Attached files
| file | filename |
|---|---|
| 8-K - 8-K TCT DATA RELEASE - SPECTRANETICS CORP | a20168ktctdatarelease.htm |
| EX-99.2 - EXHIBIT 99.2 TCT DATA RELEASE - SPECTRANETICS CORP | lydentct2016illlumenatep.htm |
| EX-99.1 - EXHIBIT 99.1 TCT DATA RELEASE - SPECTRANETICS CORP | ex9912016tctdatarelease.htm |
1
Top-tier outcomes in the
most complex patient
population studied in DCB IDE trials
Stellarex
November 2, 2016
Exhibit 99.3
2
Safe Harbor
This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the
Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. You can identify these statements because they do
not relate strictly to historical or current facts. Such statements may include words such as “anticipate,” “will,” “estimate,” “expect,” “look
forward,” “strive,” “project,” “intend,” “should,” “plan,” “believe,” “hope,” “enable,” “potential,” and other words and terms of similar
meaning in connection with any discussion of, among other things, future operating or financial performance, strategic initiatives and business
strategies, clinical trials and regulatory approvals, regulatory or competitive environments, outcome of litigation, our intellectual property and
product development. These forward-looking statements include, but are not limited to, statements regarding our competitive position,
product development and commercialization schedule, expectation of continued growth and the reasons for that growth, growth rates,
strength, integration and product launches, and 2016 outlook and projected results including projected revenue and expenses, net loss and
gross margin. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and
results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements and to note they speak only as
of the date of this presentation. These risks and uncertainties may include financial results differing from guidance, increasing competition and
consolidation in our industry, the impact of rapid technological change, slower revenue growth and losses, inability to successfully integrate
AngioScore and Stellarex into our business and the inaccuracy of our assumptions regarding AngioScore and Stellarex, market acceptance of
our technology and products, our inability to manage growth, increased pressure on expense levels resulting from expanded sales, marketing,
product development and clinical activities, uncertain success of our strategic direction, dependence on new product development and
successful commercialization of new products, loss of key personnel, uncertain success of or delays in our clinical trials, costs of and adverse
results in any ongoing or future legal proceedings, adverse impact to our business of healthcare reform and related legislation and regulations,
including changes in reimbursements, adverse conditions in the general domestic and global economic markets and volatility and disruption of
the credit markets, our inability to protect our intellectual property and intellectual property claims of third parties, availability of inventory
and components from suppliers, adverse outcome of FDA inspections, including FDA warning letters and any remediation efforts, the receipt
of FDA clearance and other regulatory approvals to market new products or applications and the timeliness of any clearance and approvals,
product defects or recalls and product liability claims, cybersecurity breaches, ability to manufacture sufficient volumes to fulfill customer
demand, our dependence on third party vendors, suppliers, consultants and physicians, unexpected delays or costs associated with any
planned improvements to our manufacturing processes, risks associated with international operations, lack of cash necessary to satisfy our
cash obligations under our outstanding 2.625% Convertible Senior Notes due 2034 and our term loan and revolving loan facilities, our debt
adversely affecting our financial health and preventing us from fulfilling our debt service and other obligations, and share price volatility due
to the initiation or cessation of coverage, or changes in ratings, by securities analysts. For a further list and description of such risks and
uncertainties that could cause our actual results, performance or achievements to materially differ from any anticipated results, performance
or achievements, please see our previously filed SEC reports, including those risks set forth in our 2015 Annual Report on Form 10-K and our
Quarterly Report on Form 10-Q for the three months ended September 30, 2016. We disclaim any intention or obligation to update or revise
any financial or other projections or other forward-looking statements, whether because of new information, future events or otherwise.
3
No Compromise
ILLUMENATE Series
“We no longer need to compromise on safety or efficacy to
bring optimal treatment to our PAD patients.”
- Dr. Prakash Krishnan, Mount Sinai
Largest patient
population studied
in randomized,
core-lab
adjudicated
DCB trials
4
No Compromise
ILLUMENATE Series
Leading the way in clinical science to provide
Proven Treatment Algorithms
5
Patency
6
Randomized DCB Data – Comprehensive View
86.0% 87.5%
73.5%
26.5%
8.1%
17.6%
0.0%
15.0%
30.0%
0.0%
25.0%
50.0%
75.0%
100.0%
ILLUMENATE RCT IN.PACT SFA LEVANT 2
Patency Rate
Severe Ca++
“While three drug-coated balloons have been rigorously studied,
only two warrant adoption due to clinical efficacy.”
– Prof. Brodmann
ILLUMENATE
EU RCT & US Pivotal
n=422
LEVANT 2
US and OUS
N=316
In.PACT SFA
1 and 2
n=220
ILLUMENATE:
The highest proportion of severe calcification
Se
ve
re
C
al
ci
u
m
8
6
.
