The healthcare and vaccine delivery sectors, while essential, face significant challenges in ensuring global vaccine accessibility and minimising wastage. These challenges are compounded by the reliance on cold chain logistics and the necessity for skilled healthcare personnel for vaccine administration. In response, CipherX and Nemaura have embarked on a ground-breaking project to develop the Self-administered Microneedle-Assisted Responsive Tattoo (S.M.A.R.T) vaccine-patch. This initiative aims to transform the Micro-Array Patch Vaccine (MAPV) landscape by introducing an innovative, user-friendly solution that reduces vaccine wastage and circumvents the limitations of the cold chain. Conventional MAPVs, despite their potential to mitigate cold-chain and wastage issues, fall short in terms of end-user confidence and verifiable self-administration. The S.M.A.R.T vaccine patch addresses these shortcomings by integrating a temporary-tattoo that visually confirms successful vaccine delivery, enhancing user confidence and promoting wider acceptance. This project is poised to make significant strides in the MAPV market, which is projected to grow from £2.3 billion in 2024 to £3.3 billion by 2029, with a compound annual growth rate (CAGR) of 6.83%. The collaboration between CipherX (with its expertise in microneedle-tattoo technology, and Nemaura-Pharma (a UK leader in MAP development), represents a strategic alignment of complementary strengths. Together, they aim to deliver a needle-free vaccination solution that is not only more accessible and efficient but also eliminates the need for skilled healthcare personnel for vaccine administration. This is particularly crucial in low-and-middle-income-countries (LMICs) and remote areas where healthcare resources are limited. The S.M.A.R.T vaccine-patch feasibility project will assess the integration of a visual indicator(CipherX) into an advanced MAPV system (Nemaura-Pharma), and conclude with an MAPV application study to compare delivery confidence between current gold-standard MAPV devices and the S.M.A.R.T vaccine-patch. This initiative not only addresses key challenges in global health but also aligns with international efforts to improve vaccine distribution and accessibility. By enhancing the usability and acceptance of MAPV technology, CipherX and Nemaura-Pharma aim to make a pivotal contribution to public health and vaccine technology, setting new standards in vaccine delivery and patient care.

Nemaura Pharma has developed a number of drug delivery systems focusing on delivery of drugs through the skin. We wish to undertake a proof of concept to deliver the Tdap vaccine (Tetanus, Diphtheria and Pertussis) using a solid micro-dose injector. The Tdap booster vaccine must be adminsitered several times over a persons life span, and also to pregnant women during the third trimester. Pertussis alone is a highly contagious bacterial disease caused by Bordetella pertussis and affects 48.5 million people worldwide yearly, resulting in nearly 295,000 deaths. In April and May 2012, pertussis was declared to be at epidemic levels in the US state of Washington. In September 2012, a similar epidemic of pertussis was seen in parts of the United Kingdom, with several babies dying as a result. The Tdap vaccine is currently administered by needle injection to children and adults and requires refrigeration; it is completely ineffective if stored at room temperature for more than 8 hours. The vaccine also causes serious adverse skin reactions in more than 1 in 10 people. Nemaura’s device is disposable, designed to deliver a solid dose that can therefore deliver the vaccine at a fraction of the volume required for a liquid injection, thus significantly minimising skin trauma and adverse events, and the solid nature of the dosage form allows enahnced stability at room and elevated temperatures without the need for refrigeration. This method of delivery has also been independently reported to have a dose sparing effect, leading to comparable efficacy at a reduced dose. These factors have the potential to collectively transform the delivery of the Tdap vaccine and numerous other vaccines.

Our proposal is to investigate the feasibility of applying reverse iontophoresis to treat acne by removing matter which clogs pores in the skin, leading to acne and pimples. Before we invest in the risky R & D exercise to modify and apply our process in this way to create a new product ‘Acne prevention and Treatment Device (APTD), we need to understand the market and how we might enter the market, and also ensure that we are able to protect our IP by understanding the patent landscape.

The CGM Patch is a non-invasive continuous glucose monitoring patch that is worn around the arm or thigh to continuously monitor the blood glucose levels in a patient without the use of needles, without the need for blood letting and the associated difficulties and potential for infection, in a very simple user friendly format. The CGM patch consists of a disposable patch containing a sensor, and a non disposable miniature electronics module with re-chargeable power source. The system applies a small harmless electrical current to the skin and as a result leads to the efficient extraction of glucose from the skin into a chamber in the patch where a glucose sensor periodically detects the level of glucose and stores the data on the internal memory platform of the patch as well as displaying the glucose reading on an LCD display, setting off a vibration when the reading is 'out of range'. The WHO recommendation for diabetics is to monitor their blood glucose levels at least 5-7 times per day, yet most patients fail to do so more than 1-2 times daily due to the difficulties asociated with blood letting using the finger-prick method. Furthermore health care providers spend a significant portion of their budget on managing the complications of diabetes. To date there have not been any continuous non-invasive systems available that are affordable and reliable. The CGM patch is intended to not only supplement and eventually replace the fingerprick method, but also to become an entire patient management system. The carers and/or physician will have the opportunity to help to guide the patient, their diet and lifestyle according to the trends recorded over weeks and months by the CGM patch, which can be downloaded to a PC and used for evalaution and patient management. This will lead to a significant improvement in the quality of life for patients as well as improving their prognosis by reducing the rate of associated complications, and reducing the burden on the NHS.

Awaiting Public Summary