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We are on the cusp of something! I am of the belief that the market for filtration is very new and quite immature. If someone can crack the egg so to speak, then all the players will create tasty omlets for all their shareholders. Potential omlet makers? CTSO, AEMD, SIGY and maybe EDTXF. It is my speculative opinion only that EDTXF may be the chef that cracks the egg with the FDA. I use their scientific advancement and current phase 4 FDA trial tracking 28 day mortality as the main ingredient for their tasty creation. With one of our countries most respected and intelligent docs putting the Spectral apron on, I feel like EDTXF is in fact closer to making blood filtration a viable option. The unmet need is rather enormous and the amount of science EDTXF has provided the FDA would require a similar description. Good luck to all, our day here at CTSO will arrive, stay patient and look to supporting companies to cut a path with the FDA. Just my opinion FWIW!!
BTW.....the EDTXF trial sees a 2 to 1 ratio of EDTXF treatments against the SOC or standard of care for newbies! Important as well that EDTXF uses an already FDA approved and wholly owned diagnostic to guide all their treatment decision in what some call an example of "precision medicine"
Nice find Raunch! I see we are down just a hair today, could be a good entry point. In speaking to some well respected and very knowledgable investors here in Cali they seem a little confused by the decision of our trusted advisor Dr. J Kellum of Pittsburgh to sign with EDTXF. I don't see it as an issue however they do and suggest it has been putting pressure on the share price as of late. Hemodefend is surely a wildcard that could propel us to new heights as it is unique and super cool! My only concern with future earnings is the lack of expense we have had on the clinical front. For the last couple years our expense in terms of clinical programs has been quite low. When we start ramping up the FDA process in all areas...Sepsis, cardiac surgery and of course Hemodefend, our expenses will no doubt elevate and will impact the bottom line. Hopefully the rising revenues will offset this required expense. I see this as a long term positive however it would be foolish not to recognize the clinical expense holiday we have been enjoying over the last couple years. Just one Golden State resident's opinion. Best of luck to all holders and long the beads!
The problem is hard DATA, NOT Dr. Chan. Alright friends, time to lay-off Chan and recognize there is a large lack of RCT trial data to back the efficacy of our claims. We just wrapped up the UK endeavor after almost 1 year and the German covid trial is another big question mark. Achieving the value we have with little to no FDA data to back the efficacy is simply put ONE HELLUVA accomplishment! Let's call it as the facts see it. Frankly, I'm sick of everyone here calling this a wonder device and not being able to back it up! Let's give Chan some leash and allow the next FDA project to prove up the real medical benefits of the beads! Sorry for all the !!!, but geez guys, let's lay-off off the messenger and start looking at the core issues! Sometimes you folks seem so immature!!
Sorry for the rant!!
I still like CTSO and the cutting edge technology of the beads. I am curious about SIGY though as they have a dual function filter that removes endotoxin and cytokines. AEMD is a more specific viral play and EDTXF can't trade a share, has many FDA approvals and insider ownership that makes you wonder whether it is remarkably good or so bad only they are willing to buy the stock. I am mildly puzzled by the extreme success that EDTXF has had with the FDA though. Interesting the company which is based in Toronto Canada has blocked it's new releases to the US for close to 5 years despite incredible advancement with the FDA...this is a very strange event, especially when coupled with the obscene amount of insider ownership and complete lack of volume...is this the dark horse in the filtration sweepstakes?
Sadly, I am restricted to only one comment per day, so when critiqued please stand by until tomorrow for a response. Please do point out any factual oversights within my thoughtful words...thank you in advance
CB 4 ever!
I was very pleased and here is why! There is so much more to this story than many of you know!
- Hemodefend, was there an update on the timing of the pivotal trial? I believe there is a bunch of value in this unique opportunity
- Cytosorb XL, was there an update on this gamechanging filter? With so much evidence mounting in favor of endotoxin removal how is the XL product progressing? Again, way more value here than most know
- UK trial wrap-up, I get the fact we are putting our efforts into FDA trial here at home, but I expect meaningful data from the UK trial as it is almost 1 year old. Wait until we hear about this, another potential catalyst IMHO
I'm long all my remaining shares, even if I'm not the big player many of you are.
I totally trust management. For me personally, the much bigger issue is the product itself. I have been scouring the net looking for data to make the efficacy of the product a clear and concise fact. Some of my concern is the fact there is not a companion diagnostic to confirm exactly what is happening with cytokine levels. The other issue is what are we doing to other more desired components of a patient's blood. Sometimes I wonder if the constant and questionable discussion around management is purposeful because it is easy to change management but changing the product is so much a different and unrealistic task. I still have a little bit left and personally feel like Chan and company have done a super job with the cards they've been dealt. I've yet to see compelling RCT data from anywhere and the FDA experience with REFRESH and now REFRESH II is not instilling any new confidence. Let's call a diamond a diamond here, the world is turning more and more to precision medicine, if we can't precisely detail what it is we are or are not doing to a patient's blood, it will continue to be an uphill battle. Just my opinion and good luck to all holders.
