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A non-invasive way to localize breast cancer
Surgically removing a cancerous tumour requires a precise way for a clinician to locate and remove the tumour. Many breast tumours can be detected by touch during a physical exam. Others, such as the non-palpable tumours, can’t be felt during a physical examination.
For decades, surgeons and radiologists have relied on wire localization to mark the location of a tumour to be excised during surgery. While it’s effective for removing many non-palpable tumours, the procedure comes with substantial discomfort and anxiety, the risk of the wire getting dislodged out of place, and significant scheduling constraints, as it requires tight coordination between radiology and surgical schedules.
For patients with non-palpable breast cancer, breast cancer care teams need a more streamlined way to remove the tumor quickly and efficiently while minimizing patient discomfort. Sirius Medical’s Pintuition System is designed to address these challenges.
I spoke with the Sirius Medical team to first understand why they developed the Pintuition System and then highlight what it means to implement this system for breast cancer care.
The interview
Introducing the Pintuition System
PN: How were non-palpable breast tumours typically localized before Pintuition? What kinds of limitations or burdens was the system designed to address?
KR: In the past, clinicians had access to two standard methods for localizing non-palpable tumours. Both remain in widespread use in some areas today, but also leave open opportunities to combine accuracy with greater workflow flexibility:
- Wire-guided localization (WGL) has traditionally been considered the gold-standard since the 1970’s for breast cancer localization. However, WGL requires tight coordination between radiology and surgery, as the wire is typically placed on the day of surgery. The externalized wire can also be uncomfortable for patients and may shift during transfer.
- Radioactive seed localization (RSL) was later introduced to address some of these limitations by removing the need for a protruding wire and enabling more flexible scheduling. Although the technique has been adopted across the European Union, it has also seen limited adoption in the rest of the globe. It introduces additional requirements, including radiation safety protocols and specialized infrastructure, which contributed to its limited.
Pintuition is an FDA-approved, wire-free localization system that’s designed to localize non-palpable tumours that overcomes many of these challenges. The Pintuition Marker® can be placed in advance and remain in situ from biopsy through to surgery. This means that hospitals can decouple radiology and surgery schedules to support more patients per day. Furthermore, the Pintuition System provides real-time navigational feedback to the tumour, supporting better surgical planning and accurate tumour excision.
As Mr. Edward St John, principal investigator of the iBRA-NET study, summarized: “Surgical Marker Navigation with Pintuition is non-inferior to wire-based localization. Pintuition is a highly effective technique with tangible benefits for patients and surgical teams alike.”
Pintuition's benefits for clinicians
PN: Surgeons and radiologists sit in at different stages of the diagnostic and treatment process for breast cancers. How does Pintuition support each group during tumour localization, surgical planning, and removal?
BT: Pintuition was born in the operating room. It originated as the Master’s and PhD project of our Founder and CEO, Bram Schermers, who worked closely with surgeons and radiologists to develop an alternative to iodine seed localization that delivers the same clinical benefits without the associated logistical and regulatory challenges.
Breast tumour localization is inherently a multidisciplinary process, with radiologists and surgeons each playing a critical role. Radiologists use ultrasound guidance to accurately place the Pintuition marker within or adjacent to the lesion, providing a reliable target for surgery. During the procedure, surgeons use the wireless Pintuition probe to precisely locate the marker and navigate to the tumour, enabling confident and efficient removal while preserving healthy tissue.
By supporting both specialists with technology tailored to their workflow, Pintuition creates a seamless connection between tumour localization, surgical planning, and tumour excision, helping improve efficiency, confidence, and the overall patient journey.
Radiologists
For the radiologist, placement is straightforward and predictable. The Pintuition® Marker is pre-loaded into a sharp 14-gauge needle with an ultrasound-enhanced tip and a locking mechanism. On deployment, the radiologist can feel the exact moment when the marker is released and control when to place the marker, even at the time of biopsy. They can also use a 7 cm needle for broader clinical use and have the option to use probe re-sterilization to improve cost efficiency. Furthermore, since the marker is a permanent magnet, the signal is consistent and reliable regardless of marker orientation and is not impacted by fluid or electrocautery currents.
Surgeons
When surgeons use the Pintuition System, they receive something that no wire can: directional choice. Since the magnetic field can be detected from any direction, our GPSDetect® software, enable surgeons to navigate to the tumour with ease and know the precise moment they’re above the marker with TargetLOC®. These features support surgeons planning the shortest and most cosmetically favorable route to the tumor, which may offer preferred oncoplastic outcomes.
Clinician Testimonials
PN: I understand that clinicians have already begun using the Pintuition system and benefitting from it. What do they like most about it? And how has feedback helped you continue to improve on the precision and ease through which tumours can be localized for breast cancer?