0
%
8
7
.
5
%
7
3
.
5
%
2
6
.
5
%
8
.
1
%
1
7
.
6
%
0.
0
%
1
5
.0
%
3
0
.0
%
0.
0
%
2
5
.0
%
5
0
.0
%
7
5
.0
%
1
0
0.0
%
IL
L
U
M
E
N
A
T
E
RC
T
I
N
.PA
C
T
S
F
A
L
E
VA
N
T
2
P
at
e
n
c
y
R
at
e
Se
v
e
re C
a
+
+
86.0% 87.5%
73.5%
27%
8%
10%
0%
15%
30%
0%
25%
50%
75%
100%
ILLUMENATE RCT IN.PACT SFA LEVANT 2
7
-5%
5%
15%
25%
35%
45%
Severe ca++ Female Diabetic Renal insufficiency
ILLUMENATE EU RCT & Pivotal IN.PACT SFA LEVANT 2
ILLUMENATE:
The Most Complex Patient Group Studied in DCB IDE Trials
-5%
5%
15%
25%
35%
45%
Severe ca++ Female Diabetic Renal insufficiency
ILLUMENATE EU RCT & Pivotal IN.PACT SFA LEVANT 2
-5%
5%
15%
25%
35%
45%
Severe ca++ Female Diabetic Renal insufficiency
ILLUMENATE EU RCT & Pivotal IN.PACT SFA LEVANT 2-5%
5%
15%
25%
35%
45%
Severe ca+ Female Diabetic Renal insufficiency
ILLUMEN TE EU RCT & Pivotal IN.PACT SFA LEVANT 2ILLUMENATE
EU RCT & US Pivotal
LEVANT 2
OUS & US
In.PACT
SFA 1 & 2
-5%
5%
15%
25%
35%
45%
Severe ca++ Female Diabetic Renal insufficiency
ILLUMENATE EU RCT & Pivotal IN.PACT SFA LEVANT 2
8
More complex patients enrolled in
ILLUMENATE Pivotal vs. EU RCT
EU RCT patients similar to IN.PACT
SFA and LEVANT 2
US Pivotal maintains top-tier patency
in challenging patients
ILLUMENATE Pivotal – Most Complex Patients
89.0%
82.3%
0%
25%
50%
75%
100%
EU RCT
N=222
US Pivotal
N=200
37%
9%
13%
50%
18%
44%
Diabetes
Renal
Insuficiency
Severe ca++
US Pivotal EU RCT
9
(1) Renal insufficiency not reported, number represents renal failure
Randomized Data - Comparable View
N (subjects/lesion) 222/254 220/221 316/316
Severe Ca++ 12.7% 8.1% 10.4%
Renal Insufficiency 9.0% 8.3% 3.5%
Diabetes 37.4% 40.5% 43.4%
Pri
m
ar
y
Pa
ten
cy
(
K
M
)
(1)
89.0% 87.5%
73.5%
0%
25%
50%
75%
100%
ILLUMENATE EU RCT
Stellarex
IN.PACT SFA
IN.PACT Admiral
LEVANT 2
Lutonix
10
Safety Evidence
11
ILLUMENATE Safety Evidence
• ILLUMENATE EU RCT: statistical superiority for safety vs. POBA
• ILLUMENATE Pivotal: statistical superiority for safety in challenging lesions
vs. POBA
Ex
ac
t
C
D
-TL
R
r
at
es
5.2%
7.9%
4.6%
12.3%
0%
5%
10%
15%
ILLUMENATE EU
RCT
Stellarex
ILLUMENATE US
Pivotal
Stellarex
IN.PACT SFA
IN.PACT Admiral
LEVANT 2
Lutonix
5.9%
7.9%
4.6%
12.3%
0%
5%
10%
15%
ILL ILL US INPACT LE
12
ILLUMENATE RCTs
No Compromise
Top-tier patency
• Most complex patients
Top-tier safety evidence
• Single-digit CD-TLR
• Statistical superiority to PTA
PMA submission on-track
Low drug dose
• 2 µg/mm2 of paclitaxel
13
Dr. Prakash Krishnan
Dr. Prakash Krishnan of Icahn School of Medicine at Mount Sinai has a dual academic
appointment as Associate Professor of Medicine - Cardiology and Radiology. He also
serves as the Director of Endovascular Interventions at The Mount Sinai Hospital's
Cardiac Catheterization Laboratory and is Co-Director of the annual Live Symposium of
Complex Coronary & Vascular Cases.
Principal Investigators
Dr. Sean Lyden
Dr. Sean Lyden is the Chairman of the Robert and Suzanne Tomsich Department of
Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular
Institute. He serves as chief medical officer of Excelerate Strategic Health Sourcing, a
venture between Cleveland Clinic and Viizient to save health care organizations
money.