CytoSorbents Corporation

Working to Save Lives Through Blood Purification

Rodman & Renshaw 2011 Healthcare Conference Investor Presentation September 12, 2011
CytoSorbents

OTCBB: CTSO

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 Companys 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.

CytoSorbents

CytoSorbents Overview
CytoSorbents is a critical care-focused device company using blood purification to treat disease, with its first European Union approved product, CytoSorb

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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 substances from blood and fluids based on pore capture and surface adsorption

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Concept is Simple But Elegant

The polymer beads are packed into cartridges compatible with standard hemodialysis machines or blood pumps
Obtain venous access with temporary dialysis catheter Pump blood through the cartridge with standard pumps The polymer beads remove toxic substances 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

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Recent Company Highlights

Achieved European CE Mark approval for CytoSorb as a first-in-class extracorporeal cytokine filter, to be used when cytokines are elevated CytoSorb achieved the primary endpoint of its European Sepsis Trial demonstrating statistically significant reduction of IL-6 as well as other key cytokines by 30-50% in critically-ill patients CytoSorb treatment was associated with statistically significant reduction in 28-day mortality in patients with very high cytokine levels and in 14-day mortality in patients 65 years of age Currently manufacturing CytoSorb under ISO 13485 Full Quality Systems certification of manufacturing Controlled-market release of CytoSorb in Germany is now underway with a broader launch planned in 1H 2012 Clear path for reimbursement now in Germany Strong response from physicians during German Sepsis Society Congress CytoSorbents
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Management Team
Phillip Chan, MD, PhD Chief Executive Officer and President
Board-certified internal medicine physician. MD/PhD from Yale School of Medicine Internal Medicine residency at the Beth Israel Deaconess Medical Center at Harvard Former Partner at NJTC Venture Fund heading up healthcare investments for 5 years Co-founder of the venture-backed medical device firm, Andrew Technologies

Robert Bartlett, MD - Chief Medical Officer

World-renowned pioneer of extracorporeal membrane oxygenation therapy (ECMO) Former Director of the Surgical Intensive Care Unit at University of Michigan Major thought leader in critical care, extracorporeal treatments, sepsis and lung injury

Vincent Capponi, MS - Chief Operating Officer

20+ years experience in the medical device, pharmaceutical and imaging fields at Upjohn, Sims Deltec and Sabratek with strengths in operations and manufacturing

David Lamadrid, MBA - Chief Financial Officer

18+ years of business experience in finance and management, previously at Chase Manhattan Bank

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Medical Advisory Board

John Kellum, MD
Professor of Critical Care Medicine & Anesthesiology at U of Pittsburgh Medical Center Chair of the Sepsis Advisory Board

Emil Paganini, MD
Former Section Head of Dialysis and Extracorporeal Therapy at the Cleveland Clinic

Joseph Parrillo, MD
Chief and Professor of Medicine at U of Medicine and Dentistry of New Jersey Director of the Cooper Heart Institute Editor-in-Chief of the journal Critical Care Medicine

Claudio Ronco, MD
Director, Dialysis and Renal Transplantation at St. Bartolo Hospital (Vicenza, Italy)

Thomas Stewart, MD
Associate Professor of Medicine and Anesthesiology at Mount Sinai at U of Toronto Director of Critical Care Medicine

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CytoSorbents
Is A Critical Care Pure Play

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CytoSorbents Targets Unmet Needs in the ICU

There are few active therapies available for serious diseases seen in the intensive care unit Severe sepsis and septic shock Acute respiratory distress syndrome (ARDS) Burn and smoke inhalation injury Trauma Influenza Consequences of surgery Severe acute pancreatitis Many others

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Introducing CytoSorb

The cornerstone of our strategy to actively treat critical care diseases is

CytoSorb

CytoSorbents

An efficient cytokine filter that can help fight Cytokine Storm and potentially reduce deadly inflammation and organ injury

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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

CytoSorb is the first therapy specifically approved as an extracorporeal cytokine filter in the E.U. to be used wherever cytokines are elevated Because of the broad label, CytoSorb can be used on-label to treat many life-threatening illnesses commonly seen in the intensive care unit where cytokine storm contributes to organ failure and death
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CytoSorb Broadly Reduces Cytokines

A typical example of CytoSorbcytokine reduction of 50-100% during in vitro perfusion with serum (or buffer)
IL-6 TNF- IL-10

IL-1

IL-1ra

IL-8

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Valenti, I Characterization of a Novel Sorbent Polymer for the Treatment of Sepsis 2008

