The GOLIATH Study.

The GOLIATH Study1,2

• Prospective, randomised multicentre controlled trial• 29 centers, 9 European countries • First randomised controlled trial powered to compare the safety and efficacy of the

180W GreenLight XPS™ Laser Therapy System with transurethral resection of the prostate (TURP)

PRIMARY OBJECTIVES:

Non-inferiority of 180W GreenLight XPS System compared with TURP• International Prostate Symptom Score

(IPSS) at 6 months• Maximum flow rate (Qmax) at 6 months• Proportion of patients who are

complication free through 180 days

SECONDARY OBJECTIVES:

• Length of catheterisation• Length of hospitalisation• Time until stable health• Post-void residual urine volume (PVR)• Prostate volume (PV)• Prostatic-specific antigen (PSA)

Primary Efficacy Results

Primary Safety and PV Results

PV at 6 and 12 Months: Comparable Prostate Size Reduction

Primary Safety Results: GreenLight XPS System was Equivalent to TURP

Recovery Parameters

Hospital StayStable HealthCatheterisation

Adverse Events

• No significant difference could be detected between the GreenLight XPS System and TURP with regards to any adverse events (AE) (p=0.330)

• Storage symptoms (dysuria/irritative pain/discomfort) were the most commonly observed Grade I events in 18.4% (GreenLight XPS System) and 18.0% (TURP) patients

• Urinary tract infections (defined by intention to treat without microbiological confirmation documented) were the most commonly observed Grade II events in 16.2% after the GreenLight XPS procedure and 9.0% after TURP (p=0.098)

• Statistically significant difference in early AE (48 hours to 30 days) with 12 complications in the TURP group and zero in the GreenLight XPS procedure group (p=<0.001)

• At 12 months, ongoing self-reported urinary leakage of any degree was observed in 4 (2.9%) after the GreenLight XPS procedure and 4 (3.0%) after TURP; this has been easily tolerated without intervention

Reinterventions

• Surgical reinterventions during the 12 month period for an AE arising at any time was seen in 16 (11.8%) patients after the GreenLight XPS procedure and 20 (15.0%) patients after TURP

Patient Questionnaires

• Patients’ overall satisfaction with the GreenLight XPS procedure was high, with over 94% of men willing to undergo the treatment again and recommend it to a friend

Values reported as mean

Conclusions

First randomised controlled trial powered to compare safety and efficacy of the GreenLight XPS Laser System and TURP demonstrated

• TURP resulted in 5 times more surgical interventions to resolve post-operative bleeding than GreenLight XPS procedure

• Comparable results in terms of IPSS, Qmax, and complication-free after 12 months

• Patients treated with the GreenLight XPS System had a significantly shorter median length of catheterisation, time until stable health, and hospitalisation compared with TURP

• Overall portion of patients free from any AE was comparable between the GreenLight XPS procedure and TURP

• In the 48 hour to 30 day period, there were 0 AE in the GreenLight XPS System arm compared to 12 in the TURP arm (p<0.001)

• Comparable storage symptoms (dysuric or irritative symptoms) between treatment arms

• At 12 months, self reported urinary leakage of any degree was reported in 2.9% of the GreenLight XPS System procedure patients and 3% of TURP patients

• Overall post-operative re-intervention rates were not significantly different between treatment arms

Brief Summary

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 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.

Prior to using these devices, please review the Operator’s Manual and any accompanying instructions for use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events.

Rx Only™ The denoted marks are trademarks or registered trademarks of American Medical Systems, Inc.© 2014 American Medical Systems, Inc. All Rights Reserved. Minnetonka, MN 55343AMSNL/BPH-00756/April 2015 www.AmericanMedicalSystems.com 1-800-328-3881Australia and New Zealand Use Only

1. Bachmann A, Tubaro A, Barber N, et al., 180-W XPS GreenLight Laser Vaporization Versus Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 6-Month Safety and Efficacy Results of a European Multicentre randomised Trial—The GOLIATH Study; European Urology, 2014 May;65(5):931-42

2. Bachmann A, Tubaro A, Barber N, et al., An European multicentre randomised Noninferiority Trial Comparing 180-W GreenLight-XPS Laser Vaporization and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 12 Month Results of the GOLIATH-Study; Journal of Urology, 2014, 2014 Sep 11. pii: S0022-5347(14)04377-8. doi: 10.1016/j.juro.2014.09.001.