New Data Reinforce Efficacy of the UroLift® System for the Treatment of Enlarged Prostate

07/01/2022

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Presentations at the 37th Annual European Association of Urology Congress to Demonstrate Measurable and Sustained Improvement of BPH Symptoms and IPSS Scores

WAYNE, Pa., July 01, 2022 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the results of several research studies that further support the safety and efficacy of the UroLift^® System for men living with enlarged prostate, or benign prostatic hyperplasia (BPH), including among those who have a wide range of prostate sizes and/or a median lobe obstruction. The data will be presented at the 37^th Annual European Association of Urology (EAU) Congress in Amsterdam and virtually.

"Extensive research has shown that the UroLift System can consistently and rapidly improve BPH symptoms for our patients. The research conducted by some of the world's foremost BPH experts and presented at this year's EAU continues to build the body of support, which may help a broad population of men potentially avoid more invasive surgery," said Jacqueline Welch, Vice President, Global Clinical and Scientific Operations, Teleflex.

Key findings include:

• Pooled outcomes of over 300 controlled subjects from five clinical studies revealed most men shifted to lower international prostate symptom score (IPSS) symptom severity after treatment with Prostatic Urethral Lift (PUL).The majority of subjects (79%) improved by three points or more, and 66% of those patients moved into a lower IPSS severity grade 12 months post-treatment.¹
• Comparative evaluation of real-world and controlled trial outcomes of PUL demonstrated that symptom improvement is not correlated to prostate size and shape. The study examined PUL outcomes in differing gland sizes and morphologies, comparing controlled trial results from BPH6 for patients with small prostate sizes and MedLift for patients with obstructive median lobes. At 24 months, all groups demonstrated significant and sustained IPSS improvement.^2,3,6
• An analysis of U.S. healthcare claims revealed higher de novo prescription rates after transurethral resection of the prostate (TURP) and photoselective vaporization of the prostate (PVP) compared to PUL. The study revealed that post-surgical medication usage was significantly higher for BPH patients who were treated with more invasive surgical procedures as compared to those treated with the UroLift System.⁴
  

"The UroLift System is the most well-studied minimally invasive surgical therapy for BPH. In a combined analysis from five controlled studies, we found that the majority of men who had received the procedure demonstrated measurable improvement in their BPH symptoms, flow rate, and quality of life. Subjects preserved their sexual function while some patients even experienced improvement in IIEF and MSHQ-EjD scores," said Claus G. Roehrborn+, M.D., Urologist at the University of Texas Southwestern Medical Center and a lead author on the paper.*^1,5

"The evidence presented at EAU means that urologists can further help their BPH patients make an objective, data-driven, and informed decision based on real-world evidence, particularly when faced with prostate sizes and shapes that fall outside of the range of randomized clinical trials. Our research showed not only rapid, but also durable improvement," said Christian Gratzke+, Professor, Dr. Med. Medical Director, Urology Clinic, University Hospital, Freiburg.²

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 100 cc in men 45 years or older (50 years outside U.S.). The UroLift permanent implants, which can be delivered during an outpatient procedure, 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.*^7-9 Most common adverse events 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 American Urological Association and European Association of Urology clinical guidelines. More than 350,000 men have been treated with the UroLift System in select markets worldwide.¹¹ Learn more at 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.
© 2022 Teleflex Incorporated. All rights reserved. MAC02484-01 Rev.A

+Drs. Roehrborn and Gratzke are paid consultants of Teleflex.
*No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study.

References:

1. Roehrborn et al, EAU 2022. Pooled outcomes from five Prostatic Urethral Lift (PUL) controlled studies reveal most men can shift to lower IPSS symptom severity after treatment. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
2. Gratzke et al, EAU 2022. Prostatic Urethral Lift (PUL) outcomes are independent of prostate size and shape in real-world and controlled trial settings, EAU 2022. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
3. Sonksen et al. Eur Urol 2015
4. Kaplan et al. EAU 2022. De Novo BPH Prescription Rates are Higher after TURP and PVP compared to PUL: a US Healthcare Claims Analysis. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
5. Roehrborn, C.G., and Rukstalis, D.B., Eur UrolFocus 2021
6. Rukstalis, Prostate Cancer and Prostatic Dis 2018
7. Roehrborn, Can J Urol 2017
8. AUA BPH Guidelines 2003, 2020
9. McVary, J Sex Med 2016
10. Roehrborn, J Urology 2013
11. Management estimate based on product sales as of April 2022. Data on file
    

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

John Hsu, CFA
Vice President, Investor Relations
investors.teleflex.com
610-948-2836

Media:
Nicole Osmer
[email protected]
650-454-0504

Source: Teleflex Incorporated