Analyst Investor Event SAGES Conference Nashville, TN April 17, 2015 Webcast at: http://ir.transenterix.com/events.cfm Exhibit 99.1 |
Forward Looking Statement 2 Any statements contained in this presentation that do not describe historical facts, including statements about the beliefs and expectations of TransEnterix, Inc. (“TransEnterix,” "we" or "our") and other statements regarding our future plans and goals, may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expect," "anticipate," "future," "intend," "plan," "believe," "estimate," "confident" and similar statements. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties that may cause actual results to differ materially from expectations. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, whether the SurgiBot system's 510(k) application(s) will be will be submitted by mid-2015 or cleared by the U.S. FDA, the pace of adoption of our products by surgeons, the success and market opportunity of our products, most notably the SurgiBot system, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with TransEnterix's business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2014 filed with the SEC on February 20, 2015, and other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this presentation and speak only as of the date of this presentation. We undertake no obligation to publicly update or revise any forward- looking statement, whether as a result of new information, future events or otherwise. 2 |
• Corporate Update – Todd M. Pope, CEO TransEnterix • Surgeon Speakers – Dr. Helmuth Billy, Ventura, CA – Dr. Raymond Leveillee, Miami, FL – Dr. Juan-Carlos Verdeja, Miami, FL • Q&A • SurgiBot System Demo Agenda 3 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
Powered and Robotically-enabled Next-generation Platform The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. SurgiBot TM |
Investment Highlights 5 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. • Surgical robotics Focus • Developing patient-side robotic platform: SurgiBot Technology • Addresses unmet needs in today’s robotic offerings • Cost effective • Broad procedure applicability Solution • Large addressable market – ~2M US procedures Market • Strong management team Experience |
6 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. Improved surgeon ergonomics Benefits of Surgical Robotics Advanced visualization Improved dissection and retraction strength Enhanced precision and control Benefits of Surgical Robotics |
SurgiBot First Patient-side Robotic Platform 7 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. Surgeon scrubbed-in Easily repositioned for multi- quadrant surgery Flexible, articulating channels & instruments Steerable 3DHD Small, mobile platform Cost effective platform |
8 3DHD Optics/Cart SurgiBot First Patient -side Robotic Platform SurgiBot System |
9 Bariatric Surgery Cholecystectomy Colorectal Gynecology/Urology Targeted US Procedures 160K 1,140K 363K 230K Source: Millennium Research Group US Markets Laparoscopic Devices 2014 ~2M US Laparoscopic Procedures Procedure Market Opportunity The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
Hospital Market Opportunity 10 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. • • • Hospitals without Robotic Capability Hospitals with Robotic Capability • • • • • Current robotic offerings are not cost effective Surgery centers – untapped market for robotics Losing market share to robotic facilities Large underpenetrated OUS opportunity System price Limited procedure volume Invested in the strategic and competitive value of robotic surgery ROI expectations changing/under pressure Potential for diversification of robotic solutions Procedures Price Facilities • • • • |
Significant Base of Underserved Hospitals 11 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. Mid/Small Hospitals • >3,000 w/ <300 beds • >80% lack robotic offering • Losing market share to robotic facilities • Represent >800K target annual procedures Surgery Centers • ~5,000 in US • Economics driving rapid procedure growth • SurgiBot System will offer versatility and cost benefits |
Surgical Robotics >$2B Revenue High Growth Combining Advanced Technology AND Maximizing Value Price 12 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. Traditional Laparoscopy >$10B Revenue Low Growth |
• 510(k) pathway • Successfully completed GLP labs • Low-risk testing and documentation in-process • 510(k) Submission on track for mid-2015 Regulatory Update 13 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
– Helmuth Billy, MD, Ventura, CA – Raymond Leveillee, MD FRCS-G, Miami, FL – Juan-Carlos Verdeja, MD FACS, Miami, FL Surgeon Speakers 14 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
Helmuth Billy, MD Ventura, CA 15 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
