investor presentation - medigus relations/investorsppt2014.pdf · esophyx . linx . yes . yes . yes...

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Investor presentation MDGS.TASE September 2014

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Page 1: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

Investor presentation

MDGS.TASE

September 2014

Page 2: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

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.

Page 3: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

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

78 issued patents

Compelling technology; world’s smallest video camera combined with flexible, endosurgical tools

Separate camera division developed and now in operation

Page 4: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

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

Page 5: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

Leadership 5

Insert pictures and short bio

Chris Rowland

CEO

25 years of medical device senior leadership experience, including 17 years in senior leadership roles at Boston Scientific, President Americas at Given Imaging, recently acquired by Covidien for $860m, CEO of IntraPace

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)

Tom Dempsey

US

VP/GM

Milena Ridl

EU VP/GM

Innovative leader with 20 years of experience in start up through established medical device companies, including 13 years with Boston Scientific in senior leadership roles, VP Commercialization at EGS, and CEO of Medical Diagnostic Technologies which was acquired by Imagistx Canada

20 years experience in healthcare, fluent in 5 languages. Vice President Sales and Marketing Simpiria Spine, Vice President Europe, Middle East Africa MiMedx Group, Director Medtronic/Kyphon

Menashe Sonnenschein

Israel VP

Founding member and officer of Medigus, 20 years R&D leadership in starts-ups, directly responsible for the development of the MUSE platform. Menashe has his M. Sc in electrical engineering and electronics from Ben Gurion University of the Negev.

Page 6: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

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

Page 7: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

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)

Page 8: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

Current standard surgical procedure – laparoscopic Nissen fundoplication

8

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

Page 9: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

9

Page 10: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

Flexible endoscope Vision + surgical capability

Can fold on itself to complete endoluminal stapling

Small, high resolution video camera

Stapler using standard surgical staples

Ultrasound

10

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

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

Page 11: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

The opportunity – convert PPI users and lap patients to minimally invasive surgery

11

Source: US market for Gastrointestinal endoscopic devices, iData, 2012; Gut. 2012; 61(4): 501-506

Chr

onic

GER

D (2

4M 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

Page 12: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

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

severepatients

untreated treatedcontrolled

treated notcontrolled

Potentially relevant patients 8.6

Page 13: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

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

Page 14: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

Medigus MUSE™ System – clinical results similar to current surgical standard – but less invasive

14

MUSE™ Lap Nissen

Page 15: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

Medigus MUSE™ – Pilot Study of 13 patients 15

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)

Page 16: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

MUSE™ System multi center trial overview (2008-2011)

16

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

Page 17: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

MUSE™ multi center trial outcomes 17

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)

Page 18: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

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

Page 19: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

MUSE™ vs competition 19

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

Page 20: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

IP summary – key issued patents 20

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

Page 21: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

MUSE revenues • Increase commercial sales in key markets concurrently with infrastructure and promotion efforts • Expand distribution channels in other markets

Increase presence in target markets • US team is prioritizing an additional 30 MD’s in 15 Centers of Excellence • EU team is prioritizing an additional 15 MD’s in 7Centers of Excellence

Clear regulatory pathway • US 510(k) in place (MUSE March 2014) • EU CE mark in place (MUSE March 2014)

Achieve clinical and publication milestones • 5 abstracts accepted YTD and 1 peer review on line • 3 year follow up for MUSE presented at DDW 2014 • Registry protocol completed, Primary Investigator selected • Advisory board and Societies engaged

Develop a scalable commercial model • Centers Of Excellence being trained– 10 in the US and 10 in EU in 2014 • Locations identified, KOL’s recruiting patients • Reproducible training program implemented (US & EU) • Training proctors for case support • Initial commercial procedures completed

Commercialization strategy – inch wide mile deep

21

Page 22: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

Overview of camera business 22

NASA ATV-5 – VIPIR robot

• Smallest video camera in the world

• Proprietary video technology

Page 23: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

Goals of camera business 23

Yield significant partnerships • Medical applications • Industrial applications

Incubate next gen Medigus device using miniaturized camera • Natural orifice surgery • Digestive disease focus

Page 24: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

Milestones 24

2013 2014 2015

US & EU Team Build Out

US/EU Clinical and Commercial Activity

US Private Payer Program

AMA/CPT Application

REG

C

OM

MER

CIA

LIZA

TION

US 510k EU CE Mark

First MUSE Procedures

First MUSE Orders

DE NUB Submission

Global Training Program Established

Global MUSE Registry

MUSE Re-Branding

US DDW/SAGES

US DDW/SAGES

EU UEGW/EAES

EU UEGW/EAES

Page 25: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

Summary 25

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

Scoutcam established with separate division, non dilutive revenue already recognized

Page 26: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

Financial summary 26

Cash position as of June 30th, 2014: ~ $7.2 mm Number of employees – 41 Capital structure (after recent round): 249.9 million shares outstanding 352.9 million outstanding – fully diluted shares Shareholders holdings as of August 31st*: Orbimed 19.4% Migdal 12.3% Senvest 11.7% Founders 9.7% Dexxon 7.6% Armistice 6.1% Sabby 4.99% Capital Point 1.5% Public 26.7% Total 100% *Completed significant financing in August 2014: raised $11.1m in private placement for US and Israeli institutionals

Page 27: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

Thank you

Page 28: Investor presentation - Medigus Relations/Investorsppt2014.pdf · Esophyx . Linx . yes . yes . yes . yes yes . yes yes . yes . yes . 1 GI/Surgeon. Stretta . no . yes . no . 1 . no

SAGES 2014 – Salt Lake City 28

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DDW 2014 – Chicago 29