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  1. #151  
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    I'm not in EDT.TO, wish I had some of it.
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  2. #152  
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    CB Mt Batchelor is the best..It had be years since I'd been here..Maybe the best snow boarding spot I've ever been..
    Dude's just ripping it up on tight corkscrew running through old growth forest...It's really beautiful and Sunriver is a deal for lodging.

    Hard to get here but worth the effort
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  3. #153  
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    Quote Originally Posted by CoachCB View Post
    I'm not in EDT.TO, wish I had some of it.
    I thought you bought a little at one point.
    Sounds like you're crushing it with your picks.......Keep it going.
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  4. #154  
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    Quote Originally Posted by Bozzie View Post
    I thought you bought a little at one point.
    Sounds like you're crushing it with your picks.......Keep it going.
    No, I'm in EDTXF, which is doing really well.

    We're going to Big Bear (CA) next month - my wife's little sister lives there. Just a quick long weekend type thing, 3 days of snowboarding. Should be fun. They've gotten a ton of snow...but we're talking a month from now and Big Bear is pretty far south. Hopefully the snow will still be nice. Our cabin in Virginia had some nice snow last week and is getting some more this week - there's a small ski hill nearby (Bryce Resort), but it's only fun for about 2 hours as you spend most of your time on the lift.
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  5. #155  
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    Quote Originally Posted by CoachCB View Post
    No, I'm in EDTXF, which is doing really well.

    We're going to Big Bear (CA) next month - my wife's little sister lives there. Just a quick long weekend type thing, 3 days of snowboarding. Should be fun. They've gotten a ton of snow...but we're talking a month from now and Big Bear is pretty far south. Hopefully the snow will still be nice. Our cabin in Virginia had some nice snow last week and is getting some more this week - there's a small ski hill nearby (Bryce Resort), but it's only fun for about 2 hours as you spend most of your time on the lift.
    In

    EDTXF is basically tracking EDT..I hold both the majority being in EDTXF

    You'll have a great time in BB it's great little spot when the town is open ...enjoy!
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  6. #156  
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    Spectral Medical Announces that its Wholly-Owned Subsidiary Dialco Medical has been Granted FDA IDE Authorization to Conduct a Trial of DIMI for Home Hemodialysis Use

    TORONTO, Canada – February 23, 2021 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), today announced that its wholly-owned subsidiary, Dialco Medical Inc.(“Dialco”), has been granted Investigational Device Exemption (IDE) authorization by the United States Food and Drug Administration (FDA) to conduct a usability trial to demonstrate the safety and efficacy of DIMI for performing hemodialysis in the home environment.

    DIMI is an innovative renal replacement system based on a fully integrated cassette technology, which simplifies set-up, operation, and management of a dialysis session when compared to other instruments currently available on the market. DIMI was recently cleared by the FDA to treat patients with acute and/or chronic renal failure with or without fluid overload using hemodialysis, hemodiafiltration, hemofiltration and/or ultrafiltration in hospital or clinical settings.

    The approved IDE usability trial is expected to enroll 35 patients and is designed to evaluate the safety and efficacy of DIMI in the home setting by analyzing delivered dialysis dose and potential adverse events happening during six weeks of use at home compared to six weeks of use in the hospital setting on the same patients.

    Dialco is in the process of selecting its contract research organization (“CRO”) partner to run the trial, as well as identifying and evaluating clinical sites that will participate in the trial.

    “We look forward to working with our early adopters and other clinical teams to evaluate DIMI and run the usability trial to pursue the home market designation,” said Dr. Gualtiero Guadagni, President of Dialco Medical Inc. “The trial design is similar to the ones run recently by Outset Medical and previously by NxStage. The key measure of success will be demonstrating that DIMI can deliver the prescribed dialysis needs per session, both in hospital and in the home environment, while maintaining safeguards for the mitigation of safety risk.”

