® ®

PRP® & CELL THERAPY SPECIALISTS

RegenLab
®

A-PRP technology
®

SWISS R&D AND MANUFACTURER

IN BIOTECHNOLOGY

RegenLab® is recognized as a leading provider of a patented

technology to produce autologous platelet rich plasma. The
technology processes the patient’s own blood and isolates
concentrated platelets and proteins for indications in various
medical disciplines.

The RegenKit®-BCT product family is indicated by the U.S. FDA

for the safe and rapid preparation of autologous platelet rich
plasma from a small sample of blood at the patient’s point of
care. The platelet rich plasma is mixed with autograft and/or
allograft bone prior to application to a bony defect for improved
handling characteristics. The RegenKit®-BCT product family is
for single use only.

Medical Devices class II

RegenLab® USA LLC

575 Madison Avenue
Suite 1006
New York, NY 10022-2511
Phone & Fax: 1-800-220-9082
[email protected] − www.regenlabusa.com
WHAT IS A-PRP   ? ®

The patient’s platelet concentrate prepared with RegenKit®

Platelets are key factors in hard and soft tissue repair mechanisms. They provide the
essential growth factors FGF, PDGF, TGF-ß, EGF, VEGF, and IGF that are involved in stem cell
migration, differentiation and proliferation. The stimulation of fibroblasts and endothelial cells
induces new extracellular matrix deposition and neo-vascularization.

Plasma is essential for cell survival as it contains nutrients, vitamins, hormones, electrolytes
and proteins. Proteins are key molecules for the coagulation process and the formation of the
fibrin polymer that will serve as a scaffold for cell migration, differentiation and proliferation.

IDEAL PLATELET WHITE BLOOD CELLS IN

CONCENTRATION TISSUE REGENERATION
The Regen™-BCT tube prepares 5 to 6 ml of White blood cells are strongly reduced (> 85% depletion)
autologous platelet rich plasma with a platelet with the Regen™ PRP® system.
recovery greater than 80% and a concentration
factor of 1.6-fold. Although the system is technically The role of white blood cells (WBC) in healing is
capable of producing significantly higher platelet controversially discussed among physicians. To address
concentrations, it is not what some research shows this concern scientifically, WBC subsets, granulocytes
to be the most beneficial for clinical use. More and and mononuclear cells, need to be looked at individually.
more studies demonstrate that concentrations of Granulocytes, and more specifically neutrophils, are the
platelets 1 to 3 times over the baseline show more front-line defenders against invading pathogens and are
robust healing rates than those with concentrations associated with the inflammatory response. They release
of 3 to 8 times the baseline 1 . a large variety of highly active antimicrobial substances
and proteases. Uncontrolled release of these factors can
Some studies even showed that too high platelet cause severe damage to the tissue, delay healing rates
concentrations may actually have negative effects. In and increase the risk of scarring4. Thanks to the Regen™
an in vivo study2, it was shown that highly concentrated PRP® system, more than 96% of the granulocytes are
platelet preparations had an inhibitory influence removed from autologous platelet rich plasma. The few
on osteoblast activity, probably due to unwanted white blood cells still present in autologous platelet rich
inhibitory and cytotoxic effects of growth factors at plasma are mostly mononuclear cells (lymphocytes and
such high concentrations. Similarly, an in vitro study3 monocytes). These two cell types are also involved in the
demonstrated that platelet concentrations over 2.5-fold immune response, but have also been shown to support
resulted in a reduction in proliferation and a suboptimal the healing process5,6.
effect on osteoblast function.

REFERENCES:

1- Rappl LM et al. Effect of platelet-rich plasma gel in a physiologically relevant platelet concentration on wounds in persons with spinal cord
injury. Int Wound J 2011; 8:18.7–195.
2- Weibrich G. et al., Effect of platelet concentration in platelet-rich plasma on peri-implant bone regeneration. Bone 2004; 34:665-671.
3- Graziani F. et al.,The in vitro effect of different PRP concentrations on osteoblasts and fibroblasts. Clin. Oral. Impl. Res. 17, 2006; 212–219.
4- Brubaker A.L. et al. Neutrophils and natural killer T cells as negative regulators of wound healing. Expert Rev. Dermatol. 2011; 6(1), 5–8
5- Barbul, A.et al. Wound healing in nude mice: a study on the regulatory role of lymphocytes in fibroplasia. Surgery 1989;105(6): 764-769.
6- Brancato S.K. and Albina J. E. Wound Macrophages as Key Regulators of Repair. Am J Pathol 2011, Vol. 178, No. 1, 19-25
 RegenPlasma®
REGENKIT®-BCT & REGENKIT®-THT TECHNOLOGIES
The simple, safe and efficient point
of care preparation of autologous platelet rich plasma.

