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LEADERS IN MED-TECH COMMERCIALIZATION FOUNDED 2008 THAT STRATEGICALLY PRODUCING RESULTS IMPACT GROWTH

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Page 1: STRATEGICALLY PRODUCING RESULTS THAT IMPACT GROW THsprigconsulting.com/wp-content/uploads/2016/04/SPRIG_B... · 2018-09-17 · Project Management LAUNCH PLANNING Commercialization

LEADERS IN MED-TECH COMMERCIALIZATIONFOUNDED 2008

THAT

STRATEGICALLY P R O D U C I N G R E S U L T S

I M P A C T G R O W T H

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BUSINESS DEVELOPMENTMarket Research & ModelsBusiness PlansInvestor Materials

CUSTOMER REQUIREMENTSPrimary Market ResearchUser Needs AssessmentKOL Identification & Outreach

CLINICAL DEVELOPMENTClinical StrategyClinical Study Design & SetupReview of Clinical Documents

REIMBURSEMENT STRATEGIESMarket Access LandscapeStakeholder ResearchOptimization of Market Access Strategy

BRANDINGMessaging & PositioningBrand Identity & Guidelines

NAMINGCompany, Product & TechnologyLogo Development

CLINICAL MARKETINGPatient Recruitment MaterialsSAB Management

PUBLICATIONSWhite PapersCase ReviewsPosters & PresentationsClinical Manuscripts

WEBSITESCreative ConceptsCopy DevelopmentProject Management

LAUNCH PLANNINGCommercialization Plans Cross-functional Management

MARKETING COLLATERALBrochures Animation, Video & IllustrationsInfographicsSales Sheets

TRAININGSales, Distributor & Physician

EVENTSBooth Design & GraphicsEvent PlanningConference Management

COMMUNICATIONSAdvertisingPress Releases

GROWTHE COMPANY

MARKETTHE PRODUCT

NURTURETHE CONCEPT

Develop marketing strategies to build a

strong foundation for the company and product

Prepare the company for commercialization

Educate the market and build awareness

to impact growth

S P R I G | 1

OUR SERVICESFrom upstream strategy to downstream commercial execution, we work with clients on all

aspects of the marketing spectrum.

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MARKETING • BUSINESS DEVELOPMENT • ENGINEERING • SALES • CLINICAL

S P R I G | 2

OUR LOCATIONSStrategically located in med-tech hubs across the world, we have the functional

expertise and industry knowledge to help you grow your business.

OUR TEAMSPRIG delivers a team, not just a PowerPoint deck. We have extensive

healthcare industry experience that leverages functional backgrounds in:

California:

Bay Area

Orange County

Minneapolis

Chicago

Boston

Israel

Vancouver

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General Surgery

Electrophysiology

Interventional Pulmonology

Vascular/ Hemodialysis Access

Robotics

Hernia Repair

Renal Failure

Diabetes

Endovascular: Arterial & Venous

Aesthetics

Cardiac Surgery

Remote Patient Monitoring

Prenatal Diagnostics

Women’s Health

Heart Failure

Interventional Radiology

Ophthalmology

Neuromodulation

Digital Health

Structural Heart

Molecular Diagnostics

Renal Denervation

Reprocessing

Orthopedics

Minimally Invasive Surgery

Interventional Cardiology

S P R I G | 3

OUR EXPERTISESPRIG has experience across a broad range of therapeutic categories. Our industry

knowledge ensures a quick ramp-up and allows us to add immediate value.

Page 5: STRATEGICALLY PRODUCING RESULTS THAT IMPACT GROW THsprigconsulting.com/wp-content/uploads/2016/04/SPRIG_B... · 2018-09-17 · Project Management LAUNCH PLANNING Commercialization

ACCESS CLOSURE * • ANALY T ICS 4 L I F E • APAMA MED ICAL • ATHEROMED*

AUTONOMIC TECHNOLOGIES, INC. • BIOSENSORS • BLUEGRASS VASCULAR • CARDIOKINETIXCLEARSIDE BIOMEDICAL • CORINDUS • CORVIA MEDICAL • COVIDIEN* • DATUM DENTAL EBR SYSTEMS • EDWARDS LIFESCIENCES • ELIXIR • ENDOTRONIX • EPIEP FRACTYL LABORATORIES • HEARTFLOW • HOTSPUR* • ICS • INFOBIONIC • INSIGHTRA MEDICAL KALILA MEDICAL* • LAMINATE MEDICAL • MAYA MEDICAL* • MEDTRONIC • NANOSPHERE NEURAVI • NEXSTIM • OMADA HEALTH • OR SAFETY • PELVALON • PULMONX • RAD BIOMEDRDD PHARMA • RESPICARDIA • SAPHEON* • SHIFAMED • S IGHT SCIENCESSPECTRANETICS • STERILMED • TRYTON MEDICAL • TYTOCARE • VOLCANO*

*Acquired

OUR CLIENTSSPRIG is proud to have strong on-going relationships with clients in

the US, Europe, Israel, and Asia. Below is a partial list of our clients.

