Francis Medical Announces Strategic Financing to Accelerate Commercial Expansion and Complete Prostate Cancer Management Indication PMA Program

MAPLE GROVE, Minn., Nov. 10, 2026 /PRNewswire/ -- Francis Medical, Inc., a medical device company dedicated to advancing minimally invasive therapies for urological cancers, today announced that it has entered into an agreement for financing led by Johnson & Johnson through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc (JJDC). This financing agreement represents an important milestone in Francis Medical's long-term growth strategy and provides sufficient capital support to scale commercial infrastructure, expand market access initiatives, and strengthen physician training and education programs to drive broader adoption of the Vanquish System. Importantly, the investment provides sufficient capital to support the company through its planned Premarket Approval (PMA) submission to the FDA for the management of clinically localized prostate cancer.

"This is a pivotal moment in Francis Medical's evolution as we prepare to transition from a limited commercial launch to a broader U.S. market presence," said Mike Kujak, President and CEO of Francis Medical. "With the support of JJDC, we are positioned to accelerate the development of our commercial organization, expand physician access to our technology, and establish the infrastructure necessary to support sustainable growth. At the same time, we remain passionately committed to advancing the clinical evidence and regulatory milestones required to pursue an indication for the management of prostate cancer. Our vision is to make Vanquish an important minimally invasive treatment option for men facing prostate cancer."

Vanquish is a transurethral, ultrasound and electromagnetically guided thermotherapy system designed to ablate targeted prostate tissue using convective water vapor energy. The platform enables targeted delivery of thermal energy within the prostate, with the goal of achieving effective tissue ablation while minimizing impact to surrounding structures associated with urinary and sexual function. The Vanquish System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in November 2025 that was supported by positive interim follow-up data in the company's ongoing VAPOR 2 pivotal study.

Francis Medical continues to advance its clinical development program through the VAPOR 2 pivotal study, a prospective, multicenter, single-arm trial enrolling 235 patients with intermediate-risk, localized prostate cancer across 26 U.S. clinical sites. Initial results from the first 110 patients, recently published in The Journal of Urology, demonstrated that 91% had no clinically significant MRI-visible cancer in the treated area following a single procedure, with no device-related serious adverse events reported. The procedure was also well tolerated with 93% of patients indicating that they were satisfied or extremely satisfied, and 94% said that they believed that receiving the procedure was a wise decision. The study will continue to follow patients to five years, gathering longer-term outcomes.

"Francis Medical was founded on the belief that men facing prostate cancer deserve treatment options that address their disease while preserving their quality of life," said Michael Hoey, Founder and Chief Technology Officer of Francis Medical. "Behind every diagnosis is a person, a family, and a future worth protecting. That belief inspired the development of Vanquish and continues to drive everything we do. This investment brings us closer to realizing our vision, enabling us to expand access to our technology and advance our mission to improve the future of prostate cancer care."

Piper Sandler served as exclusive financial advisor to Francis Medical in relation to the transaction.

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 the company website https://www.francismedical.com

Forward-Looking Statements

This press release contains forward-looking statements regarding anticipated financing, future regulatory submissions and clearances, commercial expansion, clinical development, and potential indications for the Vanquish System. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. Francis Medical undertakes no obligation to update these statements except as required by applicable law.

SOURCE Francis Medical, Inc.