Slide 1: Working to Save Lives Through Blood Purification
Cyto Sorbents Corporation NASDAQ: CTSO Working to Save Lives Through Blood Purification Biotech Showcase Presentation January 2016
Slide 2: Safe Harbor Statement
Safe Harbor Statement Statements in this presentation regarding CytoSorbents Corporation and its operating subsidiaries CytoSorbents Medical Inc . and CytoSorbents Europe GmbH that are not historical facts are forward - looking statements and are subject to risks and uncertainties that could cause a
Slide 3: CytoSorbents is a Leader in Critical Care Immunotherapy
3 Cyto Sorbents is A Leader in Critical Care Immunotherapy Leading the Prevention or Treatment of Life - Threatening Inflammation in the ICU and Cardiac Surgery using CytoSorb ® Blood Purification
Slide 4: Severe Inflammation is Deadly in the ICU
4 Severe Inflammation is Deadly in the ICU Millions of people are admitted to the intensive care unit in hospitals worldwide each year with deadly inflammatory conditions • In these conditions, massive inflammation causes cell death and organ failure. Patients are kept alive with “life support” – ma
Slide 5: Severe Inflammation is Dangerous in Open Heart Surgery
5 Severe Inflammation is Dangerous in Open Heart Surgery Cytokine Storm SIRS Multiple Organ Failure Free Hemoglobin Vascular / Kidney Injury ~1 million Open Heart Surgeries in US and EU annually • Coronary artery bypass graft surgery • Valve repair or replacement • Heart or lung transplantation • Co
Slide 6: Cytokines Fuel the Fire of Inflammation
6 Cytokines Fuel the Fire of Inflammation • Cytokines are small proteins that normally help stimulate and regulate the immune system and control inflammation • Cytokines are a dual edged sword • They are required for proper immune system function • However, in mild to moderate excess, cytokines can
Slide 7: Massive Inflammation Causes Organ Failure
7 Massive Inflammation Causes Organ Failure Organ failure occurs when vital organs stop working, causing nearly half of all deaths in the ICU . Little can be done to prevent or treat it today
Slide 8: CytoSorb Removes the Fuel to the Fire
8 Cyto Sorb ® Removes the Fuel to the Fire • CytoSorb ® targets the $20+ billion opportunity in critical care and cardiac surgery • Approved in the European Union as the only specifically approved extracorporeal cytokine filter for use in any situation where cytokines are elevated • Clinically prove
Slide 9: Powerful Blood Purification Technology
9 The underlying blood purification technology is based on biocompatible, highly porous polymer beads that act like tiny sponges to remove harmful substances from blood • Protected by 32 issued US patents and multiple applications pending • Manufactured at our ISO 13485 certified facility in New Jer
Slide 10: CytoSorb is Plug and Play with Existing Machines
10 Cyto Sorb ® is Plug and Play with Existing Machines Place a temporary dialysis catheter in a major vein Connect the device to a standard dialysis machines found in hospitals worldwide Pump blood out of the body and through the cartridge The polymer beads directly contact blood and remove unwanted
Slide 11: CytoSorb Active in Cytokine Sweet Spot
11 Cyto Sorb ® Active in Cytokine Sweet Spot Hemodialysis 0 kDa 10 20 30 40 50 60 70 IL - 1a TNF - α monomer IFN - γ monomer IL - 1Ra IL - 10 TNF - α trimer IFN - γ dimer HMGB1 TGF - β IL - 6 sFas ligand MCP - 1 IL - 13 MCP - 1 glycosylated Albumin IL - 8 MIP - 1α IL - 18 , Pancreatic Chymotrypsin s
Slide 12: CytoSorb Broadly Reduces Cytokines
12 Cyto Sorb ® Broadly Reduces Cytokines IL - 6 TNF - a IL - 10 IL - 1 a IL - 1ra IL - 8 Cytokine reduction over time during in vitro perfusion with serum (or buffer) The two lines on each graph represent CytoSorb cytokine removal from serum (triangle) or buffer (square) Valenti, I “Characterization
Slide 13: Goal: To Prevent or Treat Organ Failure
13 Goal: To Prevent or Treat Organ Failure Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Surgical The Potential to Revolutionize Critical Care Medicine Improve Patient Outcome and Survival Decrease Costs Of ICU and Patient Care
Slide 14: CytoSorb Is A New Immunomodulation Strategy
14 Cyto Sorb Is A New Immunomodulation Strategy to Control Severe Inflammation in the ICU NSAIDS Aspirin Anti - cytokine antibodies Anti - integrin antibodies Anti - oxidants Anti - Inflammatory (too weak) Immunosuppressive (too strong) Immunomodulatory (“balanced”) Corticosteroids Chemotherapy Orga
