Periodic Reporting for period 2 - ACTIVE (Articular Cartilage Treatment with Injectable hydrogel is Valuable and long-term Effective)
Reporting period: 2023-10-01 to 2024-09-30
Hy2Care brings a regenerative Injectable Hydrogel, of joint- and cartilage-mimicking composition, that is used to treat damaged cartilage.
The cartilage defects are easily filled with a syringe during a standard one time arthroscopy. The hydrogel fill the defect, prevents ingrowth
of scar tissue and allows the body to heal itself by creating true Hyaline cartilage, ensuring an optimal regenerated tissue. The highquality
regeneration provides the basis for a long lasting repair, postponing or even preventing the onset of osteoarthritis. The gel binds
covalently to the surrounding cartilage ensuring integration of the new tissue. Revalidation is fast as the cartilage regrowth follows the
degradation of the gel. The lasting repair not only prevents additional secondary treatments but also pain, disability and escalating follow-on
costs.
The cartilage defects are easily filled with a syringe during a standard one time arthroscopy. The hydrogel fill the defect, prevents ingrowth
of scar tissue and allows the body to heal itself by creating true Hyaline cartilage, ensuring an optimal regenerated tissue. The highquality
regeneration provides the basis for a long lasting repair, postponing or even preventing the onset of osteoarthritis. The gel binds
covalently to the surrounding cartilage ensuring integration of the new tissue. Revalidation is fast as the cartilage regrowth follows the
degradation of the gel. The lasting repair not only prevents additional secondary treatments but also pain, disability and escalating follow-on
costs.
Hy2Care used the EIC Accelerator grant to accelerate and scale up its business. At first, the concept for cartilage repair in the knee was advanced into clinical trials as an alternative to Microfracturing or expensive cel-based therapeies, i.e. human studies for safety as well as pivotal clinical trials (From TRL 6 to TRL 8). The First in Human studies, including 10 patients, proved the safety and performance of the Hydrogel Implant after 3 months follow-up. During EIC Accelerator the FiH was finalized after which the pivotal trial in The Netherlands started, in cooperation with specialized cartilage clinics. The pivotal trials included an additional 36 patients, with a follow-up of 12 months. Both patient satisfaction and comfort was assessed via KOOS (Knee Injury and Osteoarthritis Outcome Score), as well as cartilage repair with MRI in a MOCART II (Magnetic Resonance Observation of Cartilage Repair Tissue) analysis. Initial analysis of the KOOS score showed a significant increase in patient comfort compared to before the surgery, with results on par with the expensive cel-based therapies.
Next to that, the FDA filing was prepared. Hy2Care received FDA Breakthrough Device Designation, which enables Hy2Care to have dedicated sprint – discussions with the FDA directly. The US trial will focus on proving the efficacy of treating cartilage defects in the TFD with the Injectable Hydrogel, tested against the current state - of - the art (i.e. debridement)in order to expand the product in the US market. The IDE will be submitted Nov 2024 and the FDA trials are expected to start end of 2025/early 2026. In parallel to the pivotal trial for TFD in the knee, Hy2Care started to work towards commercialization strategies in achieving market authorization and reimbursement for countries in Europe (i.e. Netherlands, Germany, Austria and Switzerland) with leading orthopedic centers. To prepare commercialization further, the team will be expanded in line with the scale-up activities, among others by hiring an experienced Chief Business Officer, with an extensive network in the sports medicine market, as well as an extensive network of Key Opinion Leaders. Having an experienced CBO on board will facilitate defining the commercialization roadmap as well as mapping out potential commercial partners which can distribute the Hydrogel implant into the market. Hy2Care expects to close a distribution deal with an established Medtech commercial party active in the Sports Medicine market space around 2026/2027.
Next to that, the FDA filing was prepared. Hy2Care received FDA Breakthrough Device Designation, which enables Hy2Care to have dedicated sprint – discussions with the FDA directly. The US trial will focus on proving the efficacy of treating cartilage defects in the TFD with the Injectable Hydrogel, tested against the current state - of - the art (i.e. debridement)in order to expand the product in the US market. The IDE will be submitted Nov 2024 and the FDA trials are expected to start end of 2025/early 2026. In parallel to the pivotal trial for TFD in the knee, Hy2Care started to work towards commercialization strategies in achieving market authorization and reimbursement for countries in Europe (i.e. Netherlands, Germany, Austria and Switzerland) with leading orthopedic centers. To prepare commercialization further, the team will be expanded in line with the scale-up activities, among others by hiring an experienced Chief Business Officer, with an extensive network in the sports medicine market, as well as an extensive network of Key Opinion Leaders. Having an experienced CBO on board will facilitate defining the commercialization roadmap as well as mapping out potential commercial partners which can distribute the Hydrogel implant into the market. Hy2Care expects to close a distribution deal with an established Medtech commercial party active in the Sports Medicine market space around 2026/2027.