Blood Collection Centrifugation Platelet Resuspension Ready to Use

•••
SYSTEM SPECIFICATIONS
Properties

The performance tests were carried out according to the U.S. FDA requirements for platelet rich plasma medical devices.
Platelet rich plasma samples were prepared and tested using the blood of 60 volunteers (33 women and 27 men, between 18 to 67 years old).

Performance Characteristics
The Regen BCT tubes collect The RegenTHT tubes collect 8mL
10mL of blood and prepare an of blood and prepare an average
average of 5.5mL of leukocyte of 4.5mL of a PRP enriched in
poor PRP. MNC (lymphocytes and mono-
cytes) but poor in granulocytes.
 REGENKIT®- BCT PLUS FAMILY KITS TECHNOLOGY

The simple, safe and efficient point

of care preparation of autologous thrombin serum.

Blood Collection Centrifugation Autologous Autologous Thrombin

Thrombin Serum Serum Extraction

The Regen™-ATS tube supplied in the RegenKit®-BCT Plus Addition of autologous thrombin serum to autologous
product family is used for the preparation of autologous platelet rich plasma restarts the coagulation process
thrombin serum. The coagulation process is 100% natural in a physiological manner. This natural process induces
and does not require any exogenous chemical activation. the formation of three-dimensional fibrin matrix in which
Thrombin is the enzyme that converts soluble fibrinogen the platelets are entrapped. This allows a long-lasting
to fibrin monomers which polymerize to form the clot. growth factor delivery at the treatment site and the
matrix serves as scaffold for new tissue reconstruction.

FIBRINOGEN

AUTOLOGOUS
THROMBIN THROMBIN FIBRIN
MONOMER
SERUM CLOT

AUTOLOGOUS
THROMBIN nibmorht

SERUM
EXTRACTED FROM
FIBRIN
THE CLOT
POLYMERIZATION

FIBRIN MESH
 REGENKIT®- BCT PLUS FAMILY KITS
TECHNOLOGY

The RegenKit®-BCT Plus Family Kits contain devices

(Regen™-BCT and Regen™-ATS tubes) for the
preparation of autologous platelet rich plasma and its
natural activator, the thrombin serum. Both products
are 100% autologous and prepared in a three step,
sterile, and closed system. The preparation process
is safe, reliable and efficient for patient use.

•••
REGEN™ SPRAY APPLICATOR
The Regen™ Spray Applicator enables the application of autologous platelet rich plasma combined with
its natural activator, the autologous thrombin serum. The spray applicator is a dual syringe system, al-
lowing the mixing of the two solutions to be applied in a 10:1 or 10:3 ratio.

REF: R-A/NAC1
 Regen™ Product Line Reference Description Set/Component

RegenKit®-BCT-1

1 Safety–LokTM Butterfly needle

RegenKit®-BCT-1 is designed
1 Collection holder RK-BCT-1 to prepare 5-6 ml of autolo-
1 Regen®BCT tube
gous platelet rich plasma.
1 Transfer device
1 Transfer needle
1 x 5 ml Luer-LokTM syringe

RegenKit®-BCT-2

1 Safety–LokTM Butterfly needle

RegenKit®-BCT-2 is designed
1 Collection holder RK-BCT-2 to prepare 10-12 ml of autolo-
2 Regen®BCT tubes
gous platelet rich plasma.
1 Transfer device
2 Transfer needles
2 x 5 ml Luer-LokTM syringes

RegenKit®-BCT-4

1 Safety–LokTM Butterfly needle

RegenKit®-BCT-4 is designed
1 Collection holder RK-BCT-4 to prepare 20-24 ml of autolo-
4 Regen®BCT tubes
gous platelet rich plasma.
2 Transfer devices
2 Transfer needles
2 x 5 ml Luer-LokTM syringes

The RegenKit®-BCT-3 contains

RegenKit -BCT-3
®
three individually packaged Re-
RK-BCT-3 gen®BCT tubes. Each tube is de-
3 Regen BCT Tubes
®
signed for the preparation of 5-6 ml
of autologous platelet rich plasma.

