Spectral Medical’s Wholly-Owned Subsidiary Dialco Medical Announces Receipt of Health Canada License for DIMI - Seite 3
PMX is 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 proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for in-home use of “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use. “DIMI” recently received its FDA 510k clearance for use in hospital and clinical settings.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
Lesen Sie auch
Forward-looking statement
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 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: | |||||||
Dr. Paul Walker | Mr. Chris Seto | Mr. Ali Mahdavi | |||||
President and CEO | COO & CFO | Capital Markets & Investor | |||||
Spectral Medical Inc. | Spectral Medical Inc. | Relations | |||||
416-626-3233 ext. 2100 | 416-626-3233 ext. 2004 | 416-962-3300 | |||||
pwalker@spectraldx.com | cseto@spectraldx.com | am@spinnakercmi.com | |||||
David Waldman/Natalya Rudman | |||||||
US Investor Relations | |||||||
Crescendo Communications, LLC | |||||||
212-671-1020 | |||||||
edt@crescendo-ir.com |