Slide 15: Case Report: Toxic Shock Syndrome
15 Case Report: Toxic Shock Syndrome • Recently, a 3 year old, 38 pound girl was stung on her leg by an insect and became infected with Staph aureus • Despite antibiotics, her condition rapidly worsened and she developed a systemic inflammatory response syndrome with toxic shock syndrome and multipl
Slide 16: ~$17 Million in US Government Support
16 • US Dept of Health and Human Services awarded $0.5M grant (2010) for therapies that can save lives and reduce costs under the QTDP Program • NIH grant awarded $7M five year (2006 - 2010) to University of Pittsburgh and Dr. John Kellum to research CytoSorb bead for treatment of sepsis • NIH/NHLBI
Slide 17: Drive Usage and Sales Of CytoSorb
17 Drive Usage and Sales Of CytoSorb
Slide 18: CytoSorb: An Excellent Business Model
18 • Huge market CytoSorb ® is sold to hospitals and critical care physicians, targeting a “need to have” $ 20 + billion worldwide critical care opportunity addressing organ failure • Little to no competition • Critical care physicians understand the problem • It is a plug and play high margin dispo
Slide 19: Direct Sales: Germany, Austria, Switzerland
19 Direct Sales: Germany, Austria, Switzerland We are selling CytoSorb to most of the major university and public hospitals in Germany, Austria and Switzerland. The market in Germany alone is $1.0 - 1.5 billion
Slide 20: E.U. Approval Opens Global Distribution
20 Distributed in 32 countries including the Germany, UK, France, Italy, Netherlands, Turkey, Russia, India, Israel, Poland, Romania, Scandanavia, Denmark, Middle East, Vietnam, Australia and New Zealand covering 2.1 billion lives. Expanding to other EU countries and countries outside the EU that ac
Slide 21: Quarterly Euro-Adjusted Product Sales
21 Quarterly “Euro - Adjusted” Product Sales $13,679 $87,960 $176,098 $127,969 $203,561 $314,159 $569,243 $663,233 $1,031,761 $871,150 $816,109 $920,041 $1,221,694 $1,750,000 $0 $200,000 $400,000 $600,000 $800,000 $1,000,000 $1,200,000 $1,400,000 $1,600,000 $1,800,000 $2,000,000 Q3 2012 Q4 2012 Q1 2
Slide 22: Product Sales Growth, Euro Adjusted
22 Product Sales Growth, “Euro Adjusted” $151,574 $310,779 $405,706 $595,588 $821,787 $1,214,932 $1,750,196 $2,578,396 $3,135,387 $3,382,253 $3,639,061 $3,828,994 $4,700,000 $- $500,000 $1,000,000 $1,500,000 $2,000,000 $2,500,000 $3,000,000 $3,500,000 $4,000,000 $4,500,000 $5,000,000 Q4 2012 Q1 2013
Slide 23: How This Can Get Big Quickly
23 How This Can Get Big Quickly • In Germany alone, there are ~154,000 cases of severe sepsis or septic shock each year. Here, we have: x Established reimbursement x Most of the major university and public hospitals as customers x Significant key opinion leader support throughout the country x Stron
Slide 24: Geographic Expansion – A Growth Engine
24 Geographic Expansion – A Growth Engine Q4 2015 to Q1 2016 Start 131M people *Mayr, FB, Yende S, Angus DC, “Epidemiology of severe sepsis” Virulence 2014 5(1):4 - 11 Estimated 2016 Start
Slide 25: Growth Driven by Direct, Distributor, Partner Sales
25 Growth Driven by Direct, Distributor, Partner Sales * This graph is provided only to demonstrate the concept of revenue layering. It does NOT represent revenue forecasts or guidance
Slide 26: CytoSorb Germany User's Meeting
26 2 nd CytoSorb Germany User’s Meeting
Slide 27: International CytoSorb User's Meeting
27 1 st International CytoSorb User’s Meeting
Slide 28: International CytoSorb User's Meeting
28 2 nd International CytoSorb User’s Meeting
Slide 29: International Society of Intensive Care & Emergency Medicine – Brussels 2015
29 International Society of Intensive Care & Emergency Medicine – Brussels 2015
Slide 30: Drive the Data that will Make CytoSorb Standard of Care
30 Drive the Data that will Make CytoSorb Standard of Care
Slide 31: Robust Clinical Program and Team
31 50+ Investigator Initiated Studies Additional Sepsis Trials Case Reports Germany Dosing Study Director of Clinical Operations Medical Director Trauma Advisory Board Sepsis Advisory Board Cardiac Surgery Advisory Board Chief Medical Officer Statistician Cardiac Surgery Sepsis Trauma Director of Eu
Slide 32: REFRESH I Trial To Start in US
32 • 40 - patient, eight - center feasibility study evaluating the safety of CytoSorb ® intra - operatively in a bypass circuit in a heart - lung machine during complex cardiac surgery in elective, non - emergent surgery where the patient is expected to under cardio - pulmonary bypass > 3 hours • Ao
