Teleflex Announces Regulatory Clearance for its UroLift System in China

Teleflex

WAYNE, PA — Teleflex Incorporated (NYSE: TFX) announced that it recenlty 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 that may cause bothersome urinary symptoms in men. UroLift System treatment can be performed as a same-day outpatient procedure,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.

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

References

  1. Shore, Can J Urol 2014
  2. Roehrborn, Can J Urol 2017
  3. Roehrborn, J Urology 2013
  4. Teleflex Interventional Urology estimates based on OUS Market Model 2022-24 12-1-21
  5. Rukstalis, Prostate Cancer and Prostatic Dis 2018
  6. AUA BPH Guidelines 2003, 2021
  7. McVary, J Sex Med 2016
  8. Management estimates based on product sales as of April 2022. Data on file at Teleflex Interventional Urology.
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