Professional Documents
Culture Documents
1
Model for the Future of Healthcare
CHRONIC SINUSITIS
PARTNER OF CHOICE
for ENTs
2
Innovative Solutions, Clinically Proven
~ 100 Patents
Surgery and 14 Prospective PMA / NDA
and Pending
Office Clinical Studies Pathway
Applications
SINUVA is investigational and not currently available for sale in the United States.
The implants are limited by federal (or United States) law to investigational use only. 3
Highlights
EXPANDING PORTFOLIO
Multiple Products $17.9
Multiple Indications $5.9
Multiple Settings of Care
2012 2013 2014 2015 2016
4
Chronic Sinusitis: Significant Unmet Need
1 in 8 Adults
25 work days lost per year
500,000+ Surgeries / Year
Frontal Maxillary
Frontal
Ethmoid
Ethmoid
Ethmoid
SINUVA is investigational and not currently available for sale in the United States.
The implants are limited by federal (or United States) law to investigational use only. 6
And Across the CS Continuum of Care
Early Stage Severe/Polyps: Continuing
Disease: Office Surgery Disease: Office
PROPEL, PROPEL Mini
and PROPEL Contour
PROPEL Contour SINUVA
$
$800,000 patients, 540,000 patients, $635,000 patients,
$1.1B TAM $0.8B TAM $1.3B TAM
* Company estimates. Sinus Surgery refers to ESS, or 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.
The implants are limited by federal (or United States) law to investigational use only. 7
Commitment to Evidence-Based Innovation
ETHMOID SINUS
9
PROPEL and PROPEL mini
Clinically Proven Outcomes
Meta-analysis: Han JK, Marple BF, Smith TL et al. Int Forum Allergy Rhinol, Vol. 2, No. 4, July/August 2012 10
PROPEL mini
Clinically Proven Outcomes
Smith TL, Singh A, Luong A, et al. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. The Laryngoscope. Jul 1 2016. 11
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
12
PROPEL Contour
Clinically Proven Outcomes
OVERVIEW
Designed for Patients Who Have Had Prior Surgery
Dilates Obstructed Cavity
Delivers~4x Steroid (vs. PROPEL) Over 90 Days
Regulatory Path: NDA ETHMOID SINUS
SINUVA is investigational and not currently available for sale in the United States.
The implants are limited by federal (or United States) law to investigational use only. 14
SINUVA
Clinically Proven Outcomes
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 expected to
save the plan money via reduced
Revision
HC utilization, despite the upfront
Surgery
device cost
DRIVERS OF
TODAY
GROWTH
1 in 3 ENTs
Ongoing salesforce expansion
>40% of Accounts > 100 sales representatives
TMs and Sales Consultants
18
Evolving Business and Reimbursement Landscape
ASC
Temporary Codes in Place
Securing Permanent Codes
Office
Current Post SINUVA Launch
19
Emerging Opportunity Outside the US
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Exciting Outlook: Next Three Years
2019
2018 Diversified Across
Care Settings
SINUVA
2017 Launch
Established Office
Reimbursement
PROPEL Expand Focus to Continuing
Contour Launch Include Office Financial Leverage
Setting of Care
SINUVA NDA
Submission
Clinical
Publications
SINUVA is investigational and not currently available for sale in the United States.
The implants are limited by federal (or United States) law to investigational use only. 21
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