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Current Report

 

 

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): January 12, 2015

 

 

ATRICURE, INC.

(Exact name of registrant as specified in charter)

 

 

 

Delaware   000-51470   34-1940305

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

 

6217 Centre Park Drive

West Chester, OH

   45069
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (513) 755-4100

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 2.02. Results of Operations and Financial Condition.

On January 12, 2015, AtriCure, Inc. (“AtriCure” or the “Company”) issued a press release regarding its preliminary financial results for the fourth quarter and full year ended December 31, 2014. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.

 

Item 7.01. Regulation FD Disclosure.

During the week of January 12, 2015, the Company is holding meetings with investors discussing, among other topics, an overview of the Company’s business and growth strategy. A copy of the investor presentation, which is available at www.atricure.com, is furnished as Exhibit 99.2 to this Form 8-K and is incorporated herein by reference.

The Company’s presentation discloses certain financial results both in accordance with generally accepted accounting principles (GAAP) and on a non-GAAP basis with adjustments for certain items. The Company’s management believes that presentation of these non-GAAP financial measures and their related reconciliations are useful to investors because the non-GAAP financial measures provide investors with a basis for comparing the results to financial results from prior periods.

Information in the presentation contains forward-looking statements regarding future events and performance of the Company. All such forward-looking statements are based largely on the Company’s experience and perception of current conditions, trends, expected future developments and other factors, and on management’s expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those factors described in the presentation and in the Company’s filings with the Securities and Exchange Commission.

The information in each of Item 2.02 and Item 7.01 of this Form 8-K and in the press release attached as Exhibit 99.1 and the presentation attached as Exhibit 99.2 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in each of Item 2.02 and Item 7.01 of this Form 8-K and each of Exhibit 99.1 and Exhibit 99.2 shall not be incorporated by reference in any filing or other document under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in any such filing or document.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

No.

   

Description

99.1    Press Release dated January 12, 2015
99.2    Investor Presentation

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 hereunto duly authorized.

 

    ATRICURE, INC.
Dated: January 12, 2015     By:   /s/ M. Andrew Wade
      M. Andrew Wade
      Vice President and Chief Financial Officer
Press Release

Exhibit 99.1

 

LOGO

Contact:

AtriCure, Inc.

Andy Wade

Vice President and Chief Financial Officer

(513) 755-4564

awade@atricure.com

Investor Relations Contact

Lynn Pieper

Westwicke Partners

(415) 202-5678

lynn.pieper@westwicke.com

AtriCure Announces Preliminary Results for Fourth Quarter and Full Year 2014

Issues 2015 Guidance

WEST CHESTER, Ohio – January 12, 2015 – AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments for atrial fibrillation (“Afib”) and Left Atrial Appendage Management (“LAAM”), today announced preliminary financial results for fourth quarter and full year 2014 and issued 2015 financial guidance.

Preliminary and unaudited revenue for fourth quarter 2014 is expected to be approximately $29.5 million, reflecting growth of approximately 34.6% over the fourth quarter of 2013. Based on this preliminary estimate, revenue from U.S. customers is expected to be $22.1 million, reflecting growth of 35.1%, and revenue from international customers is expected to be $7.3 million, reflecting growth of 33.2%, or 41.4% on a constant currency basis.

Preliminary revenue for full year 2014 is expected to be $107.5 million, reflecting year over year growth of 31.3% over full year 2013.

“We are pleased to report preliminary fourth quarter and full year 2014 results which reflect continued growth and momentum across our product lines. We continue to see a tremendous amount of untapped potential in our markets, and thus our plans remain focused on growth and successfully expanding the Afib market through improved patient outcomes, training and education. We are providing our outlook for 2015 and look forward to providing additional detail on our growth strategy when we release our final 2014 results in late February,” said Mike Carrel, President and Chief Executive Officer of AtriCure.

2015 Financial Guidance

Management projects that 2015 revenue will be in the range of $122.5 million to $124.5 million, which represents an increase of 14% to 16% over 2014. At current foreign exchange rates, this range reflects an estimated $1.6 million adverse currency impact due to the weakening Euro against the U.S. Dollar.

