First Head-to-Head Study Shows Greenlight XPS® Laser Therapy Equally Safe and Effective with Faster Recovery as Commonly Used

  First Head-to-Head Study Shows Greenlight XPS® Laser Therapy Equally Safe
  and Effective with Faster Recovery as Commonly Used Turp for Treatment of

 Results from Large Randomized Trial Support Use of Innovative 180 Watt Laser
 Therapy as a Viable Treatment Option for More Than 110 Million Men Worldwide
                            with Enlarged Prostate

Business Wire

MINNETONKA, Minn. -- June 4, 2013

Data presented at the American Urological Association (AUA)  Annual Meeting
demonstrate that treatment for Benign Prostatic Hyperplasia (BPH) with
GreenLight XPS^® laser therapy with MoXy^® fiber, instead of transurethral
resection of the prostate (TURP), results in significantly shorter
hospitalization, catheterization, and recovery times for patients, while
maintaining equivalent safety and efficacy.

“This trial provides important new information that may cause many urologists
and patients to choose GreenLight^TM laser therapy as an alternative to TURP,
which has long been regarded as the standard surgical treatment for BPH,” said
Professor Alexander Bachmann, M.D., University Hospital Basel, Switzerland,
and principal investigator in the GOLIATH study. “With faster recovery times,
less time spent in the hospital and less catheterization time than TURP,
GreenLight^TM is a highly effective therapy for the treatment of BPH.”

The findings from the prospective, multicenter, randomized GOLIATH trial,
demonstrate the equivalence in safety and effectiveness of the 180W GreenLight
XPS^® system for addressing lower urinary tract symptoms associated with BPH.
Manufactured by American Medical Systems, an Endo Health Solutions Inc.
(Nasdaq: ENDP) subsidiary, GreenLight XPS^® is the most widely used BPH laser
treatment currently on the market.

“GreenLight^TM laser therapy is the leading minimally invasive laser surgical
treatment for BPH world-wide, and offers patients a proven innovative option
to TURP,” said Camille Farhat, president of AMS. “Left untreated, BPH, and the
resulting symptoms, can cause permanent damage to the urinary system. We look
forward to helping more men who undergo surgery for BPH recover faster and
potentially return to their active lifestyles more quickly.”

During the GreenLight^TM procedure, the physician uses a laser to remove
excess prostate tissue, creating a larger channel for urine flow to pass
through. The innovative, outpatient procedure is suitable for most patients
with enlarged prostates, delivers rapid urine flow improvement, and provides
immediate and lasting relief of lower urinary tract symptoms. GreenLight^TM is
available in 70 countries has been used to treat more than 700,000 patients
worldwide. More information is available for physicians at and for patients at

GOLIATH Study Trial Design and Results

The GOLIATH study was designed to compare TURP and PVP (Photo-Selective
Vaporization of the Prostate) with the 180W GreenLight XPS^® system using a
variety of symptomatic, functional and safety outcome measures. The study
evaluated 269 patients from 29 sites in 11 European countries based on 6-month
post procedural results. All adverse events were adjudicated and classified by
an independent, blinded clinical events committee.

Key trial findings include:

  *Equivalency in safety, as evidenced by the number and rate of adverse
    events, and efficacy, as determined by IPSS (International Prostate
    Symptom Score) and Qmax (peak urinary flow rate)
  *Superiority of GreenLight XPS^® in recovery times including shorter
    catheterization times, shorter hospital stay, and a faster return to a
    stable health status
  *Significantly lower rate of short-term re-intervention with GreenLight
  *Numerically fewer bleeding and dysuric events with GreenLight XPS^® than
  *Comparable prostate tissue volume and PSA (prostate specific antigen)

About BPH

More than 110 million men globally suffer from BPH,^1 a condition in which an
enlarged prostate presses on the urethra, which can obstruct the flow of urine
and cause problems such as frequent urination, pain or burning while
urinating, and weak urine flow. If left untreated, BPH can lead to such issues
as kidney damage,^2 severe urinary tract infections,^3 visible blood in the

chronic renal failure.^5 According to the AUA, by 60 years of age, BPH
prevalence is greater than 50 percent and by age 85 is as high as 90 percent.
BPH  is so common it has been said that all men will have an enlarged prostate
if they live long enough.^6

About GreenLight XPS®

The GreenLight™ laser system is intended for incision/excision, vaporization,
ablation, hemostasis and coagulation of soft tissue, including photoselective
vaporization of the prostate for benign prostatic hyperplasia (BPH). The laser
system is contraindicated for patients who: are contraindicated for surgery,
contraindicated where appropriate anesthesia is contraindicated by patient
history, have calcified tissue, require hemostasis in >2mm vessels, have
uncontrolled bleeding disorders, have prostate cancer, have acute urinary
tract infection (UTI) or severe urethral stricture. Possible risks and
complications that include, but are not limited to, irritative symptoms
(dysuria, urgency, frequency), retrograde ejaculation, urinary incontinence,
erectile dysfunction, hematuria - gross, UTI, bladder neck contracture/outlet
obstruct, urinary retention, perforation - prostate, urethral stricture.

About American Medical Systems

American Medical Systems (AMS), headquartered in Minnetonka, Minn., is a
diversified supplier of medical devices and procedures to treat incontinence,
erectile dysfunction, benign prostatic hyperplasia (BPH), pelvic floor
prolapse and other pelvic disorders in men and women. AMS continues to develop
new therapies to restore bodily functions and to enable people to regain
control of their lives. AMS is an operating company of Endo Health Solutions
Inc. (Nasdaq: ENDP), a diversified healthcare company that is dedicated to
improving care through a combination of branded products, generics, devices,
technology and services. Learn more at

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. Statements including
words such as "believes," "expects," "anticipates," "intends," "estimates,"
"plan," "will," "may," "look forward," "intend," "guidance," "future" or
similar expressions are forward-looking statements. Because these statements
reflect our current views, expectations and beliefs concerning future events,
these forward-looking statements involve risks and uncertainties. Investors
should note that many factors, as more fully described under the caption "Risk
Factors" in Endo Health Solutions’ Form 10-K, Form 10-Q and Form 8-K filings
with the Securities and Exchange Commission and as otherwise enumerated herein
or therein, could affect our future financial results and could cause our
actual results to differ materially from those expressed in forward-looking
statements contained in the Endo Health Solutions Annual Report on Form 10-K.
The forward-looking statements in this press release are qualified by these
risk factors. These are factors that, individually or in the aggregate, could
cause our actual results to differ materially from expected and historical
results. We assume no obligation to publicly update any forward-looking
statements, whether as a result of new information, future developments or


^1 (AMS ppt: Benign Prostatic Hyperplasia, Understanding Market Size and
Patient Flow: An Analysis of Census Data and Available Literature 2010)

^2 Carter HB.Prostate Disorders: The Johns Hopkins White Papers.Baltimore,
MD: Johns Hopkins Medicine; 2010:1-24.

^3 Urinary tract infections. US National Library of Medicine, National
Institute of Health. Accessed Oct. 27,

^4 Enlarged prostate. US National Library of Medicine, National Institute of
Health. Accessed
Sept. 27, 2010.

^5 Aging changes in the male reproductive system: MedlinePlus Medical
Encyclopedia. National Institutes of Health. Accessed Nov 22,

^6 Enlarged prostate. US National Library of Medicine, National Institute of
Health. Accessed
Sept. 27, 2010.


American Medical Systems
Blaine Davis
(484) 216-7158
Brian O’Donnell
(484) 216-6726
Jonathan Neely
(484) 216-6645
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