Spectral Medical Inc (PK) (EDTXF) 銘柄情報

If "winner" is the firm that people are pushed towards so that the significantly superior scientific story can continue to make FDA advancements and allow insiders to maintain their positions without sharing then....surely CTSO is the big champ. I was just curious on what scientific proof or efficacy were we crowning them kings? Seems to me that Fresenius dumped them at the alter in Europe and their only sepsis RCT in Germany was a complete mess. Please provide detail if I'm incorrect. Please pay attention to the confirmatory phase 3B TIGRIS trial that EDTXF is currently running now with the FDA. For a strange and unknown reason the Canadian firm chooses not to share any FDA advances with the US audience. They appear to like the quiet accumulation by those part of the story. I only own a few, been thinking of adding many more. Thanks for checking in, I enjoy watching the bull show youre running on the CTSO site. It's one of the best of it's kind on the circuit. hehe

Ctso is the clear winner

I love modest Canadian companies!

This is humorous content. It serves as a reminder of how companies like CTSO will launch themselves on the heavy lifting done by Spectral Medical and their current FDA phase 3B PMX or Toraymyxin filter trial for endotoxemic septic shock. Spectral brings a theranostic approach to their phase 3B trial called TIGRIS. The 150 potential person trial is Open Label and is also using data from 194 patients of it's completed FDA phase 3 Euphrates trial. The current phase 3B confirmatory trial is giving 2 of every 3 patients the proposed PMX filter and is guided by Spectral's already approved EAA diagnostic. The most recent addition to the theranostic trio is the FDA approved SAMI, a stand-alone hemo-perfusion unit that delivers the PMX filter after the EAA diagnostic determines which patient is best suited for the therapy. It's quite slick and so is the effort to keep it completely under the radar...see US PINKS with NO news flow from Canada. What, you think Canadians don't know how to move a stock from 5 cetns to 20 and then consolidate it so institutions can buy it? What a brilliant idea, if you want peoples buying your paper. If you're in a state that allows it...crumble some up in your pipe and think about it.

Worth a look..but I still think the Sorb XL has to be better. I think the XL will be good, as they came up with the idea for it right after EDTXF finished their FDA phase 3 trial. Somebody watching closely must think getting rid of the endotoxin is a good idea? Maybe, I hear endotoxin is the primary cause of IL-6 and what-have-you. Can't wait for those billions of beads to start gobbling up those nasty endotoxins!! The storm, yeah the cytokine storm!!

Mucho monkee business here. Very tightly held and multiple FDA approvals including a partnership with Baxter Medical. US suppression in full throttle mode. It is an interesting little science project. These Canadians are stealthy astards.

Well I bought 20k shares at 0.50 this week knowing well a 1/20 RS is coming down the road along with the offering they withdrew due to COVD 19 market conditions, I am a CTSO bear and can’t stand those losers on that board, At least we have an active P3 trial as theirs is suspended and will never resume, I don’t think the results from the tigress trial will be overwhelming, But I think they will get approval in these new world COVD 19 world, It’s just a 10k gamble as I am having a good year so far so I figured I would take a shot since Baxter paid them 5 million upfront!

TORONTO, April 02, 2020 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, is pleased to provide an update on the commercialization activities at Dialco Medical Inc. (“Dialco”), a wholly-owned subsidiary of Spectral, with respect to its SAMI device for CRRT.

The commercialization of SAMI, an innovative and easy-to-use CRRT (continuous renal replacement therapy) device, is progressing as planned. The Company has added two new hospitals as SAMI customers, which are located in the mid-west United States and greater Toronto area. Dialco remains actively engaged in the path toward 510k clearance by the Food and Drug Administration (“FDA”) for its DIMI home hemodialysis device.

“We believe that the onboarding of these two new customers validates the value proposition of our SAMI device in the CRRT marketplace. SAMI is a cost effective, easy-to-train and easy-to-use device, which is being embraced by our growing base of customers and getting a lot of attention,” said Dr. Gualtiero Guadagni, President at Dialco. “We are fully committed to supporting these early adopters that have tested our SAMI system and have now decided to migrate it into their clinical practice. Despite the COVID-19 environment, our team continues to focus on the deployment of SAMI through the adoption and development of virtual technologies to support the remote installation, training, and clinical usage of our products with healthcare customers.”