SP Only down becuz of the "conditional" IDE. I have a few shares left and I for one am not selling here. I think today's news is wonderful and once the conditional nature of the approval to begin the trial is relinquished I see us easily going back up over $9. It is a little unusual to have a conditional tag on the approval to begin a trial however given the important nature of this most critical trial I see it only as a positive. I wish people here would remain patient as the beads could very well be one of the 21st centuries most medically altering and beneficial finds. Speculating of course as others used to when the daily idea of $60 and $80 per common share were announced on a regular basis. I'm not calling for that however given my purchase price anything around $10 makes me a happy camper! Better yet, it looks as though filtration is becoming a viable covid option as well!!
Dr. Kellum co-author on COVID-19 and PMX research
Endotoxin Adsorbent Therapy in Severe COVID-19 Pneumonia
"Conclusions: We demonstrated the clinical improvement of severe COVID-19 patients with elevated EAA level upon receiving EA therapy."
Two interesting notes- the testing was done before Dr. Kellum joined Spectral (no affiliation noted) and that the testing was was guided and monitored using our EAA
GLTA!!!!!!!!!!!!!
Concerned over Kellum choosing EDTXF. Anyone here find it strange that Dr. Kellum chose to hang his hat with Spectral Medical? Given our mostly clear position as the leader in the space of blood filtration as it perhaps to Sepsis and what-have-you, I find it disturbing that he chose the far more advanced scientific company over the revenue leader. Spectral has the rights to the delivery vehicles for blood filtration as well, so this may have been the deciding factor. Has anyone written the company and inquired about how we let the big one get away, so to speak? I wouldn't be concerned about the lack of exposure on tv last night, we will have our turn no doubt. The cutting edge nature of the specialized bead technology should ultimately rule the day!! Looking forward to that run up the $50, $60 and even $80/shre like the forum characters used to promise. I trust this is still their believe even though everyone is claiming their positions are a fraction of their former past!
Trial is ONLY SUSPENDED not Terminated. There is a HUGE difference according to Dr. Kevin.
It wouldn't surprise me if it was up and running sometime very soon!
ClinicalTrials.gov Identifier: NCT04385771
Recruitment Status : Suspended (security concerns based on preliminary results from preceding CYCOV-I-study suggesting higer mortality in cytokine adsorption group)
First Posted : May 13, 2020
Last Update Posted : March 15, 2021
Time to review the power of our science
Let's hope investors don't follow Kellum to EDTXF!
We all know the power of what we have have!
$3 is ridiculous and need not be mentioned here! At $3 it would share the same evaluation as Spectral Medical. I know, I know they have multiple FDA approvals and now Dr. Kellum as their Chief Medical Officer but big deal! They don't have anything close to us when it comes to revenue and they don't have Hemodefend which is in my opinion our secret special product nobody really understands! So what if EDTXF is in the middle of an open label confirmatory FDA phase IV trail to become the first approved treatment for Sepsis! Until they get the stamp they only have FDA approval on their diagnostic and the two pumps they have for home dialysis and the delivery of blood filtration. If their stuff was as good as people think it might be, wouldn't they be worth more than the equivalent of less than $3 a CTSO share? I really wish people would just focus on our cutting edge bead technology. Enough of the pathetic comparisons, once the Cyto XL product is approved we will eliminate ALL competition!! Read the August 2016 release on XL, it is telling!
Looong the magical beads!!!!!!
Timberr! #whatisunderthehood??
$3 is ridiculous and need not be mentioned here! At $3 it would share the same evaluation as Spectral Medical. I know, I know they have multiple FDA approvals and now Dr. Kellum as their Chief Medical Officer but big deal! They don't have anything close to us when it comes to revenue and they don't have Hemodefend which is in my opinion our secret special product nobody really understands! So what if EDTXF is in the middle of an open label confirmatory FDA phase IV trail to become the first approved treatment for Sepsis! Until they get the stamp they only have FDA approval on their diagnostic and the two pumps they have for home dialysis and the delivery of blood filtration. If their stuff was as good as people think it might be, wouldn't they be worth more than the equivalent of less than $3 a CTSO share? I really wish people would just focus on our cutting edge bead technology. Enough of the pathetic comparisons, once the Cyto XL product is approved we will eliminate ALL competition!! Read the August 2016 release on XL, it is telling!
