Urology Breakthrough Proven to Improve Sexual Function for Men

WAYNE, PA — Teleflex Incorporated (NYSE: TFX) this week announced new research from controlled and real-world studies of the Prostatic Urethral Lift (PUL) procedure with the UroLift^® System, for treating men with benign prostatic hyperplasia (BPH). Results underscore the benefits of early intervention with respect to durability, symptom improvement and sexual function that urologists around the world have come to expect from the UroLift^® System, which is the leading minimally invasive, outpatient treatment in the United States for enlarged prostate.¹ The research was presented at the 38^th Annual European Association of Urology (EAU) Congress taking place in Milan from March 10-13, 2023.

“These important new analyses show that, whether compared to other interventions or medication, the UroLift^® System offers unique benefits that make it the treatment of choice for many men searching for long-term relief of burdensome BPH symptoms,” said Jacqueline Welch, Vice President, Global Clinical and Scientific Operations, Teleflex.

The following are key findings from the studies:

Results from over 330 PUL subjects studied in a controlled setting^2,3

• PUL with the UroLift^® System was durable in most subjects at one and five years. Lower durability at one year is associated with undertreatment (≤4 implants placed).² Lower durability at five years is affected by poor baseline obstructive symptoms indicated by the International Prostate Symptom Score (IPSS).²
• Earlier treatment in the disease continuum (i.e., better IPSS and quality of life (QoL) scores at baseline) positively impacts quality of life outcomes. Similarly, treatment with the UroLift^® System prior to severe erectile dysfunction in sexually active patients predicts the likelihood of a patient achieving meaningful change in the Sexual Health Inventory for Men (SHIM) assessment.³

Comprehensive patient experience results of obstructive median lobe (OML) subjects treated with PUL⁴

• In responder analysis utilizing the novel BPH6 study endpoints (relief of symptoms, quality of recovery, preservation of sexual function, preservation of continence and safety),** UroLift^® System OML and lateral lobe patients responded consistently.⁴
• Compared to Transurethral Resection of the Prostate (TURP) done in lateral lobes, UroLift^® System OML subjects achieved superior quality of recovery and preservation of ejaculatory function. Additionally, only these TURP subjects experienced high-severity adverse events.⁴

Outcomes from the largest healthcare utilization study for BPH therapies, including medication⁵

• Approximately 6% of medical therapy patients underwent BPH-related procedures through 1 year as the disease progressed.⁵
• Procedure complication rates were similar between TURP, Photoselective Vaporization of the Prostate (PVP) and Aquablation^®, and lowest for PUL with the UroLift^® System. Although the Aquablation^® data were relatively immature because of the newness of the technology, the complication rate (~20%) indicates a safety profile similar to more invasive treatments.⁵

“The research presented at EAU reinforces the UroLift^® System as an effective and durable BPH solution, backed by meaningful quality of life data that support a superior patient experience,” said Steven Gange, M.D., F.A.C.S., of Summit Urology Group and Associate Medical Director of the Teleflex Interventional Urology Business Unit. “The results from these studies emphasize the value of the UroLift^® System in successfully treating BPH symptoms, enabling rapid recovery, preserving sexual function, and improving patients’ overall quality of life.”^2-5
*No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study

** Individual elements of the BPH6 composite endpoint assessed the following: 1) LUTS improvement; 2) Quality of Recovery; 3) Preservation of Erectile function, 4) Preservation of Ejaculatory function; 5) Continence preservation; and 6) Safety

References:

1. U.S. 2022 estimates based on US Market Model 2022-24 (5-17-22 FINAL), which is in part based on Symphony Health PatientSource® 2018-21, as is and with no representations/warranties, including accuracy or completeness
2. Roehrborn, et al, EAU 2023. Durability following treatment with the Prostatic Urethral Lift (PUL): Predictors from over 330 controlled subjects across 5 distinct studies. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
3. Barber, et al, EAU 2023. Patient characteristics and dynamic variables predictive of meaningful quality of life and sexual function improvement after Prostatic Urethral Lift (PUL). [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
4. Eure, et al, EAU 2023. Patient experience outcomes are consistent between men with median and lateral lobe obstruction following treatment with the Prostatic Urethral Lift (PUL). [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
5. Kaplan, et al, EAU 2023. The Impact of BPH Care: Procedural Complications Associated with MIST and Traditional Surgery Compared to Disease Progression with Medical Therapy. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
6. Shore, Can J Urol 2014
7. Rukstalis, Prostate Cancer and Prostatic Dis 2018
8. Roehrborn, Can J Urol 2017
9. AUA BPH Guidelines 2003, 2020
10. McVary, Urology 2019
11. Roehrborn, J Urology 2013
12. Management estimate based on product sales as of December 2022. Data on file Teleflex Interventional Urology.

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