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Spectral Medical’s Dialco Medical Announces 20 Year Exclusive License Agreement for DIMI Hemodialysis System in the United States and Canada

TORONTO, CANADA — April 8, 2021 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), today announced that its wholly-owned subsidiary, Dialco Medical Inc. (“Dialco”) has entered into an expanded, long-term licensing agreement with Infomed SA (“Infomed”) for the DIMI hemodialysis system, extending Dialco’s exclusive rights in the United States and Canada through 2041. The initial term of the agreement shall extend to December 31, 2026 (“Initial Term”), and the agreement will automatically extend for three additional five-year periods (“Renewal Terms”).

DIMI is indicated to treat patients primarily with chronic renal failure with or without fluid overload using hemodialysis (“HD”), hemodiafiltration (“HDF”), hemofiltration (“HF”) and/or ultrafiltration (“UF”). Dialco recently received 510(k) clearance by the United States Food & Drug Administration (“FDA”) for DIMI for use within a wide variety of settings including hospitals, clinics, and skilled nursing facilities.

“Finalizing the long-term licensing agreement with Infomed is an important milestone for Dialco as we continue to move forward with our regulatory and commercialization paths for DIMI,” said Dr. Gualtiero Guadagni, President of Dialco Medical Inc. “We are pleased with our recent DIMI FDA clearance for use in hospital and clinical settings, as well as receipt of our DIMI Health Canada license for use in Canadian hospitals, clinics and in home. We do have a few more regulatory milestones to achieve over the next year to unlock the full commercial capabilities of DIMI, which includes expanding DIMI’s claim to in home use in the U.S. and peritoneal dialysis (“PD”) use in the U.S. and Canada. From a commercialization perspective, we believe DIMI’s key features are best-in-class and remove all significant barriers to in home use adoption, and is positioned as the ideal device to deliver chronic dialysis treatments to patients in skilled nursing facilities.”

DIMI Value Proposition: Addressing Barriers to Adoption for Home HD

The 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. DIMI does not require any plumbing or electrical infrastructure changes or monthly maintenance that other products on the market demand. Dialco recently received its Medical Device Single Audit Program (“MDSAP”) certification, which is the highest quality and regulatory standard in the medical device industry.

Remaining Regulatory Pathway:

Dialco recently received authorization of its Investigational Device Exemption (“IDE”) protocol to conduct a 35-patient usability trial to demonstrate the safety and efficacy of DIMI for performing hemodialysis in the home environment. Management believes it has both designed its usability trial and identified the external resources required to ensure a successful trial outcome. These external resources include engaging a CRO to manage the trial and onboarding trial sites that can enroll suitable patients on an expeditious basis.

In addition to the usability trial, the other key regulatory activities and milestones are below:

FDA Approvals:

  • PD FDA 510(k) submission expected in Q3 2021. This enables patients to use DIMI for automated PD treatments at home, especially for those who are transitioning from PD to home HD;
  • Special FDA 510(k) application for remote monitoring software submission expected in Q3 2021. This unlocks the full remote monitoring software suite, allowing physicians to remotely check-in and adjust a patient’s treatment regime;
  • Special FDA 510(k) application for home HD submission expected in Q3 2022. This is the final step approval to allow for in-home use of DIMI.

Health Canada Approvals:

  • In March 2021, Dialco obtained its DIMI Health Canada license for use in Canadian hospitals, clinics and in home. There remains one final Health Canada license for DIMI to unlock the full dialysis modality of the device.
  • Health Canada PD use submission expected in Q3 2021.


Table 1: DIMI vs. Competitors
Device CharacteristicsDIMICompetitors
(w/Reverse Osmosis (“RO”)
Portability
  • High

  • Low (RO component adds significant size and weight)
Multiple Modality
  • Only device capable of performing HD/HDF and PD

  • HD only
Versatility
  • Pre-packaged dialysate fluid bags make DIMI suitable for any geographic region
  • Open platform compatible with any dialyzer

  • Need for expensive additional water treatment system in geographical areas where water quality is poor
  • Closed platform
Usability & Training
  • Easy to use – no requirement for patient to undertake maintenance
  • Peace of mind knowing dialysate is pre-mixed to a specific prescription

  • Patient/caregivers and providers are required to follow a complex maintenance and verification schedule on a daily and monthly basis
Home renovation required
  • No

  • Electric and Plumbing


Chris Seto, Chief Executive Officer of Spectral, commented, “Extending our license agreement with Infomed out to 2041 is an important milestone and will help create and maximize 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 what we see as an approximately $5 billion+ annual addressable market. Additionally, we are excited to embark on our DIMI usability trial. We believe this represents an incredible commercial opportunity to demonstrate positive real world experience and the versatility of DIMI amongst our clinical trial partners, who are also our potential customers. We remain committed to realizing the full commercial potential of DIMI and look forward to providing meaningful updates as developments unfold.”

