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CTSO is not presenting.
The Renal Research Institute (RII) has announced at http://www.renalresearch.com/RRI/index.htm the 15th International Conference On Dialysis in Puerto Rico. Rodney Kenley of Aethlon Medical (AEMD) is presenting on Day 1 “Extracorporeal Methods to Reduce Inflammation in Acute Sepsis.” This AEMD program is allegedly sponsored in part by DARPA.
Significantly RII offers 18 Continuing Medical Education (CME) credits for attending this very important conference. Typically physicians are required to have 25 CME credits each year in order to maintain current medical licensing. I am of the opinion that CTSO would have been a better candidate to have made the same presentation, but what do I know?
A world-class selection of universities and businesses including Fresenius are presenting. Notably CTSO is not presenting. But of course Dr. Chan does not have the time to present at every relevant conference and it may be that business conferences sponsored by the likes of OneMedForum and Rodman are more important in his opinion than medical conferences where the majority of attendees are physicians and KOLs.
There could still be time for CTSO to present. Could authority for someone else at CTSO have been made to make a presentation? Draw your own conclusions.
Vinovista, I enjoyed your pun, "Patients is what is needed." Indeed patience and patients are needed. Thanks.
Unmistakably the first task for CTSO
is to identify potential partners
and then announce a partnership within the next three months. Potential partners have been mentioned many times including Fresenius and Gambro. CEO Kraus seems the most qualified person on the Board to direct this first task.
The second task for CTSO is to announce a distributor partner. Dr. Chan stated once, “We firmly believe that out licensing is a key strategy to unlocking the value of our technology.” Further delays in announcing a distributor partner are no longer tolerable.
Self-denial is no longer excusable associated with rigidity in thinking that insisted previous deals offered by potential partners could not be negotiated on less favorable terms. CTSO must be psychologically prepared to give up much, not just some. A piece of the pie is better than no piece.
If there are announcements within three months or sooner of a partner for FDA studies and for distribution of Cytosorb elsewhere through Europe or other good news of dramatically improved sales or impressive results from dosing studies, the pps will recover. Otherwise, CTSO will be kaput. My strong feelings are that this period of three months is a make it or break it time for CTSO.
CTSO may go into a death spiral unless,
there is a partnership or other major good news soon. Without a major partnership the FDA studies cannot be initiated. In the Twist article some time ago CTSO projected the start of FDA studies in late 2011 or early 2012. Now in the SHL of 1/9/13 initiation of the FDA study has been delayed two full years. Further delays must not occur. Projections by CTSO leadership are now being publicly questioned unfortunately.
CTSO has neither the capital nor realistic hope of raising sufficient capital quickly enough in the eyes of investors through sales or government grants to break out of the tarring and feathering it just went through in a reasonable time. The methodical course of plodding along with minimal studies, minimal numbers of patients, and minimal resources must be altered. Slow and meticulous execution is no longer acceptable. CTSO is in the fourth quarter with less than five minutes to play and is behind. Whatever the excuses given, the head coach must take some responsibility for unexciting sales.
On a battlefield the comparisons in leadership would be between McClellan drilling month after month versus Grant charging ahead. Rigid, inflexible obedience to a plan that outlines carefully where CTSO is going must be challenged because time is running out.
Self-examination is necessary
if the CTSO Board is to recover from the recent psychological derailment caused primarily by sales being less than hoped for in Q4 12. On its present course CTSO may lose some of its sales people and if so there will be further erosions in faith leading inexorably and inevitably to a crisis of confidence in the company by its employees and investors.
First, the Board must ask if Cytosorb is effective some of the time, all of the time, or none of the time. The answer will surely be some of the time among KOLs in Germany. Questions about why sales have not been as good as expected can be deferred temporarily and should be less of a focus as long as there is a conviction that the CTSO products are effective and better than other cytokine reducing and blood filter products on the markets.
The Cytosorb filter should theoretically be more effective than the AN69ST filter that has been proven effective in cytokine reduction (Blood Purif. 34(2): 164-70. 2012) because of greater surface area. Further validation for the efficacy of the Cytosorb filter has been established as well through the EU studies and various government grants. Nevertheless doubt in the efficacy of Cytosorb will remain in the eyes of medical users and investors until all questions about efficacy are put to bed through a definitive FDA study even if good results are announced from dosing studies. Questions will linger as to whether membrane technology is more effective than porous bead technology in removing cytokines.
The key to breaking out of the current psychological morass among is to accelerate further studies using Cytosorb. Without doubt that means giving up a portion of future profits in the U.S. It has now become critically important that FDA studies be initiated more quickly than projected in the SHL of 1/9/2013. It is imperative that CTSO identify a partner speedily, pursue that partner in a deal giving away most U.S. rights in return for the partner paying for FDA studies, and then announce the partnership quickly.
Ho – Hum, Blah – Blah
At the OneMedForum on January 8, 2013 Dr. Chan made a technically impaired presentation largely because of microphone problems. Initially there were many pauses as his microphone was repeatedly adjusted until midway when he picked up steam and talked at a machine gun pace trying to catch up with presentation time he had lost. Although these problems were largely not his fault, his presentation was nevertheless impaired mirroring his reports.
The estimated $100,000 of sales in Q4 (calculated on the basis of $200,000 to date) was disappointing, and as one message board commentator wrote would have scarcely paid the salaries of the sales people and Dr. Steiner. Let us hope that there is not a crisis of confidence engendered by sales personnel disappearing elsewhere.
While the presence of 60+ KOLs is impressive and encouraging, until sales and good news materialize investor confidence will remain diminished. CTSO badly needs cash and decent news of one sort or another to increase investor confidence and pps.
While previously investors had been led to believe that the results of dosing studies would be forthcoming by the end of Q4 12 or Q1 13, the SHL the next day on 1-9-2013 gave out no update as to when the belated results of that study would be given to investors. Many investors had also anticipated that by Q1 13 an outline would be given for the FDA studies that disappointingly now are being delayed to Q4 13 or Q1 14.
The absence of sufficient information about dosing studies, the delay in the start of the FDA studies, and the lack of exciting sales in Q4 12 sent the stock price spiraling downward. Clearly healthier news is needed. At a minimum updates on the dosing studies are needed with the publication of a peer review article on Cytosorb.
