Teleflex Receives Reimbursement Approval for the UroLift® System in Japan

Rhea-AI Summary

Teleflex Incorporated has received reimbursement approval for its UroLift System to treat benign prostatic hyperplasia (BPH) in Japan, effective April 1, 2022. This minimally invasive procedure offers symptom relief and improved quality of life for men suffering from BPH. CEO Liam Kelly emphasized the strategic investment in UroLift's commercial capabilities in Japan, aiming to train medical staff by early 2022. The UroLift System, already used in over 300,000 cases worldwide, is expected to significantly benefit the over two million affected men in Japan.

Positive

• Reimbursement approval for UroLift System in Japan opens market access, enhancing potential revenue.
• UroLift provides a minimally invasive treatment option, leading to improved patient quality of life.
• Plans for a post-market clinical study indicate ongoing commitment to product efficacy and safety.

Negative

• None.

Will expand patient access to breakthrough BPH treatment

WAYNE, Pa., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX) today announced that the company has received reimbursement approval from the Central Social Insurance Medical Council of Japan (Chuikyo) of its UroLift System for patients who require treatment for benign prostatic hyperplasia (BPH).

The UroLift System treatment is a minimally invasive approach to treating BPH, commonly known as an enlarged prostate, a condition that causes bothersome urinary symptoms in men. Performed as a same-day outpatient procedure,¹ the UroLift System can help improve quality of life,² and offers lasting relief from symptoms with minimal downtime for patients.^1,3

Liam Kelly, Chairman, President and Chief Executive Officer said, “I am proud of how the team has achieved reimbursement approval for the UroLift System in Japan. We have strategically directed investment into developing our UroLift commercial and clinical capabilities in Japan and will be in a position to perform our first training cases in the first quarter of 2022. We are excited to bring this clinically beneficial treatment to the more than two million men suffering from BPH in Japan.⁴”

“The UroLift System is a major advancement in the treatment of BPH and can positively impact patients’ quality of life. We are very excited to have this technology available soon in Japan and look forward to its use in treating our patients,” said Satoru Takahashi, Professor and Chairman, Department of Urology, Nihon University School of Medicine.**

The newly approved reimbursement for the UroLift System in Japan goes into effect April 1, 2022. Teleflex currently plans to enroll a PMDA-mandated, post-market clinical study to expand its already robust clinical data on the efficacy of the UroLift System and support widespread adoption of the UroLift System in Japan.

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, 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.⁵ It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.^*2,6,7 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 and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine, 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.^*2,6,7   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:

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

John Hsu, CFA
Vice President, Investor Relations

investor.relations@teleflex.com
610.948.2836

Media:
Nicole Osmer
nicole@healthandcommerce.com 
650.454.0504

*No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study.
**Previously a paid consultant of Teleflex Incorporated or its affiliates.

References

1. Shore, Can J Urol 2014
2. Roehrborn, Can J Urol 2017
3. Roehrborn, J Urology 2013
4. Management market estimates for Japan 2021, data on file
5. Rukstalis, Prostate Cancer and Prostatic Dis 2018
6. AUA BPH Guidelines 2003, 2020
7. McVary, J Sex Med 2016
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.
© 2021 Teleflex Incorporated. All rights reserved

MAC02332-01 Rev A

FAQ

What is the UroLift System and how does it work?

The UroLift System is a minimally invasive treatment for BPH that relieves prostate obstruction without removing tissue, offering symptom relief with minimal downtime.

When will the UroLift System be available for use in Japan?

The UroLift System will be available for use in Japan starting April 1, 2022.

How many men suffer from BPH in Japan?

Over two million men in Japan are estimated to suffer from benign prostatic hyperplasia (BPH).

What are the benefits of the UroLift System compared to traditional BPH treatments?

The UroLift System is less invasive and has been shown not to cause new onset erectile or ejaculatory dysfunction, which is a common concern with traditional treatments.

What indicates Teleflex's commitment to the UroLift System in Japan?

Teleflex's strategic investments and plans for training healthcare professionals highlight their commitment to expanding the UroLift System's adoption in Japan.