mtm laboratories (Heidelberg, Germany), a privately held diagnostics company developing in vitro diagnostics for cervical cancer early detection and diagnosis, reported last month the signing for an additional tranche of e7 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 e39 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 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 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).
Golden Meditech subsidiary gets private $28M
Golden Meditech (Hong Kong), a medical device and healthcare service corporation in China, reported that its hospital subsidiary - Golden Meditech Hospital Group (GMHG) has entered into an agreement to issue senior 5% redeemable convertible notes due in 2014 with an aggregate principal amount of $28 million (HK$217 million). The funds will be used to accelerate business developments in China, the company said.
GMHG will issue 15,747 new shares to investors upon full conversion, valuing the entire GMHG in excess of $200 million. Upon full conversion, the note holder will hold about 13.61% of enlarged share capital of GMHG, and the company's holdings in GMHG will be diluted from current 60% to 51.8%.
Golden Meditech completed its strategic entry into China's hospital management and service market in June this year, and now owns the first nationwide management license granted by China government to a foreign entity.
Golden Meditech operates an integrated portfolio of healthcare businesses including medical devices, healthcare services and natural herbal medicines.
Activiews raises $5M to set up sales network
Medical device start-up ActiViews (Tirat Hacarmel, Israel) raised $5 million in an investment round led by 7 Health Ventures. Previous investors Ofer HiTech and Evergreen Venture Partners participated in the round as well.
ActiViews, founded in 2007, is developing optical guidance systems used in CT, fluoroscopy and Magnetic MRI procedures. Its first product, ActiSight, is designed to improve minimally invasive oncology diagnosis, with future applications in guiding therapeutic devices to malignant targets. The ActiSight already has the CE mark.
The funds will be used to set up a sales network in Europe and for obtaining marketing approval in the US, the company said.
AtriCure wins CE mark for AtriClip system
AtriCure (West Chester, Ohio), a developer of cardiac surgical ablation systems, last month reported CE mark approval for its AtriClip Gillinov-Cosgrove left atrial appendage exclusion system. The AtriClip system is designed to safely and effectively exclude the left atrial appendage and is being launched in Europe through a phased approach in 4Q09.
The system was used last month in multiple European centers during both open-heart and minimally invasive cardiac procedures.
"European approval of the AtriClip system represents a major product and clinical milestone for AtriCure," said David Drachman, president/CEO. "We believe that the AtriClip System provides a safe, efficient and clinically superior method to exclude the left atrial appendage. This key innovation represents a large and exciting new growth platform and we look forward to full commercial release in Europe and the United States during 2010."
The AtriClip system includes a clip device that is designed to exclude the left atrial appendage, a hollow sac-like structure attached to the heart's left atrium. The left atrial appendage has internal peaks and valleys, or trabeculations. During atrial fibrillation, stagnant blood pools in the trabeculations of the left atrial appendage and is known to form clots that can migrate to other parts of the body. The AtriClip is designed to be implanted from the outside of the heart, avoiding contact with circulating blood and eliminating blood flow between the left atrial appendage and the atria.
Medtronic gets CE mark for Captiva system
Adding to portfolio of medical technology for endovascular aortic repair, Medtronic (Minneapolis) reported the CE mark and international launch of the Captivia delivery system for the Valiant thoracic stent graft, a minimally invasive treatment for aneurysms and other lesions of the thoracic aorta.
The Captivia system features tip capture for enhanced control of the Valiant graft during deployment and a hydrophilic coating applied to the graft cover to facilitate iliac access and delivery through patients' vasculature. The new Valiant Captivia system enables physicians to treat a wide range of anatomies with a highly conformable stent graft, with accuracy and ease of delivery to achieve optimal clinical results, according to the company. Both the Valiant thoracic stent graft and Captivia delivery system are investigational in the U.S., where their use is limited to clinical trials approved by the FDA.
