Company Status One-Liner
A proof-of-concept study has demonstrated utility of the system in reliably capturing data from 50 patients undergoing major surgery with qualitative studies documenting acceptability to patients and clinicians. In collaboration with the NIHR Surgical Technologies MedTech Co-operative, PPIE focus groups have enabled a better understanding the barriers and facilitators to clinical application from the patient’s perspective.
A large observational clinical study, co-designed with PPIE and recruiting 200 patients, initiated in Dec 2022, is currently evaluating the Asclepius System as a decision-support tool assessing fitness for surgery.
We are progressing with regulatory planning, UKCA/MDR and FDA roadmap and Quality Management System(QMS). This is essential for Asclepius MedTech Ltd’s AI medical device technology approval for use in surgical pre-operative assessment. This regulatory planning will inform our development programme, plug evidence gaps, identify and mitigate potential risks, and develop our QMS system. Once completed our innovation will be at TRL level 5.
We plan making additional non-dilutive funding applications for enhanced product development and clinical research to take our innovation to TRL level 6 and 7. We will upgrade the platform, app interface for the sensor and patient facing data recording, cloud analytics and begin AI validation.
At present our team is 4 our CTO Ramm Mylvaganam, Clinical Advisor renowned Professor David Jayne, Market Access Advisor Dr Neville Young and myself CEO. During 2023 will subcontract the platform and app development to a third-party provider and contract a specialist Regulatory Expert agency and during this period will hire in-house, a regulatory specialist, a data scientist, a clinical manager, an AI developer, and a full stack developer.
In 2024, we shall launch an unregulated commercial version of our system employing marketing, business development and customer success support. With the regulated ‘software as medical device’, Class 2a, estimated to launch 2026, we shall undertake additional clinical validation in specific patient surgical populations with NHS and European investigators/organisations. For which we again apply for non-dilutive funding. Our plan is to launch the System in the UK, EU and the US markets. The US will require us to work with US based partners and regulatory specialists for 510k regulatory approval. The QMS and technical filing for EU MDR regulation will serve requirements for the US FDA process.
The final stage before we commercialise and once in receipt of UE CE/UKCA (and latterly FDA) regulatory approval is to undertake additional research assessing our medical device AI technology in real-world healthcare settings, including health economic modelling to evidence NHS Long Term Plan objectives to improve planned surgery, cut long waits, reduce waiting lists, improve post-surgical outcomes and recovery, and deliver a more scalable and efficient surgical pre-operative assessment service for community application. This evaluation study will place us firmly at TRL level 9 and significantly accelerate our commercial plans. Whilst validating the additional operational support we will recruit to scale the business in the UK, Europe with further developer, data science, clinical managers, marketing, business development and customer success full time equivalents.
It is important to note that non-dilutive funding application is highly competitive and not usually full funded; requiring a high percentage contribution by the applicant. Having additional investment from NLC and external investors will help us build larger more statistically significant clinical research studies, develop larger data sets, undertake further research in additional target surgical procedure populations and increase operational headcount to scale more quickly particularly with the unregulated version of the system because we know there is an underserved unmet need. Building a customer based with unregulated version of the System and by establishing ourselves as a provider partner will help us commercialise transition to the regulated and clinically more effective system version in 2026/27.