Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 300,000 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 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (“RRT”) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
Chris Seto is the Chief Executive Officer of Spectral Medical. In his role, he oversees the financial management of the company including, finance, accounting, treasury and capital market financings as well as corporate planning/development and investor relations.
Prior to joining Spectral Medical, Chris was the CFO of MJardin Group Inc. (CSE:MJAR) and GrowForce Holdings Inc. Additionally, Chris has over 20 years of capital markets and financial management experience, including senior investment banking positions with Paradigm Capital, UBS Securities and CIBC World Markets;and financial management experience in the telecom and healthcare industries with Bell Canada and Warren Shepell.
Chris holds a B. Comm. from McMaster University, an MBA from Richard Ivey School of Business, and a Certified Management Accountant designation (C.M.A. 1999).