Low Blood Volume Required
Regen® products are designed to prepare a high quality PRP or cell therapy from a sample of blood 10mL or less. The low blood volume requirement allows for ease of use and a positive patient experience.
Therapeutic Platelet Recovery
Plasma based PRP products are becoming more heavily implemented in practices across the nation as more education about the benefits of plasma is shared. RegenLab's preparation method was developed to recapture both small and large platelets in a volume of plasma while selectively removing the desired levels of white blood cell contaminants.
By understanding the behavior of the gel separator technology, RegenLab has developed methods to consistently prepare high quality PRP and other cellular therapies. As long as the protocol is respected, the gel separator will isolate the desired composition of PRP, regardless of who is performing the preparation.
Safe and Easy to Use
Patient and user safety is our first priority. All products are manufactured according to Good Manufacturing Practice (GMP) standards. The simplicity of the closed system technology eliminates the need to transfer the cellular product from material to material, removing the risk of environmental contamination.
RegenLab continues to grow its patent portfolio to include numerous process patents for the preparation of cellular therapies in the Unites States.
With over 16 years of cell therapy focused research from around the world, RegenLab has an expansive clinical library that supports PRP as a reliable treatment option for indications in many areas.
* BCT stands for Blood Cell Therapy
WARNINGS AND PRECAUTIONS 1. Use proper safety precautions to guard against needles. 2. Use a horizontal head (swinging bucket) centrifuge or a fixed angle head centrifuge. Follow manufacturer instructions when using centrifuge. 3. Excessive centrifugation force (over 2200 RCF) may cause tube breakage, exposure to blood, and possible injury. Regen™ BCT tubes should be centrifuged, as recommended in the instructions for use, at 1500 RCF. 4. Centrifuge carriers and inserts should be of the size specific for the Regen™ BCT tubes. Use of carriers too large or too small for the tube may result in breakage. Care should be taken to ensure that Regen™ BCT tubes are properly seated in the centrifuge cup. Tubes must be balanced in the centrifuge head to minimize the possibility of glass breakage. 5. Do not use sterile component of this kit if the package is opened or damaged. 6. Single use device, do not reuse any part of the kit. 7. The practitioner is to be thoroughly familiar with the equipment and the procedure prior to using the kit 8. The patient is to be made aware of general risks associated with treatment and possible adverse effects. 9. PRP concentrate is to be prepared from fresh blood and used extemporaneously. 10. The platelet rich plasma must be used within four (4) hours of blood collection. 11. Store between 5°C - 30°C – Bring kit at ambient temperature before using Regen™ BCT tubes. 12. Do not use components of this kit if they are broken or present a defect.
POSSIBLE ADVERSE EFFECTS 1. Damage to blood vessels, hematoma, delayed wound healing and/or infection. 2. Temporary or permanent nerve damage that may result in pain or numbness. 3. Early or late operative infection.