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Company highlights
3
Lead product – rebranded MUSE™ System for minimally invasive GERD
surgery – FDA cleared and CE marked, initial revenue
Large market opportunity, high gross margin, single-use device
81 issued patents
Compelling technology; world’s smallest video camera combined with
endosurgical tools
Multiple shots on goal with unique visualization platform
What we do
4
See & treat
Transoral endosurgical platform to deliver
minimally invasive solutions for common
surgical procedures:
1. Vision + light + tools
2. Ultrasound guided
3. Endoscope mounted surgical stapler
4. Single operator
5. Disposable surgical device
6. Cost efficient
Leadership
5
Insert pictures and short bio
Chris Rowland
CEO
25 years of medical device senior leadership experience,
including 17 years in commercial roles at Boston Scientific,
President Americas at Given Imaging, recently acquired by
Covidien for $860m, CEO of IntraPace
Dr. Elazar
Sonnenschein
COO
Founder and inventor of the Medigus technology platform.
Managed the company since inception, taking it through public
listing on TASE and the 510(k) clearance of the MUSE™, Medigus’
lead product.
Dr Nissim
Darvish
Chairman
Senior Managing Director, OrbiMed Israel. MD, PhD. Previously
partner with Pitango, Founder and CEO of Impulse Dynamics -
$250m realization event. Led investment through several exits
including SuperDimension ($300m to Covidien)
GERD (gastric reflux) – the condition
6
Stomach acid
rising through
lax sphincter
Resulting in
pain and
eventually
esophageal
cancer
Current
therapy: drugs
and surgery
good
bad
GERD – significant unmet need
7
Aliment Pharmacol Ther. 2010 Nov;32(10):1222-7 http://www.ncbi.nlm.nih.gov/pubmed/20955441
24m adults suffer from GERD in the US
14.5m have GERD symptoms 2 x / week
8.6m with severe GERD go untreated
7x increased probability of esophageal
cancer from daily GERD
40% of PPI (proton pump inhibitor such as Nexium /
Omeprazole) users - not satisfied- woken up by
GERD, daily life impact. 72% of them would try
new MIS therapy
Anti PPI trend, FDA Warning; Chronic PPI
users are 2.2x more likely to suffer hip fractures (4.5x more likely after 7 years)
Current standard surgical procedure – laparoscopic Nissen fundoplication
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Source: Gut. 2012; 61(4): 501-506
Unpopular (2% of patients) – invasive (laparoscopic) procedure
Early complications: bleeding, perforation, conversion to open
surgery, death. Late complications: dysphagia, bloating/pain
Flexible endoscope Vision + surgical capability
Can fold on itself
to complete
endoluminal
stapling
Small, high resolution
video camera
Stapler using
standard surgical staples
Ultrasound
9
MUSE™ System for GERD; FDA cleared, CE marked, on market OUS
The Medigus Solution – The intersection of ‘See & Treat’
The opportunity – convert PPI users and lap patients to minimally invasive surgery
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Source: US market for Gastrointestinal endoscopic devices, iData, 2012; Gut. 2012; 61(4): 501-506
Ch
ron
ic G
ER
D (
24
M p
atie
nts
)
Severity of Symptoms and Dissatisfaction
Low High
Disease Progression Continued Heartburn Lifelong PPI Use Regurgitation
Continued PPI Therapy
Therapy Gap
Fundoplication Market
Current Surgical Threshold
New Surgical Threshold
GERD – US Market Map (millions of patients)
12
Source: US market for Gastrointestinal endoscopic devices, iData, 2012; Gut. 2012; 61(4): 501-506
24 8.9
3.8
severe
patients
untreated treated
controlled
treated not
controlled
Potentially relevant
patients 8.6
The MUSE™ device is then retroflexed below the Z line and
the stapling position is located using direct visualization
and ultrasound.
How MUSE™ works – trans-oral fundoplication
13
The MUSE™ device is
placed through the
esophagus and into
the stomach
The MUSE™ ratchet
is engaged and
positioned to
correct stapling
position.
