Teleflex Incorporated Introduces the UroLift™ 2 System With Advanced Tissue Control, a Revolutionary Unified Platform Designed to Treat All Prostate Types

Rhea-AI Summary

Teleflex Incorporated (NYSE:TFX) announces the full market release of the Advanced Tissue Control (ATC) feature on its UroLift™ 2 System for treating benign prostatic hyperplasia (BPH), offering personalized treatment options and enhanced physician control. The FDA-cleared UroLift™ 2 ATC system provides improved tissue manipulation, targeting accuracy, and efficiency, revolutionizing BPH care.

Insights

Medical Device Analyst

The FDA clearance of Teleflex's UroLift™ 2 System with Advanced Tissue Control (ATC) is a pivotal moment for the company's portfolio expansion within the medical devices sector. The UroLift™ 2 ATC system is positioned to capture a broader market share within the benign prostatic hyperplasia (BPH) treatment space, catering to men with all prostate types up to 100g. The medical device industry often sees incremental innovation; however, the ATC feature represents a significant leap, providing a personalized treatment approach that could enhance patient outcomes and reduce the need for more invasive procedures.

From an investment perspective, this clearance could potentially drive revenue growth for Teleflex. The emphasis on improved physician comfort and procedural efficiency addresses a vital aspect of product adoption and user experience. Analysts may see this as an opportunity for Teleflex to solidify its market leadership in BPH treatments, especially considering the aging population and the increasing prevalence of BPH. The potential reduction in healthcare delivery costs, due to more efficient procedures and reduced waste, aligns with the broader industry trend towards cost-effective medical solutions.

Healthcare Economist

The introduction of the UroLift™ 2 ATC system may have a ripple effect on healthcare economics. By offering a minimally invasive alternative to traditional BPH medications and surgeries, Teleflex could influence the standard of care for BPH, potentially reducing long-term costs associated with more invasive treatments and post-operative care. The ability to customize treatments to each patient's unique anatomy with the ATC feature could lead to better health outcomes and shorter recovery times, which in turn may result in lower overall healthcare expenditures.

Moreover, the streamlined delivery system, which utilizes one handle per procedure and individual implant cartridges, suggests a reduction in procedure time and resource utilization. This efficiency gain could translate into higher throughput for urologists and healthcare facilities, potentially improving access to care for patients. As healthcare systems worldwide grapple with cost containment, innovations like the UroLift™ 2 ATC system that can deliver value through improved outcomes and operational efficiencies become particularly attractive.

Urology Specialist

The UroLift™ 2 ATC system represents a significant clinical advancement in the treatment of BPH. The system's ability to adapt to various prostate anatomies and offer a personalized treatment plan is a substantial improvement over the one-size-fits-all approach of many existing treatments. The ATC's tissue control wings and laser-etched needle markers enhance the precision of tissue manipulation and implant delivery, which is critical in the delicate urological procedures required for BPH treatment.

For urologists, the advent of such technology promises to transform patient care by minimizing the invasiveness of the procedure and potentially improving recovery times. This level of innovation not only has the potential to improve patient satisfaction but also sets a new standard in the field of urology. If the UroLift™ 2 ATC system delivers on its promises, it could become the preferred method for treating a wide range of BPH cases, thereby influencing treatment protocols and clinical training for urology professionals.

WAYNE, Pa., April 02, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced the upcoming full market release of the Advanced Tissue Control (ATC) feature on its unified UroLift™ 2 System platform designed for the treatment of benign prostatic hyperplasia (BPH) symptoms in men with all prostate types up to 100g. The UroLift™ 2 System with Advanced Tissue Control (UroLift™ 2 ATC) has received FDA clearance, marking a significant advancement in BPH care.

The UroLift™ 2 System is a market leader and proven minimally invasive treatment for BPH that provides an effective alternative to BPH medications and major surgery.^1,2 The UroLift™ 2 ATC represents a breakthrough in BPH treatment, with its adaptable design that enables physicians to customize treatments to each patient’s unique anatomy and allows a personalized approach to help maximize effectiveness.