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 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 set of proprietary platforms addressing renal replacement therapy (“RRT”) across the dialysis spectrum. “SAMI” is targeting the acute RRT market, while “DIMI” is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of “DIMI”, which is based on the same RRT platform as “SAMI”, but will be intended for home hemodialysis use. “DIMI” recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.

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:
Mr. Chris Seto
CEO
Spectral Medical Inc.
416-626-3233 ext. 2004
cseto@spectraldx.com
Mr. Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com

David Waldman/Natalya Rudman
US Investor Relations
Crescendo Communications, LLC
212-671-1020
edt@crescendo-ir.com

 

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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


It might trade down ..I like the pump comparison chart, it's about time they start taking the pump up.
I'm guessing someone steps up for a small percentage of the pump 5 to 7 %..the potential was mentioned in the latest google doc posted here.
If the right player steps in we'll see value but I have no clue on the timeline.
 

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Chart looks good to me, i own some and looking to add over 46 hopefully next week
 

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I had a very informative call last week about the company.
I think this fall they make a move to a US market.. witch lead to a conversation about the competitors pumps that are publicly traded.
Outset who went public last year and is valued at 2.3 by the market the stock was underwritten at 27 bucks and It opened at 52 on the first day of trading was the main subject.
I didn't know lot about Outset except it was valley money( Venture capital guys) who saw the opening in the pump market and jumped in and got Outset approved quickly..Very quickly witch I could never understood till this weekend. Apparently the Outset pump is a rehash of another older pump with an added water purifying system and a few other features that were needed to legally make it a new product. This guy I spoke to said he doubts any major will buy them and even questions weather the company will make it at all in the end...I noticed on the 9th Outset added a secondary offering.

Here's the part that's telling..Davita who has +2500 location serving dialysis sessions for those in need did the Human Fault Testing on the Outset pump...Side note DaVita buys their in clinic machines from their biggest competitor Fersenius who owns the nextstage pump. DaVita ran the HF test for outset successfully then got and option to run the Outset machines in clinic at a deep discount instead of buying pump from Fersenius...they passed and will continue to buy their major competitors pump. Says a lot about the Outset machine.

Sounds like DaVita will be running the spectral HF tests coming upon here .. DaVita needs a pump but for now it'll continue supporting it biggest competitor fersenius and the Nextstage platform

Pretty juicy. The Uplist may be a good time to sell my original investment..then let the rest ride .
As far as Outset goes I don't see why it wouldn't be a good short at 54 dollars, new equity offering at 53.50 ..worth watching just for fun.

https://finance.yahoo.com/quote/OM?p=OM&.tsrc=fin-srch

Outset Pump 70,000 = 20,000 building a room with 240 and an expensive water system.. the machine pays for itself in 7.2 years
Spectral's machine (Demi) 20,000 no special hook up..plug and play 1.5 years to pay off


Insurance companies will love Demi.
 

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[FONT=&quot]Another point that was mentioned was Outset has 1100 sales reps working just the outset machine and it's expendables witch is a recipe for failure ..Only in a great instance can a company in the medical device field do everything from sell through to manufacturing..It's a game for the huge companies with multiple products and distributors

Checking out the Yahoo Outset board this AM for kicks



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[FONT=&quot]GVG745 days ago
300+ dialysis machines sold in 10 years and a >$2B market cap. What is wrong with this picture?




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Canadian Insider should list those who exercised in the next day or two.
Good, good confidence from within the company.

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Spectral Medical Announces Exercise of Warrants for Gross Proceeds of Approximately $3.0 Million
TORONTO, CANADA - April 15, 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”), today announced that over the course of the last month the Company has received approximately $3.0 million in gross proceeds from the exercise of 6,669,830 share purchase warrants, which entitled the warrant holders the right to purchase common shares of Spectral at an exercise price of $0.45 until April 20, 2021.

