Products

Vital Tissues bone grafts derived from femoral heads exclusively from living donors by orthopaedic surgeons during hip arthroplasties.

Vital Bone is an allograft with minimal to no damage to the extracellular matrix

HCM Medical has developed a special technique for degreasing and removing viruses for allografts. Supercritical CO₂ (scCO₂ ) causes minimal to no damage to extracellular matrix composition and growth factors, resulting in an excellent scaffold for biocompatibility and tissue integration during remodeling. scCO₂ Technology meets international quality requirements for an optimal tissue graft because HCM can thoroughly purify and/or sterilize tissues without affecting the original biological characteristics. Research has shown that the use of scCO₂ has a minimal negative impact on the structural integrity of tissue implants compared to conventional processing techniques. The scCO₂ treatment also removes the medullary tissues responsible for unwanted immune responses.

Donor Screening Selection

Donor selection is an essential step in ensuring the safety of human transplants for patients. Bone tissue can be donated by living donors (who undergo total hip replacement) after which the femoral heads can be used for allogeneic transplantation. All tissue donors are serologically tested for infectious diseases transmitted by blood and tissue. HCM Medical only processes bone tissue from donors with a negative serology for various tests**

Vital Bone Chips

VitalBone Chips are cancellous and/or cortical bone chips with strong structural, mechanical, and biological properties for use as a filler.

• Form a stable structure for the patient’s adjacent bone
• Minimal damage to collagen and BMP proteins
• Preservation of extracellular matrix (ECM)
• Treatment with scCO2 Technology provides excellent osteoconductive properties

Vital Bone Putty

Vital Bone Putty is cortical bone processed with scCO2 Technology, in which the BMPs (Bone Morphogenetic Proteins) present provide osteoinductive properties.

• Promotes bone regeneration
• Putty, ready to use in a syringe

Cortical Plates

Cortical Plate is an allogenic bone graft from human donor bone (allograft), which is prepared by HCM Medical (Nijmegen) in a special purification process (SuperCritical CO2 process). Cortical Plate is a thin (1mm), stable cortical plate specially developed for the shell (Fouad Khoury) technique. The shell technique creates a biological container which can be filled with particulate bone substitute material, facilitating revascularization and migration of bone-forming cells into the defect zone for rapid bone regeneration.

Use of scCO₂-technology

CO₂ enters a supercritical state when both temperature and pressure simultaneously exceed the critical point of 31 °C and 73 °C atmospheres respectively. In this state, CO₂ has both gaseous and liquid-like properties, providing ideal conditions for cleaning a wide variety of tissues of both human and animal origin (allografts and xenografts).

scCO₂ can enter tissue as a gas and dissolve materials as a liquid. By controlling the pressure and temperature, the solvent strength can be adjusted to simulate a wide variety of organic solvents.

This resolving power can be used to purify and sterilize various types of tissues.

Publications

1. Fages J., Marty L., Delga C., Condoret J.-S., Combes D., Frayssinet P.
   Use of supercritical CO2 for bone delipidation
   Biomaterials, 1994, 15: 650-5
2. Perrut M.
   Les fluides supercritiques: un nouveau type d’extraction
   BioFutur, Juin 1989 :43-47
3. Fages J., Frayssinet P., Poirier B., Barbier Y., Joffret ML, Larzul D., Majewski W., Bonel G.
   Viral inactivation of human bone tissue using supercritical fluid extraction
   ASAIO Journal 1998, 44 : 289-293.
4. Frayssinet P., Rouquet N., Mathon D., Autefage A., Fages J.
   Histological integration of allogeneic cancellous bone tissue treated by supercritical CO2 implanted in sheep bones
   Biomaterials 19 (1998), 2247-2253

Note for guidance on virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses, Revised (CPMP/BWP/268/95, London, February 1996);

*HCM Medical has aBSI Certificate of registration for ISO 13485:2016, a WVKL recognition as a tissue establishment, a GMP Certificate for Human Investigational Medicinal Productsand a NVWA recognition forthe manufacturing of medical devices from category 3-materialaccording to Article 23 of Regulation (EC) no. 1069/2009

** HBsAg, HBc antistoffen, HBV-DNA, HCV-antistoffen, HCV-RNA, HIV 1/2 antistoffen, HIV-antigen, HIV 1 –RNA, HTLV I/II antistoffen, syfilis en Q-koorts