Analyst Event - DDW - Medigus Relations/Medigus...Analyst Event - DDW MDGS.TASE May 2015 Forward...

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Analyst Event - DDW MDGS.TASE May 2015

Transcript of Analyst Event - DDW - Medigus Relations/Medigus...Analyst Event - DDW MDGS.TASE May 2015 Forward...

Page 1: Analyst Event - DDW - Medigus Relations/Medigus...Analyst Event - DDW MDGS.TASE May 2015 Forward looking statements This presentation contains "Forward Looking Statements" as defined

Analyst Event - DDW

MDGS.TASE

May 2015

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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.

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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

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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

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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

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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

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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

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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 ‘

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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

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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

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Physician speakers

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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

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Ralf Kiesslich, MD, PhD 16

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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

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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

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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

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Stavros Stavropoulos, MD 20

http://www.>winthropendoscopy.org

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Endoscopic Surgery

Lap Surgery

Open Surgery

Stavros Stavropoulos, MD 23

Current MIS landscape

• Efficiency and outcomes • Growing applications • Eliminating incisions is attractive to patients

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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

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Ali Lankarani, M.D 25

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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

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Q&A

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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

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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

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End