As a reminder, the Company issued these share purchase warrants in connection with its financing that closed on April 23, 2018, with each warrant entitling the holder the right to purchase one common share of the Company at an exercise price of $0.45 per share for a three-year period ending April 20, 2021 (the “April 2018 Warrants”). The Company also issued certain other share purchase warrants in connection with its financing that closed June 18, 2020, with each such warrant entitling the holder the right to purchase one common share of the Company at an exercise price of $0.75 per share for a two-year period ending June 18, 2022 (the “June 2020 Warrants”).

A total of 802,501 April 2018 Warrants remain outstanding and a total of 4,760,000 June 2020 Warrants remain outstanding.

As a result of the recent exercises of warrants, the Company has 243,425,575 total shares outstanding as at April 14, 2021.

“The warrant exercises strengthen our balance sheet and show a vote of confidence in Spectral’s business model and our future growth prospects,” said Chris Seto, CEO of Spectral. “We are thankful to our investors and welcome this exercise of warrants which provides us with additional capital to continue to pursue our business plan.”

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 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 set of proprietary platforms addressing renal replacement therapy (“RRT”) across the dialysis spectrum. “SAMI” is targeting the acute RRT market, while “DIMI” is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of “DIMI”, which is based on the same RRT platform as “SAMI”, but will be intended for home hemodialysis use. “DIMI” recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.

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:
Mr. Chris Seto
CEO
Spectral Medical Inc.
416-626-3233 ext. 2004
cseto@spectraldx.com
Mr. Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com

David Waldman/Natalya Rudman
US Investor Relations
Crescendo Communications, LLC
212-671-1020
edt@crescendo-ir.com

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We need this to pop!!


This Fall I think they do an up-list and a small IPO for 10%, I'm not sure if the company is split or not..I'm hoping not.
I think that'll be the pop short term...I'm still nibbling on down days and will till the up-list.

Hope Florida was good.
 

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This Fall I think they do an up-list and a small IPO for 10%, I'm not sure if the company is split or not..I'm hoping not.
I think that'll be the pop short term...I'm still nibbling on down days and will till the up-list.

Hope Florida was good.

I'm doing the same, I'm at almost 34k shares.

Florida was great. Did 2 nights in Cape Coral/Ft. Myers, one night in Naples, and the last night in Sarasota. Florida is pretty much wide open, although there are people still wearing masks (many are not). It was packed too, the airport, hotels, restaurants (we went to a place on the water in Cape Coral and got turned away - told "we can't seat you tonight"). Weather was great until Sunday. I'm nice and sunburned! Sucks coming back to DC though!
 

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I'm doing the same, I'm at almost 34k shares.

Florida was great. Did 2 nights in Cape Coral/Ft. Myers, one night in Naples, and the last night in Sarasota. Florida is pretty much wide open, although there are people still wearing masks (many are not). It was packed too, the airport, hotels, restaurants (we went to a place on the water in Cape Coral and got turned away - told "we can't seat you tonight"). Weather was great until Sunday. I'm nice and sunburned! Sucks coming back to DC though!

Nice dude.. sounds fun
Naples is nice town..My folks live in Naples.
Great spot for a beer and grouper Sammy if you make it back to Naples
https://www.cknaples.com
 

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Small study but Kellum did put his name on it.

Good good.


Introduction: Uncontrolled systemic inflammation may occur in severe coronavirus disease 19 (COVID-19). We have previously shown that endotoxemia, presumably from the gut, may complicate COVID-19. However, the role of endotoxin adsorbent (EA) therapy to mitigate organ dysfunction in COVID-19 has not been explored. Methods: We conducted a retrospective observational study in COVID-19 patients who received EA therapy at the King Chulalongkorn Memorial Hospital, Bangkok, Thailand, between March 13 and April 17, 2020. Relevant clinical and laboratory data were collected by inpatient chart review. Results: Among 147 hospitalized COVID-19 patients, 6 patients received EA therapy. All of the 6 patients had severe COVID-19 infection with acute respiratory distress syndrome (ARDS). Among these, 5 of them were mechanically ventilated and 4 had complications of secondary bacterial infection. The endotoxin activity assay (EAA) results of pre-EA therapy ranged from 0.47 to 2.79. The choices of EA therapy were at the discretion of attending physicians. One patient was treated with oXiris® along with continuous renal replacement therapy, and the others received polymyxin B hemoperfusion sessions. All patients have survivedand were finally free from the mechanical ventilation as well as had improvement in PaO[SUB]2[/SUB]/FiO[SUB]2[/SUB] ratio and decreased EAA level after EA therapy. Conclusions: We demonstrated the clinical improvement of severe COVID-19 patients with elevated EAA level upon receiving EA therapy. However, the benefit of EA therapy in COVID-19 ARDS is still unclear and needs to be elucidated with randomized controlled study.
© 2021 S. Karger AG, Basel



https://www.karger.com/Article/Abstract/515628

 

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Going public on the NAS in 3 to 5 months
AMG was yesterday.
 

