Sirius Medical's Pintuition Shows Outstanding Results in iBRA-NET Study

Introduction

In a significant breakthrough for breast surgery, Sirius Medical has announced impressive findings from the iBRA-NET localization study. The study validates the efficacy of the Pintuition Surgical Marker Navigation system, asserting its effectiveness as a safe and reliable solution, especially in the context of non-palpable breast lesions.

iBRA-NET Study Overview

Conducted as part of the largest international multicenter patient cohort to date, the iBRA-NET study involved 1,899 patients and provided compelling evidence favoring the Pintuition system over traditional wired localization methods. Comparatively, Pintuition achieved a remarkable success rate of 99.4%, closely mirroring the performance of a significant cohort utilizing wire-guided localization (n=1,170).

Notably, the Pintuition system was associated with a significantly lower rate of positive margins at 10.4%, compared to 15.0% for the wire-guided group. This is a crucial metric, as positive margins can lead to additional surgeries and complications. Moreover, rates of re-excision and general safety outcomes showed no significant differences between the two methodologies, highlighting the reliability of Pintuition.

Clinical Significance

"These results reaffirm the clinical value of the Pintuition Surgical Marker Navigation system," stated Kitty Kempen, the Director of Clinical Medical Affairs at Sirius Medical. She emphasized the company's mission to provide intuitive navigation solutions that enhance surgical precision, streamline workflows, and improve patient experiences.

The Pintuition system utilizes a GPS-like navigation platform that aids surgeons in precisely locating tumors during breast-conserving surgeries. With its unique TargetLOC® feature, it indicates when the probe is directly above the Pintuition marker, combined with real-time acoustic and visual guidance. This sophisticated approach alleviates the limitations posed by conventional wired techniques, resulting in unparalleled accuracy in tumor localization.

The Expert's Perspective

Edward St John, the lead investigator of the iBRA-NET study, noted, "This represents the largest prospective dataset comparing wire-based localization to a wireless alternative. The findings demonstrate that the surgical marker navigation with Pintuition is not inferior to wire-based localization. Pintuition is an effective technique that offers tangible benefits for both patients and surgical teams."

These encouraging results were presented at the 2025 Association of Breast Surgery (ABS) conference by Mr. Edward St John and Mr. Rajiv Dave, further underscoring the clinical relevance and dynamism of surgical marker navigation in breast-conserving surgeries. A complete publication detailing the study's methodologies and findings is anticipated in the coming months.

About iBRA-NET

iBRA-NET consists of a multidisciplinary network of breast and plastic surgeons, health practitioners, and patients from across the UK. The initiative emphasizes the importance of rigorous evaluations of new surgical techniques, devices, and implants within the domain of oncoplastic breast surgery, adhering to the philosophy of "No innovation without evaluation." Their work receives support from esteemed professional organizations, including the Association of Breast Surgery (ABS), the Royal College of Surgeons of England (RCSE), and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS).

About Sirius Medical

Rooted in the Netherlands' cancer institute, Sirius Medical is dedicated to enhancing the treatment of cancer patients by offering innovative yet affordable solutions that facilitate precise and efficient tumor removal. The Pintuition technology is designed to be simple, accurate, and accessible, earning both CE marking and FDA certification. Sirius Medical is experiencing rapid growth, with over 50,000 procedures performed globally across more than 250 centers, supported by an extensive distribution network spanning the USA, Western Europe, Australia, and New Zealand.