Purchase of Confocal Microscopy Device

The Histolog Scanner from SamanTree Medical is a unique medical device that currently has no alternative supplier or equivalent solution on the market to our knowledge. It is the only CE-marked and FDA-cleared technology providing real-time, histology-grade intraoperative tissue assessment directly in the operating room.

Unique functionality of the Histolog Scanner:

1.) Portable confocal laser microscope: the only clinical-use portable confocal scanner on the market with an objective lens large enough to scan the entire prostate gland in ~50-60 seconds.

2.) Remote pathology access: the only scanner with a remote viewer, enabling pathologists to assess images instantly from outside the OR, avoiding the need for specimen transport or pathologist presence in the theatre.

3.) Speed: high-resolution images in ~1 minute per field of view, with complete intraoperative margin assessment in 8-20 minutes.

4.) Non-destructive process: tissue remains intact for further routine histopathology.

5.) Patented technology: massively parallel confocal microscopy is proprietary to SamanTree Medical.

The Histolog® Scanner is being purchased for use in intraoperative margin evaluation during radical prostatectomy for prostate cancer. UCLH is the largest centre for radical prostatectomy in the NHS, and it is essential that the Service maintains leadership in innovation and patient outcomes.

The need is based on published data showing that intraoperative margin evaluation significantly increases the rate of nerve-sparing procedures. This directly translates into improved quality of life for patients (RCT NeuroSAFE PROOF) - better continence and potency outcomes after surgery. At the same time, published studies show that the Histolog® Scanner achieves high accuracy in detecting positive surgical margins. If present, such margins can necessitate immediate secondary resection during the same operation, thereby avoiding compromised cancer control.

In summary, the scanner enables UCLH to:

1.) Improve functional and potential oncological outcomes for patients.

2.) Avoid repeat procedures, which are costly and distressing for patients.

3.) Offer margin assessment without frozen section infrastructure.

4.) Strengthen UCLH's position as the leading NHS centre for radical prostatectomy and robotic surgery.