Title: A Novel Device for Efficient Accurate Skin Cancer Surgery
Funder: Department of Health and Social Care

Abstract: Our novel device dramatically improves the efficiency of skin cancer surgery by enabling the surgeon to map the extent of the skin cancer before surgery, so that it can be removed in just one surgical procedure. 'Mohs surgery' is an effective, minimally invasive form of skin cancer surgery with highest cure rates (99%) and best cosmetic outcomes (small scars); it involves histological control of the surgery to ensure that there are clear tumour-free surgical margins with minimal loss of healthy tissue, and often requires multiple cycles of surgery to completely remove the tumour. As a result it is costly and resource intensive, and so is only available at 28 centres in the UK and in half the hospitals in Germany. There are long waiting lists for Mohs in UK and patients may have to travel 100 km. In our research, we will develop an integrated scanner/marker device that enables the skin cancer surgeon to map the tumour extent prior to surgery, so that he/she can remove the tumour in one surgery, and at the same time minimise the amount of healthy tissue removed. Histological control will still be maintained on the excised tissue for final confirmation of clear borders. Using our device, a typical hospital treating 500 - 1,000 patients p.a. using our device will save an estimated 250 - 500 hours of Mohs surgery team and facility time, enabling the hospital to treat many more patients with the same resources, reducing waiting times and increasing access to Mohs surgery for many more patients. A proof of principle concept design, made in 3D-printed material, has already been developed by our customer Guy's and St Thomas NHS Foundation Trust and patented. This has been evaluated by UK and German Mohs surgeons with very positive feedback, but is far from a commercial product. It is too bulky and unwieldy to access all parts of the face, requires fiddly manual focusing, and is not designed for manufacture. In this project we will: Develop and build a pre-production prototype marker device and integrate in our VivoSight skin scanner. Validate the margin mapping procedure to prove the benefits in a clinical setting Major innovation challenges we will solve in this i4i project are: How to miniaturise the marking system and integrate it into the handheld OCT probe without compromising the surgeon's ability to access all parts of the face where cancers occur Development of a low cost compact motorized autofocus to replace the cumbersome manual focus Development of a disposable single-use marker/lens spacer which can be manufactured cheaply in high volume Working with skin cancer surgeons, develop and optimise the tumour mapping procedure with our device

Lay abstract: Our novel device dramatically improves the efficiency of skin cancer surgery by enabling the surgeon to map the extent of the skin cancer before surgery, so that it can be removed in just one surgical procedure. 'Mohs surgery' is an effective, minimally invasive form of skin cancer surgery with highest cure rates (99%) and best cosmetic outcomes (small scars); it involves histological control of the surgery to ensure that there are clear tumour-free surgical margins with minimal loss of healthy tissue, and often requires multiple cycles of surgery to completely remove the tumour. As a result it is costly and resource intensive, and so is only available at 28 centres in the UK and in half the hospitals in Germany. There are long waiting lists for Mohs in UK and patients may have to travel 100 km. In our research, we will develop an integrated scanner/marker device that enables the skin cancer surgeon to map the tumour extent prior to surgery, so that he/she can remove the tumour in one surgery, and at the same time minimise the amount of healthy tissue removed. Histological control will still be maintained on the excised tissue for final confirmation of clear borders. Using our device, a typical hospital treating 500 - 1,000 patients p.a. using our device will save an estimated 250 - 500 hours of Mohs surgery team and facility time, enabling the hospital to treat many more patients with the same resources, reducing waiting times and increasing access to Mohs surgery for many more patients. A proof of principle concept design, made in 3D-printed material, has already been developed by our customer Guy's and St Thomas NHS Foundation Trust and patented. This has been evaluated by UK and German Mohs surgeons with very positive feedback, but is far from a commercial product. It is too bulky and unwieldy to access all parts of the face, requires fiddly manual focusing, and is not designed for manufacture. In this project we will: Develop and build a pre-production prototype marker device and integrate in our VivoSight skin scanner. Validate the margin mapping procedure to prove the benefits in a clinical setting Major innovation challenges we will solve in this i4i project are: How to miniaturise the marking system and integrate it into the handheld OCT probe without compromising the surgeon's ability to access all parts of the face where cancers occur Development of a low cost compact motorized autofocus to replace the cumbersome manual focus Development of a disposable single-use marker/lens spacer which can be manufactured cheaply in high volume Working with skin cancer surgeons, develop and optimise the tumour mapping procedure with our device

Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES;5.4 SURGERY
Health categories: CANCER AND NEOPLASMS