Percutaneous Intervention

1. Percutaneous Intervention Inventing Breakthroughs and Commercializing Science

2. Catheter use in clinical setting

3. Technology – State of the Art (start 1:04)

4. Catheter Placement: State of the Art

5. Complications Rates

6. Technology – What can go wrong?

7. Technological Innovation: Mechanical Insight

8. Technological Innovation: Medical Application

9. Technological Innovation: Demonstration

10. Competitive Technology – Image Guided Placement

11. Advantages of Technology

12. Top Three Selections Fistula for kidney dialysis High frequency High complication rate and cost of complication Large market Reliable reimbursement by Medicare for dialysis The “centesis” procedures (Pericardio, pleural, amnio) Costly complications Vascular Access Large market High frequency of complications because often performed by novices

13. Fistula

14. Final Recommendation Capital needs: $0.5 - $1 million for additional proof-of-concept data to reach a viable exit event Current data: 1 porcine model, PoC established Need small trial in humans: safety and PoC data Reasons the option to pursue independent company model difficult Low margins in Dialysis procedures, because Medicare supported No premium pricing on devices, no room to undercut competition Customers heavily concentrated in large organizations Difficult to compete with large players in these channels Licensing deal ~$5-10M upfront plus single-digit royalty on sales Implies 1.3-2.5x return on invested capital of $1 million

15. IP Key Facts: Priority date reserved: Feb 7, 2007 Filed International application Feb 7, 2008 International search report pending Coverage Broad claims which encompass vessels, organs, and body cavities Both product and method claims which describe the steps in operating prototype device Validity Inventor does not know of any prior art that invalidates claims No opinions yet from patent office Freedom to Operate Search of Google patents and WIPO database for broad claims in cannulation, percutaneous intervention, catheterization did not reveal any major findings Possibility of combining our product with other technologies that will need to be licensed

16. INDEX

17. Fistula

18. Fistula Fistula provides access for hemodialysis Nurse uses needles for cannulation Needle overshooting ? bleeding and hematoma ? infiltration ? access dysfunction ?hospitalization for catheter placement ? catheter related infection Overshooting depends on quality of dialysis staff

19. TEAM

20. Problem: Catheter Placement Multiple step process which requires time to carry out successfully Operator expertise dependent Small part of entire clinical experience but can lead to complications which extend hospital stay and increase healthcare burden

21. Complications Mechanical Pneumothroax – collapsed lung, requiring insertion of chest tube Hemothorax – blood in pleural cavity Hematoma - collection of blood outside the blood vessels, could require blood transfusion or surgery Arterial puncture

22. Criteria for Evaluating Clinical Procedures Time it takes for the procedure to be executed Complication rates involved in procedure Frequency of procedures Current standard of care for procedure Reimbursement landscape Other relevant factors

23. Summary of Applications Considered

24. Summary of Applications Considered

25. Channel Strategy 63% of all patients treated by one of the four large dialysis organizations Per year: DaVita (94K patients), Dialysis Clinics Inc. (13K patients), Fresenius (111K patients ) Hospital-based clinics treated 40K patients in 2006, a drop of 6% despite a 1.3% growth in the number of hospital-based units Independent clinics treated 65K patients in 2006 and saw an 9% increase in unit and patient counts Small dialysis organizations (20-29 clinics) accounted for 24K patients in 2006 Renal Advantage, Satellite Healthcare, Renal Research Institute, Dialysis Corp. of America, National Renal Institutes, National Renal Alliance and American Renal Associates

26. Market Opportunity Capital needs: $0.5 - $1 million for additional proof-of-concept data Current data: 1 porcine model, PoC established Need small trial in humans: safety and PoC data Premarket notification 510(k), not PMA Only substantial equivalence needed Shorter and cheaper development timeline Injection device market of ~$2B in US and $4B worldwide Includes renal, coronary, and infusion US syringes and needles ~ $1B market opportunity

27. Startup? >500K End-stage Renal Disease (ESRD) patients receiving therapy., growing at 4% $23 billion spend by Medicare p.a., over $33 billion total Large market opportunity, but large gorilla payor Low margins in Dialysis procedures, because Medicare supported No premium pricing on devices, no room to undercut competition Customers heavily concentrated in large organizations Difficult to compete with large players in these channels Product not as valuable alone in a salesforce’s bag Could gain pricing power by combining with other devices on a sales call $1 million investment on $3 million pre-money

28. License? Potential Partners: Distributors and device players: Cardinal Health, Tyco, needle companies Customers: Davita, Dialysis Clinics Inc. Fresenius Need easy math for corporate partners: how does this contribute to net income? Licensing deal: ~$5-10M upfront plus single-digit royalty on sales Implies 1.3-2.5x return on invested capital of $1 million

29. Interviews Conducted Dr. Tamara Isakova (Nephrologist) Dr. Diane Sacco (Urologist) Dr. Steven Wu (Interventional Nephrologist) Dr. Raul Uppot (Abdominal Interventional Radiologist) Dr. Benjamin Medoff (Pulmonary Medicine and Intensive Care) Dr. Kathleen Corey (Gastroenterologist) Dr. Stephan Wicky (Interventional Radiologist) Dr. Faisal Merchant (Interventional Cardiologist) Dr. Thomas Wolf (Neuro-Ophthalmologist) Dr. Kiran Reddy (Neurologist) Dr. Ugwuji Maduekwe – TBD Dr. Mark Conrad - TBD

30. References Avgerinos DV et al. Management of endoscopic retrograde cholangiopancreatography: related duodenal perforations. Surg Endosc 2008. Holzmann M et al. Complication rate of right ventricular endomyocardial biopsy via the femoral approach: a retrospective and prospective study analyzing 3048 diagnostic procedures over an 11-year period. Circulation 2008;118:1722-8 Liang SJ et al. Application of ultrasound-guided pigtail catheter for drainage of pleural effusions in the ICU. Intensive Care Med 2008. Klein SV et al. CT directed diagnostic and therapeutic pericardiocentesis: 8- year experience at a single institution. Emergency Radiology 2005; 11: 353 – 363 McGee DC, Gould MK. Preventing complications of central venous catheterization. NEJM 2003

31. References Myers RP et al. Utilization rates, complications and costs of percutaneous liver biopsy: a population-based study including 4275 biopsies. Liver Int 2008 28:705-12. Skolarikos A et al. Ultrasound-guided percutaneous nephrostomy performed by urologists: 10 year experience. Urology 2006 Raad II and Bodey GP. Infectious complications of indwelling vascular Catheters. Clin Infec Dis 1992; 15: 197-210 Weber A et al. Complications of percutaneous transhepatic biliary drainage in patients with dilated and nondilated intrahepatic bile ducts. Eur J Radiol 2008 Wu Y et al. Ventriculoperitoneal shunt complications in California: 1990 to 2000. Neurosurgery 2007;61:557-62