EDT.TO/ Spectral medical

[CoachCB]

I think more changes are coming that will be viewed as very positive at the top of the company.
I feel as good about this as I have in a long while...

Kellum is an absolute catch he'll open doors this company couldn't even knock on a few months ago.

Today .42 cents/ 10X is very doable here


Hang tight 69er and CB

I've got 14,000 shares counting on it!!

 

[Steiner69eR]

From Bullboards:

List of events and recent accomplishments

* Full FDA approval for wholly-owned EAA diagnostic

* FULL not "EUA" FDA PMX ( blood filtration device ) approval for CV19 in US

* FULL Canada Health PMX approval for CV19

* FULL FDA approval for SAMI device

* FDA approval for DIMI device ( home dialysis pending on FDA home study detail )

* 6.5 MILLION CAD from Baxter for selling partnership arrangement - no strings / no surrender of any company value.

* Pending FULL Canadian DIMI approval with detail to come imminently

* Data from 179 ( 194-16 CAD sites + 1 ) patients identified as usable data from phase 3 trial, to carry substantial weight in TIGRIS approval

* TIGRIS phase 3B/4 confirmatory trial that boasts a 2:1 in favor of our proposed PMX blood filtration device ( used safely and efficacously on over 200,000 patients in Japan and the EU ) * this was a 10 site trial expanded to 15 - Interim analysis H2 2021

* CV19 trial initially 2 sites expanded to 3 ( Conn , NY, Mass ) and expected to look at 75 patients - approaching one year mark - covid trial, expect covid didn't reduce recruitment

* Recent finance at 60 cents ( 11 new institutional players ) and 45 cent warrants to come due April/21 to add to adequate cash position

* Consolidation of 10 for 1 approved at last AGM ( by those able to vote )

* January 2021 hire of US investor relations firm - see next point!

* Awaiting 2020 financials to make the move to a "senior US listing"

* Options are due to be issued in days to weeks - new hire and BoD etc..

* NO other serious competition in our space. NOBODY has the FDA advancement of us when it comes to the treatment of an endotoxemic septic shock patient...."

 

[CoachCB]

From Bullboards:

List of events and recent accomplishments

* Full FDA approval for wholly-owned EAA diagnostic

* FULL not "EUA" FDA PMX ( blood filtration device ) approval for CV19 in US

* FULL Canada Health PMX approval for CV19

* FULL FDA approval for SAMI device

* FDA approval for DIMI device ( home dialysis pending on FDA home study detail )

* 6.5 MILLION CAD from Baxter for selling partnership arrangement - no strings / no surrender of any company value.

* Pending FULL Canadian DIMI approval with detail to come imminently

* Data from 179 ( 194-16 CAD sites + 1 ) patients identified as usable data from phase 3 trial, to carry substantial weight in TIGRIS approval

* TIGRIS phase 3B/4 confirmatory trial that boasts a 2:1 in favor of our proposed PMX blood filtration device ( used safely and efficacously on over 200,000 patients in Japan and the EU ) * this was a 10 site trial expanded to 15 - Interim analysis H2 2021

* CV19 trial initially 2 sites expanded to 3 ( Conn , NY, Mass ) and expected to look at 75 patients - approaching one year mark - covid trial, expect covid didn't reduce recruitment

* Recent finance at 60 cents ( 11 new institutional players ) and 45 cent warrants to come due April/21 to add to adequate cash position

* Consolidation of 10 for 1 approved at last AGM ( by those able to vote )

* January 2021 hire of US investor relations firm - see next point!

* Awaiting 2020 financials to make the move to a "senior US listing"

* Options are due to be issued in days to weeks - new hire and BoD etc..

* NO other serious competition in our space. NOBODY has the FDA advancement of us when it comes to the treatment of an endotoxemic septic shock patient...."

Is this good?

 

[Bozzie]

From Bullboards:

List of events and recent accomplishments

* Full FDA approval for wholly-owned EAA diagnostic

* FULL not "EUA" FDA PMX ( blood filtration device ) approval for CV19 in US

* FULL Canada Health PMX approval for CV19

* FULL FDA approval for SAMI device

* FDA approval for DIMI device ( home dialysis pending on FDA home study detail )

* 6.5 MILLION CAD from Baxter for selling partnership arrangement - no strings / no surrender of any company value.

* Pending FULL Canadian DIMI approval with detail to come imminently

* Data from 179 ( 194-16 CAD sites + 1 ) patients identified as usable data from phase 3 trial, to carry substantial weight in TIGRIS approval

* TIGRIS phase 3B/4 confirmatory trial that boasts a 2:1 in favor of our proposed PMX blood filtration device ( used safely and efficacously on over 200,000 patients in Japan and the EU ) * this was a 10 site trial expanded to 15 - Interim analysis H2 2021

* CV19 trial initially 2 sites expanded to 3 ( Conn , NY, Mass ) and expected to look at 75 patients - approaching one year mark - covid trial, expect covid didn't reduce recruitment

* Recent finance at 60 cents ( 11 new institutional players ) and 45 cent warrants to come due April/21 to add to adequate cash position

* Consolidation of 10 for 1 approved at last AGM ( by those able to vote )

* January 2021 hire of US investor relations firm - see next point!