Looong the magical beads!!!!!!
Anyone figure out why Kellum joined Spectral ( EDTXF )??
This is a mystery wrapped in a twinkie!
Why would a world renowned expert in AKI and Sepsis join a tiny little Canadian company that is only valued at a fraction of what we are?
Does anyone have a theory on this?
I just read a release from the U of Pitt and he took a 2 year leave to pursue this opportunity. I've been calling for a "companion diagnostic" for years here at CTSO. Note the use of "personalized medicine" in his statement in the Spectral news release. I think CTSO holders should all take a moment to thank him for the massive advances he has been a part of here. I believe he has been a special adviser for quite some time.
"I am very pleased to join the Spectral and Dialco teams," said Dr. Kellum. "Their combined diagnostic and therapeutic approach to the treatment of septic shock is unique, and I believe this represents the most likely pathway to success. This approach to personalized medicine is also applicable in many other disease processes and can lead to improved patient outcomes. I look forward to helping bring new approaches to renal replacement therapy, both in the intensive care units as well as in home. Dialco's instrumentation offers distinctive advantages for both acute and chronic renal failure and the opportunity to improve the lives of a large number of patients."
More scientific content a "must" here. The real question for the fellows dropping piano and pretend car ownership is, "what is up with out Sorb XL product"? Is it still a priority or has it been surpassed by the Hemodefend project?
Strange lack of content on this message board? Don't get me wrong guys, I love the stories of cool cars and even cooler pianos, you gents strike me as wealthy industrialists with lifestyles most not dare dream of! It must be sooo awesome to live such extravagant lives. Actually, I find it odd you have so much time to talk about it on a meaningless and sometimes questionable public message board.
For me personally, I am still learning all about the biotechnology stocks and specifically CTSO and their global leadership position in the filtration game. I have been banned or restricted for 2 years on this board and am only allowed to formulate 1 POST per day. Why is it that me, with only $2,000 currently invested in this knows far more amount the science than any of you? I never see any meaningful discussion about science, proof of concept, publication of RCT data or any other hard data that would prove efficacy ( that's actual proven benefit of usage ) Hand picked case studies are not accepted by the scientific community when it comes to proving efficacy. Our family friend Dr Kevin told me a long time ago not to pay much attention to case studies as the medical community does not.
What is going on with the Cytosorbent XL filter to remove endotoxin? It has been removed from the product listing on the website. I wish the gang here would focus on real and proven reasons to own this stock and keep the boasting about cars and pianos for facebook and what not. What happened to the "Hemodefend" trial? It was supposed to start more than a year before the pandemic was even a thing? Why are we always jumping from one potential blockbuster treatment to another? It seems now that removing blood thinners for cardiac purposes is the real focus. Heck, when I first bought, the beads didn't even do this! Are they just such a medical wonder that we keep finding newer, bigger and better uses for the beads? I am a little confused guys, can we reset and explain what we know for certain is the reason we are all here? I still maintain we need better cytokine diagnostics to guide usage. Did you know there are about 130 different varieties of cytokines? Some are helpful some are not. In my opinion ( not to boast, but seems I am far more educated than most of you ) personalizing medicine is the key moving forward and knowing which patient to treat at what time will become very important. The other nice thing with a companion diagnostic is that you can quickly measure the effectiveness of the therapy or in this case, the filtration process. Don't be afraid to ask questions, I'll be able to answer tomorrow when I next my next meal of bread and water and my chance to make my ONE DAILY post. Is there something fishy going on here guys??
All the very best to everyone, the rich, the poor and the naive
Former special advisor to CTSO moves north to join Spectral Medical as a full-time Chief Medical Officer for both Spectral and their wholly-owned division Dialco. I'm not too sure when he last worked for us, but too bad he wasn't reading this forum more to understand what is really going on! Should he be joining EDTXF? Has anyone seen their trading activity? I have to wonder if this is a bad career move? OH well. like they say, even the world's best doctors don't always make the best business decisions. It will be interesting to see if he has made the right decision. I wish him the very best and all CTSO holders should thank him for his past support of our company.
Spectral Medical Appoints Dr. John Kellum as Chief Medical Officer
T.EDT | 45 minutes ago
A World Authority in Blood Purification and Renal Replacement Therapy
TORONTO, Feb. 01, 2021 (GLOBE NEWSWIRE) -- 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 appointment of Dr. John Kellum, MD, MCCM as Chief Medical Officer.
Dr. Kellum’s appointment is effective March 1, 2021. He will assume the full-time role of Chief Medical Officer at both Spectral and Dialco, where he will be responsible for leading all medical and scientific activities, clinical activities and scientific evaluation of all partnership opportunities.
