UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
April 17, 2015
Date of Report (date of earliest event reported)
TransEnterix, Inc.
(Exact name of Registrant as specified in its charter)
| Delaware | 0-19437 | 11-2962080 | ||
| (State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
635 Davis Drive, Suite 300
Morrisville, North Carolina
(Address of principal executive offices)
919-765-8400
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 8.01 | Other Events. |
On April 17, 2015, TransEnterix, Inc., a Delaware corporation (the “Company”) updated its Company presentation and first used it during an Analyst Investor Event held in Nashville, Tennessee. A copy of the Company presentation is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit |
Description | |
| 99.1 | TransEnterix, Inc. Company presentation dated April 17, 2015 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| TRANSENTERIX, INC. | ||||||
| Date: April 21, 2015 | /s/ Joseph P. Slattery | |||||
| Joseph P. Slattery | ||||||
| Executive Vice President and Chief Financial Officer | ||||||
 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. |