Teleflex Announces Clinical and Real-World Evidence Studies and Physician Educational Opportunities to Be Highlighted at the 2025 American Urological Association (AUA) Annual Meeting

WAYNE, Pa., April 24, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced the presentation of several clinical studies at the 2025 American Urological Association Annual Meeting, which is being held in Las Vegas from April 26 - 29, 2025. These studies contribute to the expanding body of clinical and real-world evidence supporting innovations in benign prostatic hyperplasia (BPH) treatment and rectal spacing to protect tissue during radiation treatment for prostate cancer.

"Understanding how leading treatment options perform—both in rigorous clinical trials and in everyday practice—is essential to empowering the future of healthcare for patients," said Travis Gay, president and general manager of Teleflex Interventional Urology. "At Teleflex, we are deeply committed to advancing evidence-based innovation. Through ongoing real-world clinical trial research, we continue to support the safe and effective use of the UroLift™ System and Barrigel™ rectal spacer, helping physicians enhance outcomes and quality of life for patients."



Clinical Study Presentations:

1. Results from the CLEAR Randomized Controlled Trial (RCT) Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL Versus Rezum WVTT†– Moderated Poster Presentation; Saturday, April 26, 3:30–5:30 pm in Casanova, Room 505
   
   The CLEAR randomized controlled trial compares patient outcomes between UroLift™ PUL and Rezum WVTT.¹ The presentation is being moderated by Dr. Bilal Chughtai^*, urologist, Northwell Health, Garden City, N.Y.
   
   
2. Patients Dissatisfied with BPH Medication in the IMPACT RCT Demonstrate Worse Patient Experience and Sleep Quality Before Crossing Over to UroLift PUL.† – Podium Presentation; Saturday April 26, 1:00–3:00 pm in Galileo, Room 901
   
   The IMPACT randomized controlled trial evaluates safety, efficacy, and patient experience in BPH patients treated with UroLift™ PUL versus medication (tamsulosin).² The presentation is presented by Dr. Dean Elterman^*, associate professor of urology, the University of Toronto.
   
   
3. Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment. Moderated Poster Presentation; Saturday, April 26, 3:30–5:30 Casanova 505.
   
   An analysis utilizing the AQUA database moderated by Dr. Claus Roehrborn^*, Professor and Chairman, Department of Urology, University of Texas Southwestern Medical Center, Dallas, Tex.³
   
   
4. Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration (RWI) and Reversibility – Poster Session; Tuesday, April 29, 9:30 – 11:30 am in Marco Polo 703
   
   A research team in Australia, led by Professor Dr. Michael Chao^*, a radiation oncologist at the Olivia Newton John Cancer Wellness & Research Centre in Victoria, Australia, conducted a study on the safety of sHA rectal spacers in cases of RWI.⁴
   
   

Teleflex and AUA are also hosting multiple educational events:

"Semi-Live Barrigel Case Review and Discussion" on Saturday, April 26, 2:35 – 3:05 pm in the Venetian Ballroom. In this AUA event, Dr. Varun Sundaram^*, a urologist with Urology Austin, in Tex., will present insights from a recent Barrigel™ rectal spacer case, offering commentary and technical guidance on spacing procedures. This is an AUA event for which Teleflex provided funding.

The second annual advanced practice provider (APP) educational breakfast, "Engaging the APP in an Efficient Urology Practice" on Sunday, April 27, 6:45 – 8:00 am in Palazzo Ballroom B. Dr. Gregg Eure^* with University of Virginia Health, Culpeper, Va.; Janelle Bunce^*, PA-C with Advanced Urology Institute in Naples, Fla.; and Jamie Giovanelli^*, PA-C with Urology of Virginia in Suffolk, Va. will discuss how to empower APPs to support the patient care pathway for patients with BPH and lower urinary tract symptoms. The discussion will center on the role of the APP in minimally invasive surgical therapies, including ultrasound gland sizing, if within scope of practice; in-office post procedure observations; and return post-op visits.