CytoSorb is State of the Art Technology

Clinically proven as an effective cytokine filter Biocompatible and hemocompatible ISO 10993 certified Good safety track record 160 canine and 650+ human treatments Massive capacity Easier to use than dialysis Compatible with standard hospital dialysis equipment plug & play Low cost of production and inherently high gross margins 3-year shelf life at room temperature High quality manufacturing under ISO 13485:2003 Certification Covered by 29 issued patents
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CytoSorbents Initial Focus is the Treatment of Sepsis

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Sepsis is a Worldwide Crisis

Sepsis is the result of an overzealous immune response to 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 Represents a major unmet medical need with only Xigris (Lilly) approved to treat sepsis in the US or Europe

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Sepsis has two facets but only one is treated

The infectious insult can be treated with antibiotics/antivirals, but there are currently no therapies to treat the immune response and cytokine storm

Cytokine Storm
Pro-Inflammatory
TOXIC

Anti-inflammatory

IN SU L

Death

Organ Failure

Recovery

Time (days to weeks)

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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 vast excess, often called cytokine storm, cytokines can cause organ injury and failure, and often death

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Cytokine Storm Leads to Organ Failure Cytokines

Clotting Shock Lung Injury Cell Death Inflammation, Organ Failure and Infection
Intestinal Injury

Immune Paralysis

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Treating Cytokine Storm The Holy Grail

Reduction in Cytokine Storm has been the target of the industry for three decades
Unfortunately, most drugs and biologics can only reduce a single cytokine or inflammatory mediator Too much redundancy in the immune system for this strategy to work

A Broad Spectrum Solution is needed that can remove many different cytokines and toxins

CytoSorb is a leader in this field

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CytoSorb Helps Fight Cytokine Storm

TOXIC

IN SU L

T
Organ Damage

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Recovery

Time
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CytoSorb Yields Clinical Benefit in Animals

CytoSorb animal models simulating sepsis from a ruptured appendix with no antibiotics and only a single 3-hour treatment
Increased survival to 65% (treated) from 12.5% (sham)

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Prevented hemodynamic shock Reduced IL-6, TNF-, IL-1 and IL-10 by 50-80% May reduce cytokine production as well
Peng, ZY, Carter, MJ, Kellum, JA Effects of hemoadsorption on cytokine removal and short term survival in rats Crit Care Med (2008) 36(5): 1573-7 22

CytoSorb Data from the European Sepsis Trial

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CytoSorb European Sepsis Trial

Completed a 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 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 trends to benefit in mortality, ventilator dependence, organ failure scores, other cytokine reduction, vasopressor use, and others
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Three Phases of Sepsis Trial

Pilot Study (22 patients) Manual Randomization (31 patients) Electronic Randomization (47 patients) 100 patients total

Our CRO did not have electronic randomization capability and instead distributed sealed envelopes containing patient randomization assignments to each site. During the manual randomization phase, the Company noted a large number of patients with renal failure being entered into the treatment arm versus control (57% vs 17% control, p=0.05) resulting in a much sicker treatment arm. Envelopes were audited and two sites most responsible for this bias were also found to have had envelopes opened with no corresponding patient enrolled. After a thorough review by the SAB and external DSMB, they concluded that data from the manual randomization phase was biased by a compromise of randomization and unanimously recommended to reset the clock with electronic randomization. It was believed that the remaining 47 patients to be enrolled under electronic randomization could be sufficient to achieve the goals of the study. Statistically, electronic randomization corrected the randomization issue. Except for safety data, only data from the electronic randomization phase will be presented here. CytoSorbents
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CytoSorb Treatment was Safe

All 100 patients from the trial were included in this safety analysis No serious device related adverse events in more 300 treatments in septic 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, common to other extracorporeal therapies Additional biochemical analysis and other marker removal is still underway

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CytoSorb Broadly Reduces Cytokines

49.1% reduction p=0.01*

36.5% reduction p=0.001

49.5% reduction p=0.002

30.2% reduction p=0.002

Achieved statistically significant 30-50% reduction in key cytokines across the 7-day treatment period. Others are pending CytoSorbents Electronic Randomization Only: N = 43 (18 treatment; 25 control) *interim/final analysis

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Study Demographics (Electronic Randomization)

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These Patients Have a High Risk of Death

Patients have many risk factors for death Presence of multiple organ failure
Shock Acute respiratory distress syndrome (ARDS) Renal failure Age 65 Accounts for approximately two-thirds of all sepsis cases Relative risk is 13-fold compared to younger population * High cytokine levels: IL-6, IL-1ra, MCP-1, IL-8 others

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* 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

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Can Cytokine Reduction with CytoSorb Improve Clinical Outcome In These High Risk Patients?

