Supplemental Devices
Horizon 6FA Centrifuge
The Horizon 6FA Centrifuge is expertly designed to complement RegenKit® medical devices, accommodating tubes up to 125 mm in length, including 8 mL, 10 mL, and 20 mL variations. This fixed-angle centrifuge spins tubes at a precise 45-degree angle, ensuring optimal separation of blood components for clinical applications. With pre-programmed settings for ease of use, the Horizon 6FA Centrifuge enables healthcare professionals to achieve consistent, reliable results at the push of a button. The chamber accommodates up to six tubes, offering a streamlined solution for high-volume clinical settings while maintaining exceptional safety and performance standards.
Neo Oxus Trocar
The Medax® Neo Oxus Trocar, designed for bone marrow biopsy procedures, combines ergonomic precision with ease of use. The trocar (Model: 11G x 100 mm) is crafted for single-use applications, ensuring the highest standards of safety and sterility. Manufactured in Italy by Medax® s.r.l. Unipersonale, this device is renowned for its innovative engineering and durable construction.
The Neo Oxus Trocar is exclusively available to properly licensed medical professionals and includes comprehensive safety precautions to minimize risks during use. With its intuitive design, the Neo Oxus Trocar provides healthcare providers with an efficient tool for bone marrow biopsy procedures
Spray Applicator
The Regen® Spray Applicator is a Class 2 medical device designed for the efficient application of non-homogenous fluid mixtures, such as Platelet-Rich Plasma (PRP) and Autologous Serum, directly to treatment sites. Initially packaged in an assembled form, the applicator must be disassembled for filling and reassembled for use.
This innovative tool simplifies the process of evenly dispersing mixtures across larger surface areas, making it ideal for procedures requiring precise coverage. Engineered for ease of use and optimal performance, the Regen® Spray Applicator enhances clinical workflows and delivers superior results in wound healing and regenerative applications.
Blood Draw Accessories
RegenLab® Blood Draw Accessories are specifically designed to enhance the efficiency and reliability of blood collection when used with RegenKit® medical devices. Available in 10 mL (Ref: BCA-SET3-U) and 20 mL (Ref: BCA-SET3-20) configurations, these accessories are fully compatible with RegenKit® products, including RegenWound® Gel and RegenPlasma®.
Each accessory set includes high-quality components such as Safety-Lok™ Butterfly needles, collection holders, transfer devices, and syringes, ensuring safe and sterile blood collection. These accessories are highly recommended for maximizing preparation efficiency and maintaining the highest standards of clinical care.
The simple, safe & efficient point of care preparation of autologous platelet rich plasma
Device Technology
All Regen™ tubes consist of pharmaceutical-grade class I borosilicate and use vacuum for automated blood collection. The hallmark of the Regen™ technology is a thixotropic separating gel composed of a mixture of polymers for gravimetric plasma separation (elimination of RBC and WBC). RegenTHT, Regen BCT and A-CP are devices designed for the preparation of PRP and contain a sodium citrate anticoagulant solution above the separating gel. The RegenATS device does not contain anticoagulant. In this device, the plasma coagulates and a serum rich in activated thrombin is extracted from the plasma clot.
Regen Lab devices intended for PRP preparation consist of evacuated glass tubes containing a thixotropic gel with a specific density designed for platelet or platelet and MNC isolation, and anticoagulant solution. The gel acts as a mechanical separator of blood components, and sodium citrate solution as blood anticoagulant. Thixotropy is a physical property of some gels which are thick under static condition, become more fluid when submitted to physical stress (in this case, the centrifugal force) and regain their original consistency when the physical stress stops.
How it works
Thanks to the vacuum system, blood is gently collected into the tube and mixed with an anticoagulant by gentle inversion. The blood-filled device is centrifuged at 1500 g for 5 (A-CP and Regen BCT) or 9 minutes (RegenTHT). During centrifugation, the thixotropic separator gel becomes fluid and migrates upwards, while red and white blood cells move downwards. The gel forms a solid barrier, isolating platelets and plasma above it, while trapping RBC and most WBC below.
