RegenLab® USA logo with cellular icon and the words 'Tissue Engineering Specialists

Cell Therapy & Tissue Engineering

The standardised & patented Platelet Rich Plasma

Regen Lab Technology

Regen Lab’s patented technology revolutionises blood component separation using thixotropic gel. Our kits undergo rigorous biocompatibility and safety testing, and are designed, manufactured, and packaged according to European and international standards.

They meet the requirements of the European Medical Device Directive 93/42/EEC and the European Medical Device Regulation 2017/745.

Regen Lab kits are CE certified and have clearance in multiple countries, including the USA, Canada, Australia, and China.

RegenLab® USA BCT blue-capped tube with Safety-Lok™ Butterfly Needle and blood collection holder

Quality Product & Management

Regen Lab’s Quality System Management ensures product consistency, with monitored production facilities for sterile medical devices. Adhering to strict regulatory standards, their operations align with ISO 13485 standard, which specify requirements for medical device manufacturers’ management systems. Additionally, their quality system complies with the European Regulation 2017/745 and European Directive 93/42EEC for product still on the transition of Regulation on medical devices, ensuring that Regen Lab’s products are safe, effective, and reliable.

Quality Product & Management

Regen Lab’s Quality System Management ensures product consistency, with monitored production facilities for sterile medical devices. Adhering to strict regulatory standards, their operations align with ISO 13485 standard, which specify requirements for medical device manufacturers’ management systems. Additionally, their quality system complies with the European Regulation 2017/745 and European Directive 93/42EEC for product still on the transition of Regulation on medical devices, ensuring that Regen Lab’s products are safe, effective, and reliable.

CERTIFICATIONS

CERTIFICATIONS

Technological benefits

 

  • Standardized preparation
  • Minimum Blood Requirements
  • Closed-Loop System:  maximized safety
  • Stable Physical Separation
  • Reversible, Pharmaceutical-Grade Anticoagulation
  • pH Neutral Anticoagulant for Patient Tolerability
  • Rapid Centrifugation: 5 minutes
  • Ease of Preparation:  efficient & reproducible
  • Facilitates and streamlines routine practice

    Biological benefits

     

    • Standardized, Leukocyte-Poor, and Consistent
    • Platelet Recovery >80%
    • High Platelet Quality: viability & functionality
    • Full Plasma Recovery:  maximized Growth factor and fibrinogen content
    • Maximized Purity:  >99.7% RBC depletion
    • Extreme Cellular Selectivity:  ~96.5% GRN & 70-80% MNC elimination

      Scientific benefits

       

      • Demonstrated safety and efficacy
      • Evidence-based outcomes for numerous therapeutic indications
      • Large number of clinical studies, with over 200 publications

        More benefits for patients

        Commitment to Patients

        Beyond our commercial success, what matters most to us is the positive impact we have on patients’ health. Every healing story, every testimony of pain relief, every regained smile motivate us to continue our mission. We are proud to contribute to cutting-edge healthcare that puts patients at the center of every treatment.

        Enhanced Healing and Tissue Regeneration

        RegenPRP™ is specially designed to provide an optimal concentration of platelets and growth factors, maximizing the repair and regeneration of damaged tissues. This advanced technology promotes faster and more effective recovery after injuries or surgical procedures, helping you get back to your active lifestyle sooner.

        Significant Reduction in Pain and Inflammation

        RegenPRP™ offers enhanced anti-inflammatory properties that help reduce chronic pain and inflammation associated with conditions such as osteoarthritis. Experience long-lasting relief and an improved quality of life with RegenPRP®.

        Safety and Efficacy with Technology

        RegenPRP™ utilises advanced techniques for the treatment and preparation of platelets, ensuring the highest purity and optimal concentration of therapeutic components. This results in minimal risk of complications and increased efficacy, providing you with a safe and highly effective treatment.

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