The document discusses the introduction and clinical evidence for the UroLift system, a minimally invasive treatment for benign prostatic hyperplasia (BPH). It summarizes the clinical trials demonstrating UroLift's rapid and durable relief of BPH symptoms with minimal side effects. It also outlines UroLift's journey to approval and reimbursement in the UK, including a positive NICE recommendation and being granted an Innovation Technology Tariff to facilitate adoption in the NHS. UroLift is positioned as a cost-effective alternative to traditional BPH surgeries that allows for quicker recovery and preservation of sexual function.

1. Measuring the true pathway of
innovation into the NHS
UroLift® – A Case Study
Justin Hall, Vice President & General
Manager EMEA, NeoTract Inc.

2. Mission:
Identify Clinical Needs
Develop Paradigm Shifts
Invent or License
Prove Feasibility
Launch Medtech Companies
Innovation driven by clinical need
Improve Quality of Care
NeoTract, Inc. initiated within
ExploraMed, a Medical Device
Incubator

3. ExploraMed – results
• 1995 Founded
• 1996 EndoMatrix,Inc.
• Tissue bulking device for incontinence.
• Acquired by C.R. Bard in 1997
• 1996 TransVascular,Inc.
• Percutaneous bypass, stem cell therapy
• Acquired by Medtronic in 2003
• 2004 Acclarent,Inc.
• ENT “Balloon Sinuplasty”
• Acquired by J&J in 2010
• 2005 NeoTract,Inc.
• UroLift BPH implant
• 2006 Vibrynt,Inc.
• Implant for morbid obesity
• 2007 Moximed,Inc.
• KineSpring for knee osteoarthritis
• 2014 Nuelle launched
• Female sexual health
• 2015 NC7 launched

4. NeoTract at a Glance
• Developer of the UroLift® system, a minimally invasive
treatment for Benign Prostatic Hyperplasia (BPH)
• Founded in 2004
• All Manufacturing in Pleasanton: Certified Class 8/100,000 CER
• UroLift approved in USA, Canada, Europe, S Korea,
Singapore, Mexico and Australia
• 15000+ patients treated with UroLift worldwide to
date
150 Employees, Headquartered in Pleasanton, CA

5. Anatomy of BPH secondary to LUTS?
Normal BPH
Hypertrophied
detrusor muscle
Obstructed urinary
flow
PROSTATE
BLADDER
URETHRA
Roehrborn CG, McConnell JD. In: Walsh PC et al, eds. Campbell’s Urology. 8th ed. Philadelphia, Pa: Saunders; 2002:1297-1336.

6. Recognizing the Symptoms of BPH-
A couples disease!
• Frequent urination
• Multiple trips to the bathroom at night
• Sudden urge to urinate
• Difficult or painful urination
• Weak or slow urine flow
• Incomplete elimination of urine
• Stopping and starting of flow
Abrams, et al., Neurourology and Urodynamics 2002; Maximilian, et al., BJU Intl 2012
SO WHAT?

7. The burden of BPH In Europe

8. BPH: It’s not about the prostate…
• It’s about bladder health.
– Continued obstruction makes bladder
work harder
– Eventually bladder decompensates
– Well documented
– BPH medications affect symptoms but
do not reduce obstruction – bladder
health inevitably worsens
• Men undergo surgery much later in
the disease process
• Bladder remains obstructed, less
opportunity for recovery
1 Flanigan, Reda, Bruskewitz et al. J Urol 1998.
WW: watchful waiting
TURP: transurethral resection of the prostate
DiseaseProgression

9. Delayed Disobstruction Also Increases COST
Disease Progression
CostofCare
Prevention
Surgery

10. Recently we set out to map this
cost for NICE and Lord Carter’s
review…....

11. BPH – Annual burden for Primary Care
NeoTract Confidential
£9,047,638.54
£16,421,465.42
£14,480,338.04
£1,687,089.52
£7,166,325.84
£57,667,708.81
£1,770.28
Finasteride
Dutasteride
Alfuzosin Hydrochloride
Indoramin
Tamsulosin & Dutasteride
Hydrochloride
Tamsulosin Hydrochloride
Terazosin Hydrochloride
Annual Spend on BPH drugs1
£107 Million
Primary Care Consultations2
1.6 Million
Cost of Primary Care
Consultations (2003)3
£44 Million
1. Health and Social Care Information Centre 2014. 2. Kirby R et al. ProState of the Nation report. A call to action: delivering more effective care
for BPH patients in the UK. 2009. 3. Speakman M et al. BJU Int 2015; 115:508-519

