Zenflow secures funding and distribution deal

Cook Medical has partnered with Zenflow as the U.S. distributor in a urology device market that includes competitors Boston Scientific, Olympus, and Teleflex. On Monday, Zenflow announced it secured $52 million in funding and formed a partnership with Cook Medical to advance the commercialization of a urology device.

The partnerships underpin the Zenflow Spring system, a therapy for benign prostatic hyperplasia that earned FDA approval in December. This device’s design differs from BPH treatments provided by Boston Scientific, Olympus, and Teleflex, aiming to fill the space between medications and more invasive surgeries.

Benign prostatic hyperplasia impacted roughly one-third of Medicare beneficiaries aged 65 and older between 2016 and 2023, per National Institutes of Health data. Available treatments encompass medications and surgical interventions to partially or completely remove the prostate.

Since 2013, the FDA has broadened the spectrum of minimally invasive treatments by approving products such as Boston Scientific’s Rezum, Olympus’ iTind, and Teleflex’s UroLift. Zenflow Spring belongs to a novel device category that has the potential to further enhance treatment choices.

The system introduces a nitinol expander into the prostatic urethra, repositioning lateral lobes to improve urine flow. During a clinical study, 60% of patients receiving Zenflow Spring achieved the predefined response criteria, defined as at least a 30% reduction in symptom scores after one year.

Cook Medical spearheaded the Series D funding round alongside new investor ClavystBio and existing backers such as Invus Opportunities, F-Prime, and Medtech Venture Partners. Zenflow also obtained venture debt financing. The company announced these financial developments concurrently with an agreement that designates Cook Medical as the exclusive U.S. distributor of the BPH device.

Cook Medical will utilize its established connections with urologists to roll out Zenflow’s treatment. The initial commercial Zenflow Spring procedure was conducted by a physician in July, with four sites completing procedures by early September, setting the stage for Zenflow to capitalize on its early market entry.