Dr. Chan did stress the obvious fact that CTSO needs to “monetize” part of its pipeline. Candidates would be HemoDefend and/or ContrastSorb through a partnership or partnerships with immediate infusions of cash. Distributor partnerships for other parts of the world are critically needed too.
At this time CTSO simply does not have the time or financial resources to develop on its own portions of its pipeline. “Monetizing” part of the CTSO pipeline is absolutely essential and has become critical. As Dr. Chan mentioned, patents do run out and so can investor patience.
An important stock price to overcome is the $0.14 level so that the previously announced 39 million shares that can be sold at a price of $0.14 or higher can be sold thereby lessening greater dilution through LPC financing.
It has been tough sledding for CTSO. Better PR, better sales, and better overall performance are needed to maintain investor enthusiasm. Long range strategic thinking needs revisiting. What could be done, for example, to move up the start of a FDA Cytosorb study? How much should CTSO give up expediting development of its pipeline?
If CTSO’s strategic planners come to believe that a small piece of the pie is better than no piece in some instances, CTSO needs desperately to find partners willing to share the costs of development and profits. It remains obvious that CTSO does not have the financial wherewithal to initiate a FDA study on its own or even develop further substantial studies for HemoDefend and ContrastSorb.
If for one reason or other significant sales of Cytosorb do not develop within the next two quarters or good news with cash infusions do not emerge, the financial integrity of the company could become threatened. Investors will have little patience for hearing more excuses why significantly improved sales or other good news are not materializing.
CTSO management needs to get its collective ostrich head out of the sand, and become more self-critical. Unfortunately, some investors are even suggesting now a change in management is needed.
The earlier downgrade by Zacks to Hold from Outperform seems warranted, although I continue to accumulate stock for the simple reasons I see still more positives than negatives. I still believe in the efficacy of Cytosorb, the strengths of its patents, and the overall ability of its management.
Nice summary Ping. I would add that FDA trials would be financed by a major partner, such as Fresenius, Gambro or Baxter. It is doubtful that CTSO would have the financial capability to embark upon FDA trials estimated by some experts to be 8 - 12 million, and I suspect substantially more, without help. I do not believe FDA trial could be started easily without definite financial help on board.
Zacks has reduced its rating on CTSO
From 2 and Outperform to 3 (hold). The Analyst report is no longer available as a link, only the Snapshot.
Why has Zacks downgraded CTSO? Is it possibly because the dosing study that was hopefully going to be out by the end of 2012 has not come out yet? Was it because sales for Q3 2012 were not as good as Zacks initially projected? I am only speculating why Zacks has downgraded CTSO in the last month although I feel these questions reflect concerns of many investors.
EVEN MORE CAPITAL EFFICIENCY IS LIKELY
There is nothing in the recent announcement of 39,634,615 shares being available to be sold that precludes CTSO selling shares at a higher price than $0.14 per share. Even if the sales price of $0.14 per share provides a temporary resistance point level, the market price of CTSO stock could easily exceed the current level of around $0.14 when positive sales information is released. CTSO’s need for capital raised by selling shares at $0.14 or above could easily result in less dilution than anticipated. That would be good news too.
LPC FINANCING HAS APPARENTLY ENDED
The recent announcement referenced earlier of 39,634,615 shares being available to be sold at a pps of $0.14 strongly suggests that LPC financing has now officially ended. Obviously selling shares to the public at a pps of $0.14 is a more efficient method of raising capital than selling shares to LPC at a pps of $0.10 that in turn sells its shares to the public.
This announcement also means that dilution will probably be less in the future as the amount of capital raised is 40 per cent higher for the same number of shares previously sold to LPC.
I like this development very much.
MORE DILUTION IN A DIFFERENT MANNER MAY SET AN UPWARD RESISTANCE POINT OF $.14
In the last few days the pps of CTSO has risen above .14. Why in the world one might ask should CTSO continue to use LPC financing at .10 pps when CTSO could sell directly to the public? The Post-Effective Amendment to Registration suggests the intent of CTSO is to sell shares directly to the public. This selling might be accomplished whenever the pps exceeds .14 thereby making the .14 pps an upward resistance point. 39,634,615 Shares at a maximum offering price of $0.14 may be offered. No additional shares are being registered. “It is not known how many shares of our common stock will be sold under this registration statement or at what price or prices such shares will be sold.” Nevertheless, this number of shares being offered at a price of $.014 a share suggests that there is little likelihood of the pps being greater than $.14 in the near future. The wording “to prevent dilution resulting from stock splits, stock dividends, or similar transactions” suggests that a reverse stock split to raise the pps to the $3 level in order to be listed on a more major exchange is not imminent.
Recent Cytosorbents Cor, CTSO News
Post-Effective Amendment to Registration Statement (POS AM)Edgar (US Regulatory) • Wed Dec 5,2012 3:33 PM
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: From time to time after the effective date of this registration statement, as determined by the selling stockholder.
On February 10, 2012, the Securities and Exchange Committee declared effective the registration statement on Form S-1 (File No. 333-178654) (the “Registration Statement”) filed by Cytosorbents Corporation. (the “Company”). The Company is filing this post effective amendment to the Registration Statement for the purpose of updating its financial and other disclosures.
No additional securities are being registered under this Post-Effective Amendment No. 2.
Shares of Common Stock, par value $0.001 per share 39,634,615 Shares $ 0.14
(1) This registration statement covers 39,634,615 shares of our common stock. Pursuant to and in accordance with Rule 416 under the Securities Act, there are also registered hereunder such indeterminate number of securities as may be issued to prevent dilution resulting from stock splits, stock dividends, or similar transactions. This registration statement covers the 39,634,615 shares of our common stock previously registered in the S-1/A registration statement filed on February 6, 2012. No new shares are being registered.
Ping, How do you reconcile the absence of CTSO on the DLT lists with the Darpa 5-year award of @ 3.8 million? Different emphasis? Different goals? Or simply CTSO was mistakenly overlooked?? I do find this apparent discrepancy a bit puzzling.
