Teleflex Showcases New Clinical Data Presented At The 2025 American Urological Association (AUA) Annual Meeting

2025-05-15 06:31:23

(MENAFN- GlobeNewsWire - Nasdaq) Two Head-to-Head Randomized Trials Highlight Superior Early Patient Experience with the UroLiftTM System for BPH¹^-2

First-Ever Analysis Utilizing the American Urological Association Quality Registry (AQUA) to Assess BPH Treatment Modalities Shows Strongest Symptom Improvement Score Shift with UroLiftTM System at Three Months.³

First Study to Confirm Safety of Stabilized Hyaluronic Acid (sHA) Rectal Spacer in Cases with Rectal Wall Infiltration (RWI).⁴

WAYNE, Pa., May 15, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a global leader in medical technologies, today announced the presentation of compelling new clinical data at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, held April 26–29. Data from two randomized controlled trials (RCTs) reinforce the UroLiftTM System's advantages compared with Rezūm and tamsulosin, particularly in terms of early patient satisfaction, rapid symptom relief, and sexual function outcomes.^1-2 The UroLiftTM System, also referred to as Prostatic Urethral Lift (PUL), is the chosen leader in minimally invasive procedures for benign prostatic hyperplasia (BPH) in the U.S.⁵

“These studies underscore our commitment to evidence-based innovation. The UroLiftTM System continues to stand out as a patient-centered therapy offering meaningful improvements in symptoms and quality of life,” said Claus Roehrborn, MD,* professor of urology at UT Southwestern Medical Center and primary investigator on the studies.“With more than 14 years of BPH research behind us, including ongoing head-to-head comparisons, we're giving clinicians and patients the critical data to support evidence-based shared decisions.”
The following research presentations outlined the key findings from the studies:

Results from the CLEAR RCT Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL vs. Rezum WVTT ¹†

Men treated with the UroLiftTM System were significantly more satisfied with their results at two weeks and at one month after treatment.¹
Those who received the UroLiftTM System procedure also had shorter catheterization times, better symptom relief, and better sexual function outcomes during the early recovery period compared to RezūmTM patients.¹

UroLiftTM PUL Demonstrates Significantly Better Efficacy and Patient Experience Outcomes vs. Tamsulosin: Results from the IMPACT RCT ²†

At three months, men who were treated with the UroLiftTM System showed significantly better symptom improvement compared to those who took medication.²
UroLiftTM System patients reported better sexual function outcomes and overall experience.‡ In fact, 70% of men randomized to the medication treatment arm eventually chose to crossover to the UroLiftTM System.²

Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment ³

Real-world data from the AQUA BPH database corroborate evidence that BPH drugs provide modest or no improvement and that PUL provides rapid symptom score improvement at three months.³

Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility ⁴

This study presents the first evidence for the safety of sHA rectal spacer in cases of RWI, demonstrating sHA spacers are safe, effective, and allow for individualized spacing with low risk of severe complications, such as ulcers or fistulas.⁴

“These findings reaffirm the safety profile of stabilized hyaluronic acid as a rectal spacer and highlight its reversibility as a distinct clinical advantage,” said Michelle Svatos, director of BarrigelTM rectal spacer product development and research.“With a low incidence of rectal wall infiltration and no severe complications observed, this study strengthens our confidence in sHA as a safe and customizable option for protecting patients during prostate cancer treatment."

For more information about the UroLift System, visit , and for more information about Barrigel Rectal Spacer, visit .

About the UroLiftTM System
The UroLiftTM 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 UroLiftTM System permanent implants, which can be delivered during an outpatient procedure,⁶ relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue. The UroLiftTM 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.**^8-9 A study conducted over 5 years showed a low retreatment rate of about 2-3% per year, or a total of 13.6% over the course of the study, demonstrating UroLiftTM System durability.¹⁰ 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 UroLiftTM System) is recommended for the treatment of BPH in both the 2021 American Urological Association and 2022 European Association of Urology clinical guidelines. 500,000 men have been treated with the UroLiftTM System in select markets worldwide.¹² Learn more at .

