One Step Cartilage Repair Therapy


The "Joint" Challenge

Lesions of the joint surface are a very common clinical challenge, frequently diagnosed also in young people. If untreated, they may degenerate into chronic, disabling conditions that can be addressed only by an invasive approach. In most cases, articular cartilage damage implies a simultaneous suffering of the sub-chondral bone structure. To guarantee the successful restoration of a healthy and functional joint, we should go "to the core of the problem".

MaioRegen is a new therapeutic concept, inspired by nature and shaped by state-of-the-art Nanotechnologies. It promotes and guides an effective bone and cartilage regeneration, thus restoring the natural joint physiology.

Why OSCAR?

The concept of using Bone marrow cells and scaffolds are not a new one, however currently scaffolds and cells are used separately with or without concentrated bone marrow. For instance, the current technique Bone marrow concentrate (BMC) has limitations/in acceptance due to the challenge in homing and holding the cells. OSCAR fulfills the gap by integrating the concept of seeding cells and scaffolding together to bring out better clinical outcomes. While Maioregen on its own has the capabilities to address the underlying issue, but for chondral injuries the challenge remains as it is.

oscar

OSCAR concept could potentially be the successful standalone combined product in the market addressing the needs of the surgeon at the time of requirement. The use of such procedure/products are decided on the table and current therapies like autologous chondrocyte implantation (ACI) or BMC could not be made available as it requires complex logistical considerations. The ideation is a spin- off from experiencing difficulties to make the much needed therapeutic service available at reach of every treating physician.

Highlights of Maioregen Osteochondral Substitute:

- Dual 3-dimensional architecture: Apart from the scaffold unit being built as porous 3-diemnsional matrix, the individual collagen protein molecule used as the building blocks of the scaffold also possesses intrinsic 3-dimesnional architecture.

- Pure protein Scaffolds: Each scaffold unit will have more than 99% pure collagen as the ingredient for better mimicking capabilities.

- Sterility: The scaffolds are developed and produced under conditions built according to EMEA/CE standards.

- Long-term stability of Scaffolds: Unlike certain available collagen scaffolds that require low temperature during storage and shipment, Maioregen scaffold is stable for prolonged periods of time at room temperature and will maintain its intrinsic scaffold architecture even at elevated temperature.

- Time-dependent biological resolution: Maioregen scaffold are studied and followed for more than 5 years in a randomized controlled trial to show time dependent integration in to the healing /regenerating site.

Technical Specifications - MaioRegen:

Composition & Structure:

MaioRegen is a three-dimensional matrix which mimics the entire osteo- cartilaginous tissue: cartilage, tide-mark and sub-chondral bone. It is a monolithic, multi-layer scaffold: the superficial layer consists of deantigenated type I equine collagen and resembles the cartilaginous tissue, while the lower layer consists mostly of magnesium-enriched hydroxyapatite (Mg-HA), and simulates the sub-chondral bone structure.

The intermediate layer, composed of Mg-HA and collagen, reproduces the tide-mark. MaioRegen is obtained through a unique, patented process, the result of the cooperation between Finceramica and internationally recognized research centres.

Biomimetism:

Biomimetic is a substance recognised and accepted by the body as self, without triggering any immune response. The peculiar chemical composition and structure make MaioRegen a fully biomimetic scaffold. The "chemical" biomimetism is given by using collagen macromolecules and Mg-HA nanocrystals, combined through an innovative nucleation mechanism which resembles the biologic neo-ossification process. The "structural" biomimetism is given by the characteristic orientation of collagen fibres, organised as they would be within the human osteo-chondral tissue.

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oscart

Flexibility:

Flexible and elastic, MaioRegen can perfectly fit the anatomic curvature of the application site.

Conformability:

Its peculiar characteristics make MaioRegen perfectly conformable. During surgery, it can be adapted to the defect dimensions and used for the treatment of large lesions.

Degradability:

The biomimetic chemical composition of MaioRegen allows for its complete degradation, thus facilitating the regenerative processes.

Indications of Maioregen Osteochondral Substitute:

MaioRegen is indicated in all cases where it is necessary to restore osteo-cartilaginous connective tissue in the joints, in particular in the treatment of:
- Osteo-chondral lesions of traumatic, post-traumatic, degenerative origin or due to osteochondritis dissecans;
- III-IV grade lesions (Outerbridge classification)
- Focal, single or multiple lesions.

MaioRegen should not be used in patients with advanced osteoarthritic conditions, immune system disorders, neoplastic diseases, infectious diseases, obesity (BMI > 30) or above 60 years of age.