ZACKS RANK GOES FROM PREVIOUS 3 TO 2
Zacks Rank
Short-Term Rating 1-3 Months
Zacks #1 Rank Strong Buys Zacks Premium 2 - Buy
Zacks Recommendation
Long-Term Rating 6+ Months
All Outperform Rated Stocks Zacks Premium OUTPERFORM
Zacks Industry Rank 67 out of 265
Target Price $0.50
IS DR. CHRISTIAN STEINER THE MOST IMPORTANT MAN IN CTSO?
Without significant sales emerging CTSO could implode from too much debt and debt equity ratios gone astray. Without buying sentiment from German-speaking doctors in Germany, Switzerland, and Austria, Cytosorb could end up being just another good idea in the pantheon of good ideas that never matriculated to greatness leaving their corporate hosts in bankruptcy and investors in misery.
Without a moneyed partner able to fund studies CTSO may still wither and die, but one fact is almost certain. Unless Dr. Steiner is successful and without a moneyed partner, it will become increasingly likely CTSO fades away.
IMO the answer to the question above is, “YES!”
NO CTSO STOCK SALES THE LAST THREE HOURS LAST FRIDAY?
There were no sales of CTSO stock after 1:15 p.m. last Friday.
When the pps of CTSO appeared to have bottomed possibly at around .0133, I felt an urge to test the market by placing an open MARKET order for 20,000 shares. I almost never place an open market order on a thinly traded, low cap stock. To my surprise, this order was not filled. In other words, for almost three hours there were no sales following the opening and downward draft of sales from investors like those who have expressed disappointment with CTSO and in particular the confusion regarding sales as reported in the last 10 Q.
What does the lack of any selling for almost three hours up to the market close last Friday mean? What is the significance of the well drying up for about three hours? Well, it certainly means there were no sales and that suggests strongly in turn that selling sentiment has largely dried up. We shall of course see.
LESS STONEWALLING AND MORE TRANSPARENCY PLEASE
More transparency is badly needed from management.
What are the sales? We were told sales for the first nine months were @$63,000 and then Dr. Chan added they were $83,000 I understood as of the 10 Q publication, therefore, suggesting sales of @20,000 for early Q4. But then Market Watch added that sales were @ 70 K in Q4. The contradictions are glaringly provocative. Clarification regarding sales would be appropriate from somewhere.
What we do apparently know is that sales in Q3 were @ 13 K well below all expectations and/or projections made by Brean Murray and Zacks. Why after all this time were sales so slow? It has been more than two years since CE Mark approval was given. How much inventory was given out free the last three months? Why is inventory increasing if not from lack of sufficient sales?
Some have suggested that sales were manipulated by delaying delivery of Cytosorbs until Q4 in order to push up sales in early Q4. I doubt that any sales representative would do that because CTSO is dealing with the life and death situation of septic shock, and yet uncertainty as to what actual sales were in Q4 has breed unwarranted speculation that there was manipulation or other games afoot.
Repeatedly Dr. Chan has informed us that the dosing studies should be out by the end of the year, and yet there was no mention of the dosing studies in the 10 Q and their progress or lack of progress in completing them. Why is the study not listed on clinicaltrials.gov? Again investors were not fully informed and left wondering in some cases after reading a confusingly written 10 Q whether the dosing studies were no longer relevant.
On Sept 24th CTSO released news that the "US Army Grants CytoSorbents $1 Million Phase II SBIR Trauma and Burn Injury Award." This announcement indicated that that this grant was successfully concluded but the Q3 Corporate update stated, "Award of an up to $1 million U.S. Army Phase II SBIR for trauma and burn injury research, currently in contract negotiations." Is it too much to ask for the truth?
The 10 Q referenced that there were six independent investigator led studies. What does this mean? Does this mean that CTSO has so little funds available that it cannot organize studies itself? Are these independently led studies being sufficiently well coordinated? Dr. Lowenstein raised this question earlier. Who is doing these studies?
What progress has been made on finding a moneyed partner? Without a partner where will the funds come from to initiate FDA approved trials in the U.S.? How much longer can CTSO last once remaining LPC financing estimated to be about $1.2 million is used up that a present rate of burn could be in Q2 2013.
And then what role does HemoDefend have at this point? Over the last few months there has been repeated speculation, even from the well-informed Ping, that HemoDefend would probably be sold to raise capital very possibly before the end of the year. Yet there was nothing significant said about HemoDefend.
Investors need encouragement. If there is good news, why wait three months to let investors know and then turn out information that is incomplete and/or confusing? If there are questions why not address them? Better PR is needed.
The last four times over a five month period that I have written Dr. Chan there has been not a single reply. Even a request for an appointment in visiting the company headquarters in New Jersey was ignored. Then I wrote Dr. Steiner asking if an appointment would be possible sometime if he visited Switzerland where my wife and I have a home. Again there was no reply. In all my years of investing I have never been turned down when I have written management requesting an appointment. CTSO does not even deign to give responses all most of the time now.
No doubt, Dr.Chan is just too busy to answer all queries. Despite answering many Email queries previously it has become apparent now at least to me that he needs help from a person willing to respond to questions addressed to him. Certainly corporate visits should be acceptable. A better editor for reviewing 10 Qs and other announcements would be appropriate. Just a few changes could improve communications immensely.
Lack of sufficient transparency is deeply disappointing to me, and yet despite all the failings and my petulant complaints I still rate CTSO a strong buy believing Cystosorb's efficacy will be proven beyond a reasonable doubt in treating septic shock. Even if my good humor reflects a leap in faith in trusting the integrity of Dr. Chan, it could have limits.
MY RECAPITULATION AND INTERPRETATION OF 10Q RESULTS FOR Q3 2012:
According to the 10Q for Q3 2012 released November 21, 2012 sales were 83 K to date including 70 K sold in Q4. That means sales were only about 13K (actually $13,679) in Q3. Brean Murray estimated that Cytosorb sales for Q3 would be 35 K and 53 K for Q4 2012. While Cytosorb sales were disappointing in Q3 and less than that projected by Brean Murray and Zacks, the pickup in sales in Q4 (70 K in 7 weeks from October 1st to November 21st)or about $10,000 a week is encouraging and exceeded the 53 K of Cytosorb sales projected by Brean Murray for all of Q4 2012. Cytosorb sales were poor in Q3 because of start-up problems.