12. Burden of BPH – Hospital admissions
NeoTract Confidential
Annual burden of BPH (2014/15)
Unique patients: 130,584
Admissions: 184,449
Procedures: 237,341
Cost per year £321 Million
50% non-elective
Average LOS = 9.5 days
5-year burden of BPH (2009 -2014)
Total admissions: 1 Million (trending up)
Cost £1.7 Billion
£2,457
Health Episode Statistics. Patients entering hospital who are diagnosed with BPH (N40X
any diagnosis position). Cost based on national Tariff

13. BPH surgery – Annual cost
NeoTract Confidential
Health Episode Statistics – OPCS M65, 2014/15. Cost based on National Schedule of
References Costs LB25E 2013/14
Procedures: 18,699
Cost per patient £2,718
Cost per year £51 Million
Inpatient bed days 51,000
Elective theatre hours 19,000-29,000
94% Elective vs 6% day case
Average LOS = 2.74 days
60% patients have major or intermediate
complications and co-morbidities
£51 Million

14. 5 year pathway burden of post-operative
complications following BPH surgery
NeoTract Confidential
Source: Health Economic Statistics. For every patient who had BPH surgery (OPCS M65) in 2009, an analysis of complications (listed by
ICD10) for each of the 5 years following the procedure. Numbers of spells and costs (based on tariff) for this activity

15. Cumulative and annual cost burden of
complications from BPH surgery
NeoTract Confidential
£0
£20,000,000
£40,000,000
£60,000,000
£80,000,000
£100,000,000
£120,000,000
2009 2010 2011 2012 2013 2014
Total annual cost of
complications
£109 Million
70,000
hospital spells
Cumulative cost of complications from single cohort of
patients treated in 2009
Source: Health Economic Statistics. For every patient who had BPH surgery (OPCS M65) in 2009, an analysis of complications (listed by
ICD10) for each of the 5 years following the procedure. Numbers of spells and costs (based on tariff) for this activity

16. > 1 in 5 patients return to BPH drug treatment
after surgery
NeoTract Confidential
Strope S et al. Urology 2015; 86: 1115-1122
BPH Medication after TURP or Laser
21%25%

17. Even 1 in 10 de-novo patients require BPH
medication after surgery
NeoTract Confidential
11% 8%
BPH Medication after TURP or Laser

18. The LUTS / BPH Cycle – Burden of Care
NeoTract Confidential
Primary Care
(Medication / GP
Consultations)
Emergency
Admission
Surgery
Post-operative
Complications

19. SOLUTION?: Can we Shift Paradigm of BPH care to Increase
Impact & Lower Cost
Disease Progression
CostofCare
Prevention
Surgery
Prostatic
Urethral Lift
• Earlier disobstruction reverses bladder decay

20. Only 3 procedures tried for BPH:
1. Remove prostate tissue
• Enucleation: Simple, HoLEP, Robotic, […Water jet?]
• Resection: TURP, TUIP, Bipolar
• Vaporization: PVP laser, HoLAP, Button
1. Injure/scar/ablate prostate tissue
• Microwave (7), TUNA(3)
• Ethanol, Toxins (4), […Steam?]
1. Open the prostate
• Stents(6)
• Excellent disobstruction
• Serious adverse events
• Lengthy recovery
• Modest disobstruction
• Poor consistency, durability
• Lengthy recovery
• Immediate disobstruction
• Irritation
• Complications requiring removal

