Francis Medical Announces Publication of VAPOR 2 Pivotal Trial Results in The Journal of Urology

• Published data demonstrates promising early-stage oncological control, a favorable safety profile, and the ability to treat lesions throughout the prostate using Vanquish® Water Vapor Ablation

MAPLE GROVE, Minn., June 30, 2026 - Francis Medical, Inc., a medical device company dedicated to advancing minimally invasive therapies for urological cancers, today announced the publication of the initial report from its VAPOR 2 pivotal clinical study in The Journal of Urology , one of the world's leading peer-reviewed urology journals.

The publication reports outcomes from the first 110 patients enrolled in the multicenter VAPOR 2 study evaluating the Vanquish® Water Vapor Ablation System, a minimally invasive transurethral therapy designed to ablate targeted prostate tissue using convective thermal water vapor energy. The VAPOR 2 study is a prospective, multicenter, single-arm pivotal trial enrolling 235 patients with intermediate-risk, localized prostate cancer across 26 U.S. clinical sites.¹

Among the key findings reported:

• 91% clearance of targeted MRI-visible Grade Group 2 or greater disease following a single treatment¹
• No device-related serious adverse events¹
• Low rates of urinary incontinence and erectile dysfunction¹
• 93% patient satisfaction¹
• Demonstrated ability to effectively treat lesions throughout the prostate, including anatomically challenging locations that have historically limited other focal therapy technologies.¹

"The publication of the VAPOR 2 study in The Journal of Urology represents a significant milestone for Francis Medical and for the evolving field of focal therapy," said Mike Kujak, President and CEO of Francis Medical. "The initial results support the potential of water vapor ablation as a safe and effective minimally invasive therapy capable of achieving meaningful prostate tissue ablation while preserving quality of life in men with localized prostate cancer."

The VAPOR 2 study will continue following patients to five years, gathering longer-term outcomes to support a pre-market approval (PMA) submission for an expanded indication for the management of clinically localized prostate cancer.

"This publication adds to the growing body of evidence supporting thermal water vapor ablation as a promising focal therapy ablative modality," said Dr. Samir Taneja, Co-Principal Investigator of the VAPOR 2 study and corresponding author of the publication. "The ability to target and ablate prostate tissue while minimizing impact on surrounding structures may provide an important treatment option for appropriately selected patients."

Vanquish utilizes sterile water vapor delivered directly into targeted prostate tissue through a transurethral approach. As the vapor condenses, stored thermal energy is released within the treatment zone, causing cellular necrosis while remaining confined to natural tissue boundaries. This enables targeted treatment of prostate lesions while helping preserve structures associated with urinary continence and erectile function.

"The publication of VAPOR 2 marks an important step in our commitment to generating high-quality clinical evidence," said Kujak. "We remain focused on building the evidence necessary to expand treatment options for men seeking effective, minimally invasive prostate care."

The full manuscript is now available via online open access in The Journal of Urology ¹ .

Disclosure: The Vanquish Water Vapor Ablation System has been cleared as a tool for the thermal ablation of targeted prostate tissue via a transurethral approach. The FDA has not evaluated the Vanquish System for the treatment of any disease, including prostate cancer, or evaluated the Vanquish System for any long-term prostate cancer treatment outcomes.

About Francis Medical

Francis Medical is committed to developing urological cancer treatments that are tough on cancer and gentle on patients, driven by compassionate belief and clinical data supporting minimally invasive therapies that safely and effectively treat cancerous tissue. For more information on Francis Medical, visit www.francismedical.com or call (763) 951-0370.