    “We are very excited to announce that the FDA has granted IDE authorization to commence this landmark trial of DIMI for at home use,” said Chris Seto, COO and CFO of Spectral. “This latest authorization follows our recent FDA 510(k) Clearance of DIMI for use within hospitals, clinics and skilled nursing facilities. Assuming this trial is successful, we believe Dialco’s addressable home hemodialysis market alone will approach $3 billion by 2025, due to increasing pressure to transition hemodialysis to an at-home setting in the U.S. We are more excited than ever by the outlook for the business and look forward to announcing a number of important upcoming milestones.”

    About Spectral
    Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.

    PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 200,000 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.

    Forward-Looking Statement

    Information in this news release that is not current or historical factual information may constitute forward-looking information or forward looking statements 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 including but not limited to the ongoing impact of COVID-19. Actual results could differ materially from what is currently expected, and readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company disclaims any obligation to update or revise any forward-looking statements. Reference is also made to the other risks and uncertainties that may affect the Company which are more fully described in Spectral’s Annual Information Form dated March 26, 2020 and other filings of Spectral with the securities regulatory authorities which are available at www.sedar.com.

    The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

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  7. #157  
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    Not surprised this isn't having a positive effect on the price, to some investors means more time till home approval.
    I look at it as a ratchet up of pressure on any potential buyer and I'd bet more eyes than just Baxter are on this.
    This has a bit more time but I'd expect another few announcements aimed at forming the perception that the Pump will be spilt out and the company will Up-list.

    Crazy but I may buy more if it fades, sitting with +540k right now.
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  8. #158  
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    Boz you sound like you are pot committed to this one. I may have to join the action. I have a pretty good cash position and I am getting bored waiting to jump in. Been buying silver and some cryptos thinking that the band is going to stop playing and the party may be over for awhile in the the stock market. What price are you looking to add?
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  9. #159  
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    Today..I like the way this is looking, I bought this AM again and last week on the dip on the Canadian side.(Better liquidity if you can buy off an international desk EDT.TO on the Toronto EX)
    I think It'll recover a little today..5500.00 bucks in my account when if moves a penny either direction keeps this ass clinching at times if nothing else.
    I've hard some dark days with this one..Toughest, longest hold of my life and I like to hold.

    I like it more than ever NS
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  10. #160  
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    Quoting from another board.

    Little background on Outset, The Company was started by VC guys and one super powerful women in the valley with the mission of getting a home device approved, they did it without going public but spent a huge amount of VC capital getting approved. It's been approved for about a year.. the word is they want 4 billion as a take out...VC guys$$$$$

    "It is great news. This is actually a month shorter than Outset had to do. They had to do 8 weeks and 8 weeks, and we only have to do six and six. I expect the investor presentation to be updated and the Dialco timeline to be moved up atleast a quarter on the extension for home use.

    Here's Outsets human factors trial if you're curious."


    https://www.outsetmedical.com/wp-con...lysis_syst.pdf
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  11. #161  
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    Till recently the NEO.Alpha & Omega saw no action, anyone have a theory on why these markets have had an up-ticked in volume when you could buy on the TSX? I don't why volume shifted to these markets.

    TSX shows 80K, real volume closer to 300K combining the markets..

    https://www.stockwatch.com/Quote/Detail?C:EDT




    T:EDT - SPECTRAL MEDICAL INC - http://www.spectraldx.com 14:03:59 EST
    Sym-X Bid - Ask Last Chg %Ch Vol $Vol #Tr Open-Hi-Lo Year Hi-Lo Last Tr News Delay
    EDT - T ▲ATS 28.5 0.65 0.66 0.5 0.66 -0.04 -5.7 277.0 177 141 0.63 0.70 0.62 0.81 0.345 13:19:43 10:01 15 min RT 2
    TSX - T 28.5 0.65 0.66 0.5 0.66 -0.04 -5.7 80.1 51 47 0.63 0.67 0.62 0.81 0.345 13:16:56 15 min
    NEO ATS - U 0.66 -0.04 -5.7 45.0 29 30 0.70 0.70 0.62 13:16:56 15 min
    Alpha - A 0.66 -0.04 -5.7 80.3 52 15 0.65 0.66 0.63 13:00:20 15 min
    Omega - O 0.66 -0.04 -5.7 20.0 13 6 0.64 0.66 0.62 13:19:43 15 min
    CX2 - H 0.65 -0.05 -7.1 48.5 31 19 0.65 0.66 0.62 12:58:38 15 min
    CXD - D 0.70 0.3 0 2 Dec 08 15:50:01 15 min
    TriAct - M 0.70 2.9 2 22 Sep 11 14:53:46 15 min


