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Volume uptick the past few days..the company has been saying this would be the quarter the HD pump news from the FDA would be announced.
Again this is a high risk play but more than that this company has little daily volume if you buy you're in a sense in long.

If this ever hit a few bucks I'd be filthy rich... it's long shot but I swear there is value here someplace.
 

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NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES


Spectral Medical Provides Corporate Update


  • Early Tigris trial observations in-line with Euphrates post-hoc results

  • Investigator-driven studies show endotoxin levels significantly elevated in most patients with COVID-induced septic shock

  • Q4 2020 EAA multi-country European launch

  • DIMI traditional FDA 510(k) approval for in hospital use expected in Q3 2020

TORONTO, Canada – August 5, 2020 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided a corporate update on its Tigris trial, COVID-19 initiatives, EAA launch, and Dialco regulatory activities.

EAA and PMX Update
Tigris Trial Update:
As previously disclosed in the Company’s Corporate Update dated April 28, 2020, the Tigris trial recruitment activity slowed at the beginning of March 2020 due to the COVID-19 pandemic, with most trial site ICUs diverting their research resources and focus to treating COVID-19 positive patients. While several Tigris sites continued to screen and enroll patients throughout the pandemic, enrollment was lower than anticipated rates. As a result, the Tigris timeline has been negatively impacted with a delay of approximately three months. The Company anticipates a return to normalized recruitment levels, with all 10 sites indicating active screening status by mid-August.

Tigris Enrollment and Site Status:

  • Current Tigris enrollment at 9 patients:
    • Initial observations, with 28-day mortality end point data in-line with Euphrates post-hoc results
  • All 10 sites expected to be actively screening in early August:
    • 5 sites currently actively screening and the 5 remaining sites expected to be active by mid-August

“While Tigris enrollment is not currently at the levels we had anticipated due to the unforeseen onset of the COVID-19 pandemic, we are encouraged both by the preliminary observations as well as the full re-activation of all our Tigris sites,” said Dr. Paul Walker, CEO and President of Spectral. “We are committed to a trial that can demonstrate a positive mortality signal, one which we believe will support both premium pricing and enhanced market penetration for PMX. We continue to believe that demonstrating an improvement in the mortality of these critically ill patients, rather than only changes in physiological parameters or levels of mediators, will drive significant value enhancement for all Spectral shareholders. We are maintaining our stringent patient screening standards, which we believe can provide for a positive mortality signal data and could lead to a successful FDA outcome, and we are not willing to compromise these standards to increase trial enrollment rates. That being said, we have a number of mitigation strategies that we have embarked upon in order to complete the trial in Q4 2021.”

The Company continues to focus on finalizing the Tigris trial within the reasonably shortest timelines, and has implemented mitigation strategies to reduce or eliminate the timing delays, including:
  • Spectral submitted a protocol amendment to the FDA on July 10, 2020 to increase the number of Tigris sites to 15;
  • Spectral’s clinical team has identified 4 sites for its FDA supplemental IDE, targeting the use of the PMX cartridge for treatment in patients with COVID-19. Two sites are actively screening for this protocol and the data from which could be subsequently added to support the PMA for the PMX cartridge;
"We continue to be pleased by the early observations in our Tigris trial,” said Debra Foster, VP Clinical & Regulatory Development. “While the the existing randomized patient sample size is limited, the mortality outcome data to-date is in-line with what we expected based on our Euphrates post-hoc experience. Additionally, the Tigris mortality assumptions continue to be validated with current evidence. In the last few weeks the Journal of Intensive Care Medicine published two review articles on the epidemiology and mortality of sepsis [https://link.springer.com/article/10.1007/s00134-020-06151-x and https://link.springer.com/content/pdf/10.1007%2Fs00134-020-06106-2.pdf]. In summary, the ICU mortality for sepsis is between 42% to 52% – which reinforces that sepsis remains a severe global health problem.”

EAA and PMX COVID-19:
Spectral’s PMX cartridge continues to be utilized in the treatment of patients with COVID-19, with 6 patients treated to-date through either emergency access or the IDE supplement. The general observations are that the earlier PMX is used in COVID-19 patients, the better the outcome – with a reduction in EAA levels after each PMX treatment with an accompanying improvement in critical organ function.

Spectral believes that there is a very strong scientific case for the use of PMX in COVID-19 patients. Endotoxin is the primary driver of the cytokine storm and there is reliable evidence that by removing endotoxin using the PMX cartridge, there is a reduction in circulating levels of cytokines. Increased levels of endotoxin activity as measured by Spectral’s FDA approved Endotoxin Activity Assay (EAA) have been identified in COVID-19 patients in the US, Italy and Asia.

Most recently, 2 US hospitals ran investigator-driven studies during the COVID-19 pandemic to measure endotoxin activity levels in COVID-19 positive patients, with the following summary observations:
  • EAA administered on over 180 COVID-19 positive patients in the ICU;
  • High levels **> 0.60 EAA** were observed in 68% of patients at ICU admission;
  • Data compares to 42% incidence in Thailand reports and 60% incidence in Italy reports with EAA >0.60.
In another investigator-driven study at a US hospital, EAA levels were measured in 90 COVID-19 positive patients, and tracked for incidence of AKI. While results have not yet been published, preliminary observations suggest that COVID-19 positive patients with high EAA are associated with developing AKI.

