EDT.TO/ Spectral medical

[Bozzie]

LINK UP TO SEE THE PRESENTATION LAST WEEK


https://journey.ct.events/view/923496fb-7e39-42e0-af23-03681fb7eb61

 

[CoachCB]

This thing's killing me. I'm red now.

 

[Steiner69eR]

This thing's killing me. I'm red now.

Patience...I continue to get caught adding at 52W highs as well, which is frustrating, but sooner or later the top will blow off.
Bozzie is sitting on a monster amount, can’t complain, relatively speaking!

 

[Steiner69eR]

FYI, added a nibble for a few thousand before the bell.

 

[Steiner69eR]

Volume heating up today...surprising to see it come out of the TSX, for a change...

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

18:14:36 EST

Sym-X	Bid - Ask	Last	Chg	%Ch	Vol	$Vol	#Tr	Open-Hi-Lo	Year Hi-Lo	Last Tr	News	Delay
EDT - T ▲ATS	14.0	0.51	·	0.52	0.5	0.51	-0.01	-1.9	438.0	222	320	0.52 0.54 0.48	0.81 0.345	15:58:35	Mar 08	15 min RT 2¢
TSX - T	14.0	0.51	·	0.52	0.5	0.51	-0.01	-1.9	302.3	152	169	0.52 0.53 0.48	0.81 0.345	15:58:35		15 min
NEO ATS - U		0.51	-0.01	-1.9	59.0	30	35	0.51 0.53 0.49		15:58:35		15 min
Alpha - A		0.54	+0.02	3.8	10.0	5	1	0.54 0.54 0.54		10:13:49		15 min
Omega - O		0.51	-0.01	-1.9	14.0	7	10	0.51 0.53 0.49		15:58:35		15 min
Chi-X - X		0.50	-0.02	-3.8	2.5	1	4	0.525 0.525 0.50		14:30:10		15 min
CX2 - H		0.51	-0.01	-1.9	32.5	17	28	0.51 0.53 0.49		15:58:35		15 min
CXD - D		0.52			0.1		4			Dec 08		15 min
TriAct - M		0.52			17.6	9	69			Sep 11		15 min

 

[Bozzie]

Yeah it's a waiting game, not fun watching numbers $$$ being push around but there is a plan in place I believe will cash eventually.

 

[Bozzie]

Only guess here is these were about to expire /exercised while EDT was trading in the .50's. All the tickers today show EDT.TO traded at .60 today at some point?
Vote of confidence from the inside if nothing else.

I like it.


[FONT=&quot][h=2]You are here[/h]

[/FONT]
[FONT=&quot][h=1]Filing Details[/h][FONT=&quot][/FONT]

Issuer Name​

Spectral Medical Inc.

Insider Name​

Giese, Kevin Arnold

Relationship as filed with regulators​

4 - Director of Issuer

Transaction ID​

3704743

Filing Date​

Mar 13, 2021

Transaction Date​

Mar 12, 2021

Security Type​

Common Shares

Transaction Nature​

54 - Exercise of warrants

Ownership Type​

Direct Ownership

Registered Holder


# or Value Acquired or Disposed of​

200,000

Unit Price or Exercise Price​

$0.450

Closing Balance​

3,626,336

Conversion or Exercise Price​

0.000

Date of Expiry or Maturity


Underlying Security Designation​

[h=4]Equivalent # or Value of Underlying Securities[/h]

Acquired or Disposed of


Closing Balance


General Remarks​

[/FONT]

 

[Bozzie]

Nice move this AM..looks like new coverage with a 1.70 near term target..

I haven't seen the release yet.

Up almost 10% on the news

 

[CoachCB]

$1.70? I'll take that!!!

 

[Bozzie]

good good..Canadian regulatory process finally completed.