21. NEED: Nothing Fills the Ideal Space
Tolerability
Effectiveness
•Decreased libido
•Ineffective first 2-3 mo.1,5
•Difficult recovery period
•Catheter 1-2 wks3
•4-6 wks before improvement4
•30-70% irritative symptoms1
•Inconsistent response
1 AUA Guidelines 2003
2 Varkarakis et al, The Prostate 58: 248-251(2004)
3 Rubenstin J, Transurethral Microwave Thermotherapy of the Prostate (TUMT), eMedicine article, July 2004
4 Muruve, N, Transuretheral Needle Ablation of the Prostate (TUNA), eMedicine article, June 2005
5 AUA: Urologyhealth.org
5ari
TUMT
TUNA
•Fatigue, dizziness,
anejaculation, impotence1,5
•Surgical Standard
•5% Re-op at 10 yrs1,2
•3-5 hospital days
•4-6 weeks recovery
•65% ejac dysfunction1
•10% impotence1
•TURP-like with
reduced bleeding
Alpha
Blocker
Laser
TURP

22. The Solution that Urologists & Healthcare
Systems Seek
• Straightforward Procedure
– Rapidly and easily deployable (no capital outlay, infrastructure
or staff changes
– Reliable, reproducible
– Ambulatory - Local anesthesia
• Rapid Relief
– Reduce patient complications, recovery time and healthcare burden
• Preserve Function
– Bladder function
– Sexual function
• Durable
– Years of relief
• Cost Effective
– Less expensive for system

23. A NEW View: What is BPH really?
• BPH is a mechanical problem.
• Benign Prostate Hyperplasia is, by
definition, benign tissue.
• Removing or destroying this benign
tissue can cause complications.
• Why not just move it out of the way?
Pressure
Hyperplastic
tissue takes more
work to open

25. Fast Forward The Award Winning UroLift® Implant
Permanent Transprostatic Implant
2015 BRONZE

26. UroLift Becoming a Standard of Care
11 years of Diligent Development
PUBLISHED
Randomized
Crossover Study
Positive
Guidance
N.I.C.E.PUBLISHED
2 Year
Durability
De Novo
Approval
HCPCS Coding
Coverage
AETNA
PUBLISHED
Randomized
Blinded Study
PUBLISHED
Sexual
Function
Over 8,000
treated
PUBLISHED
3 Year
Randomized
Durability
PUBLISHED
BPH6 Study:
Randomized
to TURP
Coverage
Medicare 49 states
Kaiser, Aetna
Several Blue Cross
Several privates
PUBLISHED
‘Real-World’
European
Registry
PUBLISHED
Safety &
Feasibility
Category 1
CPT Codes
[Effective Jan’15]
PUBLISHED
LOCAL Study
MAC00226-01 Rev A Positive MTEP
N.I.C.E.

27. Clinical evidence – unrivaled in BPH
technologies
Published:
Can J Urol USA Randomized (n=206, 3 yr)
EU J Urol BPH6 Randomized (n=80, 1 yr)
Blad Dys Rep Meta-Analysis
Urology Practice USA Randomized (n=206, 2 yr)
J Urology USA Randomized (n=206, 1 yr)
J Sex Med USA Sexual Function Analysis (n=140, 1 yr)
BJUI USA Crossover Study (n=53, 1 yr)
Can J Urol USA LOCAL Study (n=51, 1 mo)
EU J Urol EU Multi-National Study (n=102, 1 yr)
Urology J. 2 Year Multi-Center Study (n=64, 2 yrs)
J. Sex Med Sexual Function Analysis (n=64)
BJUI First-in-Man Experience (n=19, 1 yr)
Pop Health Health Economics of UroLift
Can J Urol Technique
Prog Urologie French experience
Urol Neur Uro Spanish experience

28. Rapid, reproducible and durable results
0
5
10
15
20
25
0 6 12 18 24 30 36 42 48
MeanIPSS
Months
Roehrborn et al.
Sonksen et al.
McNicholas et al.
Chin et al.
Roehrborn et al. Can J Urol 2015; Sonksen et al. Eur Urol 2015; McNicholas et al. Eur Urol 2013; Chin et al. Urology 2012
MAC00226-01 Rev A
Retreatment remains low: 12.6% at 4 years
4-year data presented at EAU
Congress March 2016 recently
published

