Zenflow Secures $24 Million to Advance Minimally Invasive BPH Treatment
Key Insights
Zenflow (search) has raised $24 million in Series C funding to support the FDA Pre-Market Approval (PMA) submission for its Spring System (search), a BPH (search) treatment.
The Spring System (search) is designed to alleviate urinary obstruction by gently propping open the urethra, preserving natural anatomy and function.
Clinical trial data demonstrates promising outcomes in symptom relief, urinary flow rates, and preservation of sexual function, with a strong safety profile.
Zenflow (search), Inc., a medical device company focused on minimally invasive treatments for benign prostatic hyperplasia (search) (BPH (search)), has announced the successful completion of a $24 million Series C financing round. The funding will primarily support the Pre-Market Approval (PMA) submission to the FDA and subsequent commercial preparation for its Spring System (search).
Spring System: A Novel Approach to BPH Treatment
The Spring System (search) represents a significant advancement in BPH (search) treatment. It employs a small, spring-like coil to gently open the urethra, thereby restoring normal urinary function while preserving the natural anatomy of the prostate. This approach aims to alleviate the debilitating symptoms of BPH, which affects over 40 million men in the U.S., without the need for tissue removal, ablation, or piercing of prostatic tissue.
Clinical Evidence and Expert Opinion
Zenflow (search)'s progress toward FDA approval is underpinned by robust clinical research, including the pivotal BREEZE trial involving over 200 patients with lower urinary tract symptoms due to enlarged prostate. Claus Roehrborn, M.D., professor and chair of the Department of Urology at UT Southwestern Medical Center, noted that the clinical trial data demonstrates promising outcomes in patient symptom relief, urinary flow rates, and preservation of sexual function. He also highlighted the Spring System (search)'s proven safety profile and reversibility, suggesting it could become a first-line treatment option for urologists treating BPH (search).
Strategic Investment and Commercialization
The financing round included new investor Cook Medical, alongside existing investors such as Invus Opportunities and F-Prime Capital. D.J. Sirota, Senior Vice President of Cook Medical’s MedSurg division, emphasized the investment as a reflection of confidence in Zenflow (search)'s technology and Cook's commitment to supporting innovation that serves customer needs. Shreya Mehta, CEO of Zenflow, stated that Cook Medical's expertise and partnership would bolster the company's ability to prepare for commercialization.