Ultrasound and
concave/convex
surfaces provide
alignment
Medigus MUSE™ System – clinical results similar to current surgical standard – but less invasive
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MUSE™ Lap Nissen
Medigus MUSE™ – Pilot Study of 13 patients
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The pilot study was conducted in 2007 in India with 13 patients – 11/13 available for 5 year follow up
5 year results (2007-2012) – comparison to current standard
90% success GERD-HRQL score dropped
≥ 50% from baseline (10/11 pxts)
73% Stopped or
reduced PPI usage
≥ 50% (8/11 pxts)
MUSE™ System multi center trial overview (2008-2011)
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69 patients treated, 69 in safety analysis, 66 in efficacy analysis at 6 months (3 excluded, treated, but excluded – did not meet IC
centers, PIs patients
72 patients enrolled, 69 treated, 66
followed (ITT) for 6 months
Inclusion criteria: GERD diagnosed at
least 2 years, on PPI at least 6 months,
GERD HRQL off PPI >20
Exclusion criteria: hernia >3cm
endpoints
PRIMARY: >50% improvement in GERD related HRQL (Health Related Quality of
Life) score off PPI, vs baseline
SECONDARY:
• Reduction of acid exposure off PPI at 6 months, vs baseline
• Proportion of patients reducing daily PPI use by >50%
• Anatomical change – satisfactory flap valve (endoscopy, 6 months);
percentage of patients without hernia after 6 months
• Correlation of primary with secondary effectiveness variables
procedure
Partial fundoplication. Place 2 or 3 groups of B
shaped staples 1.5 cm above the GE junction,
connecting the stomach fundus to the
esophagus
Under general anesthesia, using over tube
and either 2 or 3 staples
Amol Bapaye, MD Deenanath Mangeshkar Hospital Medical Research Center Pune, India Prof. Luigi Bonavina Policlinico San Donato Milan, Italy
Santiago Horgan, MD UCSD Medical Center San Diego, CA
Prof.Dr.Ralf Kiesslich Med. Klinik Universitatsmedizin Mainz, Germany Glen Lehman, MD Indiana University Hospital Indianapolis, IN Prof. Johannes Zacherl
Medical University of Vienna Vienna, Austria
MUSE™ multi center trial outcomes
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66 patients at 6 months
85% of patients stopped or significantly reduced PPI usage
65% were off PPI completely
20% reduced dosage by ≥50%
73% reduced GERD HRQL (off PPI) score by ≥50%
Acid Exposure
Mean percentage of time pH <4.0 significantly reduced
from 10.9 to 7.3 between baseline and 6 months (p<.001)
Anatomical Change
The proportion of patients with Hill Grade score >2 was
0.661 before and 0.062 after the procedure (p<.0001)
Competitive landscape
18
clinical
technology
operator
True anterior fundoplication (identical to current standard)
Minimally invasive
Minimal risk of migration or damage to adjacent organs
Minimal/no potential of erosion
Direct vision as part of the endoscope, no other devices needed
Ultrasound to guide tissue thickness and stapling accuracy
Use of standard surgical staples
Single use surgical endoscope
MRI safety
Number of operators
Medical specialty
MUSE™ Esophyx Linx
yes yes yes yes
yes yes yes yes yes
1 GI/Surgeon
Stretta
no yes no yes
1 GI/Surgeon
no no no no
no no no no no
1 Surgeon
yes yes yes yes
no no no no yes
no no no no yes
2 GI/Surgeon
MUSE™ vs competition
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Torax/ EGS/
Stretta
Lap Nissen
MUSE™
drugs
rew
ard
risk
Summary – why MUSE™?
Clinical value No Incision, no scar, less invasive True surgical anterior fundoplication Clinical equivalence to current standard
Durable results using standard surgical staples
Economic benefit Single operator, surgical endoscope Out patient procedure Potential to eliminate lifelong medication
Efficient and cost effective
CE marked, FDA 510(k) cleared
IP summary – key issued patents
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Endoscopic device
having ultrasonic
positioning
USA, South Africa, Australia, Israel, Mexico
Transgastric method for
carrying out a partial
fundoplication
USA
Autoclavable imager
assembly
USA, Australia, Israel, Canada, South Korea
Stapling device
USA, Australia, Israel, Germany, UK, France, South Korea
Articulation section
USA
Endoscopic device
comprising linear
staplers and a video
camera on its distal end
USA
Method of performing
surgical procedures on
patients suffering from
hiatal hernia USA
Endoscopic stapler
having camera USA
Fundoplication
apparatus and method USA, Europe, Australia, New Zealand, S.Africa, Mexico, Israel, Japan, Canada
Stapler for endoscopes USA, Europe, Australia, New Zealand, S.Africa, Mexico, Israel, Japan, Canada
Multiple view
endoscopes USA, Europe, Australia, New Zealand, S.Africa, Mexico, Israel, Japan
Multiple view
endoscopes USA, Europe, Australia, New Zealand, S.Africa, Mexico, Israel, Japan, Canada
MUSE™ revenues • Increase commercial sales in key markets concurrently with infrastructure and promotion efforts
• Expand distribution channels in other markets
Increasing presence in target markets • Office opened in Bay Area (California)
• VP appointed for EU operations (Austria)
Clear regulatory pathway • US 510(k) in place, updating for MUSE™ version II
• EU CE mark in place
Achieve clinical and publication milestones • Peer review publications and abstracts submitted
• Leveraging long-term clinical follow-up data
• Forming advisory board of Key Opinion Leaders
• Strengthen insurance reimbursement status in key markets
Develop a scalable commercial model • Train Centers Of Excellence – 10 in the US and 10 in EU in 2014
• Initiate targeted commercial use
• Institute reproducible training program
• Rebranding GERD device as MUSE™
• Develop Society support
Commercialization strategy – inch wide mile deep
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Milestones
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2013 2014 2015
China SFDA
US DDW/SAGES
Launch Event
EU UEGW Launch
Event
US team build out EU team build out
US/EU clinical and commercial activity
US private
payor program
AMA/CPT
application
REG
C
OM
MER
CIA
LIZA
TIO
N
Gen II
510k
Summary
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Unique single use, surgical platform will re-define natural orifice
surgery (NOS)
Large market opportunity, high gross margin, differentiated,
procedure specific device
Industry-leading investors; OrbiMed and J&J
Compelling clinical data, less trauma to patient, no incision,
cost effective
Developed and currently sell world’s smallest video camera
Financial summary
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Cash position as of December 31st, 2013: ~ $11,300,000
Number of employees - 40
Capital structure
• 164.6 million shares outstanding
• 231.4 million outstanding – fully diluted shares
Shareholder profile:
• OrbiMed - 24%
• Founders – 15%
• J&J & Dexxon – 15%
• Public & Other – 46%