Periodic Reporting for period 1 - ARMOURY (Arthroscopic Regenerative Medicine for Early-Stage Treatment of OA)
Reporting period: 2016-08-01 to 2017-01-31
The overall objective of the ARMOURY project was to explore the commercial feasibility of a new cell-based treatment for early-stage osteoarthritis (OA). This treatment includes combining: 1) a single-stage Advanced Therapeutic Medical Product (ATMP) tested in the knee and shown to be both safe and efficacious in Phase II clinical trial; and 2) new arthroscopic instrumentation called Hummingbird that allows access to the joint surface of the hip for preparation, tissue harvest and final delivery of prepared cells.
The specific objectives of this feasibility study were to: 1) a fully-define regulatory map for approval of the ATMP for the EU, (with recommendations for a future FDA submission); 2) fully-plan first-in-human study with written report on the scientific meeting with the MHRA, to form part of the regulatory approval process; 3) develop a Target Product Profile that includes an assessment of reimbursement price potential; 4) detail specification and work-package definitions of a full Health Economics study; 5) conduct a current competitor analysis; 6) report on the patent landscape detailing the freedom-to-operate; 7) develop the IP regime; 8) detail a business plan, including: cost of goods, margins from potential price, ramp-up of sales from proposed roll-out, and return on investment; 9) conduct a Risk Assessment of the overall innovation project, which will form the live Risk Registry for future project phases; 10) detail a plan for full User Engagement; and 11) outline a proposal for an Advisory Board with specific individuals for the study recommended.
This feasibility study showed that, while the UMCU treatment is technically possible with Hummingbird, it is not commercially sustainable in its current form for JRI. However, JRI found a simpler version of this therapy that can be performed faster and will cost less to develop, which they will look to launch this. Working with the CGT, the next phase will involve a first-in-human study: a critical step in meeting the regulations and launching this new cell-based treatment hip.
Although the initial therapy studied by this Feasibility Study proved to be uncommercial, it should still be seen as a great success because it has defined a cell-based therapy that is more commercially suitable.
Industrial/economic/social problem to be solved: with the high prevalence of OA (8.75 million people in the UK and 30 million in Europe), the impact on society is high . The creation of new therapies that allow OA to be treated at an earlier stage than is currently possible will alleviate this impact.