SEPSIS

A Killer Illness

Paul McMahon

A Killer Illness

Bloodstream is overwhelmed by bacterial infection that can begin anywhere in the body & can result in chronic organ failure!

Primary Sites include: The lungs (bacterial pneumonia) -45% The bowel (usually seen with peritonitis)-17% The kidneys (upper urinary tract infection) -9% The liver or the gall bladder- 9% The skin (cellulitis)- 7%

• Between US & EU; >1.5m episodes Sepsis/year• 25 ~ 30% mortality rate.• > 120,000 Deaths/yr in the US• US Hospital Records ’79~’00 show Mean Sepsis increase of 13%

pa• Due to Immune suppression, Wider Invasive Procedures, More

Resistant Microorganisms & Aging Population.

• Rapid Diagnosis is Key• High Dependency Unit/ICU Treatment• ICU Treatment costs €2,500 per Day• Average Stay is 15 ~ 20 days• Survivors need long rehabilitation up to 1 yr (€)• Misdiagnosis costs Hospital $4,500/case in

Insurance Re-imbursement• Annual costs to Western economies of € 45 billion

Cost of Sepsis

SEPSIS: A Costly Illness

World opinion leaders recognise that the present tests which are based on Pathogen detection post onset are not making a significant difference

The biomarkers available right now are C-reactive protein and procalcitonin. Both have shortfalls!

Biomarkers now needed to monitor patient predisposition post surgery to genetic susceptibility, immuno suppression, coexisting complications.

“PRECYSION”

A Paradigm Shift

Patent Pending Diagnostic and Prognositc Tool Using Genetic Biomarkers (Cytokine Gene Expression).

Developed by St James Hospital & Trinity College Dublin

To screen patients & accurately predict those susceptible to Sepsis post surgery. Majority will tolerate infection without critical illness.

To optimise individual treatment, care stratification. Identify groups with Sepsis at low, intermediate & high risk.

• Biomarkers is Expanding Global Market • Drug Development, Clinical Trials & Diagnostics. • $4.8 Billion – ’06, 18% CAG to $12.7 Billion – ‘12 (*)• Diagnostics 17.5% Growth $2.3B - ‘07 to $5.15B -’12 (*)• US trend for Sepsis predicted to reach 1 million patients by 2010,

Avg cost of $30K per patient ($30B)• European market is similar.• For each case Sepsis diagnosed 3~4 patients with infection need

to be tested & screened.• Septifast by Roche costs $100~180 per test.• PRECYSION expected to cost €150 per test• Potential Sepsis Patient Only Market = €1.2 Billion

(*) BCC Research

Market Potential

Competitive EnvironmentCompetition focus on pathogen detection after

onset! Precysion focuses on Predisposition using

biomarkers!

Roche “Septifast”; PCR Sepsis pathogen detection product.

• Annual revenue €10 million• Annual revenue €360 million - PCR molecular

diagnostics

Thermo-Fisher “BRAHMS” test • Annual sales of US$ 105 million

Others:SIRS Labs, Biomerieux, Biosite, Spectral, Mobidiag!

Precysion is complimentary!

1. Finish academic research (PoC) – Oct ‘092. Verify route to market with science advisory board ‘09.3. Establish TCD campus company – ’09.4. Prototype & EU Validation – ’10 /‘115. License or JV with Platform Partner(s) – ’10/’11.6. US Validation & Market Entry – ’11/’127. 3 year go-to-market plan.

Commercial

Plan

€ € € € € € € - Potential Multi-Billion Market - € € € € € €

1. ‘10 - Preparation of Prototype – €50,0002. ‘10 – EU Clinical Validation Program – €150,0003. ‘11 - External validation – €150,0004. ’11 - Regulatory CE marking – €50,0005. Contingency and staff – €100,000

Total costs = €500,000 for Validated Prototype for EU Market

EU Prototype Costs

€ € € € € € € € € € € € € € €

Inventor & CSODr. Thomas Ryan, Consultant, Anaesthesia & IC, St. James Hospital, Dublin.

Former Member of staff, Dept of Anesthesiology & Critical Care Medicine, Cleveland Clinic, Ohio

Scientific Advisor: Dr John Thornback, BSc & PhD in Chemistry, Imperial College London (worked

with Prof. Sir Geoffrey Wilkinson, Nobel Laureate). Visiting Fellow, Harvard University ‘87-88 & MIT ‘86, Amersham/Imanet, Medgenix, Enigma, Myconostica

Technical Leader: Bruce Murdoch, BSc (Hons), Univ of Nottingham. >30 years MD/VP in Biopharma

Schering-Plough, Kabi Pharmacia, Bioaccelerate Inc., Avesthagen Ltd & Biotech start-upsFinancial Leader

Clive Kendall qualified from Deloitte Plender Griffiths, Hill Samuel & Arthur Andersen. 20 yrs experience as FD of 2 London Listed Companies, Business Advisor to £500 million T/O companies Private & Public, Co-Founder GLSS.

Business Leader:Paul McMahon, BSc (Hons), Trinity College Dublin. 25 years setting up Teams &

Operations in Japan, UK & Irl incl. projects in Electronics, Pharma, IT, Health Centres, Stem Cell & Diagnostics. Consultant, Global Life Science Services & CMR

Development Team

IP Commercialisation Opportunity

Pre Sepsis Tech

PoC

IP Portfolio

Real HUMAN Data Sets

Team

Hospital Protocols

Prototype

EU Validated

Real RoI €€€

Lives Saved

Healthcare Savings

Prime Mover in Market

€€500K500K

Save Lives/Reduce Healthcare Costs

In Multi-Billion Market

JV & Investment Partner Needed!

Phase 1; €0.5m EU Market Prototype

Phase 2; €3.5m Enter US Market

PoC (EI/TCD)Oct ‘09