Outcomes From Two New Head-to-Head Randomized Controlled Trials Involving the UroLift™ System Highlight a Superior Patient Experience* Against Rezūm and Its Advantage Over Medical Therapy as an Early Intervention for BPH

WAYNE, Pa., May 07, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE:TFX), a global leader in medical technologies, today announced the presentation of new research findings from the 2024 American Urological Association Annual Meeting in San Antonio, TX, May 3 – 6, 2024, showcasing excellent patient experience* with the Prostatic Urethral Lift (PUL) with the UroLift^™ System for benign prostatic hyperplasia (BPH).

This year's research marks the first time results from two randomized head-to-head trials were presented that reinforce the UroLift^™ System as the leading minimally invasive surgical therapy (MIST) that can provide rapid relief and durable outcomes with preservation of sexual function.**^1-5

"These significant new randomized head-to-head studies and real-world analyses demonstrate the UroLift^™ System provides distinctive patient experience* advantages, positioning it as an early treatment option compared to medications for men whose quality of life is impacted by oppressive BPH symptoms," said Jacqueline Welch, Vice President of Global Clinical and Scientific Operations at Teleflex. "For over 10 years, Teleflex has advanced BPH research through numerous trials involving the UroLift™ system and now other contemporary treatments. Our continued investment and focus on direct comparative research helps to facilitate more informed discussions between clinicians and their patients about treatment options."

The following research presentations outlined the key findings from the studies:

In the largest head-to-head randomized controlled trial (RCT) study (IMPACT), early patient outcomes were studied among UroLift™ PUL and Tamsulosin medication subjects.¹

• Preliminary data suggest that PUL with the UroLift™ system offers better symptom relief, quality of life improvements and patient satisfaction compared with alpha blockers within three months following the initiation of treatment.¹
  
  
• These findings could help to advance evidence-based shared decision making.¹

First head-to-head RCT study comparing UroLift^™ System experience against Rezūm (CLEAR) showcases a superior early patient experience* with the UroLift™ System (PUL) compared with water vapor thermal therapy (WVTT).²

• Patients undergoing PUL with the UroLift™ System experienced more rapid symptom relief and quality of life improvements within the first three months post-treatment.²
  
  
• Outcomes can aid healthcare providers and patients in gaining a clearer understanding of the perioperative experience, facilitating informed decisions regarding treatment options.²

A comprehensive analysis of post-surgery medication usage over five years among patients treated with the UroLift^™ System, transurethral resection of the prostate (TURP), and GreenLight™ photoselective vaporization of the prostate (PVP).³

• Post-surgery medication usage is an important and relatively unexplored facet of the BPH patient journey.³ The analysis found that medication use was similar among the three procedures through five years.³
  
  
• This may indicate that in a real-world setting, contrary to expectations, not all TURP and PVP patients fully respond to the benefits of the intervention.³
  
  
• Additionally, the medication rate following PUL with the UroLift™ System was consistent with what was observed in the L.I.F.T. pivotal study, further validating the integrity of the trial.³
  
  

A real-world analysis of hospitalizations and emergency department visits following surgical treatments for BPH showed patients treated with UroLift™ PUL had the lowest unplanned visits.⁴

• Real-world evidence serves as a litmus test for how minimally invasive and surgical therapies for BPH perform outside the highly managed settings of a clinical trial.⁴
• These events are often not reported in controlled trials but should be considered when evaluating BPH treatment options.⁴

A review of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database of medical device reports (MDRs) showed UroLift™ PUL had the lowest rates of mild, moderate, and severe complications year over year.***⁵

• Once procedure volume is factored in, the UroLift™ System has the lowest rates of mild, moderate, and severe postoperative complications on a per case basis from 2019 to 2022 in the MAUDE database.***⁵
• The yearly rates of mild, moderate and severe events are significantly higher for invasive procedures like Aquablation^® than the minimally invasive surgical therapies analyzed.⁵