Adjusted EBITDA, a non-GAAP measure, is projected to be a loss in the range of $7 to $9 million for 2015 as we continue to make strategic investments to drive our long-term growth plan. We will provide a reconciliation of this non-GAAP measure to the related GAAP measure in our release of final 2014 results.

About AtriCure, Inc.

AtriCure, Inc. is a medical device company providing innovative atrial fibrillation (Afib) solutions designed to produce superior outcomes that reduce the economic and social burden of atrial fibrillation. AtriCure’s Synergy™ Ablation System is the first and only surgical device approved for the treatment of Persistent and Longstanding Persistent forms of Afib in patients undergoing certain open concomitant procedures. AtriCure’s AtriClip Left Atrial Appendage Management (LAAM) exclusion device is the most widely sold device worldwide that’s indicated for the occlusion of the left atrial appendage. The company believes cardiothoracic surgeons are adopting its ablation and LAAM devices for the treatment of Afib and reduction of Afib related complications such as stroke. Afib affects more than 33.5 million people worldwide.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that address activities, events or developments that AtriCure expects, believes or anticipates will or may occur in the future, such as earnings estimates (including projections and guidance), other predictions of financial performance, launches by AtriCure of new products and market acceptance of AtriCure’s products. Forward-looking statements are based on AtriCure’s experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances and are subject to numerous risks and uncertainties, many of which are beyond AtriCure’s control. These risks and uncertainties include the rate and degree of market acceptance of AtriCure’s products, AtriCure’s ability to develop and market new and enhanced products, AtriCure’s ability to retain and attract key employees, the timing of and ability to obtain and maintain regulatory clearances and approvals for its products, the timing of and ability to obtain reimbursement of procedures utilizing AtriCure’s products, AtriCure’s ability to continue to be in compliance with applicable U.S. federal and state and foreign government laws and regulations, AtriCure’s ability to consummate acquisitions or, if consummated, to successfully integrate acquired businesses into AtriCure’s operations, AtriCure’s ability to recognize the benefits of acquisitions, including potential synergies and cost savings, failure of an acquisition or acquired company to achieve its plans and objectives generally, risk that proposed or consummated acquisitions may disrupt operations or pose difficulties in employee retention or otherwise affect financial or operating results, competition from existing and new products and procedures, including the development of drug or catheter-based technologies, or AtriCure’s ability to effectively react to other risks and uncertainties described from time to time in AtriCure’s SEC filings, such as fluctuation of quarterly financial results, fluctuations in exchange rates for future sales denominated in foreign currency, which represent a majority of AtriCure’s sales outside of the United States, reliance on third party manufacturers and suppliers, litigation or other proceedings, government regulation and stock price volatility. AtriCure does not guarantee any forward-looking statement, and actual results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can be found in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.