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

About BarrigelTM Rectal Spacer
Barrigel^TM rectal spacer is the first and only hyaluronic acid rectal spacer that separates the prostate from the rectum to protect the rectum during radiation therapy treatment for prostate cancer.¹³ BarrigelTM rectal spacer is made from Non-Animal Stabilized Hyaluronic Acid (NASHA).¹⁴

Hyaluronic acid is a substance naturally present in the human body and is highly biocompatible and fully absorbable. NASHA has a proven history of safety and efficacy in a wide variety of medical applications in men, women and children worldwide.^15-16

Barrigel^TM rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy¹³ and is cleared for rectal spacing in the United States, Australia, and Europe.¹⁷ Barrigel^TM rectal spacer is indicated for prostate cancer patients with T1-T3b disease. For more information about Barrigel^TM rectal spacer, please visit .

BarrigelTM Rectal Spacer Important Safety Information
BarrigelTM rectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and, in creating this space, it is the intent of BarrigelTM rectal spacer to reduce the radiation dose delivered to the anterior rectum. BarrigelTM rectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient's body over time.

BarrigelTM rectal spacer should only be administered by qualified and properly trained physicians with experience in ultrasound guidance and injection techniques in the urogenital/pelvic area.

As with any medical treatment, there are some risks involved with the use of BarrigelTM rectal spacer. Potential complications associated with the use of BarrigelTM rectal spacer include, but are not limited to: pain associated with BarrigelTM rectal spacer injection; needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of BarrigelTM rectal spacer into the bladder, prostate, rectal wall, rectum, urethra, or intravascularly; local inflammatory reactions; infection; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency. More information on indications, contraindications, warnings and instructions for use can be found in the Instructions For Use at . Individual results may vary.

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 ArrowTM, BarrigelTM, DeknatelTM, LMATM, PillingTM, QuikClotTM, RüschTM, UroLiftTM and WeckTM – 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 .

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, Barrigel, 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.

References

*Paid consultants of Teleflex.
**No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study
†Studies sponsored by Teleflex.
‡Sexual function is a combination of MSHQ EjD, MSHQ Bother, and IIEF scores. For overall patient experience, this includes a combination of results from tools to assess Symptoms, QoL, Patient Perception, Goal Achievement, and Sleep.

Chughtai et al, AUA 2025. Results from the CLEAR Randomized Controlled Trial (RCT) Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL Versus Rezum WVTT. †

Roehrborn et al, AUA 2025. UroLiftTM PUL Demonstrates Significantly Better Efficacy and Patient Experience Outcomes vs. Tamsulosin: Results from the IMPACT RCT.†

Roehrborn. Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment. Poster presented at AUA; April 26, 2025. Las Vegas, NV.

Chao et al, AUA 2025. Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility.

U.S. 2023 estimates based on US Market Model 2023-25 (3-14-23 FINAL), which is in part based on Symphony Health PatientSource® 2018-22, as is and with no representations/warranties, including accuracy or completeness.

Shore, Can J Urol 2014

Rukstalis, Prostate Cancer and Prostatic Dis 2018

AUA BPH Guidelines 2003, 2020

McVary, Urology 2019

Roehrborn, Can J Urol 2017

Roehrborn, J Urol 2013

Management estimate based on product sales as of June 2024. Data on file Teleflex Interventional Urology.

Mariados NF, Orio PF III, King MT et al. JAMA Oncol (2023).

Barrigel Injectable Gel Instructions for Use (2022).

Svatos M, Chell E, Low DA, et al. Symmetry, separation, and stability: Physical properties for effective dosimetric space with a stabilized hyaluronic acid spacer. Med Phys. 2024; 1-15. †

Restylane^® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021. Available at: . Accessed Sept 30, 2021.

Data on file Teleflex. 2025.

MAC03086-01 Rev A

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Teleflex
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Vice President, Investor Relations and Strategy Development
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610-948-2836

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