Viewray Inc (NASDAQ:VRAY)’s MRIdian Linac Gets The FDA 510(k) Nod! Viewray Inc (NASDAQ:VRAY)

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Viewray Inc (NASDAQ:VRAY), one of the biotech stocks in the U.S has announced receiving the much awaited 510(k) clearance to market the MRIdian Linac system in the United States. This approval of the MRIdian-Linac systems by the FDA comes as a result of low demand of the company’s MRIdian-Cobalt systems as many consumers eagerly awaited the introduction of the new system.

Since the upgraded MRIdian-Linac system maintains the legacy system, it can be easily be replace by the Cobalt. Although initial reports have indicated that first two MRIdian Linac systems will be installed at Barnes-Jewish Hospital at Washington University and Henry Ford Hospital in Detroit it is highly possible that many people will opt for a Linac system because it is designed to be upgraded easily.

Viewray Inc CEO Chris Raanes said during the third quarter conference call that customers are very flexible and a big percentage is eagerly waiting for the new system to be launched. The company already has a total of 23 orders with a total value of $133 million. With the new system, it is highly expected that Viewray Inc will quickly rise to the top of the quickly growing market and cement its position through competitive pricing.

The company which is one of U.S’s top biotech stocks in September 2016 received the approval to market the MRIdian-Linac in the EU. The German Research Foundation (DFG) has bought and installed the system at the University Clinic Heidelberg which is the biggest and most re renowned medical center for cancer treatment. The institution becomes the first and only to use the MRIdian Linac in a clinical environment within Europe.

Viewray Inc recorded revenue amounting to $16 million in the fourth quarter of 2016. The company earned revenue amounting to about 22 million for fiscal 2016 from the sale of four of its MRIdian systems. The company recorded a net loss of $11 million for the fourth quarter and $50 million for the whole financial year 2016. For the fourth quarter of 2016, the company earned around $14 million in revenue. To help finance its 2017 operations, the company earned gross proceeds amounting to around $26 million from a private offering from the sale of a total of 8.6 million shares of common and warrants.


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