Luminate has developed an innovative approach for the prevention of chemotherapy induced side effects that is safe, effective, and potentially generalisable to other indications. The company has successfully developed a novel therapy, called localised microvascular compression therapy (LMCT), that can sufficiently reduce the side effects of chemotherapeutic agents without causing significant tissue injuries or discomfort. The safety of the technology was studied through histology analysis of pre-clinical samples that were exposed to pressure testing. Following this, benchtop analysis using a high-density sensor array on a replica scalp was used to mitigate the risk of over pressurisation in small areas. Finally, healthy volunteer testing was used to confirm the safety and tolerability of using the device over the intended use duration. Initial efficacy of the technique was shown through recruitment of patients in a first-in-human clinical study. The potential for enhanced efficacy using this technique is being studied through computational modelling of the drug distribution through the different tissues of the body.
From a product design & development perspective, Luminate has completed the design of components with design for manufacture principles, resulting in easily transferable design to higher scale manufacturing methods. The electronic design development work to date has produced a miniature electronic control system to enable a fully self-contained unit to be produced, meaning patients have full portability during treatment in line with the market need for an easy-to-use, portable, and safe device. From a usability perspective, Luminate has completed formative and summative usability sessions with healthcare staff to review design, provide feedback, and improve user workflow. Additional design procedures have been developed to ensure risks to patient are sufficiently mitigated through design control and testing, reinforcing compliance with QMS. Finally, a manufacturing line was successfully set up to enable supply of product for testing and clinical trials.
On the commercial front, Luminate has developed significant commercial relationships with key market stakeholders, patient representatives, and investors. A series of online patient engagement initiatives have been conducted through targeting social media advertising, alongside local community engagement through print and radio, leading to in-person feedback sessions with patient representatives in the US and EU. A successful fundraise with institutional healthcare investors to support commercialisation was completed in 2024 leading to increased awareness of the company and its novel approach for the prevention of chemotherapy induced side effects. Significant industry KOLs, such as Dr Maryam Lustberg, have been added as project advisors to support ongoing development. Domain experts with significant industry networks have also joined the company’s Board, including Steve Pacelli, ex-COO of Dexcom. In preparation for our US pivotal trial, there has been continued positive engagement with the FDA resulting in agreed regulatory and clinical trial pathway to commercialisation.