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 has been 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. (“Dialco”), is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use.

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:

Dr. Paul WalkerPresident and CEOSpectral Medical Inc.416-626-3233 ext. 2100pwalker@spectraldx.com Mr. Chris SetoCFOSpectral Medical Inc.416-626-3233 ext. 2004cseto@spectraldx.com Ali MahdaviCapital Markets &Investor Relations416-962-3300am@spinnakercmi.com
Source: Spectral Medical Inc.

Lets go

Where state of the art thou?

EDTXF has FDA Compassionate Care approval - see Euphoria on Trials.gov. Note that 12 days ago the site was refreshed. EDTXF has the PROVEN clinical ability to do the following:

- Reduce critically ill patients time on a ventilator
- decrease 28 day mortality
- remove endotoxin from the bloodstream - source of cytokines
- improve blood pressure
- preserve organ function

Also of note, EDTXF have two portable devices one is already FDA approved and the other in final days. Their SAMI FDA unit may serve as a valuable tool to provide dialysis and run the Toraymyxin filter in MASH type hospital units.

I'm looking for EDTXF and their partner Baxter to offer some kind of help in this critical time.

Bless you all!

Wow

Response to CTSO poster

It's Toray of Japan that will be devastated Professor. The brilliant Sorb XL product will be Spectral's best friend. You see Toray manufactures the PMX column and has only given the rights to Spectral in exchange for the FDA stamp of approval. Spectral is in prime position to pounce and make a whack of bread off the sure to be blockbuster Sorb XL. Spectral already has the EAA, an FDA approved diagnostic to measure endotoxin and the state of the art and FDA approved CRRT machine to deliver the magical beads at bed side. Spectral's ingenuity will allow the XL filter to dominate the globe and instantly give it "theranostic" powers that will catapult the XL to the top of the sales charts. As you can see, I'm wildly excited about the Sorb XL and am anxiously awaiting it's first human usage so that Spectral can partner up with CTSO and make Endotoxemic Septic Shock a thing of the past. I just feel sorry for Toray and their 50,000 employees, sure they will continue on, but PMX might be absorbed by the spongy success of the Sorb XL. Fortunately Toray owns about 46 MILLION shares of Spectral, so they will at least benefit from the sales of the EAA and the CRRT machine that will help make the Sorb XL great and EDTXF shareholders a heck of a whack of money! Great post Professor, I like your advanced thinking! Remember too that there is talk of the Hemodefend being FDA'd in like 20 patients, wouldn't surprise me of the Sorb XL only required a similar amount! Dare to dream, look what jack grew from his magical beads!

Nice to see EDTXF is attending the JP Morgan show is January. This is by INVITE only. What up with this underachiever??

Poster Paulness part of CTSO pump group. I think EDTXF will achieve a FDA approval years before CTSO. I liked CTSO, but have noticed a complete unwillingness for them to even discuss Spectral on their IHIUB page. Something strange is afoot here. I'm starting a position on EDTXF. You need to go to the EDT forum up in Canada to get info and news on this company. Try Spectrals website to start.

Poster Paulness part of CTSO pump group. I think EDTXF will achieve a FDA approval years before CTSO. I liked CTSO, but have noticed a complete unwillingness for them to even discuss Spectral on their IHIUB page. Something strange is afoot here. I'm starting a position on EDTXF. You need to go to the EDT forum up in Canada to get info and news on this company. Try Spectrals website to start.

Is there any reason to believe this blood filter treatment will rebound back to close to where it was a few years back? I am a CTSO owner and soon to be AEMD. I could get about 6000 of these shares compared to 1500 AEMD. Can someone advise which would be the better gamble on a $1500 plunge?

I am surprised it is still trading at such a high level, should be under 10 cents by now.