EAA Launch Q4 2020:
The Company is currently in the market planning phase, collaborating with one of its distribution partners on a multi-country European launch of EAA at the beginning of Q4 2020. Spectral’s distribution partner currently anticipates a simultaneous launch in five countries in western Europe. The Company is pleased with the efforts and engagement of its distribution partner and looks forward to continue working with its partner to launch EAA in other potential new markets.

Dialco Medical Inc. Update
Dialco is continuing the commercial deployment of its proprietary renal replacement (“RRT”) machine SAMI and gaining the U.S. and Canada regulatory approvals of its home hemodialysis (“HHD”) machine branded as DIMI.

SAMI:
Dialco continues its commercialization activities in building its RFP and clinical evaluation pipeline. While the Company believes there are significant penetrable commercial opportunities in the approximately $200 million US CRRT market, Dialco will strategically utilize these commercial activities to increase brand awareness and open the door for DIMI. To-date, the feedback on SAMI has been positive amongst its customers:
  • SAMI CRRT/PIRRT units continuously being used on a daily basis in the treatment of numerous patients with acute renal failure at several prominent renal programs in North America:
    • Since the beginning of 2020, over 100 treatments carried out on SAMI devices
  • Research group from the University of Michigan, one of Dialco’s early adopters, recently submitted a paper to an international medical journal discussing the institution’s successful deployment of SAMI during the COVID-19 pandemic with innovative virtual training and technical support
DIMI:
DIMI is a flexible and user-friendly dialysis platform targeting the rapidly growing home dialysis segment. The Company believes there are several differentiating features to its DIMI device from current devices in market, as well as other potential new entrants. For example, DIMI is the only dialysis machine capable of performing both forms of dialysis, peritoneal (PD) and hemodialysis (HD); DIMI will be equipped with remote monitoring and control functions for physicians; DIMI can be used with any dialyzer; and DIMI uses pre-packaged sterile dialysate bags to reduce user workload and to increase safety. Moreover, DIMI’s portability allows patients to easily manage, store and travel with the device. Dialco is currently pursuing DIMI’s regulatory approvals, in a stepwise process as outlined below:
U.S.FDA (“FDA”) Regulatory Pathway for DIMI:
  • FDA traditional 510(k) approval for utilization of acute and chronic dialysis treatment in hospitals and other health care facilities expected in Q3 2020. This approval has been delayed slightly due to further biocompatibility and electro-magnetic immunity tests required by the FDA. These tests, which are carried out at external labs, were interrupted by the COVID-19 lockdown. To-date, these tests are now complete;
    • Immediately enables DIMI to be used within hospitals, clinics and skilled nursing facilities (“SNFs”)
  • FDA home HD usability and safety trial in Q4 2020. This is will be a required six-month, 25-patient safety and usability trial which tests the ability of non-medical professionals to assist the patient in setting up and running the dialysis treatment;
  • PD FDA 510(k) submission expected in Q4 2020. 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 Q1 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 Q2 2021. This is the final step approval to allow for in-home use of DIMI.
Health Canada Approvals:
  • In Q2 2020, Dialco submitted its application to add DIMI as an extension of the existing SAMI approval. With respect to Health Canada approval timelines, there are no standard turnaround times. However, Dialco anticipates Health Canada response in H2 2020;
    • The advantage of obtaining this approval is that it will immediately unlock the full HD use of DIMI across hospitals, clinics, nursing homes and home in Canada
  • Health Canada PD use submission expected in Q4 2020 with possible approval in early 2021.
“We are committed to bringing to market an innovative dialysis system that can allow an increasing number of patients to embrace the choice of home dialysis,” said Gualtiero Guadagni, President of Dialco. “Our attention is focused on the regulatory approvals for DIMI as well as on providing outstanding service and customer experience to our SAMI early adopters. In parallel to the approvals process, we will continue to evaluate value maximizing structures for Dialco, whether it is through vertical integration, partnerships or other value add structures.”

Corporate Activities Update
  • Organizational Changes: The Company recently announced the appointment of Chris Seto as COO where he will oversee the daily operations of the Company, in addition to his responsibilities as company CFO. Spectral is at a pivotal point in its regulatory and commercial development processes. The re-alignment allows Dr. Walker to focus on the successful outcome of the Tigris trial, and Dr. Guadagni to focus on the regulatory approvals for DIMI and the further commercialization of Dialco. Additionally, on August 4[SUP]th[/SUP] the Company announced the appointment of Mr. John Nosenzo to the Board. Mr. Nosenzo brings over 30 years of senior commercialization experience across the healthcare sector working in multi-billion dollar enterprises. His appointment comes at a critical time, as Spectral continues its commercialization efforts with Dialco and prepares for the commercialization of PMX.
  • Recent Financing: On June 18, 2020, the Company closed a brokered prospectus offering for gross proceeds of approximately $5.1 million. The financing accomplished two important achievements for the Company. First, the proceeds raised addresses the Company’s anticipated costs to complete the Tigris trial. Second, the financing broadened the Company’s shareholder base to a supportive, and aligned institutional audience comprised of Canadian and US-based institutions which were all new to the Spectral shareholder register.
  • Filing of Base Shelf Prospectus: On July 6, 2020, the Company filed a $50 million base shelf prospectus as a measure to maintain financing flexibility in a volatile capital markets environment. The decision to file the base shelf prospectus shortly after closing the June 2020 financing was to take advantage of significantly reduced prospectus drafting costs, as well as potentially reducing the regulatory review burden. The base shelf prospectus provides Spectral with the flexibility to access the capital markets as potential corporate development opportunities arise, including potential commercial scale-up activities, acquisitions and in-licensing opportunities. The Company, at this time, has no immediate plans for a financing.
  • Upcoming Presentations: Spectral will be presenting at the H.C. Wainwright 22[SUP]nd[/SUP] Annual Investment Conference to be held virtually from September 14-16, 2020. Presenting at this conference continues the Company’s efforts to increase its efforts to broaden its exposure to US institutional investors, including the opportunity for further one-on-one meetings with US investors. Additionally, in November 2020, Spectral will be sponsoring a symposium at the 38[SUP]th[/SUP] Vincenza Course – this year a virtual conference which focuses on AKI and CRRT. Details on the sponsored symposium are being finalized, with details to be provided shortly.

