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Money will support a PMA submission of minimally invasive treatment for enlarged prostate symptoms.
January 13, 2025
By: Michael Barbella
Zenflow Inc. has closed a $24 million Series C financing round that includes new investor Cook Medical as well as existing support from Invus Opportunities, F-Prime Capital, Medical Technology Venture Partners, and others.
“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.”
The money will be used to support the company’s Pre-Market Approval (PMA) submission and to prepare for commercialization upon U.S. Food and Drug Administration (FDA) approval of its Spring System, a minimally invasive treatment option for patients suffering from debilitating enlarged prostate symptoms. 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. More than 40 million U.S. patients suffer from benign prostatic hyperplasia (BPH)—a.k.a., an 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.”
The company’s path to FDA approval is based on its foundation of clinical research, covering more than 300 patients in multiple studies including its most recent pivotal clinical trial BREEZE—a prospective, multicenter, controlled study in over 200 BPH patients with lower urinary tract symptoms.
“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,” Zenflow CEO Shreya Mehta said. “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.”
Zenflow, Inc. is a medical device company striving to improve treatment for patients suffering from urinary obstruction caused by enlarged prostate. The Zenflow Spring System is an investigational device and is not approved for commercial sale.
Since 1963, Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. The company invents, manufactures, and delivers medical devices to healthcare systems worldwide.
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