HyaloFast® receives MDR certification

HyaloFast® — One-Step Cartilage Regeneration

Hyalofast® is a three-dimensional, biodegradable matrix of HYAFF® fibers (esterified hyaluronic acid), which was specially developed to support cartilage regeneration. This 3D matrix serves as a framework for mesenchymal stem cells (MSCs) and promotes the formation of hyaline-like cartilage in knee, ankle and hip joints. It can be used both arthroscopically and by means of mini-arthrotomy and adapts flexibly to the shape of the lesion thanks to its soft texture.

Unique properties of Hyalofast®

• One step therapy: No second operation required
• Regenerative environment: HYAFF® fibers release hyaluronic acid when broken down, which creates an optimal environment for cell regeneration
• adaptable: available in two sizes and can be flexibly adapted to various defect sizes
• Self-adhesive: No additional fixation required
• Biologically active: Specifically supports the growth and differentiation of MSCs for cartilage formation
• Safe: 100% pure, non-animal hyaluronic acid, completely biodegradable
• Versatile: Suitable for arthroscopic or minimally invasive procedures and for the treatment of chondral and osteochondral lesions (ICRS grade III & IV)
• Proven clinical evidence: Over 20 years of successful use in regenerative cartilage therapy with documented long-term results

After implantation, the non-woven 3D structure of Hyalofast® creates a favorable microbiological environment for regeneration by supporting the adhesion and organization of MSCs. During the breakdown of HYAFF® fibers, hyaluronic acid is released, which promotes the restoration of normal tissue.

Clinical evidence and scientific studies

Several long-term studies prove the effectiveness of Hyalofast® during cartilage regeneration. A recent long-term study (Whyte et al. 2024) shows that Hyalofast® in combination with Bone Marrow Aspirate Concentrate achieved lasting results in the treatment of knee cartilage injuries.

With a follow-up period of up to 16 years, patients report significant pain reduction and functional improvement. In addition, the structural quality of the newly formed cartilage was objectively confirmed using MRI-based T2 mapping technology.

With MDR certification, Hyalofast® is setting new standards in cartilage regeneration and strengthening future prospects for minimally invasive treatment methods for cartilage damage.

Study overview

One-Step Cartilage Repair of Full-Thickness Knee Chondral Lesions Using a Hyaluronic Acid-Based Scaffold Embedded With Bone Marrow Aspirate Concentrate: Long-term Outcomes After Mean Follow-Up Duration of 14 Years
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Validity of T2 mapping in characterization of the regeneration tissue by bone marrow derived cell transplantation in osteochondral lesions of the ankle
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Hyalofast Cartilage Repair Surgery with a Full Load-Bearing Rehabilitation Program One Day After Operation Reduces the Time for Professional Athletes to Return to Play
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Long-term Clinical Outcomes of One-Stage Cartilage Repair in the Knee With Hyaluronic Acid-Based Scaffold Embedded With Mesenchymal Stem Cells Sourced From Bone Marrow Aspirate Concentrate
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One-step surgery with multipotent stem cells and hyaluronan-based scaffold for the treatment of full-thickness chondral defects of the knee in patients older than 45 years
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One-step repair in talar osteochondral lesions: 4-year clinical results and T2-mapping capability in outcome prediction
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certificates

Hyalofast certificate - part 1

Hyalofast certificate - part 2