cytosorbents rodman presentation september 2011

7/31/2019 CytoSorbents Rodman Presentation September 2011

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CytoSorbents

Rodman & Renshaw 2011 Healthcare ConferenceInvestor PresentationSeptember 12, 2011

OTCBB: CTSO

CytoSorbents Corporation

Working to Save Lives

Through Blood Purification


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CytoSorbents 2

Safe Harbor Statement

Statements in this presentation regarding CytoSorbents Corporation and its operatingsubsidiary CytoSorbents, Inc that are not historical facts are forward-looking statementsand are subject to risks and uncertainties that could cause actual future events or

results to differ materially from such statements. Any such forward-looking statementsare made pursuant to the safe harbor provisions of the Private Securities LitigationReform 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 ifthey do. Actual events or results may differ materially from those contained in theprojections or forward-looking statements. The following factors, among others, couldcause our actual results to differ materially from those described in a forward-looking

statement: our history of losses; potential fluctuations in our quarterly and annualresults; competition, inability to achieve regulatory approval for our device, technologysystems beyond our control and technology-related defects that could affect thecompanies products or reputation; risks related to adverse business conditions; ourdependence on key employees; competition for qualified personnel; the possibleunavailability of financing as and if needed; and risks related to protecting ourintellectual 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 thatcould cause actual results to differ from those discussed in the forward-lookingstatements. Readers are referred to a discussion of important risk factors detailed in theCompanys 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 availableonline at www.sec.gov.


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CytoSorbents 3

CytoSorbents Overview

CytoSorbents is a critical care-focused device companyusing blood purification to treat disease, with its first

European Union approved product, CytoSorb


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CytoSorbents 4

Technology Overview

The heart of the technology is abiocompatible, highly porous, polymer bead

that can remove a wide range of toxic substancesfrom blood and fluids based onpore capture and surface adsorption


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CytoSorbents 5

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

The polymer beads are packed into cartridges compatible

with standard hemodialysis machines or blood pumps

Concept is Simple But Elegant


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CytoSorbents 6

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 keycytokines 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

Recent Company Highlights


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CytoSorbents 7

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 ChaseManhattan Bank


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CytoSorbents 8

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

CytoSorbentsIs A Critical Care

Pure Play


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CytoSorbents 10

CytoSorbents Targets Unmet Needs in the ICU

There are few active therapies available for serious diseases seenin 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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CytoSorbents 11

Introducing CytoSorb

The cornerstone of our strategy to actively treatcritical care diseases is

CytoSorb

An efficient cytokine filter that can help fightCytokine Storm and potentially reduce

deadly inflammation and organ injury


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CytoSorbents

CytoSorbApproved 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

12


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CytoSorbents

CytoSorb Broadly Reduces Cytokines

IL-6 TNF- IL-10

IL-1 IL-1ra IL-8

A typical example of CytoSorbcytokine reduction of 50-100%during in vitroperfusion with serum (or buffer)

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


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CytoSorbents 14

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

CytoSorbents

Initial Focus

is the Treatment ofSepsis


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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 anysingle 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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CytoSorbents

Time (days to weeks)Time (days to weeks)

Sepsis has two facets but only one is treated

IN

SULT

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 arecurrently no therapies to treat the immune response and cytokine storm

17


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CytoSorbents 18

Cytokines: A Dual-Edged Sword

Cytokines are small proteins that, in moderation,normally help stimulate and regulate the

immune system. They are required for properimmune system function

However, in excess, cytokines can causedisease

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


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CytoSorbents 19

Shock

Clotting

Cytokine Storm Leads to Organ Failure

Cytokines

Inflammation, Organ Failure and Infection

Lung Injury Cell Death

IntestinalInjury

Immune

Paralysis


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CytoSorbents 20

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 singlecytokine or inflammatory mediator

Too much redundancy in the immune system for this strategy to work

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

CytoSorb is a leader in this field


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CytoSorbents

CytoSorb Helps Fight Cytokine Storm

INSULT

TOXICTOXIC

Organ DamageOrgan Damage

TimeTime

RecoveryCytoSorb

22


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CytoSorbents

CytoSorb Yields Clinical Benefit in Animals

CytoSorb animal models simulating sepsis from a ruptured appendixwith no antibiotics and only a single 3-hour treatment

Increased survival to 65% (treated) from 12.5% (sham)

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 cytokineremoval and short term survival in rats Crit Care Med (2008) 36(5): 1573-7 22