The exact figures were product revenues of $63,614 and $-0- and $13,679 and $-0- in the current nine month and three month periods ending September 30, 2012 and 2011 respectively. Dr. Chan added, “Our sales force came together in August 2012, and in the span of only a few months, the Company has generated cumulative sales of approximately $83K.”
To recapitulate in part, Cytosorb sales for the last three months of Q3 were $13,679 followed shortly later by a huge increase in sales of 70 K during the seven weeks from October 1 – November 20th. This 70 K of Cytosorb sales following and not including Q3 sales exceeded the 53 K for all of Q4 that Brean Murray estimated.
The current rate of Cystosorb sales of approximately $10,000 per week can be projected to show approximately 130 K of Cytosorb sales for Q4, more than twice that projected by Brean Murray. I view this as being a very positive trend.
Overall revenue was about 605 K for Q3 well above the revenue of 96.3 K projected by Zacks for Q3. The expansion from about 40 to more than 60 key opinion leaders throughout German, Austria and Switzerland who are interested in using or are currently using Cytosorb is particularly encouraging as is the planning of at least six new investigator-initiated human pilot studies in a growing list of critical care applications.
Although results of dosing studies were not announced, interim results will no doubt be released before the end of the year. A reasonable guess is that by the end of Q1 2014 dosing results should be in hand so as to enable an application for definitive studies in the US for support of 510(k) or PMA registration.
I am very encouraged by the trends seemingly well-established and now in place. I shall be purchasing more stock. It could well be that investors misunderstand the import of the information released in the recent 10 Q because of some awkwardness in the language, and that on Friday, November 23rd, there could be a sell-off enabling more purchases at lower prices than the .12 to .13 range.
FDA Panel Wants More Info About Hep B Vaccine
http://www.medpagetoday.com/InfectiousDisease/Hepatitis/35979
Anti-viral Hep C therapy improves survival after resection for Hepatocellular Carcinoma (HCC).
The most recent issue of the Journal of the American Medical Association (JAMA November 14, 2012, Vol 308, No. 18, pg. 18) has an article titled, “Does Antiviral Therapy Prevent Recurrence of Hepatitits B Virus – Related Hepatocellular Carcinoma After Curative Liver Resection?” The answer is yes.
“HCC recurrence rate after surgical resection is high: 50% to 70% at 5 years.” “In a retrospective study of 193 patients who underwent surgical resection for HBV-related HCC in Taiwan, 13+ (69&) had HCC recurrence after a median follow-up of 58 months; 71% of the recurrences occurred within 2 years.” Antiviral therapy was given in one cohort and not in another cohort. “1765 patients (43.6%) in the untreated cohort and 106 patients (20.5%) in the treated cohort developed HCC recurrence.” “Overall mortality was also lower in the treated cohort, with 6-year cumulative mortality of 29% vs 42.4% in the untreated cohort (P<.001).”
It would be relatively easy to add the HemoPurifier as an adjunct treatment for HEP-B related HCC where one cohort would have standard anti-viral HCC therapy and the other the same treatment plus dialysis using the HemoPurifier. Please note that this was HCC related to HEP- B rather than HEP-C.
I suspect funding for such a study could be arranged relatively easily through the government of Taiwan, the US Government, and/or The University of Michigan that sponsored the studies in Taiwan. For a company like AEMD that is cash starved, outside financing for studies proving the efficacy of the HemoPurifier as an adjunct modality of treatment for HCC could be a godsend.
The answer to Jeffpacman's two questions are almost certainly yes and yes. They are excellent questions whose answers have not been proven to the best of my knowledge. Tumors can and do spread early. For example, Stage 1 localized breast cancers frequently suspected to have been present months before detection are well known to spread early from time-to-time. Early spread of breast cancer is one of the main reasons that super radical Halstead mastectomies were discredited. Extensive surgery often does not improve survival beyond that when more local excisions of tumors are done because of early spread.
Larger tumors are more apt to spread. Spread to different physiological human environments can be by the lymphatics, blood vessels, and direct extension. More advanced tumors that have invaded certain defining layers, e.g. the bowel wall in the case of g.i. cancer, the capsule in the case of prostate cancer, or the dermis in melanoma, are more apt to spread distantly and locally. Cancer cells are usually credited for causing distant spread. Obviously, even advanced tumors could be still undetected at the time a blood donor gives blood.
Since exosomes are now known to facilitate spread, it is likely that undetected cancer exosomes could be in the blood stream of blood donors especially with large primary tumors.
As an aside, CTSO has a product called HemoDefend that is credited with removing toxins related to the degradation of old blood that has been in storage. Combining HemoDefend serially with the HemoPurifier makes theoretical sense IMO as filters when blood is transfused. Such usage has not been FDA approved.
It is clear to me that there are many, many avenues available for research in the usage of the HemoPurifier.
Using the Hemopurifier to cleanse donated blood for exosomes particularly with donors who have a history of cancer makes a good deal of theoretical sense. Actually it is a common practice that blood donors who have cancer are proscribed from giving blood for a period of time. The length of time may vary from one blood center to another.
http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/bloodproductdonationandtransfusion/blood-product-donation-and-transfusion-blood-donation-by-cancer-survivors
Could the Hemopurifier help in cancer surgery?
It is well known among surgical oncologists that during cancer surgery seeding of cancer cells or exosomes is apt to occur. But seeding can occur after chemotherapy and radiation as well. Could the Hemopurifier be of use routinely in cancer surgery and possibly during radiation and/or chemotherapy treatments? If proven effective, the markets in these arenas would be humongous.
http://www.naturalnews.com/028241_cancer_tumors.html
Cancers can re-seed themselves after chemo, surgery or radiation
Wednesday, February 24, 2010 by: Ethan A. Huff, staff writer
(NaturalNews) Researchers from the Memorial Sloan-Kettering Cancer Center in New York have published findings in the journal Cell that explain how tumor cells can re-seed and spread throughout the body after they have been removed through conventional chemotherapy, surgery, or radiation treatments. Tiny tumor cells that circulate throughout the body often begin to send out seeds to the places where the tumor originated, essentially planting the cancer back into the body.
