RegenKit® A-PRP

Class III CE certified
Medical Devices

What is RegenKit®BCT ?

The RegenKit® BCT are medical devices intended for the preparation of RegenPRP.

They contain RegenBCT tubes and accessories for blood collection and PRP recovery. RegenBCT tubes are made of pharmaceutical grade glass with a vacuum for automated blood collection.

They contain a sodium citrate anticoagulant solution and a separating gel to separate plasma and platelets from the blood cells and produce RegenPRP with a standardized composition.

RegenKit®BCT visual

Technology platform for standardized autologous regenerative medicine

The simple, safe and efficient point-of-care preparation of autologous platelet-rich plasma.

Blood Collection Blood Collection
Centrifugation Centrifugation
Platelet Resuspension Platelet Resuspension
Ready to use Ready to use

TECHNOLOGY ADVANTAGES

  • User-independent standardized preparation
  • Minimum volume of blood required
  • Safe closed-circuit system
  • Mechanical isolation of PRP using a biologically inert gel after a 5-minute centrifugation
  • Reversible anticoagulation with a pharmaceutical grade solution of sodium citrate at pH 7
  • Minimal learning curve and ease of use
  • Operationally and clinically efficient process
  • Facilitates and streamlines routine practice
product

Scientific advantages

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

Biological advantages

  • RegenPRP is standardized, leucocyte reduced and easily reproducible
    Regen Lab specific separating gel technology guarantees minimal variability
  • Concentration of platelets in CM-PRP-HA >70%
  • High platelet quality
    Viable & functional platelets
  • Full plasma recovery
    No loss of plasma growth factors and fibrinogen
  • Leucocyte reduced PRP Depletion ~ 94.3% of pro-inflammatory granulocytes, leaving mainly lymphocytes and monocytes
  • Virtually no red blood cells
    Depletion of ~ 99.5% of erythrocytes

RegenPRP standardized performance

Regen Lab devices use a separating gel technology that separates the plasma and
platelets from the blood cells to produce RegenPRP with a standardized composition:

Blood sample vol per tube
Blood sample vol per tube

10 ml

PRP vol per tube
PRP vol per tube

5 to 6 ml

Platelet recovery
Platelet recovery

> 80%

Red blood cell depletion
Red blood cell depletion

> 99.7%

Platelet concentration factor (native)
Platelet concentration factor (native)

1.6 X

RegenBTC Tubr Properties.
Summary of new RegenBCT and A-CP tube performance tests-2017, date on file

Our products

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RegenACR
Regenkit A PRP
Regenkit A PRP

Intended use of the device

Preparation of Autologous Platelet Rich Plasma & other plasma-derived products.

product
price 2797

RegenKit®-BCT-1-2

Ref: RK-BCT-1 // RK-BCT-2
1 Safety–Lok™ Butterfly needle
1 Collection holder
1 to 2 Regen BCT* tubes
1 Transfer device
1 to 2 transfer needles
1 to 2 x 5 ml Luer-Lok™ syringe

product
ce 2797

RegenKit® str-BCT-3

Ref: RK-BCT-3
3 Regen BCT* tubes

product
ce 2797

RegenKit® BCT-T

RK-BCT-T
1 Regen BCT* tube
*BCT stands for Blood Cell Therapy

Warnings and precautions

Strict aseptic technique must be followed during phlebotomy. Use proper safety precautions to avoid contact with patient blood or cross-contamination. Use proper safety precautions to guard against needles or broken tubes. Do not use sterile component of this kit if package is opened or damaged. Do not use components of this kit if they are broken or present a defect. Do not use the tube if it lost vacuum. Do not use the sodium citrate solution or other tube components alone. Store between 5 ºC and 30ºC; bring kit at ambient temperature before using tubes. Do not re-sterilise, do not use after the expiry date. Single use device, do not reuse any part of the kit. Reuse may lead to infection or other illness / injury. Transfer needles must be used to transfer liquids or prepare injections, it must not be used for injection. The preparation of plateletrich plasma (PRP) must be performed by a physician trained on the device and the procedure, or under his supervision. The treatment with PRP must be performed by a qualified physician. The patient must be informed of the general risks associated with the treatment and of possible adverse effects. The PRP must be prepared from fresh blood and must be used within four hours (extemporaneous use only).

Throw away each tube and the other components after use, using the method of elimination for potentially contaminated blood products. Use a horizontal head (swinging bucket) centrifuge or a fixed angle head centrifuge (ex. RegenPRP Centri provided by Regen Lab). Follow manufacturer instructions when using centrifuge. Excessive centrifugation force (over 2200 RCF) may cause tube breakage, exposure to blood, and possible injury. Tubes should be centrifuged, as recommended in the instructions for use, at 1500 RCF. Lower centrifugal force (below 1500 RCF) may lead to incorrect blood separation and red blood cell contamination of PRP. Centrifuge carriers and inserts should be of the size specific for the tubes. Use of carriers too large or too small for the tube may result in breakage. Care should be taken to ensure that tubes are properly seated in the centrifuge cup. Tubes must be balanced in the centrifuge head to minimize the possibility of glass breakage.

Possible adverse effects

Possible adverse effects :

Damage to blood vessels, hematoma, delayed wound healing and/ or infection. Temporary or permanent nerve damage that may result in pain or numbness. Early or late operative infection.

Patented by Regen Lab SA
Platelet Rich Plasma

U.S. patent US8529957
European patent EP2073862B
Swiss patent CH696752

All our Patent

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