Periodic Reporting for period 1 - Hy2Care (INJECTABLE HYDROGELS FOR CARTILAGE REPAIR) Reporting period: 2016-06-01 to 2016-11-30 Summary of the context and overall objectives of the project Osteoarthitis (OA) is the number 1 muscoskeletal limitation on the current quality of life of humans. It also represents an increasing burden on the affected patients, on the health care system and to society as a whole. It is projected that, without treatment, by the year 2020 OA will become the 4th leading cause of disability in the world. For example, in US only 1.6 million people experience work limitations. The loss of economic productivity due to OA is valued at € 15.000 per patient per annum, representing 8.3% of all main conditions. Actually, orthopedic surgeons are actively searching for a regenerative treatment which is offering better prospects for the patients for pain free and subtle joint movement.Hy2Care develops Injectable, in situ gelating and bioresorbable Hydrogels, intended for the repair of articular cartilage defects. The first product will be developed for application in the human knee joint during a single step arthroscopic procedure, thereby providing a/o bio-scaffolding, mechanical support, natural healing and reduction of further degeneration and pain.OA is not only an unresolved health care problem for man, but also in veterinary medicine it is a rising and significant health care problem. Within the Western world, there is a rapidly increasing demand for treatment of pets and owners are willing to pay significantly in order to have their pet cured. The Injectable Hydrogels of Hy2Care can drastically change the management of osteoarthritis in companion animals. Moreover, Hy2Care’s Hydrogels have potential in stem cell therapy for treating tendonitis in equine or low back pain in dogs. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Hy2Care’s main objective in participating to H2020- SME-phase 1 wasTo ensure successful market uptake in Europe/Northern America and the other continentsTherefor a feasibility study has been performed focusing on:Economical aspects: the market environment has been mapped out and business strategies have been determined based on Canvas business models, market segmentation, analysis of route to reimbursement, positioning versus competitive products, analyzing additional product-market combinations and estimation of forecast and profitability. As part of the partner search the Hy2Care business network has been broadened: Venture Capitalists, informal investors, industrial partners for cGMP production, partners supporting in regulatory/ quality affaires and reimbursement.Technical aspects: operational plans have been worked out to develop the product from TRL 6 to TRL 9 level; particular attention points are: cGMP contract manufacturing, clinical trials in large animals as well as humans, obtaining CE approval in Europe through Notified Bodies, Pre-market approval by FDA.Practical aspects: the intellectual property strategy has been defined based on three cornerstones (protecting existing IP; strengthening the IP portfolio and creation of additional value); a basic Quality Management System according to ISO 13485:2012 and Design Control have been implemented; process and product risk analysis conform ISO 14971:2012 has been initiated; need for toxicology and biocompatibility testing has been mapped out in line with ISO 10993-1:2009. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) The impact of Hy2Care’s product on treatment of osteoarthritis (OA) will be enormous. OA is the number 1 muscoskeletal limitation on the current quality of life of humans. It also represents an increasing burden on the affected patients, on the health care system and to society as a whole. It is projected that, without treatment, by the year 2020 OA will become the 4th leading cause of disability in the world.The Hy2Care B.V.‘s Injectable Hydrogels are very well positioned to revolutionize the OA market with potential to enter even more market segments in the future: - An innovative platform technology based on proprietary intellectual property - A concrete answer to a clear clinical need - Offering additional business opportunities in earlier accessible market segments such as in veterinary medicine and life sciences/ biotechnology markets - A huge market potential with a large societal and economic impact hy2care-colored.png
