Summative evaluation of a novel cancer detection probe, SENSEI®, in a simulated environment

Presented by Dr Kunal Vyas and Miss Francesca Oldfield of Lightpoint Medical Ltd

Introduction
Summative evaluation of a novel cancer detection probe, SENSEI®, with 10 surgeon participants. The study simulated radio-guided robotic surgery using a pelvic phantom and a robotic system.

Aim/Challenge
To complete simulated, robotic, radio-guided surgery with a pelvic phantom for 10 participants to provide sufficient data to evaluate the safety and effectiveness of the SENSEI® product prior to CE mark, commercial release and clinical trials.

Solution
For 10 surgeons to test SENSEI® on a custom 3D printed pelvic phantom with a robotic surgical system in a simulated operating theatre environment.

Result
All 10 participants successfully completed simulated radio-guided surgery using the SENSEI® device. As a result, a summative evaluation report has been written and will contribute toward our EU regulatory submission to attain CE mark.

Benefit
Staff and facility were willing to go above and beyond to ensure we had the access to the equipment and facilities required, even if this meant scheduling early or late opening hours. Northwick Park medical physics team provided excellent support and guidance on all aspects of radiation safety and was available when needed to confirm that the study activities were safe. Access to the robotic system was an essential part of our study and the robotic surgical system in The Griffin Institute is an excellent resource.

Biocompatibility study of biomaterials for use as an immune-protective membrane

Dr Mehri Behbehani (R&D Scientist) of The Electrospinning Company Ltd

Introduction
In the UK, approximately 400,000 people are currently living with Type 1 Diabetes (T1D), a serious and lifelong condition where the immune system attacks and destroys insulin-producing beta cells in the pancreas.
Every year, the number of new diagnoses of T1D is increasing by about 4%, and patients have to monitor blood glucose levels carefully and inject insulin. Offering a treatment such as the transplantation of healthy donor beta cells that eliminates the need for insulin injections and reduces the risk of complications would be life changing.

Aim / Challenge
Transplanted beta cells are vulnerable. They need protection from the patient’s immune system and an abundance of nutrients and oxygen to keep them alive.
The advantage of electrospun fibrous membranes is their versatility. The Electrospinning Company used its expert knowledge to create six membrane prototypes using different synthetic polymers, architectures, and thicknesses to be used as immuno-protective membranes for those transplanted cells.
The Griffin Institute was used as a test partner to evaluate the biocompatibility of these membranes and their ability to support a healthy vasculature around its surface.

Result
All membranes tested showed good biocompatibility with minimal foreign body response. One of the materials performed exceptionally well with only mild inflammation in the adjacent tissue. As is often seen with synthetic biopolymers, a thin fibrous capsule formed around the membrane by 21 days, which was however much smaller than the current standard of device materials. There was also an abundance of small blood vessels around the device.

Benefit
Thanks to the professional team at The Griffin Institute, The Electrospinning Company Ltd was able to select an immuno-protective membrane candidate that is biocompatible and supports good vascularisation.
We are continuing with further studies and working with cell therapy partners to bring this technology to the patient.