* Awaiting 2020 financials to make the move to a "senior US listing"

* Options are due to be issued in days to weeks - new hire and BoD etc..

* NO other serious competition in our space. NOBODY has the FDA advancement of us when it comes to the treatment of an endotoxemic septic shock patient...."

NICE...I've been here for all of it on and off.
I'd hope they get jumped by someone big before a Up-list.. or do it after a major event and price spike.

The way this is structured you're somewhat protected by the institutional investors..Retail and institutional are 100% alined ..No A or B shares, they win, we win.

So many players are eyeing the HD market right now, all this needs is US approval on the Pump side to run.

Out for the day..Have a good one fellas.

 

[Bozzie]

Looks like a size buyer is eating shares..good to see.

 

[NorthernStar]

Looks like a size buyer is eating shares..good to see.

I thought you were going skiing

 

[Bozzie]

I thought you were going skiing

Monday we leave for Mt Bachelor...3.5 hour drive through some pretty great scenery.
Just hit balls for my GFs B day.

Actual Volume not including the US side

T:EDT - SPECTRAL MEDICAL INC - http://www.spectraldx.com

17:12:56 EST

Sym-X	Bid - Ask	Last	Chg	%Ch	Vol	$Vol	#Tr	Open-Hi-Lo	Year Hi-Lo	Last Tr	News	Delay
EDT - T ▲ATS	0.5	0.56	·	0.57	5.0	0.56	+0.04	7.7	294.2	162	136	0.54 0.56 0.51	0.81 0.345	15:44:56	Feb 01	15 min RT 2¢
TSX - T	0.5	0.56	·	0.57	5.0	0.56	+0.04	7.7	224.5	124	71	0.54 0.56 0.52	0.81 0.345	15:44:56		15 min
NEO ATS - U		0.55	+0.03	5.8	43.0	23	21	0.52 0.56 0.52		15:32:26		15 min
Omega - O		0.55	+0.03	5.8	9.0	5	6	0.52 0.55 0.52		13:29:03		15 min
Chi-X - X		0.56	+0.04	7.7	0.5	0	1	0.56 0.56 0.56		13:33:34		15 min
CX2 - H		0.55	+0.03	5.8	15.2	8	26	0.52 0.55 0.51		15:02:32		15 min
CXD - D		0.52			0.4	0	6			Dec 08 15:50:01		15 min
TriAct - M		0.52			1.6	1	5			Sep 11 14:53:46		15 min

Trade times are ET. News times are ET. Bid/ask/vol sizes in thousands. NOTE: Delayed ATS trade data is included - click System Status for more information

 

[Bozzie]

Yep nice little move CB

People are speculating this is being driven to the 60 cent range for a financing....Makes some sense actually as the last round was done at the .61 level, funding or splitting the pump off as another Co. is a real possibility IMO....
If it keeps moving Monday I'll be a buyer for a short hold of some amount till around the 60 cent area then sell the part I bought and continue the long hold on the remaining position.
60 cents would be around a 30% premium as it stands today...Worth watching next week.

Done for the day..enjoy your Sunday fellas[/QUOTE


I still think this is being driven to a sale of some sorta % at around 60 cents..Financing, basically toward the eventual sale or up listing.
It'll be driven to some price then executed would be my guess....
Who knows but it's the next logical step here and nothing is getting done at 48 cents.

Going fishing enjoy the day....

EDT.TO .62 today
Price pasted the 60 cent warrants and then some today .. Next warrant level 75 cents and another 30% if you're watching.

 

[CoachCB]

Wow. Nice run!!

 

[Bozzie]

Wow. Nice run!!

Lots of odd lots...I don't totally understand the trading the past two weeks...I still think this is being driven to a financing or an exercise of some sort with the outstanding warrants (Next warrants 75 cents with a half warrant at 45 cents for those who stepped up during the last financing)..but I've thought that for the past 3 months..I'm probably wrong but this feels a little more solid than past moves.

I'm long here . i'll see this out but if I was just trading this I'd set a stop loss 20%or 25% down the line ..unfortunately this has a history of sliding after moves and I'd like us all to make money but this is still a risky play ..Protect yourself here.

 

[CoachCB]

I'm not in EDT.TO, wish I had some of it.

 

[Bozzie]

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

 

[Bozzie]

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.

 

[CoachCB]

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.

 

[Bozzie]

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!

 

[Bozzie]

​ 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 [url]www.sedar.com[/URL]. The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement. ​

 

[Bozzie]

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.

 

[NorthernStar]

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?

 

[Bozzie]

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

 

[Bozzie]

[FONT=Arial, Helvetica, sans-serif]Quoting from another board.[/FONT]

[FONT=Arial, Helvetica, sans-serif]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$$$$$[/FONT]

[FONT=Arial, Helvetica, sans-serif]"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.[/FONT]

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

https://www.outsetmedical.com/wp-co...d_efficacy_of_the_Tablo_hemodialysis_syst.pdf