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 or forward looking statements within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities including but not limited to the ongoing impact of COVID-19. Actual results could differ materially from what is currently expected, and readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company disclaims any obligation to update or revise any forward-looking statements. Reference is also made to the other risks and uncertainties that may affect the Company which are more fully described in Spectral’s Annual Information Form dated March 26, 2020 and other filings of Spectral with the securities regulatory authorities which are available at www.sedar.com.

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


 

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In the spectral wheel house...

Upped the test locations to 15.
fed0372a-a1bf-4e28-ad49-8534c1204b3c.jpg
US FDA Approves Spectral Medical’s Protocol Amendment for TIGRIS

Protocol Amendment allows for increase in TIGRIS sites to 15 while potentially accelerating patient enrolling and offsetting any COVID-19 pandemic-related delays

TORONTO, Canada – August 10, 2020 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that the United States Federal Food and Drug Agency (“FDA”) has approved a protocol amendment to Spectral’s Tigris trial allowing for an increase in the number of clinical sites to 15 from the 10 in the initial protocol.

“We are pleased with the FDA’s acceptance of our recently submitted IDE supplement which included a protocol amendment to increase the number of our Tigris sites to fifteen,” said Debra Foster, VP Clinical Development and Regulatory at Spectral. “The protocol amendment was one of the measures we enacted to potentially mitigate the unforeseen delay in patient enrollment due to the COVID-19 pandemic. We continue to focus on completing the Tigris trial within the reasonably shortest timelines, and the increase in number of sites should have a positive impact with access to a potentially much larger population of eligible patients. At this time, our clinical team has already identified 4 potential Tigris site candidates.”

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 or forward looking statements within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities including but not limited to the ongoing impact of COVID-19. Actual results could differ materially from what is currently expected, and readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company disclaims any obligation to update or revise any forward-looking statements. Reference is also made to the other risks and uncertainties that may affect the Company which are more fully described in Spectral’s Annual Information Form dated March 26, 2020 and other filings of Spectral with the securities regulatory authorities which are available at www.sedar.com.

 

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U.S. FDA Grants 510(k) Clearance for Spectral’s DIMI

  • Immediately enables DIMI to be used within U.S. hospitals, clinics and skilled nursing facilities
  • U.S. skilled nursing facilities market represents an estimated US$2 billion market annually
TORONTO, Canada – August 31, 2020 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), today announced that its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”) has been granted 510(k) clearance by the United States Food and Drug Administration (“FDA") for DIMI to treat patients with acute and/or chronic renal failure with or without fluid overload using hemodialysis (“HD”), hemodiafiltration (“HDF”), hemofiltration (“HF”) and/or ultrafiltration (“UF”) in hospital or clinical settings. As previously communicated, this is the first major step of the full regulatory development of DIMI. Further advances will be clearance for home and peritoneal dialysis (“PD”) use.

DIMI is an innovative renal replacement system that shares the same patented platform as Dialco’s FDA cleared SAMI system, which is indicated for continuous renal replacement therapy (“CRRT”) in the intensive care unit (“ICU”) setting. Based on a fully integrated cassette technology, the set-up, operation and management of a dialysis session is significantly simplified compared to other instruments currently available on the market. Moreover, DIMI (similarly to SAMI) is specifically designed to avoid all contact between the console and a patient's biological fluids, helping to reducing the risk of cross infection when it is used to treat multiple patients.

“The overall 510(k) clearance process was completed in less than nine months including review, and time to address and resolve deficiencies, despite the COVID 19 pandemic,” said Dr. Gualtiero Guadagni, President of Dialco Medical Inc. “This FDA 510(k) clearance is significant for Spectral. Not only is it an important first step in the full regulatory development of DIMI, but it also opens up significant commercial markets and opportunities which we expect would result in significant revenue growth for the Company. We look forward to working with our SAMI early adopters and other clinical teams to evaluate DIMI and run the usability trial to pursue the home market designation."

Current DIMI Market Opportunities:

As Dialco prepares to extend the indication for DIMI to include both home and PD use, Dialco will focus on the chronic dialysis centers and long-term care facilities markets. These segments offer promising markets where DIMI can offer unique advantages over current products in this space.


