CytoSorbents Corporation (CTSO)

[21ZNA9]

Interesting older article before they changed to CTSO:

CTSO: CytoSorbents Corporation, Formerly Known as MedaSorb Technologies
MedaSorb Technologies issued a press release on May 6th announcing a name change to CytoSorbents Corporation. On May 7th trading resumed for the newly-named company under the ticker CTSO.ob.

Shortly thereafter, CytoSorbents announced a $6 Million purchase agreement with Lincoln Park Capital Fund, LLC, giving the company the means to effectively fund the remainder of the European clinical trial that is testing CytoSorb for the treatment of sepsis.



As humans, we would all like to hear about a company which holds novel technology that could solve an age-old problem and could save millions of people’s lives per year. As speculators, we would all like it if the company was publicly traded and seeking approval for this life-saving technology at the end of this year. As investors, we would like it if the company was financially healthy but unknown and extremely undervalued. On top of it all, the risk taker in us would like to have the company’s long term future rest on approval for their medical device, which could generate them $5 BILLION per year in revenues. Well now you can have it all with Medasorb (MSBT).
Medasorb is the owner of 26 key patents surrounding their two products in development, CytoSorb and BetaSorb. These medical devices utilize their adsorbent polymer technology; known medically as hemoperfusion devices. During hemoperfusion, blood is removed from the body via a catheter or other blood access device, perfused through a filter medium where toxic compounds are removed, and returned to the body. The most common of hemoperfusion you are probably familiar with is kidney dialysis. The BetaSorb device is indeed for kidney dialysis, but the Cytosorb is a device that seeks to fulfill the unmet medical need of treating sepsis.

Sepsis, known in layman terms as “blood poisoning” is caused by a systemic infection from a pathogen (bacteria, fungi, etc). This can arise from a wound, ingestion of contaminated food, and even surgery. In the United States alone, there are more than one million new cases of sepsis annually; the worldwide incidence is estimated to be 18 million cases per year. With sepsis, the body undergoes a systematic inflammatory response (SIR). This causes an increase in temperature, increased heart and breathing rate, and dramatic changes in white blood cell count and cytokine levels. Sepsis is mediated by high levels of cytokines which are released into the blood stream as part of the body’s auto-immune response to severe infection or injury. These toxins cause severe inflammation and damage healthy tissues, which can lead to organ dysfunction and failure. Sepsis has a high mortality rate, and an effective treatment for sepsis has not arisen yet.

Pharmaceutical companies have been unsuccessfully trying to develop drug therapies to treat the condition. With the exception of a single drug, Xigris (Eli Lilly), which demonstrated a small improvement in survival in a small segment of the patient population, all other efforts to date have failed to significantly improve patient survival. CytoSorb has been designed to achieve broad-spectrum removal of both pro- and anti-inflammatory cytokines, preventing or reducing the accumulation of high concentrations in the bloodstream. This approach is intended to modulate the immune response without blocking or suppressing the function of any of its mediators. Medasorb claims their technology is better than the current state of the art blood purification technology (such as dialysis), which is currently incapable of effectively clearing the cytokines intended to be adsorbed by the CytoSorb. With the CytoSorb device, as blood passes over the polymer beads in the cartridge, toxins (cytokines) are adsorbed from the blood, thereby preventing organ failure.

In December 2006, Medasorb submitted a proposed pilot study for approval to the FDA for CytoSorb. In 2007, they received approval from the FDA to conduct a limited study of five patients in the adjunctive treatment of sepsis. However, Medasorb felt that proceeding with the approved limited study would add at least one year to the approval process for the United States, so they made a determination to focus their efforts on obtaining regulatory approval in Europe before proceeding with the FDA. The market potential in Europe for CytoSorb is equivalent to that in the U.S. Since a European CE Mark approval for a medical device should be faster than FDA approval, Medasorb filed a request for a clinical trial in Europe. They received approval to conduct a clinical study in Germany of up to 100 patients with acute respiratory distress syndrome or acute lung injury in the setting of sepsis. As of April 2009 they had 10 hospitals participating in the study.

As of August, Medasorb has enrolled over 30 patients in the clinical study, and expect to complete the patient enrollment by the end of 2009. Each study only lasts seven days, so time-to-results is fast. In conducting the study they have utilized the CytoSorb device in over 75 treatments to date with no adverse effects attributable to the device (efficacy results of the study will no be released until it is completed). Assuming a successful outcome of the study, Medasorb expects to commence the CE Mark submission process by the beginning of 2010. Management believes it will take an additional 6-9 months following its submission for CE Mark approval to receive the European regulatory approval, placing it in the first half of 2010 at the earliest.

The clinical protocol for our European clinical study has been designed to allow Medasorb to gather information to support future U.S. studies. In addition to the sepsis indication, they intend to continue their research in other acute conditions where CytoSorb has indicated potential in preliminary studies to prevent or reduce the accumulation of cytokines and other toxic compounds in the bloodstream. These conditions include, but are not limited to, the prevention of post-operative complications of cardiac surgery (cardiopulmonary bypass surgery), damage to organs donated for transplant prior to organ harvest, and removing drugs from blood. In the event they receive the European CE Mark they will decide on plans for the United States to determine whether to conduct clinical trials in support of 510K or PMA registration.

