Public Funding for Mint Neurotechnologies Ltd

MintNeuro, a pioneer in neural implant technology, is addressing critical unmet healthcare needs in the neurological sector. Our focus is on developing advanced semiconductor technology to revolutionise neuromonitoring, brain-computer interfaces (BCIs), and neuromodulation implants. This innovation aims to enhance functionality, efficiency, and reduce invasiveness of implantable treatments for Drug-Resistant Epilepsy (DRE), paralysis, neurodegeneration, mental health disorders, and other severe neurological conditions. Leveraging our expertise and the success in developing the DREAM sensing chip for epilepsy neuromonitoring---funded by the NIHR---we propose to extend its application beyond epilepsy to a broader spectrum of neurological conditions. Led by Dr. Dorian Haci (CEO), our team comprises members with extensive experience in neural interfaces, implantable medical devices, and semiconductor technology. Given MintNeuro is an Imperial College London spinout with agreements for facility access in place, the project will utilise the resources and facilities of the Centre for Bio-Inspired Technology at Imperial. Moreover, our collaboration with critical partners providing electronic services, manufacturing, and packaging ensures quality and efficiency in our deliverables. Governed under an ISO13485 Quality Management System, our project framework guarantees structured and quality-assured development. Our target market, positioned at the intersection of the "Active Implantable Medical Device" and "Neurotechnology" industries, shows a high growth potential. Our entry strategy involves collaborating with UK-based and international medical device SMEs and BCI leaders, and later expanding to larger multinational medtech companies. With regulatory infrastructure already in place and exclusive licenses on key patents, we are well-positioned to overcome barriers and assert our freedom-to-operate in this rapidly expanding market.

Neurological conditions are the leading cause of disability and the second cause of deaths worldwide. Monitoring and treating these diseases is incredibly difficult as targets are encased in thick bone and special membranes in the circulatory system block many drugs. Advanced neural implants, comprising electronics placed inside the skull or spine, are an exciting technology that could revolutionise our understanding of the brain and treat associated conditions---enabling people to walk again; children to hear for the first time; or relieving the symptoms of epilepsy or Parkinson's disease. However, such devices require complex electronics with tight constraints on size and power, whilst also complying with the most stringent regulatory requirements (Active Implantable Medical Devices). As a result, implants can take years and hundreds of millions of pounds to develop---a major barrier and risk for innovators, investors, and small-medium sized companies. Our vision is to create a set of modular chips (or microchips) that meet these challenges. Advanced packaging techniques combine these together into tiny systems to enable companies and researchers to rapidly address different needs. In this way, we minimise implant size and power consumption, opening up new approaches for surgery (akin to the switch to keyhole surgery) that reduce risks to patients. This project is a collaboration between Mint Neurotechnologies, Amber Therapeutics, and Imperial College London to co-create a "chipset" (group of chips designed to work together for a specific application) and package it into a device. This will first constitute the electronics of a medical device for treating mixed urinary incontinence (no other treatment available on the market yet) and will unlock new device therapies beyond the first application. More long-term, these chipset and packaging capabilities will enable faster, cheaper development of implants, making the technology accessible for patients with rarer or currently untreated neurological conditions.

Neurotechnology refers to a broad range of devices which can directly record and/or modulate the activity of the nervous system. These devices can either be implanted into the brain or nervous system (invasive) or placed on the surface of the skin (non-invasive). Neurotechnologies have been used, and are in development for, many different purposes, both medical and non-medical. Examples of medical uses include 'Deep Brain Stimulators' or 'Brain-Computer Interfaces' for injuries or diseases that effect movement. An example of a non-medical use is for gaming. Neurotechnologies for all use cases are developing rapidly and have the potential to offer enormous benefit to people. Because of this more must be done to ensure that people who would benefit from such devices have timely and safe access to them. To achieve the safe, efficient, and ethical translation of neurotechnologies from innovators to the clinic, and public, there is a consensus amongst UK regulators and innovators in academia and industry that new regulatory practices in neurotechnology are needed. In support of this reform, the UK government commissioned a report produced by the Regulatory Horizons Council (RHC) which made recommendations for stakeholders in this area. This proposal is in response to the report. Our network will establish a community of public, academic, government, and industry advisors and act to implement key recommendations from the RHC Neurotechnology Regulation report.