Teleflex Announces Multiple Clinical and Real-World Evidence Studies to Be Highlighted at the 2024 American Urological Association Annual Meeting

• Highlights include two head-to-head randomized clinical trials (RCT) data presentations of UroLift™ System vs. other modalities to treat benign prostatic hyperplasia (BPH) -
• Additional studies examine post-surgery medication use, rates of hospitalization and adverse events of standard BPH treatments -
  
• Teleflex unveils latest advancements in BPH treatment with UroLift™ 2 System with Advanced Tissue Control (ATC) designed to treat all prostate types -
  

WAYNE, Pa., May 01, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a global leader in medical technologies, today announced the presentation of multiple clinical studies at the 2024 American Urological Association Annual Meeting, which is being held in San Antonio, TX, from May 3 – 6, 2024. These studies add to the growing body of clinical evidence around the safety, efficacy and patient experience* with a Prostatic Urethral Lift (PUL) using the UroLift^™ System for benign BPH.

In addition to the presentation of clinical data, Teleflex will offer the first opportunity to view the UroLift™ 2 System with Advanced Tissue Control (ATC), which has recently received FDA clearance. The UroLift™ 2 ATC System offers physicians enhanced confidence, easier 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.¹ A streamlined delivery system, utilizing typically one handle per procedure and individual implant cartridges, promotes increased physician comfort and improved efficiency during the procedure.¹

BPH is a common condition in which the prostate enlarges as men get older. The enlarged prostate can press on and block the urethra, causing bothersome urinary symptoms. 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.²** It is the only leading enlarged prostate procedure that does not require heating, cutting or destruction of prostate tissue.^3,4

“Assessing the comparative safety and effectiveness of leading therapeutic modalities through clinical trials is paramount in optimizing patient-centered care for benign prostatic hyperplasia,” said Liam Kelly, Chairman, President and CEO of Teleflex. “It’s also critical to understand how these therapies perform in real-world settings and reflect patient experience. Teleflex has always made a strong commitment to generating both clinical and real-world evidence that supports and optimizes the use of the UroLift™ procedure to improve patient outcomes.”

Clinical Study Presentation Information:

1. The Early Patient Experience Following Treatment With PUL and WVTT, Two Contemporary MISTs for BPH: Preliminary Results From the CLEAR Study; May 5, 7:00-9:00 AM, Room 303B
   This is a preliminary look at the CLEAR trial, the first head-to-head randomized controlled trial (RCT) comparing early patient outcomes after UroLift™ PUL and Rezūm™ Water Vapor Therapy (WVTT).⁵
   
   
2. Preliminary RCT Analysis of Minimally Invasive Surgery vs. Medication in the Initial Treatment of BPH-Associated LUTS; May 5, 1:24-1:32 PM, Stars at Night Ballroom
   IMPACT is the largest head-to-head RCT comparing minimally invasive surgical treatments (MISTs) to medication in the treatment of lower urinary tract symptoms (LUTS) secondary to BPH.⁶
   
   Real-world Evidence Study Presentation Information:
   
   
3. Real-World Analysis of Hospitalizations and Emergency Department Visits Following Surgical Treatments for Benign Prostatic Hyperplasia (BPH) Reveal Distinctions Between Minimally Invasive and Traditional Surgery; May 4, 7:00-9:00 AM, Room 221C
   This U.S. healthcare insurance claims analysis examines unplanned hospital admittance and emergency department visits that occurred within 30 days of the procedure. These events are often not reported in controlled trials but should be considered when evaluating BPH treatment options.⁷
   
   
4. Total Procedural Context Is Crucial in Understanding BPH Treatment Device Safety in the FDA’s MAUDE Database; May 5, 7:00-9:00 AM, Room 303B
   The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database of medical device reports (MDRs) provides valuable information regarding safety and patient experience for BPH treatment devices. This analysis examines the number and severity of MDRs for BPH treatment devices in MAUDE and contextualizes those entries in the broader landscape of total procedures performed annually.⁸***
   
   
5. A US Healthcare Claims Analysis Reveals Post-surgery Medication Use Through 5 Years Is Similar Between PUL, TURP, and GreenLight; May 5, 3:30-5:30 PM, Room 304B
   Data are limited regarding medical therapy use following traditional surgical procedures and MISTs for BPH. In this large-scale, real-world analysis, rates of BPH medical therapy use are explored following transurethral resection of the prostate (TURP), GreenLight™ photovaporization of the prostate (PVP), and UroLift™ PUL procedures in a large database of U.S. healthcare claims.⁹

Teleflex is hosting two educational events:

1. A first-of-its-kind advanced practice provider (APP) educational breakfast, “Advancing BPH Care: Role of APPs in a New Era of Diagnosis and Treatment” on May 5 at 6:45 AM - 7:30 AM in the Hemisfair Ballroom 2. Matt Ashley, MD, associate medical director at Teleflex Interventional Urology, and Erin Dwyer, FNP-C,^† urology nurse practitioner at Genesis Healthcare Partners, will discuss the impact of the APP role in BPH management and urology care.
   
   
2. Barrigel™ Educational Symposium, “The Science of Personalized Spacing,” on May 4 starting at 6:00 PM in the Carlos C. Alvarez Theater at the Tobin Center. Rizwan Nurani, MD,^† radiation oncologist at Interventional Radiation Oncology of CA, and Zachry Klaassen, MD, MSC,^† urologic oncologist at August University Medical Center, Georgia Cancer Center, will discuss the Secondary Analysis of the Barrigel Pivotal Trial to highlight the benefits of controlled, personalized spacing for improving patient outcomes and quality of life.
   

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,¹⁰ 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.^11-12 It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.**^4,13 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.² Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.³ 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. 475,000 men have been treated with the UroLift™ System in select markets worldwide.¹⁴ Learn more at www.UroLift.com.

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

Barrigel™ Rectal Spacer Important Safety Information
Barrigel 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 to reduce the radiation dose delivered to the anterior rectum. Barrigel 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 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. Potential complications associated with the use of Barrigel include, but are not limited to: pain associated with Barrigel injection; needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of Barrigel 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.

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.

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 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. MAC02883-01 Rev A

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.

†Erin Dwyer, Rizwan Nurani, and Zachry Klaassen are paid consultants of Teleflex.

1. Data on file
2. Roehrborn, Can J Urol 2017
3. Roehrborn, J Urology 2013
4. AUA BPH Guidelines 2003, 2020
5. 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
6. 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
7. Kaplan, Prostate Cancer Prostatic Dis 2023
8. 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)
9. 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
10. Shore, Can J Urol 2014
11. Rukstalis, Prostate Cancer and Prostatic Dis 2018
12. UroLift System Instructions for Use
13. McVary, Urology 2019
14. 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. MAC02883-01 Rev A

Contacts:
Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610-948-2836