REVEEL
GENTLE, FAST and EASY Laparoscopic Retraction
PRODUCT OVERVIEW
for
PUSULA MEDICAL
CONFIDENTIAL - RETRACTION LIMITED
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Why something better?
Obesity and upper abdomen procedures are
a large market
Patients are getting heavier, as are their
organs
Liver retraction poses special problems in
obese patients
Existing retractors are ineffective and injure
patients
REVEEL is designed to overcome these
challenges
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Obesity: a global problem
400 million people
across the world are
considered obese
15%
15%
US
70%
EU
700 million people
are expected to be
obese by 2015
ROW
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
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Liver retraction: large opportunity
600,000 procedures
require a new
solution
600,000
500,000
CAGR ≥ 7%
400,000
300,000
200,000
100,000
US Upper Gut Other (3)
OUS Band/Bypass/Sleeve (4)
2009
(1)
(3)
(4)
2010
US Band/Bypass/Sleeve (1)
2011
2012
2013
Total Upper Gut Procedures
2014
2015
Susan Cox, American Society for Metabolic and Bariatric Surgery (ASMBS) direct communication via email, dated March 29, 2010
Marketing Initiatives Clinical Plus ICD-9 Procedure Data Projections (based on all payer data)
Bariatric (Obesity) Surgical Devices - A US & European Market Report 07/09
Global Industry Analysis, Inc., 5645 Silver Creek Calley Road, San Jose, CA 95138
Calculated by device revenues divided by ASP $1500/procedure to achieve procedure estimates
CONFIDENTIAL - RETRACTION LIMITED
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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
• Liver size and weight
overwhelm current designs
– Larger patients have larger,
heavier livers [5.1]
– Preoperative liver-reducing
diets are common
‘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.
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What is needed?
A better, stronger, atraumatic retraction
surface
A shape that optimizes access and
visualization
Slip prevention without pressure
Easy and fast to set up and use
Cost effective: nothing to break, maintain or
clean
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Current retractors don’t work
Too small
• Liver obstructs access and view
Improper shape
• Liver flops into operating field
Slippy with low CoF
• Liver slips
• High pressure / force required
Poor design
• Tedious to set-up
• Constant repositioning
Link / cable structure
• Unreliable, expensive
• Impossible to clean
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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
CONFIDENTIAL - RETRACTION LIMITED
[8.2] Tamhankar AP, Kelty CJ,
Jacob G et al (2011)
Retraction-Related Liver
Lobe Necrosis After
Laparoscopic Gastric
Surgery. JSLS 15:117–121
8
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
CONFIDENTIAL - RETRACTION LIMITED
[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
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Fan Retractors: surgeons say “No!”
• Traumatic: fan blades can
damage liver (especially
5mm versions)
• Requires 5mm or 10mm
trocar
• Poor rigidity
• No traction features
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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 bloodflow” [11.4]
[11.1] Kinjo Y, Okabe H, Obama K et al (2011)
Elevation of Liver Function Tests After
Laparoscopic Gastrectomy Using a Nathanson
Liver Retractor.
World J Surg 35:2730–2738
[11.2] Tamhankar AP, Kelty CJ, Jacob G et al
(2011) Retraction-Related Liver Lobe Necrosis
After Laparoscopic Gastric Surgery.
JSLS 15:117–121
[11.3] Lohlun JC, Guirguis A, Wise L (2004)
Elevated Liver Enzymes Following
Open Roux-en-Y Gastric Bypass for
Morbid Obesity – Does Timing of Liver Retraction
affect the Rise in the Levels of Transaminases?
Obes Surg 14:505-508
CONFIDENTIAL - RETRACTION LIMITED
[11.4] Saranita J, Soto RG, Paoli D (2003)
Elevated Liver Enzymes as an Operative
Complication of Gastric Bypass Surgery.
Obes Surg 13:314-316
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The
Advantage
TheREVEEL
REVEEL
advantage
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Unparalleled exposure
• Harp shape conforms to
liver shape
• I-Beam prevents
drooping liver
• Better access to upper
gut; better visualization
of operative site
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Exposure: can yours do this?
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CONFIDENTIAL - RETRACTION LIMITED
REVEEL in action
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Active traction: stop the crushing!
• Radical re-think of retraction:
• NiTi arms – flexible yet rigid
• Soft, atraumatic overmold
• Braid actively engages tissue
• Gently holds without
crushing pressure
• Active traction prevents loss
of time and prevents injury
due to slippage and pressure
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Friction is the secret
0.70
REVEEL CoF
= Nathanson CoF X 2
REVEEL
Nathanson
0.60
0.50
More Friction
 Less Pressure
COF
0.40
0.30
Less Pressure
 Less Liver
Disruption / Damage
0.20
0.10
0.00
5
10
15
20
25
30
35
40
45
Tilt Angle (Degree)
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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
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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!
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A radical re-think of retraction
Exposure
• Best in class visualization
Optimized shape
• Designed to fit and accommodate the liver
Active traction
• Reduces risk of trauma and liver infarction
• Prevents slippage and repositioning
Speed and ease
• Percutaneous
• Rapid insertion, actuation, and removal
Strong
• Solid mechanical architecture
• Won’t break!
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Key milestones
Non Sterile Demo Units
02/13
Sterile Demo Units
04/13
Formal US Launch – SAGES
04/13
Friction comparison study poster – SAGES 04/13
Human study results – CUHK
04/13 [21.1]
Formal EU Launch – EAES
06/13
[21.1] Provisional results of Chinese University Hong Kong’s
Randomized Study of REVEEL versus Nathanson
in Bariatric and Upper GI procedures
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RETRACTION LIMITED
Revealing Solutions in Laparoscopy Surgery
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RETRACTION Limited
Revealing Solutions in Laparoscopic Retraction
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RETRACTION Limited
Opportunity
Mission
The global obesity
epidemic has
created
new opportunities
in laparoscopic
retraction
To make a dramatic
improvement in large
organ retraction,
improving patient
outcomes and
surgeon satisfaction
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