Teleflex Announces Regulatory Clearance for its UroLift® System in China for the Treatment of Benign Prostatic Hyperplasia (BPH)
Teleflex Incorporated has announced the National Medical Products Administration (NMPA) approval for its UroLift® System in China, aimed at treating benign prostatic hyperplasia (BPH). This minimally invasive treatment offers symptom relief with same-day outpatient procedures. CEO Liam Kelly highlighted this as a critical step in the company's international expansion, providing treatment options for over 25 million men in China diagnosed with BPH. The company anticipates commercialization by Q4 2022.
- NMPA approval for UroLift System enhances market reach in China.
- Targeting over 25 million men suffering from BPH in China.
- Minimally invasive treatment improves patient quality of life and offers same-day procedures.
- None.
Will expand patient access to BPH treatment
WAYNE, Pa., May 19, 2022 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that it has received National Medical Products Administration (NMPA) approval for its UroLift® System in China for treating benign prostatic hyperplasia (BPH).
Treatment with the UroLift® System is a minimally invasive approach to treating BPH, commonly known as an enlarged prostate, a condition which may cause bothersome urinary symptoms in men. UroLift System treatment can be performed as a same-day outpatient procedure,1 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 of Teleflex said, “China is another milestone in our overseas expansion strategy for the UroLift® System and provides healthcare practitioners in that region more options for treating men suffering from BPH. As a key component of our durable growth strategy, Teleflex remains committed to making the UroLift® System the standard of care in the treatment of BPH globally.”
Ben Cheong, Managing Director in China for Teleflex said, “Launching the UroLift® System in China and offering new treatment options for patients with BPH is exciting. We are pleased to be able to bring this novel treatment option to the over 25 million men diagnosed with BPH in China.”4
With regulatory clearance now received, Teleflex will seek commercialization of the product in China in the fourth quarter of 2022.
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 in the U.S. In China, it is indicated for the improvement of symptoms due to urinary outflow obstruction secondary to BPH (lateral and median lobe hyperplasia, prostate volume after hyperplasia is between 30cc-80cc) in men 50 years of age or older. The UroLift 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.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 350,000 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.* 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.
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.
Contacts:
Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
John Hsu, CFA
Vice President, Investor Relations
investor.relations@teleflex.com
610-948-2836
*No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study.
References
- Shore, Can J Urol 2014
- Roehrborn, Can J Urol 2017
- Roehrborn, J Urology 2013
- Teleflex Interventional Urology estimates based on OUS Market Model 2022-24 12-1-21
- Rukstalis, Prostate Cancer and Prostatic Dis 2018
- AUA BPH Guidelines 2003, 2021
- McVary, J Sex Med 2016
- Management estimates based on product sales as of April 2022. Data on file at Teleflex Interventional Urology.
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. MAC02466-01 Rev A
FAQ
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