cytosorbents investor short presentation nov 2011
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CytoSorbents
CytoSorbents Investor Short PresentationNovember 2011
OTCBB: CTSO
CytoSorbents Corporation
Working to Save Lives Through Blood Purification
CytoSorbents 2
Safe Harbor Statement
Statements in this presentation regarding CytoSorbents Corporation and its operating subsidiary CytoSorbents, Inc that are not historical facts are forward-looking statements and are subject to risks and uncertainties that could cause actual future events or results to differ materially from such statements. Any such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. It is routine for our internal projections and expectations to change. Although these expectations may change, we are under no obligation to inform you if they do. Actual events or results may differ materially from those contained in the projections or forward-looking statements. The following factors, among others, could cause our actual results to differ materially from those described in a forward-looking statement: our history of losses; potential fluctuations in our quarterly and annual results; competition, inability to achieve regulatory approval for our device, technology systems beyond our control and technology-related defects that could affect the companies’ products or reputation; risks related to adverse business conditions; our dependence on key employees; competition for qualified personnel; the possible unavailability of financing as and if needed; and risks related to protecting our intellectual property rights or potential infringement of the intellectual property rights of third parties. This list is intended to identify only certain of the principal factors that could cause actual results to differ from those discussed in the forward-looking statements. Readers are referred to a discussion of important risk factors detailed in the Company’s Form 10-K filed with the Securities and Exchange Commission on May 31, 2011 and other reports and documents filed from time to time by us, which are available online at www.sec.gov.
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CytoSorbents Overview
CytoSorbents is a publicly-traded critical care-focused device company using blood purification to treat disease, with its first European Union approved product, CytoSorb™
CytoSorbents 4
• Achieved European CE Mark approval for CytoSorb™ as a first-in-class extracorporeal cytokine filter, clinically proven in its European Sepsis Trial to reduce key cytokines by 30-50% in critically ill septic shock patients
• In this trial, CytoSorb™ treatment also resulted in statistically significant improvement in mortality in patients at high risk of death from sepsis
• Building CytoSorb™ inventory, manufactured under ISO 13485 Full Quality Systems certification
• Limited-market release of CytoSorb™ in Germany began September 2011 with modest revenue expected year-end. Full launch: April 2012
• Reimbursement for CytoSorb™ has been established in Germany
• Xigris, formerly the only treatment for sepsis, withdrawn from all markets
Recent Company Highlights
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Technology Overview
The heart of the technology is a biocompatible, highly porous, polymer bead
that can remove a wide range of toxic substancesfrom blood and fluids based on
pore capture and surface adsorption
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Beads Can Be Used In Many Forms
Hemoperfusion “Beads in a Bag” In-line Filter
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CytoSorb™ Is Our Flagship Product
The cornerstone of our critical care strategy is
CytoSorb™
An efficient cytokine filter that can help fight“Cytokine Storm” and potentially reduce
deadly inflammation and organ injury
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• Obtain venous access with temporary dialysis catheter
• Pump blood through the cartridge with standard pumps
• The polymer beads remove cytokines
• “Purified” blood is pumped back into the patient
• Can treat 20-30 total blood volumes per 6 hr treatment
• Each treatment uses a new cartridge
The polymer beads are packed into cartridges compatible
with standard hemodialysis machines or blood pumps
Concept is Simple But Elegant
CytoSorbents
CytoSorb™ Approved For Sale in the E.U.