Indicated for the treatment of a variety of thoracic aortic lesions, the company said the Valiant has emerged as the minimally invasive "system of choice" for thoracic endovascular aortic repair outside the U.S. In four years of clinical experience, more than 15,000 patients worldwide have received the Valiant.
Hologic gets CE mark for its ThinPrep imager
Hologic (Bedford, Massachusetts) a developer, of diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, reported that it has received the CE mark for its ThinPrep integrated imager.
The integrated imager represents the latest innovation in cervical cancer screening by combining proven ThinPrep imaging technology and slide review into a single, convenient stand-alone device. This exciting new product offering allows laboratories of all sizes to benefit from clinical advantages of ThinPrep imaging for cervical screening.
"This represents a tremendous opportunity for Hologic and our current and future laboratory partners throughout Europe," said Howard Doran, senior VP, diagnostics products for Hologic. "The ThinPrep integrated imager is designed to provide the small and medium volume laboratory access to the most effective and efficient cytology screening technology available, while allowing them the flexibility to address their specific productivity and throughput needs." The majority of laboratories in Europe would fall into the small or medium category, the company noted.
The integrated imager analyzes a ThinPrep pap test slide in about 90 seconds, during which time each cell and cell cluster is scanned. Using optical density analysis, the integrated imager identifies diagnostically-relevant cells or cell groups and then stores coordinates of the 22 fields of interest. These 22 fields of interest are presented to the cytotechnologist for interpretation. If no abnormalities are identified by the cytotechnologist, the slide can be signed out as negative or proceed through the laboratory quality control system. A complete slide review is required if the user detects any suspicious cells within the 22 fields of view. This dual review process combines human interpretative expertise with the power of computer imaging.
The ThinPrep integrated imager is currently not approved by the FDA.
EDAP gets OK for HIFU liver cancer study
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, the company said.
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 (Lyon, France) and INSERM 556 Unit (Lyon, France) with the financial support from CLARA and OSEO, organizations respectively dedicated to supporting innovative cancer treatment initiatives and technological innovation.
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, EDAP said.
Ingen receives Chinese Oxyview patent
Ingen Technologies (Yucaipa, California), a device manufacturer focused on the respiratory market, reported that the company has received a Chinese patent for the Oxyview and the Oxyview Nasal Cannula.
The designated Chinese patent application no. 200710005067.4 was officially issued and published on July 1 for the cannula gas flow meter referred to as Oxyview.
The company's pending patents in Japan, Canada, and Europe are expected to issue in 2010, Ingen said.
CellaVision analyzer okayed for sale in Canada
CellaVision (Lund, Sweden), which develops digital morphology products for the routine analysis of blood and other body fluids, said it has received official approval for the new analyzer CellaVision DM1200 in Canada. The approval is strategically important for CellaVision's penetration of the North American market, the company said.
"We have invested a large amount of resources into the studies and documentation necessary for selling this product on our main markets. We are now able to offer Canadian hospitals with somewhat smaller test volumes a fully automated analyzer, contributing to a more efficient workflow at the laboratory. We are expecting this product to have a positive effect on our sales in North America," said Yvonne M rtensson, CEO of CellaVision.
The CellaVision DM1200 is intended to replace manual microscopy of blood samples and is aimed at medium-sized hospital laboratories. The distribution between different types of white blood cells and their appearance are important criteria in diagnosis of a number of conditions such as infections and blood cancer. Automated technology increases productivity, reduces response times, and improves diagnostic quality.
Solace reports CE mark for Intravesical system
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 its 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 company noted.
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 Seven Plus 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.
Meridian makes diagnostic test kits, purified reagents and related products.
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 that offers a solution to patients for snoring and obstructive sleep apnea.
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.
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, the company said.
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 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.
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.
De Novo 510(k): Strategies for Successful Class III Appeals
The de novo 510(k) provides a pathway for devices that are safer than Class III, but do not have a predicate. But you must move fast-you have only 30 days from the NSE to request a de novo reclassification.
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