OTC:EDTXF / TSX:EDT - Spectral Medical Inc.

No coverage on BNN Market call, probably because the guest said they don't buy phase III companies....

great news that the trial enrolment has completed, now we just wait to hear the results.

 

FDA Accepts Spectral’s Expanded Access Protocol for ToraymyxinTM ToraymyxinTM may now be used at hospitals that participated in EUPHRATES trial

Toronto, Ontario, June 27, 2016 – Spectral Medical Inc. ("Spectral" or the "Company"), (TSX:EDT) (OTCQX:EDTXF), a Phase III Company advancing a precision treatment targeting specific patients at high risk of death from endotoxemic septic shock, today announced that the U.S. Food and Drug Administration (FDA) has accepted its protocol for Expanded Access of ToraymyxinTM, the Company's investigational therapeutic device that removes endotoxin from the bloodstream.

The Expanded Access program, sometimes referred to as Compassionate Use, can now begin at certain of the 29 U.S. hospitals that had participated in the recently completed Phase III EUPHRATES clinical trial and have agreed to be part of this program. Patients who meet the clinical criteria for septic shock, are in multiple organ failure and who have elevated levels of endotoxin in the blood, as measured by the Company's FDA cleared Endotoxin Activity Assay (EAATM), would be eligible for the treatment. A similar program is planned for Canada, where there were 12 hospitals engaged in the clinical trial.

"As we move to complete our PMA submission for ToraymyxinTM with the FDA later this year, physicians in our clinical trial locations can now have immediate access to a therapy that has been used on more than 150,000 patients outside of North America for more than a decade,” said Dr. Paul Walker, President and CEO of Spectral. “Prior clinical research has demonstrated that removing endotoxin from the blood with ToraymyxinTM can result in positive patient outcomes and a reduction in mortality.”

A novel therapy for certain patients in septic shock, ToraymyxinTM is a medical device specifically targeted at those with elevated levels of endotoxin in the blood. ToraymyxinTM is a direct hemoperfusion adsorption column that has been shown to be highly effective in removing endotoxin. Studies have shown that ToraymyxinTM can remove up to 90 percent of an endotoxemic patient’s circulating endotoxin when administered twice within a 24 hour period.

http://www.spectraldx.com/assets/spectral-rls-06.27.16.pdf

 

Compassionate use is AMAZING NEWS!!! This is big

 

PRESS RELEASE FROM MARKETWIRE
Spectral Announces Normal Course Issuer Bid
Monday, July 04, 2016

Spectral Announces Normal Course Issuer Bid
08:00 EDT Monday, July 04, 2016
TORONTO, ONTARIO--(Marketwired - July 4, 2016) - Spectral Medical Inc. ("Spectral" or the "Company") (TSX:EDT) (OTCQX:EDTXF) a Phase III Company advancing a precision treatment targeting specific patients at high risk of death from septic shock, today announced that the Toronto Stock Exchange ("TSX") has accepted Spectral's notice of intention to proceed with a normal course issuer bid through the facilities of the TSX.

Pursuant to the notice, Spectral may purchase up to 4,134,664 of its common shares ("Shares"), representing approximately 2% of its issued and outstanding Shares, during the twelve month period commencing July 6, 2016 and ending July 5, 2017. As of June 27, 2016, there were 206,733,209 Shares issued and outstanding. Under the normal course issuer bid, Spectral may purchase up to 25,757 Shares on the TSX during any trading day, which represents approximately 25% of the average daily trading volume on the TSX, which is 103,028 Shares for the most recently completed six calendar months as of May 31, 2016. This limitation does not apply to purchases made pursuant to block purchase exemptions. Purchases will be executed through the facilities of the TSX at market prices under the normal course issuer bid rules of the TSX. Any Shares purchased under the normal course issuer bid will be cancelled.

Although Spectral intends to purchase Shares under its normal course issuer bid, there can be no assurances that any such purchases will be completed. Such purchases, if any, may commence on July 6, 2016 and will terminate on July 5, 2017, or on such earlier date as Spectral may complete its purchases pursuant to the notice of intention filed today with the TSX or provide notice of termination. Any such purchases will be made by Spectral at the prevailing market price at the time of acquisition and through the facilities of the TSX.

Spectral commenced a normal course issuer bid on December 17, 2014 that ended on December 16, 2015. Under such normal course issuer bid, Spectral purchased 480,000 Shares and the weighted average price paid per Share was $0.7396.

Spectral believes that the Shares have been trading in a price range which does not adequately reflect their value in relation to the business of Spectral and its future business prospects. As a result, depending upon future trading prices of the Shares and other factors, Spectral believes that the Shares may represent an attractive investment to Spectral. Furthermore, any purchases made under the normal course issuer bid can be expected to benefit all persons who continue to hold Shares by increasing their percentage equity interest in Spectral.

http://www.theglobeandmail.com/glob...20160704&archive=ccnm&slug=201607041061150001

 

Sep 07, 2016
OTC Disclosure & News Service

Spectral Announces Participation at the 18th Annual Rodman & Renshaw Global Investment Conference in New York City September 11-13th, 2016
TORONTO, ONTARIO--(Marketwired - Sep 7, 2016) - Spectral Medical Inc. ("Spectral" or the "Company") (TSX:EDT)(OTCQX:EDTXF) a Phase III Company advancing a precision treatment targeting specific patients at high risk of death from endotoxemic septic shock, today announced it will be featured as a presenting company at the 18th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC. The conference is being held on September 11-13, 2016, at Lotte New York Palace Hotel in New York City.

Dr. Paul Walker, President & CEO of Spectral Medical Inc., will provide an overview of the Company's business during the live presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the conference.

If you are an institutional investor, and would like to attend the Company's presentation, please access the following link (www.rodmanevents.com) to register for the Rodman & Renshaw conference. Once your registration is confirmed, you will be prompted to log into the conference website to request a one-on-one meeting with the Company.

Event: 18th Annual Rodman & Renshaw Global Investment Conference
Date: September 11-13, 2016
Location: Lotte New York Palace Hotel
455 Madison Avenue at 50th Street, New York, NY 10022
Presentation: Monday, September 12, 2016, 4:15PM to 4:40PM ET
Room: Holmes II (4th Floor)
Webcast Link: www.wsw.com/webcast/rrshq26/edt.to
The presentation will be webcast live. The slides will appear on our webcast page 15 minutes prior to the start of our presentation. To access the webcast, please visit the link above, or www.rodmanevents.com, or the Company's website www.spectraldx.com. The webcast replay will remain available for 90 days following the live presentation.


http://www.otcmarkets.com/stock/EDTXF/news?id=139882