Still got this and still don't know why...but it's going up so...who cares...lol

Analyst report from 2014...a good read indeed

Cormack report dated Nov 6 2014

Very bullish

http://dashboard.cormark.com/servlet/display.pdf?repid=ddean%40cormark%2Ecom_20141106023807257&userid=ddean%40cormark%2Ecom

Rock bottom?? Insiders pick up 30 thousand shares this week
Is this minor buy enough to garner some attention...don't think so as the EDTXF site is still heavily shorted on tiny volume...NO hope, unless of course the shorting is intentional and why on earth would that be????? game set and match for CTSO imo Boris

Has this stock ceased trading here in the US?
It has not traded for many days!! Is their filing up to date? Something appears a little stinky here...I would NOT want to be holding large chunks of this given the liquidity scene...if you get my drift. BB

NP Biotech#guy, all good here carry on
Please take notice of more advancement for CTSO this morning. They produce a lot of news! Also note it looks like Spectral is bailing on their promise of NO MORE money needed until FDA answer. In their latest update they now say "should not" when it comes to a money raise. With 210 million shares already in circulation, this group can NOT afford another dilutive round of financing...it will look desperate and perhaps their final swan song! CTSO has a tiny number of shares and a magic marketing team. Good old American know how is tough to beat!

You are correct on that I'm not sure why I said venture as I own almost 200k shares on the tsx. My mistake though on that however, every single piece of information I have given is factual. You can argue about the 150-170k treatments but all the information I gave in regards to the trial and subgroups along with personalized medicine where the FDA is headed, all completely factual.

You seem confused Biotech#guy
You have claimed that EDTXF trades in Canada on the Venture exchange. The Venture exchange in is British Columbia ( a province in the west ) Spectral as EDT trades on Canada's largest platform the TSX in Toronto. Your info is hit and miss pal. We do appreciate your enthusiasm though, do keep it up, don't let me deter you..just try to stay factual. Thanks in advance...Boris

You're looking at old information, you guys are seriously hopeless, it's unbelievable. And about the 5%, see if you're actually capable of reading through the first post I made about the STATISTICAL AND CLINICAL EFFICACY achieved in those subgroups, it's far better than 5%, also look at the underpowered part of the post and how I said it shows personalized medicine is needed. You know the part where I mentioned the 21st century cures act? You're hopeless, I don't have a need to sell anything, I was simply informing people but you're all too ignorant to open your eyes so I won't waste my time.

170,000 uses , you sure?? they state 150,000
Caught you red-handed here pal, you've topped up your story without factual backing...error on your part...you've lost credibility on ALL the other info you've provided. Sorry Charlie!

looks like a salesman has arrived on the EDTXF message board
Did you see the results of the trial from early November?
THe trial was a flop with a 5% benefit against an advertised 20% hope. Unless of course they chose to lay down in the first round, this stock is all but deed! Check out CTSO, it is the real deal with growing revenues and almost 30,000 way more recent users. I smell a desperate Canadian looking to sell to a misinformed US audience. Ya, there is a stink here for certain. Recall that CTSO has a next gen endotoxin filter of their own and it is not 25 year old technology....geesh, get informed bud!

I'll post this here as well for all the misinformed CTSO investors on their board. They deleted the post, no reply no nothing? Hmm, I wonder why?

Oh where do I start here...

First off, I do like Cytosorbs technology and do believe it will be instrumental in the fight against sepsis and other disorders. You all are very misinformed as to what Spectral has on the table as are many investors hence their share price at the moment. This is 100% managements fault but I don't believe they are concerned as they are aware of what they have and that there are big name pharma companies looking at purchasing as they have 22 employees where as large pharma companies have large inside sales forces inside hospitals already to effectively market their product; the exact thing spectral needs. This is also the reason PMX hasn't been used in Canada, they have a spineless government which relies on US FDA approval as a baseline for its drugs and medical devices. Without US FDA approval the Canadian health care system being paid for by the government will not cover such a treatment.

To start, when you compare CTSO to spectral you're comparing a company with one very small Trial to another company who is 5 years ahead which has completed a very large, double blinded FDA PMA study. Spectral looked great at the stage CTSO is at currently and there was evidence of extreme efficacy with little to no known adverse safety effects.

