Agendia plans IPO

Maker of the MammaPrint in vitro diagnostic multivariate index assay for predicting breast cancer recurrence seeks to raise up to $110 million through an initial public offering on the NYSE Euronext stock exchange in Amsterdam, the firm announced June 6. The Dutch molecular diagnostics firm plans to offer up to 4.59 million shares at $24.01 to $28.12 per share, based on current exchange rates. The proceeds are tabbed mainly to expand U.S. sales and marketing capabilities. Agendia’s flagship MammaPrint is part of the firm’s Symphony suite of four currently available breast cancer tests, which also includes TargetPrint , BluePrint and TheraPrint . The complementary tests provide “a comprehensive support system for oncologists to determine whether a breast cancer patient is likely to benefit from hormonal therapy, chemotherapy and targeted therapies,” Agendia explains. The company, which reported 2010 sales of $6.9 million, gained an initial FDA market go-ahead for MammaPrint in 2007. (See “ Also see "FDA Clears First-Of-A-Kind Breast Cancer Recurrence Test" - Medtech Insight, 12 February, 2007. ” – “The Gray Sheet” Feb. 12, 2007.)

Agendia products in the pipeline include the firm’s ColoPrint gene expression profiling test for colon cancer recurrence. A portion of the IPO proceeds is earmarked “to complete technical and clinical validation and initial commercialization of ColoPrint,” the company says. Agendia plans to seek FDA market clearance for ColoPrint within the next two years. R&D projects also include expanded breast cancer offerings and a test for lung cancer. Agendia expects trading of its IPO shares to begin on June 21 under the stock symbol “AGDX.” Underwriters for the offering include ABN AMRO, ING, KBC Securities and Kempen & Co.

Mauna Kea Technologies eyes IPO

Maker of the 510(k)-cleared Cellvizio probe-based confocal laser endomicroscopy system for in vivo cellular imaging plans an initial public offering later this year on the NYSE Euronext Paris stock exchange, according to the company. The Paris-based firm notes that Cellvizio is cleared by FDA for use in the gastrointestinal and pulmonary tracts and also has received a CE mark in Europe. The device can be used for cellular-level imaging of tissue in the body to improve the diagnosis of cancer and other diseases, according to the company. Mauna Kea Technologies announced its preliminary IPO filing June 6. “The potential IPO is planned for 2011, depending on market conditions and [Autorite des Marches Financiers, or French market authority] approval of the company’s prospectus,” the company says.

Arstasis raises $25.5 million

Arterial access device maker raises $25.5 million in a “Series E” private placement with a combination of 12 institutional and individual investors, the firm announced May 25. Headquartered in Redwood City, Calif., Arstasis announced earlier in May the U.S. launch of its Axera next-generation system for femoral artery access. Use of the device allows minimal manual compression to be used for secure closure of the vessel following a femoral procedure, the company explains. The device makes Arstasis’ first-generation Arstasis One Access device obsolete, as it “streamlines procedural steps to make the overall procedure easier,” the company explains. The latter device debuted in January. Arstasis has raised $67 million in capital to date. (See “ Also see "News In Brief" - Medtech Insight, 17 January, 2011. ” – “The Gray Sheet” Jan. 17, 2011.)

Sapiens gets $19 million

Sapiens Steering Brain Stimulation raises $19 million in a “Series A” private placement co-led by Wellington Partners and Edmond de Rothschild Investment Partners, announced June 1. The funds will be used for further development of Sapiens’ deep brain stimulation (DBS) system, as well as software, first-in-man validation and regulatory approval in Europe, according to the company. The Dutch firm is initially developing its MRI-compatible DBS implant for patients with Parkinson’s disease. The SBS steering brain stimulation system comprises both implants and navigation and steering software to facilitate accurate placement of electrodes in the target area of the brain, the company explains.

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