Spectral Medical Inc.
TSX : EDT
OTCQX : EDTXF

Spectral Medical Inc.

April 22, 2015 08:00 ET

Spectral Medical Provides Regulatory Update

FDA Accepts Spectral's Rolling Pre Market Approval Submission Plan

TORONTO, ONTARIO--(Marketwired - April 22, 2015) - Spectral Medical Inc. ("Spectral" or the "Company") (TSX:EDT)(OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that the United States Food and Drug Administration (FDA) has accepted the Company's plan, and related content, for a rolling Pre Market Approval (PMA) submission for its treatment for septic shock.

The submission consists of four separate modules. The first three modules will include physical, chemical and safety testing data, as well as requisite manufacturing information. The fourth, and final, module provides clinical data.

Spectral has completed the first three modules and plans to submit them beginning in May 2015 in accordance with an agreed timeframe with the FDA over the next four to six months. The final module will be submitted upon availability of clinical data from the EUPHRATES trial. This process allows for timely review of the various modules so that the timeframe to commercialization, after completion of clinical data analysis, can be reduced significantly.

"The commencement of our rolling PMA submission represents a major milestone for the Company," stated Dr. Paul Walker, President and CEO of Spectral. "We remain fully on track with our clinical and regulatory program to bring to market a unique therapy for septic shock, which is an area of large unmet medical need in North America and worldwide."

About Spectral Medical Inc.

Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of endotoxemic septic shock. Toraymyxin ™ (PMX) is a therapeutic hemoperfusion device that removes endotoxin, a main trigger of sepsis, from the bloodstream. Directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis, Spectral's EUPHRATES trial is the world's only active and most innovative Phase III study for a medical device in the area of septic shock.

PMX has been approved for therapeutic use in Japan and Europe, and has been used on more than 100,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 350,000 patients are diagnosed with septic shock in North America each year, representing a greater than $3 billion market opportunity for Spectral.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT, and on the OTCQX under the symbol EDTXF. For more information please visit www.spectraldx.com.

Forward-looking statements

Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the commercialization of Spectral's septic shock treatment, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

Contact Information

  • Spectral Medical Inc.
    Anthony Businskas
    Executive Vice President and CFO
    416-626-3233 ext. 2200

    Spectral Medical Inc.
    Ali Mahdavi
    Capital Markets & Investor Relations
    416-962-3300
    am@spinnakercmi.com
    www.spectraldx.com