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RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 5/31/2016 2:29:40 PM   
minvestor42

 

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PRESS RELEASE FROM MARKETWIRE
Spectral Medical Files Expanded Access Protocol With FDA For Toraymyxin(TM) Septic Shock Treatment
Four patients remaining to enroll in the EUPHRATES clinical trial Company expects to announce trial results and submit final PMA module before end of 2016

Tuesday, May 31, 2016

Spectral Medical Files Expanded Access Protocol With FDA for Toraymyxin(TM) Septic Shock Treatment
08:00 EDT Tuesday, May 31, 2016
TORONTO, ONTARIO--(Marketwired - May 31, 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 it has filed a protocol and is in discussions with the U.S. Food and Drug Administration (FDA) for Expanded Access of Toraymyxin™, the Company's investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream. The Company also announced several significant updates and milestones achieved on its path to potential regulatory approval and anticipated commercial availability of its treatment in the United States.

The Expanded Access program, sometimes referred to as Compassionate Use, if approved by the FDA, would begin upon the completion of patient enrollment - expected no later than June 30, 2016 - at most of the 29 U.S. hospitals currently participating in the Phase III EUPHRATES clinical trial. 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 (EAA™), would be eligible for the treatment. A similar program is planned for Canada, where there are 12 hospitals engaged in the clinical trial.

"Currently, there is no approved treatment for patients in septic shock, the most advanced and lethal stage of sepsis, and clinicians are left with very few options to treat the sickest of patients," said Dr. Paul Walker, President and CEO of Spectral. "Toraymyxin™ represents a new solution for sepsis treatment and has been used on more than 150,000 patients outside of North America over the course of more than a decade. Provided the FDA approves our Expanded Access program, this treatment could be available soon for use in select patients at participating clinical trial locations in the United States."

Spectral also provided guidance today on several significant clinical and regulatory milestones:

As of today, only four patients remain to be enrolled in the EUPHRATES trial, which is fully on track to be completed by no later than June 30, 2016.

The FDA has accepted Spectral's statistical analysis plan for the PMA submission of Toraymyxin™. Subsequent to analysis of the trial data, the Company expects to announce primary end point results around the end of September 2016 and will then submit the last module of the PMA. The first three modules have already been submitted to the FDA. Assuming positive clinical data and barring any unexpected delays, Spectral anticipates a decision from the FDA as early as the first quarter of 2017.

The Company has submitted a 510K to the FDA for a proprietary stand-alone pump dedicated to the Toraymyxin™ therapy that would facilitate treatment delivery in the Intensive Care Unit (ICU) and increase options available to clinicians. The pump is also designed to provide an open platform for other hemoperfusion cartridges and to deliver continuous renal replacement therapy when indicated. A decision is expected in Q3 2016 and, if approved, the pump will be available for use in the Expanded Access program where needed.

In anticipation of potential FDA approval of Toraymyxin™, Spectral and Toray Industries Inc. (Toray) are both taking the necessary operational steps to scale up manufacturing capabilities in order to be ready to begin sales in the first half of 2017. A new plant has been built by Toray in Japan for the manufacture of Toraymyxin™ and EAA™ manufacturing capacity has been expanded in Toronto. The Company is also currently engaged in confidential discussions with potential interested partners that have existing sales and marketing infrastructures and it will be evaluating all potential options going forward.
"The progress we have demonstrated so far represents the culmination of six years of diligent work on clinical, regulatory and commercialization programs to bring the first approved product for endotoxemic septic shock to market and the finish line is in sight," added Dr. Paul Walker. "The imminent completion of patient enrollment in the EUPHRATES trial is an important step that brings Spectral significantly closer to addressing an enormous unmet medical need."

Over 1,000,000 patients are diagnosed with sepsis in the United States each year and over 300,000 of these patients die annually despite best practices employed by critical care and intensive care unit hospital staff.

