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Also coming in 2019, AFERETICA AND CYTOSORBENTS DEBUT THE PERLIFE™ SYSTEM FOR ORGAN PRESERVATION AND REHABILITATION. PerLife™ Is the First System Integrating a Sorbent Purification Technology to Perfuse, Cleanse, Recondition, and Preserve Harvested Solid Organs for Transplantation.PerLife™ is the first integrated system that incorporates sorbent purification to perfuse, cleanse, recondition, and preserve harvested kidneys and livers, which account for 89% of all solid organ transplants globally The PerSorb sorbent cartridge leverages CytoSorbents’ state-of-the-art adsorptive porous polymer technology, targeting the reduction of a broad range of toxins from the perfusate that can compromise organ function
https://cytosorbents.com/aferetica-and-cytosorbents-debut-the-perlife-system-for-organ-preservation-and-rehabilitation-at-the-27th-international-congress-of-the-transplantation-society/
pearsby, it is really very simple, 20 people were expected to die, were actually on their deathbeds, were treated with Cytosorb for their sepsis and 41% survived because of it. Indeed, they met the 28% mortality that you aspire to.
it has been press released, please follow the link. https://cytosorbents.com/data-presented-on-first-cytosorb-investigator-initiated-septic-shock-study/
me and the rest of the world prefer the Griefwald study pearsby, 20 patients on their deathbed with refractory sepsis, with a 0-10% chance, at best of living. They were treated with Cytoborb and 41% survived after 28 days! Now that is a miracle treatment pearsby.
lakersrback, I answered this same quesion before, for you, under pearsby. The study under Doctor Sigrun Friesecke in Griefwald Germany, " Preliminary key findings of the CytoSorb® Greifswald study: 28-day-survival was 41%, an approximately 30-40% absolute improvement in survival compared to what was expected (0-10%) Resolution of shock, the main cause for mortality in this patient population, was achieved in 68% of the patients with CytoSorb® therapy, which translated into improvement in clinical outcomes Reduction of IL-6, one of the cytokines most closely associated with severity of illness, inflammation, and mortality in sepsis, decreased rapidly from initial mean values of approximately 87,000 ." This was a sepsis study with refractory sepsis, where none of the patients were expected to live and after being treated with Cytosorb, the 28 day survival was 41%. Of course, the company will eventually do a much larger trial.
Dr. Chan should also provide information regarding the upcoming HemoDefend trial in the US. It has already been paid for with grant money and is to be a short trial. Our old manufacturing facility is already producing the product. It could be huge as it will give is our first US sales upon approval.
bustingmyask, I agree with you. This slide began about 4 months ago with no bad news. The share price loss is totally out of proportion to the overall market loss. The 3rd quarter could have been better but still was the second best quarter ever. I believe that this is pure manipulation by shorts, with a very prolific poster on our board involved. I cannot see how you could blame management for this, nor the PR firm. They publicize what there is, cannot fabricate news.
lakersrback, I mean pearsby, my point is that you are more pumping Spectral than making a 28 day mortality point. Also, if your intentions are good, why do you constantly change your aliases?
lakersrback please cease your daily pumping of Spectral on this board.
lakersrback, you are definitely creative...and prolific.
astray, Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020
that is not so far away, there will also be interim reports from the study that could increase share price. The sky is not falling.
https://investorshub.advfn.com/secure/post_reply.aspx?message_id=145462612
eskay1954, you are incorrect about there being no fast track status for a medical device.
Expedited Access Pathway Program
"The FDA recently published draft guidance on the Breakthrough Devices program. You can submit your comments on the draft guidance, which describes the policies that the agency intends to use to implement the program, by December 26, 2017.
On December 13, 2016, the Breakthrough Devices provisions were added to the Food, Drug, and Cosmetic Act through section 3051 of the 21st Century Cures Act. This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.
The Breakthrough Devices Program expands upon the Expedited Access Pathways (EAP) program by making future 510(k)s eligible as well as Premarket Approval applications (PMA) and De Novo device submissions. All participants previously granted EAP designation will have designation as Breakthrough Devices; no separate action is necessary.