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  12. #162  
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    Bozzie:

    I am in......nothing as large as you in terms of $$$. Maybe we can score big and I can come out to Oregon for a round of golf and a nice bottle of wine!!

    Good Luck to us.
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  13. #163  
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    This next phase of FDA requirements is Human factors testing, basically people are trained to use the machine in clinic for 6 weeks and are scored on every interaction with the machine...then sent home for 6 weeks with the machine and someone to monitor and scored the interactions again. Vetting the machine basically vs Human interaction fault rates. Another thing the FDA is looking at separately is a newly installed remote monitoring system for home use.
    It's finally coming together, some good young minds have been pulling the strings for the past year, it looks like they have a clear strategy (FDA home approval) to drive the price and another to scare the Bjeee'$ outa anyone looking to buy a HD pump company on the cheap...(FDA approval with an up-listing)
    Consider yourself invited NS.. I think we'll win here.
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  14. #164  
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    I have 29,500 EDTXF @ .40/avg per share. I added some today when it was down big. I've been buying the dips and will probably add some more if it gets below .50 again.
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  15. #165  
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    Quote Originally Posted by CoachCB View Post
    I have 29,500 EDTXF @ .40/avg per share. I added some today when it was down big. I've been buying the dips and will probably add some more if it gets below .50 again.

    Nice CB you been slowly buying seems like....This has at least another 6 months before Fault testing is done plus a bit of time for the FDA to do its thing with the data afterward.

    Outset up-date..I haven't been following them that closely, they went public during the pandemic....
    https://www.bizjournals.com/sanjose/...-ipo-jump.html

    Also Outset has a ER call on the march 9th I'll be listening , feels like EDT is mirroring Outsets moves in a smaller way plus I'm curious what the plan is to get that 4 billion they think can be had on a takeout..Valued at 2.0 billion today by the market...on 20 mIllion in sales.

    https://www.tullahomanews.com/news/business/outset-medical-to-report-fourth-quarter-and-full-year-2020-financial-results-on-tuesday-march/article_36441f75-61c6-5792-b5b9-569d4d497179.html


    Just background noise for EDT at this point, Money is flowing to this market segment, I'd just like to see it flow EDTs direction before Outset pulls a player outa the loop on a takeout.
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  16. #166  
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    Quote Originally Posted by CoachCB View Post
    I have 29,500 EDTXF @ .40/avg per share. I added some today when it was down big. I've been buying the dips and will probably add some more if it gets below .50 again.
    Dam it Coach.....you had to post that you had 29,500 shares......being competitive now I will have to buy more just to have bragging rights that I didnt make as much as Bozzie but I made more than Coach.....when we all become filthy rich. hahaha
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  17. #167  
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    Quote Originally Posted by Northern Star View Post
    Dam it Coach.....you had to post that you had 29,500 shares......being competitive now I will have to buy more just to have bragging rights that I didnt make as much as Bozzie but I made more than Coach.....when we all become filthy rich. hahaha
    Yes...but my dollar cost average will be lower! Unless of course it tanks.....
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  18. #168  
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    It'll have some down days still but long..They have the assets, it's all dependent on FDA approvals now.
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  19. #169  
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    Just added another 1000 shares, it opened down 11%, under .50.
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  20. #170  
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    Nice, it'll bounce around a bit..Health care Canada "Home approval" on the pump should come at any time.
    It'll be viewed as good news.
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  21. #171  
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    This will be a boost for both retail and institutional investors in the US
    Good good.