S P R I G | 4

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SPRIG was a huge part of our success that

led to our recent acquisition.”

Gary McCord

Former VP New Business Development, Sapheon*

In our business, speed to market is everything.

In selecting SPRIG, we found a partner that

can meet our marketing needs in a manner

consistent with which we operate.”

Amr Salahieh

President & CEO, Shifamed LLC

We retained SPRIG early in our company’s

development, during our first clinical studies

when we were engaging new partners

and preparing for commercialization.

SPRIG’s ability to translate complex clinical

information into impactful and appropriate

messaging across a variety of marketing

materials was essential to our early success.”

Aaron Kaplan, MD

Founder, Tryton Medical

I have many urgent needs... I essentially need

an outsourced marketing department, or parts

of one, that allows me to receive ‘on-demand’

marketing expertise when and where I need it.”

Jim Clifton

COO, Bluegrass Vascular Technologies *Acquired by Covidien in August 2014

S P R I G | 5

IN THEIR OWN WORDS Quotes from Our Clients

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Improving Heart Health

NURTURE THE CONCEPT• BR ANDING •

A brand defines who you are and

builds your value proposition.

What is YOUR story? At SPRIG,

we believe a thoughtfully chosen

name and logo design improve

the brand experience and

enhance your key messages.

S P R I G | 6

Page 8: STRATEGICALLY PRODUCING RESULTS THAT IMPACT GROW THsprigconsulting.com/wp-content/uploads/2016/04/SPRIG_B... · 2018-09-17 · Project Management LAUNCH PLANNING Commercialization

IMPROVE THE LIVES OF YOUR SEVERE EMPHYSEMA PATIENTS

We IDENTIFIED patient’s needs.

We CHALLENGED the status quo.

We REDEFINED the treatment

of lung disease.

We INVITE you to advance the care

of your patients, using a minimally

invasive device that has been

used in over 10,000 patients and

is currently in use in Europe, Asia,

Australia, and South America.

Pulmonx_Liberate-Phy_Brochure-PRESS.indd 8-9 4/24/15 10:42 AM

INITIAL ELIGIBILITY SCREENINGSigned Informed ConsentPhysical Examination & Medical HistoryLung Function Testing:

• Spirometry• Body Plethysmography• DLCO

High Resolution CT (HRCT) Assessment Electrocardiogram (ECG)Echocardiogram6-minute walk distance (6MWD)Blood Work:

• ABGs• CBCs• Alpha-1 antitrypsin• Plasma cotinine• Serum fibrinogen

BASELINE ELIGIBILITY SCREENINGPulmonary Rehabilitation Eligibility Criterion CompletedSpirometry6MWDQOL Questionnaires

STUDY PROCEDURE ELIGIBILITY SCREENINGBronchoscopy procedure to assess collateral ventilation using the Chartis System

IF ASSIGNED TO STUDY TREATMENT EBV5 night hospital stay, discharge on Day 6X-ray seriesHRCT AssessmentPulmonary RehabilitationClinic Visits:

• 7 days post discharge• 30 and 45 days• 3, 6, and 9 months• 1 year• Annually at 2, 3, 4, and 5 years

IF ASSIGNED TO CONTROL ARMPulmonary RehabilitationClinic Visits:

• 45 days• 3, 6, and 9 months• 1 year

After successful completion of the 1-year visit, control arm patients may be eligible for crossover to the study treatment (EBV).

Zephyr® Endobronchial Valve Study Plan & Assessments

Place Study Site Contact Information Here

CAUTION: The Zephyr® Endobronchial Valve is an investigational device in the US, limited by US law to investigational use. Inclusion/Exclusion criteria listed above are not all inclusive – please reference study protocol.

