RegenWound-HA Set

Set for the safe preparation of autologous RegenPRP™ and subsequent wound dressing.

What is RegenPRP™-Ca-HA gel?

Cellular Membrane tube (CM-HA) is designed for the preparation of RegenPRP™ combinedwith a hyaluronic acid gel that contains calciumgluconate (Ca-HA). The resulting product,RegenPRP™-Ca-HA gel, is a platelet rich fibringel embedded in a hyaluronic acid network.RegenPRP™ is the platelet rich plasma (PRP)prepared with Regen Lab separator geltechnology from a small sample of patient’sblood. It has a standardised composition and isa reservoir of autologous growth factors.
Platelets, in addition to their role in haemostasis,are key factors in tissue repair mechanisms.1They provide essential growth factors, suchas FGF, PDGF, TGF-ß, EGF, VEGF, IGF, which areinvolved in stem cells migration, differentiationand proliferation. Platelet growth factors alsostimulate fibroblasts and endothelial cells toinduce the deposition of new extracellularmatrix and neovascularisation, respectively.
Plasma contains many factors essential for cellsurvival including nutrients, vitamins, hormones,electrolytes, growth factors (such as IGF andHGF), and proteins. Among the plasmaproteins, the molecules involved in the coagulationprocess allow the formation of the fibrin polymerthat serves as a scaffold for cell migrationand new tissue generation.2
Platelet-Rich Plasma
• Proven role in the healing of tissues,with key roles in cell migration,proliferation and differentiation
• Mechanism of action comprisesanti-inflammatory activity and activationof cell-signalling cascades
• Key role in the synthesis of new extracellularmatrix for tissue regeneration
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RegenPRP™-Ca-HA gel preparation

RegenPRP™ in combination with HA
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RegenPRP™ in combination with HA
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A 5-minute centrifugation separates theplasma and the platelets from the other blood components. Plasma and platelets are above theseparator gel, with the Ca-HA in the upper partof the tube. The homogenisation step enablesputting the platelets back in suspension in theplasma that is combined with the Ca-HA gel.The calcium of the Ca-HA gel counterbalancesthe effect of the anticoagulant and triggers thecoagulation process in a physiological manner.
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This results in the activation of the enzymesof the coagulation cascade and among themthrombin. Thrombin is the enzyme that convertssoluble plasma fibrinogen to fibrin monomerswhich polymerise to form a clot. When fibrinpolymerisation occurs in presence of hyaluronicacid, it induces the formation of more porousthree-dimensional fibrin matrix in which theplatelets are entrapped.3 This allows a long-lastinggrowth factor delivery at the treatment site.

Blood sample volume per tube

Output (PRP combined with 2 ml of Ca-HA)

%

Platelet recovery

%

Red blood cell depletion

%

Granulocyte depletion

RegenWound-HA Set

Set for the safe preparation of autologous RegenPRP™ and subsequent wound dressing.

COMPOSITION

  1.  Cellular Membrane CM-HA tube
  2.  Silicone Wound Contact Layer
  3.  Surgical bowl
  4.  5ml syringe Luer-Lock
  5.  Safety-Lok Blood Collection Set with Pre-Attached Holder
  6.  Blood Transfer Device

Cellular Membrane CM-HA tubes are provided in the RegenWound-HA Set.

Cellular Membrane is a CE certified medical device.

INTENDED USE OF THE DEVICE : Preparation of autologous platelet-rich plasma (RegenPRP™) and other plasma-derived products.

The plasma-derived product obtained with this device is for topical use only.

Read the instructions provided with the device before use.

Technology Platform for Standardised Autologous Regenerative Medicine

Cellular Membrane technology: The simple, safe and efficient point-of-care preparation of RegenPRP™ in a gel form for topical application on breached dermis.

PREPARATION OF THE REGENPRP™-Ca-HA GEL IN A STERILE CONTAINER

Pour the RegenPRP™-Ca-HA mixture into a sterile container. Wait for at least 10 minutes for complete coagulation. Gently transfer the resulting clot to the treatment site. Cover with nonadherent dressing.

DIRECT APPLICATION

Apply the RegenPRP™-Ca- HA drop by drop directly on the treatment site. Wait for coagulation. Cover with nonadherent dressing.

PREPARATION OF THE REGENPRP™-Ca-HA GEL ON A DRESSING

Gently pour the RegenPRP™- Ca-HA mixture on a nonadherent dressing. Wait for at least 10 minutes for complete coagulation. Gently apply the resulting clot covered by the dressing on the treatment site

Bibliography

1. Fountain, J.H. and S.L. Lappin, Physiology, Platelet, in StatPearls. 2025, StatPearls Publishing: Treasure Island (FL)

2. Mathew, J., P. Sankar, and M.A. Varacallo, Physiology, Blood Plasma, in StatPearls. 2025, StatPearls Publishing: Treasure Island (FL)

3. Smith, J.D., et al., Improved growth factor directed vascularization into fibrin constructs through inclusion of additional extracellular molecules. Microvasc Res, 2007. 73(2): p. 84-94.

4. A-CP-HA performance summary-v7ml, data on file

Since 2003, Regen Lab SA has been committed to the development of a unique expertise for the design and manufa​cturing of high-quality medical devices, intended for cells therapies.

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About Us

Since 2003, Regen Lab SA has specialized in designing and manufacturing high-quality medical devices for cell therapies and the preparation of autologous platelet-rich plasma (PRP) from the patient's own blood for bedside procedures.

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Milestones

2003 - Foundation
2010 - RegenKit first approval in bone graft
2013 - A new state-of-theart laboratory in Lausanne
2014 - Cellular Matrix first approval
2015 - Launch of Cellular Matrix in Europe

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Vision

Founded in 2003, Regen Lab has become a global reference thanks to its commitment to innovation, quality, and the effectiveness of its therapeutic solutions. Here’s how we have transformed the medical landscape over the past two decades.

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RegenPRP™

RegenPRP™ is a medical treatment that uses platelet-rich plasma from the patient's own blood to enhance and tissue regeneration.

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RegenPRP™ - HA

RegenPRP™ - HA combination is an innovative treatment combining platelet-rich plasma (PRP) and hyaluronic acid to improve tissue regeneration and healing.

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CM-Skin

RegenPRP™ - ATS

RegenPRP™ combined with ATS (Autologous Thrombin Serum) is an advanced approach to tissue regeneration that uses autologous thrombin-enriched platelet-rich plasma (PRP) to maximise healing effects.

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RegenExtracell®

RegenExtracell is an innovative tissue regeneration treatment using an extracellular matrix enriched with platelet-rich plasma (PRP).

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RegenWound

RegenWound is a fully autologous solution prepared from the patient’s own blood, with the objective of providing a standardised and reproducible approach for clinical use.

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Regulatory

Manufacturers of medical devices based outside the EU must designate an Authorized Representative (EU-REP) established within the EU in order to meet the CE requirements for placing medical devices on the EU market.

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Quality Management

Regen Lab Quality System Management ensures the consistency of our products quality in total GMP compliance.

Our production facility rooms atmosphere is monitored to satisfy non-pyrogenic medical devices manufacturing.

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Patents

As a leader in the PRP&HA regenerative field and as an innovation-driven company, Regen Lab SA has devoted important resources since 2004 to put on the market pioneering and diversified products constituting a complete set of tools/technologies for the medical community.

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