This study (Euphrates) was underpowered from the start, it is believed that the study was largely done this way to see where EXACTLY PMX was effective because like any drug or device treatment there are cases where people are simply too far gone to respond to treatment. Why do I say this? Simple, look at the 21st century cures act that was brought in which mandates the FDA to look differently at devices or drugs in which no treatment exists or there is an extreme need for where we all know Sepsis falls in that category. It also mandates them to take a different approach when looking at data including looking at real world data in other studies as well as subgroup analysis which if you look into the details on Spectral's trial they achieved extreme efficacy in the subgroups where EAA was above 0.6 and below 0.9. Furthermore for the group which was above 0.9 the endotoxin levels were above 50 iu and the absorption capacity of each cartridge of PMX was 12.5 iu meaning that in the most sick patients we only removed less than 50% of their endotoxin which indicates the study was underpowered as spectral did achieve up to a 42% risk reduction at 28 days (21% mortality versus 42% mortality) in a subgroup where arterial pressure was maintained in both arms and where there was no culterable bacteria present (antibiotics not gonna help you there). One needs to ask, if the trial allowed for 3 or 4 columns to be used on these sicker patients, could we have had the same results as the subgroup?? This is exactly the type of data the FDA is going to start looking at. Precision medicine is the future and the 21st century cures act clearly outlines it's happening now.

In respect to the SAM pump, spectral does not need this for the PMX treatment, a dialysis pump works fine but they have refined the average dialysis pump making it more economical, more effective, less bulky and easier to use.

As far as Spectral's EAA diagnostic which is approved in Canada and the US, this is the holy grail and it will be used in many different cases other than sepsis. The market for this diagnostic alone is huge! Imagine being a doctor with an approved treatment available and you now have the data to show you when exactly it is effective and also the instrument/test to show you where exactly you are in that spectrum and if it's working.

Also to note is the fact that there is a Taiwanese study going on right now starting treatment sooner with EAA levels at 0.5 vs 0.6. This doesn't seem like much of a difference but when you look at it in detail, you are 3 times as likely to die with EAA levels of 0.6 than 0.5.

Someone on this board said that PMX cannot treat patients who actually have sepsis. I'm sorry but you are sadly mistaken. With the Euphrates trial look at what MODS 9 means. (Multiple organ disfunction score) multiple organs were required to be not operating as they should or failing to receive treatment, this includes the subgroup where there was success listed above. These organs were failing as a direct result of sepsis and these patients were going into septic shock (multiple organs failing, health drastically deteriorating).

Finally, the Euphrates Trial was done at some of the top hospitals in the US where the SOC (standard of care) is above average compared to your national average across the USA. This also impacted Spectral's absolute reduction and primary end point in the Euphrates Trial with a baseline mortality rate of 42%. They also were using the sham cartridge PLUS EAA which is not the current standard of care. One must ask, without EAA being used and in an average hospital would that baseline mortality be much higher than 42% as it has been in previous studies. Food for thought.

Toray and Birch hill own over 70 million shares and have not sold anything. Now approval isn't a certainty but with the EAA, Sam Pump, 21st century cures act, the fact there is no cure and the closest one is 5 years away, also the "smart money" not going anywhere. You have to ask yourself the following question:

If you were the FDA and you have hundreds of thousands dying each year from a disease which there is no cure or viable approved treatment for do you wait 5 years and let countless more die or do you approve or at the very least conditionally approve a treatment which is approved in many countries around the globe, has been used over 170,000 times effectively and also has minimal adverse safety effects through the countless number of trials conducted?

I'm very confident it will go the right direction but that's just my opinion.

FDA approval or not, CTSO will rule Sepsis Mountain

I don't care which company is mentioned, PERIOD. I'm here to mind my dollars. The lack of discussion around our competition is troubling as far as I am concerned. Know your competition and know that Chan has us covered. We are double their valuation and do more than triple their sales. The key though is Chan's brilliant positioning...allow me to explain. Spectral is focussed on the endotoxemic crowd and if that's a BIG if, they obtain FDA approval, we will trump their ace immediately with our superior next generation filter. It's almost an unfair fight here, good old American know how versus ancient Canadian technology. Let the little bunch of Canadians have their couple days of glory, Chan will squash any advancement with our astonishing next generation cytosorb filter. Game, set and match Spectral, Dr. Chan is our most powerful leader and king of Sepsis Mountain!

well! you are not the ONLY ONE.NOT TODAY: MAJOR REVERSAL= 50% + . MARK MY WORD!

Discussion around CE mark at CTSO
I would assume that Spectral has the CE mark. Are they approved in as many countries as CTSO? CTSO people keep talking about approval in the tiny Canadian market, is EDTXF approved in the very country they call home? Based on their sales I am going to say no, for their sake let us hope the answer is no!

