A Medical Device Daily

Epigenomics (Berlin), a cancer molecular diagnostics company, and Warnex Medical Laboratories (Laval, Quebec) reported the launch of a molecular diagnostic blood testing service for colorectal cancer in Canada, based on Epigenomics' biomarker Septin9 and DNA methylation technologies. Warnex is the first laboratory to offer Septin9 testing in Canada, after obtaining the non-exclusive rights from Epigenomics in May. Prior to its launch, Warnex's Septin9 test was independently developed and validated using clinical blood samples from colorectal cancer patients and individuals with no apparent disease as verified by colonoscopy.

“Colorectal cancer is curable if caught early enough and blood tests like this may play an important role in saving lives. We are delighted that patients in Canada will now also be able to benefit from Septin9 testing, alongside patients in the United States, Europe and the Middle East,“ said Epigenomics CEO Geert Nygaard.

Mark Busgang, president/CEO of Warnex, said his company is “pleased“ to add the test to its service offering.

“The Septin9 test is a convenient and specific blood test for colorectal cancer detection that can easily be integrated into the patient's routine physical, as it is non-invasive and does not require any drug or dietary restrictions,“ Busgang said.

Cytomedix receives ISO 13485

Cytomedix (Gaithersburg, Maryland) reported that it has received certification for the ISO 13485 Quality Management Standard for Medical Devices as well as Canadian Medical Device Certification for its Gaithersburg facility. The announcement certifies Cytomedix as a provider of devices for the medical industry and allows the company to operate commercially in Europe and in Canada.

“Receipt of these certifications is the culmination of a great deal of cross-functional diligence and hard work by our employees. It is reflective of our mission to meet, if not exceed, all quality standards, and allows us to expand our global footprint and advance the international launch of our platelet rich plasma products,“ said Martin Rosendale, president/CEO of Cytomedix. “Our customers in the medical industry understand the value of the ISO 13485 certification. We remain committed to the clinicians and patients we serve, and to continuously improving the effectiveness of the quality management system under which we operate.“

Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis.

CMT closes its $150M convertible note offering

In vitro diagnostics company China Medical Technologies (Beijing) reported that it has closed the private offering of $150 million in aggregate principal amount of convertible senior notes due 2016 including an additional $25 million principal amount of the notes to cover over-allotments.

The company has used a large portion of the net proceeds of the offering to repurchase $105.9 million aggregate principal amount of its outstanding convertible notes due 2011 through privately negotiated transactions, and has used about $10 million to pay for expenses associated with a previously reported capped call transaction (Medical Device Daily, Dec. 2, 2010)

The company said it intends to use the remaining net proceeds from the offering to repurchase its outstanding convertible notes and for general corporate purposes.

“The principal amount of the remaining outstanding convertible notes due 2011 is $29.1 million and the outstanding convertible notes due 2013 is $248 million,“ said Sam Tsang, CFO of the company. “We believe that we have addressed the refinancing concern on our outstanding convertible notes due 2011 and 2013 by this offering together with our cash on hand, expected cash flows to be generated from our operations over the next 3 years and credit facilities to be provided by banks.“