Investor Presentation
Investor Presentation
January 2015
Exhibit 99.2

2
Forward Looking Statements/Non-GAAP Measures
This
presentation
contains
“forward-looking
statements”
within
the
meaning
of
the
Private
Securities
Litigation
Reform
Act
of
1995.
Forward-
looking
statements
include
statements
that
address
activities,
events
or
developments
that
AtriCure
expects,
believes
or
anticipates
will
or
may
occur
in
the
future,
such
as
earnings
estimates
(including
projections
and
guidance),
other
predictions
of
financial
performance,
launches
by
AtriCure
of
new
products
and
market
acceptance
of
AtriCure’s
products.
Forward-looking
statements
are
based
on
AtriCure’s
experience
and
perception
of
current
conditions,
trends,
expected
future
developments
and
other
factors
it
believes
are
appropriate
under
the
circumstances
and
are
subject
to
numerous
risks
and
uncertainties,
many
of
which
are
beyond
AtriCure’s
control.
These
risks
and
uncertainties
include
the
rate
and
degree
of
market
acceptance
of
AtriCure’s
products,
AtriCure’s
ability
to
develop
and
market
new
and
enhanced
products,
AtriCure’s
ability
to
retain
and
attract
key
employees,
the
timing
of
and
ability
to
obtain
and
maintain
regulatory
clearances
and
approvals
for
its
products,
the
timing
of
and
ability
to
obtain
reimbursement
of
procedures
utilizing
AtriCure’s
products,
AtriCure’s
ability
to
continue
to
be
in
compliance
with
applicable
U.S.
federal
and
state
and
foreign
government
laws
and
regulations,
AtriCure’s
ability
to
consummate
acquisitions
or,
if
consummated,
to
successfully
integrate
acquired
businesses
into
AtriCure’s
operations,
AtriCure’s
ability
to
recognize
the
benefits
of
acquisitions,
including
potential
synergies
and
cost
savings,
failure
of
an
acquisition
or
acquired
company
to
achieve
its
plans
and
objectives
generally,
risk
that
proposed
or
consummated
acquisitions
may
disrupt
operations
or
pose
difficulties
in
employee
retention
or
otherwise
affect
financial
or
operating
results,
competition
from
existing
and
new
products
and
procedures,
including
the
development
of
drug
or
catheter-based
technologies,
or
AtriCure’s
ability
to
effectively
react
to
other
risks
and
uncertainties
described
from
time
to
time
in
AtriCure’s
SEC
filings,
such
as
fluctuation
of
quarterly
financial
results,
fluctuations
in
exchange
rates
for
future
sales
denominated
in
foreign
currency,
which
represent
a
majority
of
AtriCure’s
sales
outside
of
the
United
States,
reliance
on
third
party
manufacturers
and
suppliers,
litigation
or
other
proceedings,
government
regulation
and
stock
price
volatility.
AtriCure
does
not
guarantee
any
forward-looking
statement,
and
actual
results
may
differ
materially
from
those
projected.
AtriCure
undertakes
no
obligation
to
publicly
update
any
forward-looking
statement,
whether
as
a
result
of
new
information,
future
events
or
otherwise.
A
further
list
and
description
of
risks,
uncertainties
and
other
matters
can
be
found
in
our
Annual Reports on
Form 10-K and Quarterly Reports on Form 10-Q..
This
presentation
includes
the
use
of
non-GAAP
measures.
Reference
AtriCure’s
Form
8-K
filings
which
include
the
furnishing
of
our
earnings releases
for a reconciliation to the related GAAP measures.

3
Vision
AtriCure seeks to develop solutions
for and become a leader in the
treatment of Atrial Fibrillation (Afib)
and left atrial appendage (LAA)
management for stroke reduction

4
Top 10 disease related deaths worldwide
Afib is the second leading cause of stroke!

5
Key Takeaway Messages
•
Atrial Fibrillation is a health problem of epidemic proportions
•
Only 27% of all surgical patients with AF are treated leaving a big opportunity for
treatment
1
•
Many current therapies such as anti-arrhythmic medications are ineffective
•
The Cox-Maze IV procedure is very effective at treating Afib
•
Patients
with
Afib
on
average
4-6
times
more
likely
to
have
a
stroke
2
•
Large,
under-penetrated
market
(10M+
people
globally
–
conservative
estimate)
•
$26 Billion annual health economic burden from Afib in the U.S. alone
AND ATRICURE IS POISED FOR SUCCESS …
1
Circulation:
Cardiovascular
Quality
and
Outcomes.
Estimation
of
Total
Incremental
Health
Care
Costs
in
Patients
With
Atrial
Fibrillation
in
the
United
States.
Michael
H.
Kim
et
al.
2
.http://www.ninds.nih.gov/disorders/atrial_fibrillation_and_strok e/atrial_fibrillation_and_stroke.htm

6
•
The leading global player in the surgical Afib market
Only FDA-approved device for surgical treatment of Afib
Broad and deep product portfolio with deepest IP in the field
World-class training
•
Strong and Consistent Revenue Growth  and Gross Margins
17% growth in 2014
31% growth in 2014; organic growth of close to 20%
Expect 14-16% growth in 2015
-
weakening
Euro
impacting
business
–
guidance
would
have
been
higher
with
a
flat
exchange
rate from 2014
Gross Margins 70% in 2014 and on path to 75% over five years
•
Growth
Short
Term
=
Open
Ablation
+
Clip
+
International
Education,
Awareness, Training
Long
Term
=
MIS
+
MIS
Clip
+
New
Products
Trials
Upside = MIS and International
AtriCure Is Poised For Growth

