UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 9, 2016

 

 

VIEWRAY, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   333-193498   42-1777485

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

2 Thermo Fisher Way

Oakwood Village, Ohio 44146

(Address of principal executive offices, including zip code)

(440) 703-3210

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 8.01 Other Events

ViewRay, Inc. (the “Company”) announced significant progress in the development of a linear accelerator version of its MRIdian® product (the “MRIdian® linac”).

The Company has achieved critical milestones in the technological development of the MRIdian® linac, including human imaging testing, delivery of radiation beams in a magnetic field using a linear accelerator and modification of the treatment planning system to incorporate linear accelerator technology. Other significant technology incorporated into the MRIdian® linac includes radio frequency “cloaking” technology to preserve the integrity of MR image quality in the presence of radio frequencies emitted by a linear accelerator, magnetic shielding technology to enable undistorted delivery of radiation, double-focused multi-leaf collimator technology for the delivery of sharp radiation beams and incorporation of existing MRIdian® proprietary “pop-apart” magnet design. During development, the Company plans to offer a limited number of MRIdian® linac systems for non-clinical research purposes.

The Company is designing the MRIdian® linac such that its commercially-available cobalt-based MRIdian® systems can be modified to incorporate the MRIdian® linac technology. The Company is in the process of preparing marketing applications for submission in 2016 for 510(k) clearance by the United States Food and Drug Administration and for CE marking in the European Union, as required for commercial launch of its MRIdian® linac.

The Company believes the MRIdian® linac, when commercially available, will broaden the Company’s addressable market, accelerate the Company’s sales cycle, accelerate backlog conversion time and improve gross margins.

Forward-Looking Statements

This report contains forward-looking statements. Statements in this report that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to the development of the MRIdian® linac, the market applications required for commercial launch of the MRIdian® linac, the broadening of the Company’s addressable market, the acceleration of the Company’s sales cycle, the acceleration of the backlog conversion time and the improvement of gross margins. Actual results could differ from those projected in any forward-looking statements due to numerous factors, including, among other things, the ability to raise the additional funding needed to continue to pursue the Company’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize the MRIdian® linac, competition in the industry in which the Company operates, overall market conditions and those other risks and uncertainties described in the Company’s most recent Quarterly Report on Form 10-Q under the caption “Risk Factors.” Other risks, uncertainties and factors that could cause actual results to differ materially from those projected may be described from time to time in reports the Company files with the Securities and Exchange Commission, including reports on Forms 10-K, 10-Q and 8-K. These forward-looking statements are made as of the date of this report, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  VIEWRAY, INC.
Dated: March 9, 2016   By:   /s/ Chris A. Raanes
    Name:   Chris A. Raanes
    Title:   Chief Executive Officer