#USA #Eindhoven #Sirius Medical #Pintuition #iBRA-NET

Pintuition's Validation: A New Era in Surgical Navigation

Sirius Medical has recently shared groundbreaking results from the iBRA-NET study that proves Pintuition's effectiveness as a navigation system for surgical procedures, especially for locating impalpable breast lesions. This validation is particularly significant, as it demonstrates Pintuition as a reliable and safe alternative to traditional wire-guided localization techniques.

In an extensive international multicenter cohort comprising 1,899 patients, the study revealed that Pintuition achieved an impressive localization success rate of 99.4%. This rate of success is comparable to that observed in a large cohort using wire-guided localization, which consisted of 1,170 patients. Notably, Pintuition showed a substantially lower rate of positive margins at 10.4%, compared to 15.0% with wire-guided methods, with a p-value of 0.013. Both groups exhibited no significant differences in re-excision rates and overall safety outcomes.

Kitty Kempen, Sirius Medical's Director of Clinical and Medical Affairs, expressed, "These results affirm the clinical value of Pintuition Surgical Marker Navigation. They strengthen our mission to provide intuitive navigation solutions that enhance surgical precision, streamline workflows, and elevate patient experiences."

Pintuition serves as a GPS-like navigation platform for surgeons, allowing for precise tumor localization during breast-conserving surgeries. Its unique TargetLOC® feature signals when the probe is directly aligned above the Pintuition marker and is complemented by real-time audio and visual guidance. This innovation enables unparalleled precision, streamlining tumor localization, while overcoming the limitations of traditional wire-based techniques.

Edward St John, the principal investigator for the iBRA-NET study, shared insights on the significance of this research: "This represents the largest prospective dataset to date comparing wire localization with a wireless alternative. Our findings demonstrate that surgical marker navigation with Pintuition is not inferior to wire localization. It is an exceedingly effective technique that provides tangible benefits to patients and surgical teams alike."

The iBRA-NET Pintuition results were presented by Edward St John and Rajiv Dave at the 2025 Association of Breast Surgery (ABS) conference, underscoring the clinical relevance and momentum of Surgical Marker Navigation in breast-conserving surgery. A comprehensive publication of these findings is anticipated in the upcoming months.

About iBRA-NET

The iBRA-NET project brings together a multidisciplinary network of breast surgeons, plastic surgeons, healthcare professionals, and patients across the UK. Guided by the mission “no innovation without evaluation,” the network is committed to rigorously assessing new surgical techniques, systems, and implants within the realm of oncoplastic breast surgery. Their efforts are supported by leading professional bodies 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

Sirius Medical, with its roots at the Netherlands Cancer Institute, is dedicated to enhancing care for cancer patients by providing affordable yet unmatched solutions for precise tumor excision. The Pintuition® technology is designed to be simple, accurate, affordable, CE marked, and FDA approved. Having seen rapid growth, Sirius Medical has facilitated over 50,000 procedures globally across more than 250 centers and develops a commercial network covering the USA, Western Europe, Australia, and New Zealand.

For press inquiries, please contact:
Benjamin Tchang
Global Marketing Director
Sirius Medical
Phone: +31 647 852 805
Email: [email protected]