UroLift® System Research Data from EAU Highlight Durability and Superior Patient Experience, Along with Benefits of Earlier Treatment for BPH

Rhea-AI Summary

Teleflex (NYSE: TFX) presented significant findings regarding the UroLift^® System for treating benign prostatic hyperplasia (BPH) at the 38th Annual European Association of Urology Congress. Research from over 330 controlled subjects indicates that the UroLift^® offers durable results at one and five years, with lower durability linked to undertreatment. Early intervention positively affects quality of life and sexual function. Notably, UroLift^® demonstrated a lower complication rate compared to traditional surgeries like TURP. The studies reinforce UroLift^® as a leading minimally invasive treatment for BPH, emphasizing its safety and effectiveness.

Positive

• Durability of UroLift^® results at one year (low retreatment rate) and five years (2-3% per year, 13.6% total).
• Early intervention linked to improved quality of life and sexual function outcomes.
• Lower complication rates for UroLift^® compared to traditional BPH treatments like TURP.

Negative

• Lower durability at one year associated with undertreatment (≤4 implants).
• Five-year durability impacted by poor baseline obstructive symptoms.

Presentations at the 38th Annual European Association of Urology Congress Reinforce
Low Surgical Retreatment of the UroLift^® System

WAYNE, Pa., March 13, 2023 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today 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.

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

About the UroLift^® System

The UroLift^® System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). It is indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older (50 years outside U.S.). The UroLift^® permanent implants, which can be delivered during an outpatient procedure,⁶ relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue. The UroLift^® System can be used to treat a broad spectrum of anatomies, including obstructive median lobe.⁷ It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.*^8-10 The 5-year L.I.F.T. study results demonstrate UroLift^® System durability with a surgical retreatment rate of about 2-3% per year and 13.6% total over 5 years.⁸ Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.¹¹ Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. The prostatic urethral lift procedure (using the UroLift^® System) is recommended for the treatment of BPH in both the 2021 American Urological Association and 2022 European Association of Urology clinical guidelines. More than 400,000 men have been treated with the UroLift^® System in select markets worldwide.¹² Learn more at www.UroLift.com. Rx only.

About Teleflex Incorporated

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

Contacts:

Teleflex Incorporated:
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
Investors.teleflex.com
610-948-2836

Media:
Nicole Osmer
nicole@healthandcommerce.com 
650-454-0504

*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.

Teleflex is the home of Arrow^®, Deknatel^®, LMA^®, Pilling^®, QuikClot^®, Rüsch^®, UroLift^®, and Weck^® – trusted brands united by a common sense of purpose.

Teleflex, the Teleflex logo, Arrow, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks are the property of their respective owners.

© 2023 Teleflex Incorporated. All rights reserved. MAC02656-01 Rev A

FAQ

What are the benefits of the UroLift® System presented at the EAU Congress 2023?

The UroLift® System provides durable results at one and five years, improves quality of life and sexual function, and has lower complication rates compared to traditional treatments.

How does early intervention with UroLift® affect treatment outcomes?

Early intervention has shown to positively impact quality of life outcomes and sexual function in patients.

What was the complication rate of UroLift® compared to TURP?

UroLift® demonstrated lower complication rates compared to TURP, highlighting its safety as a treatment option for BPH.

What does the research say about the durability of UroLift® results?

Research indicates that the UroLift® System has a low surgical retreatment rate of 2-3% per year and a total of 13.6% over five years.

What implications did the EAU Congress 2023 findings have for UroLift® and Teleflex (TFX)?

The findings reinforce the UroLift® System's position as a leading minimally invasive treatment option for BPH, potentially strengthening investor confidence in Teleflex (TFX).