Joan Massague and her colleagues at the Center are finding that conventional treatments leave behind malignant cells that relocate to other areas of the body to avoid being destroyed. Eventually they return as stronger and more aggressive tumors, having gathered back the worst leftover cells from the previous cancer. The result is a second cancer that is worse than the first.
Chemicals present in the immune system also appear to signal tumor cells in circulation to return to their source. Following conventional treatment, the immune system actually works against the body by drawing the vagrant cancer cells back to where they originally seeded, kick starting a relapse.
Medical professionals typically attribute recurrences of cancer following conventional treatment to a few remaining cells that survived treatment and remained at the source. However this study illustrates definitively that lingering cells hide throughout the body and later return to self seed back where they originally started.
What these findings illustrate is that conventional cancer treatments are not effective at eradicating cancer from the body. The targeting of a specific area with surgery, radiation treatment, and chemotherapy cannot successfully remove the cancer from the body because its cells will find another place to live temporarily, only to return even stronger the next time.
Biopsies cause cancer to spread
A conventional biopsy is usually recommended as the best way to identify the presence of cancer, both before and after treatments. Needle biopsies involve taking tissue samples at various places in order to identify the presence of cancer cells. Official diagnosis of cancer cannot take place without a biopsy, resulting in the pressuring of patients to get one if they suspect a tumor.
Many doctors will insist that a person needs a biopsy, but the threat of spreading cancer far outweighs any perceived benefits. Those who receive biopsies will most likely experience unnecessary cancer spread and, following conventional treatment, will probably experience cancer reseeding. Cancer is known to develop at the puncture sites of biopsies.
Chemotherapy leads to reseeding
Chemotherapy treatments involve targeting cancer cells that are rapidly dividing and spreading with harsh chemicals designed to kill them. While treatment may kill the primary tumor, it fails to eradicate the cells that divide more slowly, resulting in a continued replication of cancer cells following treatment.
Many who believe they are in remission following their chemotherapy treatments later discover that their cancer has returned. Not only do they undergo the horrors of the treatment which leaves their body and health in shambles, but they often end up with a more severe version of their original cancer.
Conventional therapies are a failure
Conventional medicine is at a loss for how to deal with the problem of reseeding. Within their paradigm, chemotherapy, radiation, drugs, and surgery are the only options for treating someone with cancer. Now that these are proving to be largely ineffective, scientists are searching for yet another new drug to combat the tendency of cancers to re-seed in order to continue promoting these accepted forms of cancer treatment. They are even investigating the possibility of developing vaccines that will allegedly use the body's immune system to stop vagrant cancer cells.
The problem with drugs, surgery, and radiation is that they will never be able to systematically rid the body of the problem because they are only capable of targeting a confined area. These methods are also wrought with negative side effects so severe that many people end up dying simply from the treatment.
Conventional treatment is also extremely expensive, heavily burdening an already overwhelmed health care system. It is simply assumed that there are no alternative methods by which cancer can be treated, let alone prevented.
Many recently published studies have found that pomegranates, mangoes, and other natural foods contain valuable phytonutrients that effectively prevent and stop malignant cancer cells while preserving good cells. These nutrients holistically rid the body of harmful cells, targeting them wherever they hide in the body and eliminating them.
Conventional medicine would do best to begin focusing heavily on the compounds found in nature that are designed to deter cancer without inflicting negative side effects as an alternative to the mainstream methods that are only making the problem worse. Whether in aloe vera, peach pits, raw almonds, or the many fruits and vegetables found around the world, anti-cancer nutrients are everywhere and modern medicine is only beginning to recognize them. They may not result in the next big blockbuster drug but they work and they are inexpensive. Perhaps this is the reason they are generally marginalized and looked down upon by the cancer industry.
Sources for this story include: http://www.reuters.com/article/idUSTRE5BN2N320091224, http://www.ethiopianreview.com/news/7209, http://www.healingcancernaturally.com/biopsies-surgery-spread-cancer....
Learn more: http://www.naturalnews.com/028241_cancer_tumors.html#ixzz2CJ4uBum1
Could the Hemopurifier lessen cancer re-occurrence following surgery?
The Annals of Surgery published an article recently cited below implying IMO an additional usage for the Hemopurifier. It seems a reasonable supposition that by adding the HemoPurifier through a CVP line during surgery on patients with hepatocellular carcinoma long-term Hep cancer re-occurrence would be decreased and survival increased. This has not been proven of course. The results in this Annals of Surgery article suggest furthermore IMO that by adding the Hemopurifier in any surgery on any patient with a previous cancer history that re-occurrences could be diminished. If this idea should be proven ever, the market for such usage would be enormous.
Interferon Following Surgery May Improve Survival in Advanced Liver Cancer
Interferon Following Surgery May Improve Survival in Advanced Liver Cancer
According to an article recently published in the Annals of Surgery, administration of the immune stimulating agent interferon following surgery may improve survival among patients with advanced hepatitis B-related hepatocellular carcinoma (HCC).
The liver is the largest organ in the body and is responsible for more than 500 functions. These include the secretion of glucose, proteins, vitamins, and fats; the production of bile; the processing of hemoglobin; and the detoxification of numerous substances. Individuals with hepatitis infections have an increased risk of developing cancer of the liver.
Hepatocellular carcinoma is the most common type of liver cancer; it is named for the type of cell within the liver where the cancer originated. Standard treatment options for HCC are determined by the stage, or extent of spread, of the cancer and by the patient’s overall health. A preferred treatment approach is the surgical removal of the cancer. Unfortunately, cancer recurrences following surgical removal are common. Researchers continue to evaluate ways to reduce these recurrences.
Researchers recently conducted a clinical trial to evaluate the use of interferon following surgery in patients with HCC. Interferon is an agent that stimulates the immune system to fight cancer cells. This trial included 80 patients with hepatitis B and HCC that had been surgically removed. One group of patients then received interferon while the other group received no further treatment (control group). The group treated with interferon experienced better survival rates:
At one year survival rates were 97% for the group treated with interferon compared with 85% for the control group.
At five years survival rates were 79% for the group treated with interferon compared with 61% for the control group.
