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Zenflow Launches Pivotal Clinical Trial of Minimally Invasive Spring« Treatment for Enlarged Prostate Symptoms

10/04/2021 | 12:02pm EST

Prospective, multinational, randomized, controlled trial designed to support FDA clearance

SOUTH SAN FRANCISCO, Calif., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Zenflow, Inc., a medical device company developing a minimally invasive treatment for enlarged prostate, or benign prostatic hyperplasia (BPH), has initiated the BREEZE™ pivotal clinical trial to evaluate its Spring System. The first procedure was successfully conducted by Michael D. Trotter, M.D., lead investigator at Midtown Urology Associates in Austin, Texas.

Over 40 million men in the United States suffer from BPH, which occurs as men age and causes uncomfortable symptoms such as frequent urination and interrupted sleep. The Spring treatment was designed with the patient experience in mind and relies on a small spring-like coil to gently prop open the urethra, relieving symptoms while preserving the natural anatomy.

Thought-leading urologist Claus Roehrborn, M.D., Professor and Chair, Department of Urology, at UT Southwestern Medical Center in Dallas, is serving as Principal Investigator for the study. “The symptoms associated with enlarged prostate have a substantial impact on patients’ quality of life,” said Dr. Roehrborn. “I am encouraged by the potential for the Spring treatment to improve the patient experience and am proud to be part of this rigorous clinical trial program.”

According to Dr. Trotter, “The efficiency of the procedure and clear visual opening of the prostatic urethral channel makes the Zenflow device an exciting new tool in the treatment for BPH.”

BREEZE Trial Builds on Successful Clinical Study Results

The BREEZE clinical trial builds on data from previous successful studies. To date, over 100 patients have been treated with the Spring System in a collection of studies that demonstrated promising safety, effectiveness, and long-term durability.

Recent results from Zenflow’s pilot studies showed that at 12 months, patients displayed statistically significant symptom relief, including improved quality of life scores and increases in maximum urinary flow rates. The outcomes were recently presented at the American Urological Association 2021 annual meeting.

“We are pleased with the results we have seen to date and are excited to continue to build our foundation of clinical evidence supporting this patient- and physician-friendly device,” says Nick Damiano, Zenflow CEO. “We believe our minimally invasive treatment, which has demonstrated rapid and durable results without piercing or cutting tissue, will provide a significant benefit for the millions of men experiencing the burdensome symptoms of BPH.”

About the BREEZE Clinical Trial

The BREEZE trial is a prospective, multicenter, controlled study in patients with lower urinary tract symptoms due to enlarged prostate. Over 200 subjects will be randomized to receive either treatment using the Spring System or undergo a sham procedure at up to 25 U.S. and international centers. After three months, the BREEZE trial patients will be unblinded, and participants who received the sham procedure and meet certain criteria will be eligible to receive treatment with the Spring System. The trial’s primary effectiveness endpoints are based on change from baseline in patient-reported symptoms at three and twelve months, as measured by the International Prostate Symptom Score (IPSS).

About Zenflow

Zenflow, Inc. is a privately held medical device company dedicated to improving quality of life for patients suffering from urinary obstruction caused by enlarged prostate. The company was founded by Stanford University Biodesign Fellows working in collaboration with top global urologists who, after witnessing patients' frustration with existing treatment options, made it their mission to find a better solution. The innovative Spring® technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props open the urethra, restoring its normal function while preserving the natural anatomy. The Zenflow Spring System is an investigational device and is not approved for commercial sale.
For more information, visit www.zenflow.com.


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