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 and septic shock, 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 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. Over 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.

http://www.theglobeandmail.com/globe-investor/news-sources/?date=+20160531&archive=ccnm&slug=201605311056922001

(in reply to minvestor42)
Post #: 21
RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 6/16/2016 9:14:49 AM   
minvestor42

 

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Joined: 9/24/2015
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June 16, 2016 08:00 ET

™ by FDA[/size]
Company remains on track and anticipates final submission in Q4 2016

FDA accepts Spectral's 510(k) filing for its standalone pump for review

TORONTO, ONTARIO--(Marketwired - June 16, 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 U.S. Food and Drug Administration (FDA) has reviewed and accepted one of the two pre-clinical modules in its PMA application for Toraymyxin™, the Company's investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream. With acceptance of this module the Company remains on track to complete its full PMA submission by the end of 2016.
"As we look toward completing our submission to the FDA this year, the Agency's acceptance of this module is a significant milestone," said Dr. Paul Walker, President and CEO of Spectral. "This particular section contains key pre-clinical data on the use of Toraymyxin™ for patients with septic shock, including the device's engineering and bench testing; sterilization and shelf life; packaging and transport details. We are encouraged that the FDA accepted this data, which is critical to our submission, as we continue to advance our regulatory filing with the goal of bringing this treatment to people in need."
A novel therapy for certain patients in septic shock, Toraymyxin™ is specifically targeted at those with elevated levels of endotoxin in the blood. Toraymyxin™ is a direct hemoperfusion adsorption column that has been shown to be highly effective in removing endotoxin. Studies have shown that this medical device can remove up to 90 percent of an endotoxemic patient's circulating endotoxin when administered twice within a 24 hour period.
As part of the modular PMA filing, Spectral will submit a total of four modules of documentation for review in stages by the FDA. Two of the modules include pre- clinical information, one describes the manufacturing process and the last module contains clinical data. Three modules have been submitted and one of the pre- clinical modules has now been fully reviewed and accepted. Spectral plans to submit its fourth and final module, comprising data from its pivotal EUPHRATES trial, by the end of 2016.
In related news, Spectral announced that the FDA has also accepted for review the Company's separate 510(k) filing for a standalone pump that could facilitate treatment delivery in the Intensive Care Unit (ICU) and increase options available to clinicians.

http://www.marketwired.com/press-release/spectral-medical-announces-acceptance-pre-clinical-pma-module-toraymyxin-fda-tsx-edt-2134898.htm

(in reply to minvestor42)
Post #: 22
RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 6/20/2016 9:51:24 AM   
minvestor42

 

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Spectral Medical Announces Completion of Enrolment for Its Pivotal EUPHRATES Clinical Trial

Jun 20, 2016
OTC Disclosure & News Service

-

Spectral Medical Announces Completion of Enrolment for Its Pivotal EUPHRATES Clinical Trial

Company expects to announce primary clinical outcome results by end of September Final module of PMA submission anticipated in Q4 2016

TORONTO, ONTARIO--(Marketwired - June 20, 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 due to endotoxemia, today announced that patient enrollment has been completed for the Company's pivotal Phase III EUPHRATES clinical trial.

The clinical trial is intended to demonstrate the safety and efficacy of Toraymyxin™, an investigational device that removes endotoxin from the bloodstream. Over 900 patients who met clinical entry criteria for septic shock were evaluated using the Company's proprietary Endotoxin Activity Assay, which measures the level of endotoxin in the bloodstream. This lead to a total of 446 evaluable patients who were enrolled and randomized into the trial at 42 hospitals in the United States and Canada. The primary endpoint of the trial is a reduction in 28 day mortality in patients treated with Toraymyxin™.

"The EUPHRATES trial is a randomized, prospective, blinded trial evaluating a novel approach to the treatment of septic shock, combining a targeted diagnostic and therapeutic. This protocol required tremendous dedication and hard work from clinical research staff at each of the hospitals," stated Debra Foster, VP Clinical Development for Spectral. "We also thank the many patients and their loved ones who consented to be part of this trial."