Dr. Kellum is considered one of the leading critical care researchers and world’s foremost experts on blood purification and acute kidney injury (“AKI”). He has pioneered research in the area of blood purification and has published original work on its application to clinical practice. Dr. Kellum is a founding member and past president of the Acute Dialysis Quality Initiative (ADQI) where he developed the first widely accepted consensus definition for acute renal failure - the original manuscript has been cited over 6,000 times. He is also a co-chair of the Kidney Diseases Improving Global Outcomes (KDIGO) clinical practice guideline on acute kidney injury. His research has received continuous funding from the National Institutes of Health since 2001. In addition, Dr. Kellum has served as a consultant to the FDA, the Department of Defense, the medical device industry and the pharmaceutical sector.
At the University of Pittsburgh, Dr. Kellum is a Professor of Medicine, Bioengineering, and Clinical & Translational Science, and serves as a Chair in Critical Research. He is also Vice Chair for Research within the Department of Critical Care Medicine and Director of the Center for Critical Care Nephrology. He has authored more than 400 publications. He lectures widely and has given more than 300 seminars and invited lectures worldwide related to his research.
“We are honored that Dr. Kellum has agreed to serve as our Chief Medical Officer,” stated Dr. Paul Walker, President and CEO of Spectral Medical Inc. “As one of the preeminent critical care researchers in the world in the field of sepsis, we expect he will be invaluable in helping complete our Tigris pivotal trial of PMX (Toraymyxin™ PMX-20R) for the treatment of patients with septic shock and endotoxemia, proven by an elevated endotoxin activity assay ( “EAA” ). The appointment of such a highly accomplished and respected clinician will be integral to the next phase of our growth as we move forward with our goal of combatting sepsis with our personalized therapeutic approach. Dr. Kellum’s international leadership in the critical role of directed renal replacement therapy will help guide the commercial rollout of our new “SAMI” and “DIMI” platforms targeting both the acute and chronic renal dialysis therapy markets. Given his unique capabilities and relationships, Dr. Kellum will also assist us in exploring new strategic opportunities, which could include partnerships, grants or opportunistic acquisitions of complementary assets and therapies in the fields of septic shock and acute kidney disease.”
“I am very pleased to join the Spectral and Dialco teams,” said Dr. John Kellum. “Their combined diagnostic and therapeutic approach to the treatment of septic shock is unique and I believe this represents the most likely pathway to success. This approach to personalized medicine is also applicable in many other disease processes and can lead to improved patient outcomes. I look forward to helping bring new approaches to renal replacement therapy, both in the intensive care units as well as in-home. Dialco’s instrumentation offers distinctive advantages for both acute and chronic renal failure and the opportunity to improve the lives of a large number of patients.”
About Spectral
Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 200,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for in-home use of “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use. “DIMI” recently received its FDA 510k clearance for use in hospital and clinical settings.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com .
Contact:
Dr. Paul Walker Mr. Chris Seto Ali Mahdavi
President and CEO COO & CFO Capital Markets & Investor
Spectral Medical Inc. Spectral Medical Inc. Relations
416-626-3233 ext. 2100 416-626-3233 ext. 2004 416-962-3300
pwalker@spectraldx.com cseto@spectraldx.com am@spinnakercmi.com
David Waldman/Natalya Rudman
US Investor Relations
Crescendo Communications, LLC
212-671-1020
edt@crescendo-ir.com
Strange lack of content on this message board? Don't get me wrong guys, I love the stories of cool cars and even cooler pianos, you gents strike me as wealthy industrialists with lifestyles most not dare dream of! It must be sooo awesome to live such extravagant lives. Actually, I find it odd you have so much time to talk about it on a meaningless and sometimes questionable public message board.
For me personally, I am still learning all about the biotechnology stocks and specifically CTSO and their global leadership position in the filtration game. I have been banned or restricted for 2 years on this board and am only allowed to formulate 1 POST per day. Why is it that me, with only $2,000 currently invested in this knows far more amount the science than any of you? I never see any meaningful discussion about science, proof of concept, publication of RCT data or any other hard data that would prove efficacy ( that's actual proven benefit of usage ) Hand picked case studies are not accepted by the scientific community when it comes to proving efficacy. Our family friend Dr Kevin told me a long time ago not to pay much attention to case studies as the medical community does not.
