How NAMSA Helped Francis Medical with Clinical Support Thinking Outside of the Box

Client Background

Francis Medical is an innovative urology‑focused medical device company dedicated to developing minimally invasive therapies in urology. Driven by a mission to offer safer, gentler treatment options for the prostate, the company is currently advancing a proprietary water‑vapor ablation technology intended to precisely target and destroy targeted prostate tissue in the US, having executed clinical studies addressing a population of patients diagnosed with prostate cancer. They are bringing awareness to urologists and patients looking for alternatives to more invasive prostate treatments.

As Francis Medical pursued U.S. market entry for their Vanquish® System, a transurethral, outpatient procedure designed to ablate targeted prostate tissue using the thermal energy stored in sterile water vapor, they faced a regulatory challenge: while FDA had a clear pathway for prostate tissue ablation devices, no established pathway existed for obtaining a cancer‑specific indication using water‑vapor ablation technology. To advance this groundbreaking therapy, the company needed a partner with strategic biostatistics expertise to support a novel study design proposed by Francis Medical. They collaborated with NAMSA on development of the biostatisical plans.

Project Scope

Francis Medical approached NAMSA with an ambitious challenge:
How do we integrate two statistical analyses into the study design to support obtaining two unique indications, one for a novel indication of management of prostate cancer.

Client goals included:

Collaborate on a strategic pathway leading toward a future prostate cancer‑specific indication.
Provide support for managing safety adjudication and oversite.
Partner with Francis Medical on development of a electronic data capture system.

NAMSA’s scope included cross‑functional collaboration with Francis Medical’s team on study design, statistical strategy, electronic database, and safety support.

The Solution

NAMSA approached the project with a unified, strategic mindset focused on helping Francis Medical achieve both immediate and long‑term regulatory goals through creative statistical thinking and efficient execution. Working closely with Francis Medical, NAMSA developed statistical analysis plans that allowed the company to pursue 510(k) clearance while simultaneously generating data to support a future prostate cancer‑specific indication—an approach that required navigating FDA guidance and synthesizing methodologies from other medical device areas. NAMSA’s biostatistics and regulatory experts collaborated with internal and external advisors, refined protocol elements, prepared the Statistical Analysis Plans, supported FDA interactions, and guided key strategic decisions around blinding, communication, and risk.

As the trial progressed, NAMSA also transformed the study’s safety oversight structure. Initially, Francis Medical operated with a Clinical Events Committee (CEC) responsible for reviewing all adverse events. NAMSA introduced a dedicated medical monitor to streamline AE assessment and transitioned the CEC into a Data Safety Monitoring Board (DSMB) focused on aggregate data review and trial oversight, enabling a more efficient and sustainable safety review process without compromising quality or compliance.

Throughout the project, NAMSA acted not only as a CRO partner but as a strategic collaborator, integrating expertise in study design, statistics, EDC development, and safety oversite. This cross‑functional, “think‑outside‑the‑box” approach allowed the team to address challenges quickly, align multiple stakeholders, and maintain a strong, unified clinical strategy.

The Outcome

The collaboration between Francis Medical and NAMSA resulted in a milestone achievement by Francis Medical: FDA 510(k) clearance for the Vanquish® System, marking the first major step in a broader, unprecedented regulatory strategy toward a future prostate cancer‑specific indication. While the clearance itself was critical, the true breakthrough was the FDA’s agreement on a novel dual‑indication pathway, establishing a regulatory roadmap that had not previously existed for ablation technologies in prostatic oncology.

Through strategic alignment sessions, iterative FDA interactions, and innovative study design work, NAMSA helped Francis Medical achieve something far more significant than a single regulatory milestone. Francis Medical has secured a forward‑looking framework to pursue its ultimate goal of a prostate cancer-specific indication using a minimally invasive, outpatient treatment approach.

Key achievements by Francis Medical include:

FDA acceptance of an innovative dual‑indication regulatory pathway, unlocking a new model for cancer‑related device claims.
Successful 510(k) clearance of the Vanquish® System

Ultimately, this partnership established Francis Medical not as “another player” in the urological landscape, but as a true innovator, and showcased how collaborative, creative study design can reshape what is possible in medical device development.

Francis Medical prides itself in thinking outside the box on all aspects of technology development, including its clinical and regulatory strategy.  With our clinical leadership having a long history with Chris Mullin, we knew we were well positioned to develop a novel strategy and successfully collaborate with FDA on a unique study design. This first 510(k) clearance milestone was an important step in that longer-term strategy.

Michele Shepard, VP of Clinical Affairs at Francis Medical