After centrifugation, platelets form a thin layer on the gel’s surface. To resuspend the platelets in the plasma, the tube is gently inverted repeatedly. The PRP is then collected using a blood transfer device and syringe, ready for physician use. This automated process ensures reliable and reproducible PRP isolation with high platelet recovery and low contamination levels, independent of the operator.
Preparation Process
- Collection: Blood is drawn into evacuated pharmaceutical grade borosilicate tubes containing an anticoagulant solution and separating polymer gel.
- Mixing: The blood is gently mixed with the anticoagulant by
gentle inversion of the tube. - Centrifugation: The tube is centrifuged for 5 to 9 minutes, depending on the model and gel type, using either a tabletop centrifuge with a fixed angle rotor or a larger centrifuge with a swing-out horizontal rotor.
The RegenLab® USA technology is based on the use of a thixotropic gel to separate blood components. Thixotropy is a physical property of some gels. The gel acts as a mechanical separator of the blood components. To learn more about the patents protecting this process, please visit www.regenlabusa.com/patents.
Thixotropy is a physical property of some gels. The gel is thick under static conditions. It becomes more fluid when submitted to physical stress (in this case, a centrifugal force of 1500 g) and regains its original consistency when the physical stress stops (Barnes, 1997).
The gel acts as a mechanical separator of the blood components. Two types of thixotropic gels with different specific densities are used in Regen Lab devices. One type is designed to separate platelets only, while the other allows the recovery of platelets with mononuclear cells (lymphocytes and monocytes). Performance studies have shown that the Regen tubes are reliable and produce a consistent separation of platelets and plasma from erythrocytes and leukocytes.
Regen Lab medical devices consist of evacuated pharmaceutical grade borosilicate tubes that contain a pharmaceutical grade anticoagulant solution and a separating polymer gel specifically designed for PRP isolation. The vacuum in the tube allows the preparation of PRP in fully closed circuit. A predetermined amount of blood (8-10 mL) is automatically collected in the tube by connecting it to a blood collection set. Using an evacuated tube for blood collection is not only less traumatic for the blood than using a syringe but is also safer for the operator and the patient.
Blood is mixed with the pre-loaded anticoagulant by gentle inversion of the tube and centrifuged for 5 to 9 minutes depending on the model of tube and the type of separating gel. The centrifugation can be performed using either a small tabletop centrifuge equipped with a 45° fixed angle rotor or in a larger centrifuge with a swing out horizontal rotor.
STANDARDIZED AUTOLOGOUS PREPARATION
With the ability to rapidly generate fresh autologous preparations at point of care, cellular components are selectively isolated in a manner which not only serves to maximize their biocompatibility, but also their bioactivity. This allows Platelets, and their supporting elements, to maintain their function whilst being concentrated in a manner which ensures the utmost standard of purity, thanks to what we have termed as the “GMP Lab in a Tube.”
ACADEMIC COLLABORATION
RegenLab® works closely with leading experts around the globe in order to assess and refine approaches with the goal of revolutionizing approaches toward regenerative medicine and improving quality of life for the patient.
Our academic partnerships represent a key component of our mission, to further initiatives of both public health and patient welfare.
CLINICAL EXPLORATION
With Platelets already having a proven role in the healing of tissues (e.g. as key components in migration, proliferation and differentiation), the importance of further study in this regard is paramount in our initiatives.
With over 200 publications worldwide, and 4 textbooks published in collaboration with the BioBridge Foundation and our academic partners, RegenLab® prides itself as a leader of clinical advancement in the field of Regenerative Medicine.
PERSISTENT INNOVATION
With this methodology comes a persistent need to raise the bar, innovating new technological approaches to further develop the fields of Cell Therapy &; Tissue Engineering.
RegenKit® Medical Device Kits represent just the beginning, with a significant portfolio of RegenLab® technology under investigative status and pending FDA Clearance or Approval.