For any questions about the Breakthrough Devices program or EAP, please contact CDRHExpeditedAccessPathway@fda.hhs.gov.
https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ucm441467.htm
Is Aferetica scheduled to begin sales of it's Perlife system utilizing PerSorb in January?
the Hemodefend trial has not started yet.
slappie, you keep repeating with your offering scare. What do you have to back that up? The company has $25 million in the bank, an active ATM, soon the ability to borrow another $5 million if needed. Company profitability to come in this quarter per Dr. Chan and the upcoming Hemodefend trial is government funded by $3 million. I can only guess another attempt to try to drop share price.
pearsby, why would they possi ly need an offering when they have $29 million in the bank, the ATM bringing in cash and about to be profitable. Dr. Chan has stated that .50 of each dollar in sales above breakeven will go to the bottom line.
Could the shorts have manipulated it/shorted down too far, lost it to high demand and now we have a short squeeze?
Dr. Chan has stated that the second half sales would be greater than the first half sales, also that we would become profitable, in 2018. All this is caused by short attacks trying to save themselves from the great news coming tomorrow.
How could you not feel good about 3rd quarter results? Dr. Chan had stated that 2H will be better than 1H. In my opinion, this is the opposite of what you are posting. That shorts are having their attack because of anticipated great Q3 earnings and first ever operating profit.
We have seen this before. Shorts trying to manipulate share price to bring it down before earnings that will again be record setting and possibly the first profitable quarter ever. They are trying to change sentiment to negative with negative messages, all of which are from one person from Coral Gables. I do wish the company would contact FINRA regarding this manipulation.
burnttoast, I strongly believe that most of the buys and sells were by the shorts, selling to each other, dropping the price. They are trying to cover before earnings occur and the top blows off. We should reach profitablility then and that will be huge!
Dr. Chan also stated that 2H sales were going to be higher than 1H sales this year.
Dr. Chan stated in the 2Q report that 2nd half sales would be higher than 1st half sales.
spooked the market with loon behavior? Really? Best unemployment rate in forever, tax cuts, record high stock markets. Some wish that the economy will crash before the mid term elections.
Lakersrback, you said that you are disappointed by many that called for such lofty share prices today. How about September 2, 2018 you posted "What area of care offers us the biggest chance to really surge into that $50 to $60 a share category?" Sounding a lot like pearsby.
looks like coldterinvestor is short.
We know that Cytosorb filters out variety of harmful cells from the blood. The size of the beads can be adjusted for different uses. Could cancer cells be captured and eliminated?
Shorting CTSO, a topic rarely discussed here and with which I am ignorant. I have never shorted a stock, am very long here. On 8/15/18 the short interest was 2,405,443 shares, 9.62% of the float, that is $34,878,923 at today’s price. Does anyone have any insight into who/what would short CTSO? My best guess, for most of it, is a hedge fund, it would almost have to be to finance that amount. A brokerage is going to require collateral so they have funds tied up for that, additionally they must pay interest.
I do feel that there was a bear raid after the Q2 earnings on August 2, 2018. We reached $12.90 that day with an excellent earnings report. The next day, we closed at $11,63. I realize that some of that was profit taking, but it seems that the share price should have exploded the next day, as it has done recently, perhaps a delayed response. Those of you that have been here a long time have seen this occur periodically. I suppose that the only cure will be for the Company to continue to outperform the rest of the market.
With this "$3 million, to facilitate and accelerate the commercialization of its HemoDefend" coming from the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), moving into the revenue column (although over 3 years), it will assist us in making the company profitable, probably this quarter.
You have to be kidding me.Just what PR's would you have them do that they haven't, and keep from being sued by shareholders that might feel that they were lured into buying purchasing sales under false pretenses? You want us to sponsor the Olympics? Also, why the old story about nothing happening until the next quarter? The company is always pulling surprise announcements and you have events like the runup before we were added to the Russell 2000 and share price increased by 50%. I always get suspicious of motivation when there are multiple attacks, at the same time by "different" posters.
ersky, do you recall the 3 million shares purchased when we were added to the Russell 2000. All of those shares went to index and or mutual funds. Their interest in us is growing.