7
How Are We Doing?
A look at the last ten quarters:
2014
31% growth
Q3 2012
6% growth
Q4 2012
9% growth
Q1 2013
11% growth
Q2 2013
12% growth
Q3 2013
25% growth
Q4 2013
19% growth
Q1 2014
28% growth
Q2 2014
30% growth
Q3 2014
32% growth
Q4 2014
35% growth
Includes revenue from
12/31/13 Estech
acquisition
–
organic
revenue above 17%

8
Be the recognized leader in Afib and
appendage management
Have improved the lives of more than
250,000 Afib patients and treated over
150,000 with Clips
By The End Of The Decade We Will…

9
AF Clinical Hierarchy

10
Emerging Clinical Paradigm
PAROXYSMAL
(INTERMITTENT)
NON-PAROXYSMAL
(CONTINUOUS)
OPEN
(CONCOMITANT)
PULMONARY VEIN
ISOLATION
(CLAMP or FUSION)
COMPLETE MAZE
STAND-ALONE
PULMONARY VEIN
ISOLATION
(CATHETER)
HYBRID
(SURGERY + EP PROCEDURE)

11
Ablation Global Market Opportunity –
Open
•
Labeling advantage in U.S.*
•
Best products
•
High gross margins
•
Education is key
•
Competition is large device
AtriCure has the only
on-label products for the
surgical treatment of Afib*
Open Ablation
$600M
$120M
Current
Market
Potential
Market
Estimated open heart surgeries per year
750,000
Estimated % that have Afib
33%
Estimated Afib patients undergoing surgery
250,000
Estimated
Market
Opportunity
–
Annual
$600,000,000
Source: AtriCure estimates
* PMA approved products include our OLL2 and OSL2
clamps., along with the ASU RF generator and ASB
switchbox; see AtriCure website for full indication language

12
Ablation Global Market Opportunity –
Stand-alone
•
High reimbursement
•
High gross margins
•
Growing internationally
•
Development needed
•
Competition is start-ups
Developing Market
Trial Key to FDA
Approval for Afib
treatment
MIS / Stand Alone Ablation
Estimated
Afib
patients
–
E.U.
and
U.S.
Only
8,000,000
Estimated % drug refractory and symptomatic
50%
Subtotal
4,000,000
Estimated Persistent and Longstanding Persistent subset
50%
Subtotal -
Patients
2,000,000
Estimated
Market
Opportunity
–
Total
$20,000,000,000
Estimated % treated annually
5%
Estimated
Market
Opportunity
–
Annual
$1,000,000,000
$1B
$40M
Current
Market
Potential
Market
Source: AtriCure estimates

13
LAA Global Market Opportunity –
Open
•
Best in class LAA management
•
Superior
safety
-
No
adverse
events
•
Mechanical & Electrical Solution
•
Competition includes Tiger Paw,
staple, suture, ligature (endo loop)
•
2014
Revenue
-
$8.7M
•
2014
Revenue
-
$12.4M
(+44%)
4+ years of clinical experience
Over
43,000
clips
implanted
–
well
ahead of competitive products
Estimated Open heart surgeries per year
750,000
Estimated % that have Afib
33%
Estimated Afib patients undergoing surgery
250,000
Estimated
Market
Opportunity
–
Annual
$250,000,000
$250M
$10M
Current
Market
Potential
Market
UPSIDE:
Prophylactic treatment could more than
double this market
Open Clip
Source: AtriCure estimates

14
LAA Global Market Opportunity –
MIS (AtriClip
®
Pro)
One Product, Two Markets
Concomitant with MIS Ablation 
•
Today’s market …will draft MIS growth
•
Virtually ALL revenue from MIS Clip is
for concomitant treatment along with
MIS ablation –
90% attach rate
Attractive sole therapy market
•
NEW market for us…
•
Today only a couple cases have been
done with OUR products “sole
therapy”…
a lot done percutaneous
•
Competition includes implants and EP
closure (without FDA approval)
•
Stroke trial key to success
Estimate of treatment resistant Afib patients
1,000,000
Estimated global revenue per device (all modes)
$5,000
Estimated
Market
Opportunity
–
Total
$5,000,000,000
Estimated % treated annually
10%
Estimated
Market
Opportunity
–
Annual
$500,000,000
Estimated
Afib
patients
–
E.U.
and
U.S.
Only
8,000,000
Estimated % drug refractory and symptomatic
50%
Subtotal
4,000,000
Estimated Persistent and Longstanding Persistent
subset
50%
Subtotal -
Patients
2,000,000
Estimated
Market
Opportunity
–
Total
$5,000,000,000
Estimated % treated annually
5%
Estimated
Market
Opportunity
–
Annual
$250,000,000
MIS Clip With Ablation
MIS Clip
Source: AtriCure estimates

