A Medical Device Daily

Diagnostics firm BMD (Biomedical Diagnostics: Marne-la-Vall e, France) reported raising EUR 5 million ($6.25 million) in a new funding round, its third, following rounds of EUR 4.6 million ($5.75 million) in 2000 and EUR 9.3 million ($11.6 million) in 2003.

This latest round will enable BMD, it said, to further develop its Fidis-Caris products and technology, as well as boost international sales, particularly in the U.S.

BMD recently obtained a first FDA approval for its Fidis diagnostics products. Fidis (for Fast and Innovative Diagnostic Instrument Solution), the firm’s flagship technology, combines the measurement platform of BMD’s U.S. licensing partner Luminex (Austin, Texas) and its own immunoanalysis technology.

BMD bills this combination as a “multiplex” system that enables multiple, high-throughput autoimmune diagnostics to be carried out simultaneously and on a single patient blood sample, and calling it “a breakthrough in autoimmune diagnostics, compared to the labor-intensive methods involving separate and successive tests and samples.”

The Caris platform (Caris, for Carrier for Assay Reagents and Immuno Samples) is a biological automated sample preparation module for use with Fidis or other diagnostics systems. The current version of Fidis diagnostic kits focuses on autoimmune pathologies, and BMD said it will soon be available for infectious and genetic diseases.

Truffle Venture and CDC Enterprises Innovation led the round, followed by AGF Private Equity, Siparex, Auriga Partners, Ventech and 123 Multinova.

The investors said that the key factor in supporting the financing was the “disruptive” technology used in Fidis. BMD says that it holds a key position “in international markets, particularly through Fidis,” and that it is pursuing a strategy of developing niche markets “where the major players in this sector are absent.”

“This new investment is a strong vote of confidence in BMD from our investors and will allow us to consolidate our international position in this extremely competitive part of the market,” said Dr. Patrick Poty, CEO of BMD. “This is particularly true of the U.S., where we are competing with the market leaders and where this new funding will allow us to gain market share.”

Dr. Philippe Pouletty, a co-founder of Truffle Venture and president of France Biotech, said that BMD’s Fidis technology “provides an excellent basis for continued growth, and the company’s international positioning and the new management’s strategy for growth are equally strong reasons for us to make this investment.”

Founded in 1986, BMD offers solutions in the fields of autoimmune diseases, infectious diseases and allergies. The company also offers immunochemical tests for diagnosing heart failure and other coronary problems.

BMC reported 2004 sales of EUR 20 million.

EDAP, Sigmacon in distribution pact

EDAP TMS (Lyon, France) reported forming a distribution agreement with Sigmacon UK (Stanmore), giving it exclusive rights to promote and market Edap’s Ablatherm-HIFU in the UK.

Sigmacon reports marketing therapeutic devices to the urological community in the UK for more than 25 years. It also organizes workshops and seminars promoting the utilization of new technologies to enhance patient outcomes and grow physician business. Its focus has included sales and marketing of lasers and radiofrequency devices.

With the partnership, EDAP said it will reach the majority of British clinics and hospitals where urology procedures are performed, thus expanding the population served by Ablatherm-HIFU treatment for localized prostate cancer. Based on the recent guidance from the National Institute for Clinical Excellence supporting the use of HIFU for the treatment of prostate cancer, Sigmacon introduced Ablatherm-HIFU to the UK market and adding new treatment sites.

EDAP has been providing Ablatherm-HIFU treatment to British patients from its pilot installation in Stockport, UK, for more than a year, saying that it has done so “with great success.”

Hugues de Bantel, CEO of EDAP, pointed to Sigmacon’s “long history in medical devices, including winning approvals and reimbursement in the UK for dedicated products. He added: “EDAP continues to build on its already strong presence in key European markets, including the UK. We are working to earn appropriate reimbursement approvals and further the acceptance and awareness of Ablatherm-HIFU as a preferred treatment for prostate cancer, especially in cases where the patient’s health may make traditional treatments less favorable or in cases where the patient wishes to avoid the many side effects associated with surgery and radiation.”

More than 27,000 men in the UK are diagnosed with prostate cancer every year, and 10,000 die from the disease. Ablatherm-HIFU requires only a short period of hospitalization and has low complication and side-effect rates. HIFU treatment can also be safely repeated.

Besides manufacturing Ablatherm, the company is developing its technology for the treatment of other types of tumors. It also manufactures equipment for treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy.

NorDiag adds licenses from Genzyme

NorDiag AS (Bergen, Norway) reported signing a license agreement with Genzyme (Cambridge, Massachusetts) for European rights to the p53 and APC genes.

NorDiag said the agreement will allow it to incorporate additional gene markers into its Genefec assay for the early detection of colorectal cancer and “further increase the sensitivity of the assay and allow it to detect colorectal cancer at an even earlier stage.”

The Genefec assay is described by NorDiag as a non-invasive test that uses fecal samples as the specimen. The test is specific, easy to automate and ideal for use in both a diagnostic or screening environment.

Christian Horn, chairman of NorDiag, said, “Our Genefec assay already allows for pre-malignant colorectal cancer to be detected at a stage when the chances of successful treatment are high. However, the addition of these extra markers will further increase our assay’s sensitivity, making it an even better tool for both diagnostic and public screening programs.”

Colorectal cancer is the second most common cause of cancer deaths in the Western world, but with a high rate of success in treatment when detected early.