  • According to the CDC, there are approximately 15,600 skilled nursing facilities (“SNFs”) in the U.S. providing care to approximately 1.7 million residents;
  • An estimated 74,000 dialysis patients live in SNFs, with the majority traveling to dialysis centers to receive treatment;
  • Installation of easy-to-use dialysis machines in SNFs could help reduce risks of patient travel to clinics, reduce overall costs of care and provide a new source of revenue for the SNF;
  • Existing U.S. SNF markets represent an estimated US$2 billion market annually (combined devices and disposables).
Dialco’s key operating activities to commercialize DIMI in the near term will focus on gaining clinical acceptance of DIMI amongst nephrologists and nurse practitioners, given the importance of peer reference in the dialysis industry. Some of the key activities include:

  • DIMI evaluations at SAMI early adopter customer sites;
  • Addition of three additional clinical/academic sites in the U.S. and Canada over the next six months;
  • Initiate pilot evaluations in SNFs;
  • Ramp up sales activity; and
  • Develop a complete product portfolio (by adding ancillary disposables) for the DIMI system.
Remaining Regulatory Pathway:

While the U.S. SNF market is a significant opportunity, the Dialco team is focused on unlocking the full commercial capabilities of DIMI, which includes both home and PD use. The regulatory pathway forward will be on a stepwise basis, with key regulatory activities and milestones laid out below:

FDA Approvals:


  • FDA home HD usability and safety trial in Q4 2020. This will be a required six-month, 25-patient safety and usability trial which tests the ability of non-medical professionals to assist the patient in setting up and running the dialysis treatment;
  • PD FDA 510(k) submission expected in Q4 2020. 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 Q1 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 Q2 2021. This is the final step approval to allow for in-home use of DIMI.
Health Canada Approvals:

  • In Q2 2020, Dialco submitted its application for DIMI. With respect to Health Canada approval timelines, there are no standard turnaround times. However, Dialco anticipates a Health Canada response in H2 2020;
  • Health Canada PD use submission expected in Q4 2020 with possible approval in early 2021.
“We are very pleased with this clearance for DIMI by the FDA,” said Chris Seto, COO and CFO of Spectral. “Our regulatory and commercialization paths of these renal replacement products are continuing despite the challenges of limited access to hospitals and the usual selling cycle for capital equipment in hospitals.”

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. (“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 or forward looking statements within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities including but not limited to the ongoing impact of COVID-19. Actual results could differ materially from what is currently expected, and readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company disclaims any obligation to update or revise any forward-looking statements. Reference is also made to the other risks and uncertainties that may affect the Company which are more fully described in Spectral’s Annual Information Form dated March 26, 2020 and other filings of Spectral with the securities regulatory authorities which are available at www.sedar.com.

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



For further information, please contact:

Dr. Paul Walker
President and CEO
Spectral Medical Inc.
416-626-3233 ext. 2100
pwalker@spectraldx.com
Mr. Chris Seto
COO and CFO
Spectral Medical Inc.
416-626-3233 ext. 2004
cseto@spectraldx.com
Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com

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Never can tell with this company but this should move the price...finally.
 

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fell back down..I will say this got more attractive today..I like the plan they've developed for finding a customer base.
Analyst coverage in the US seems like the next step up.. it will come todays news is huge although it can't be officially released in the US on a news service because of the penny stock status.

Hopefully an uplisting will come soon but more than that this is now on pump wannabe players radar..It's a massive market someone will buy them eventually and it won't be for pennies.
 

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Here's manipulation in it's most blatant form.
After yesterday great news a group or individual sold 500 share lots at close to 1 minute increments..slowly walking it down.
I wrote the company yesterday asking if they were aware of the situation? No answer naturally.


Very dirty stuff happening with this..IMO up listing is the only solution to wash out the seller with better liquidity.

I'm thinking about the whole situation..I will say that pump approval is huge!








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I normally don't mess around in penny stocks and this is the reason..up 31% early then the selling started and never stopped all day with the 500 @ 1 min pattern.
These guys have the assets, it was confirmed yesterday by the FDA pump approval.
I'll buy more if the overhang moves along.
 

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A few things about this company..All the seed money was raised in silicon valley it’s basically a group of venture capital guys who saw a market developing before anyone.I’ve been following Outset for a while..approval in 2014 and home approval this year..IOP valuation this week + 2 billion on 41 Million S/ outstanding. ..64 dollars.
As far as being a take out target i think the management (VC guys) would be looking for more than the market would be willing to give up at this point.
The machine is super expensive, it’s the Cadillac of machines..Insurance companies will mandate the cheaper Nextstage pump IMO.
This is where Spectral fits..The Spectral machine will be by far the cheapest on the market..I’d call it the future “Toyota" of home dialysis pumps once approved... insurance companies will like it but over that some mover in the field will want it.. spectral is a seller no doubt.
They will be up listing and they should get that home approval.. Spectrals IR mentioned a valuation of 4 billion witch I think is insane...there isn’t any doubt two sellers are driving this down on news.. it's a fight over the pump part of the company and the way it will be split up.


I like it but it's been painful lately

Outset Medical: Very Interesting MedTech Growth Play


Sep. 17, 2020 10:20 PM ET|
2 comments
|
About: Outset Medical, Inc. (OM)
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Summary
Outset Medical is a very promising company in the (home) dialysis market.
The company has seen spectacular revenue growth from a very low base.
This growth is translating into a high valuation based on implied sales multiples, but nonetheless, I find this a very interesting company to keep an eye on.
I look forward to learning more about the sequential revenue numbers in the quarters to come, including the contribution from the home segment.
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Outset Medical (OM) has made a splashing public debut, as a combination of hyper growth and medical technology is very hot at this moment. There is a great deal to like about the company, including an inherent strong and interesting product. Moreover, appeal comes from the hyper growth and the fact that recent FDA action essentially quadrupled the addressable market, thereby creating tons of potential to create lasting (spectacular) revenue growth.
The Business

