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 * About Optilume®BPH
 * The PEAK Study




IT’S TIME TO TAKE ON YOUR
ENLARGED PROSTATE (BPH).


LEARN ABOUT AN FDA-APPROVED, NON-SURGICAL APPROACH
THROUGH THE PEAK STUDY • NO COST TO PARTICIPATE

Millions of men struggle with urinary symptoms caused by an enlarged prostate,
or BPH (benign prostatic hyperplasia). Nearly half of all men in their 50s and
over 70% of men in their 60s have BPH.1 As the prostate enlarges, it can cause a
range of symptoms such as:

 * Frequent need to urinate both day and night
 * A weak or interrupted urinary stream
 * A sense that you cannot completely empty your bladder
 * A sudden urgency to urinate

While there are medications and surgical treatments available for BPH, they do
not work for everyone and can also cause unwanted side effects, including sexual
dysfunction and urinary incontinence.

If you’re living with BPH and are interested in exploring non-surgical treatment
options, you may qualify for the PEAK Clinical Study. The study is for the
Optilume® BPH Catheter System, an FDA-approved device and minimally invasive
procedure with quick recovery time and immediate symptom relief that is
durable.2,3 Participants in the PEAK Study will receive the Optilume BPH
procedure at no cost.

ABOUT OPTILUME® BPH

The Optilume BPH Catheter System: Safe. Effective. Durable

Typically administered as an outpatient procedure, Optilume® BPH is a
drug-coated balloon that is inserted into the urethra via a telescopic camera,
to the prostate.

Once in the prostate, the balloon expands creating an opening, and releases the
safe and proven drug4, paclitaxel, into the open prostate. When the drug coating
is fully released, the balloon is deflated and removed. The drug coating helps
keep the prostate open, restoring the flow of urine and relieving you of your
bothersome symptoms.

No cutting. No heating. No burning. No lasering. No steaming. No implantation.

The Optilume BPH Catheter System is FDA-approved. Patients treated with Optilume
BPH reported immediate and durable symptom relief, quick recovery, no impact on
sexual function, and the highest clinically reported flow rates of any minimally
invasive therapy.2,3


What is the PEAK Study?

Doctors at select centers across the US are conducting the PEAK Clinical Study
to gather additional information about the Optilume® BPH Catheter System. If you
qualify and choose to join the study, you will receive the Optilume procedure
and all study-related care at no cost. Following the procedure, your study
doctor will continue to see you over a 5-year period to check on how you are
doing and to discuss your experiences. You will be compensated for your time and
travel to attend these visits.

SEE IF YOU QUALIFY

See If You Qualify

To see if you might qualify for the PEAK Clinical Study, and to get connected
with your local study center to learn more, please take the pre-screening
questionnaire below:

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 1. Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign
    prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9. doi:
    10.1016/s0022-5347(17)49698-4. PMID: 6206240.
 2. Kaplan, Steven; Pichardo, Merycarla; Rijo, Edwin; Lay, Ramon Rodriguez;
    Espino, Gustavo; Estrella, Rafael MP76-02 AT 4 YEARS, OPTILUME BPH HAS THE
    HIGHEST SUSTAINED IMPROVEMENT IN PEAK FLOW (QMAX) OF ANY MINIMALLY INVASIVE
    BPH THERAPY, Journal of Urology: April 2023 - Volume 209 - Issue Supplement
    4, doi: 10.1097/JU.0000000000003350.02
 3. Kaplan, Steven A.*; Moss, Jared; Freedman, Sheldon; Coutinho, Karl; Wu,
    Ning; Efros, Mitchell; Elterman, Dean; D’Anna, Richard; Padron, Osvaldo;
    Robertson, Kaiser J.; Lawindy, Samuel; Mistry, Sandeep; Shore, Neal; Spier,
    Jeffrey; Kaminetsky, Jed; Mazzarella, Brian; Cahn, David; Jalkut, Mark; Te,
    Alexis The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study
    Evaluating the Optilume BPH Catheter System for the Treatment of Lower
    Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia, Journal of
    Urology: September 2023 - Volume 210 - Issue 3, doi:
    10.1097/JU.0000000000003568
 4. Kamath KR, Barry JJ, Miller KM. The Taxus™ drug-eluting stent: a new
    paradigm in controlled drug delivery. Adv Drug Deliv Rev 2006;58:412-36