"The AUA guidelines acknowledge there are patients with LUTS secondary to BPH who do not respond favorably to medicine and recommend reevaluations within a reasonable period after the initiation of treatment. The goal is for the provider and patient to decide whether to continue, stop, or switch to another therapy based on the symptomatic response of medication. In this context, IMPACT is of interest as it allows us to observe the patient journey after treatment with the UroLift™ System versus medication with the option for a cross-over after reassessment," said Claus Roehrborn, MD, professor of urology at UT Southwestern Medical Center and primary investigator on the study.^† "Initial results help us to understand not only efficacy comparisons, but also distinctions in patient satisfaction and goal attainment, where UroLift™ has an advantage. I commend Teleflex for facilitating a groundbreaking trial that will serve urologists and patients for years to come."

In addition to the presentation of clinical data, Teleflex showcased the new UroLift™ 2 System with Advanced Tissue Control (ATC), which has recently received FDA clearance. The UroLift™ 2 ATC System offers physicians enhanced confidence, improved control of obstructive tissue, and targeting accuracy through tissue control wings and laser-etched needle markers designed to make tissue manipulation and implant delivery more precise.⁶ A streamlined delivery system, typically utilizing one handle per procedure and individual implant cartridges, ensures increased physician comfort and improves efficiency during the procedure.⁶

BPH is a common condition in which the prostate enlarges as men get older. As the prostate enlarges, it can press on and block the urethra, causing bothersome urinary symptoms.^7-8 The UroLift™ System is a minimally invasive treatment option for BPH that can help men get off BPH medications and avoid major surgery, while preserving sexual function.^**9 It is the only leading enlarged prostate procedure that does not require heating, cutting, or destruction of prostate tissue.^10-11

For more information about the UroLift™ System, visit www.UroLift.com.

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,¹² 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.¹³ It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction^.**11,14 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.⁹ Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.¹⁰ 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 2023 American Urological Association and 2024 European Association of Urology clinical guidelines. More than 475,000 men have been treated with the UroLift^™ System in select markets worldwide.¹⁵ Learn more at www.UroLift.com.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.

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

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

References:

* Symptom relief and quality of life improvement following treatment

**No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study

*** While the MAUDE Database is a powerful resource, it is subject to certain limitations. These include the potential for underreporting of adverse events and the variability in the quality and consistency of the information reported. MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions.

†Claus Roehrborn is a paid consultant of Teleflex.

1. Roehrborn, et al, AUA 2024. Preliminary RCT Analysis of Minimally Invasive Surgery vs. Medication in the Initial Treatment of BPH-Associated LUTS. AUA Study sponsored by Teleflex Incorporated or its affiliates
2. Roehrborn, et al, AUA 2024. The Early Patient Experience Following Treatment With PUL and WVTT, Two Contemporary MISTs for BPH: Preliminary Results From the CLEAR Study. AUA Study sponsored by Teleflex Incorporated or its affiliates
3. Kaplan, et al, AUA 2024. A US Healthcare Claims Analysis Reveals Post-surgery Medication Use Through 5 Years Is Similar Between PUL, TURP, and GreenLight. AUA Study sponsored by Teleflex Incorporated or its affiliates
4. Kaplan, Prostate Cancer Prostatic Dis 2023
5. Shinghal R, Ashley M, Eure G, AUA 2024. Total Procedural Context is Crucial in Understanding BPH Treatment Device Safety in the FDA's MAUDE Database. (Manuscript in preparation)
6. Data on file
7. Rosenberg, Int J Clin Pract 2007
8. Vuichoud, Can J Urol 2015
9. Roehrborn, Can J Urol 2017
10. Roehrborn, J Urol 2013
11. AUA BPH Guidelines 2003, 2020
12. Shore, Can J Urol 2014
13. Rukstalis, Prostate Cancer and Prostatic Dis 2018
14. McVary, Urology 2019
15. Management estimate based on product sales as of January 2024. Data on file Teleflex Interventional Urology.
    
    

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.

Teleflex, the Teleflex logo, Arrow, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck, list all Teleflex-owned trademarks in alphabetical order] are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2024 Teleflex Incorporated. All rights reserved.

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