PowerPoint Presentation Relations/roth_march_2014_ppt_final.pdfThis presentation contains "Forward...

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Investor presentation March 2014 MDGS.TASE

Transcript of PowerPoint Presentation Relations/roth_march_2014_ppt_final.pdfThis presentation contains "Forward...

Investor presentation March 2014

MDGS.TASE

Forward looking statements

This presentation contains "Forward Looking Statements" as defined in the Israeli Securities Law, 1968, which are based upon the current estimates, assumptions and expectations of

the company's management and its knowledge of the relevant market. Forward Looking Statements involve uncertainties which may cause future results of the company's activity to differ significantly from the content and implications of such statements. Among the factors which may cause the actual results to differ from the Forward Looking Statements are changes in the target market and the introduction of competitive products, regulatory, legislative and policy changes, and clinical results. Forward Looking Statements are pertinent only as of the date on which they are made, and the company undertakes no

obligation to update or revise any Forward Looking Statements, whether as a result of new information, future developments or otherwise.

Neither the company, nor its shareholders, officers and employees, shall be liable for any action and the results of any action taken by any person based on the information contained herein, including without limitation the purchase or sale of company securities.

Nothing in this presentation should be deemed to be medical or other advice of any kind.

Company highlights

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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

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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

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Stomach acid

rising through

lax sphincter

Resulting in

pain and

eventually

esophageal

cancer

Current

therapy: drugs

and surgery

good

bad

GERD – significant unmet need

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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

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MUSE™ System for GERD; FDA cleared, CE marked, on market OUS

The Medigus Solution – The intersection of ‘See & Treat’

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SRS™ endoscopy system rebranded as MUSE™

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)

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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

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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

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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%

Thank you