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CytoSorb Reduces 28-day Mortality With High IL-6 and/or IL-1ra Levels
CytoSorb treatment shows statistically significant reduction in 28-day mortality (0.0% vs 62.5% control, p=0.03)
Control Day 1 IL-6 (pg/mL) 1095 8230 1521 3548 2730 73459 1030 888 Day 1 IL-1ra (pg/mL) 19,769 1949 >22,000 >22,000 21518 >22,000 >22,000 >22,000 Outcome (28 day) Treated Day 1 IL-6 (pg/mL) 13857 1023 8076 664 772 301 Day 1 IL-1ra (pg/mL) >22,000 8896 16,110 >22,000 >22,000 >22,000 Outcome (28 day)

A B C D E F G H

Dead Live Dead Dead Live Dead Dead Live

P Q R S T U

Live Live Live Live Live Live

Treament Mortality: IL-6 >1,000 pg/mL &/or IL-1ra > 16,000 = 0%

Control Mortality: IL-6 >1,000 pg/mL &/or IL-1ra > 16,000 pg/mL = 62.5%

N=14 (6 treatment, 8 control)

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CytoSorb Reduces 60-day Mortality With High IL-6 and/or IL-1ra Levels
Even at 60-days, CytoSorb treatment shows strong trend to benefit towards reduction in 60-day mortality (17% vs 63% control, p=0.14)
Control Day 1 IL-6 (pg/mL) 1095 8230 1521 3548 2730 73459 1030 888 Day 1 IL-1ra (pg/mL) 19,769 1949 >22,000 >22,000 21518 >22,000 >22,000 >22,000 Outcome (28 day) Treated Day 1 IL-6 (pg/mL) 13857 1023 8076 664 772 301 Day 1 IL-1ra (pg/mL) >22,000 8896 16,110 >22,000 >22,000 >22,000 Outcome (28 day)

A B C D E F G H

Died Live Died Died Live Died Died Live

P Q R S T U

Live Live Live Died Live Live Live

Treament Mortality: IL-6 >1,000 pg/mL &/or IL-1ra > 16,000 = 17%

Control Mortality: IL-6 >1,000 pg/mL &/or IL-1ra > 16,000 pg/mL = 63%

N=14 (6 treatment, 8 control)

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CytoSorbents

Reduced Need for Ventilation with High IL-6 and/or IL-1ra Levels

55% absolute improvement in patients with high IL-6 or IL-1ra levels showing strong trend to benefit (p=0.09, N = 14; 6 treated, 8 control)
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Improvement in Ventilator-Free Days

with High IL-6 and/or IL-1ra Levels
Ventilator-Free Days IL-6 >= 1000 pg/mL OR IL-1ra >= 16,000 pg/mL

8 7 6 5 4 3 2 1 0 Ventilator-Free Days

Control Treatment

Ventilator-free days are the number of days out of 28 that a patient is off the ventilator and alive. Higher is better. Death is treated as 0 days CytoSorb shows trend to benefit in increased vent-free days in the treated group (7.8 vs 2.3 days control, p=0.2) n = 14 (6 treated, 8 control)
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Statistically Significant Reduction in 14-Day Mortality (Age 65)

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CytoSorb demonstrates a protective effect for up to 14 days with a statistically significant survival advantage (100% survival vs 64% control, p=0.04, n=21 (10 treated, 11 control) in patients 65 years of age

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Longer Treatment May Be Needed (Age > 65)

28-day mortality shows gradual loss of treatment effect on mortality (40% vs 45% control, p=0.6; n=22 (10 treated, 11 control)) CytoSorb treatment was limited to only 7 days by protocol to ensure patient safety, regardless of how patients were doing. In this sick population, longer treatment beyond 7 days may yield even greater benefit CytoSorbents

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Improvement in Organ Dysfunction (Age 65)

The Multiple Organ Dysfunction Score (MODS) is used to measure the level of organ injury over time (high score is worse) CytoSorb treated patients 65 years old demonstrate a trend to benefit in a reduction of MODS (-28% vs -9% control) during 7 days of treatment
0% -5% -10% -15% -20% -25% -30%

Control Treatment

% Reduction in MODS Score on Day 7 (versus Day 1)

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Reduced Need for Ventilation (Age 65)

