REVEEL GENTLE, FAST and EASY Laparoscopic Retraction

1. REVEELGENTLE, FAST and EASY Laparoscopic Retraction PRODUCT OVERVIEW for PUSULA MEDICAL CONFIDENTIAL - RETRACTION LIMITED

2. Why something better? CONFIDENTIAL - RETRACTION LIMITED

3. Obesity: a global problem • 400 million people across the world are considered obese • 700 million people • are expected to be obese by 2015 Obese Population in the World (2009): Percentage by Region [3.1] [3.1] Bariatric (Obesity) Surgical Devices - A US & European Market Report 07/09 Global Industry Analysis, Inc., 5645 Silver Creek Calley Road, San Jose, CA 95138 CONFIDENTIAL - RETRACTION LIMITED

4. Liver retraction: large opportunity • 600,000 proceduresrequire a new solution CAGR ≥ 7% CONFIDENTIAL - RETRACTION LIMITED

5. Heavy patients require better retractors • Obese livers create problems for surgeons • Visualization is poor • Liver slips requiring repositioning of retractor • Retraction pressure on liver is increased, causing injury • Procedures are lengthened, made more complex • ‘It can be seen that as body weight increases, the liver weight increases . . . ’ [5.1] [5.1] “Relationship Between Liver Size and Body Size” Frank H. DeLand, M.D. and Wendy A. North, M.I.R. Johns Hopkins Medical Institutions 615 N. Wolfe St., Baltimore, Md. 21205 Division of Nuclear Medicine, The Johns Hopkins Medical Institutions, Baltimore, Maryland. December 1968 Radiology, 91, 1195-1198. • Liver size and weight overwhelm current designs • Larger patients have larger, heavier livers [5.1] • Preoperative liver-reducing diets are common CONFIDENTIAL - RETRACTION LIMITED

6. What is needed? CONFIDENTIAL - RETRACTION LIMITED

7. Current retractors don’t work CONFIDENTIAL - RETRACTION LIMITED

8. Nathanson: dangerous and tedious • Not suitable for large livers: can injure liver[8.1][8.2] • Slips constantly • Shape allows liver to hang in visual field • Difficult to set up and requires frequent repositioning • Can only be used in medial position • [8.1] Nathanson LK,“very large, fatty livers and force being exerted upwards, some damage can occur” [to the liver]. Cook Training Video • [8.2] Tamhankar AP, Kelty CJ, Jacob G et al (2011) Retraction-Related Liver Lobe Necrosis After Laparoscopic Gastric Surgery. JSLS 15:117–121 CONFIDENTIAL - RETRACTION LIMITED

9. Diamond-Flex: expensive, impossible to clean • Prone to breakage - components deposited in patient [9.1] • Reusable but expensive to buy and to repair • Difficult and slow to set up • Impossible to clean [9.2] • Slips, requiring frequent repositioning [9.1] Diamond flex angled triangular retractor broke [during surgery]; surgeons felt they had retrieved all pieces. A postop x-ray revealed pieces of broken retractor still inside the patient. FDA Adverse Event Report [9.2] Radionuclide testing conducted under EU CRAFT Research program “Testing and measurement procedure for the validation of the cleaning behaviour of reusable surgical devices” (CLEANTEST) G6ST-CT-2001-50121 CONFIDENTIAL - RETRACTION LIMITED

10. Fan Retractors: surgeons say “No!” • Traumatic: fan blades can damage liver (especially 5mm versions) • Requires 5mm or 10mm trocar • Poor rigidity • No traction features CONFIDENTIAL - RETRACTION LIMITED

11. Liver trauma: what the clinical papers say “Care should be taken to minimize intraoperative liver damage by decreasing the duration of liver retraction or using a gentle retraction method” [11.1] “Liver retraction [pressure] causes abnormal transaminase levels” [11.3] “Patient died after surgery and the death was attributed to liver infarction caused by retraction using Nathanson” [11.2] “Direct mechanical pressure may result in a transient decrease in hepatic blood-flow” [11.4] CONFIDENTIAL - RETRACTION LIMITED

12. The REVEEL Advantage The REVEEL advantage CONFIDENTIAL - RETRACTION LIMITED

13. Unparalleled exposure • Harp shape conforms to liver shape • I-Beam prevents drooping liver • Better access to upper gut; better visualization of operative site CONFIDENTIAL - RETRACTION LIMITED

14. Exposure: can yours do this? CONFIDENTIAL - RETRACTION LIMITED

15. REVEEL in action CONFIDENTIAL - RETRACTION LIMITED

16. Active traction: stop the crushing! • Radical re-think of retraction: • NiTiarms – flexible yet rigid • Soft, atraumaticovermold • Braid actively engages tissue • Gently holds without crushing pressure • Active traction prevents loss of time and prevents injury due to slippage and pressure CONFIDENTIAL - RETRACTION LIMITED

17. Friction is the secret REVEEL CoF = NathansonCoF X 2 More Friction  Less Pressure Less Pressure Less Liver Disruption /Damage REVEEL Nathanson CONFIDENTIAL - RETRACTION LIMITED

18. Faster and easier • Dilating tip allows rapid introduction without a trocar • One-step handle is fast and easy to actuate, set up, and remove • Effective retraction achieved in 30 to 50 s • Fast and easy to use CONFIDENTIAL - RETRACTION LIMITED

19. Strong • Strength and rigidity derived from: • Integral I-beam • Super-elastic arms • Won’t bend or break in bariatric procedures • 1 kg kimchi:no problem! • obese liver:no problem! CONFIDENTIAL - RETRACTION LIMITED

20. A radical re-think of retraction CONFIDENTIAL - RETRACTION LIMITED

21. Key milestones Non Sterile Demo Units 02/13 Sterile Demo Units 04/13 Formal US Launch –SAGES04/13 Friction comparison study poster – SAGES 04/13 Human study results– CUHK 04/13 [21.1] Formal EU Launch – EAES06/13 [21.1] Provisional results of Chinese University Hong Kong’sRandomized Study of REVEEL versus Nathansonin Bariatricand Upper GI procedures CONFIDENTIAL - RETRACTION LIMITED

22. RETRACTION LIMITED Revealing Solutions in Laparoscopy Surgery CONFIDENTIAL - RETRACTION LIMITED

23. RETRACTIONLimitedRevealing Solutions in Laparoscopic Retraction CONFIDENTIAL - RETRACTION LIMITED

24. RETRACTION Limited CONFIDENTIAL - RETRACTION LIMITED

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