"The completion of patient enrollment in the EUPHRATES trial is an important step in our mission to commercialize a treatment that addresses an enormous unmet medical need," said Dr. Paul Walker, President and CEO of Spectral. "Over the coming months, we will collect and analyze all required data with the expectation of announcing primary outcome results in September. We remain fully on-track to complete our PMA application with the FDA by year's end."

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

http://www.otcmarkets.com/stock/EDTXF/news?id=134240

(in reply to minvestor42)
Post #: 23
RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 6/27/2016 11:03:04 AM   
kwinvestor85

 

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FDA Accepts Spectral's Expanded Access Protocol for Toraymyxin(TM)
Toraymyxin(TM) may now be used at hospitals that participated in EUPHRATES trial


TORONTO, ONTARIO -- (Marketwired) -- 06/27/16 -- 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 Toraymyxin(TM), 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 (EAA(TM)), 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 Toraymyxin(TM) 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 Toraymyxin(TM) can result in positive patient outcomes and a reduction in mortality."

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

http://news.sys-con.com/node/3858192

(in reply to minvestor42)
Post #: 24
RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 7/4/2016 1:49:03 PM   
kwinvestor85

 

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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/globe-investor/news-sources/?date=+20160704&archive=ccnm&slug=201607041061150001

(in reply to kwinvestor85)
Post #: 25
RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 7/5/2016 1:29:47 PM   
minvestor42

 

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Awesome Interview with the CEO of Spectral explaining the company what the devices do and some timelines. worth the 14 min listen

http://www.massdevice.com/leading-battle-sepsis-massdevice-podcast-spectral-medical-ceo-paul-walker/

(in reply to kwinvestor85)
Post #: 26
RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 7/14/2016 10:30:18 AM   
minvestor42

 

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Article by Reuters:

Canada's Spectral hoping to win U.S. approval for sepsis treatment
BY NATALIE GROVER

A small Canadian drugmaker is in the final stages of testing technology designed to treat sepsis, the surprisingly common condition that killed boxing legend Muhammad Ali.

If data from late-stage trial is positive, Spectral Medical Inc thinks it can win approval from the U.S. Food and Drug Administration as early as next year.

The technology has been in use in Japan and parts of Europe for years but has never been approved for wide use in the United States because, in the view of the FDA, it has never been tested in trial large enough to prove its effectiveness and safety.

Sepsis, derived from the Greek word for putrefaction, occurs when the immune system goes into overdrive to fight infection or bacterial toxins, triggering a cascade of physiological changes that can lead to multiple organ failure.

The leading cause of hospitalizations in the United States, it can result from a simple cut, routine surgery or infections associated with chronic disease - Parkinson's, in Ali's case.

Sepsis costs the U.S. healthcare system about $20 billion a year, according to the Sepsis Alliance, a San Diego-based patient advocacy organization.

Infants, the elderly and those with weakened immune systems are most at risk.

In extreme cases, a dramatic drop in blood pressure can lead to life-threatening septic shock.

This is where Spectral comes in.

The Toronto company holds North American rights to a system developed by Japan's Toray Industries Inc designed to restore blood pressure and correct organ dysfunction by using an antibiotic to detoxify the blood.

Once the patient's blood has been extracted it is passed through a column to remove a type of toxin, called an endotoxin, which is believed to be a major trigger for sepsis.

The system allows you to "take the blood, clean the blood and return the blood," said Dr. Claudio Ronco, an Italian kidney specialist who has used the system extensively during more than two decades in the field.

Ronco said he has no financial ties to Spectral and has received only honorariums for speaking about his experience with the treatment at industry-sponsored symposiums embedded in scientific meetings, once by Toray.

"Even if the trial in the United States is not positive ... I will treat my patients with this device, because we have seen it works," he added.

EFFECTIVENESS CONCERNS

Toray has been selling the Toraymyxin system in its home market since 1994 and through distributors in Europe since 2002. The system is also approved for use in Canada.

Still, data supporting use of the device is intensely debated, with trials conducted outside of Japan and Italy failing to prove its effectiveness, Cormark Securities analyst David Novak wrote in a research note last month.