Slide 33: REFRESH I Update
33 REFRESH I Update RE duction in FRE e H emoglobin Trial • Working with major cardiac surgery centers in this trial • Baylor College of Medicine • Baystate Medical Center • Columbia University • Cooper University Hospital • University of Kentucky • University of Maryland • University of Pennsylvani
Slide 34: Severe Sepsis or Septic Shock US Trial
34 Severe Sepsis or Septic Shock US Trial • Severe sepsis and septic shock are the overzealous immune response to a serious infection that can cause organ injury, organ failure and death • It is the largest, but also the most complex, critical care market, afflicting 27 million people worldwide, kil
Slide 35: Many Published Peer-Reviewed Articles
35 Many Published Peer - Reviewed Articles
Slide 36: CytoSorb Website – A Wealth of Info
36 CytoSorb Website – A Wealth of Info Visit us at www.cytosorb.com
Slide 37: International CytoSorb Registry
37 International CytoSorb Registry • The home of 50+ planned investigator initiated studies with many already enrolling
Slide 38: Leverage Pipeline to Establish Strategic Partnerships
38 Leverage Pipeline to Establish Strategic Partnerships
Slide 39: Fresenius Medical Care
39 Fresenius Medical Care • In December 2014, entered into a multi - year, 6 country partnership with Fresenius, the largest dialysis company in the world for exclusive distribution of CytoSorb® in critical care in France, Sweden, Norway, Finland, Denmark and Poland • CytoSorb® is a key part of Fres
Slide 40: Fresenius Launch Expected in Q1 2016
40 Fresenius Launch Expected in Q1 2016 • In 2015, we worked with Fresenius to complete all of the documentation, country registrations, certifications, development of marketing materials, and training needed for the launch • Fresenius is currently marketing the technology to critical care key opini
Slide 41: Strategic Partnership: The Most Comprehensive Treatment for Sepsis
41 Strategic Partnership: The Most Comprehensive Treatment for Sepsis Treat the Massive Inflammatory Response Treat the Primary Infection • Biocon is the largest biotechnology company in India • Partnered with Biocon since late 2013 • Significantly growing usage in India with now expansion into Sri
Slide 42: Cardiac Surgery Partner Update
42 • In November 2014, we established an initial partnership in France with one of the top 4 cardiac surgery companies in the world. The partner successfully completed its test evaluation of CytoSorb with one of the leading cardiac surgeons in France. • We are currently having discussions with multi
Slide 43: Beads Enable a Broad and Valuable Pipeline
43 Critical Care, High Risk Surgery Blood Collection & Transfusion CT Imaging, Interventional Radiology Contrast Sorb Drug Overdose, Chemo Removal Drug Sorb Beta Sorb Improving Dialysis Under Development CE Mark Approved Beads Enable a Broad and Valuable Pipeline
Slide 44: Potential for More Strategic Partnerships
44 Potential for More Strategic Partnerships* Cardiac Surgery Renal Dialysis Blood Transfusion Biotech and Immunotherapy Critical Care or Catheters *Companies listed here are used simply as examples of companies in these respective verticals. We make no other representations to our relationship with
Slide 45: Increase Investor Awareness
45 Increase Investor Awareness
Slide 46: NASDAQ Capital Market Listed
46 NASDAQ Capital Market Listed • Clean capital structure with good liquidity for investors
Slide 47: Added to the Russell Microcap Index
47 Added to the Russell Microcap Index June 2015
Slide 48: Increase Institutional Ownership
48 Increase Institutional Ownership Source: NASDAQ
Slide 49: Increase Analyst Coverage
49 Increase Analyst Coverage
Slide 50: Increase Media Coverage
Increase Media Coverage ‘cyasorbents Files 1801) Seen onnas cytoSorbents To Advance HemoDefend Towards Commercialization with $* ‘5 Million Phase Il SBIR) Contract from NHLBUNIH maw CvtOSorbents
Slide 51: CytoSorbents Has Tremendous Potential
51 Cyto Sorb ® may help revolutionize critical care medicine, saving lives, and reducing costs • Massive untapped $20 billion unmet, medical need in critical care • CytoSorb ® sales are generating significant growth with attractive 60+% gross margins • Continued geographic expansion throughout the w
Slide 52: Dr. Phillip Chan, MD, PhD – CEO
NASDAQ: CTSO Dr. Phillip Chan, MD, PhD – CEO pchan@cytosorbents.com