Among patients with more advanced cancers (Stages III and IV), survival at five years was 68% for the group treated with interferon compared with only 24% for the control group.
The researchers concluded that treatment with interferon following the complete surgical removal of HCC among patients with hepatitis B appears to significantly improve survival, particularly among patients with more advanced disease. Patients with HCC may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial further evaluating treatment with interferon or other novel therapeutic agents. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (www.cancer.gov) and www.eCancerTrials.com.
Reference: Lo C, Liu C, Chan S, et al. A Randomized, controlled trial of postoperative adjuvant interferon therapy after resection of hepatocellular carcinoma. Annals of Surgery. 2007;245:831-842.
Related News: Early Recurrence Associated with Poorer Prognosis in Patients with Liver Cancer Who Undergo Surgery (02/21/2006)
Copy and paste: http://www.medpagetoday.com/MeetingCoverage/AASLD/35897?utm_source=share&utm_medium=mobile&utm_campaign=medpage%2Biphone%20app
Random thoughts: Yes, I agree with RockYourStock that there has been deep bid support around .126. Charting shows repeated support around that level. Although there has been accumulation at that level, I do not have numbers. Off setting accumulation in my opinion is LPC selling on certainly a weekly if not daily basis. It is unlikely that there is predatory shorting IMO as some seemingly partially paranoid members on the Yahoo message board repeatedly allege. Until there is a catalyst of some sort or another, such as the announcement of a partnership, positive dosing studies, or excellent sales, my strong suspicion is that CTSO will remain in a tight trading range of .125 bid to .135 bid. The odds are increasing that positive news is just around the corner, and so I am accumulating also around the .125 to .126 bid level. My belief now is that there will be an upwards breakout from this range before the end of the year as one major catalyst or another among many possibilities materializes. One piece of news that seems to have floated into the nether world is an announcement of the Integrator awards seemingly postponed to some time in December some now allege. Random thoughts from others and RockYourStock would be appreciated.
CTSO data has been presented at the recent ESAO congress - European Society of Artificial Organs - and will be presented at the upcoming DIVI congress in Dec in Hamburg - the biggest interdisciplinary Crit Care congress in Germany.
Membrane filters on the market currently have surface areas of around two square meters. In contrast, Cytosorb has a surface area of about 5-6 European soccer fields. Although the greater surface area of Cytosorb in comparison to AN69ST strongly suggests Cytosorb would be more effective in removing cytokines, comparative animal studies would seem essential to prove this point.
The Hirasawa study has given validation to the concept promoted by CTSO that lessening or removing cytokines improves survival in septic shock. That is a positive. IMO Cytosorb is almost certainly the better product than AN69ST.
No doubt questions will arise about AN69ST sooner or later in Germany, Austria, and Switzerland as word of the Hirasawa study is disseminated. Dr. Steiner will need to answer these questions fully and competently. IMO he will have no difficulty doing just that.
Ping,
Hirasawa et al. have shown that the AN69ST filter is effective in treating severe sepsis and septic shock.
What impact do you see for this filter in competing with the Cytosorb of CTSO? How does Cytosorb compare with the readily available AN69ST? How much of a threat do you anticipate the AN69ST being to Cytosorb sales please? What competitive advantages if any does Cytosorb have over the AN69ST?
If might be rewarding if at the Brean Murray presentation by Dr. Chan Nov. 7th these and similar questions could be answered for the benefit of investors.
Thank you.
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Continuous hemodiafiltration with a cytokine-adsorbing hemofilter for sepsis.
Hirasawa H, Oda S, Nakamura M, Watanabe E, Shiga H, Matsuda K.
Blood Purif. 2012;34(2):164-70. doi: 10.1159/000342379. Epub 2012 Oct 24.
Source
Department of Emergency and Critical Care Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
Abstract
Since the introduction of the new pathophysiological concept of pathogen-associated molecular patterns (PAMPS) and alarmins, endotoxin has been recognized as only one of the PAMPS. It is widely accepted that hypercytokinemia plays a pivotal role in the pathophysiology of sepsis. Many kinds of blood purification modalities have been proposed as a therapeutic tool against sepsis, including high-volume continuous hemofiltration whose efficacy has recently been questioned. We report that continuous hemodiafiltration (CHDF) with a cytokine-adsorbing hemofilter (CAH), such as polymethyl methacrylate hemofilter and AN69ST hemofilter (CAH-CHDF), can remove many kinds of cytokines and has been very effective in the treatment of severe sepsis and septic shock. Based on the understanding of the recent pathophysiology, we suggest that CAH-CHDF is an alternate therapy to direct hemoperfusion with endotoxin-adsorbing column in the treatment of sepsis.
From other sources:
The need for continuous anticoagulation remains a significant drawback in continuous renal replacement therapy (CRRT), especially in patients with increased bleeding risk. Polyethyleneimine treatment of the AN69 membrane (AN69ST) reduces thrombogenicity through decreased contact activation and promotion of heparin binding.
Compared with the original AN69 membrane, the surface-treated AN69ST membrane does not prolong filter survival during CVVH without systemic anticoagulation. Polyacrylonitrile (AN69ST) showed the highest adsorption capacity of high mobility group membranes.
http://www.sciencenews.org/view/generic/id/343100/title/Supersmall_lab-on-a-chip_is_superfast
Microarray technology keeps improving in terms of smaller size and faster speed. It seems like a variation of Moore's Law is at play.
Some day genetic and protein marking will be routine.
ANESRI, it might be rewarding to manufacture a diagnostic test device that combines the ELLSA where viral particles are collected with deep sequencing biosensors that immediately identify those particles. These biosensors might even employ oscillating microscopic beads on a chip that you previously referenced. Such a diagnostic device would be invasive with the insertion of a CVP line connected to a HP if and when the HP becomes an adjunct to SOC for severe viremia where an unacceptable mortality rate is suspected (e.g. Ebola, West Nile, the Yosemite hantavirus, etc.). Collecting viral particles through ELLSA for deep sequencing would be useful in identifying the specific viral etiology in addition to attacking the viremia. I can envision such a future device being used in ERs when patients present with severe symptoms strongly suggesting a viral etiology.
I am enjoying reading your references.