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I hope this helps....it's been down for over a month now.

Me too buddy,
Down years... in reality


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Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders
TORONTO, June 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”), today announced the results of its Annual and Special Meeting of shareholders (the “Shareholders”) held on June 3, 2021 (the “Meeting”). The Company is pleased to announce that all resolutions put forward in the Management Information Circular dated April 29, 2021 (the “Circular”) to its Shareholders were approved.

Results of the matters voted on at the Meeting are set out below.

Election of Directors

Spectral’s five director nominees were elected:

NomineeVotes For (percent)Votes Withheld (percent)
Jan D’Alvise99.28%0.72%
Anthony Bihl III98.13%1.87%
Jun Hayakawa99.63%0.37%
John Nosenzo99.27%0.73%
William Stevens99.23%0.77%
Paul M. Walker98.27%1.73%
Appointment of Auditors

PricewaterhouseCoopers LLP, Chartered Accountants, was re-appointed as auditor of Spectral.

  • Votes For (percent): 99.99%
  • Votes Withheld (percent): 0.01%

Approval of Consolidation

A special resolution authorizing the future amendment of the articles of the Company to consolidate all of the Company’s issued and outstanding common shares (the “Shares”), on the basis of a consolidation ratio in the range of 1 post-consolidation Share for 10 pre-consolidation Shares to 1 post-consolidation Share for 20 pre-consolidation Shares to be selected by the board of directors of the Corporation (the “Board”), at such time as the Board so determines within 12 months of the date of the Meeting was approved.

  • Votes For (percent): 96.72%
  • Votes Against (percent): 3.28%
About Spectral Medical Inc.

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 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 set of proprietary platforms addressing renal replacement therapy (“RRT”) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit
www.spectraldx.com.

Forward-looking statements

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:
Mr. Chris Seto
CEO
Spectral Medical Inc.
416-626-3233 ext. 2004
cseto@spectraldx.com
Mr. Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com

David Waldman/Natalya Rudman
US Investor Relations
Crescendo Communications, LLC
212-671-1020
edt@crescendo-ir.com
 

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A few notes on the AGM..I'm hoping Devita runs the Dimi usability trial for reasons I've mentioned before.

I thought it was a strong presentation. Sounds like they are going to finalize the companies that are going to run the Dimi usability trial soon. They also made a point that the Covid delay on Tigris is lessening and they think they can get to normal enrollment soon. They are hopeful Tigris can start enrolling like 8-10 people per month. They also really emphasized why they believe their strategy of not using a reverse osmosis water purifier is best.

Kellum presented a newly published retrospective Japanese study of 4000 PMX patients. It showed a 7% absolute reduction in mortality and they didn't use EAA. He said Tigris using EAA should get that 7% number up to the 10-11% that we need. They are also really close to adding 2 new trial sites and then they are going to get 2-3 more sites ready and approved in case they need them.
Seto said they are and will continue to do a lot of one on one presentations to wealthy and or institutional investors. I can't remember if he said one a day or one a week but it sounded like a lot. We'll see if it bares fruit. All of the shareholder questions were basically foolish accusations that Spectral was keeping the share price low. Seto did a good job of totally shooting this foolish notion down.

There was a super brief mention by Seto that SAMI is currently looking for a partner. And I think there was something about Dimi looking for a partner later this year but I'm more sure about the Sami thing. Seto said they are talking to everyone from investment bankers to large pharma's. Kellum also said something strange when he said they were looking into starting up an observational study this fall with PMX. I didn't know what that was about and all I can assume is that maybe they are going to start pursuing the use of PMX for major cardiac surgeries. I wish there was a replay of the presentation.

There is definitely a seller of a large position and they've been there for atleast 2-3 weeks. Everyday for atleast 2 weeks there has been a 'sell on close' order for 10k shares. So this large position has been selling as much as the market will bare during trading hours and then they sell 10k at the close with a sell on close order. I think we'll be stuck in this range until they are gone. I also wonder if this seller isn't tied to the Kevin Giese being off the board thing.