CytoSorb™ has received European regulatory approval
under the CE Mark and can now be sold
throughout the European Union
as an Extracorporeal Cytokine Filter
to be used whenever cytokines are elevated
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Cytokines: A Dual-Edged Sword
• Cytokines are small proteins that, in moderation, normally help stimulate and regulate the immune system. They are required for proper immune system function
• However, in excess, cytokines can cause disease
• But in life-threatening illnesses seen commonly in the ICU, they are produced in vast excess, often called “cytokine storm”, and can leadto cell death, organ damage, ultimately organ failure and death
CytoSorbents
Sepsis is a Worldwide Crisis
Sepsis is the result of an overzealous immune responseto infection, causing systemic inflammation
• Top 10 killer afflicting 18 million people worldwide every year
• Incidence of sepsis doubled in the past 10 years and is increasing
• Severe sepsis kills 1 in every 3 despite the best medical treatment. Septic shock kills 1 in every 2
• Kills more people in the U.S. than either heart attacks, strokes, or any single type of cancer
• Only approved product, Xigris, was just removed from all markets following its PROWESS SHOCK trial that showed no benefit in mortality
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CytoSorbentsTime (days to weeks)Time (days to weeks)
Sepsis has two facets but only one is treated
INSULT
Pro-InflammatoryPro-Inflammatory Anti-inflammatoryAnti-inflammatory
Organ FailureOrgan Failure
DeathDeath
RecoveryRecovery
TOXICTOXIC
Cytokine Storm
The infectious insult can be treated with antibiotics/antivirals, but there are currently no therapies to treat the immune response and cytokine storm
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CytoSorbents
Antibiotics
CytoSorb Designed to Fight Cytokine Storm
INSULT
TOXICTOXIC
Organ DamageOrgan Damage
TimeTime
RecoveryCytoSorb
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CytoSorb™ European Sepsis Trial
Completed a 43-patient randomized, controlled clinical trial to treat patients with severe sepsis or septic shock in the
setting of acute respiratory distress syndrome/ALI
• Compared standard of care therapy alone with standard of care therapy plus CytoSorb™ treatment(6 hours a day for 7 consecutive days)
• Two goals of the trial • Demonstrate safety of treatment• Achieve statistical significance of primary
endpoint of IL-6 reduction
• Secondary and exploratory endpoints were included to examine effecton clinical endpoints like mortality and ventilator dependence
CytoSorbents
These Patients Had a High Risk of Death
These risk factors are predictors of mortality
• All had multiple organ failure• Nearly 100% had septic shock • 100% had respiratory failure with ~ 65% with Acute Respiratory
Distress Syndrome (ARDS)• ~ 30% had Renal failure
• Roughly half were Age ≥ 65 • Historically accounts for approximately two-thirds of all sepsis cases• Relative risk of death is 13-fold compared to younger population *
• About one-third had extremely high cytokine levels: IL-6†, IL-1ra‡, MCP-1, IL-8 others
* Martin GS, Crit Care Med 2006, 34(1):15-21† Spittler A, Clin Infect Diseases, 2000, 31:1338-1342‡ Pablo R, J Intensive Care Med, 26(2):125-132 15
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CytoSorb™ Treatment was Safe
• No serious device related adverse events in more 300 treatments inseptic patients in the trial, increasing the total number of safely administered human CytoSorb™
treatments to more than 650
• Treatment was well-tolerated by patients
• No clinically significant change in electrolytes or increase in markers of organ injury in nearly completed analysis
• Small reduction in platelets and albumin, common to other extracorporeal therapies
• Additional biochemical analysis and other marker removal is still underway
CytoSorbents
Achieved statistically significant 30-50% reduction in key cytokines across the 7-day treatment period. Others are pending
49.1%reductionp=0.01*
49.5%reductionp=0.002
36.5%reductionp=0.001
30.2%reductionp=0.002
CytoSorb™ Broadly Reduces Cytokines
Electronic Randomization Only: N = 43 (18 treatment; 25 control) *interim/final analysis 17
CytoSorbents
CytoSorb™ Reduces 28 and 60-day Mortality in Patients with High Cytokines
In patients with very high IL-6 (>1,000 pg/mL) or IL-1ra (>16,000 pg/mL) levels:
• CytoSorb™ treatment shows statistically significant reduction in 28-day mortality (0% vs 63% control, p=0.03, n=14, 6 treated, 8 control)
• Treatment also shows strong trend to benefit in reduction of 60-day mortality (17% vs 63% control, p=0.14, n=14)
• Only 33% of treated patients requiredmechanical ventilator support at the end of 28-days, versus approximately 87% of control patients (p=0.09, n = 14)
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CytoSorbents
CytoSorb™ Reduces 14-day Mortality in Patients Age ≥ 65
• CytoSorb™ treatment for 7 days shows statistically significant reduction in 14-day mortality (0.0% vs 36% control,p=0.05, n=21, 10 treated, 11 control)
• 7 days of treatment was not enough to demonstrate 28-day mortality benefit (40% vs 45% control; p=0.6, n=21) suggesting that longer treatment in this very sick population is needed
• Trend to benefit in:• Organ dysfunction as measured by MODS score, improved by 28%
in treated patients vs 9% control (n=21) during the treatment period
