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Chronic Sinusitis Innovations

This document discusses delivering innovation for chronic sinusitis. It summarizes an investigational drug-releasing sinus implant called SINUVA, and the PROPEL family of sinus implants including PROPEL and PROPEL mini which are clinically proven to improve surgical outcomes, and PROPEL Contour which expands the addressable markets. It notes the large patient population and market opportunity for chronic sinusitis treatments.

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0% found this document useful (0 votes)
5K views22 pages

Chronic Sinusitis Innovations

This document discusses delivering innovation for chronic sinusitis. It summarizes an investigational drug-releasing sinus implant called SINUVA, and the PROPEL family of sinus implants including PROPEL and PROPEL mini which are clinically proven to improve surgical outcomes, and PROPEL Contour which expands the addressable markets. It notes the large patient population and market opportunity for chronic sinusitis treatments.

Uploaded by

medtechy
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Delivering Innovation.

Where Its Needed.


November 2017
Forward-Looking Statements
Certain statements in this presentation constitute forward-looking statements within
the meaning of the Securities Act of 1933, as amended (the Securities Act), and
Securities Exchange Act of 1934, as amended (Exchange Act), including, without
limitation, statements regarding our outlook for financial performance, sales force growth,
clinical studies, approval of new products and indications and the receipt of reimbursement
coverage. We intend these forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in the Securities Act and the Exchange
Act and are making this statement for purposes of complying with those safe harbor
provisions. These forward-looking statements reflect our current views about our plans,
intentions, expectations, strategies and prospects, which are based on the information
currently available to us and on assumptions we have made. Although we believe that our
plans, intentions, expectations, strategies and prospects as reflected in or suggested by those
forward-looking statements are reasonable, we can give no assurance that the plans,
intentions, expectations or strategies will be attained or achieved. Furthermore, actual results
may differ materially from those described in the forward-looking statements and will
be affected by a variety of risks and factors that are beyond our control, including those risks
and uncertainties discussed under Risk Factors in our 10-K filing dated February 28, 2017
and subsequent quarterly filings with the SEC. All information in this presentation is as of the
date of this presentation, and we undertake no duty to update this information unless required
by law.

1
Chronic Sinusitis: Significant Unmet Need

DEBILITATING INFLAMMATORY CONDITION

1 in 8 Adults
25 work days lost per year

500,000+ Surgeries / Year

Top 10 Most Common Reason for


Most Costly Condition Adult Antibiotic Rx
for US Employers
2
Innovative Solutions, Based on Clinical Evidence

1ST DRUG RELEASING IMPLANTS FOR CHRONIC SINUSITIS*


Local Delivery, Mechanical Spacing, Bioabsorbable

FAMILY

Improving Surgical Outcomes Reducing Surgical Need


and Treating Polyps*

*Based on proposed indication for use for SINUVA


SINUVA is investigational and not currently available for sale in the United States .

3
Playing a Meaningful Role in CS Patient Journey
ENT Visit

Medical Management
Nasal Intranasal
Antibiotics
Rinses Steroids

Nasal Endoscopy / CT Scan

Balloon FESS
FAMILY

Post-Surgical
Management

Propel Family Has Treated Over 200,000 Patients to Date


4
SINUVA is investigational and not currently available for sale in the United States
Large Patient Population and Market

FAMILY

Early Stage Disease Advanced Disease Continuing Disease


(Office) (Surgery) (Office)

PATIENTS 800,000 540,000 635,000

TAM $1.1B $0.8B $1.3B

~2M Patients, $3B TAM

Company estimates; estimates for SINUVA based on proposed indication.


Sinus Surgery refers to FESS, or functional endoscopic sinus surgery, and sinus
opening refers to opening of the frontal or maxillary sinuses
SINUVA is investigational and not currently available for sale in the United States. 5
Expanding Portfolio Across
CS Indications and Care Settings
HOSPITAL / ASC OFFICE *

Frontal

Ethmoid

Maxillary

* Based on Proposed Indication For Use.


SINUVA is investigational and not currently available for sale in the United States. 6
Commitment to Evidence-Based Innovation
FAMILY

Pilot (PROPEL) 43 Patients 4 Sites EXCEED (Contour) 15 Patients 2 Sites


RESOLVE pk 5 Patients 1 Site
ADVANCE 50 Patients 7 Sites RESOLVE pilot 12 Patients 4 Sites

ADVANCE II 105 Patients 11 Sites RESOLVE 100 Patients 18 Sites

RESOLVE II 300 Patients 40 Sites


PROGRESS (mini) 80 Patients 11 Sites
3 PROPEL In-Office Studies 80 Patients 2 Sites
PROGRESS (Contour) 80 Patients 12 Sites ENCORE 50 Patients 12 Sites

14 Prospective 40 > 900


Clinical Studies Centers in US Patients

SINUVA is investigational and not currently available for sale in the United States. 7
FAMILY
Improving Surgical Outcomes

8
PROPEL and PROPEL mini
Surgical Products to Improve Outcomes

ETHMOID SINUS

OPENS DELIVERS MAINTAINS


Advanced into Self-Expanding Implant Sustained, Targeted Opening by Reducing
Surgically Enlarged Conforms to and Delivery of Steroid Post-Operative
Sinus Cavity Holds Open Sinus Over 30 Days Inflammation and Scarring

9
PROPEL and PROPEL mini
Clinically Proven Outcomes

Approved for Placement in Ethmoid Sinus


Only Devices Used in Sinus Surgery Backed by
Level 1a Evidence

ETHMOID SINUS 35% Reduction in Post-Operative Intervention

META-ANALYSIS 200+ Patient Prospective, Randomized, Blinded, Multi-Center Trials


POST-OPERATIVE INFLAMMATION NEED FOR SCARRING
INTERVENTION (POLYPOSIS) ORAL STEROIDS (ADHESIONS)