KR: The name “Pintuition” is comprised of the words “pinpoint” and “intuitive” to reflect the precision and ease-of-use of the technology. We’ve been able to integrate these features thanks to clinician feedback, which has been the engine of every product iteration.
GPSDetect itself was developed in direct response to surgeon requests for clearer directional and distance information. As Mr. Edward St John noted, “The speed of innovation has been impressive, and the Sirius team did an amazing job of addressing surgical user feedback by introducing the GPSDetect software.” The Pintuition Slim Probe is another example; we reduced the tip surface area by 55% without affecting precision or performance, in response to requests from surgeons doing axilla procedures and Hidden Scar™ surgeries. Most recently, the 7 cm needle variant, probe re-sterilization options, and the long-term implant indication all came directly from clinician and hospital input.
As we developed Pintuition, we’ve seen three themes emerge time and time again, all of which reflect the name of our system:
Reliability
Miss Tamara Kiernan, a leading breast surgeon consultant, summarized the reliability of the Pintuition system in four words:
“It simply works every time.”
That feeling is now backed by real-world data. Dr. Jean Bao at Stanford also recently put this statement on the record: “I can say with confidence that we can find the Pintuition seed 100% of the time, regardless of tissue density or the presence of fluid or hematoma.” For a surgeon mid-lumpectomy, that consistency matters more than any single feature.
Intuitive feel
The combination of audio and visual guidance through GPSDetect means surgeons can keep their eyes on the patient rather than on a screen. Prof. Dr. Thorsten Kuehn captured it nicely: “I like the Pintuition System because it has an excellent navigation system, it is easy to use and the experience is excellent.” In Dr. Bao’s Stanford study, that ease translated into something quantifiable — a 21% reduction in operative time compared to another wire-free technology, with median OR times of 37 minutes versus 50 minutes. She described the learning curve as effectively non-existent: “It’s just so intuitive to use.” 1
Assurance that you are above the marker
We designed the navigation workflow with TargetLOC® to easily guide the surgeon to the marker from any orientation. Surgeons consistently appreciate being able to choose how to reach the tumour, which translates directly into better oncoplastic and cosmetic outcomes.
Benefits for the patient
PN: What does Pintuition mean for the patient herself — both on the day of surgery and in the days leading up to it?
KR: For us at Sirius Medical, this is deeply personal. We exist to improve care for women with breast cancer, and the patient experience is where it shows.
The difference begins well before the patient arrives at the operating theatre. With our recent long-term implant indication, the Pintuition Marker can be placed at the time of biopsy. That one change removes a significant source of pre-operative anxiety and physical discomfort. The marker itself is the size of a grain of rice, encapsulated in biocompatible titanium, and entirely non-radioactive, so there are no radiation precautions to follow at home, and nothing visible or protruding.
During surgery, the precision matters because the surgeon can navigate to the tumour with the most favorable angle. For the patient, this can lead to less healthy tissue is removed and minimal cosmetic changes. The Stanford data also pointed to something patients don’t always see but feel afterwards: shorter, smoother operations mean less anaesthesia time, and at scale, more women can be treated each day1. Real-world studies have consistently shown higher patient satisfaction with Pintuition compared with wire-guided localization. It is a quiet kind of innovation where the patient often doesn’t know what wasn’t done to her, but the impact is real.
A significant milestone: MDR CE-mark
PN: Given all these benefits, it’s not surprising to see that the Pintuition System achieved MDR CE-mark with significant new indications. What does this milestone unlock for clinicians and patients?
KR: MDR CE-mark is the most stringent regulatory standard in the world, and securing it is a real moment for us because it underscores our commitment to meeting the highest safety and performance requirements set by the European Commission. Just as importantly, MDR brought three significant new capabilities into the European market, all already available in the US:
- Long-term implant status: Surgeons and radiologists can now place the Pintuition Marker at the time of biopsy, giving radiology teams full flexibility on when to place it, depending on patient needs and how the hospital wants to organize the pathway. Corinne Balleyguier, Head of the Imaging Division at Gustave Roussy, has noted that combined with contrast-enhanced imaging modalities, this is expected to further optimize clinical workflows and enhance the patient experience.
- Probe re-sterilization: Multiple options for reprocessing, which reduces barriers to access and improves cost-efficiency, an important factor for hospitals balancing innovation with budget realities.
- 7-cm needle variant: A shorter needle option that further broadens clinical use, particularly in anatomically challenging cases.
Together, these unlock more flexibility for clinical teams, more comfort and choice for patients, and a stronger foundation for us to expand into the soft tissue tumour indications beyond breast cancer. As we have said on the channel: “Trust & embrace Surgical Marker Navigation”, MDR makes that trust easier to extend.
Key takeaway
In conclusion, these insights highlight a shift away from traditional localization approaches toward more flexible, wire-free systems like Pintuition. In Part 2, we’ll explore the technology behind Pintuition and how surgical marker navigation supports precise, streamlined localization.