Accessories Set
Blood collection set for
BCA-SET3
3 Safety–LokTM Butterfly needles Regen Lab tubes.
3 Transfer devices

The RegenKit®-BCT Family Kit is designed to be used for the safe and rapid preparation of autologous platelet rich plasma from a small sample of
blood at the patient’s point of care. The platelet rich plasma is mixed with autograft and/or allograft bone prior to application to a bony defect for
improved handling characteristics. The RegenKit®-BCT Family Kit are for single use only.
FDA clearance number BK 110061, comply with 21CFR820
Manufactured in accordance with Quality System Regulations and ISO 13485, CE0086
RegenKit®-BCT-1 (RK-BCT-1)
RegenKit®-BCT-2 (RK-BCT-2)
RegenKit®-BCT-3 (RK-BCT-3)
RegenKit®-BCT-4 (RK-BCT-4)

RegenLab® Intellectual Property Rights as Core Assets: www.regenlab.com/patents

U.S. patents US9833478 and US8529957
 Regen™ Product Line Reference Description Set/Component

RegenKit®-BCT-1 Plus

1 Safety–LokTM Butterfly needle RegenKit®-BCT-1 Plus is

1 Collection holder designed for the preparation
1 Regen®BCT tube RK-BCT-1A of autolougous platelet
1 Regen®ATS tube rich plasma and autolgous
1 Transfer device thrombin serum.
1 Transfer needle
1 x 5 ml Luer-LokTM syringe

RegenKit®-BCT-2 Plus

1 Safety–LokTM Butterfly needle

1 Collection holder RegenKit®-BCT-2 Plus is
2 Regen®BCT tubes designed for the preparation
1 Regen®ATS tube RK-BCT-2A of autolougous platelet
1 Transfer device rich plasma and autolgous

1ml

2ml

3ml

4ml

5ml
5ml

4ml

3ml

2ml

1ml
2 Transfer needles thrombin serum.
2 x 5 ml Luer-LokTM syringes

Regen™ Spray Applicator

Ratio 10:1 or 10:3

2 transfer needles Regen™ Spray Applicator 10:1

1 10 ml Luer lock syringe & 10:3 is designed to obtain an
1 1ml Luer lock syringe R-A/NAC-1 autologous biological glue by
1 3ml Luer lock syringe combination of autolougous
1 Nozzle for spray application platelet rich plasma and
1 Double piston stopper autolgous thrombin serum.
1 Applicator syringe holder
1 Luer lock connector
1 10:3 ratio adapter

The Drucker 642 VFD Plus is a continuous-duty,

T
electrically controlled, fixed-angle centrifuge with a lid
safety interlock system. The unit is controlled by two 3
Drucker 642 VFD Plus 3
electronic push–button timers that have been preset 3
for five (5) minutes 1,500RCF and nine (9) minutes 3
1,500RCF, for precise spin times and ease of use. 3

The RegenKit®-BCT Plus Family Kits are designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) and
autologous serum from a small sample of blood at the patient’s point of care. The combined PRP and autologous serum are mixed with autograft
and/or allograft bone prior to application to a bony defect for improving handling characteristics. The RegenKit®-BCT Plus Family Kits are for single
use only.
FDA clearance number BK 120066, comply with 21CFR820
Manufactured in accordance with Quality System Regulations and ISO 13485, CE0086
RegenKit®-BCT-1 Plus (RK-BCT-1A)
RegenKit®-BCT-2 Plus (RK-BCT-2A)
Regen™ Spray Applicator is a sterile, single use device for application of two non-homogeneous fluids or liquids to a treatment site as deemed
necessary by the clinical use requirements. Ref: R-A/NAC1 / FDA clearance number K122122

RegenLab® Intellectual Property Rights as Core Assets: www.regenlab.com/patents

U.S. patents US9833478 and US8529957
 Regen™ Product Line Reference Description Set/Component

RegenKit®-THT-1

1 Safety–LokTM Butterfly needle

RegenKit®-THT-1 is designed
1 Collection holder RK-THT-1 to prepare 4-5 ml of autolo-
1 Regen®THT tube
gous platelet rich plasma.
1 Transfer device
1 Transfer needle
1 x 5 ml Luer-LokTM syringe

RegenKit®-THT-2

1 Safety–LokTM Butterfly needle

RegenKit®-THT-2 is designed
1 Collection holder RK-THT-2 to prepare 8-10 ml of autolo-
2 Regen®THT tubes
gous platelet rich plasma.
1 Transfer device
2 Transfer needles
2 x 5 ml Luer-LokTM syringes

RegenKit®-THT-4

1 Safety–LokTM Butterfly needle

RegenKit®-THT-4 is designed
1 Collection holder RK-THT-4 to prepare 16-20 ml of autolo-
4 Regen®THT tubes
gous platelet rich plasma.
2 Transfer devices
2 Transfer needles
2 x 5 ml Luer-LokTM syringes

The RegenKit®-THT-3 contains

RegenKit -THT-3
®
three individually packaged Re-
RK-THT-3 gen®THT tubes. Each tube is de-
3 Regen THT Tubes
®
signed for the preparation of 4-5 ml
of autologous platelet rich plasma.