• General & Bariatric Surgeon • Laparoscopic training at Cedars- Sinai, USC • Private Practice • Ventura and Oxnard, CA • Primarily operate at St. John’s Regional and Community Memorial • Operate at freestanding outpatient surgery center • Visiting Consultant Surgeon, Hamad Hospital, Doha, Qatar 2012-present Helmuth Billy, MD Experience & Background 16 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
• 21 years laparoscopic experience • Routine laparoscopic procedures are: – Cholecystectomy – Gastric Sleeve – Gastric Bypass – Colons – Hernia repair – Appendectomy • Robotic Experience: – Trained, but not currently using Helmuth Billy, MD MIS Practice 17 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
Efficient to set up and dock, keeps room turnover time low Ease of use amongst multiple ORs within a day Quick learning curve… second case was total OR time of 38 minutes Preserves multiport lap skills already learned Eliminates need for almost any assistance Helmuth Billy, MD SurgiBot System Assessment 18 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
• OR Efficiency • Application for broad range of general surgery procedures • Reducing number of incisions is attractive to patients • May consolidate significant volume to facility that acquires Helmuth Billy, MD How SurgiBot System Fits My Practice 19 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
Raymond Leveillee, MD FRCS-G Miami, FL 20 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
• Urologist • Trained at UMASS Medical, Brown University • MIS Fellowship U of Minnesota • Dept appointments in Urology, Radiology, and Biomedical Engineering • Academic Medical Center • University of Miami, 20+ years • Past President Southeast Section of AUA • Alt. Rep, AUA BOD Raymond Leveillee, MD FRCS-G Experience & Background 21 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
• 26 years laparoscopic experience • Routine laparoscopic procedures are: – Nephrectomies – Prostatectomies – Pyeloplasties – Adrenalectomy – Reconstruction • Laparoscopic and Robotic Fellowship Director 99-14 • Robotic Experience: – 14 years, over 1,000 cases Raymond Leveillee, MD FRCS-G MIS Practice 22 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
• Value in robotic system that keeps surgeon in sterile field • Lower cost system for smaller hospitals and for benign and some malignant conditions • Overcomes limitations of single port surgery • Adjustable triangulation • Clutching is a major benefit in improving ergonomics of single port lap surgery • A hybrid… combines lap experience with robotic assistance Raymond Leveillee, MD FRCS-G SurgiBot System Assessment 23 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
• Being in sterile field for key maneuvers • Value in multiple Urologic surgeries • Replicates lap approach that many urologists still prefer for renal procedures • Urologists eager for robotic alternatives Raymond Leveillee, MD FRCS-G How SurgiBot System Fits My Practice 24 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
Juan-Carlos Verdeja, MD FACS Miami, FL 25 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
• General Surgeon • Trained at U of Miami • Authored first report in world's literature on Laparoscopic Colon Surgery • Primarily operate at three hospitals in Baptist Health South Florida • Director of General Surgery Division of Baptist Health Medical Group • Director of Minimally Invasive Surgery, Associate Professor and Affiliate Dean at FIU College of Medicine Juan-Carlos Verdeja, MD FACS Experience and Background 26 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
• 25 years laparoscopic experience, >10K cases • Routine laparoscopic procedures are: – Cholecystectomy – Colectomy – Appendectomy – Hernia Repair • Robotic Experience: – Nissen Fundoplication – Splenectomy – Gastrectomy Juan-Carlos Verdeja, MD FACS MIS Practice 27 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
• 3DHD is vital and significant benefit • Being in sterile field is important • Strength of flexible instruments is outstanding • Maintains the best approach for single site surgery with excellent triangulation • Laparoscopic motion is natural after >10K cases Juan-Carlos Verdeja, MD FACS SurgiBot System Assessment 28 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |
• Can be the primary tool for single port cholecystectomy • Extends approach to other procedures with additional vision and strength • Opportunity at smaller hospitals and surgery centers in Baptist Health Network Juan-Carlos Verdeja, MD FACS How SurgiBot System Fits My Practice 29 The SurgiBot System is currently in development and has not yet been cleared by the FDA for sale in the United States or by other regulatory authorities for sale outside the United States. |