The design of a study using the HP as an adjunct treatment for cancer will not be easy. First there has to be an IDE proving the safety. While that may be incorporated into the HEP C FDA IDE application, it still has to be done. Then there would be a P2 proving further safety and then efficacy. The P3 trial could take several years and many millions to do and would necessitate the involvement of other cancer centers. How the P3 trial would be designed would be cause for considerable debate I suggest. What cancer(s) would be investigated using the HP would be the first question demanding an answer. Melanoma would certainly be on the list, but why not Stage IV breast cancer or any of a multitude of cancers that might benefit from the HP being added in treatment.
Another question that needs answering is under what service(s) would treatment be initiated. Placing a CVP line whether through a jugular or subclavian stick requires expertise that most internists would not have. Anesthetists and surgeons do them commonly. Complications can occur. So how treatment is initiated may not be just a simple decision. If an AV fistula is already in place where a patient is receiving dialysis there would be no problems inserting the HP device.
How long the CVP line necessary for treatment should be left in would be another question. Leaving CVP lines in place weeks definitely carries risks. Chemotherapy requires frequently weeks for treatment, and re-inserting CVP lines each time a new round of chemotherapy is started would increase the risks. Protocols would have to be carefully thought out for a treatment modality never before employed at a quality cancer center.
All in all it would definitely take the backing of an institution like the MD to complete studies proving the efficacy of the HP as an adjunct treatment for some cancers. There is no way IMO that AEMD could do this on its own.
The main point I am making is that investors need to think years rather than months when it comes to considering the HP as an adjunct modality for treating certain cancers. My best guess is that the HP will be proven to be efficacious for some tumors, but by no means all tumors, and it could take 5-10 years to be proven efficacious for even just one tumor type.
While it is obviously of considerable importance that the HP be investigated in the oncology arena, I would caution against early enthusiasm. A MOON landing would not be any time imminent. A far better earlier investor bet is the usage of the HP in the treatment of HEP C.
If the HP as an adjunct modality for HEP C receives CE Mark approval with an average treatment period less than a week, AEMD could be off to the horse races. A rapid virologic response (RVR), defined as undetectable HCV RNA, after just a week of treatment is incredible.
The daily short interest for CTSO has dropped to nearly the lowest level seen in about a year. This last week it averaged 5.7%. http://otcshortreport.com/most-popular-tickers What is the significance of short interest at this level?
I have postulated for months that the short interest has reflected CTSO sales by LPC of stock for which it has been awaiting delivery. This has been in effect IMO "shorting against the box" recorded as short sales. Ping and Dr. L have disagreed with this analysis so take my interpretation with caution.
Therefore, lower short sales may indicate that LPC financing has decreased -- and that may indicate in turn increasing EU sales providing funding that is replacing LPC financing.
I admit this reasoning is speculative.
Indirectly, this reasoning has led me to opine that sales for Q4 will be much, much higher than what Zacks projects coming in part from outside Germany and perhaps from the DACH (Austria and Switzerland)as well. Perhaps some of you may know of other indirect evidence as well for better sales than expected.
We should know fairly soon (presumably mid to late October) sales for Q3. Than other probable positive catalysts will be on October 23rd when we learn of the DARPA integrator awards, SBIR US Army grant results around November I'm guessing, and finally the dosing results before the end of the year.
I remain very upbeat about CTSO.
Zacks estimated revenues for Q3 of 96.3 thousand and for Q4 817.5 thousand, and for all of 2012 949.9 thousand. Sales of 250,000 for Q3 would be about 2 1/2 times Zack's estimates and remembering that on a DCF basis Zacks estimated a fair value of $0.50 an estimate of a pps of around 20 cents seems more than reasonable. The problem with this reasoning is that markets are often unreasonable.
I might add that since approximately half of all sepsis cases have gram negative bacteremia, the EAA would only be applicable in about half the cases. Nevertheless, in that half high endotoxin levels are a reliable correlate of mortality.
"I would love to see CTSO have diagnostic testers for cytokine levels that can guide dosage for CytoSorb treatment." I agree completely. Until there is a reliable scoring system for the severity of sepsis that correlates well with the incidence of mortality, dosing may be problematic. CTSO has focused on age >65 and high cytokine levels for increased dosing. Undoubtedly there are other criteria that are relevant. I continue to suggest that high endotoxin levels as determined by the EAA would be another criterion. SDI-T (Spectral) has proven to my satisfaction that high endotoxin levels correlate with greater mortality in sepsis.
There is no clinical proof to the best of my knowledge that combining filtration modalities such as Cytosorb and the Hemopurifier would be more or less harmful to the body than using only one modality.
Ping, you wrote, “Spectral's EAA tests for the levels of endotoxin. Endotoxin is a precursor to sepsis. CytoSorbents would use a test that looks at the cytokine levels.”
Endotoxins (a.k.a. LPSs) are not just precursors to sepsis; they are present during gram negative sepsis just as elevated Cytokines are frequently present in all forms of sepsis and especially where there is MOF. Endotoxins are produced by the disruption of gram negative bacteria and therefore are not precursors to gram positive sepsis.
The problem with just using cytokine levels and not endotoxin levels as an inclusion criteria in any forthcoming FDA IDE studies for CTSO is that the FDA has reputedly said (reference is CEO Walker of SDI at 9-2012 R&R conference) when conducting sepsis trials THE ONLY CRITERION THAT THE FEDA WILL ACCEPT FOR APPROVING AN ANTI-SEPSIS AGENT IS A REDUCTION IN THE 28-DAY MORTALITY. This was the primary endpoint in the EUPHAS study. Although mortality was reduced in the EU trials of CTSO the main endpoint was a reduction in cytokine levels. Mortality was also reduced in the CTSO EU trials but the findings were suspect because of the trial numbers.
It seems obvious to me that using the EAA test patented by SDI could be helpful for CTSO in designing a FDA IDE trial since the FDA has already approved the EAA test for the P3 trial of SDI. Presumably the EAA assay could be leased and if not it seems unlikely that SDI would deny employing the assay for sepsis studies conducted by parties other than its self.
It could also be true that Cytosorb might also somehow reduce endotoxin levels. If EAA measurements showed endotoxins were reduced during Cytosorb treatment, one might argue Cytosorb was responsible. So why not measure endotoxins to see if there is an association? I also think it relevant that in any future FDA IDE studies pathogens should be identified.
