Zenflow Spring System Nears FDA OK for BPH Treatment

Zenflow, Inc., a San Francisco-based medical device innovator, has secured $24 million in a Series C funding round for its innovative Spring System, a groundbreaking solution for BPH treatment, addressing urinary obstruction caused by an enlarged prostate and advancing toward FDA approval through rigorous clinical research.

The current funding will accelerate Zenflow’s efforts toward FDA approval and commercialization of its cutting-edge Spring System, a minimally invasive solution designed for patients with enlarged prostate.

Zenflow, Inc. is a leading medical device company committed to enhancing treatment options for BPH. Its innovative Spring System is currently an investigational device pending FDA clearance. Zenflow continues to push boundaries to improve the quality of life for millions affected by urinary obstruction caused by an enlarged prostate.

“This investment reflects our confidence in the Zenflow team and technology, as well as Cook’s ongoing commitment to support innovation that serves customer needs,” said DJ Sirota, Senior vice president of Cook Medical’s MedSurg division.

“The Spring System will provide men afflicted with BPH the patient-friendly treatment they deserve — one that doesn’t require tissue removal, ablation, or piercing of the prostatic tissue and allows for reversibility at the patient and physician’s discretion,” he added.

Zenflow Transforming BPH Treatment with Innovative Technology

At the heart of Zenflow’s mission lies its groundbreaking Spring System, which relies on a small, spring-like coil to gently prop open the urethra, restoring normal function while preserving the natural anatomy. With over 40 million Americans affected by BPH, the Spring System offers a promising alternative for those experiencing debilitating lower urinary tract symptoms.

The company’s CEO, Shreya Mehta, said that the Spring System’s patient-focused design ensures comfort and efficacy without compromising the body’s natural structure.

“The Zenflow Spring clinical trial data presented thus far demonstrates promising outcomes concerning patient symptom relief, urinary flow rates, and preservation of sexual function. Given its proven safety profile and option for reversibility, the Zenflow Spring System is poised to become a first-line option for urologists treating patients that suffer from symptoms of BPH,” said Claus Roehrborn, M.D., professor and chair, Department of Urology UT Southwestern Medical Center in Dallas, Texas.

Clinical Research Paves the Way for FDA Approval

Zenflow’s progress toward FDA approval is underpinned by robust clinical research, including its pivotal BREEZE trial. This prospective, multicenter, controlled study involved over 200 participants and demonstrated the effectiveness of the Spring System in alleviating symptoms caused by BPH. Zenflow’s studies encompass more than 300 patients, providing a solid foundation for its Pre-Market Approval (PMA) submission.

The funding round was led by new investor Cook Medical, alongside existing investors such as Invus Opportunities, F-Prime Capital, and Medical Technology Venture Partners. This financial boost will support Zenflow’s PMA submission and preparations for market launch upon FDA approval.

“Zenflow’s strategic focus and commitment to building a solid foundation of clinical evidence has put us in a definitive position to advance towards PMA approval,” said Shreya Mehta, CEO at Zenflow. “The addition of Cook Medical’s expertise and partnership will bolster our ability to prepare for commercialization, and we are thrilled to have their support.”

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