TORONTO, Feb. 15, 2018 (GLOBE NEWSWIRE) -- Spectral Medical Inc., (TSX:EDT), a Phase III company developing a
treatment for patients with endotoxemic septic shock, today announced that Health Canada (HC) has approved, under Licence No.
100541, the Spectral Apheresis Machine (“SAM”) for use in continuous renal replacement therapy ("CRRT"), therapeutic plasma
exchange ("TPE") as well as for Hemoperfusion (HP), a modality specifically designed to facilitate patient treatment with the
Toraymyxin™ (“PMX”), cartridge used for endotoxin removal in patients with septic shock.
SAM was initially developed to be user friendly and support the commercialization of PMX by removing the need to
use more cumbersome dialysis instruments by providing specific hemoperfusion capabilities. However, SAM’s final design allows it to
now meet all acute dialysis needs in the critical care environment. The company has exclusive license rights for SAM in North
America for all CRRT applications and has worldwide exclusivity for hemoperfusion applications.
"We believe that SAM with its innovative patented technology, represents a significant innovation for patients
in ICU needing CRRT for acute kidney injury, as well as the potential to become a flexible open platform for other extracorporeal
blood treatments, already available as well as some under development," said Dr. Gualtiero Guadagni, Vice President of Sales &
Marketing at Spectral.
Spectral Medical Inc. is an importer of Class I and Class III medical devices and as such is subject to
regulatory inspections by Health Canada to assess compliance with the Food and Drugs Act and Medical Device Regulations under
Health Canada’s Medical Devices Inspection Programme. This past week Health Canada inspected Spectral’s establishment and gave
Spectral a compliant rating.
“In 2017, Spectral Medical Inc. has expanded the scope of its quality system certificate to add the Spectral
Apheresis Machine (“SAM”) and has undergone an upgrade to the Medical Device Single Audit Program (“MDSAP”) which covers
ISO13485:2003,” said Danijela Domljanovic, Director of Quality for Spectral.
About Spectral Medical
Spectral Medical is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of
patients with endotoxemic septic shock, ToraymyxinTM (‘PMX”). PMX is a therapeutic hemoperfusion device that removes
endotoxin, which can cause sepsis, from the bloodstream.
PMX has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more
than 150,000 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 severe sepsis and septic shock in North America each year. Spectral is listed on the Toronto Stock Exchange
under the symbol EDT. For more information, please visit www.spectraldx.com.
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.
For further information, please contact:
Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com