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Treating the Chronic Pain Patient earlier in the Pathway

Periodic Reporting for period 1 - CAPRI (Treating the Chronic Pain Patient earlier in the Pathway)

Reporting period: 2020-02-01 to 2021-01-31

Capri Medical are developing neurstimulation solutions for the treatment of chronic pain which a primary initial focus on Chronic Migraine

Primary headache disorders are among the most prevalent disorders worldwide. They are classified into clinically distinct disorders based on well-defined diagnostic criteria. The most prevalent headache disorder is Tension-Type Headache (TTH), followed by Migraine, itself subdivided into Migraine without Aura, Migraine with Aura and less common forms of migraine. However, because Tension-Type Headache has a much lower disability weight than Migraine and is generally easier to manage, Migraine disorders have been the focus of much more research. Despite this intense effort, the management of a significant proportion of Migraine sufferers remains inadequate. This project therefore aims at addressing this unmet need in the management of migraine patients, in particular those suffering from intractable and/or Chronic Migraine (CM).

Migraine is the third most common disease in the world with an estimated global prevalence of 14.7% or 1 in 7 people (more prevalent than diabetes, epilepsy and asthma combined). The estimated proportion of time spent experiencing an attack during an average person’s life is 5.3%. Migraine is the seventh most disabling disease among all diseases, responsible for 2.9% of all years of life lost to disability. In 2019, Migraine was classified as a European epidemic 1. Migraine affects three-times as many women as men (1 in every 5 women, 1 in every 15 men) with this higher rate being most likely hormonally driven.

Migraine, often as a consequence of poor management, can progress to Chronic Migraine (CM), which affects approximately 2% of the world population. It is defined as a headache persistent for more than 3 months or a severe headache persistent for more than 15 days within a month. Medication overuse is the most common cause of chronicity, it is associated with a separate but clinically related diagnosis called Medication Overuse Headache. Many orally active acute (e.g. NSAIDS, triptans) and prophylactic medications (e.g. beta-blockers, antiepileptic drugs, tricyclic antidepressants) are effective in episodic Migraine without Aura and Migraine with Aura, but they all have contra-indications and side-effects and often remain ineffective in CM patients. Importantly, even Migraine-specific acute medications like the triptans can lead to Medication Overuse Headache when used on a frequent basis, and the prophylactic agents, designed for non-Migraine indications, only show an overall combined efficacy of at best 65%3. Hence, considering the very large prevalence of Migraine, about 5% of the global population are left with intractable Migraine or suffering from intermittent Migraines even when they respond to prophylactic agents.
Work is progressing according to plan across all work packages.

WP1 focuses on Hardware development where we have completed 2 iterations of electronic systems.
WP2 focuses on Software development where we have begun Sofware and hardware integration testing.
WP3 focuses on Quality Assurance where we have implemented a robust quality process and ready for stage 1 auditing
WP4 focuses on Clinic Trials where we are on track to complete preclinical trails in Q1/Q2 2021 and FIH trails in Q4 2021.
WP5 focuses on Commercialisation activities with our major deliverables and milestones focusing on IP generation. In year one we have filed 3 new core patent applications of the 4 projected in the overall project.
Our patent applications describe some of our key differentiators and progress beyond the state of the art.

Delivery System: Focuses on minimally invasive delivery of bioelectronic implants.
Wireless Power Transfer: Focuses on how to provide efficient power transfer in a dynamic anatomical location.
Neural Circuits: Focuses on habituation stimulation and increased efficacy of neurostimulation over time.

Together, these 3 pieces of core IP developed in Year 1 of this project will enable a more effective, accessible and defendable solution for the treatment of chromic migraine.
The Solution
The Problem