Population on Mechanical Ventilation Age >= 65
100%
% Population on Ventilator Control Treat

90% 80% 70% 60% 50%

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Days

Weaning off of mechanical ventilation reflects recovery from lung injury Trend to benefit in ventilation independence is seen in treated patients (60% vs 73% control; n = 21 (10 treatment, 11 control))
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Commercial Strategy

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Sales and Marketing Overview

Focus is on direct sales in Germany the largest medical device market in the E.U. and the third largest in the world with a population of 82M Just begun a 3-6 month controlled market release of CytoSorb in select areas in Germany, and plan a broader launch in Germany in Q2 2012 German Sepsis Society booth traffic was strong, with very encouraging response to our trial data. Many physicians, including key opinion leaders, have asked to try the device in many different applications Manufacturing under ISO 13485 has fully ramped CytoSorb reimbursement exists in Germany today
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Continue to Foster Clinical Data

Generation of clinical data will drive adoption of CytoSorb
Plan to sponsor additional studies in sepsis
Goal is to give clinicians greater flexibility in how to use CytoSorb Dosing study will examine length of treatment on outcome Plan to conduct a US pivotal study to help drive approval in the US

Plan to support studies in other critical care applications such as lung injury, burn injury, trauma, and severe acute pancreatitis Will seek support of the government, NIH, the military, and potential strategic partner to help finance these studies
Submitted application to DARPA BAA for Dialysis-like Therapeutics Submitted an SBIR application for trauma application Recently attended ATACCC and garnered substantial interest for our technologies

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CytoSorb has big market potential

Assumptions
CytoSorb hemoperfusion CytoSorbents treatment (7 days) Average patient treatment revenue Annual sepsis patients in US and EU ~ $500/device ~ 7 devices ~ $ 3,500 ~ 2.5 million

$6-10 Billion US and EU Market (Sepsis alone) $500-800M total addressable market (Germany only and sepsis) $10-15 Billion US and EU Market (All critical care apps including Sepsis) ~$1 Billion market in Germany for critical care applications

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CytoSorbents Pipeline
CytoSorbents has a robust, innovative pipeline with strong development capabilities
NAME INDICATION DESCRIPTION STATUS

CytoSorb

Severe sepsis and septic shock ARDS/ acute lung injury Burn and smoke inhalation injury Trauma Severe acute pancreatitis Complications of influenza Autoimmune disease flares Cardiac Surgery Protection of organ transplants

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

Highly efficient cytokine filter to reduce cytokine-induced organ injury

Observational human study completed Human pilot study completed Four human pilot studies completed Pre-clinical proof of concept completed Pre-clinical proof of concept completed Pre-clinical proof of concept completed

BetaSorb CST 101 CST 201 CST 301

Improvement of hemodialysis in end-stage renal disease Drug overdose, chemical exposure or intoxication Adjunct cancer treatment: Chemotherapy removal during high dose regional chemotherapy Trauma

Removal of mid-molecular weight toxins that are inefficiently removed by standard dialysis Efficient single pass removal of a number of drugs from blood Efficient single pass removal of certain chemotherapy agents from blood Removal of myoglobin from blood caused by muscle breakdown and rhabdomyolysis in trauma

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CytoSorbents Seeks Strategic Alliances

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

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Historical Milestones and Projections

Uplisting to NASDAQ/AMEX CytoSorb manufacturing ramp Completed European Sepsis Trial QTDP $500K Grant ISO 13485 Cert PROJECTED US FDA Study Start

Positive Data at German Sepsis Society Congress Begin Controlled Market Release European Society of Intensive Care Medicine Official CytoSorb launch

Q3 2010

Q4

Q1

Q2 2011

Q3

Q4

Q1

Q2 2012

Q3

Q4

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CytoSorbents Investment Highlights

CytoSorb is the first cytokine filter approved in the E.U. with differentiated, best of breed approach with strong IP CytoSorb has good clinical data in sepsis to help drive near-term sales but can be used on-label for other critical care applications Controlled-market release is now ongoing with formal market launch anticipated for late Q1 2012 US and EU total addressable market for critical care exceeds $10 billion The first of a number of novel therapies in the pipeline

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CytoSorbents CytoSorbents Corporation

Working to Save Lives Through Blood Purification OTCBB: CTSO

Phillip P. Chan, MD, PhD

CEO and President 7 Deer Park Drive, Suite K Monmouth Junction, NJ 08852 (732) 329-8885 pchan@cytosorbents.com

CytoSorbents