HYALOFAST

HYALOFAST® Hyaluronic Acid Based Matrix Supports Regeneration of Hyaline-like Cartilage

One-Step Regeneration Made Easy

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HYALOFAST is a non-woven 2×2 cm or 5×5 cm biodegradable hyaluronic acid-based scaffold for hyaline-like cartilage regeneration. It is used for the entrapment of mesenchymal stem cells (MSCs) to arthroscopically treat both chondral and osteochondral lesions in the knee and ankle.

Unlike other multi-layered collagen or synthetic products, HYALOFAST is composed of a single 3D fibrous layer of HYAFF®, a benzyl ester of hyaluronic acid (HA), a natural component of the extracellular matrix. It can be cut and adaptively fit into irregular lesions aided by its soft and non-woven structure. HYALOFAST can be implanted in mini arthrotomy or arthroscopic surgery in any orientation or stacked due to its single uniform layer of HYAFF. Once implanted, it maintains its structure to support MSC attachment, proliferation and differentiation to completely fill the lesion. As HYAFF degrades over time, it releases hyaluronic acid into the lesion and forming an embryonic-like microenvironment rich with HA.

HYALOFAST delivers positive results, enabling patients to regenerate hyaline-like cartilage with the goal of allowing them to avoid or delay total joint replacement and helping them return to daily activities naturally.

The HYALOFAST Advantage

Clinically Proven

  • Chondral & Osteochondral Solution: In combination with HYALOFAST, MSCs have shown to differentiate into chondrocytes for hyaline-like cartilage regeneration1 & osteocytes for subchondral bone formation2
  • Clinically Effective: Several HYALOFAST publications demonstrate effective outcomes in knees3,4,17 and ankles5,16 with over 5 years of follow-up data

Unique HYAFF Composition

  • Embryonic-like Environment: As HYAFF fibers degrade, hyaluronic acid is released into the lesion, creating an embryonic-like microenvironment rich with HA
  • Bio-resorbable: Hyaluronic acid is a natural and major component of human cartilage and is highly biocompatible. Once the HYAFF degrades into HA, it is naturally resorbed into the body.
  • Excellent Safety Profile: HA is sourced from bacteria, so HYALOFAST is not an animal-based product. HYAFF has been used in the tissue regeneration field for more than 15 years with an excellent safety and efficacy profile.

Easy-to-use

  • Versatile: Can be used as a chondroprotective coverage after microfracture, or in combination with bone marrow aspirate concentrate to treat chondral & osteochondral lesions via a one-step procedure
  • Flexible Application Options: Can be applied via arthroscopy or miniarthrotomy without requiring additional fixation in most cases, given its naturally adherent properties
  • Adaptive Fit: Given its soft texture, HYALOFAST conforms, covers and fills both regular and irregular lesions. Due to its uniform single-layer structure, the scaffold can be applied in any orientation or stacked.

Hyalofast-video-4_603Indications

HYALOFAST is CE-marked as a biodegradable support for the entrapment of mesenchymal stem cells for the repair of chondral and osteochondral lesions. It acts as a support for bone marrow aspirate or as a chondroprotective coverage which favors in situ residence of mesenchymal stem cells after their mobilization due to microfracture or perforation procedures.

For additional details and information about the product, please refer to the Instructions for Use that are included in the product’s packaging or refer to the HYALOFAST website.

HYALOFAST is not approved for use in the United States.