Spectral Chief Executive Paul Walker told Reuters that a lack of major recognized clinical trials that proved efficacy beyond question had "definitely slowed adoption."

The company's late-stage U.S. data is expected by September.

In the meantime, the FDA has approved the "compassionate use" of the product in select hospitals.

To accompany the device, Spectral has created a diagnostic test that can determine whether a patient has high endotoxin levels. The FDA cleared the test in 2003 and it has been approved elsewhere since then.

About 68 percent of patients with Ali's condition - those that develop septic shock - have high endotoxin levels, said Walker, a medical doctor and co-inventor of the test.

There are no specific FDA-approved medicines for the treatment of sepsis, and there have been several high-profile clinical failures.

The only drug to win FDA endorsement - Eli Lilly & Co's Xigris - was pulled off the market in 2011, a decade after approval, when follow-up clinical trials showed its use did not reduce mortality. (bit.ly/1OnzgpK)

The U.S. Centers for Disease Control and Prevention estimates that up to half of the estimated 1 million annual cases of sepsis in the United States result in death.

Every year, about 350,000 patients in North America are diagnosed with septic shock. Even a 15 percent cut in the mortality rate would be sufficient to justify an estimated $20,000 price tag per treatment, Walker said.

Spectral - which has a market value of about $160 million but generated just $3.08 million in revenue in 2015 - hopes to capture about half of the estimated $3 billion market within five years of FDA approval, he said.

If approved, Cormark's Novak expects the product to achieve peak annual sales of more than $800 million.

(Reporting by Natalie Grover in Bengaluru; Additional reporting by Amrutha Penumudi; Editing by Robin Paxton and Ted Kerr)

http://uk.reuters.com/article/us-spectral-medical-sepsis-idUKKCN0ZT1RH

(in reply to minvestor42)
Post #: 27
RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 8/17/2016 7:13:22 PM   
minvestor42

 

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PRESS RELEASE FROM MARKETWIRE
Spectral Announces Second Quarter Results
Friday, August 12, 2016

Spectral Announces Second Quarter Results
08:00 EDT Friday, August 12, 2016
TORONTO, ONTARIO--(Marketwired - Aug. 12, 2016) - Spectral Medical Inc., (TSX:EDT) (OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced its unaudited financial results for the second quarter ended June 30, 2016.

Financial Review

Revenue for the three months ended June 30, 2016 was $870,000 compared to $818,000 for the same period in the preceding year. For the six months ended June 30, 2016 revenues were $1,932,000 compared to $1,695,000 in the first half of 2015. Revenues for both the quarter and the year were consistent with prior year levels and this trend is expected to continue for the remainder of the year.

Operating costs for the quarter ended June 30, 2016 amounted to $4,393,000 compared to $3,242,000 in 2015. Operating costs for the six months ended were $8,462,000, an increase of $2,088,000 from $6,374,000 for the first six months of 2015. The increase is almost entirely attributable to higher costs for the EUPHRATES trial, resulting from completion of patient enrolment, collection of data, and preparation of its final submission to the U. S. Food and Drug Administration (FDA). Trial related expenses are expected to decline significantly starting in the third quarter. Apart from clinical trial activities, the Company continues to maintain a low cost operating structure for its base business operations.

For the three months ended June 30, 2016, the Company reported a loss of $3,498,000 ($0.02 per share) compared to a loss of $2,400,000 ($0.01 per share) for the three months ended June 30, 2015. The loss for the six months ended June 30, 2016 was $6,492,000 ($0.03 per share) compared to $4,722,000 ($0.03 per share) for the same six month period in the prior year.

The Company concluded the second quarter of 2016 with cash on hand of $10,044,000 compared to $6,369,000 as of December 31, 2015.

The total number of shares outstanding for the Company was 206,733,209 as at June 30, 2016.
http://www.theglobeandmail.com/globe-investor/news-sources/?date=+20160812&archive=ccnm&slug=201608121065739001

(in reply to minvestor42)
Post #: 28
RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 9/7/2016 2:17:57 PM   
minvestor42

 

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Joined: 9/24/2015
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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

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