OPEN UP TO A PROVEN APPROACH TO BPH™
AUA Guideline Highlights
• Urologists “should consider” PUL (UroLift® System) for the treatment of men with BPH.
• Patients “should be made aware that surgical treatment can cause ejaculatory dysfunction (EjD) and may worsen ED.”
• “In men so concerned about new onset of ED and/or EjD, PUL likely does not pose additional risk.”
The guidelines also highlight the attractive risk-benefit profile of minimally invasive surgical therapies (MIST), such as PUL, compared to medical therapy. Specifically, the Guidelines state that, “with this procedure class, perhaps a significant portion of men with [BPH] who have stopped medical therapy can be treated prior to impending bladder dysfunction.”
To review the guidelines, visit auanet.orgClick on Education and Policies > Guidelines > Benign Prostatic Hyperplasia
The Prostatic Urethral Lift (UroLift® System)RECOMMENDED BY THE AUA GUIDELINES FOR THE TREATMENT OF MEN WITH BPH
Redefining BPH Treatment
12 Million Men in the U.S. are Treated for BPH/LUTS
The UroLift® System is a proven option for patients seeking an alternative to a daily pill
NeoTract US Market Model estimates for 2018 based on IQVIA Health Drug and Procedure data
Surgery/Procedure
21% 2.6 Million
Patients
3% Elect Surgery
303,000 Patients
Medical TherapyWatchful Waiting
is a proven option for patients seeking
an alternative to a daily pill
62% 7.5 Million Patients
Each Year,
~13.9% or 1.7 Million discontinue drugs
(inadequate relief, side effects, etc.)
Pre-Procedure Post-Procedure Pre-Procedure Post-Procedure
*No instances of new, sustained erectile or ejaculatory dysfunction1. Roehrborn, J Urology 2013 LIFT Study 2. Shore, Can J Urol 2014 Local Study
3. McVary, J Sex Med 2016 4. Roehrborn, et al. Can J Urol 2017
• Rapid relief and recovery in days, not months1,2
• Lowest catheter rate of the leading BPH procedures2
• The only BPH procedure with no new, sustained erectile or ejaculatory dysfunction*1,3
• The only BPH procedure that does not destroy tissue
• Proven durability through 5 years4
• 25 peer-reviewed clinical publications, 2 randomized controlled studies and 8 additional studies
The UroLift® System Procedure
A minimally invasive approach to treating BPH that lifts and holds the enlarged prostate tissue out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue.
Earlier Treatment Alternative FOR MORE BPH PATIENTS
(Images courtesy of Dr. Peter Chin, Wollongong, NSW, Australia) (Images courtesy of Dr. Euclid deSouza, Omaha, NE, USA)
Bladder
Prostate
Straightforward ApproachMECHANICAL SOLUTION TO A MECHANICAL PROBLEM
The UroLift® Delivery Device
The UroLift® Delivery Device is inserted transurethrally through a rigid sheath under cystoscopic visualization in order to reach the targeted area of obstruction.
The obstructing prostatic lobes are retracted by small permanent UroLift Implants which are deployed via a needle that comes out of the delivery device.
Each UroLift Delivery Device contains one UroLift Implant. Typically, 4 UroLift Implants are placed into the prostate.