Outset is a medtech company which aims to reduce the cost and complexity of dialysis through its Tablo Hemodialysis System (Tablo). This novel dialysis care product can be used in acute and home settings, with dialysis being performed anytime, anywhere and by anyone.
Tablo only requires an electrical outlet and tap water to operate, thereby releasing patients and caregivers from the traditional dialysis machines. Its equipment includes water purification integration and dialysis production. The machine, furthermore, is connected, allowing for streamlined reporting. On top of the comfort for patients, the cost saving aspect is very large as well, pegged at an 80% advantage compared to ICU treatment. For all these reasons, the FDA has approved the usage of the machine in hospital, clinic or home settings.
Dialysis is a huge part of healthcare, yet the segment has seen little innovation over the past decades. Spending on dialysis is pegged at $74 billion a year, with kidney failure affecting more than 800,000 people in the US in 2020. Preconditions and demographic factors unfortunately mean that the number of patients is set to reach the million mark by the end of this decade.

Tablo has been cleared by the FDA in 2014 for the use of acute or chronic care facility, and on the final day of March of this year, it was cleared for the home market, which is very important for Outset Medical. Note that the acute care market is pegged at $2.2 billion, as expansion into the home setting is very important, with this segment pegged at $8.9 billion, thereby quadrupling the addressable market.
IPO and Valuation Thoughts

Outset and its underwriters initially aimed to sell 7.6 million shares at a price range between $22 and $24 per share, but strong demand resulted in the size of the offering being increased to nearly 9 million shares. These shares were priced at $27 per share, resulting in gross proceeds of $242 million.
The roughly 41 million shares outstanding gave the company an equity value of $1.11 billion at the offer price. With net cash seen around the $300 million mark on a pro forma basis, operating assets are valued at around $800 million. Of course, this was before shares rose to $60 on their opening day of trading, thereby boosting the equity valuation to $2.5 billion and the operating asset valuation to $2.2 billion.
To put this number into perspective, we have to look at the actual financial results. Revenues for 2018 came in at $2.0 million, on which Outset reported gross loss of more than $6 million and operating loss of $46 million. Last year, the company reported sales of $15.1 million, with operating losses increasing to more than $70 million. The revenue composition reveals very strong growth throughout the year with revenues amounting to $5.4 million in the first half of 2019, increasing to $9.7 million in the second half of the year.
To date, the results for the first half of 2020 are known, with revenues of $18.9 million comfortably coming in above the revenues reported for all of 2019. Operating losses for the six-month period rose from $33 million to $45 million. Of course, the losses are a concern, although the pro forma net cash position allows to fund these losses for about three years to come. Of course, the company aims to lower losses with its own manufacturing facility in Mexico as well as sales leverage.

Unfortunately, we have not seen results being broken down on the back of individual quarters. Knowing that revenues totaled nearly $19 million in the first half of the year, the composition between the first and second quarters might be $7 and $12 million (estimating here) given the rapid pace of growth. If this is realistic, revenues trend at $50 million per annum already, which still translates into a very steep 50 times sales multiple at $60 per share.
Of course, growth is very impressive, with revenues more than tripling on an annual basis and the home market only being approved a quarter ago, representing a target market 4 times as large.
So, basically, in a time period of just 1-2 years, Outset Medical has grasped a $50 million run rate in a market segment pegged at $2.2 billion, as home sales were cleared just a quarter ago. If the company can see the same adoption in the home care market, it might be a $200-300 million business in a year or two.
That still translates into a 10 times sales multiple, yet, undoubtedly, losses might turn in profits or come down, as the very strong growth warrants a steeper multiple in such a case.
What Now?

With shares having more than doubled from the IPO price, and having essentially tripled from the preliminary offering range, valuations have risen quite sharply. While a >$2 billion valuation is very high for the business in its current state, it leaves quite some room to grow, as it is very obvious that sales momentum is very strong. Furthermore, we still have to see a big impact from the home care segment.
The risks include mostly the valuation and losses, but furthermore, include reliance on suppliers and on a single product. Note that while the FDA has granted approval, the Tablo system is subject to a post-market surveillance order for the home setting.
Other key risks include, of course, a competitive field which includes names like Fresenius (FMS), Baxter International (BAX) and Medtronic (MDT), which have far greater (financial) resources. Fresenius actually made a big deal in this area last year when it acquired NxStage in a $2 billion deal, although that company was far larger with revenues reported around $400 million, though it must be said that growth was very modest.

Here and now, I am very interested in the quarterly revenue trends which will become visible in the third quarter, as I look forward to learning more about Outset Medical's growth trajectory and certainly the composition of revenues between acute care and home care. For now, shares deserve a prominent position on my watch list, as I look forward with great enthusiasm to learn about the near-term revenue developments.
If you like to see more ideas, please subscribe to the premium service "Value in Corporate Events" here and try the free trial. In this service we cover major earnings events, M&A, IPOs and other significant corporate events with actionable ideas. Furthermore, we provide coverage of situations and names on request!


Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.







 

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Any fears that mgmt might try to sneakily take this thing private and, only then, start putting out press releases and uplisting?

I still believe in this one and am debating hammering more at these levels...the above is a concern in the back of my mind, though. Maybe just jaded from what I've seen with these relatively illiquid small caps (mgmt takes private at a "50% premium", which maybe gets us back to $0.50, and then the privateco blows up).
 

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Any fears that mgmt might try to sneakily take this thing private and, only then, start putting out press releases and uplisting?

