Periodic Reporting for period 1 - LILY (LILY: A Breakthrough Technology to Prevent Chemotherapy-Induced Hair Loss)
Période du rapport: 2023-10-01 au 2024-09-30
Chemotherapy-induced alopecia (CIA) is hair loss associated with chemotherapy treatment for cancer. LILY is a portable, comfortable, and effective CIA prevention device that uses localised microvasculature compression therapy (LMCT) to prevent CIA. The LILY device uses this unique LMCT technique to reduce perfusion at the scalp and prevent the destructive action of chemotherapy on hair follicles. By applying a consistent low-level pressure (between 35 and 60 mmHg) to the local micro blood vessels, which could deliver chemotherapy drugs to fast-dividing hair follicles, the vessels are temporarily compressed, inhibiting drug delivery. The device comprises a proprietary pneumatic bladder network design and soft robotics system with the ability to noninvasively induce vasoconstriction in superficial vessels of the scalp to mechanically control tissue perfusion, and an electronic control system for both patient management of the system and real-time feedback into the treatment protocol.
9.8 million cancer patients undergoing chemotherapy treatments suffer from hair loss annually, of whom nearly half view chemotherapy-induced alopecia (CIA) as the most traumatic element of treatment. Currently, patients’ options in treatment of CIA are reduced to either cover-ups post-hair loss (headscarves or wigs) or scalp-cooling treatments such as cold caps, however these are not FDA regulated or CE Mark approved and are more problematic and painful to use. Patients in the EU spend €1.8 billion annually on these hair loss "solutions" which do little or nothing to solve the problem. Cold caps and scalp cooling technology subject patients to extreme discomfort with temperatures of -20degC without guaranteeing results. Over 40% of patients lose more than half their hair and continue to experience severe side effects due to the treatment, including headache, nausea, chills, dizziness, cold pain, dry skin, sinus pain, and pruritus. The cryogenic equipment is fixed in place and not widely accessible due to the significant capital investment they represent.
LILY is a novel medical device development specifically to prevent hair loss during chemotherapy. The unique portable, comfortable and wearable solution allows patients to maintain their confidence and dignity during treatment. As a portable, patient-controlled solution, LILY empowers the patient to make their own treatment decisions, helping them to maintain a better quality of life. It is a comfortable, elegant, and effective treatment that can be used inside or outside the clinic at an average 31% cost saving compared to cold caps/scalp cooling. LILY uses a new approach to achieve this revolution in the treatment of CIA: Localised Microvascular Compression Therapy (LMCT) to reduce scalp blood flow (perfusion) and the destructive chemotherapy drug delivery to the hair follicle. By safely reducing the blood supply to the scalp in the short term, the drugs do not reach the hair follicles. Existing hair is preserved safely with no tissue damage.
9.8 million cancer patients undergoing chemotherapy treatments suffer from hair loss annually, of whom nearly half view chemotherapy-induced alopecia (CIA) as the most traumatic element of treatment. Currently, patients’ options in treatment of CIA are reduced to either cover-ups post-hair loss (headscarves or wigs) or scalp-cooling treatments such as cold caps, however these are not FDA regulated or CE Mark approved and are more problematic and painful to use. Patients in the EU spend €1.8 billion annually on these hair loss "solutions" which do little or nothing to solve the problem. Cold caps and scalp cooling technology subject patients to extreme discomfort with temperatures of -20degC without guaranteeing results. Over 40% of patients lose more than half their hair and continue to experience severe side effects due to the treatment, including headache, nausea, chills, dizziness, cold pain, dry skin, sinus pain, and pruritus. The cryogenic equipment is fixed in place and not widely accessible due to the significant capital investment they represent.
LILY is a novel medical device development specifically to prevent hair loss during chemotherapy. The unique portable, comfortable and wearable solution allows patients to maintain their confidence and dignity during treatment. As a portable, patient-controlled solution, LILY empowers the patient to make their own treatment decisions, helping them to maintain a better quality of life. It is a comfortable, elegant, and effective treatment that can be used inside or outside the clinic at an average 31% cost saving compared to cold caps/scalp cooling. LILY uses a new approach to achieve this revolution in the treatment of CIA: Localised Microvascular Compression Therapy (LMCT) to reduce scalp blood flow (perfusion) and the destructive chemotherapy drug delivery to the hair follicle. By safely reducing the blood supply to the scalp in the short term, the drugs do not reach the hair follicles. Existing hair is preserved safely with no tissue damage.
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.
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.
Therapy: We have developed a novel treatment protocol for the prevention of chemotherapy induced side effects with no requirement for additional cooling apparatus.
Device: We have completed the design & development of a wearable compression device suitable for use with 97% of intended user population within one single size.
Usability: We have run successful summative usability testing with 20 nurses from intended user population, indicating a significantly decreased usability workload compared to predicate devices
Manufacturing: By utilising a novel moulding process to create compression membrane from a compliant but non-cytotoxic material we have designed the first compression device suitable for accurate delivery of pressure across the entire surface of the scalp.
Pharmacokinetics: Through our research and development we have created new knowledge in relation to the mechanism of delivery of chemotherapy to the hair follicles.
Device: We have completed the design & development of a wearable compression device suitable for use with 97% of intended user population within one single size.
Usability: We have run successful summative usability testing with 20 nurses from intended user population, indicating a significantly decreased usability workload compared to predicate devices
Manufacturing: By utilising a novel moulding process to create compression membrane from a compliant but non-cytotoxic material we have designed the first compression device suitable for accurate delivery of pressure across the entire surface of the scalp.
Pharmacokinetics: Through our research and development we have created new knowledge in relation to the mechanism of delivery of chemotherapy to the hair follicles.