Hardly trades on otc

Is this story over? Was there ever a story at all? So you own some and don't know why? You must be either very sloppy or a very new investment player? Does anyone know anything about this company beyond the confusing news releases? Will CTSO eat their lunch once the next generation cytosorbent filter is released? You have to wonder if the modern bead technology finally surpassed the old and questionable polymyxin B approach? So many questions and only a contributor that doesn't know why he bought. This message board needs a spark, who might step up for a swing at the short porch in right? BB

I got some of this on the TSE...don't know why tho...

What do you think of ...

OTCQX Delisted Today PR


http://www.spectraldx.com/assets/spectral-rls-12.14.16.pdf

News is OUT today .

Why Am I The Only One Person In This Board ?

Death Cross pps !!!

**** NEWS IS OUT LAST FRIDAY NOV. 11TH ****

*** KEEP OUT ***

BROKEN ROCKET SHIP

Garbage ! RS , BK and delist soon !

BIG NO !

Big Yes !

Idk EDTXF may have hit bottom

Massive sell off yesterday on the phase 3 results. Look for a healthy bounce down the road when company breaks down their results and provides the path forward.

Canadian Network for Environmental Scanning in Health

I had a chance to do a little homework the other night to quantify the last news release about Spectral Medical Inc. and that the Canadian Network for Environmental Scanning in Health (CNESH) had named Toraymyxin for Sepsis ( Spectral ) on the Top 10 New & Emerging Health Technology Watch List: 2015 for it's importance and impact on health care.

It turns out CNESH is the real deal. If you do some of your own reading you'll descover it has a wide and deep depth of industy professionals, Doctors, specialists from all areas. Basically a medical think tank to keep the medical "industry" advised of whats coming.

To quote from their web site :

Why a Top 10 Technology Watch List?

Health innovation is recognized as important for the long-term sustainability of our publicly funded health care system. CNESH aims to inform health-related decision-makers and support health system quality by identifying technologies that may have a significant improvement on patient outcomes, quality of life, health care costs, or efficiency in health practices.

They go on to list beyond the top ten .... but the top ten get special mention as the most important.

Long story short ....... this "news" looks really really really good on Spectral Medical Inc and Toraymyxin's future in contributing to helping save lives against Sepsis.

Dig deep into their website and find out more ..... pretty exciting stuff.

https://www.cadth.ca/toraymyxin-sepsis

https://www.cadth.ca/

DIAGF changed to EDTXF:

http://otce.finra.org/DailyList

Spectral Diagnostics Inc. changed to Spectral Med Inc.:

http://otce.finra.org/DailyList

Cormack report dated Nov 6 2014

Very bullish

http://dashboard.cormark.com/servlet/display.pdf?repid=ddean%40cormark%2Ecom_20141106023807257&userid=ddean%40cormark%2Ecom

Cytosorbents stock symbol CTSO is the competition selling product in the European union very effective cytokine filter ,Doctors love it, reordering more filters great quarter over quarter sales, on the big boards in 60 days .

Spectral Diagnostics, Inc. Joins OTCQX

NEW YORK, Jan. 11, 2012 /PRNewswire/ -- OTC Markets Group Inc. (OTCQX: OTCM), the financial information and technology services company that provides the world's largest electronic marketplace for broker-dealers to trade unlisted stocks, announced that Spectral Diagnostics, Inc. (OTCQX: DIAGF; TSX: SDI), a Phase III company seeking U.S. FDA approval of its product for treating severe sepsis and septic shock, is now trading on the highest tier of the OTC market, OTCQX®.

Spectral Diagnostics began trading today on the OTC market's prestigious tier, OTCQX International. Investors can find current financial disclosures and Real-Time Level 2 quotes for the Company on www.otcmarkets.com.

"The OTCQX platform offers investor-focused companies a winning combination of quality control, transparency, and broader visibility to U.S. investors," said R. Cromwell Coulson, President and Chief Executive Officer of OTC Markets Group. "We are pleased to welcome Spectral Diagnostics to OTCQX."

Brean Murray, Carret & Co. will serve as Spectral Diagnostic's Principal American Liaison ("PAL") on OTCQX, responsible for providing guidance on OTCQX requirements.

http://ih.advfn.com/p.php?pid=nmona&article=50702028&symbol=DIAGF