29. Minimally Invasive Safety Profile
Most common AE were mild to moderate, typically resolve by 2-4 weeks:
No incidence (0%) of de novo sustained ejaculatory or erectile dysfunction.
PUL
Subjects
Control
Subjects
Dysuria 34% 17%
Hematuria 26% 5%
Pelvic pain 18% 5%
Urgency 7% 0%
Urge Incontinence 4% 2%
UTI 3% 2%
Roehrborn et al. Can J Urol 2015

30. Improved Quality of Care
• UroLift patients recover more quickly
– TURP catches up only between 6 to 12 months
• UroLift patients satisfied sooner and to greater extent
20%
30%
40%
50%
60%
70%
80%
90%
100%
0 3 6 9 12
Recovered(QoRVAS)
Months
PUL
TURP
p<0.05
p<0.05
Sonksen et al. Eur Urol 2015; 68; 643-652.
55%
60%
65%
70%
75%
80%
85%
90%
95%
1 2 3 4 5 6 7 8 9 10 11 12
SatisfiedPatients*
Months
PUL
TURP
*would recommend procedure
PUL randomized to TURP [gold standard surgery]

31. UK N.I.C.E. Approves UroLift as Cost Effective
Alternative to TURP
• Only BPH procedure to be
shown to be cost effective
when compared to TURP
and HoLEP (e.g. Greenlight
laser is not recommended).

32. The Solution that Urologists & Healthcare
Systems Seek
• Straightforward Procedure
– Reliable, reproducible
– Local anesthesia
• Rapid Relief
– Reduce patient “earn out” and practice burden
• Preserve Function
– Bladder function
– Sexual function
• Durable
– Years of relief
• Cost Effective
– Less expensive for system

33. Perceived cost
True cost
• Consumables
• Procedure cost
• Diathermy
• Morcellation
• Histology
• Maintenance
• Repair
• Upgrades
• Servicing
• Amortisation
The “Current Gold standards” Myth

34. UroLift® and The

35. Mapping our Journey into the NHS … and we are
just getting going
CE Mark
NICE IPG
Urolift
given
incorrect
OPCS
code)
NICE
Medical
Technology
Guidance
New
combination
code in
HRG4+
announced
Introduction
of HRG4+
delayed for
1 year
Urolift
included in
Accelerated
Access
Review
Urolift
awarded
Innovation
Technology
Tariff*
(effective 1
April 2017)
*Subject to consultation
Oct 2014
First NHS patients treated
with UroLift as part of pilot
at Frimley Park
Other hospitals adopt Urolift – at risk
due to insufficient funding through
tariff
Start programme of
engagement with
AHSNs
Innovation
EXPO –
showcased
by Wessex
AHSN
Jan 20142010 Aug 2015 Sept 2015 Apr 2016 Oct 2016 Nov 2016

36. Mapping our Journey into the NHS … and we are
just getting going
CE Mark
NICE IPG
Urolift
given
incorrect
OPCS
code)
NICE
Medical
Technology
Guidance
New
combination
code in
HRG4+
announced
Introduction
of HRG4+
delayed for
1 year
Urolift
included in
Accelerated
Access
Review
Urolift
awarded
Innovation
Technology
Tariff*
(effective 1
April 2017)
*Subject to consultation
Oct 2014
First NHS patients treated
with UroLift as part of pilot
at Frimley Park
Start programme of
engagement with
AHSNs
Innovation
EXPO –
showcased
by Wessex
AHSN
Jan 20142010 Aug 2015 Sept 2015 Apr 2016 Oct 2016 Nov 2016
The UroLift system should be considered for use in men with
lower urinary tract symptoms of benign prostatic hyperplasia
who are aged 50 years and older and who have a prostate of
less than 100 cm3.