15
Summary High-Level Plan
Market
Open is growth in short term
LAA Market is here now
Clinical data key to MIS growth
Short-Term (3-year)
Focus on commercial execution
Education, Education, Education
Cryo enhancements
Clip innovation
Long-Term (5-year)
Stroke trial success
DEEP trial success
LoLA on beating heart
SubX Clip
Financial
15%+ growth target
(17% in 2014 / 31% in 2014)
75% Gross Margin Target
(70%  2014)
Strategic Focus

16
Business Overview -
Diversified and Growing Portfolio
Focus Areas
Preliminary
2014 Growth
Global
Market
Size
Keys to Success
Current Trials
Open Ablation
(Concomitant)
$44.7M U.S.
+18%
$600M
Annually
•
Education and awareness
•
Conversions and add-on sales
PMA Post Approval Study
(350 Patients; Five Years)
Open Clip
$16.7M
U.S.
+54%
$250M
Annually
•
Education and awareness
•
Tie to ablation growth
Sponsored Investigator Study Design
Underway
MIS Ablation
$16.0M U.S.
+18%
$20B total
$1B+
Annually
•
Trial
•
Collaborative care
•
Integration of Estech
IDE Staged DEEP (Hybrid)
Pivotal Approved
220 Patients; 25 sites
1, 2 and 3 year follow-up
MIS Clip
Included
In Open Clip
line above
$5B total
$500M+
Annually
•
Awareness
•
Trial
Stroke Safety Feasibility Study
Approved
30 patients, 7 sites
International
$27.3M
+39%
Included
above
•
Market expansion
•
Reimbursement
•
Coverage
Involvement Above and Several E.U.
Studies in Process
Overall
$107.5M
+31%
$1B+
Annually
$20B+
Total
2015 Revenue Guidance:
$122.5 -
$124.5 million
14-16% growth
(Reflects estimated $1.6 million adverse currency impact due to weakening Euro)

17
Growth Strategy: Overview
Expand Open Heart Sales
Penetrate LAA Opportunity
Build MIS Platform
International Expansion
•
Leverage Afib indication
•
Increased training and education
•
Capitalize on sales force
•
Afib Program Development
•
Capitalize on investments in sales team
•
Geographic expansion and new products
•
Increase support for distributors
•
Penetrate concomitant ablations
•
Validate stroke prevention with trial
•
Support existing MIS surgeons
•
Support Staged DEEP AF trial
•
Integrate Estech Acquisition
AtriCure
is
the
only
company
with
FDA
approval
to
surgically
treat
the
Afib
disease
state
and
is
a
leader
in
the emerging market of LAA exclusion

18
•
Highly experienced sales and marketing team
•
45 U.S. sales territories; additional clinical team of 25
–
Up from 35 and 12 two years ago respectively
–
Adding 5+ territories in 2015
•
E.U. subsidiary and 30 countries (generate ~25% of revenue)
–
Direct presence in Germany, France, BENELUX
over 10 people
–
Estech brings strong presence in E.U.
–
Well-established international network of independent distributors
–
Japan, China, Eastern Europe, UK, Italy, Russia
Robust Commercial Infrastructure
AtriCure
has
established
a
strong
commercial
infrastructure
which
will
drive
superior
growth
going
forward

19
Other Key Investments For Long-term Growth
Innovation
Education
Clinical Science
AtriCure
is a leading Afib
solutions partner,
passionately
focused on reducing
the global Afib
epidemic and
healing the lives of
those affected.

