Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — MedaSorb Technologies — Rodman & Renshaw Healthcare Conference 2009
27 slides from Cytosorbents's conference presentation, Sep 15, 2009
Slide 1: Working to Save Lives Through Blood Purification
Technologies Corporation Ss. Working to Save Lives Through Blood Purification And its Wholly-Owned Operating Subsidiary CytoSorbents OTCBB: MSBT Rodman & Renshaw Healthcare Conference 2009
Slide 2: Safe Harbor Statement
Safe Harbor Statement Statements in this presentation regarding CytoSorbents, Inc and its parent MedaSorb Technologies Corporation 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 materi
Slide 3: Company Overview
Clinical Status Future Patents Management Company Overview To treat severe sepsis due to infection (bacterial or viral) Sori” — highly porous resin cartridge that acts as a cytokine filter to reduce cytokine storm in severe sepsis Currently enrolling up to a 100 patient European trial to treat septi
Slide 4: The Sepsis Problem
The Sepsis > Severe sepsis is often called “Overwhelming Infection” Afflicts 18 million people worldwide every year and growing Kills 1 in every 3 despite the best treatment Kills more people in the U.S. than heart attacks, strokes, or any single type of cancer Treatment costs the U.S. more than $18
Slide 5: What causes Severe Sepsis?
What causes Severe Sepsis? Pro-Inflammatory a f fracoxt %, Organ Failure | (days to weeks)
Slide 6: Cytokine Storm fuels the sepsis cascade
Cytokine Storm fuels the sepsis cascade — Cytokines ~ > ' Intestinal Clotting / | | \> Injury Immune Siigex Paralysis Lung Injury! Cell Death Tissue Ischemia, Organ Damage, Infectio! n v
Slide 7: Example of Pure Cytokine Storm
Example of Pure Cytokine Storm TeGenero Anti-CD28 monoclonal antibody Phase | Trial Designed to stimulate the immune system to treat cancer Phase | safety trial (2006) — 6 healthy adult males + 90 minutes from injection — All had systemic inflammatory response Headache, nausea, muscle pain, diarrhea
Slide 8: Treating Cytokine Storm — The Holy Grail
Treating Cytokine Storm — The Holy Grail Reduction in Cytokine Storm has been the target of Drugs and Biologics 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
Slide 9: Introducing CytoSorb
Introducing CytoSorh” ioSorb" is a highly porous polymer resin that broadly removes cytokines and toxins from blood Concept is very straightforward Obtain venous access with temporary dialysis catheter Pump blood through the Sort cartridge The Sorl resin removes cytokines/toxins “Purified” blood is
Slide 10: Simulated for illustrative purposes only
‘Simulated for illustrative purposes only Blood Flow
Slide 11: CytoSorb Active in Cytokine Sweet Spot
»Sorb" Active in Cytokine Sweet Spot iL-1p TNF-a monomer (FN-y monomer L-1Ra MCP IL-13 Hemodialysis ye-18 HMGB1 TGF-B IL-6 sFas ligand sTNFR MCP-1 glycosylated IFN-y dimer TNF-a trimer
Slide 12: CytoSorb is State of the Art Technology
Sorb is State of the Art Technology Very efficient in removing cytokines Compatible with blood Massive capacity Easy to use Compatible with standard hospital dialysis equipment Low cost Long shelf life Low manufacturing risk
Slide 13: CytoSorb Expected to Limit Cytokine Storm
Sorh Expected to Limit Cytokine Storm
Slide 14: CytoSorb has been extensively tested
Sor has been extensively tested Sorli removes cytokines in vitro and in simulated whole blood circulation systems on the order of 80-95% Sorli increases survival to 35-65% from 5% in sham treated animals in different rat sepsis models Sori helped stabilize a 71 year old man in septic shock from gang
Slide 15: CytoSorb improves survival in animals
CytoSorb improves survival in animals Endotoxin Cha 7/20 vs 1/20 for sham Kellum, JA, Song M, Venkataraman, R “Hemoadsorption removes TNF, IL-6, and IL-10, reduces NF-KB DNA binding, and improves short-term survival in lethal endotoxemia” Crit Care Med (2004) 32(2)- 801-805 Pe nota ‘Srl prapenity 4)