  1. Battaglia M., Rimondi E., Monti C., Guaraldi F., Sant’Andrea A., Buda R., Cavallo M., Giannini S., Vannini F. Validity of T2 mapping in characterization of the regeneration tissue by bone marrow derived cell transplantation in osteochondral lesions of the ankle. European Journal of Radiology, EURR-4905; 2011
  2. Buda R., Vannini F., Cavallo M., Grigolo B., Cenacchi A. Giannini S. Osteochondral lesions of the knee: a new one-step repair technique with bone-marrow-derived cells. J Bone Joint Surg Am. 2010; 92:2-11.
  3. Buda R., Vannini F., Cavallo M., Baldassarri M., Luciani D., Mazzotti A., Pungetti C., Olivieri A., Giannini S. One-step arthroscopic technique for the treatment of osteochondral lesions of the knee with bone-marrow-derived cells: three years results, Musculoskelet Surg. 2013 Feb 19.
  4. Gobbi A., Chaurasia S., Karnatzikos G., Nakamura N, Matrix-Induced Autologous Chondrocyte Implantation versus Multipotent Stem Cells for the Treatment of Large Patellofemoral Chondral Lesions: A Nonrandomized Prospective Trial. Cartilage. 2014 Dec:1-16.
  5. Giannini S., Buda R., Battaglia M., Cavallo M., Ruffilli A., Ramponi L., Pagliazzi G., Vannini F. One-Step Repair in Talar Osteochondral Lesions 4-year Clinical Results and t2-Mapping Capability in Outcome Prediction. The American Journal of Sports Medicine.  2013 Mar.
  6. Lisignoli G., Cristino S., Piacentini A., Toneguzzi S., Grassi F., Cavallo C., Zini N., Solimando L., Mario Maraldi N., Facchini A. Cellular and molecular events during chondrogenesis of human mesenchymal stromal cells grown in a three-dimensional hyaluronan based scaffold. Biomaterials 2005;26(28):5677-86.
  7. Lisignoli G., Cristino S., Piacentini A., Zini N., Noel D., Jorgensen C., Facchini A. Chondrogenic differentiation of murine and human mesenchymal stromal cells in a hyaluronic acid scaffold: Differences in gene expression and cell morphology. J Biol Mat Res. 2006.
  8. Lisignoli G., Cristino S., Piacentini A., Cavallo C., Caplan A., Facchini A. Hyaluronan-based polymer scaffold modulates the expression of inflammatory and degradative factors in mesenchymal stem cells: Involvement of Cd44 and Cd54. J Cell Physiol. 2006;207(2):364-73.
  9. Zavan B., Giorgi C., Bagnara G.P., Vindigni V., Abatangelo G., Cortivo R. Osteogenic and chondrogenic differentiation: comparison of human and rat bone marrow mesenchymal stem cells cultured into polymeric scaffolds. European Journal of Hystochemistry 2007; vol. 51 supplement 1:1-8.
  10. Grigolo B., Lisignoli G., Desando G., Cavallo C., Marconi E., Toschon M., Giavaresi G., Fini M., Giardino R., Facchini A. Osteoarthritis treated with mesenchymal stem cells on hyaluronan-based scaffold in rabbit. Tissue Eng Part C Methods. 2009 Feb 27. (Epub ahead of print)
  11. Cavallo C., Desando G., Columbaro M., Ferrari A., Zini N., Facchini A., Grigolo B. Chondrogenic differentiation of bone marrow concentrate grown onto a hyaluronan scaffold: Rationale for its use in the treatment of cartilage lesions. J Biomed Mater Res A. 2012 Nov. 7. Clinical
  12. Giannini S., Buda R., Vannini F., Cavallo M., Grigolo B. One-step Bone Marrow-derived Cell Transplantation in Talar Osteochondral Lesions. Clin Orthop Relat Res. 2009 May 16. (Epub ahead of print).
  13. Giannini S., Buda R., Cavallo M., Ruffilli A., Cenacchi A., Cavallo C., Vannini F. Cartilage repair evolution in posttraumatic osteochondral lesions of the talus: From open field autologous chondrocyte to bone-marrow-derived cells transplantation. Injury, 2010 Nov.
  14. Vannini F., Battaglia M., Buda R., Cavallo M., Giannini S. One Step Treatment of Juvenile Osteochondritis Dissecans in the Knee: clinical results and T2 mapping Characterization. Orthop Clin N Am, 2012 Apr.
  15. Buda R., Vannini F., Cavallo M., Baldassarri M., Luciani D., Mazzotti A., Pungetti C., Olivieri A., Giannini S. One-step arthroscopic technique for the treatment of osteochondral lesions of the knee with bone-marrow-derived cells: three years results. Musculoskelet Surg. 2013 Feb 19.
  16. Buda R., Vannini F., Castagnini F., Cavallo M., Ruffilli A., Ramponi L., Pagliazzi G., Giannini S.
    Regenerative treatment in osteochondral lesions of the talus: autologous chondrocyte implantation versus
    one-step bone marrow derived cells transplantation. International Orthopaedics (SICOT) (2015) 39:893–
    900.
  17. Gobbi A, Scotti C, Karnatzikos G, Mudhigere A, Castro M, Peretti GM. 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. Knee Surg Sports Traumatol Arthrosc. 2016 Jan 14. (Epub ahead of print).