What is going on with the Cytosorbent XL filter to remove endotoxin? It has been removed from the product listing on the website. I wish the gang here would focus on real and proven reasons to own this stock and keep the boasting about cars and pianos for facebook and what not. What happened to the "Hemodefend" trial? It was supposed to start more than a year before the pandemic was even a thing? Why are we always jumping from one potential blockbuster treatment to another? It seems now that removing blood thinners for cardiac purposes is the real focus. Heck, when I first bought, the beads didn't even do this! Are they just such a medical wonder that we keep finding newer, bigger and better uses for the beads? I am a little confused guys, can we reset and explain what we know for certain is the reason we are all here? I still maintain we need better cytokine diagnostics to guide usage. Did you know there are about 130 different varieties of cytokines? Some are helpful some are not. In my opinion ( not to boast, but seems I am far more educated than most of you ) personalizing medicine is the key moving forward and knowing which patient to treat at what time will become very important. The other nice thing with a companion diagnostic is that you can quickly measure the effectiveness of the therapy or in this case, the filtration process. Don't be afraid to ask questions, I'll be able to answer tomorrow when I next my next meal of bread and water and my chance to make my ONE DAILY post. Is there something fishy going on here guys??
All the very best to everyone, the rich, the poor and the naive.
Funny stuff guys! I played the recorder in 3rd grade, LOL!
Mikey, we trust you like you wouldn't believe....BUT hey good buddy...you need to get some sleep : )
Hey fellow CTSO holders, what a morning, sure I only have 200 shares, but I am very, very interested in what might happen with the Cytosorb XL product...here's why;
Sepsis is killing A LOT of covid patients and often as a result of gastro-intestinal issues. "Leaky Gut" is a syndrome affecting covid patients and leads to endotoxin translocating or leaving it's balanced existence in the gut and circulating in the covid patient's bloodstream. WE HAVE the Cytosorb XL product, the soon to be crowned champion of endotoxin removal according to the August 2016 news release and likely advancement over the last 4 plus years! THIS is exciting, not as exciting as a new piano or even two lips on your organ, but fellas, let's address this critical point in time, we are or least should be, on the cusp of absolute medical history thanks to the ability of the Cytosorb XL and it's crazy good claims of endotoxin removal...sooo excited and looking for more intel!
Holy Chit!! My guess is Cytosorb XL news!! GO CTSO GO !!
Endotoxin removal remains front and center. What ever happened to our Sorb XL product? I hope it will be discussed in the upcoming shareholder letter. It sure looks more and more like endotoxin is a primary trigger of sepsis and the subsequent cytokine storm. I am certain I don't have to remind other shareholders of our letter dated August 2016 that claimed our XL product would, "for all intents and purposes", make other more proven endotoxin filters obsolete. Don't we have to run a trial or provide some sort of actual usage and efficacy around the shiny new filter? I don't think a planted Q&A session inside a competitor's AGM is enough to get this hidden gem across the finish line but I may be wrong. Anyone know if it has been used yet, at least on a human and not just on the lab bench. Their IR guy had told me a long time ago that it was being used in REHASH II, but that turned out to be incorrect intel. I can't wait to see this unleashed in a nice 500 patient RCT trial that leaves the competition in our endotoxic dust! Bring on the XL and bring on the BIG profits!!!!!!!
Holy Chit!! My guess is Cytosorb XL news!! GO CTSO GO !!
Endotoxin removal remains front and center. What ever happened to our Sorb XL product? I hope it will be discussed in the upcoming shareholder letter. It sure looks more and more like endotoxin is a primary trigger of sepsis and the subsequent cytokine storm. I am certain I don't have to remind other shareholders of our letter dated August 2016 that claimed our XL product would, "for all intents and purposes", make other more proven endotoxin filters obsolete. Don't we have to run a trial or provide some sort of actual usage and efficacy around the shiny new filter? I don't think a planted Q&A session inside a competitor's AGM is enough to get this hidden gem across the finish line but I may be wrong. Anyone know if it has been used yet, at least on a human and not just on the lab bench. Their IR guy had told me a long time ago that it was being used in REHASH II, but that turned out to be incorrect intel. I can't wait to see this unleashed in a nice 500 patient RCT trial that leaves the competition in our endotoxic dust! Bring on the XL and bring on the BIG profits!!!!!!!
Endotoxin removal remains front and center. What ever happened to our Sorb XL product? I hope it will be discussed in the upcoming shareholder letter. It sure looks more and more like endotoxin is a primary trigger of sepsis and the subsequent cytokine storm. I am certain I don't have to remind other shareholders of our letter dated August 2016 that claimed our XL product would, "for all intents and purposes", make other more proven endotoxin filters obsolete. Don't we have to run a trial or provide some sort of actual usage and efficacy around the shiny new filter? I don't think a planted Q&A session inside a competitor's AGM is enough to get this hidden gem across the finish line but I may be wrong. Anyone know if it has been used yet, at least on a human and not just on the lab bench. Their IR guy had told me a long time ago that it was being used in REHASH II, but that turned out to be incorrect intel. I can't wait to see this unleashed in a nice 500 patient RCT trial that leaves the competition in our endotoxic dust! Bring on the XL and bring on the BIG profits!!!!!!!
