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

Discussion in 'Canadian Stocks Message Boards' started by kwinvestor85, Apr 7, 2016.

  1. kwinvestor85

    kwinvestor85 New Member

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    About Spectral:
    Spectral Medical Inc. (TSX:EDT / OTC:EDTXF) is Toronto-based pharmaceutical company enrolling the final 75 patients into the only active Phase III clinical trial for a theranostic (diagnostic/therapeutic combination) treatment for severe sepsis and septic shock, a deadly condition which is the most common cause of death in people who have been hospitalized.

    The treatment consists of a diagnostic device developed by Spectral (EAA, Endotixin Activity Assay; already approved by the FDA and Health Canada) used for determining the patients eligibility for treatment (based on endotoxin levels in the blood), and the Toraymyxin PMX, a blood filtration catridge which can be used with a dialysis machine to filter those identified toxins out of the blood.
    Spectral owns the commercialization rights for the Toraymyxin PMX cartridge in North America, a device developed by Toray Industries which has already been used to treat 100,000+ patients in Japan and Europe, and has already shown efficacy in Japanese and European clinical trials (EUPHAS and EUPHAS2).

    There is currently no effective treatment for servere sepsis and septic shock, despite it affecting around 300-350 thousand people in North America per year (a portion of the 1,000,000+ people who will develop sepsis annually in North America) and having a mortality rate in excess of 50%. Spectral expects ~175,000 patients out of the 300-350 thousand who develop severe sepsis to be eligible for treatment with the Toraymyxin PMX catridge (eligibility is dependent on Endotoxin levels in the blood), and for the revenue per patient to be ~$20,000 USD. This amounts to an untapped market of potentially $3+ billion USD annually (assuming 100% market penetration).

    Spectral is engaged in a rolling pre-market approval consisting of 4 modules, of which 2 have been submitted to the FDA with the 3rd expected to be submitted by the end of Q4 2015.
    On September 14th 2015, a sample-size recalculation was approved by the DSMB (Data Safety and Monitoring Board) reducing the overall patient enrollment by 251 and cutting down the time to clinical trial completion significantly. Current patient enrollment is expected to be completed by the end of Q2 2016 (current enrollement rate of 8 patients per month with 75 patients left to enroll) and topline data should be available shortly thereafter. The application for FDA approval is scheduled to be presented to the FDA in Q4 2016.
     
  2. kwinvestor85

    kwinvestor85 New Member

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  3. kwinvestor85

    kwinvestor85 New Member

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    Latest Press Release:

    CORRECTION FROM SOURCE: Spectral Announces Fourth Quarter and Fiscal 2015 Results
    T.EDT | 1 day ago

    TORONTO, ONTARIO--(Marketwired - March 30, 2016) -

    This document corrects and replaces the press release that was sent today at 8:00 a.m. The error occured in the 4th Paragraph in Financial Review where $14,048 should be $14,048,000. The complete and corrected version follows.

    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 financial results for the fourth quarter and for the year ended December 31, 2015.

    Financial Review

    Revenue for the three months ended December 31, 2015 was $715,000 compared to $699,000 for the same three month period last year. Revenue for the year ended December 31, 2015 was $3,089,000 compared to $2,964,000 for the prior year, representing an increase of $125,000, or 4%.

    For the quarter ended December 31, 2015, the Company reported operating costs of $3,130,000 compared to $3,195,000 for the corresponding period in 2014. Operating costs for the year ended December 31, 2015 amounted to $12,696,000 compared to $13,125,000 in 2014. Most of the Company's expenses are incurred in its Phase III clinical trial and will vary depending on the timing and level of patient enrolment. Apart from clinical trial activities, the Company continues to maintain a low cost operating structure for its base business operations.

    Loss for the quarter ended December 31, 2015 was $2,400,000 ($0.01 per share) compared to $2,463,000 ($0.01 per share) for the same quarter last year. For the year ended December 31, 2015, the Company reported a loss of $9,524,000, ($0.05 per share), compared to a loss of $9,492,000 ($0.06 per share), for the year ended December 31, 2014.

    The Company concluded the 2015 year with cash and cash equivalents of $6,369,000 compared to $10,054,000 cash and cash equivalents on hand as of December 31, 2014. After closing of its bought deal financing subsequent to the year end, the Company had $14,048,000 of cash to fund its operations.

    The total number of shares outstanding for the Company was 190,771,405 as at December 31, 2015.

    Link: http://www.stockhouse.com/news/pres...tral-announces-fourth-quarter-and-fiscal-2015
     
  4. Treeaholics

    Treeaholics New Member

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    The first report is outdated. Spectral is now in the process of recruiting its last 22 patients, not 75!
     
  5. Treeaholics

    Treeaholics New Member

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    The following is taken from Spectral's latest investor prestation:

    The Company is now on track to recruit the last 22 of the required 446 evaluable trial patients. Based on current enrolment rates, it is expected that the trial should be completed in the first half of 2016. Provided this target is achieved, top line trial data should be available by the end of the third quarter and the final PMA module should be submitted to the FDA shortly thereafter.