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CytoSorbents

CytoSorb

Data from the European Sepsis Trial


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CytoSorbents 24

CytoSorbEuropean Sepsis Trial

Completed a randomized, controlled clinical trialto treat patients with severe sepsis or septic shock in the

setting of acute respiratory distress syndrome/ALI

Compared standard of care therapy alone withstandard 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 includedto examine trends to benefit in mortality, ventilatordependence, organ failure scores, other cytokinereduction, vasopressor use, and others


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CytoSorbents

Three Phases of Sepsis Trial

Pilot

Study(22 patients)

Manual

Randomization(31 patients)

Electronic

Randomization(47 patients)

Our CRO did not have electronic randomization capability and instead distributedsealed envelopes containing patient randomization assignments to each site. Duringthe manual randomization phase, the Company noted a large number of patientswith 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 auditedand two sites most responsible for this bias were also found to have had envelopesopened with no corresponding patient enrolled.

After a thorough review by the SAB and external DSMB, they concluded that datafrom the manual randomization phase was biased by a compromise of randomization

and unanimously recommended to reset the clock with electronic randomization. Itwas believed that the remaining 47 patients to be enrolled under electronicrandomization 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.

25

100

patientstotal


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CytoSorbents 26

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 safelyadministered human CytoSorb treatments to more than 650

Treatment was well-tolerated by patients

No clinically significant change in electrolytes or increase in markers oforgan 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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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%reduction

p=0.002

36.5%

reductionp=0.001

30.2%reduction

p=0.002

CytoSorbBroadly Reduces Cytokines

Electronic Randomization Only: N = 43 (18 treatment; 25 control) *interim/final analysis 27


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CytoSorbents

Study Demographics (Electronic Randomization)

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CytoSorbents

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

* 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

29


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CytoSorbents

Can Cytokine Reductionwith CytoSorb

Improve Clinical OutcomeIn These High Risk Patients?

C t S b


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CytoSorbents

CytoSorb

Reduces 28-day MortalityWith High IL-6 and/or IL-1ra Levels

CytoSorb treatment shows statistically significant reduction in28-day mortality (0.0% vs 62.5% control, p=0.03)

Control Day 1IL-6

(pg/mL)

Day 1IL-1ra

(pg/mL)

Outcome(28 day)

A 1095 19,769 Dead

B 8230 1949 Live

C 1521 >22,000 Dead

D 3548 >22,000 Dead

E 2730 21518 Live

F 73459 >22,000 DeadG 1030 >22,000 Dead

H 888 >22,000 Live

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

Treated Day 1IL-6

(pg/mL)

Day 1IL-1ra

(pg/mL)

Outcome(28 day)

P 13857 >22,000 Live

Q 1023 8896 Live

R 8076 16,110 Live

S 664 >22,000 Live

T 772 >22,000 Live

U 301 >22,000 Live

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

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N=14 (6 treatment, 8 control)

C t S b

R d 60 d M li


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CytoSorbents

CytoSorb Reduces 60-day MortalityWith High IL-6 and/or IL-1ra Levels

Even at 60-days, CytoSorb treatment shows strong trend tobenefit towards reduction in 60-day mortality (17% vs 63%control, p=0.14)

Control Day 1IL-6

(pg/mL)

Day 1IL-1ra

(pg/mL)

Outcome(28 day)

A 1095 19,769 Died

B 8230 1949 Live

C 1521 >22,000 Died

D 3548 >22,000 Died

E 2730 21518 Live

F 73459 >22,000 DiedG 1030 >22,000 Died

H 888 >22,000 Live

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

Treated Day 1IL-6

(pg/mL)

Day 1IL-1ra

(pg/mL)

Outcome(28 day)

P 13857 >22,000 Live

Q 1023 8896 Live

R 8076 16,110 Live

S 664 >22,000 Live

T 772 >22,000 Live

U 301 >22,000 Live

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

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Died

N=14 (6 treatment, 8 control)


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CytoSorbents

Reduced Need for Ventilation with

High IL-6 and/or IL-1ra Levels

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

I t i V til t F D


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CytoSorbents

Improvement in Ventilator-Free Dayswith High IL-6 and/or IL-1ra Levels

Ventilator-free days are the number of days out of 28 that a patient isoff the ventilator and alive. Higher is better. Death is treated as 0 days

CytoSorb shows trend to benefit in increased vent-free days in thetreated group (7.8 vs 2.3 days control, p=0.2) n = 14 (6 treated, 8 control)

