2.3.2025

HyaloFast® receives MDR certification

An important step in regenerative medicine: Hyalofast® has successfully received MDR approval (Medical Device Regulation, EU 2017/745). The innovative hyaluronic acid matrix product now meets the highest European quality and safety standards and is one of the first cartilage-regenerative medical devices to be certified in accordance with the new regulation. With this early MDR certification, the US manufacturer Anika Therapeutics is underlining its commitment to quality and safety. Comprehensive testing through clinical and preclinical studies as well as detailed safety data confirm the effectiveness and tolerability of Hyalofast®.

Hyalofast®: MDR approval for cartilage regeneration

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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