I still believe in this one and am debating hammering more at these levels...the above is a concern in the back of my mind, though. Maybe just jaded from what I've seen with these relatively illiquid small caps (mgmt takes private at a "50% premium", which maybe gets us back to $0.50, and then the privateco blows up).


Ex board member selling in the market..he's almost clear.
Home approval of that pump changes everything.

Pretty hard to go private with the Japanese controlling the interest unless they aline with the Meddwell gang involved here and that looks extremely doubtful.
I still love this but fucking hell.. its been a drag.
If I get info I'll PM you..but you'll need to keep it under the hat.

BOL brother.
 

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[h=3]Polymyxin B haemoperfusion treatment for respiratory failure[/h][h=2]Case Report[/h]In April 2020, a 69yearold man with a history of type 2 diabetes and high blood pressure presented with five days of dry cough and fever. A polymerase chain reaction (PCR) test for SARSCoV2 on nasal swabs was positive, and the patient was diagnosed with COVID19. On the eighth day after onset, he was admitted to the COVID19 ward of our hospital.
On admission, he presented with a body temperature of 37.6°C, and 2 L/min oxygen via nasal cannula was started because his oxygen saturation (SpO2) was 89% on room air. Computed tomography (CT) scan of the chest revealed bilateral patchy groundglass opacity (GGO) consistent with COVID19 pneumonia (Fig. (Fig.1).1). Laboratory tests showed a white blood cell count (WBC) of 3700/μL (lymphocyte 1010/μL), and Creactive protein (CRP) was 8.7 mg/dL, ferritin was 4000.0 ng/mL, and ddimer was 1.17 μg/mL. Antiviral therapy with favipiravir was started on hospital day 1 (eighth day after symptom onset), with a firstday dose of 1800 mg twice, and then 800 mg twice a day for two weeks.

On day 4 (11th day after symptom onset), sudden dyspnoea and oxygen saturation drop required an oxygen supplementation increase up to 8 L/min using a face mask. Laboratory tests showed an elevation of inflammatory markers: CRP was 21.5 mg/dL, ferritin was 7735.0 ng/mL, and ddimer was 1.81 μg/mL. Xray revealed bilateral deterioration with GGO (Fig. (Fig.1).1). Highdose corticosteroid (methylprednisolone 1 g/day for three days) and ceftriaxone antibiotics were administered. Nevertheless, the patient's clinical condition, including oxygenation, worsened despite a slight decrease in CRP. On day 6 (13th day after symptom onset), 5 h of PMXDHP therapy was initiated to address the hyperinflammation. Post PMXDHP, the oxygenation and blood inflammation markers, including serum ferritin, were significantly improved. The progression to ARDS was halted and the need for intubation and mechanical ventilation was avoided. Serum ferritin levels promptly decreased to 2132 ng/mL after PMXDHP. Chest Xray showed that the bilateral infiltration gradually improved after PMXDHP (Fig. (Fig.1).1). No supplementary oxygen was required on day 19 (26th day of onset). The patient fully recovered from COVID19 symptoms and was discharged home after a 30day hospitalization.

COVID19 causes a spectrum of diseases ranging from mild symptoms (~80%) to respiratory failure (~20%), ARDS, and multiple organ failures. The leading causes of death are cytokine storm syndrome and ARDS, and 50% of patients with cytokine storm syndrome subsequently develop ARDS. Although the precise pathogenesis of severe COVID19induced ARDS remains unclear, hyperferritinaemia, which is categorized as hyperinflammation, is associated with severity and poor outcomes in COVID19 [1, 2]. Hyperinflammation is defined as follows: CRP concentration greater than 15 mg/dL; a doubling of CRP concentration within 24 h from a concentration of greater than 5 mg/dL; or a ferritin concentration of greater than 1500 ng/dL [1]. Ferritin levels at admission in COVID19 nonsurvivors were reported to be around 1400 ng/mL [3]. In the present case, even when concomitant treatment with an antiviral agent and highdose corticosteroid were administered, serum ferritin levels were elevated (up to 7735 ng/dL) and no improvement in oxygenation was observed. We speculated that COVID19associated hyperinflammation or hypercytokinaemia induced severe respiratory failure, which could progress to ARDS. Next, we introduced DHP with PMX in order to remove inflammatory cytokines or mediators. Oxygenation and hyperferritinaemia were improved immediately after PMXDHP therapy. PMX was originally developed for the removal of endotoxins and is used to treat endotoxaemia. Recent reports have demonstrated the beneficial effect of PMX in severe influenza pneumonia, including both 2009pH1N1 and H5N1 [4, 5]. Hypercytokinaemia induced by 2009pH1N1 influenza was reported to be successfully treated with PMX, suggesting the potential efficacy of PMX to address hyperinflammation [4]. The removal of inflammatory mediators by PMX appears to be a promising treatment in patients at risk of developing ARDS due to COVID19.
In conclusion, we report the first case of COVID19induced hyperferritinaemia and severe respiratory failure successfully treated with PMX, which decreased the inflammatory markers and improved oxygenation. As a result, the patient's progression to ARDS was halted and the need for mechanical ventilation was avoided. Further studies are needed to determine the optimal timing of PMX in the disease course and its indication based on clinical parameters including hyperferritinaemia.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7604553/
 

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very promising investigations stock up 10% today..but it's been drubbed over the last 6 months.

