Zenflow, Inc., a medical device company developing a minimally invasive treatment for urinary obstruction caused by enlarged prostate, or benign prostatic hyperplasia, closed a $24 million Series C financing round. The round includes new investor Cook Medical as well as existing investors Invus Opportunities, F-Prime Capital, Medical Technology Venture Partners and others.
Funds will be used to support the company’s Pre-Market Approval (PMA) submission and to prepare for commercialisation upon FDA approval of its Spring® System, a minimally invasive treatment option for patients who suffer debilitating symptoms due to enlarged prostate. 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.
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The company’s progress towards FDA approval is based on its solid foundation of clinical research, covering over 300 patients in multiple studies including its most recent pivotal clinical trial BREEZE™, a prospective, multicenter, controlled study in over 200 patients with lower urinary tract symptoms due to enlarged prostate.
“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,” said Claus Roehrborn, M.D., professor and chair, Department of Urology UT Southwestern Medical Center in Dallas, Texas. “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.”
“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 D.J. 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.”
“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 commercialisation and we are thrilled to have their support.”
