Teleflex Announces the Launch of the UroLift® System in Japan for the Treatment of Benign Prostatic Hyperplasia (BPH)

Rhea-AI Summary

Teleflex Incorporated (NYSE: TFX) has launched the UroLift System in Japan, addressing benign prostatic hyperplasia (BPH). This minimally invasive treatment offers quick symptom relief and allows patients to resume normal activities while preserving sexual function. With prior reimbursement approval from the Central Social Insurance Medical Council of Japan, the system is now commercially available. Teleflex aims to make the UroLift System the standard of care for BPH globally, marking a significant step in its overseas expansion strategy.

Positive

• Launch of the UroLift System in Japan enhances market presence.
• Approval from Japan's Central Social Insurance Medical Council facilitates reimbursement.
• Minimally invasive treatment provides quick recovery and symptom relief for patients.

Negative

• None.

Initial Cases Have Now Been Performed in Japan

WAYNE, Pa., April 11, 2022 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, has announced the launch of the UroLift System in Japan for treating benign prostatic hyperplasia (BPH), or enlarged prostate. The UroLift System is now available for purchase, effective immediately. Teleflex previously announced reimbursement approval from the Central Social Insurance Medical Council of Japan (Chuikyo).

BPH is a common condition marked by bothersome urinary symptoms that can cause loss of productivity, depression, interrupted sleep, and decreased quality of life.¹ The UroLift System is a minimally invasive approach to treating BPH that can be performed as a same-day outpatient procedure^.2  The UroLift System provides rapid symptom relief for men with BPH and allows a quick recovery time for patients.³ Men can return to their normal routines and can preserve sexual function*^4-6 with minimal downtime.^2,3 The UroLift System can help improve quality of life.⁴

Liam Kelly, Chairman, President, and Chief Executive Officer of Teleflex said, “As we execute on our overseas expansion strategy for the UroLift System, Japan represents an important milestone in our progress. The UroLift System offers clinical benefits in the minimally invasive treatment of BPH. Our commercialization in Japan marks another step in our goal to make this novel therapy more broadly available to men outside the United States suffering from BPH. Teleflex remains committed to its goal to make the UroLift System the standard of care in the treatment of BPH globally.”

Nam Lee, Teleflex Managing Director in Japan said, “Launching the UroLift System in Japan and offering new treatment options for patients with BPH is monumental. We are pleased to be able to help more patients with BPH with this proven treatment and look forward to the continued global growth of the UroLift System.”

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 in the U.S. In Japan, the UroLift System is indicated for patients with difficulty urinating associated with benign prostatic hyperplasia (BPH). The UroLift permanent implants, delivered during an outpatient procedure, relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue.² The UroLift 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.*^4-6 Most common adverse events 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 American Urological Association and European Association of Urology clinical guidelines. More than 300,000 men have been treated with the UroLift System in select markets worldwide.⁸ 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.

About Teleflex Interventional Urology
The Teleflex Interventional Urology Business Unit is dedicated to developing innovative, minimally invasive, and clinically effective devices that address unmet needs in the field of urology. Our focus is on improving the standard of care for patients with BPH using the UroLift^® System, a minimally invasive, permanent implant system that treats symptoms while preserving sexual function.* ^4-6 Learn more at UroLift.com

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

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

Yuka Shigeno
Japan Marcom External Communication Department
yuka.shigeno@teleflex.com
090-9017-8213

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

References:
1. Speakman et al. 2014 BJUI International
2. Shore, Can J Urol 2014
3. Roehrborn, J Urology 2013
4. Roehrborn, Can J Urol 2017
5. AUA BPH Guidelines 2003, 2020
6. McVary, J Sex Med 2016
7. Rukstalis, Prostate Cancer and Prostatic Dis 2018
8. Management estimate based on product sales and average units per procedure

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. MAC02420-01 Rev A.

FAQ

What is the UroLift System launched by Teleflex in Japan?

The UroLift System is a minimally invasive treatment for benign prostatic hyperplasia (BPH), designed to relieve urinary symptoms.

When was the UroLift System made available for purchase in Japan?

The UroLift System became available for purchase immediately following its launch announcement on April 11, 2022.

How does the UroLift System benefit patients with BPH?

It offers rapid symptom relief, allows for same-day outpatient procedures, and helps preserve sexual function with minimal downtime.

What approval did Teleflex receive for the UroLift System in Japan?

Teleflex received reimbursement approval from the Central Social Insurance Medical Council of Japan.

What are the key goals of Teleflex with the UroLift System?

Teleflex aims to expand the UroLift System's availability globally and establish it as the standard of care for BPH treatment.