Investor presentation March 2014 MDGS.TASE

Transcription

1 Investor presentation March 2014 MDGS.TASE

2 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 kwledge 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 obligation to update or revise any Forward Looking Statements, whether as a result of new information, future developments or otherwise. Neither the company, r 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.

3 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 Compelling techlogy; world s smallest video camera combined with endosurgical tools 81 issued patents Multiple shots on goal with unique visualization platform

4 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

5 Leadership 5 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 Insert Covidien pictures for $860m, and CEO of short IntraPace bio Dr. Elazar Sonnenschein COO Founder and inventor of the Medigus techlogy 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)

6 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

7 GERD significant unmet need 7 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 - t 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) Aliment Pharmacol Ther Nov;32(10):

8 Current standard surgical procedure laparoscopic Nissen fundoplication 8 Unpopular (2% of patients) invasive (laparoscopic) procedure Early complications: bleeding, perforation, conversion to open surgery, death. Late complications: dysphagia, bloating/pain Source: Gut. 2012; 61(4):

9 The Medigus Solution The intersection of See & Treat 9 Flexible endoscope Vision + surgical capability Can fold on itself to complete endoluminal stapling Stapler using standard surgical staples Small, high resolution video camera Ultrasound MUSE System for GERD; FDA cleared, CE marked, on market OUS

10 SRS endoscopy system rebranded as MUSE 10

11 Chronic GERD (24M patients) The opportunity convert PPI users and lap patients to minimally invasive surgery 11 New Surgical Threshold Current Surgical Threshold Continued PPI Therapy Therapy Gap Disease Progression Continued Heartburn Lifelong PPI Use Regurgitation Fundoplication Market Low Severity of Symptoms and Dissatisfaction High Source: US market for Gastrointestinal endoscopic devices, idata, 2012; Gut. 2012; 61(4):

12 GERD US Market Map (millions of patients) Potentially relevant patients severe patients untreated treated controlled treated t controlled Source: US market for Gastrointestinal endoscopic devices, idata, 2012; Gut. 2012; 61(4):

13 How MUSE works trans-oral fundoplication 13 The MUSE device is placed through the esophagus and into the stomach The MUSE device is then retroflexed below the Z line and the stapling position is located using direct visualization and ultrasound. The MUSE ratchet is engaged and positioned to correct stapling position. Ultrasound and concave/convex surfaces provide alignment

14 Medigus MUSE System clinical results similar to current surgical standard but less invasive 14 Lap Nissen MUSE

15 Medigus MUSE Pilot Study of 13 patients 15 5 year results ( ) 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) The pilot study was conducted in 2007 in India with 13 patients 11/13 available for 5 year follow up

16 16 MUSE System multi center trial overview ( ) centers, PIs 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 patients 72 patients enrolled, 69 treated, 66 followed (ITT) for 6 months Inclusion criteria: GERD diagsed at least 2 years, on PPI at least 6 months, GERD HRQL off PPI >20 Exclusion criteria: hernia >3cm procedure endpoints 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 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 69 patients treated, 69 in safety analysis, 66 in efficacy analysis at 6 months (3 excluded, treated, but excluded did t meet IC

17 MUSE multi center trial outcomes 17 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 before and after the procedure (p<.0001) 66 patients at 6 months

18 Competitive landscape 18 MUSE Esophyx Linx Stretta clinical True anterior fundoplication (identical to current standard) Minimally invasive Minimal risk of migration or damage to adjacent organs Minimal/ potential of erosion techlogy Direct vision as part of the endoscope, other devices needed Ultrasound to guide tissue thickness and stapling accuracy Use of standard surgical staples Single use surgical endoscope MRI safety operator Number of operators Medical specialty 1 GI/Surgeon 2 GI/Surgeon 1 Surgeon 1 GI/Surgeon

19 reward MUSE vs competition 19 Summary why MUSE? drugs MUSE Torax/ EGS/ Stretta Lap Nissen Clinical value No Incision, scar, less invasive True surgical anterior fundoplication Clinical equivalence to current standard Durable results using standard surgical staples Ecomic benefit Single operator, surgical endoscope Out patient procedure Potential to eliminate lifelong medication Efficient and cost effective CE marked, FDA 510(k) cleared risk

20 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

21 Commercialization strategy inch wide mile deep Clear regulatory pathway US 510(k) in place, updating for MUSE version II EU CE mark in place 21 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 Increasing presence in target markets Office opened in Bay Area (California) VP appointed for EU operations (Austria) MUSE revenues Increase commercial sales in key markets concurrently with infrastructure and promotion efforts Expand distribution channels in other markets

22 COMMERCIALIZATION REG Milestones 22 Gen II 510k 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

23 Summary 23 Unique single use, surgical platform will re-define natural orifice surgery (NOS) Large market opportunity, high gross margin, differentiated, procedure specific device Compelling clinical data, less trauma to patient, incision, cost effective Industry-leading investors; OrbiMed and J&J Developed and currently sell world s smallest video camera

24 Financial summary 24 Cash position as of December 31 st, 2013: ~ $11,300,000 Number of employees - 40 Capital structure million shares outstanding million outstanding fully diluted shares Shareholder profile: OrbiMed - 24% Founders 15% J&J & Dexxon 15% Public & Other 46%

25 Thank you