Ferritin as a Marker of Severity in COVID-19 Patients: A Fatal Correlation



Abstract

Background: Ferritin, the cellular protein storage for iron, has emerged as a key molecule in the immune system, orchestrating the cellular defense against inflammation. At the end of 2019, the novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) rapidly spread throughout China and other countries around the world, resulting in a viral pandemic.
Objectives: To evaluate the correlation between ferritin and disease severity in coronavirus disease-2019 (COVID-19).
Methods: In this cross-sectional study, we obtained clinical and laboratory data regarding 39 hospitalized patients with confirmed COVID-19 from two hospitals in Israel.
Results: A significant increase in ferritin levels was demonstrated in patients with moderate and severe disease, compared to patients with mild disease (P = 0.006 and 0.005, respectively). Severe patients had significantly higher levels of ferritin (2817.6 ng/ml) than non-severe patients (708.6 ng/ml) P = 0.02.
Conclusions: In this preliminary cross-sectional study, elevated ferritin levels were shown to correlate with disease severity in 39 patients from Israel with confirmed COVID-19 infection. Our results further strengthen the hypothesis that severe COVID-19 disease might be due to an underlying dysregulated hyperimmune response. In order to identify these patients early and prioritized resources, we believe that all patients with COVID-19 should be screened for hyperferritinemia.


https://pubmed.ncbi.nlm.nih.gov/32812717/







RE:RE:polymyxin B haemoperfusion treatment for respiratory failure

Serum ferritin levels were positively correlated with severity of COVID-19 (Fig. 1B) and hyperferritinemia (ferritin level > 500µg/L), was observed in all patients with severe disease on admission. Moreover, ROC curve analysis confirmed the excellent prognostic accuracies of serum Ferritin in discriminate patients with severe clinical conditions. (AUC 0.939, CI: 0,894 to 0,985 p < 0.001) (Fig. 1C).

Our data strongly confirm that increased levels of ferritin were directly related with the disease severity (Fig 2 A). Particularly, not only severe group showed 2.6 times higher ferritin levels than the mild group, but patients who needed admission to the ICU showed 5.8 times higher ferritin compared to patients with mild COVID-19. Among all parameters considered, we also noted that the NLR was statistically correlated with the severity of disease. (Fig. 2B). Conversely, D-D, LDH and CRP increased only in the group of critical patients (group 3), being substantially stable in the other groups characterized by mild, moderate and severe disease (Fig. 2, panel C, D, E).

This is the first Italian report about the prognostic value of laboratory biomarkers considering 4 groups of mild, moderate, severe and critical patients with COVID-19. We clearly demonstrated that serum levels of ferritin progressively increased with the severity of disease and correlate with poor prognosis in COVID-19 patients.


Read more.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7490639/


RE:RE:RE:polymyxin B haemoperfusion treatment for respiratory failure

Italy, Isreal and China.



In this Journal, Li and colleagues recently reported that Serum Amyloid A is a biomarker of severe Coronavirus Disease and poor prognosis1. Evidence shows that severe COVID-19 cases exhibit features of systemic inflammatory reactions, including hyperferritinemia. We conducted a retrospective study included 147 confirmed COVID-19 patients in Changsha, a non-epicenter city of China. The overall proportion of severe disease was 16.32% (24/147). Table 1 shows the differences in the baseline characteristics between severe and nonsevere COVID-19 patients. The severe patients had higher levels of serum ferritin than the nonsevere patients (Fig. 1 A).

Wu et al. investigated 201 confirmed cases of COVID-19 to study the clinical characteristics and outcomes in patients with COVID-19 pneumonia who developed acute respiratory distress syndrome (ARDS) or died; their findings showed that higher serum ferritin was an independent risk factor associated with ARDS development.2 Another meta-analysis also recommended serum ferritin as a candidate variable for risk stratification models that may serve as clinical predictors of severe and fatal COVID-19.3 In our study, when patients were grouped according to the serum ferritin level with a cut off of 500ng/ml derived from the HLH-2004 criterion, hyperferritinemia accounted for 29.93% (44/147) of patients. The hyperferritinemia group had a higher proportion of severe cases (31.82% vs. 9.71%, P=0.0009) and bilateral pulmonary infiltration rate (95.45% vs. 79.61%, P=0.0297) than patients without hyperferritinemia. Hyperferritinemic COVID-19 patients were older and more likely to be male.Moreover, these patients had significantly higher levels of serum creatine, ALT, AST and LDH, lower levels of lymphocytes, and significantly higher levels of inflammatory markers, such as CRP, PCT and d-dimer, than the patients in the nonhyperferritinemia group. All these indicators have been reported as warning parameters for severe or critical COVID-19 patients. In addition, these correlations may indicate that patients with hyperferritinemia tend to have more severe disease than those without hyperferritinemia. Multivariate logistic regression models were adjusted for several disease-related risk factors at admission, including age, neutrophil count, lymphocyte count, d-dimer, LDH, C-reactive protein, and procalcitonin, the analysis found that the serum ferritin level was an independent risk factor for disease severity in COVID-19 patients(OR=3.302, 95% CI, 1.141∼9.553, P=0.028). And ROC curve study confirmed the predictive value of serum ferritin (AUC=0.7480, P <0.001).

In conclusion, this retrospective study performed in a Chinese population demonstrated that a high level of serum ferritin is an independent risk factor for the severity of COVID-19. Assessing serum ferritin levels during hospitalization may be important to recognize high-risk individuals with COVID-19.


