SuperShot®PRP - Extracellular Vesicle Concentrate

SuperShot®PRP - Extracellular Vesicle Concentrate

SuperShot® - A more complete PRP SuperShot® is a 2mL solution in a 10x concentrate of Poly(ethyleneglycol) 6000 (PEG)/10% Dextran 500 (Dex).  Provides autologous extracellular vesicles at the point-of-care.

Regulatory Position Statement

Based on FDA’s analysis, we submit that SuperShot® PRP qualifies for the same exemption in 21 CFR 1271 as PRP does and for the same reasons that FDA defines above. Like PRP: 1) it is a blood derivative product, 2) it is autologous, 3) it is....Click Below to read the entire statement.

SuperShot Regulatory StatementSuperShot Product BrochureVisit www.SuperShotPRP.comClinical Observation Statement

What is SuperShot®?

SuperShot® is a more complete Platelet Rich Plasma.  In standard Platelet Rich Plasma (PRP) centrifugation, potent biological agents are discarded with the Platelet Poor Plasma (PPP).  Blood plasma is rich in low-density extracellular vesicles.  These extracellular vesicles transport proteins and microRNAs that are essential for tissue regeneration, healing, vascularization, and rejuvenation.  Standard PRP centrifugation does not isolate these vesicles and the important therapeutic molecules they contain within.  With SuperShot ® technology, the autologous EVs are quickly isolated and incorporated into your PRP, resulting in a more complete PRP therapy.

 

Why use SuperShot®?

Extracellular vesicles in the plasma carry potent biologically active molecules including non-coding microRNAs. MicroRNAs are critical signaling components during wound healing, tissue regeneration, and neo-vascularization.  SuperShot® technology enables the isolation of low-density EVs, increasing their concentration in PRP, and the important microRNAs they carry within.  The EVs isolated by SuperShot® are autologous and collected and used at point-of-care, not shipped, or stored before use.  EVs and the microRNAs they contain within are damaged by freezing and lyophilization.  Aside from introducing serious risks such as infection from prions or viruses, allogeneic products are functionally degraded by processing and storage.

In a standard PRP preparation, whole blood is centrifuged into three components, separated by density: red blood cells, Platelet Rich Plasma, and Platelet Poor Plasma.  In SuperShot ® PRP, the Platelet Poor Plasma is centrifuged one additional time using the SuperShot ® patent-pending aqueous two-phase system, that precipitates low-density lipid-rich EVs from the Plasma.

 

How do you process SuperShot®?

SuperShot® is quick and easy. With just one additional 1 minute spin at 4200 rpm, SuperShot ® adds hundreds of billions of therapeutic EVs (and the important signaling molecules they contain within) to your PRP.  SuperShot® leverages the patient’s own biology Isolation of the low-density EV fraction from the patient’s plasma resulting in a more complete PRP.  SuperShot® does not use allogeneic or xeno-sourced materials.  SuperShot ® PRP is 100% autologous, which means no risk from donor pathogens, unknown sourcing, unproven allogeneic biologics, or immuno-rejection.

 

 

 

1

Minute 4200 rpm spin

10x

Poly/Dextran concentrate

503b

Manufacturer Facility

2mL

Solution

SuperShot PRP