Analyst Event - DDW
MDGS.TASE
May 2015
Forward looking statements
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Agenda 3
Why Medigus?
• Chris Rowland, CEO Physician Speakers
• Prof. Dr. Ralf Kiesslich Clinic Director of the Clinic of Internal Disease II – Wiesbaden Germany
• Prof. Stavros Stavropoulos Chief of Endoscopy, Director Program in Advanced GI Endoscopy – NY
• Dr. Ali Lankarani; Advanced Therapeutic Endoscopy - FL
Q&A MUSE Demo
Why Medigus? 5
MUSE™ System for natural orifice GERD therapy – FDA cleared and CE marked, initial revenue
Received positive recommendation from AMA for a new Category 1 CPT Code for Esophagogastric Fundoplasty Trans-Orifice Procedure
Compelling technology; world’s smallest video camera combined with flexible, endosurgical tools
Large market opportunity, high gross margin, single-use device
72 issued patents
The opportunity – GERD Natural Orifice Surgery 6
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
16M Potential
Procedures
100K Proc.
The opportunity – GERD Natural Orifice Surgery 7
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
New Surgical Threshold
Surgical Device
Scope Through the
Middle
Standard Scope
Surgical Device “Piggyback”
Standard Scope
????
Standard Scope
Surgical Device
Surgical Device “Piggyback”
Surgical Device “Piggyback”
Scopes are a critical tool in NOS/NOTES
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 – MUSE
10
CPT code development 11
o What happened • Cat 1 application submitted Nov 5th 2014, by 3 GI societies & 2 surgical • Procedure name; “Esophagogastric Fundoplasty Trans-Orifice Approach” • Application for Cat 1 code discussed during Feb CPT panel agenda
Proposed Panel Agenda February 2015 CPT® Editorial Panel Meeting
‘Esophagogastric Fundoplasty Trans-Orifice Approach 432XX: Add a code for trans-orifice esophagogastric fundoplasty ‘
CPT code result 12
CPT® Editorial Summary of Panel Actions February 2015
13 Esophagogastric Fundoplasty Trans-Orifice Approach 432XX1 addition of code 432XX1 to describe trans-oral esophagogastric fundoplasty Accepted
12 Esophageal Sphincter Augmentation 4328X1 4328X2 Rejected
Summary 13
Positive recommendation from AMA for a new Category 1 CPT Code for MUSE procedure
Unique single use, surgical platform will re-define natural orifice surgery (NOS)
Compelling clinical data, less trauma to patient, no incision, cost effective
Large market opportunity, high gross margin, differentiated, procedure specific device
Industry-leading healthcare investors; OrbiMed and J&J
Physician speakers
Ralf Kiesslich, MD, PhD 15
• Head of GI department, Medical Center of Wiesbaden Germany Frankfurt Germany
• Board certified in Internal Medicine and Gastroenterology • Full Professor of Internal Medicine and Gastroenterology • Editorial board of Gut, Endoscopy and Gastroenterology • Past President for the section of Endoscopy (German Society of
Gastroenterology) • Head of the Research Section of Endoscopy (German Society
of Gastroenterology) • Nov 2012 Head of the department of Internal Medicine,
Gastroenterology and Oncology, St. Mary’s hospital Frankfurt, Teaching hospital of the University of Frankfurt, Germany
• May 2008 Full Professorship at Johannes Gutenberg University of Mainz
• Jan 2005 Head of Endoscopy Unit, University of Mainz • Jan 2004 Visiting Professor Massachusetts General Hospital,
Boston, USA • Oct 2004 Assistant Professor of Internal Medicine
(Gastroenterology), University of Mainz
Ralf Kiesslich, MD, PhD 16
Ralf Kiesslich, MD, PhD 17
SRS – Gen 3 MUSE – Gen 6 Two consoles One console Basic text interface Software control CCD CMOS Manual staple ejection Powered staple ejection No alignment pin, ultrasound or ergonomics
Yes, yes and yes
Ralf Kiesslich, MD, PhD 18
Pilot Study1 n=13; 5 years
Pivotal Study2 N=69; 6 months
Laparoscopic anti-reflux surgery3
Quality of Life