Accessories Set
Blood collection set for
BCA-SET3
3 Safety–LokTM Butterfly needles Regen Lab tubes.
3 Transfer devices

The RegenKit®-THT is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of blood
at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to an orthopaedic surgical site as deemed
necessary by the clinical use requirements. The RegenKit®-THT is for single use only.
FDA clearance number BK 090048, comply with 21CFR820
Manufactured in accordance with Quality System Regulations and ISO 13485, CE0086
RegenKit®-THT-1 (RK-THT-1)
RegenKit®-THT-2 (RK-THT-2)
RegenKit®-THT-3 (RK-THT-3)
RegenKit®-THT-4 (RK-THT-4)

RegenLab® Intellectual Property Rights as Core Assets: www.regenlab.com/patents

U.S. patents US9833478 and US8529957
 GOOD PRACTiCES WiTH
GOOD PRACTiCES
REGEN LAB A-PRP KiTS ®

• Users must be trained in the preparation of PRP before starting to use Regen Lab kits.

• Patient must be informed of the general risks associated

with the treatment and of possible adverse effects.

• Integrity of the packaging must be checked before opening the kit.

• Treatments are registered in the patient file, using the removable

stickers to record reference and lot number of the kit used.

• Document any undesired events and report them to our quality affairs department.

• Use surgical aseptic technique throughout the procedure

(blood draw, A-PRP collection, injection).

• Use appropriate safety precautions to protect yourself

from needles and beveled cannulas.

• Throw away the entire kit after use, using the appropriate method
of elimination for potentially contaminated blood products.

• Use a Regen Lab centrifuge. Centrifuges from other manufacturers can be used
only if they have a centrifugation angle of 45°or spin the tubes horizontally.

• Tube holders must correctly fit Regen Lab tubes.

• Speed in round per minutes (RPM) should be set to reach the desired
relative centrifugal force (RCF) of 1500 x g. Use manufacturer instructions
and RCF to RPM converter to calculate the appropriate speed in RPM.

• Tubes must be correctly balanced. If necessary, fill a counterbalance tube with

water until it reaches the same volume as the blood filled tube.

• Respect the centrifugation protocol (time, centrifugal force). Any

modifications will lead to lowering the device performances.

• Regen PRP is prepared and kept until used at room temperature.

Never refrigerate. Use within four hours after blood collection.

• Take time to resuspend the platelets in the plasma before PRP collection. Always
perform a visual control that platelets are well detached from the separating gel.

• If a cell and platelet count is desired, dedicate a full tube for this
evaluation. Ensure that all aggregates, even the microscopic ones, are
well disrupted before performing the automated cell counting.

• Respect injection or application protocol. Avoid injecting

too high volumes that would distend tissues.
RegenLab USA marketing materials are available to all customers.
Please reference our order form or ask your local representative
for more details.

Name Quantity (min)

Syringe pen 100

Background:
Your body has inherent healing and regenerative
properties that are activated after sustaining
an injury. A well-organized sequence of events
PRP® & CELL THERAPY SPECIALISTS
uses chemical signals transported through the
bloodstream to orchestrate a healing response.
Signaling molecules such as growth factors facilitate
communication between cells. They are present in
large numbers within blood component molecules
called platelets. Platelets come from bone marrow
and circulate throughout the bloodstream in a
non-activated form. Once they detect an injured
tissue, platelets become activated, collecting
at the site of injury and changing their shape
to release their contained signaling molecules.
By concentrating platelets from the blood and
introducing them to a specific area, we can
RegenKit®-BCT Family
stimulate the body’s natural healing properties.
AUTOLOGOUS PLATELET
RICH PLASMA AND

50
RegenKit®-BCT kits

Patient Flyer
GROWTH FACTORS
prepare A-PRP® from a
small sample of blood
in under ten minutes.
ASK YOUR DOCTOR
A-PRP is a regenerative repair solution
that effectively accelerates the
IF PLATELET RICH
healing of damaged tissues. www.regenlab.com PLASMA IS RIGHT
FOR YOU!
Homogenization Collection
CONSULT YOUR PHYSICIAN FOR
APPROPRIATE TREATMENT OPTIONS,
CONTRAINDICATIONS AND POSSIBLE
SIDE EFFECTS.