[h=2]Spectral Medical’s Wholly-Owned Subsidiary Dialco Medical Announces Receipt of Health Canada License for DIMI[/h] Immediately enables DIMI to be used within Canadian hospitals, clinics and in home TORONTO, March 31, 2021 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), today announced that its wholly-owned subsidiary, Dialco Medical Inc. (“Dialco”) has obtained its Health Canada license for the DIMI RRT system.As per the Health Canada license, DIMI is a prescription only medical device, indicated for hemodialysis (“HD”), hemodiafiltration (“HDF”) and ultrafiltration (“UF”) for patients weighing 20 kgs or more, and can be used in hospitals, clinics and at home (by a trained and qualified individual considered to be competent in the use of this device).“With DIMI licensed in Canada, Dialco can continue to move down its commercialization pathways,” said Dr. Gualtiero Guadagni, President of Dialco Medical. “DIMI’s versatility addresses many of the barriers to adoption for home hemodialysis, and positions DIMI as the ideal device for multiple segments of chronic dialysis patients across Canada. DIMI provides patients and their care partners with the option and flexibility to dialyze conveniently at home, while reducing lengthy and time exhaustive travel to in-centre hemodialysis. For nursing homes this provides the opportunity to care for their patients safely on site. Additionally, DIMI’s use of pre-packaged dialysate fluid bags addresses water quality issues as barriers to hemodialysis in rural and indigenous communities. Ultimately, we believe DIMI can assist healthcare networks across Canada to meet the needs of chronic dialysis patients while improving health outcomes and reducing costs.”Remaining Health Canada Approval:There remains one final Health Canada license for DIMI to unlock the full dialysis modality of the device. Management expects to make its submission to Health Canada for peritoneal dialysis (“PD”) in Q3 2021. Currently, there are no competing chronic dialysis devices with multiple modality. DIMI is the only device capable of performing both HD and PD, which helps late-stage PD patients transition to HD seamlessly.DIMI Value Proposition: Addressing Barriers to Adoption for Home HDThe DIMI renal replacement system is 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. The DIMI system comes fully assembled and uses pre-packaged dialysis fluid bags providing greater portability and versatility. Table 1: DIMI vs. Competitors​ Device Characteristics DIMI Competitors (w/Reverse Osmosis (“RO”) Portability [*=left]High [*=left]Low (RO component adds significant size and weight) Multiple Modality [*=left]Only device capable of performing HD/HDF and PD [*=left]HD only Versatility [*=left]Pre-packaged dialysate fluid bags make DIMI suitable for any geographic region [*=left]Open platform compatible with any dialyzer [*=left]Need for expensive additional water treatment system in geographical areas where water quality is poor [*=left]Closed platform Usability & Training [*=left]Easy to use – no requirement for patient to undertake maintenance [*=left]Peace of mind knowing dialysate is pre-mixed to a specific prescription [*=left]Patients/care givers and providers are required to follow a complex maintenance and verification schedule on a daily and monthly basis. Home renovation required [*=left]No [*=left]Electric and Plumbing Chris Seto, COO and CFO of Spectral, commented, “The Health Canada license for the DIMI RRT system is an important milestone in creating value for our shareholders. We believe DIMI is a disruptive technology that is at the forefront of addressing the most significant barriers to adoption for HHD, and DIMI’s best-in-class differentiating characteristics should be an advantage in penetrating both the Canadian and U.S. markets. We look forward to providing meaningful updates as commercial developments unfold.”Dialco recently received its Medical Device Single Audit Program (“MDSAP”) certification, which is the highest quality and regulatory standard in the medical device industry.About SpectralSpectral 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 300,000 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 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 Walker President and CEO Spectral Medical Inc. 416-626-3233 ext. 2100 pwalker@spectraldx.com Mr. Chris Seto COO & CFO Spectral Medical Inc. 416-626-3233 ext. 2004 cseto@spectraldx.com Mr. Ali Mahdavi Capital Markets & Investor Relations 416-962-3300 am@spinnakercmi.com ​ ​

 

[CoachCB]

$$$$$$$$$$$

 

[Bozzie]

$$$$$$$$$$$

Part of the process in building this up for a sale..I'm ready whenever the company is.

IDK what sorta effect todays news will have on the price..I feel like todays news has been built in/ expected..Even overdue..Hopefully I'm wrong.

Hope you're well pal and that much closer to Florida

 

[CoachCB]

They still have one more hurdle/approval - right? If they sell, I imagine this will more than double from where it is today. That would be nice! I know it would be REALLY nice for you!

I saw you were up in the 0500 hour west coast time! I was sound asleep! Going well here, hoping for Florida by June. Wife and I are going down next weekend for our anniversary (staying in Cape Coral/Ft. Myers at the Westin) for 3 nights. Cherry Blossoms are in full bloom here in DC.

 

[Bozzie]

US approval for the pump then the filter approval but that looks like the timing is getting beat up by covid complications/ delays
One thing I'd say about the filter is it's been proven and there is a lot of evidence supporting use..Baxter is partnered.. somehow I think the trial gets cut short in the end. The medical need is massive.
I look at the pump as the driver..And I still say Baxter needs both the filter and pump.

This is building slowly.. but the steps have been big this year so far.

Nice CB ...a run around the mall, tidal basin and Jefferson memorial. Great run we miss parts of DC life.
The Best time of year in the mid Atlantic ..falls not bad either.

Enjoy Florida !!!!!!

 

[CoachCB]

The Cherry Blossom 10 Miler is a fun race. When I was in racing shape, I ran it in just over 62 minutes twice. My best 10 mile time though was at the Army 10 miler, in the fall. The cherry blossom race is cool, because it runs through the mall area, tidal basin, and Hains Pointe.

 

[CoachCB]

What's up w/ this today? It seems like it's not trading?

 

[Bozzie]

Paradigm put out an update on Monday. It's attached. Nothing exciting in it but they do still talk about Spectral thinking about selling off a small percentage of Dialco. I'm not sure how I feel about this delay (C19) or parsing out a part of the company although an investment in part by someone big might mean shareholder value depending on the player and deal.

On my the drive I can't see any info on downloads. Just a heads up if you follow.

https://drive.google.com/file/d/1zfUwruSd877OEi9tKheps_In_PWmAoHS/view?usp=sharing

 

[CoachCB]

This thing doesn't make sense! I added a little more today, but I'm at about even now (actually down about 1%).

 

[Steiner69eR]

This thing doesn't make sense! I added a little more today, but I'm at about even now (actually down about 1%).

I wouldn’t stress. Very thinly traded.

In fact, I am temporarily out of this, so the movement was mostly me.

Really hoping I don’t get caught with my pants down in the interim (as I do really believe in it) but trimmed 50k of my 75K shares yesterday to play the risk/reward on Amigo Holdings out of the UK. Hopeful proceeds will be rolled back into Spectral, but I don’t think any major moves coming here over the next month.

 

[Steiner69eR]

https://stockhouse.com/news/press-r...announces-20-year-exclusive-license-agreement

Gulp....I just can't catch a break....let's see how the market reacts...knowing Spectral, it may trade down