Dive Brief:
- Zenflow said Monday it has raised $52 million and partnered with Cook Medical to facilitate the commercialization of a urology device.
- The agreements support the Zenflow Spring system, a treatment for benign prostatic hyperplasia that received Food and Drug Administration approval in December.
- Zenflow’s device has a different design from the BPH treatments offered by Boston Scientific, Olympus and Teleflex to bridge the gap between medicines and more invasive procedures.
Dive Insight:
BPH affected about one-third of men enrolled in Medicare aged 65 years and older from 2016 to 2023, according to National Institutes of Health data. Treatment options include drugs and surgery to partly or fully remove the prostate. Since 2013, the FDA has expanded the range of minimally invasive options by authorizing products including Boston Scientific’s Rezum, Olympus’ iTind and Teleflex’s UroLift.
Zenflow Spring is part of a new class of devices that could further expand treatment options. The device delivers a nitinol expander into the prostatic urethra, displacing lateral lobes for improved urinary flow.
In a pivotal trial, 60% of patients treated with Zenflow Spring met the response criteria, which required a 30% or greater improvement on a symptom scale at one year. The sham control treatment had a 33% response rate. In addition to the primary endpoint win, Zenflow reported a mean 37% improvement on the symptom scale, exceeding the 30% prespecified threshold for clinical success.
A physician performed the first commercial Zenflow Spring procedure in July. Four sites had completed procedures by early September. The financing and distribution deals position Zenflow to build on its early commercialization progress.
Cook Medical led the Series D round with support from new backer ClavystBio and existing investors including Invus Opportunities, F-Prime and Medtech Venture Partners. Zenflow also secured venture debt financing.
Zenflow disclosed the funding alongside news of an agreement with Cook Medical, which will be the sole U.S. distributor of the BPH device. Cook Medical will leverage the relationships it has built with urologists to launch Zenflow’s treatment.