The RegenKit®-BCT Family Kit is designed to be used

PATENTED TECHNOLOGIES for the safe and rapid preparation of autologous
www.regenlab.com/patents platelet-rich-plasma (PRP) from a small sample of blood
A patented gel within the tubes isolates your platelets and plasma at the patient’s point of care. The PRP is mixed with
from the red blood cells and proinflammatory white blood cells. autograft and/or allograft bone prior to application to a
En Budron B2 CH-1052 Le Mont-sur-Lausanne − SWITZERLAND bony defect for improving handling characteristics.
The platelets are homogenized in your plasma and the preparation USA-FLY-ENG-USA-V180725 The RegenKit®-BCT Family Kits are for single use only.
applied into the damaged tissue.

PLATELET-RICH PLASMA
PRP STANDARDIZATION
& CELL THERAPIES
U S A E D I T I O N

PRP Book 1

Antoine Turzi & REGEN LAB team

BIOBRIDGE FOUNDATION EDITIONS

PRP® & CELL THERAPY SPECIALISTS PRP® & CELL THERAPY SPECIALISTS

HAVE Your body has built-in healing potential that

can be quickly and easily harnessed by
HAVE Your body has built-in healing potential that
can be quickly and easily harnessed by
YOU isolating components of your own blood.
YOU isolating components of your own blood.

HEARD ? These isolated components can be used

to prepare a regenerative therapy called
HEARD ? These isolated components can be used
to prepare a regenerative therapy called
platelet rich plasma. platelet rich plasma.

Platelet rich plasma is created using the Platelet rich plasma is created using the
three simple steps below : three simple steps below :

STEP 1 STEP 2 STEP 3 STEP 1 STEP 2 STEP 3

Patient
1
A small sample Rapid separation Regen™ PRP ® A small sample Rapid separation Regen™ PRP ®

Banner
of your blood of blood product isolation of your blood of blood product isolation
is taken components is taken components

Ask your doctor today if Ask your doctor today if

Regen™ PRP ® is right for you!
The RegenKit®-BCT Family Kit is designed to be used for the safe and rapid preparation of autologous platelet rich plasma from a
Regen™ PRP ® is right for you!
The RegenKit®-BCT Family Kit is designed to be used for the safe and rapid preparation of autologous platelet rich plasma from a
(white or blue)
small sample of blood at the patient’s point of care. The platelet rich plasma is mixed with autograft and/or allograft bone small sample of blood at the patient’s point of care. The platelet rich plasma is mixed with autograft and/or allograft bone
prior to application to a bony defect for improved handling characteristics. The RegenKit®-BCT Family Kits are for single use only. prior to application to a bony defect for improved handling characteristics. The RegenKit®-BCT Family Kits are for single use only.

FDA clearance number BK 110061, comply with 21CFR820 FDA clearance number BK 110061, comply with 21CFR820
Manufactured in accordance with Quality System Regulations and ISO 13485, CE0086 Manufactured in accordance with Quality System Regulations and ISO 13485, CE0086

RegenLab® Intellectual Property Rights as Core Assets: www.regenlab.com/patents RegenLab® Intellectual Property Rights as Core Assets: www.regenlab.com/patents
U.S. patents US9833478 and US8529957 U.S. patents US9833478 and US8529957

PRP® & CELL THERAPY SPECIALISTS

100 pens
50 Flyers
Bundle Option 1 Patient
1
Banner
NOTES
 ® ®
PRP® & CELL THERAPY SPECIALISTS

Regen Lab® USA LLC

575 Madison Avenue
Suite 1006
New York, NY 10022-2511
Phone & Fax: 1-800-220-9082 − [email protected]
−
www.regenlabusa.com

Regen Lab®, RegenKit®, ®

, Regenmatrix®, Regen PRP®, A-PRP®, PRP®, Regen®, RegenPlasma® , RegenCell®
are registered trademarks of Regen Lab SA.

RegenLab® Intellectual Property Rights as Core Assets: www.regenlab.com/patents

U.S. patents US9833478 and US8529957

RL-TECHNO-USA-V190319