Prostate Health Symposium, "Transforming Quality of Life Through Personalized Prostate Care" on Sunday, April 27, 5:15 – 8:00 pm at Allegiant Stadium. In this first-ever combined UroLift™ System and Barrigel™ rectal spacer forum, a panel of experienced physicians—Dr. Zachary Klaassen^*, urologic oncologist with Augusta University Medical Center/Georgia Cancer Center; Dr. Olubayo Tojuola^*, urologist with Memorial Hermann Hospital at Houston, Tex.; and Dr. Ned Ruhotina^*, a urologist with Associated Medical Professionals in Syracuse, N.Y.—will share real-world techniques for optimizing prostate radiation therapy with Barrigel™ rectal spacer and enhancing BPH outcomes with the UroLift™ System.

In addition to these events, presentations will take place daily at Teleflex booth 1401 as follows:

Presentations focused on Barrigel™ rectal spacer:

Zachary Klaassen, MD, MSC* – Getting Started with Barrigel Rectal Spacer

Saturday, April 26, 3:00 pm

Anne Hong, MD* – RWIs & Reversibility

Sunday, April 27, 11:00 am

Presentations focused on UroLift™ System:

David Sussman, DO, FACOS* – The Importance of Implant Density & Updates Regarding Recent Publications

Saturday, April 26, 1:30 pm

Silvia Secco, MD* – UroLift System: Surgical Experience & Competitive Advantages

Sunday, April 27, 1:30 pm

For more information about the UroLift System, visit www.UroLift.com, and for more information about Barrigel Rectal Spacer, visit www.Barrigel.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™ System permanent implants, which can be delivered during an outpatient procedure,⁵ 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.⁶ It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.**^7-8 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 UroLift™ System durability.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 2021 American Urological Association and 2022 European Association of Urology clinical guidelines. 500,000 men have been treated with the UroLift™ System in select markets worldwide.¹¹ Learn more at www.UroLift.com.

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

About Barrigel™ Rectal Spacer

Barrigel^™ 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.¹² Barrigel™ rectal spacer is made from Non-Animal Stabilized Hyaluronic Acid (NASHA).¹³

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.^14-15

Barrigel^™ rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy¹² and is cleared for rectal spacing in the United States, Australia, and Europe.¹⁶ Barrigel^™ rectal spacer is indicated for prostate cancer patients with T1-T3b disease. For more information about Barrigel^™ rectal spacer, please visit https://barrigel.com/hcp/barrigel-control-matters.

Barrigel™ Rectal Spacer Important Safety Information

Barrigel™ 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 Barrigel™ rectal spacer to reduce the radiation dose delivered to the anterior rectum. Barrigel™ 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.

Barrigel™ 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 Barrigel™ rectal spacer. Potential complications associated with the use of Barrigel™ rectal spacer include, but are not limited to: pain associated with Barrigel™ rectal spacer injection; needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of Barrigel™ 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 www.barrigel.com. 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 Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, 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.

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.

© 2025 Teleflex Incorporated. All rights reserved.

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.

1. 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. †
2. Roehrborn et al, AUA 2025. Patients Dissatisfied with BPH Medication in the IMPACT RCT Demonstrate Worse Patient Experience and Sleep Quality Before Crossing Over to UroLift PUL.†
3. 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.
4. Chao et al, AUA 2025. Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility.
5. Shore, Can J Urol 2014
6. Rukstalis, Prostate Cancer and Prostatic Dis 2018
7. AUA BPH Guidelines 2003, 2020
8. McVary, Urology 2019
9. Roehrborn, Can J Urol 2017
10. Roehrborn, J Urol 2013
11. Management estimate based on product sales as of June 2024. Data on file Teleflex Interventional Urology.
12. Mariados NF, Orio PF III, King MT et al. JAMA Oncol (2023).
13. Barrigel Injectable Gel Instructions for Use (2022).
14. 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. https://doi.org/10.1002/mp.17292†
15. Restylane^® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021. Available at: https://www.prnewswire.com/news-releases/restylane-celebrates-25-years-of-natural-looking-results-with-its-signature-line-of-hyaluronic-acid-fillers-301388779.html. Accessed Sept 30, 2021.
16. Data on file Teleflex. 2025.

Contacts:

Teleflex

Lawrence Keusch

Vice President, Investor Relations and Strategy Development

[email protected]

610-948-2836

Media Contact:

Glenn Silver

Partner National Media Relations Specialist

[email protected]

646-871-8485

MAC03077-01 Rev A