20
Education and Training Focus
•
Robust training program
•
Course designed by Dr. James Cox
•
Leading KOL Education Steering Committee
•
700+ unique accounts and more than 1500
surgeons trained on the MAZE IV™
procedure
•
Over 400 courses completed
•
International Expansion Underway

21
Impact of Label and Educational Programs
Growth of Open Ablation due to
ATRC Educational Programs
•
FDA
Approval
of
Synergy™
System
in
December
2011
for
the
treatment
of
persistent
Afib
•
Have trained ~62% of cardiac surgeons in the U.S.; 38% more to go!
Sources: STS Adult Cardiac
Surgery
Database
-
2006-
2014;
Ad
2014
-
Ann
Thor
Surg
Vol
96
-
763-769;
company estimates

22
Evidence-Based Benefits of AtriCure Technology
•
$15M+ annual R&D expense –
includes clinical trial expense
•
Over 100 peer-reviewed publications to date
•
Post Approval Study –
350 patients; 50 sites; 5 years with 3 year follow-up
•
EXCLUDE Trial demonstrating safety and efficacy of AtriClip System
•
Staged DEEP Protocol –
FDA-approved hybrid trial
•
Stroke trial design underway
•
International trials –
reimbursement focus
•
Combined with Estech, 185 issued and nearly 50 patents pending
•
Compelling animal and early clinical data with Estech Fusion System
Commitment to Clinical Science

23
Financial Snapshot
•
Approximately
$68.5
million
in
cash
and
investments
at
12/31/2014
•
No debt outstanding
•
Approximately 27.5 million shares outstanding
Revenue and Gross Margin
Balance Sheet and Share Statistics
•
2014 Total Revenue Growth: 31%
•
2014 US Growth: 29%
•
2014 OUS Growth: 39%
•
Four Year CAGR of 16%
•
Gross Margins 70-73%, with expansion
opportunity

24
Positioned for Success
•
Strong and growing revenue base
•
2014 Revenue: $81.9 million (17% growth)
•
2014 Revenue (expected): $107.5 million (31% growth; ~ 20% organic growth)
•
2015
Revenue
(guidance):
$122.5
-
$124.5
million
(14%
to
16%
growth,
even
with
a
weak
Euro)
•
Accelerating revenue growth
•
Open
only
device
FDA-approved
for
surgical
treatment
of
Afib
•
Minimally
Invasive
Solutions
(MIS)
trial,
Estech
acquisition,
education
and
clinical
data
key
•
Left
Atrial
Appendage
(LAA)
open
and
future
trial
•
International
Expansion
improve
share
and
enter
new
markets
•
Opportunity
for
expanding
gross
margins
path
to
75%+

26
Atrial Fibrillation Overview
Condition Overview
Continuum of Care
•
Abnormal electrical impulses cause the upper
chambers of the heart to quiver at rapid rates of 400
to 600 BPM
•
Frequently associated with cardiovascular disease,
in particular hypertension, congestive heart failure,
coronary artery disease, etc.
Effects
•
Causes blood in the atria to become static,
increasing the risk of blood clot formation, stroke,
and other serious complications
•
Symptoms include heart palpitations, dizziness,
fatigue and shortness of breath, and these
symptoms can be debilitating / life threatening
Types
•
Paroxysmal: rapid heart rate begins and stops
suddenly
lasting
24
hours
–
1
week
•
Persistent: abnormal heart rate continuing for more
than a week
•
Permanent: normal heart rhythm can't be restored;
often the result of paroxysmal and persistent Afib
becoming more frequent
•
Initial treatments include electrical cardioversion
(shock to return heart to normal rhythm) and
anticoagulant medicines such as warfarin
•
If persistent, anticoagulants are augmented by rate-
control medicines such as beta blockers
•
When drugs fail, MIS catheter ablation and open-
procedure surgical ablation are used to disrupt the
electric impulses that cause Afib

