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System for the Preparation of Autologous Platelet-rich Fibrin Gel (PRFG)

MyoRegen Platelet-Rich Fibrin Gel (PRFG) ​

The MyoRegen System is designed for the safe and rapid preparation of Platelet-rich Fibrin Gel (PRFG) from a small sample of blood at the patient point of care. Many PRP systems require operator skill, have varying results and have extensive contamination with red blood cells and white blood cells. MyoRegen removes virtually all contaminating cells and is independent of operator technique. PRP is converted to PRFG through a controlled process, creating a scaffold that serves to protect and preserve platelets. Think of MyoRegen PRFG as the next generation PRP.

What is Platelet-Pich Plasma (prp)?

  • PRP is a solution of plasma and platelets where the platelet concentration is higher than whole blood.
  • Optimal platelet concentration is 2-3X greater than whole blood.
  • Definition of PRP does NOT include red blood cells (RBC) or white blood cells (WBC).
  • RBC and WBC should be removed as much as possible from PRP preparation.
  • PRP kits that out high platelet concentrations often have contaminating RBCs or WBCs which have inflammatory and catabolic effects causing opposite effect of desired outcome.
  • Pink or red PRP has RBC contamination.
  • The ideal PRP solution will be a golden, straw-like color.

Platelet-Rich Fibrin Gel (PRFG)

Features

  • "Golden" Visual Guide to Quality
  • Purest PRP/PRFG
  • Closed-System
  • Secondary Proprietary Step
  • Converts PRP to PRFG

Fibrin Matrix Scaffold is Key!

  • Fibrin Matrix Scaffold is KEY!
  • Calcium chloride allows for controlled fibrin polymerization
  • Scaffold is a biologic connector
  • Platelets are localized and viable
  • Sustained growth factor release

PRP VS. PRFG

PRP

  • Platelets in plasma
  • Activation is immediate
  • Alpha granules release growth factors quickly (bolus)
  • Short-term tissue signaling
  • Minutes - Hours

PRFG

  • Platelets in fibrin
  • CaCl2 binds to Na Citrate 1:1
  • Clotting cascade resumes (Fibrinogen - Fibrin)
  • Platelets remain viable with controlled GF release
  • Hours - Days

The Power of Blood

As part of the body's capacity to heal itself, platelets and other components in human blood migrate to a site of injury. Platelets are known to release a variety of factors that respond to tissue injury, where they initiate and promote healing. By concentrating platelets at the site of injury, physicians have the potential to enhance the body's natural capacity for healing.

1. Anitua E, Andia I, Ardanza B, Nurden P, Nurden AT, Autologous platelets as a source of proteins for healing and tissue regeneration, Thromb Haemost, 2004; 91(1):4-15

2. Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma. Am J Sports Med. 2009; 37:2259-2272.

The MyoRegen system 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 point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.

Platelets Release Growth Factors

Sustained Growth Factor Release

The Myoregen Process

Optimal Platelet Concentration

In Vitro, Animal and Human Studies Physiologic Range is Better Than Pharmacologic Range [Wound Healing, Bone, Spinal Cord Injury]

showed more robust healing rates than those with higher concentrations 3 to 8 times baseline."

Rappl LM et al., Int Wound J 2011; 8:187-195

"The use of highly concentrated platelet preparations appeared to have an inhibitory influence...reasons could be unwanted inhibitory and cytotoxic effects of growth factors at such high concentrations."

Weibrich G et al., Bone 2004; 34:665-671

"PRP might exert positive effects...in a dose-dependent manner up to a certain level, but adverse effects occur when it is highly concentrated."

Yamaguchi R et al., J Surg Res 2012; 173(2): 258-266

"Optimal results were observed at a platelet concentration of 2.5 X... increased concentrations resulted in a reduction in proliferation and a suboptimal effect on osteoblast function."

Graziani F et al., Olin Oral Imp! Res 2006; 17: 212-219

THE MyoRegen Kit

Affordable and Cost-effective

4cc or 8cc of PRFG available for administration

A. SAFETY BLOOD COLLECTION SET - "Butterfly Wing"

B. PROPRIETARY VACUTAINER PRP TUBE - "Yellow Top"

  • Proprietary 9cc whole blood collection tube with cell separator gel

C. DEVICE FOR THE STERILE TRANSFER OF FLUID

  • Safe, closed system
  • Needle protection sleeve (Jacketed)

D. PRFG PREPARATION TUBE - "Red Top"

  • 4cc liquid per tube
  • HemogardT" Cap
  • Calcium Chloride Solution

E. ADDITIONAL MATERIALS REQUIRED (not included in the kit)

  • syringe and needle

Regulatory status: FDA cleared 510(k) Class II medical device

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