34

0

1

2

3

4

5

6

7

8

Ventilator-Free Days

Ventilator-Free Days

IL-6 >= 1000 pg/mL OR IL-1ra >= 16,000 pg/mL

Control

Treatment

S i i ll Si ifi R d i i


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CytoSorbents

Statistically Significant Reduction in

14-Day Mortality (Age

65)

CytoSorb demonstrates a protective effect for up to 14 dayswith 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 35


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CytoSorbents

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 patientsafety, regardless of how patients were doing. In this sick population, longertreatment beyond 7 days may yield even greater benefit

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CytoSorbents

Improvement in Organ Dysfunction (Age 65)

37

-30%

-25%

-20%

-15%

-10%

-5%

0%

% Reduction in MODS Score

on Day 7 (versus Day 1)

Control

Treatment

The Multiple Organ Dysfunction Score (MODS) is used to measure thelevel 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


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CytoSorbents

Reduced Need for Ventilation (Age 65)

38

Population on Mechanical Ventilation

Age >= 65

50%

60%

70%

80%

90%

100%

1 2 3 4 5 6 7 8 9 10 1 1 12 13 1 4 15 1 6 17 1 8 19 2 0 21 22 2 3 24 2 5 26 27 2 8

Days

%P

opulationonVentilator

Control

Treat

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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CytoSorbents

Commercial Strategy

S O


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CytoSorbents

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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Sales and Marketing Overview


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CytoSorbents 41

C ti t F t Cli i l D t


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CytoSorbents 42

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 lunginjury, burn injury, trauma, and severe acute pancreatitis

Will seek support of the government, NIH, the military, and potentialstrategic 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

C toSo b h bi k t t ti l


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CytoSorbents

Assumptions

CytoSorb hemoperfusion ~ $500/device

CytoSorbents treatment (7 days) ~ 7 devices Average patient treatment revenue ~ $ 3,500

Annual sepsis patients in US and EU ~ 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

CytoSorb has big market potential

43

C t S b t Pi li


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CytoSorbents 44

CytoSorbents has a robust, innovative pipeline with

strong development capabilities

CytoSorbents Pipeline

NAME INDICATION DESCRIPTION STATUS

CytoSorb Severe sepsis and septic shock

ARDS/ acute lung injuryBurn and smoke inhalation injuryTraumaSevere acute pancreatitisComplications of influenzaAutoimmune disease flares

Highly efficient cytokine filter that is

designed to treat cytokine storm andinflammation

European CE Mark

approved as a cytokinefilter in cases wherecytokines are elevated

CytoSorb Cardiac Surgery

Protection of organ transplants

Highly efficient cytokine filter to reduce

cytokine-induced organ injury

Observational human

study completedHuman pilot studycompleted

BetaSorb Improvement of hemodialysis inend-stage renal disease

Removal of mid-molecular weight toxinsthat are inefficiently removed by standarddialysis

Four human pilot studiescompleted

CST 101Drug overdose, chemicalexposure or intoxication

Efficient single pass removal of a numberof drugs from blood

Pre-clinical proof ofconcept completed

CST 201 Adjunct cancer treatment:Chemotherapy removal duringhigh dose regional chemotherapy

Efficient single pass removal of certainchemotherapy agents from blood


CST 301 Trauma Removal of myoglobin from blood causedby muscle breakdown and

rhabdomyolysis in trauma


CytoSorbents S k St t i Alli


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CytoSorbents 45

CytoSorbents has an active business development programseeking partners for its growth technology portfolio

Potential partners include companies involved in: Dialysis and renal therapies

Pharmaceuticals

Critical care Advanced materials

Blood purification

CytoSorbents Seeks Strategic Alliances

Historical Milestones and Projections


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CytoSorbents 46

Historical Milestones and Projections

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4Q3 Q4

ISO 13485 Cert

CytoSorb manufacturing ramp

Completed European Sepsis Trial

QTDP $500K Grant PROJECTED

Begin Controlled Market Release

Official CytoSorb launch

2011 20122010

Uplisting to NASDAQ/AMEX

US FDA Study Start

Positive Data at German Sepsis Society Congress

European Society of Intensive Care Medicine

CytoSorbents Investment Highlights


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CytoSorbents 47

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 launchanticipated 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

Phillip P. Chan, MD, PhDCEO and President

7 Deer Park Drive, Suite KMonmouth Junction, NJ 08852

(732) 329-8885

[email protected]

CytoCytoCytoCytoSorbents CorporationSorbents CorporationSorbents CorporationSorbents Corporation

Working to Save LivesThrough

Blood Purification

OTCBB: CTSO

cytosorbents rodman presentation september 2011

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