It is not true that “Toraymyxin is good for gram negative bacterial sepsis only” at therefore applicability is limited. Gram positive bacteria can also in rare instances produce endotoxins, and if even half the estimated 750,000 cases of sepsis each year in the U.S. are caused by gram negative bacteria applicability would be extensive indeed. It is also relevant that many instances of sepsis have both gram negative as well as gram positive bacteria. Since frequently there are multiple bacteria causing sepsis, and definitive diagnoses lacking as to specific bacteria present, the SDI device would have greater applicability possibly than suspected.
The Toramyxin SDI columns are not used primarily as a bactericidal but rather as a means for reducing endotoxins. Apparently it is not through bactericidal action that endotoxins are reduced primarily with the SDI device. The actions are different in my understanding and the columns are selectively removing endotoxins apparently in a filter like action. One might draw a parallel with the selectivity of removing agents through the ADAPT AEMD technology.
A further point is that through rapid PCR analysis it is possible to differentiate between gram positive and gram negative sepsis, thereby enabling the employment of the SDI columns where gram negative sepsis is present. The LightCycler SeptiFast Test can also do this analysis rapidly, but unfortunately is still unapproved in the U.S. at this time almost seven years after CE Mark approval in the EU.
There is no reason I can see that SDI filters could not be used conjunctively with Cytosorb when there is gram negative sepsis. There can also be anaerobic infections (e.g. necrotizing fasciitis) where conceivably the SDI filters could be peculiarly effective.
Quoting Dr. Chan, “Endotoxin doesn't kill by itself, but kills by inducing cytokine storm that then leads to multi-organ failure and death. There are many animal studies that demonstrate if you block the recognition of endotoxin by the immune system, it can reduce cytokine storm and reduce mortality.”
The main point I would like to make is that Cytosorb and the SDI device will be shown in my opinion almost certainly to be effective in treating gram negative bacterial sepsis, albeit the SDI device would be limited primarily to gram negative sepsis and not gram positive sepsis.
Until such time as a prospective double blind studies are done comparing the two devices in gram negative sepsis it seems pointless to claim one device is better than the other in reducing mortality where there is gram negative sepsis with MOF. There is also a strong possibility in my opinion that at some future date both devices could be used conjunctively in addition to SOC treatments. I do agree that Cytosorb has greater applicability than the SDI device in the ICU where Cytokine storm is present but when gram negative sepsis is present it could make sense to add the SDI device in treatment.
As an aside we have been discussing sepsis caused by bacteria. AEMD’s device (HemoPurifier) has shown great effectiveness in treating viremia, that is blood stream infections caused by viruses. There is no reason either that I can see that AEMD’s HemoPurifier could not be used conjunctively with Cytosorb in addition to anti-viremic SOC.
A theranostics approach similar to that Spectral (SDI-T) uses may be necessary for CTSO in obtaining FDA IDE approval for Cytosorb. SDI uses its proprietary EAA test for measuring endotoxin levels as an entry criteria for the patients in its P3 Terramycin sepsis study, the so-called Euphrates trial. The EAA is the only diagnostic FDA approved test for endotoxin levels in whole blood.
Sepsis is a complex disease. Treatment varies and may not be effective at many centers. A number of disease processes can underline the diagnosis of sepsis. In other words, the clinical presentation of sepsis with MOF may be very misleading to the extent that inclusion criteria may not be as helpful as hoped in picking a patient population for a sepsis study. Many patients with clinical MOF and shock have low endotoxin levels and do not respond as well to sepsis treatment as other patients. Patients with low endotoxin levels are being excluded in the Euphrates trial.
Randomized SOC patients had 35% mortality in the SDI study versus SOC patients with high endotoxin levels that had about a 40% mortality. Endotoxin is an independent indicator of mortality. Picking the right patients for a sepsis trial is critical.
The SDI inclusion criteria for its sepsis trial are not those that CTSO used in the EU trials, although there is some overlap. Since the FDA has approved the design of the SDI P3 trial, to what extent should CTSO mirror more the criteria that SDI used? Should CTSO rent the EAA test from SDI? Is it not entirely possible that the FDA may require the EAA test to be used in a future FDA trial for Cytosorb? Is it not possible also that the inclusion criteria for patients may be a challenge for CTSO meeting in obtaining FDA approval for a definitive IDE trial? What inclusion criteria CTSO uses in a future FDA IDE trial may be critically important for obtaining FDA approval.
Forget my request for a link to the R&R conference. Go to http://www.wsw.com/webcast/rrshq22/ctso and register.
After listening to the presentation I am optimistic that because of the deep pipeline the potential is indeed humongous for future sales. Dr. Chan feels there is a potential for a 15 B market altogether for CTSO products. CTSO may indeed be at an inflection point, as Dr. Chan stated. His opinion about an inflection point suggests IMO sales will be much better than Zacks projected and/or there will be an announcement forthcoming soon of a commercial partner for one of the products in the pipeline. Dr. Chan's optimism at the conference further confirmed by his purchase of 190,000 shares is very reassuring. SENTIMENT: Strong Buy
Ping, do you have a link please for the R&R Conference? I do not see a link on the company website.
Thanks for the interesting references. Yes, the time for 510K approval should be comparatively quick versus that for drug approval. I would also add that in the EXPECT study the criteria for effectiveness reported that "the two most recent hepatitis c (HCV) infected patients to receive Hemopurifier® therapy in combination with peginterferon+ribavirin (PR) drug therapy achieved undetectable viral load at day-7, which represents a significant clinical milestone in HCV care." Wow, seven days to prove effectiveness possibly is truly a short time. No doubt the FDA would want studies of viral loads at later dates, e.g. six months or even longer, before agreeing the HemoPurifier as an adjunct treatment is effective. Still the time periods could be very short in comparison to studies P1-3 for drugs as treatment for any condition.
It is very encouraging that the final FDA trials might have as few as 200 patients and start possibly late 2013 or 2014. Any price less than $10 million may approach being affordable without a necessity hopefully for a major partner. Thanks for the additional info. I am impressed by your due diligence as a non-insider.