Slide 16: ...with prevention of shock
...with prevention of shock Effects of hemoadsorption jj ‘on mean arterial pressure CytoSorb (MAP) (Mean #/- SEM, mm Hg) in the CLP rat sepsis model. Hemoadsorption is shown in the dashed line while sham results are shown in the solid line. MAP was significantly different over time and between group
Slide 17: ...and reduction of cytokines
..and reduction of cytokines 116 dn pom Peng, ZY, Carter, MJ, Kellum, JA “Effects of hemoadsorption on cytokine Black bars = CytoSorb removal and short term survival in rats” Crit Care Med (2008) 36(5): 1573-7 White bars = Sham
Slide 18: European Clinical Trial
European Clinical Trial Randomized, controlled, multi-center, open-label study in up to 100 patients with severe sepsis in the setting of respiratory failure « Primary endpoint: IL-6 reduction * Secondary and tertiary endpoints include * 28-day and 60-day mortality Ventilator free days Organ damage
Slide 19: Anticipate CE Mark Approval in 2010
Anticipate CE Mark Approval in 2010 European Sepsis Trial has enrolled 31 patients to date Acceleration of recruitment is expected with twelve sites Treatment is well-tolerated No serious device related adverse events in more than 460 treatments, with more than 100 in sepsis patients With a successf
Slide 20: What makes CytoSorb different?
What makes Sorh different? No product is approved to treat cytokine storm directly Sorli is the most logical way to treat cytokine storm In doing so, may positively impact many of the pathways that lead to death in sepsis and improve survival
Slide 21: Limited Competition
Limited Competition Pharmaceuticals and Biologics ¢ Historically unsuccessful * Xigris (Lilly) is the only approved drug by the FDA, but limited usage * Phase III TLR-4 inhibitors (Takeda and Eisai) * Others are Phase II or earlier Devices * Standard blood purification techniques ineffective or inef
Slide 22: CytoSorb has big market potential
bh has big market potential Assumptions ¢« Gambro Adsorba hemoperfusion ~ $500/device CytoSorb hemoperfusion ~ $500/device (base) CytoSorbents treatment (7 days) 7 devices Average patient treatment revenue $ 3,500 Annual incidence of severe sepsis 3 in 1000 $3.5 Billion US Market (~1 million sepsis
Slide 23: CytoSorb is a Potential Blockbuster
Sorb is a Potential Blockbuster Multi-billion dollar market with limited competition Differentiated, broadly patented “best of breed” approach Highly profitable “razor/razorblade” model Reimbursement in the US and Germany is covered under favorable DRG reimbursement Commercialization is near-term Sw
Slide 24: Not just a sepsis company
is not just a “sepsis” company c device company with a valuable polymer technology and a robust pipeline a INBICATION TEGO STATS CytoSorb™ | Severe sepsis Highly efficient cytokine filter that is Registration clinical designed to treat cytokine storm in sepsis | trials in Europe BetaSorb™ Improvemen
Slide 25: Valuation Comparables
Valuation Comparables* 1) Renal Solutions - $190 M + Privately-held company with a resin technology that regenerated dialysate * $40M in private equity, $25M in debt financing + $1M in revenue (2007) * Acquired by Fresenius in November 2007 for $190M 2) NxStage Medical (Nasdaq: NXTM) - $ 300 M + Pub
Slide 26: Meda Investor Advantages
Meda Investor Advantages Strong overall return potential based on current near-term targeted milestones Successful trial completion CE Mark approval Out-licensing the sepsis application to a strategic partner Commercial sales anticipated in 2010 Commencement of pivotal trial in the US Out-licensing
Slide 27: Technologies Corporation
Technologies Corporation y
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