MAPLE GROVE, Minn., June 30, 2026
Francis Medical announced the publication of initial results from its VAPOR 2 pivotal clinical trial in The Journal of Urology, highlighting encouraging early outcomes for the Vanquish® Water Vapor Ablation System in patients with intermediate-risk localized prostate cancer. The published data include findings from the first 110 patients enrolled in the prospective, multicenter, single-arm pivotal study, which is evaluating the safety and effectiveness of the minimally invasive transurethral water vapor ablation technology across 26 clinical sites in the United States. The publication represents a significant milestone in the company’s clinical development program as it continues to generate evidence supporting future regulatory expansion.
VAPOR 2 Trial Demonstrates Promising Early Clinical Outcomes
The published results showed that 91% of MRI-visible Grade Group 2 or higher prostate cancer lesions were successfully cleared following a single treatment. Investigators also reported no device-related serious adverse events, along with low rates of urinary incontinence and erectile dysfunction, highlighting the therapy’s favorable safety profile. Additionally, 93% of treated patients reported satisfaction with the procedure. The study further demonstrated the system’s ability to effectively treat lesions throughout the prostate, including anatomically challenging regions that have traditionally limited other focal therapy technologies.
Water Vapor Ablation Designed to Preserve Quality of Life
The Vanquish® Water Vapor Ablation System delivers sterile water vapor directly into targeted prostate tissue through a minimally invasive transurethral approach. As the vapor condenses, thermal energy is released within the treatment zone, causing localized cellular destruction while remaining confined to natural tissue boundaries. This targeted mechanism is intended to destroy cancerous tissue while minimizing damage to surrounding structures responsible for urinary continence and erectile function, potentially offering an effective treatment option that preserves patients’ quality of life.
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Long-Term Follow-Up Continues Toward PMA Submission
The VAPOR 2 study plans to enroll 235 patients and will continue monitoring participants for five years to evaluate long-term safety and oncological outcomes. Francis Medical intends to use the complete clinical dataset to support a future Premarket Approval (PMA) submission seeking an expanded indication for the management of clinically localized prostate cancer. Company leadership stated that the publication strengthens the growing body of clinical evidence supporting thermal water vapor ablation as a promising minimally invasive focal therapy for prostate cancer.
Source: Francis Medical press release