OrangeCat, I believe that we are worrying too much about plant capacity. Management is very conservative about what they publish, there have been very many surprises. If they can double capacity for $100, 000, they may be able to double again for very little. I believe that they will also build a plant in Germany within the next few years also to handle capacity. A separated plant would reduce the possibility of a disaster, such as fire, flood, etc. creating stoppages. I don't worry about enough capacity, nor sales that are right at doubling each year. The power of compounding sales is incredible.
erskay, I know how you like to get the last word in, but that PR came to me as an email!
Eskay, that was not a fluff email. Any serious CTSO owner would like to know that additional territories have been added and that a new distributor was taking over the UK. These new countries may or may not add much in sales in the near future, but over time they will. "Recently added countries (and distributors), accounting for an additional 31 million people, include:
Lebanon – Pharma World LB
Bosnia, Herzegovina, and Croatia – Medis, d.o.o.
Estonia, Latvia, and Lithuania – SIA Scanmed
Moldova – Smart Medical Solutions
Montenegro and Serbia – Mar Medica, d.o.o.
The Company also announced the change of the company's distributor in the United Kingdom to Chalice Medical Ltd., with a focus on England and Ireland.
Eskay, there is a simple answer to why Dr. Chan does not hire a COO, Dr. Chan has always attempted to keep costs down, so that we can reach profitability sooner. Dr. Chan wears several hats, I imagine that he easily works 60-80 hours a week. I can see where he would not want to take on a $250,000 additional salary at this time when he already has a director of sales.
I like the last sentence of this Case of the Week, "The authors state that cytokine adsorption was used after all other treatment modalities had failed in her management, which lead to complete recovery of the patient."
wow Kid-A, 5 million euros, that would be 5.8 million dollars. That would give us a big bump. I hope that you are right.
Rival Novartis, Gilead CAR-T therapies win CHMP recommendations
Jun. 29, 2018 9:27 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Carl Surran, SA News Editor
Rival cancer cell therapies from Novartis (NYSE:NVS) and Gilead Sciences (NASDAQ:GILD) win key recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use, likely clearing their way for approval.
CHMP recommends NVS’s Kymriah for treatment of B cell acute lymphoblastic leukaemia and diffuse large B cell lymphoma; the product already has been approved in the U.S.
The panel also recommends GILD's Yescarta, which also has U.S. approval in blood cancer, got the CHMP's nod for treatment of diffuse large B cell lymphoma, and would compete with the NVS medicine, as well as in primary mediastinal B-cell lymphoma and transformed follicular lymphoma.
The European Commission must issue final approval before the medicines can be sold in Europe.
The Preliminary additions/deletions for the Russell Indexes were published 6pm ET on June 8th, our big upward rise began on the morning of June 14th.
This regarding the Russell 3000, from 2015 but appropriate.
It comes but once a year, and Friday is like a holiday for many Wall Street stock traders: it's Russell rebalance day.
Russell Rebalance Day — Does It Influence Small Stock Moves?
The annual reshuffling of the Russell 2000 Index of small-capitalization stocks tends to be the heaviest daily trading volume of the year. That's because FTSE Russell , a unit of London Stock Exchange (LSEG), implements the roster changes for which stocks belong in large-cap Russell 1000, Russell 2000, and the combined Russell 3000 indexes. Volumes crescendo at the end of the day, typically the last five minutes, because funds that follow these indexes aim to match their portfolios with end-of-day prices for stocks that are entering or exiting the indexes.
Anticipation for benchmark additions tends to help prices of stocks headed on to the new indexes. Colas finds that, this year, the 120 or so companies that are being added to the Russell 2000 have gained, on average, 11% since the start of May. Meanwhile, shares of the average company that leaving has declined 2%.
https://www.barrons.com/articles/russell-rebalance-day-does-it-influence-small-stock-moves-1435336799