• Reduced ventilator need at 28-days (60% vs 73% control; n = 21)
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CytoSorbents
• Focus is on direct sales in Germany
• Have begun a 3-6 month controlled market release
of CytoSorb™ in September 2011 in select areas in
Germany, and plan a broader launch in Q2 2012
• Expect modest revenue this year (2011)
• Manufacturing under ISO 13485 is in full swing
• Reimbursement for CytoSorb™ has been established in Germany
• Plan to use independent distributors to penetrate rest of Europe
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CytoSorb™ Now Commercialized
CytoSorbents
HemoDefendDefendSafeguarding the Quality and
Safety of the Blood Supply
HemoDefend is a technology platform not yet approved in the US or EU
CytoSorbents
Transfusions Represents a Big Market
• 15 million pRBCs transfused in the US alone each year15 million more other blood product transfusions
• Rate of adverse reactions is 3-4%
• Rate of TRALI is 1:2,000 to 5,000 with 10% deaths
• Exact cause is unknown, but linked to accumulation of many substances during storage and degradation of blood cells, as well as donor factors
• Antibodies• Cytokines and other inflammatory mediators• Bioactive lipids, free hemoglobin• Drugs, Foreign antigens
• Ongoing concern that “old blood” is “bad blood” with increased risk of adverse events including cardiovascular death
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CytoSorbents
HemoDefend “Beads in a Bag” Platform
• This is a highly innovative approach thatis unique to the characteristics of our highly biocompatible porous beads
• Beads that remove different substances are placed into the bag during bag manufacturing
• When blood is added, the neutrally buoyant beads distribute uniformly, preventing the need to mix the blood
• Purification takes place during blood storage – a key to efficiency
• A macrofilter prevents bead escape
• No additional equipment is needed
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CytoSorbents
Removes A Broad Range of Substances
Antibodies Bioactive Lipids
Hemoglobin
Cytokines
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CytoSorbents
HemoDefend Can Be Transformative
HemoDefend converts a low margin blood storage bag into a higher margin, self-contained, “Blood Treatment System” that
is both cost effective and easy to deploy
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With strong development capabilities
CytoSorbents Has a Robust Pipeline
NAME INDICATION DESCRIPTION STATUS
CytoSorb™ Severe sepsis and septic shockARDS/ acute lung injuryBurn and smoke inhalation injury TraumaSevere acute pancreatitisComplications of influenzaAutoimmune disease flares
Highly efficient cytokine filter that is designed to treat cytokine storm and inflammation
European CE Mark approved as a cytokine filter in cases where cytokines are elevated
CytoSorb™ Cardiac Surgery
Protection of organ transplants
Highly efficient cytokine filter to reduce cytokine-induced organ injury
Observational human study completedHuman pilot study completed
BetaSorb™ Improvement of hemodialysis in end-stage renal disease
Removal of mid-molecular weight toxins that are inefficiently removed by standard dialysis
Four human pilot studies completed
HemoDefend Purification of blood transfusion products
“Beads in a Bag” purification technology Pre-clinical proof of concept completed
CST 101/201 Drug overdose/ Chemotherapy removal during high dose regional chemotherapy
Efficient single pass removal of drugs and certain chemotherapy agents from blood
Pre-clinical proof of concept completed
CST 301 Trauma Removal of myoglobin from blood caused by muscle breakdown and rhabdomyolysis in trauma
Pre-clinical proof of concept completed
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CytoSorbents has an active business development program seeking partners for its growth technology portfolio
Potential partners include companies involved in:• Dialysis and renal therapies
• Pharmaceuticals
• Critical care
• Advanced materials
• Blood purification
Partnerships help validate the technology, provideresources to further develop products, are a source of
non-dilutive funding, and are potential M&A candidates
CytoSorbents Seeks Strategic Alliances
CytoSorbents
CytoSorbents represents a major potential growth story
• CytoSorb™ addresses the root cause of why many patients die in the ICU from a wide range of critical illnesses
• The total addressable market in critical care exceeds $10 billion
• With approval of CytoSorb™, the company is transitioning for the first time in its history from a development-stage company to a revenue-based company with modest revenue expected in 2011
• The company has a strong IP position with 29 issued patents
• The pipeline for products continues to expand with HemoDefend and others, enabling the company to monetize its rich technology portfolio while pursuing core applications on its own
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CytoSorbents Seeks New Investors
CytoSorbents
Phillip P. Chan, MD, PhDCEO and President
7 Deer Park Drive, Suite KMonmouth Junction, NJ 08852
(732) 329-8885pchan@cytosorbents.com
CytoCytoCytoCytoSorbents CorporationSorbents CorporationSorbents CorporationSorbents Corporation
Working to Save LivesThrough
Blood Purification
OTCBB: CTSO
CytoSorbents Corporation
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