Read more.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7313486/

RE:polymyxin B haemoperfusion treatment for respiratory failure


RCR2-8-e00679-g001.jpg




 

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I didn't have much time to dig in to this info much till this AM...
Looks as if the market for PMX is growing as evidence is compiled.The lung X-rays here are impressive (in the link)..PMX removed the glassing associated with lung failures during Covid..glassing isn't exclusive to C19.
I've been holding this for a long ass time because I do believe in the technology and the fact this is one of the bigger unmet needs in medicine.

"Sepsis Accounts for 1 in 5 Deaths, Leading Cause of Death in Hospitals. A new study published by the medical journal The Lancet, has revealed that sepsis accounts for 1 in 5 deaths globally. Additionally, sepsis is the most common cause of deaths in the hospital in the United States"

I always looked at the potential here being 5 bucks max now I thinking it's somewhat bigger...
250mill x 5 roughly 1.5 billion..in a 4 billion dollar market by estimate done by the company and outside sources.

Interesting for sure.....




Polymyxin B haemoperfusion treatment for respiratory failure

Case Report

In April 2020, a 69yearold man with a history of type 2 diabetes and high blood pressure presented with five days of dry cough and fever. A polymerase chain reaction (PCR) test for SARSCoV2 on nasal swabs was positive, and the patient was diagnosed with COVID19. On the eighth day after onset, he was admitted to the COVID19 ward of our hospital.
On admission, he presented with a body temperature of 37.6°C, and 2 L/min oxygen via nasal cannula was started because his oxygen saturation (SpO2) was 89% on room air. Computed tomography (CT) scan of the chest revealed bilateral patchy groundglass opacity (GGO) consistent with COVID19 pneumonia (Fig. (Fig.1).1). Laboratory tests showed a white blood cell count (WBC) of 3700/μL (lymphocyte 1010/μL), and Creactive protein (CRP) was 8.7 mg/dL, ferritin was 4000.0 ng/mL, and ddimer was 1.17 μg/mL. Antiviral therapy with favipiravir was started on hospital day 1 (eighth day after symptom onset), with a firstday dose of 1800 mg twice, and then 800 mg twice a day for two weeks.

On day 4 (11th day after symptom onset), sudden dyspnoea and oxygen saturation drop required an oxygen supplementation increase up to 8 L/min using a face mask. Laboratory tests showed an elevation of inflammatory markers: CRP was 21.5 mg/dL, ferritin was 7735.0 ng/mL, and ddimer was 1.81 μg/mL. Xray revealed bilateral deterioration with GGO (Fig. (Fig.1).1). Highdose corticosteroid (methylprednisolone 1 g/day for three days) and ceftriaxone antibiotics were administered. Nevertheless, the patient's clinical condition, including oxygenation, worsened despite a slight decrease in CRP. On day 6 (13th day after symptom onset), 5 h of PMXDHP therapy was initiated to address the hyperinflammation. Post PMXDHP, the oxygenation and blood inflammation markers, including serum ferritin, were significantly improved. The progression to ARDS was halted and the need for intubation and mechanical ventilation was avoided. Serum ferritin levels promptly decreased to 2132 ng/mL after PMXDHP. Chest Xray showed that the bilateral infiltration gradually improved after PMXDHP (Fig. (Fig.1).1). No supplementary oxygen was required on day 19 (26th day of onset). The patient fully recovered from COVID19 symptoms and was discharged home after a 30day hospitalization.

COVID19 causes a spectrum of diseases ranging from mild symptoms (~80%) to respiratory failure (~20%), ARDS, and multiple organ failures. The leading causes of death are cytokine storm syndrome and ARDS, and 50% of patients with cytokine storm syndrome subsequently develop ARDS. Although the precise pathogenesis of severe COVID19induced ARDS remains unclear, hyperferritinaemia, which is categorized as hyperinflammation, is associated with severity and poor outcomes in COVID19 [1, 2]. Hyperinflammation is defined as follows: CRP concentration greater than 15 mg/dL; a doubling of CRP concentration within 24 h from a concentration of greater than 5 mg/dL; or a ferritin concentration of greater than 1500 ng/dL [1]. Ferritin levels at admission in COVID19 nonsurvivors were reported to be around 1400 ng/mL [3]. In the present case, even when concomitant treatment with an antiviral agent and highdose corticosteroid were administered, serum ferritin levels were elevated (up to 7735 ng/dL) and no improvement in oxygenation was observed. We speculated that COVID19associated hyperinflammation or hypercytokinaemia induced severe respiratory failure, which could progress to ARDS. Next, we introduced DHP with PMX in order to remove inflammatory cytokines or mediators. Oxygenation and hyperferritinaemia were improved immediately after PMXDHP therapy. PMX was originally developed for the removal of endotoxins and is used to treat endotoxaemia. Recent reports have demonstrated the beneficial effect of PMX in severe influenza pneumonia, including both 2009pH1N1 and H5N1 [4, 5]. Hypercytokinaemia induced by 2009pH1N1 influenza was reported to be successfully treated with PMX, suggesting the potential efficacy of PMX to address hyperinflammation [4]. The removal of inflammatory mediators by PMX appears to be a promising treatment in patients at risk of developing ARDS due to COVID19.
In conclusion, we report the first case of COVID19induced hyperferritinaemia and severe respiratory failure successfully treated with PMX, which decreased the inflammatory markers and improved oxygenation. As a result, the patient's progression to ARDS was halted and the need for mechanical ventilation was avoided. Further studies are needed to determine the optimal timing of PMX in the disease course and its indication based on clinical parameters including hyperferritinaemia.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7604553/
 

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