Lack of real confirmatory data is really starting to limit shareholder opportunity here. Given the current value of the company I do not see much further growth until we can offer Wall St some real RCT data to chew on. I've seen a lot of fluff in my day and I believe the beads are in fact the real deal...that said, case of the week reports and forum posters telling the world the beads are magnificent has just about reached it's expiry date. Time to offer up some real data from a properly run RCT. To date, I've yet to see any compelling data from this firm.
We seem to move from one major opportunity to another and never really take command of any particular indication. Are we still a sepsis co or are we now moving towards reducing blood thinners? We've also appeared to be a solution in many other situations but that has come and gone...how is the Covid battle going, are we helping and if so in what specific way?
Thoughts??
SIGY CEO Joyce claims in recent interview that CTSO can't remove endotoxin. What the heck is up with that! Does he know about the launch of the XL product from the summer of 2016? Where are we with that? Has it been used on a human to date? Mingzu!! Cheers to Korea and their recent approval of the sorb! My pal Rob knows the Korean market like the back of his hand. He claims this is HUGE.
I urge people to listen to the SIGY interview available through their recent news release. Either SIGY is wrong, or we have dropped the ball on endotoxin removal. Asia and Europe are claiming severe cv19 cases are often gastrointestinal related and endotoxin is the nefarious culprit. My Korean friend is joing IHUB today or tomorrow to share knowledge about cv19 and endotoxin. He is a beaut and will be a major addition to this story line.
Best to all and GO Sorby GO!!!!!!!!!!!
Keep a close eye on Spectral Medical and Major partner Baxter...I think they have some endotoxin news up their collective sleeve..just my humble opinion for certain.
Time to unleash our Cytosorb XL filter! New studies show that severe covid cases are tied to gastrointestinal issues and what is commonly termed leaky gut. Those truly understanding the power of the Sorb know that the XL product has the clear and totally proven ability to not only remove cytokines but also endotoxin. I've written Dr. Phil this morning and requested we move XL to the front lines and in an expeditious manner. I know some of you Debbie Downers will claim that Spectral or EDTXF has the best and most proven form of endotoxin removal in the Toraymixin filter, but I suggest the XL could easily make the Japanese product a dinosaur in the blink of a an eye. Time to unleash the power of the XL filter. Who here knows about the many trials we've run with the XL and what are the results? Post them now and let's get on track to save countless American and Canadian lives!!!
Very lonnng the Sorb abd especially the dynamic XL!!!
Canadian APPROVAL is freaking HUGE!!!!
Likely why the company has released the major news twice in the last 8 days!
I'm excited...VERY excited!
I wonder what allowed Canadian officials to press the GO button on this critical decision?
I'll bet it was that German Sepsis Trial we ran where we showed a 17% absolute difference. Important to know that CTSO handled the sicker group in this RCT endeavor! I'm almost certain the 17% was in our favor...wasn't it???
The market likes it and Canadian orders should start pouring in. I have a friend Rob in Canada that works the Canadian message boards, I'll bet Canadian investors are Jonesing to buy their CTSO stocks!
This is truly incredible and worthy of SA jumping all over this news!!
Holy COw!!
The Scooter
Happy Thanksgiving to all my friends here!
Interesting comment to add to Orangecat's wonderful post. Did you know that Toraymyxin's phase 2 trial in Italy was terminated because the efficacy was so strong it was considered unethical to not give Toraymyxin to the control group? Look it up. it was called Euphas and set for 128 patients. At patient 64 the plug was pulled. Cool huh? The 21% absolute 28 day mortality was a surprise, as 28 day was a secondary endpoint..huh again and best to all!
Cytokines are so important! Great piece from Andycase. Good piece here too......
Medgadget: Do you think that in the future, Spectral Diagnostics technology will be able to control or intervene in the reactive cytokine responses towards endotoxins?
Dr. Walker: There is published evidence that shows when the endotoxin is removed from the bloodstream, cytokine production decreases significantly. However, at this point, no studies have shown that reducing cytokines alone has a direct effect on mortality rate. Endotoxin directly effects many cells and especially contributes to myocardial depression, so removing endotoxin has many potential therapeutic effects.
I can't wait for the XL to arrive on the scene! It was first announced in August of 2016! Is it sitting behind Haemodefend or in front of it in the lab?
Why did the FDA Fast-track talk completely stop?
