Device Technologies announced the official inclusion of the Histolog^® Scanner from SamanTree Medical, on the TGA’s Australian Register of Therapeutic Goods (ARTG) (ARTG 481049). SamanTree Medical is a leader in intraoperative imaging innovation.

The Swiss-developed Histolog^® Scanner features massive parallel confocal microscopy, an innovative technology that expands the imaging field by up to 40,000 times larger than standard confocal microscopy. With this capability, surgeons and pathologists are able to visualise large, fresh tissue samples in real-time with exceptional resolution and accuracy, making it uniquely suited for the operating theatre to aid intraoperative decision-making, reduce the need for repeat operations, enhance treatment plans, and improve patient outcomes.

A major study, released last month and conducted in the UK, showed that an intraoperative margin assessment using the NeuroSAFE¹ technique could revolutionise robot-assisted radical prostatectomy (RARP) procedures. NeuroSAFE is an intraoperative frozen section examination of the whole neuro-vascular bundle-adjacent prostate margin to enable informed nerve-sparing decisions. The study, led by Professor Greg Shaw from the University College London (UCL), has found that the NeuroSAFE technique almost doubles the percentage of men who maintain erectile function following prostate a RARP procedure.

The focus of the NeuroSAFE technique is on the preservation of the delicate nerves that run through the outer layers of the prostate, believed to be crucial for erectile function. During traditional prostate surgery, these nerves are often removed or damaged, leading to erectile dysfunction. The NeuroSAFE technique allows the surgeon to determine if there are positive surgical margins on the prostate where the nerves attach. This allows the surgeon to make decisions to spare the nerves or only remove one side. Sparing the nerves can lead to improved erectile function and continence.

Results from a recent study LaserSAFE², which was born from the NeuroSAFE study, showed that by utilising SamanTree Medical’s innovative Histolog^® Scanner during Robot-Assisted Radical Prostatectomy (RARP) Nerve-Sparing surgeries, offers surgeons the potential to dramatically improve the time it takes to make an intraoperative decision from over 40 minutes with the frozen section technique to just under 10 minutes.

Strong overseas case test results have led to immediate interest in a domestic rollout of the technology to healthcare providers supported by Device Technologies, a leading provider of innovative medical solutions. The first surgery utilising this technology in Australia is expected to be in May 2025.

Professor Greg Shaw will be presenting the results of the NeuroSAFE study at Device Technologies’ Connect25, a multi-specialty Australian symposium focused on robotic surgery bringing together local and international speakers to share insights, and the advancements in robotic surgery.

Lisa Kirsch, Director of Sales - Surgical & Hospital at Device Technologies, said: “With the Histolog^® Scanner, surgeons now have access to fast, high-resolution imaging, improving decision-making in both prostate and breast surgeries. It’s a game-changer for surgical imaging, ensuring better patient outcomes and reducing the emotional and physical toll of repeat operations.”

Olivier Delaporte, CEO of SamanTree Medical, said: “We are thrilled that the Histolog^® Scanner has been officially added to the Australian Register of Therapeutic Goods, marking a significant milestone in our global expansion. This inclusion allows us to bring our advanced imaging technology to clinicians across Australia, helping to improve real-time decision-making in the operating theatre. We are proud to partner with Device Technologies, whose strong local presence and expertise will be instrumental in delivering the Histolog^® Scanner to hospitals and clinics nationwide.”

References:

1 - https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00091-9/fulltext

2 - https://pmc.ncbi.nlm.nih.gov/articles/PMC11707496/

THIS PRODUCT IS NOT AVAILABLE FOR PUCHASE BY THE GENERAL PUBLIC.