Intra-operative microscope for tumor margin assessment

Project Information

HistologTM Scanner

Grant agreement ID: 823284

DOI

10.3030/823284

Project closed

EC signature date 7 August 2018

Start date 1 September 2018

End date 31 August 2021

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 310 125,00

EU contribution

€ 2 317 087,50

Coordinated by

SAMAN TREE MEDICAL SA
Switzerland

Periodic Reporting for period 3 - HistologTM Scanner (Intra-operative microscope for tumor margin assessment)

Reporting period: 2020-09-01 to 2021-08-31

Summary of the context and overall objectives of the project

- What is the problem/issue being addressed?

The Histolog® Scanner is a medical device based on a novel imaging modality that has the potential to revolutionize intra-operative tumor margin assessment.
SamanTree Medical is committed to reducing the need for cancer surgery re-operation particularly in breast surgery. For cancer surgeries, in particular for breast conserving surgery, it is crucial to control that the borders of the surgical specimen are free from cancer – a situation clinically referred to as a clean margin. When surgically excising a tumor, surgeons face the difficult trade-off between preserving healthy surrounding tissue and maximizing the confidence in removal of the entire tumor.


- Why is it important for society?

More than 500,000 lumpectomies are performed annually in the USA and Europe alone and up to 25% require re-operation. Additional operation is a burden for the patient and it increases the stress relative to the treatment; it also results in annual costs of $2.7 billion. Surgeons face a difficult trade-off: maximize confidence in removal of the entire tumor and minimize removal of healthy tissue. The “Gold Standard” for margin assessment is histopathology microscopy – these laboratory results, however, aren’t available until days after surgery. Surgeons need faster support for margin assessment in the operating room, ideally in real-time and with accuracy comparable to this “Gold Standard”.
SamanTree’s Histolog® is the only solution that enables a global mapping of a lumpectomy for full margin control with histology-grade confidence in few minutes before closing the incision. With this innovative and highly practical imaging modality, the clinician is one touch-on-the-screen away from visualizing cancerous cell on a surgical specimen immediately during surgery. Enhancing the decision-making process during the surgery, this solution carries the promise of a better patient care, by increasing the confidence in a complete tumor removal at first surgery.


- What are the overall objectives?

The objectives of the project is to complement the product offer with the best possible software tool to help clinicians in optimizing the use of this unprecedented ultra-fast imaging device. The time-to-result and ease of operation are key performance indicators for successfully solving the unmet medical need, in a way that will apply for a large majority of the clinicians. This implies developing an Histolog® software solution on the basis of the state-of-the-art Artificial Intelligence capabilities, in order to deliver efficient tool for the clinician to navigate, evaluate, share and report his results.
The overall objective is to bring to the market this global Histolog® solution which includes collecting clinical evidence and delivering on regulatory compliance.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

- CE Mark for Histolog® Scanner v2

Histolog® Scanner v2 obtained the CE Mark in October 2018. The product has been upgraded to suit the specific needs of the breast cancer surgery.
The new version of the Histolog® Scanner features an extended imaging area and an increased speed of imaging, which enables the full mapping of tumor specimens during lumpectomy surgery.


- SamanTree Medical raises CHF 9.5 million to assess the margins in cancer surgery

SamanTree Medical, committed to reducing the need for cancer surgery re-operation in breast surgery, announced in May 2019 the successful closing of its CHF 9.5 million Series A financing. Proceeds will be used to commercialize the patented Histolog® system.


- SamanTree Medical’s sustained growth

Team has grown from 7 to 17 employees since starting this project and the company recently moved to new, larger premises dimensioned to support the staff and operations volume growth foreseen in the coming years.


- Technology consortium for further developing the Histolog® Solution

SamanTree Medical has partnered with Advantech (Eindhoven, NL), a global hardware integration company, and Sioux LIME (Eindhoven, NL), a mathematical engineering company focused on industry, to leverage the recent advances in artificial intelligence. These partners complement the expertise of SamanTree Medical’s near-shore software development team from Altabel Group (Vilnius, LI) and secure the development of software tool and data analytics features to enhance the customer experience.


- Clinical network to support development and marketing of the Histolog® Solution
The Histolog® Scanner is in use for a large study including 200 breast cancer surgical specimens. This study involves breast surgeons and pathologists and benefits from a strong interaction of the two specialties. This international study takes place at Gustave Roussy in Villejuif (France) and involves physicians from this renowned center and from other centers in Reggio Emilia (Italy), Utrecht (The Netherlands) and Lausanne (Switzerland). Gustave Roussy is one of the world’s leading cancer-research institutes and the premier European Cancer Centre.

The Histolog® Scanner is also in use in observational studies at Universitätsklinikum Heidelberg (Germany), at Frauen- und Kinderklinik St. Louise (Germany), Imperial College London (United Kingdom), King's College London (United Kingdom). These studies aim to compare post-operatively the use of the Histolog® Scanner by the surgeon with the local standard-of-care intraoperative assessment: specimen x-ray and ultrasound imaging modalities.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

With this project, SamanTree Medical proposes a breakthrough innovation for checking complete tumor removal during surgery.

The great potential of the Histolog® Scanner has been highlighted in the publication of the promising clinical results established with the first breast center of Switzerland (BZ - Zurich). The publication, Elfgen C. et al. Diagn Pathol 2019, notably concludes:

“As a reliable on-site method, the Histolog® Scanner provides a visualization of cellular details equivalent to the H&E standards [...] this device offers great potential for immediate margin analysis of specimen in breast conserving therapy”

The Histolog® Scanner is setting a new imaging standard for tumor surgery. SamanTree Medical is initiating the early sales phase and the first step is to win over early adopters.
Our early sales will go along Trial & Purchase program with customers who embrace the innovation. These customers will also be the first to benefit from our latest advance in computer guidance tool, our new line of products currently in development using Artificial Intelligence and Deep Learning to provide capabilities for further analysing digital Histolog® images.

This novel imaging modality is a direct support during cancer surgery to achieve the common goal of improving patient quality of life by decreasing rates of reoperation.

Histolog Scanner - medical device