    The EUPHRATES trial is currently the only active Phase III study in the area of septic shock.
     
  6. investinglee

    investinglee New Member

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    Thanks for posting the more recent update Treeaholics, do you have the link to the actual press release?
     
  7. investinglee

    investinglee New Member

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  8. sheliademartin

    sheliademartin New Member

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  9. sheliademartin

    sheliademartin New Member

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  10. thebishh

    thebishh New Member

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    i think people are starting to become more aware of what sepsis is and how deadly it is. it also has a high number of incidence paired with a high mortality rate... we need the spectral device to be FDA approved to help us battle back!

    i found a video talking about how the recent passing of Patty Duke is bringing sepsis more in the spotlight.

     
  11. kwinvestor85

    kwinvestor85 New Member

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    Spectral Commends Inclusion Of Organ Dysfunction In New Expert Consensus Definitions Of Sepsis And Septic Shock
    New sepsis definitions align with Spectral's pivotal trial design for Toramyxin(TM)
    Monday, March 07, 2016

    Spectral Commends Inclusion of Organ Dysfunction in New Expert Consensus Definitions of Sepsis and Septic Shock
    07:00 EST Monday, March 07, 2016
    TORONTO, ONTARIO--(Marketwired - March 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 septic shock, today commented on the potential life-saving ramifications of the recently announced Third International Consensus Definitions for Sepsis and Septic Shock. Specifically, Spectral cites the definitions' new emphasis on organ dysfunction as a major contributor to the underlying pathology of sepsis and the main cause of death from septic shock. The updated definitions were issued on Feb. 23rd by a joint task force convened by the Society of Critical Care Medicine and the European Society of Intensive Care Medicine and published online by the Journal of the American Medical Association1.

    "We are pleased that these new definitions are fully consistent with the hypothesis and patient identification protocol of our Phase III EUPHRATES clinical trial for Toramyxin™, an investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream," said Dr. Paul Walker, President and Chief Executive Officer of Spectral Medical.

    The EUPHRATES trial is nearing completion and is based on prior evidence that high levels of endotoxin are associated with organ dysfunction and increased mortality from septic shock. Investigational Toramyxin™ treatment for study eligible patients is guided by the Company's FDA-cleared Endotoxin Activity Assay (EAA™) which measures endotoxin levels in the blood. The new definition and its alignment with the Surviving Sepsis Campaign Guidelines are also reflected in the EUPHRATES study protocol which presumes that fluid resuscitation requirements have been met and that vasopressors are being used to maintain normal blood pressure in the patient.

    Over 350,000 patients are diagnosed with septic shock in North America each year. An estimated 150,000 U.S. patients die annually from septic shock despite best practices employed by critical care and intensive care unit hospital staff. Septic shock is the most advanced and most lethal stage of sepsis.


    http://www.theglobeandmail.com/glob...20160307&archive=ccnm&slug=201603071045723001
     
  12. kwinvestor85

    kwinvestor85 New Member

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    Marketwire - Canada
    Published May 12, 2016



    TORONTO, ONTARIO--(Marketwired - May 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 first quarter ended March 31, 2016.

    Financial Review
    Revenue for the three months ended March 31, 2016 was $1,062,000 compared to $877,000 for the same three month period last year. First quarter revenues 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 March 31, 2016 were $4,069,000 compared to $3,223,000 in 2015. Most of the Company's expenses are incurred in its Phase III clinical trial and will vary depending on the timing and level of patient enrolment. Apart from clinical trial activities, the Company continues to maintain a low cost operating structure for its base business operations.
    Loss for the quarter ended March 31, 2016 was $2,994,000 ($0.02 per share) compared to $2,322,000 ($0.01 per share) for the same quarter last year.
    The Company concluded the first quarter of 2016 with cash on hand of $12,861,000 compared to $6,369,000 as of December 31, 2015.
    In February, 2016, the Company closed a bought deal prospectus financing for net proceeds of $9,042,000.
    The total number of shares outstanding for the Company was 206,733,209 as at March 31, 2016.

    Corporate Update
    The clinical trial is on track to complete enrollment by the end of June, 2016. There will be a corporate update on clinical and regulatory activities to be released prior to the Annual General Meeting.

    http://www.theglobeandmail.com/feeds...R_1054490001-1
     
  13. sheliademartin

    sheliademartin New Member

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    MANAGEMENT’S DISCUSSION & ANALYSIS
    (All figures are expressed in thousands of Canadian dollars)

    This Management’s Discussion & Analysis (“MD&A”) for the year ended December 31, 2015 has been prepared to help investors understand the financial performance of the Company in the broader context of the Company’s strategic direction, the risks and opportunities as understood by management, and the key success factors that are relevant to the Company’s performance. Management has prepared this document in conjunction with its broader responsibilities for the accuracy and reliability of the financial statements, as well as the development and maintenance of appropriate information systems and internal controls to ensure that the financial information is complete and reliable. The Finance and Audit Committee of the Board of Directors has reviewed this document and all other publicly reported financial information for integrity, usefulness, reliability and consistency.