Sepsis patients are critically ill and suffer a very high mortality rate of between 28% and 60%. Because they are so expensive to treat, Medasorb believes that efficacy rather than cost will be the determining factor in the adoption of CytoSorb in the treatment of sepsis. Based on current pricing of charcoal hemoperfusion devices in the market today, Medasorb estimates that the CytoSorb device will sell for $500 per unit. Seven units (1 per day times 7 days) would be required to treat a patient, costing $3500. This represents a fraction of what is currently spent on the treatment of a sepsis patient. But for Medasorb, this would represent a potential $3.5 BILLION in revenues for sepsis in Europe alone (double that again in the US), not including the other potential indications. In the US, there are more than 6,000 organ donors and 100,000 people on a transplant waiting list each year which Medasorb says could benefit from the CytoSorb to increase the number of viable organs harvested from the donor pool and improve the survival of transplanted organs. There are approximately 400,000 cardiopulmonary bypass (CPB) and cardiac surgery procedures performed annually in the U.S. A common characteristic of the 1/3 of patients who have operative complications is the presence of cytokines in the blood. Medasorb says the use of CytoSorb during and after the surgical procedure may prevent or mitigate post-operative complications for many CPB patients as well. All together, these non-sepsis uses for Cytosorb could potentially generate another $1.5 BILLION in revenue. Double all these numbers when considering approval in the EU and US.

The BetaSorb device is intended to remove beta 2 -microglobulin (B2M) from the blood of patients suffering from chronic kidney failure who rely on long term dialysis therapy to sustain their life. Due to the widely recognized inability of dialysis to remove larger proteins from blood, metabolic waste products, such as B2M accumulate to toxic levels and are deposited in the joints and tissues of patients. Specific toxins known to accumulate in these patients have been linked to their severe health complications, increased healthcare costs, and reduced quality of life. The BetaSorb device incorporates industry standard connectors at either end of the device which connect directly to a dialyzer. To date, Medasorb has conducted clinical studies in 20 patients using the BetaSorb device in patients with chronic kidney failure in the U.S. and Europe. The studies included approximately 345 treatments, with some patients using the device for up to 24 weeks (in multiple treatment sessions lasting up to four hours, three times per week) in patients suffering from chronic kidney failure. However, Medasorb shifted their priorities to focus on developing CytoSorb. They currently intend to pursue the BetaSorb product after the commercialization of the CytoSorb product.

The market for BetaSorb, if pursued, remains huge. The National Kidney Foundation estimates that more than 20 million Americans have chronic kidney disease. Left untreated, chronic kidney disease can ultimately lead to chronic kidney failure, which requires a kidney transplant or chronic dialysis (generally three times per week) to sustain life. There are more than 340,000 patients in the United States currently receiving chronic dialysis and more than 1.5 million worldwide. Approximately 66% of patients with chronic kidney disease are treated with hemodialysis. The BetaSorb device has been designed for use in conjunction with standard dialysis. Standard dialysis care typically involves three sessions per week, averaging approximately 150 sessions per year. Assuming BetaSorb use in each session, every 100,000 patients would require approximately 15 million devices annually. A potential price for this cartridge has not been stated, but it is easy to see huge revenues for approval of this device.

So if Medsorb gains the EU approval they seek by the middle of 2010, there is $5 BILLION in potential revenues waiting for them. But can they make it until approval so we can all see the big payoff? According to the last 10Q, MSBT had about $1.5MM in cash and no long term liabilities. Their current cash burn rate is about $4MM per year to run all research and development and the ongoing trial of Cytosorb. However, at the end of September, MSBT raised an additional $1.3MM through the sale of series B preferred stock, giving them about $2.8MM total in cash. This is a vote of confidence to common stock holders, who can rest assured that the company will have sufficient cash to complete the Cytosorb clinical studies and through CE Mark approval for an anticipated response by the middle of 2010. With CE Mark approval, Medasorb can begin marketing and selling Cytosorb, generating potential sales of $5 BILLION per year. Gaining approval in the EU should expidite approval in the US, and Medasorb could add another $5 BILLION in potential revenue for a total of $10 BILLION. What the market cap of MSBT would be with approval is anyone’s guess, but it is easy to see that a market cap of $500 million after approval, would be reasonable ($12 per share). This of course would increase with market penetration of their device. With its 40 million shares trading at the current price at 15 cents, MSBT has a dimunitive market cap well under $6 million. What a bargain for a company with so much promise for approval of a novel therapy that could save millions of lives and generate billions of dollars of revenue- you can have it all with Medasorb. The potential return on this one is so large, it is well worth the risk.

http://seekingalpha.com/instablog/492120-joseph-krueger/31738-medasorb-investors-need-to-absorb-the-potential