    Spectral Medical Engages Crescendo Communications to Provide
    Investor Relations Services in the United States


    TORONTO, CANADA — March 4, 2021 – Spectral Medical Inc.(“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly owned subsidiary Dialco Medical Inc. (“Dialco”), announces that it has retained Crescendo Communications, LLC ("Crescendo") as its investor relations firm to help broaden awareness of the Company in the US financial markets.

    David Waldman, President and CEO of Crescendo, commented, “We are honored to work with Spectral and look forward to supporting them in their mission of combatting the devastating impacts of sepsis, a leading cause of death in ICUs across the US. Spectral’s Toraymyxin™ PMX endotoxin removal cartridge, combined with its EAA™ diagnostic, address a dramatically underserved $1.5 billion market opportunity with no competing FDA approved solutions. Additionally, we believe there is a significant market opportunity within the Dialco business, with two first-in-class hemodialysis machines, positioned to capture significant market share within the $5.3 billion acute and home dialysis markets. We look forward to helping increase awareness within the US investment community, as Spectral advances towards a number of key milestones.”

    About Spectral
    Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.

    PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 200,000 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.



    For further information, please contact:


    Dr. Paul Walker
    President and CEO
    Spectral Medical Inc.
    416-626-3233 ext. 2100
    pwalker@spectraldx.com
    Mr. Chris Seto
    COO and CFO
    Spectral Medical Inc.
    416-626-3233 ext. 2004
    cseto@spectraldx.com
    Mr. Ali Mahdavi
    Capital Markets & Investor Relations
    416-962-3300
    am@spinnakerc
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  22. #172  
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    I missed the 5.3 Billion dollar market in Home dialysis this AM when I posted this.
    Man O man that's a lot of cheese ...$$$



    Quote Originally Posted by Bozzie View Post
    This will be a boost for both retail and institutional investors in the US
    Good good.


    Spectral Medical Engages Crescendo Communications to Provide
    Investor Relations Services in the United States


    TORONTO, CANADA — March 4, 2021 – Spectral Medical Inc.(“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly owned subsidiary Dialco Medical Inc. (“Dialco”), announces that it has retained Crescendo Communications, LLC ("Crescendo") as its investor relations firm to help broaden awareness of the Company in the US financial markets.

    David Waldman, President and CEO of Crescendo, commented, “We are honored to work with Spectral and look forward to supporting them in their mission of combatting the devastating impacts of sepsis, a leading cause of death in ICUs across the US. Spectral’s Toraymyxin™ PMX endotoxin removal cartridge, combined with its EAA™ diagnostic, address a dramatically underserved $1.5 billion market opportunity with no competing FDA approved solutions. Additionally, we believe there is a significant market opportunity within the Dialco business, with two first-in-class hemodialysis machines, positioned to capture significant market share within the $5.3 billion acute and home dialysis markets. We look forward to helping increase awareness within the US investment community, as Spectral advances towards a number of key milestones.”

    About Spectral
    Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.

    PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 200,000 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.



    For further information, please contact:


    Dr. Paul Walker
    President and CEO
    Spectral Medical Inc.
    416-626-3233 ext. 2100
    pwalker@spectraldx.com
    Mr. Chris Seto
    COO and CFO
    Spectral Medical Inc.
    416-626-3233 ext. 2004
    cseto@spectraldx.com
    Mr. Ali Mahdavi
    Capital Markets & Investor Relations
    416-962-3300
    am@spinnakerc
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  23. #173  
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    This is one I'm hanging onto.
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  24. #174  
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    Quote Originally Posted by CoachCB View Post
    This is one I'm hanging onto.

    Looking good and the drop in price isn't a big deal.
    I'd bet on Canadian home approval soon, I'd doubt it moves the price much but will be viewed as one step closer to the US market home approval.
    Anyone wanting to make a move on these guys won't be happy as this steps up the approval ladder.
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