• 92% of patients (12/13) with normalized (<10) HRQL scores
• 73% of patients with ≥ 50% reduction in HRQL scores
• 90% symptom control at 3 yrs; 67% at 7 yrs
• Quality of life significantly improved in short and long term
PPI Usage
• 54% of patients off PPI
• 77% off PPI or ≥ 50% reduction in PPI use
• 65% of patients off PPI
• 85% off PPI or ≥ 50% reduction in PPI use
• Long term medication use in 20% of patients (80% off PPI)
Other • No dysphagia • All would repeat
procedure
• Hill Grade >2 in 66% at baseline; 6% at 6 mos
• Mean % time pH < 4 and total episodes significantly reduced (p<.001)
• Reoperation rates 1.8-10.8%
• 76% dysphagia perioperatively; 20% 1 yr; 5-8% long term
• Normal pH in 88-94% of patients
1 Shapira et al (2015) Surgical Endoscopy available online ahead of print DOI 10.1007 s00464-015-4142-9. 2 Zacherl et al (2015) Surgical Endoscopy Jan 29(1):220-9; online publication Aug 2014. 3 SAGES guidelines for Surgical Treatment of GERD, www.sages.org
Stavros Stavropoulos, MD 19
• Chief of Endoscopy Director, Program in Advanced GI Endoscopy
• Adjunct Professor of Clinical Medicine, Columbia University • Specialty; Advanced Therapeutic Endoscopy • First GI to perform MUSE procedure in the US • Second MD in the world to perform POEM with currently the
highest volume POEM procedures • Pioneer in NOTES full thickness resection • Giving state of the art lecture in NOTES at this years DDW • Memberships;
American Society of Gastrointestinal Endoscopy New York Society of Gastrointestinal Endoscopy American College of Gastroenterology American Gastoenterology Association American College of Physicians
Stavros Stavropoulos, MD 20
http://www.>winthropendoscopy.org
21
22
Endoscopic Surgery
Lap Surgery
Open Surgery
Stavros Stavropoulos, MD 23
Current MIS landscape
• Efficiency and outcomes • Growing applications • Eliminating incisions is attractive to patients
Ali Lankarani, M.D. 24
• Private Practice at the Borland-Groover Clinic • Member of the Advanced Theraputic Endoscopy
Center • Trained at Mayo Clinic as a clinical instructor and
advanced therapeutic gastroenterology fellow • Studied Internal Medicine at the Johns Hopkins
University-Sinai Hospital of Baltimore. • American Board of Internal Medicine, 2008 • American Board of Internal Medicine
Gastroenterology, 2011
Ali Lankarani, M.D 25
Ali Lankarani, M.D 26
Where does MUSE fit in my practice?
• Diagnosed GERD patients who: • Lack of PPI efficacy • Concerned about long term use • Intolerant to PPI • Unable to comply • Concerned about LNF morbidity • Looking for less invasive treatment (ie ‘Therapy Gap;)
What about other endoscopic methods? • Stretta • EndoCinch • EGS
Q&A
Revenues – MUSE & Scoutcam • Increase commercial sales in key markets concurrently with infrastructure and promotion efforts • Medical and industrial partners identified for Scoutcam
Drive reimbursement • US CPT Code – Cat 1 on Jan 1st, 2016 • Germany OPS code already available
Clear regulatory pathway • US 510(k) in place • EU CE mark in place
Clinical and publication milestones • 2 abstracts submitted for 2015 and 1 peer review published • 5 year follow up for MUSE submitted for peer review • Registry procedures underway • Advisory board and Societies engaged
Scalable commercial model • Reproducible training program implemented (US & EU) • Trained 48 MD’s from 34 COE’s in 2014 • Training 80 MD’s from 40 COE’s in 2015 • Focus on commercial + registry procedures
Commercial transition 28
Summary 29
Positive recommendation from AMA for a new Category 1 CPT Code for MUSE procedure
Unique single use, surgical platform will re-define natural orifice surgery (NOS)
Compelling clinical data, less trauma to patient, no incision, cost effective
Large market opportunity, high gross margin, differentiated, procedure specific device
Industry-leading healthcare investors; OrbiMed and J&J
End