37. Mapping our Journey into the NHS … and we are
just getting going
CE Mark
NICE IPG
Urolift
given
incorrect
OPCS
code)
NICE
Medical
Technology
Guidance
New
combination
code in
HRG4+
announced
Introduction
of HRG4+
delayed for
1 year
Urolift
included in
Accelerated
Access
Review
Urolift
awarded
Innovation
Technology
Tariff*
(effective 1
April 2017)
*Subject to consultation
Oct 2014
First NHS patients treated
with UroLift as part of pilot
at Frimley Park
Start programme of
engagement with
AHSNs
Innovation
EXPO –
showcased
by Wessex
AHSN
Jan 20142010 Aug 2015 Sept 2015 Apr 2016 Oct 2016 Nov 2016
Innovative medical technologies with cost saving potential

38. Mapping our Journey into the NHS … and we are
just getting going
CE Mark
NICE IPG
Urolift
given
incorrect
OPCS
code)
NICE
Medical
Technology
Guidance
New
combination
code in
HRG4+
announced
Introduction
of HRG4+
delayed for
1 year
Urolift
included in
Accelerated
Access
Review
Urolift
awarded
Innovation
Technology
Tariff*
(effective 1
April 2017)
*Subject to consultation
Oct 2014
First NHS patients treated
with UroLift as part of pilot
at Frimley Park
Start programme of
engagement with
AHSNs
Innovation
EXPO –
showcased
by Wessex
AHSN
Jan 20142010 Aug 2015 Sept 2015 Apr 2016 Oct 2016 Nov 2016
Innovation and Technology tariff will:
• help cut the hassle experienced by clinicians and innovators in getting uptake and
spread across the NHS
• guarantee automatic reimbursement of approved technologies
NHS England, November 2016

39. Mapping our Journey into the NHS … and we are
just getting going
CE Mark
NICE IPG
Urolift
given
incorrect
OPCS
code)
NICE
Medical
Technology
Guidance
New
combination
code in
HRG4+
announced
Introduction
of HRG4+
delayed for
1 year
Urolift
included in
Accelerated
Access
Review
Urolift
awarded
Innovation
Technology
Tariff*
(effective 1
April 2017)
*Subject to consultation
Oct 2014
First NHS patients treated
with UroLift as part of pilot
at Frimley Park
Other hospitals adopt Urolift – at risk
due to insufficient funding through
tariff
Start programme of
engagement with
AHSNs
Innovation
EXPO –
showcased
by Wessex
AHSN
Jan 20142010 Aug 2015 Sept 2015 Apr 2016 Oct 2016 Nov 2016
Innovation and Technology tariff will:
• help cut the hassle experienced by clinicians and innovators in getting uptake and
spread across the NHS
• guarantee automatic reimbursement of approved technologies
NHS England, November 2016

40. Scope of the productivity and efficiency savings
from Urolift
40% Adoption
Clinical practice tells us that >40%
of men undergoing surgery for
LUTS would be clinically eligible
for a prostatic urethral lift
procedure as alternative to
current surgical practice
NeoTract Confidential
Men requiring
surgery for BPH
Urolift
>40%

41. LUTS due to BPH: Impact of UroLift on Pathway*
*Estimate based on 8,000 UroLift/yr (40% of TURP pts)
COSTS BURDEN TO THE NHS
Reduces Primary Care consultations
£ Saving to be determined
PRIMARY CARE
ACUTE CARE
BPH-related hospital
episodes
Surgery
ACUTE CARE
Reduces procedure costs
>£4 Million/yr saving
Saves 21,000 bed days and 8,000-12,000
main theatre hours
BPH drug treatment
£107 Million/yr
Primary Care Consultations
1.6 million consultations
£44 Million/yr
BPH-related hospital episodes
£321 Million/yr
Average length of stay: 9 days
50% of acute care is non-elective
Elective BPH surgery
£54 Million/yr
20,000 TURP procedures/yr
60,000 inpatient bed days/yr
20-40,000 theatre hours/yr
Surgery-related complications
£109 Million/yr
70,000 hospital spells
Reduces complication costs and hospital spells
>£22 Million/yr
Saves 14,000 hospital spells
New drug
use within
3 yrs of
TURP:
22%
Reduces BPH drug treatment
£ Saving to be determined
ESTIMATED COST SAVING

42. Thank you and questions