investor presentation - medigus relations/investorsppt2014.pdf · esophyx . linx . yes . yes . yes...
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Investor presentation
MDGS.TASE
September 2014
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 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
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 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.
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
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
9
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’
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
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
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
14
MUSE™ Lap Nissen
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)
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
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)
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 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
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
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
Overview of camera business 22
NASA ATV-5 – VIPIR robot
• Smallest video camera in the world
• Proprietary video technology
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
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
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
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
Thank you
SAGES 2014 – Salt Lake City 28
DDW 2014 – Chicago 29
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