CL069_23FEB2015

Pulmonx Corporation700 Chesapeake DriveRedwood City, CA 94063 USATel: +1 (650) [email protected]

Clinicaltrials.gov NCT01796392

JOIN US IN CREATING NEW HOPE

Pulmonx_Liberate-Phy_Brochure-PRESS.indd 2-3 4/24/15 10:42 AM

CAUTION: The Zephyr Endobronchial Valve is an investigational device in the US, limited by US law to investigational use.

Pulmonx Corporation700 Chesapeake Drive, Redwood City, CA 94063 USATel: +1 (650) 364-0400

www.pulmonx.com

CL079_13APR2015

...a Patient Selection Tool for Personalized Treatment

Over 65% of severe emphysema patients have one or more target lobes with low collateral ventilation

10,000+ Patients Treated with Zephyr® Endobronchial Valves

Chartis® Pulmonary Assessment System

...Clinical Data Demonstrating SustainedBenefitsto5Years

Source: Hübner 2014 Source: Venuta 2012

250

300

350

400

450

Baseline

Year

1

Year

3

Year

5

6 MWT (m)

0.8

1

1.2

1.4

Baseline

Year

1

Year

3

Year

5

FEV 1 (L)

Pulmonx Offers the Only Lung Volume Reduction Therapy with...

RCT SUMMARY Design Follow-up Period

FEV1%Improvement

6 MWTImprovement

SGRQImprovement

STELVIOn = 68

1:1 RCT Valves vs. SOC

Heterogeneous & Homogeneous

6 months 22.7%* 106m* -15 pts*

BeLieVeR-HIFin = 50

1:1 RCT Valves vs. Sham Heterogeneous

3 months 20.9%* 33m -5 pts

VENT (US + OUS)

n = 492 (122 in subset)2:1 RCT

Valves vs. SOC Heterogeneous & Homogeneous

6 months 24.7%* 28m* -8.4 pts*

In all three RCTs, patient outcomes exceeded the MCID in measures of lung function, exercise capacity and quality of life.

*Statistically significant difference from controlSources: STELVIO (ATS 2015), BeLieVer-HIFi (ERS 2014), Sciurba 2010/Herth 2012, Pulmonx data on file.

900+Patients in

Clinical Trials

NEW

NEW

Pulmonx_Transform-Trial_Poster-PRESS_OTL.indd 1 6/5/15 4:44 PM

Physician Brochure

Clinical Study Sheet

Website

Trial Poster

S P R I G | 7

GROW THE COMPANY• CLINICAL MARKETING •

Clinical evidence solidifies your

position in the market. Expedite

patient enrollment. SPRIG can

help drive study enrollment with

engaging materials for patients

and physicians that incorporate

your brand and messaging.

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Elixir Medical | elixirmedical.comEBR Systems | ebrsystemsinc.com

HeartFlow | heartflow.com

Fractyl | fractyl.com

Shifamed | shifamed.comPulmonx | pulmonx.com

Corvia Medical | corviamedical.com

S P R I G | 8

GROW THE COMPANY• WEBSITE DEVELOPMENT •

A website is your company’s

first impression in the market.

Make yours impactful.

SPRIG has a long track record

of transitioning corporate

identities into websites that

become effective resources.

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UNIQUE Drug Agent

ClINICal Performance Sets New Standards

Advanced Drug/Polymer Coating Technology Thin polymer and drug matrix coating without the need for a primer coating

Superior DES clinical performance with excellent safety profile1

Lowest Polymer Coating Load2

Reduced risk of adverse clinical events 1

Improved polymer biocompatibility3

Low Drug Dose Sustainable performance with lower drug dose

EXCELLA II RCT (n = 210)

Proprietary Novolimus Drug Elution Established safety and performance• Clinically proven ‘olimus’ drug family• Active metabolite of Sirolimus

Proprietary drug facilitates superior clinical efficacy1

• Potent anti-proliferative agent with known safety profile

Significant reduction in late lumen loss, p = 0.001 Lowest published late lumen loss 4

Low neointimal volume obstruction

Significant reduction in CI-TLR at 2 years, p<0.05

Sustained clinical performance over time

Optimal neointimal coverage with low neointimal volume obstruction

MACE defined as target lesion revascularization, cardiac death and myocardial infarction

1 » Serruys, P.W. et. al, EuroIntervention 2010.

2 » As compared to manufacturer reported thickness for Xience V® and Resolute®. Data on file at Elixir Medical.

3 » Data on file at Elixir Medical.

4 » As compared to manufacturer reported late lumen loss at follow up from similar trials. Data on file at Elixir Medical.