UroLift® Permanent Implant
Nitinol Capsular Tab
Stainless Steel Urethral End Piece
PET Suture
8mm
UroLift® Delivery Device
Safe and Effective ALTERNATIVE TO MEDICATIONS AND SURGERY
Significant improvement without the significant downsides of laser/TURP Comparison of outcomes at 1-2 years
1. Roehrborn, J Urol 2013; There was no occurrence of new onset, sustained erectile or ejaculatory function in the L.I.F.T. study. Most common adverse events reported include hematuria, dysuria, micturition urgency,
pelvic pain, and urge incontinence. Most symptoms were mild to moderate and resolved within two to four weeks after the procedure. 2. Roehrborn, Urol Practice 2015 3. Sonksen, Eur Urol 2015
4. Montorsi, J Urol 2008 5. Naspro, Eur Urol 2009 6. AUA BPH Guidelines 2003, 2010 7. Jan Teper, Cent Eur J Urol 2011 8. Traish, J Sex Med 2011
SUI – Stress Urinary Incontinence ED – Erectile Dysfunction EjD – Ejaculatory Dysfunction QOL – Quality of Life
SUI4,5
Transfusion6
Stricture
6
ED6
EjD6
Laser/TURP
IPSS Improvement6
14/14.8
QOL6
1.7/3.342%/65%2%/ 7%
7%/ 10%
3%/ 7%
3%/ 8%
1%/ 3%
Mild to Moderate AE’s1
IPSS Improvement1,3 QOL1
2.410.8-11.4
Stricture
2
0.7%
QOL
QOL
IPSS Improvement
IPSS Improvement
Other side effects include syncope, hypotension, eye surgery complications6,7
Other side effects include syncope, hypotension. Sexual side effects can linger after medication is stopped.8
Alpha Blockers6
5ARI65%8%9% 4%4%5%2%
5-12%5-15%4-15% 6-11% 3-5% 1-10% 1-3%
Asthenia
Asthenia
Dizziness
Dizziness
Headache
Headache
ED
ED
EjD
EjD
Reduced Libido
Reduced Libido
Nasal
Congestion
Nasal
Congestion
4.0 0.8
1.4- 1.56.0 - 7.0
Benefits and side effects of BPH medications Comparison of outcomes at 1-2 years
ED – Erectile Dysfunction EjD – Ejaculatory Dysfunction QOL – Quality of Life
Reproducible Results
ACROSS MULTIPLE STUDIES
• Endoscopic results can be immediately confirmed
• Rapid symptom relief and recovery1,2
• Maintained IPSS (36%) and QOL (50%) improvements at 5 years, p<0.0013
• Qmax improves over 44% by 3 months and sustained to 5 years, p<0.0013
• Preservation of sexual function*1,4
• Low surgical retreatment rate of 5% at 1 year and 13.6% at 5 years2,3
• The UroLift® System procedure does not preclude future UroLift System, TURP or laser procedures
*No instances of new, sustained erectile or ejaculatory dysfunction1. Roehrborn, J Urology 2013 LIFT Study 2. Shore, Can J Urol 2014 Local Study
3. Roehrborn et al. Can J Urol 2017 4. McVary, J Sex Med 2014
LIFT IDE Randomized StudyBPH6 Randomized Study
LOCAL IDE StudyEuropean Multicenter Study
Australian Study
30
20
10
00 1 2 3 4 5
Rapid Durable
AU
ASI
0 1 2 3 4 5
6
4
2
0
QO
L
0 1 2 3 4 5
30
20
10
0
Qm
ax (m
l/s)
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Pleasanton, CA 94588Tel: (925) 401-0700 • (877) 408-9628
NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our initial focus is to improve the standard of care for patients with Benign Prostatic Hyperplasia (BPH), a broadly underserved market. Our first product is the UroLift® System, a minimally invasive device designed to treat lower urinary tract symptoms (LUTS) due to BPH.
FOR MORE INFORMATIONVisit www.UroLift.com Customer Service: 877.408.9628 (toll-free) Reimbursement Resource Center: 844.516.5966 (toll-free)
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“ The procedure has allowed me to regain my quality of life. I have no urgency, no frequency and I’m thoroughly satisfied with the results.”
STEPHEN RICHARDSON, MD (patient)
“ It’s just a friendlier option for the patient – they recover quickly and get on with their life.”
DR. STEVEN GANGE
“ It is our responsibility to educate the patient about all the options. Many of my patients prefer the UroLift® System procedure over a pill.”
DR. ROBERT COWLES
“ There will still be guys who want medications, but you bring a lot more people to the table who see that there is an effective way to treat their symptoms.”
DR. RONALD ANGLADE