35% 46% 40% 70%


p=0.0008 p<0.0001 p=0.0023 p=0.0013

Meta-analysis: Han JK, Marple BF, Smith TL et al. Int Forum Allergy Rhinol, Vol. 2, No. 4, July/August 2012 10
PROPEL Contour
Expanding Addressable Markets

OVERVIEW
Designed for Patients in Surgical or Office Setting
of Care
Enhances Physician Choice: Smaller Size, Unique
Hourglass Shape, Flexible Applicator
FRONTAL AND
MAXILLARY SINUSES

FRONTAL PLACEMENT FLEXIBLE APPLICATOR

11
PROPEL Contour
Clinically Proven Outcomes

FDA Approved Feb 2017:


Frontal and Maxillary Sinuses
Designed for Use in OR or Office
FRONTAL AND Setting of Care
MAXILLARY SINUSES

CONTOUR STUDY 80 Patient Prospective, Randomized, Blinded, Multi-Center Trial


POST-OPERATIVE ORAL STEROID OCCLUSION/ SURGICAL
INTERVENTION I NTERVENTION* RESTENOSIS* I NTERVENTION*

65% 35% 63% 73%


p=0.0023 p=0.1094 P<0.0001 p=0.0078

Data on file at Company. 12


PROPEL Family
Continuing Commercial Traction

TODAY GROWTH DRIVERS

1 in 3 ENTs
> 40% of Accounts Ongoing Salesforce Expansion
> 100 Sales Representatives
TMs and Sales Consultants

PROPEL Contour Launch

1 in 9 Sinus Surgeries Market Development Initiatives

13
PROPEL Family
Product Cost Offset by Clinical and Economic Value

Drugs
COST EFFECTIVENESS STUDY
Repair of Placement of PROPEL following FESS
Turbinate is a cost-effective intervention
Lateralization for preventing a postoperative
intervention within 60 days
Surgical PROPEL after surgery.
Adhesion Lysis

BUDGET IMPACT MODEL


Polypectomy
Use of PROPEL is
Revision expected to save the plan money
Surgery via reduced HC utilization,
despite the upfront device cost

Focus on Higher Quality of Care with Lower Overall Cost


1Rudmik L and Smith TL. Economic Evaluation of a Steroid-Eluting Sinus Implant follow ing Endoscopic Sinus Surgery for Chronic Rhinosinusitis.
Otolaryngol Head Neck Surg. 2014 May 5;151(2):359-366.
2Rudmik L, Mallow P, Sw etha, P and Rizzo, J. Budget Impact Analysis of Bioabsorbable Drug Eluting Sinus Implants for Endoscopic Sinus Surgery;

International Society of Pharmocoeconomics Outcomes and Research, 2015. 14


14
PROPEL Family
Attractive Reimbursement Profile

VIA EXISTING FACILITY FEE

Cost of PROPEL
Primarily Private Payors
Included in Facility Payment
(10% Medicare)
Rate for Procedure

15
PDUFA Target Action Date: January 7, 2018

SINUVA name tentatively approved by FDA subject to NDA approval


SINUVA is investigational and not currently available for sale in the United
States. 16
SINUVA
Designed for Office Treatment for Recurrent CRS/Polyps

OVERVIEW
Designed for Patients Who Have Had Prior Surgery
Designed to Dilate Obstructed Cavity
Designed to Deliver~4x Steroid (vs. PROPEL) Over
90 Days
ETHMOID SINUS
Regulatory Path: NDA

Ethmoid Sinus Immediately 6 Weeks


Pre-implant Post-implant Post-implant**

* Proposed indication for use.


SINUVA is investigational and not currently available for sale in the United States. 17
SINUVA
Clinical Studies

NDA Submitted March 2017


4 Studies Conducted in over 400 patients
Anticipate FDA Approval Q118
ETHMOID SINUS

RESOLVE II Study 300 Patient Prospective, Randomized, Blinded, Multi-Center Trial


Improvement in Nasal Obstruction/Congestion (p=0.0074)
CO-PRIMARY and
Reduction in Bilateral Polyp Grade (p=0.0073)
KEY SECONDARY
Reduction in Need for Repeat FESS, Reduction in Ethmoid
ENDPOINTS MET Obstruction, Improvement in Sense of Smell

REDUCTION IN NEED
60% Reduction at Day 90
FOR SURGERY

Data on file at Company.


SINUVA is investigational and not currently available for sale in the United States. 18
SINUVA
Studied for Reduction in Polyps and Sinus Obstruction

ENDOSCOPIC OUTCOMES

BILATERAL POLYP GRADE ETHMOID SINUS OBSTRUCTION


Day 14 Day 30 Day 60 Day 90 Day 14 Day 30 Day 60 Day 90
0 0
0%

-5
-5%
Change from Baseline

-0.5
-10
-10%

-1 -15
-15%

-20
-20%
-1.5
* * * -25%
-25

* *
-2 -30%
-30
* * *
Treatment Control

* p-value < 0.0001


Data on file at company.
SINUVA is investigational and not currently available for sale in the United States. 19
Emerging Opportunity Outside the US

~250K FESS / Year


~450K FESS / Year
~540K FESS / Year

ATTRACTIVE MARKET OPPORTUNITIES DEVELOPING MARKET


Initial Targets Germany and Japan COMMERCIALIZATION PLANS
PROPEL Has CE Mark Approval Regulatory Pathways
KOL Support
Reimbursement Activities
Market Entry Strategy

20
NASDAQ: XENT

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