the company's last Series C in March 2008 and increases the total for the round to €39 million ($57 million) in equity.

This completed Series C financing was led by a new investor to mtm laboratories, Gilde Healthcare Partners (Utrecht, the Netherlands), with a consortium which includes HBM BioVentures, HBM BioCapital Invest, LBBW Venture Capital, and mtm and Friends. At the same time, Arthur Franken from Gilde Healthcare Partners will join as a new member of the supervisory board.

"This additional tranche will put mtm in a more favorable position to further leverage the clinical and commercial development of additional product lines," said Bob Silverman, CEO of mtm laboratories. mtm said it plans to use the proceeds of this financing to expand its clinical development activities and to bolster its commercialization efforts, specifically on the company's p16INK4a based CINtec and Cervatec IVD products.

The basis of mtm's IVD products, the proprietary p16INK4a biomarker, is strongly over-expressed in pre-cancerous and cancerous cells of the cervix. Screening and diagnostic tools based on this biomarker are developed to improve the accuracy and efficiency for the screening and early diagnosis of cervical cancer. mtm's CINtec in vitro diagnostic products focus on the detection of p16INK4a over-expression in biopsies (CINtec Histology) and cervical cytology specimens (CINtec Cytology).

Solace Therapeutics reports CE mark approval

Solace Therapeutics (Framingham, Massachusetts), a device company focused on the development of non-surgical bladder control therapies reported that it has received the CE mark for its Solace Intravesical System, and ISO 13485:2003 certification for the company's Framingham facility.

"This certification and CE mark approval represent a significant achievement and major milestone for Solace," said Kevin Connors, CEO of Solace. "Successfully completing this process allows us to move forward with the clinical development of the Solace Intravesical System in Europe.

The Solace Balloon is a small lightweight device (about the size of a quarter) that floats within the urinary bladder. It acts as a "shock absorber" to reduce the temporary pressure changes in the bladder that cause urinary leakage. It is placed in the bladder with a soft tube-like catheter and inflated with air. The 5 minute procedure is performed in the physician's office without anesthesia or surgery.

The Solace Balloon for women with involuntary urine leakage is currently being evaluated in several centers throughout the U.S. in an FDA IDE approved clinical trial.

DexCom's monitoring device gets CE mark

DexCom (San Diego) reported that it has received CE mark approval for the Seven Plus continuous glucose monitoring system.

The Seven Plus is DexCom's third generation device designed to help people with diabetes better manage their diabetes and control their glucose levels.

"We have been working diligently to establish a network of distributors outside the United States and plan to launch the Seven Plus in up to 10 countries in Europe in the fourth quarter." said Terrance Gregg, DexCom's president/CEO.

Meridian to distribute GI disease test in Italy

Meridian Bioscience (Cincinnati) said that its European unit has signed an agreement with Buhlmann Laboratories to distribute a test for intestinal diseases in Italy.

The test can differentiate between inflammatory bowel disease and the less serious irritable bowel syndrome by identifying a marker called calprotectin, Meridian said.

"The Buhlmann Calprotectin test fits very well in Meridian's gastroenteric product range, providing another key technology for our lab customers," said Antonio Interno, president of Meridian Bioscience Europe.

Meridian and Buhlmann, which is headquartered in Switzerland, are discussing extending the agreement to the French market, Interno added.

Meridian manufactures diagnostic test kits, purified reagents and related products.