    This MD&A is dated March 29, 2016 and should be read in conjunction with the consolidated financial statements for the years ended December 31, 2015, and December 31, 2014.

    http://www.spectraldx.com/assets/spectral-q4-mda-2015.pdf
     
  14. kwinvestor85

    kwinvestor85 New Member

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    Spectral Investor Presentation March 2016.

    Highlights:

    Sepsis: A Significant Unmet Medical Need
    - Common: >30% of ICU admissions
    - Extremely fatal with ~300K deaths/annum in the U.S.
    - Current cost of managing sepsis at ~$20B/annum in the U.S.
    - Sepsis is a global problem with no targeted treatments available
    - Over 1M patients/annum are diagnosed with sepsis in the U.S.
    - Spectral has the only viable solution in Phase 3 clinical trials

    PMX Removes >90% of Endotoxin
    - EUPHAS Study in Italy (2009) showed a reduction in mortality of 64 patients from 53% to 32%
    - EUPHAS 2 registry of over 300 treated patients showed same survival rate as the EUPHAS study
    - Analysis of over 2,000 patients in Japan (2014) showed a reduction in mortality from 47% to 34.5%
    - Over 150,000 patients to date treated outside of North America reflect similar positive outcomes
    - PMX saves the lives of 1 in 3 patients with septic shock and high endotoxin
    - Data also shows that the sickest patients benefit most and that 2 column treatment is most effective (same as our EUPHRATES trial design)

    The Clinical/Regulatory Pathway
    - 424 patients randomized as of March 28/2016 (154 since April 2014 protocol amendment that refined patient selection)
    - Sample size reset to 176 evaluable patients post April 2014 for primary 28 day mortality end point and statistical plan accepted by FDA ; 446 evaluable patients in total (previously 650)
    - Trial enrolment now at 95%; expected trial completion in H1, 2016
    - Current trend:
     ~ 50% composite mortality for randomized patients since April 2014
     ~ 60-65% mortality in untreated patients with similar characteristics
     ~ 40% mortality in similar treated European patients
     SUGGESTS ~ 20% ABSOLUTE REDUCTION IN MORTALITY
    - 3 of 4 PMA modules have been submitted; Module 4 (clinical data) targeted for H2 2016

    Investment Highlights
    - Reputable and proven management team and board
    - First mover advantage
    -The only active Phase 3 clinical trial in septic shock, a deadly condition with a mortality rate >40%
    -Statistical plan and regulatory pathway agreed with the FDA
    - Over 150K patients in Japan and Europe have been treated with this safe and effective device
    - $3B+ annual revenue market opportunity with no competition
    -Spectral is targeting 150K + patients with septic shock in North America
    -End user price of $20K to $30K per treatment
    -40%+ EBITDA at full ramp up
    - Well capitalized with ~$14M in cash post bought deal financing
    - Clear path to submission for FDA approval in H2 2016
    -FDA approved rolling PMA submission plan



    link to full presentation: http://www.spectraldx.com/assets/spectral-medical-ir-march2016.pdf
     
  15. kwinvestor85

    kwinvestor85 New Member

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    May 31, 2016 08:00 ET

    Spectral Medical Files Expanded Access Protocol With FDA for Toraymyxin™ 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





    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.

    http://www.marketwired.com/press-re...in-septic-shock-treatment-tsx-edt-2129625.htm
     
  16. thebishh

    thebishh New Member

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    What do you think the chances are of them being around in 2017, I'm talking about a buyout post trial results.
     
  17. investinglee

    investinglee New Member

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    good question, i would assume they could be a buyout target post trial results IMO
     
  18. mercedesman

    mercedesman New Member

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    SAN DIEGO, June 4, 2016 /PRNewswire/ -- Sepsis Alliance joins with billions of people around the world in mourning the death of Muhammad Ali, the boxing legend known as "The Greatest." Ali, who had been battling Parkinson's Disease since his diagnosis in 1984, has died from septic shock due to unspecified natural causes after having been admitted to a Phoenix-area hospital five days ago due to respiratory issues.

    Ali's official cause of death was disclosed today by a spokesperson for the family. Sepsis Alliance extends its deepest condolences to the entire Ali family during this difficult time of loss.

    "We are incredibly saddened to hear of Muhammad Ali's death from septic shock," said Thomas Heymann, Executive Director of Sepsis Alliance. "Ali was a hero in many ways who inspired people to push ahead through adversity, and our thoughts and prayers are with his family during this difficult time. By his family's disclosing sepsis as the cause of death, Muhammad Ali has likely saved countless lives by raising awareness of sepsis, a medical emergency which requires rapid treatment to save lives."

    link to full article - http://www.prnewswire.com/news-rele...hammad-ali-to-sepsis-at-age-74-300279801.html
     
  19. sheliademartin

    sheliademartin New Member

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    June 16, 2016 08:00 ET
    Spectral Medical Announces Acceptance of Pre-Clinical PMA Module for Toraymyxin™ by FDA


    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-rel...dt-2134898.htm
     
  20. sheliademartin

    sheliademartin New Member

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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
     

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