Zenflow, a medical device company developing a minimally invasive treatment for urinary obstruction caused by an enlarged prostate or benign prostatic hyperplasia (BPH), announced that it had raised a $24 million Series C financing round. The funding round includes new investor Cook Medical and existing investors Invus Opportunities, F-Prime Capital, Medical Technology Venture Partners, and others.
The funds will be used to support the company’s Pre-Market Approval (PMA) submission and to prepare for commercialization upon FDA approval of its Spring System, a minimally invasive treatment option for patients who suffer debilitating symptoms due to enlarged prostate. And the Spring System was designed with the patient experience in mind and relies on a small spring-like coil to gently prop open the urethra, restoring its normal function while preserving the natural anatomy. Over 40 million patients suffer from BPH in the U.S.
The company’s progress towards FDA approval is based on its solid foundation of clinical research, covering 300+ patients in multiple studies including its most recent pivotal clinical trial BREEZE, a prospective, multicenter, controlled study in 200+ patients with lower urinary tract symptoms due to enlarged prostate.
KEY QUOTES:
“The Zenflow Spring clinical trial data presented thus far demonstrates promising outcomes with respect to 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.”
– Claus Roehrborn, M.D., professor and chair, Department of Urology UT Southwestern Medical Center in Dallas, Texas
“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. 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.”
– D.J. Sirota, Senior vice president of Cook Medical’s MedSurg division
“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. 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.”
– Shreya Mehta, CEO at Zenflow