The TMX quote page shows this trade of 10k shares at the 4pm eastern close everyday. Anonymous seller of course.

https://money.tmx.com/en/quote/EDT/trade-history



 

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"The TMX quote page shows this trade of 10k shares at the 4pm eastern close everyday. Anonymous seller of course."

https://money.tmx.com/en/quote/EDT/trade-history

I haven't seen this type of order used in 15 years. Normally it's contra to the stock price trend and never with the trend. So when spectral stock was strong and pushing 75 cents, you'd use a MOC sell order to take profits into the stocks strength. Conversely, when the stock price is weak, you'd use an MOC buy order to slowly build a position in a weak stock that you like. You don't use it with the trend because you'd be exacerbating the trend. You'd be making a weak stock look weaker, and a strong stock look stronger by having the closing print on the bid or ask respectively. It's been going on for at least 2 weeks and probably more like 3 or 4 weeks.
 

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Davita won't be running the trial unfortunately


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Dialco Medical Inc. Engages CROMSOURCE as Contract Research Organization Partner for DIMI IDE Trial

TORONTO, Canada – June 7, 2021Spectral 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), today announced that Dialco has engaged CROMSOURCE, a full-service Contract Research Organization (“CRO”), for its upcoming DIMI IDE usability clinical trial. CROMSOURCE is a high quality, ISO certified international provider of outsourced clinical trial services that has been a trusted partner to pharmaceutical, medical device, and biotechnology companies for more than 20 years.

DIMI is an innovative renal replacement system that is 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 prospective multicenter, open label, non-randomized and cross-over study 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. The trial will include 35 evaluable patients in the United States and is expected to enroll the first patient by the end of the third quarter of 2021.

CROMSOURCE is a recognized global leader in conducting clinical trials for innovative drugs, biologics, and medical devices. Specifically, more than one-fourth of the company’s activities involve the testing of medical devices, translating to more than twenty-five such trials per year. Beyond more than two decades of experience managing medical device clinical trials, CROMSOURCE’s foundation is built upon the delivery of high-quality services, and in fact is one of the only international CROs to be ISO 14155:2011 certified for medical device studies. Moreover, CROMSOURCE has recently completed multiple studies in a dialysis setting, which is one of the critical success factors for this trial. “We are excited to bring on an accomplished partner in CROMSOURCE, which has extensive expertise in managing clinical trials for small to medium size medical device companies like Dialco,” said Dr. Gualtiero Guadagni, President of Dialco Medical Inc. “Onboarding CROMSOURCE is an important milestone in the DIMI trial’s initiation process. We believe that with CROMSOURCE’s broad clinical experience in both the renal and medical device fields, as well as a deep understanding of the DIMI trial, we are poised to achieve key trial milestones within our expected timelines in the United States.”

“We are looking forward to supporting Dialco with their DIMI regulatory trial,” said Dr. Troy W. McCall, Chief Commercial Officer of CROMSOURCE. “DIMI appears to be an easy-to-use device with the potential to overcome many usability barriers to home hemodialysis. We believe the trial is well designed and positioned for successful execution. The CROMSOURCE team is excited to partner with such a recognized global leader as Dialco and their parent, Spectral Medical. While our experience in managing medical device trials is important to Dialco, our flexibility and adaptability, particularly during a global pandemic, makes us the ideal partner. We look forward to a long-term and productive partnership with the Dialco team,” continued Dr. McCall.

Chris Seto, CEO of Spectral, commented, “Dialco is committed to disrupting the current landscape in renal replacement therapies by empowering patients and their care partners to transfer to home hemodialysis (HHD) care and thereby improve their overall quality of life. Currently, just 2% of patients are eligible for HHD, however, we believe that DIMI holds the potential to increase the market for HHD to nearly 30% of patients by addressing key barriers to market adoption. Specifically, we believe DIMI overcomes the inherent complexities and skillsets required for current dialysis systems. Additionally, DIMI provides users greater confidence, is easier to set up, reduces service and maintenance requirements, lowers overall costs, and addresses water quality issues, through the use of pre-packaged water bags. As a result, we believe DIMI will be the only device capable of performing both peritoneal and home hemodialysis, a key differentiator that we believe will drive rapid market adoption. We look forward to working closely with CROMSOURCE as we rapidly advance this important trial.”

About Spectral
Spectral is a Phase 3 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 set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.

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:
Mr. Chris Seto
CEO
Spectral Medical Inc.
416-626-3233 ext. 2004
cseto@spectraldx.com
Mr. Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com

David Waldman/Natalya Rudman
US Investor Relations
Crescendo Communications, LLC
212-671-1020
edt@crescendo-ir.com
 

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