5 » SIRIUS: Weisz, G. et. al., JACC 2006 ; RESOLUTE: Serruys, P.W., EuroPCR 2009 ; SPIRIT III: Stone, G. W., Circulation 2009.

ENDEAVOR® and RESOLUTE® are registered trademark of Medtronic, XIENCE V® is registered trademark of Abbott Vascular, CYPHER® is registered trademark of Cordis Corporation.

0 .6

20.0%

60.0%

0.7

12.0%

12.0%

8.0%

8.0%

4.0%

4.0%

10.0%

10.0%

6.0%

6.0%

2.0%

2.0%

25.0%

70.0%

0.114.5%

27.3%

4.9%

4.3%

0.63

20.9%

9.9%

0.5

15.0%

50.0%

0.4

5.0%

40.0%

0.3

30.0%

0 .2

20.0%

0 .1

10.0%

0

0

0

0

0

(mm

)%

%

%

%

ENDEAVOR® ENDEAVOR®

ENDEAVOR®

ENDEAVOR®

RESOLUTE® (RESOLUTE)

XIENCE V® (SPIRIT III)

CYPHER®

(SIRIUS)

late lumen loss at 9 Months Neointimal Volume Obstruction by IVUS at 9 Months

MaCE at Year 1 and Year 2 Clinical Follow-up

Neointima-free Frame Ratio (% cross-sections without neointima coverage)

Major adverse Cardiac Events (MaCE) at 2 Years Clinical Follow-up

82% reduction

56% reduction

Similar Trial results at 8-9 months5

Similar Trial results at 2 years5

78% reduction

0.17

10.3%

0.22

7.9% 7.7%

0.16XIENCE V®

7.8 µm

RESOLUTE® 5.6 µm

3 µm

Cobalt Chromium Platform Lowest profile stent design2 with ultra-thin struts (81 microns) for high flexibility and deliverability Substantial vessel wall coverage for uniform drug delivery and open cell design for ease of side branch access 4.3%

7.0%

9.9%

4.3% 5.6%

7.0%

Coating Technology

1.4% CI -TLR

Year 1 Year 2 Year 1 Year 2

1.4%

ENDEAVOR® RESOLUTE® (RESOLUTE)

XIENCE V® (SPIRIT III)

CYPHER®

(SIRIUS)

The Path to

NExT GENERaTION

DRUG ElUTING STENT

TEChNOlOGY…

Introducing the Novolimus —

eluting DESyne™ stent —

the next generation drug

eluting stent with improved

performance and superior

clinical efficacy and safety1.

Engineered on a clinically —

proven cobalt chromium

platform, the novel design

and Formula X™ drug/

polymer coating technology

allows for thin struts, lowest

polymer load2, and lowest drug

concentration2 of any DES on

the market today.

DESyne™ maximizes

deliverability and is able to

deliver superior performance

with the lowest published

late lumen loss4.

Engineered to maximize

DELIvERAbILITy &

CLINICAL PERFORMANCE

L e a d i n g t h e W a y t o n e x t g e n e r a t i o n d e S P L a t F o r M S INNOVATING VASCULAR RESTORATION™

Novolimus ElutiNg CoroNary stENt systEm

INNOVATION fOr LIfe®

NOVOLIMUS ELUTING BIORESORBABLE CORONARY SCAFFOLD SYSTEM

introducing the DESolve Scaffold Platform

Innovating Vascular Restoration

E L I X I R M E D I C A L . C O M

Thursday 23rd May, 2013 12:00-13:30 Room 241

Chairpersons:

Faculty:

MARTIN B. LEON, MDALEXANDRE ABIZAID, MD, PHD

John Ormiston, MDStefan Verheye, MD, PHDBernhard Witzenbichler, MD

Elixir, Innovation for Life, DESyne and DESolve are registered trademarks of Elixir Medical Corporation. DESyne, DESyne BD, and DESolve CE mark approved,

international use only. MN 171 Rev A

Visit us at booth #F5 to Learn more about our complete product portfolio including the DESyne® Novolimus Eluting Coronary Stent System and DESyne®BD Novolimus Eluting Coronary Stent System

Product Brochure

Ad Campaign Product Packaging

S P R I G | 9

MARKET THE PRODUCT• COMMERCIALIZATION •

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CorPath_ReferralBrochure-PRESS_2014Mar24.indd 4-5 3/24/14 1:29 PM

