Zenflow Announces U.S. Commercialization Progress with Four Centers Completing Zenflow Spring® Implant and Delivery System Procedures

Strong Interest from Surgeons Drives Integration of New First-Line Interventional BPH Treatment Approach

SOUTH SAN FRANCISCO, Calif., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Zenflow, Inc. today announced the first commercial procedures with the Zenflow Spring^® Implant and Delivery System for the treatment of symptoms associated with benign prostatic hyperplasia (BPH), also known as enlarged prostate. The first procedure, performed by Sijo Parekattil, MD, FACS, Founder and President of Avant Concierge Urology, took place on July 29, 2026 in his office in Winter Garden, Florida.

Approved for use by the U.S. Food and Drug Administration (FDA) in December 2025, the Zenflow Spring is a novel, first-line interventional therapy (FIT) that offers the more than 30 million U.S. men living with BPH a minimally invasive treatment option with proven long-term durability and unique safety advantages -- including no need for post-procedure catheterization, and the ability to reverse treatment if desired.

“It is very exciting that we can now offer patients a truly innovative treatment solution that will bring meaningful symptom relief and improve their quality of life,” said Dr. Parekattil, who is also a Clinical Associate Professor at the Orlando College of Osteopathic Medicine. “What’s notable for providers is that the steerable cystoscope system provides us the ability to assess the bladder and urethra before and after Spring placement, and the balloon anchoring system provides consistent and accurate Spring deployment. For patients, men can experience noticeable symptom relief almost as soon as they leave and typically avoid the discomfort of post-procedural catheterization. These and other factors combined make for a remarkable treatment option that we’re excited to offer at Avant Concierge Urology to men in our community living with BPH.”

Zenflow Spring Data Shows Meaningful Symptom Relief
The Zenflow Spring is the only FDA-approved FIT with three (3) sizes for patient personalization. It is also the only treatment delivered via a single-use flexible cystoscope, designed to enhance patient comfort during the procedure and recovery. The Zenflow Spring eliminates the need for burning, cutting, piercing, or resecting tissue used by other BPH technologies and is fully reversible, if ever needed. In the pivotal BREEZE study, there were 13% device and procedure-related adverse (AE), no serious adverse events (SAE), and 99 percent of men did not need catheterization post-procedure. Notably, patients in the BREEZE pivotal trial experienced a mean International Prostate Symptom Score (IPSS) improvement of 37 percent (9 points), demonstrating clinical success. While evidence supports that the Zenflow Spring can be removed, if ever needed, without complications, nearly 98 percent remained implanted at 12 months. There was no deterioration in sexual function reported, including erectile or ejaculatory function.

Urologists at leading urology centers across the country also recently performed their first procedures, including:

• Bilal Chughtai, MD, The Smith Institute of Urology/Northwell Health
  Plainview Hospital (Plainview, NJ)
• Mohamed Bidair, MD, Alvarado La Mesa Urology/San Diego Clinical Trials (La Mesa, CA)
• Austen Slade, MD, Dr. Slade Urology (Boise, ID)
  
  

“These first procedures represent a major milestone for Zenflow, marking our transition from R&D to commercialization. We are deeply grateful to our partner surgeons and to the first patients treated, whose trust and partnership helped us reach this moment,” said Shreya Mehta, CEO of Zenflow. “We look forward to providing our solution to millions more BPH patients in need.”

About Benign Prostatic Hyperplasia
Found in the male reproductive system, the prostate is a small gland that helps make semen and surrounds the tube that carries urine out of the body called the urethra. As men get older, the prostate can grow larger, which is called benign prostatic hyperplasia (BPH) or enlarged prostate. This growth can press on the urethra, making it harder to urinate and leading to symptoms that disrupt quality of life, including difficulty starting or fully emptying the bladder, a weak or interrupted stream, increased frequency and urgency, nighttime urination, and discomfort. An estimated 32 million men over the age of 60 in the United States and 79 million men worldwide live with BPH.¹ More than 50% of men are impacted by BPH symptoms by age 50, 70% of men by age 70, and 90% of men by age 80.²

About Zenflow
Zenflow, Inc. is a medical device company dedicated to transforming urologic care with superior design and patient-focused innovation. The innovative Zenflow Spring^® Implant and Delivery System (Zenflow Spring^® Scope, Implant, and Delivery system) was designed to optimize the patient experience for men living with benign prostatic hyperplasia (BPH) symptoms. For more information, visit www.zenflow.com, and follow Zenflow on LinkedIn and X for the latest updates.

1. Ye, Z., Wang, J., Xiao, Y. et al. Global burden of benign prostatic hyperplasia in males aged 60–90 years from 1990 to 2019: results from the global burden of disease study 2019. BMC Urol 24, 193 (2024). https://doi.org/10.1186/s12894-024-01582-w https://link.springer.com/article/10.1186/s12894-024-01582-w#citeas
2. Roehrborn CG. Benign prostatic hyperplasia: an overview. Rev Urol. 2005;7 Suppl 9(Suppl 9):S3-S14. PMID: 16985902; PMCID: PMC1477638. https://pmc.ncbi.nlm.nih.gov/articles/PMC1477638/#B1

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