ViewRay wins 510(k) for MRIdian Linac system, touts Q4, FY2016 prelim results

ViewRay (NSDQ:VRAY) today announced it won FDA 510(k) clearance for its MRIdian Linac system, and released its preliminary earnings for the 4th quarter and full fiscal year 2016.

The newly cleared MRIdian Linac device replaces the cobalt it utilized with linear accelerator technology, the Cleveland, Ohio-based company said.

“FDA clearance of the MRIdian Linac is a transformative milestone for ViewRay. We believe that availability of the world’s first commercial system to combine MRI for soft-tissue visualization and a compact linear accelerator will lead to a new standard of care in radiation oncology. Clinical experience with ViewRay’s first generation MRIdian System has demonstrated the benefits of on-table adaptive therapy and real-time MRI guidance, as clinicians are seeing for the first time how much tumors and organs move and change shape during the course of treatment,” prez & CEO Chris Raanes said in a press release.

The 1st 2 MRIdian Linac systems are slated to be installed at Detroit’s Henry Ford Hospital and St. Louis, Mo.’s Barnes-Jewish Hospital at Washington University, the company said.

“With MRI-guided radiation therapy, we’re able to watch the movement of tumors and organs in the body as radiation is being delivered and adapt the dose of radiation in real-time, to help ensure the maximum dose reaches the tumor and that surrounding healthy tissue is spared. This technology helps us treat tumors such those in the lung, liver and pancreas where increased precision is important due to nearby organs and other critical structures,” Sasa Mutic of the Washington University School of Medicine said in a prepared statement.

Cleveland, Ohio-based ViewRay also released preliminary highlights for its 4th quarter and fiscal year 2016. For the quarter, the company expects to post revenue of $16.1 million, with a net loss of $11 million. For the full year, ViewRay expects to post revenue of $22.2 million, with net losses of $50.6 million.

“Our strong performance in 2016, combined with the $26.1 million we raised this January, positions us well for the launch and commercialization of MRIdian Linac,” CFO Ajay Bansal said in a prepared release.

Last month, ViewRay said it raised $26.1 million in a private placement of common stock and warrants to support the ongoing commercialization of its MRIdian linear accelerator tech.

In the placement, Cleveland-based ViewRay said it sold approximately 8.6 million shares of common stocks with warrants to purchase an additional 1.7 million shares, with an exercise prise of $3.17.

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