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.³ A streamlined delivery system, utilizing one handle per procedure and individual implant cartridges, also ensures increased physician comfort and improves efficiency during the procedure.³

“UroLift™ 2 ATC optimizes enlarged prostate treatment by providing urologists with unparalleled confidence and customization capabilities,” said Jake Newman, President, The Americas, Teleflex. “The UroLift™ 2 System with ATC offers a comprehensive solution for BPH care, combining cutting-edge technology with proven clinical outcomes.¹ Our innovative platform streamlines procedures and eliminates the need to transition between platforms during a procedure. Enhanced features, including greater and more consistent implant compression and reduced waste, will help drive outcomes and efficiency in healthcare delivery.”

Brian Wilkins, Vice President of Research and Development for Teleflex Interventional Urology, added, “The UroLift™ 2 ATC is designed to deliver the same proven effectiveness of the UroLift™ System, with significant enhancements on a unified UroLift™ 2 platform. Based on physician feedback, it maintains the efficacy of the UroLift™ System, improves overall performance, and offers physicians the advantage of efficiently treating a broader range of patients.³ This expanded capability offered by UroLift™ 2 ATC opens new avenues for patient care.”

“The UroLift™ 2 ATC is a game-changer. Bringing the enhanced tissue control capabilities onto the innovative and proven UroLift™ 2 platform allows me to deliver unparalleled precision to treat a broad spectrum of patients and anatomies. It has transformed my approach to BPH care,” said Dr. Adam Craig Thomas of Parkview Physicians Group Urology in Fort Wayne, Indiana.

Dr. Mark Pe with Genesis Urology in San Diego, California added, “I find it immensely helpful to have UroLift™ 2 ATC stocked and readily available at every procedure in case additional tissue control is needed. It ensures I’m always equipped to treat a broad range of patients with unique prostate types and anatomies.”

To learn more about UroLift™ 2 ATC, visit 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™ System permanent implants, which can be delivered during an outpatient procedure,⁴ 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.^5-6 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.¹ Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.⁹ 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. 475,000 men have been treated with the UroLift™ System in select markets worldwide.¹⁰ 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.

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

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. All other trademarks are the property of their respective owners. © 2024 Teleflex Incorporated. All rights reserved. MAC02839-01 Rev A

References:

1. Roehrborn, Can J Urol 2017
2. 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.
3. Data on file
4. Shore, Can J Urol 2014
5. Rukstalis, Prostate Cancer and Prostatic Dis 2018
6. UroLift System Instructions for Use
7. AUA BPH Guidelines 2003, 2020
8. McVary, Urology 2019
9. Roehrborn, J Urology 2013
10. Management estimate based on product sales as of January 2024. Data on file Teleflex Interventional Urology.

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

Contacts:
Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development

investor.relations@teleflex.com
610-948-2836

FAQ

What is the ticker symbol for Teleflex Incorporated?

The ticker symbol for Teleflex Incorporated is TFX.

What is the purpose of the Advanced Tissue Control (ATC) feature on the UroLift™ 2 System?

The ATC feature on the UroLift™ 2 System is designed for treating benign prostatic hyperplasia (BPH) symptoms in men with all prostate types up to 100g.

What are the benefits of the UroLift™ 2 ATC system?

The UroLift™ 2 ATC system offers enhanced confidence, improved control of obstructive tissue, targeting accuracy, personalized treatments, and increased physician comfort and efficiency.

Who commented on the UroLift™ 2 ATC system's impact on BPH care?

Jake Newman, President, The Americas, Teleflex, and Dr. Adam Craig Thomas of Parkview Physicians Group Urology in Fort Wayne, Indiana, and Dr. Mark Pe with Genesis Urology in San Diego, California.

What feedback did physicians provide about the UroLift™ 2 ATC system?

Physicians highlighted the system's unparalleled precision, enhanced tissue control capabilities, and the ability to treat a broad spectrum of patients and anatomies efficiently.