Booth Graphics

Product Brochure

Ad Campaign Sales SheetInfographic

S P R I G | 1 0

MARKET THE PRODUCT• COMMERCIALIZATION •

Page 12: STRATEGICALLY PRODUCING RESULTS THAT IMPACT GROW THsprigconsulting.com/wp-content/uploads/2016/04/SPRIG_B... · 2018-09-17 · Project Management LAUNCH PLANNING Commercialization

Needs for Advancement in Stroke Care

Lessons from Recent Trials

About Us

Outcomes Driven Innovation

ML010 Rev01

ClinicalSolution Action Video 1 2 3 4 5 6 7 8 9

Trap the Clot Inside

•  Clot gripped inside

•  Minimal compression

•  Articulated design for retention

1

ML010 Rev01

1 2 3About Us Trials Needs

Compelling Positive Trials

6

"The data are consistent and convincing. We are now obligated to use this technology in eligible stroke patients with a large vessel occlusion.”

Dr. Kyra Becker, MDISC Program Chair

“This is the most significant and fundamental change in acute ischemic stroke treatment in the last 20 years. These results will impactstroke care around the world.”

Dr. Michael Hill ESCAPE Study Co-PI

"This is a once-in-a-generation advance in stroke care.”

Dr. Jeffrey Saver SWIFT PRIME PI

“Taken together, these studies willrevolutionize the way we treat ischemic stroke caused by a blockage of one of the major cerebral arteries.”

Dr. Bruce Campbell EXTEND-IA PI

1

Results presented at ISC 2015as reported by Medscape

ML010 Rev01

CardioKinetix | Product Brochure

Sapheon | Patient BrochureNeuravi | Interactive PowerPoint Presentation

Marketing and sales collateral can be

an effective tool to build awareness

and communicate the value of your

technology. Our goal is to inspire action.

With our trusted design partners, SPRIG

has created compelling materials to convey

clients’ most important messages.

UNDERSTAND

Varicose veins may be a sign of something more

severe — venous reflux disease. Your doctor can help

you understand if you have this condition.

Healthy leg veins have valves that keep blood flowing

to the heart. Venous reflux disease develops when the

valves stop working properly and allow blood to flow

backward (i.e., reflux) and pool in the lower leg veins.

If venous reflux disease is left untreated, symptoms

can worsen over time.

1 Criqui, M. H., Denenberg, J. O., Langer, R. D., Kaplan, R. M., & Fronek, A. (2013). Epidemiology of Chronic Peripheral Venous Disease. In J. J. Bergan & N. Bunke-Paquette (Eds.), The Vein Book (pp. 27-36). New York, NY: Oxford University Press.

Superficial venous reflux disease may cause the following

symptoms in your legs:1

Varicose veins

Aching

Swelling

Cramping

Heaviness or tiredness

Itching

Open skin sores

Restlessness

DISEASED VEIN Valves that cannot

close allow blood to drain and pool

NORMAL VEINValves ensure

blood flows in one direction

SUPERFICIAL VENOUS ANATOMY

COMMON FEMORAL VEIN

SMALL SAPHENOUS VEIN

GREAT SAPHENOUS VEIN

ANTERIOR ACCESSORY

GREAT SAPHENOUS VEIN

BACK FRONT

livewith relief from varicose veins

Covidien llc

951 Aviation Parkway, Suite 900 | Morrisville, NC 27560 | United States

www.covidien.com

Talk to your doctor to learn if VenaSeal™ is right for you.

MKT-11716-01 Rev A

VenaSeal is a trademark of a Covidien company. © 2015 Covidien llc

Caution: Federal law restricts this device to sale by or on the order of a physician. Please reference the Instructions For Use (IFU) for a complete listing of indications,

contraindications, warnings and precautions, adverse effects and suggested procedure. An electronic IFU can be accessed at www.useifu.venaseal.com.

Dedicated to Advancing

Neurointerventional

Therapies for Stroke

ML010 Rev01

S P R I G | 1 1

MARKET THE PRODUCT• MARKETING AND SALES COLLATERAL •

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Vascular Interventional AdvancesInternational Symposium on

Endovascular Therapy

Innovations in Cardiac Interventions

Israel Advanced Technology Industries

S P R I G | 1 2

MEET WITH US SPRIG regularly attends the following conferences:

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Your elite med-tech

marketing team.

[email protected]

PROUD SPONSOR OF THE MEDTECHVIS ION CONFERENCE