I sure hope Ticagrelor is the powerball ticket for us. I could use the bump even on my small position. I am taken by Martyin's apparent dislike for the company. Good to see martin like miketheaccountant both seem to know just what a wonderful product we have...BUT how?? How do they know? Who knows just how beneficial it is?
It would be nice to see an initiative be followed through to both scientific and commercail success.
So far it's been cytosorb for Sepsis, then Hemodefend, then cytosorb for Ebola and just about every other disease of the week, cyto for covid and now it's Ticagrelor. I must say it's a buffet of sorts as far as the filter goes. Question remains...
How well does it work, when to use it, how much to use and when to stop. There is no reliable FDA approved test or diagnostic for cytokine measurement. Where is the 28 day mortality efficacy? Where the randomized control trial proving any of the said secondary benefits?
Isn't Marty just another disgruntled Mike9999 type that despite the concern seems to guarantee a wonder device?
Good luck to all!!!
I thought our "homerun" was Sepsis? Why does the homerun fence keep moving with this group? When will they do a real trial with meaningful results? I'm starting to wonder about this company and may finally sell my last 50 shares! Haemodefend has been on their lab bench for almost 20 years, the fact it has never amounted to anything fits in nicely with the sepsis story. Just be glad it's valued where it is! I'll stick around and likely sell half my position on Monday, even if it's at a small loss. Disappointing unless you were the group in Chicago that funded this at 5 cents or $1 on a consolidated basis. What was the name of that fund, Abe Lincoln Park or something?
If "winner" is the firm that people are pushed towards so that the significantly superior scientific story can continue to make FDA advancements and allow insiders to maintain their positions without sharing then....surely CTSO is the big champ. I was just curious on what scientific proof or efficacy were we crowning them kings? Seems to me that Fresenius dumped them at the alter in Europe and their only sepsis RCT in Germany was a complete mess. Please provide detail if I'm incorrect. Please pay attention to the confirmatory phase 3B TIGRIS trial that EDTXF is currently running now with the FDA. For a strange and unknown reason the Canadian firm chooses not to share any FDA advances with the US audience. They appear to like the quiet accumulation by those part of the story. I only own a few, been thinking of adding many more. Thanks for checking in, I enjoy watching the bull show youre running on the CTSO site. It's one of the best of it's kind on the circuit. hehe
OH indeed EDTXF's revenues are near nill...as is the marketing and retail position of the stock. Look a little closer though...the FDA approvals, insider positions and scientific advancement with the FDA is just short of stunning...somebody has a helluva strategy to own as much as possible at the cheapest price possible. I wonder why anybody would want to own so much at the best possible price and completely shutout the awareness of the US market? Three guesses for the IR here and of course the first two don't count. My EDTXF position continues to grow and grow as does the lack of real RCT scientific proof of efficacy here. Gotta love those old CE approvals...if it is safe you get the stamp. Time for Andycap to handpick another case study...too funny!
I`m a HUGE Chan Fan! Taking this to $15 and a half billion evaluation with no usable RCT data is a stroke of marketing genius. I say three cheers to Dr. Phil for making lemonade and selling it at a premium. I just wish I had bought this at 5 cents before the magical value add began. Hats off to you Dr. Phil, how do you do it!!
Baxter Medical gave 5 MILLION dollars to EDTXF just to allow them the right to sell their products. Shouldn't some large pharma offer CTSO 20 or 30 M dollars for the same right? Especially when you consider how advanced the beads are. A bit of a head scratcher for certain. I was really impressed with the level of revenue, I mean 10 million for one quarter is really quite a bit. You can understand the excitement now. What's even better is the amount of clinical trials planned. I know it's been 20 years, but it's never too late to show just how efficacious your products are, it's how you catch the big fish like Fresenius and Baxter. Looks like REHASH II will start recruiting again in H12021, which is exciting and for me it's the Hemodefend trial, can't wait to see the results from that one! Hemodefend is one of the reasons I first too an interest here. The big Vincecenza conference is on in Italy right now so we are likely getting a lot of people watching our rapid advancement. I still own just 50 shares but am starting to consider doubling my position with all this clinical advancement planned. Really, I'm kind of really excited by the prospects of the future and we only lost about 1 MILLION, even though most all our clinical trial expenses are currently NILL. Great to see friends out in support of this gamechanging device company!!!
Charles in charge! Let the fun begin!
I love modest Canadian companies!