27
Afib Population:  Large, Growing & Undertreated
(1)Miyasaka Y, et al. Circulation. 2006;114(2):119-125
(2)Lloyd-Jones D, et al. [published online ahead of print December 17, 2009].
Circulation. doi:10.1161/CIRCULATIONAHA.109.192667.
(3)Lloyd-Jones DM, et al. Circulation. 2004;110(9):1042-1046.
(4)  Fuster V, et al. J Am Coll Cardiol. 2001;38(4):1231-12665
(5)
Benjamin EJ, et al. Circulation. 1998;98(10):946-952.
(6)
Kim M, et al. Circ Cardiovasc Qual Outcomes. 2011; 4:313-320
Afib affects over 5 million
in the U.S.
(1)
Significant costs to
healthcare system
•
U.S. prevalence projected to grow to 12-15 million by 2050
•
International prevalence is comparable to the U.S.
•
Most
common
sustained
cardiac
arrhythmia
(2)
•
Lifetime
risk
of
Afib:
~1
in
4
for
adults
40
years
of
age
(3)
Afib increases 5-fold the
risk of stroke
(4,5)
•
Afib
is
leading
cause
of
stroke
–
over
15%
in
U.S.
linked
to
Afib
(5)
•
Afib
results
in
early
mortality
and
cause
of
stroke
in
elderly
(4)
•
Afib-related
strokes
are
more
severe
(5)
Issues with non-surgical
treatment of Afib
•
Warfarin drug therapy has complications
•
Anti-arrhythmic drugs often not well-tolerated and ineffective
•
<3% of Afib patients are treated with catheter or surgical ablation
•
Direct
medical
costs
are
~73%
higher
in
Afib
patients
(6)
•
Net
incremental
cost
of
$8,705
per
patient
per
annum
(6)
•
U.S.
annual
incremental
cost
of
Afib
is
~$26.0
billion
(6)

28
Ablation Procedure Comparison
J Thorac Cardiovasc Surg 2012;-:1-6; J Am Coll Cardiol 2012;60:1921–9

29
20% 1 procedure
45% 2.44 procedures
Catheter Ablation of Long-Standing Persistent Atrial Fibrillation
5-Year Outcomes of the Hamburg Sequential Ablation Strategy

30
Maze IV

31
DEEP Pivotal Study (CP2014-1)
Surgical Lesion Set
Endocardial Lesion Set
Cavo-tricuspid isthmus line
Study
Objective:
Establish
the
safety
and
effectiveness
of
a
dual
epicardial
and
endocardial
ablation
procedure
for
patients
presenting
with
Persistent
or
Longstanding
Persistent
Atrial
Fibrillation
utilizing
the
AtriCure
Bipolar
System
and
AtriClip
®
PRO
LAA
Exclusion
System
in
an
endoscopic
or
open
ablation
procedure,
followed
by
an
endocardial
mapping
and
ablation
procedure
utilizing
commercially
available
RF
based,
irrigated,
power
controlled,
ablation
catheters
for
endocardial
lesions.
The
endocardial
procedure
will
be
staged
to
occur
after
90
days
post
epicardial
surgical procedure.
Number of Subjects/Sites: 220 Subjects, 23 US/2 OUS
study locations
Lead Principal Investigators:
Kenneth Ellenbogen, MD, VCU
Vigneshwar Kasirajan, MD, VCU
Ali Khoynezhad, MD, Cedars Sinai
Paul J. Wang, MD, Stanford
Primary Endpoints:
Effectiveness:
Freedom
from
any
documented
AF,
atrial
flutter,
or
atrial
tachycardia
lasting
>30
seconds
in
duration
through
the
12
month
follow-up
visit
in
the
absence
of
Class
I
or
III
AADs
(with
the
exception
of
previously
failed
AADs
at
doses
not
exceeding
those
previously
failed).
Safety:
Composite
endpoint
consisting
of
predefined
Adverse
Events
that
are
adjudicated
by
the
CEC
to
be
serious
adverse
events
(SAEs)
and
related
to
the
AtriCure
Bipolar
System,
the
AtriClip
Pro
LAA
Exclusion
System,
within
30
days
of
the
epicardial
surgical
ablation
procedure,
or
within
7
days
of
the
index
endocardial
procedure,
or
within
7
days
after
a
repeat
endocardial
procedure
within
the
blanking
period.
Subject Population:
Key Inclusion Criteria:
•
Patient is >18 years of age and <
75 years
of age at time of consent.
•
Patient has symptomatic (e.g. palpitations,
shortness of breath, fatigue) Persistent Atrial
Fibrillation or Longstanding Persistent Atrial
Fibrillation refractory to a minimum of one Class I
or Class III AADs.
•
Patient may have had up to two (2) previously
failed catheter ablations to treat atrial fibrillation
using catheter ablation are eligible, if they
present with symptomatic Persistent or
Longstanding Persistent AF.
Key Exclusion Criteria:
•
Patient has a documented history of AF >10
years.
•
Patient has had an EP catheter ablation
procedure to treat atrial fibrillation within 6
months prior to signing consent.