This is humorous content. It serves as a reminder of how companies like CTSO will launch themselves on the heavy lifting done by Spectral Medical and their current FDA phase 3B PMX or Toraymyxin filter trial for endotoxemic septic shock. Spectral brings a theranostic approach to their phase 3B trial called TIGRIS. The 150 potential person trial is Open Label and is also using data from 194 patients of it's completed FDA phase 3 Euphrates trial. The current phase 3B confirmatory trial is giving 2 of every 3 patients the proposed PMX filter and is guided by Spectral's already approved EAA diagnostic. The most recent addition to the theranostic trio is the FDA approved SAMI, a stand-alone hemo-perfusion unit that delivers the PMX filter after the EAA diagnostic determines which patient is best suited for the therapy. It's quite slick and so is the effort to keep it completely under the radar...see US PINKS with NO news flow from Canada. What, you think Canadians don't know how to move a stock from 5 cetns to 20 and then consolidate it so institutions can buy it? What a brilliant idea, if you want peoples buying your paper. If you're in a state that allows it...crumble some up in your pipe and think about it.
Worth a look..but I still think the Sorb XL has to be better. I think the XL will be good, as they came up with the idea for it right after EDTXF finished their FDA phase 3 trial. Somebody watching closely must think getting rid of the endotoxin is a good idea? Maybe, I hear endotoxin is the primary cause of IL-6 and what-have-you. Can't wait for those billions of beads to start gobbling up those nasty endotoxins!! The storm, yeah the cytokine storm!!
This is humorous content. It serves as a reminder of how companies like CTSO will launch themselves on the heavy lifting done by Spectral Medical and their current FDA phase 3B PMX or Toraymyxin filter trial for endotoxemic septic shock. Spectral brings a theranostic approach to their phase 3B trial called TIGRIS. The 150 potential person trial is Open Label and is also using data from 194 patients of it's completed FDA phase 3 Euphrates trial. The current phase 3B confirmatory trial is giving 2 of every 3 patients the proposed PMX filter and is guided by Spectral's already approved EAA diagnostic. The most recent addition to the theranostic trio is the FDA approved SAMI, a stand-alone hemo-perfusion unit that delivers the PMX filter after the EAA diagnostic determines which patient is best suited for the therapy. It's quite slick and so is the effort to keep it completely under the radar...see US PINKS with NO news flow from Canada. What, you think Canadians don't know how to move a stock from 5 cetns to 20 and then consolidate it so institutions can buy it? What a brilliant idea, if you want peoples buying your paper. If you're in a state that allows it...crumble some up in your pipe and think about it.
Worth a look..but I still think the Sorb XL has to be better. I think the XL will be good, as they came up with the idea for it right after EDTXF finished their FDA phase 3 trial. Somebody watching closely must think getting rid of the endotoxin is a good idea? Maybe, I hear endotoxin is the primary cause of IL-6 and what-have-you. Can't wait for those billions of beads to start gobbling up those nasty endotoxins!! The storm, yeah the cytokine storm!!
What's even harder to believe is the fact an important paper was written on IL-6 and all we got was a blurb that amounted to a case study. This is IL-6, our key target and the arena where we are the kings. Shouldn't CTSO have been much more involved and perhaps dominant in this discussion? Isn't IL-6 what causes Sepsis? Aren't we a Sepsis company? Thoughts on this appreciated. Sheeesh!!
I think you kids mean, "full factual transperancy" no??
How might EDTXF obtain 5 million dollars from Baxter and make massive scientific advances with the FDA and be left with a company value less than 20% of the Sorb? Unless of course this is the one to buy as per ???
Spectral got FULL FDA approval for Covid19, NOT a simple EUA. Furthermore, EDTXF is in a phase 4 confirmatory trial with the FDA whereby EDTXF is used on 2 of every 3 patients. It's apples and oranges people. CTSO has been a promotional landing pad and EDTXF is as covert as area 51. It is a little funny though to watch this forum play-out. GL to all the fine people!
Spectral got FULL FDA approval for Covid19, NOT a simple EUA. Furthermore, EDTXF is in a phase 4 confirmatory trial with the FDA whereby EDTXF is used on 2 of every 3 patients. It's apples and oranges people. CTSO has been a promotional landing pad and EDTXF is as covert as area 51. It is a little funny though to watch this forum play-out. GL to all the fine people!
Mucho monkee business here. Very tightly held and multiple FDA approvals including a partnership with Baxter Medical. US suppression in full throttle mode. It is an interesting little science project. These Canadians are stealthy astards.
We appreciate your canader. I just thought you were here to sell the idea that it was only mgmt holding down the miracle cure. Good to know there is much less to you than meets the eye. I just wondered how you were able to determine the efficacy? I hope you didn't use the German RCT trial that ended all too soon. I heard we were -17% on the absolute efficacy. Apparently due to taking the sicker patient population. A little surprising though, I thought randomized control trials allowed for an even sickness or patient population. Learning soo much here and enjoying the 400 million evaluation on the strength of a 19M net loss. I just hope we continue to hang around these levels...but that is just me.