NewSurg, Inc.

The patented SELPHYL System enables the safe and rapid preparation of an activated Platelet-Rich Fibrin Matrix (PRFM). A small volume of the patient's blood is collected and the platelets and fibrin are concentrated during a simple centrifuge process. The resulting product (liquid, gel or membrane) can be applied to a treatment area of the face or body to stimulate natural, new tissue growth. SELPHYL prepared PRFM has been shown to increase skin volume and rejuvenation.

SELPHYL ensures a preparation of fibrin and platelets, with virtually no red or white blood cells. Studies have shown these platelets to be viable and intact. Platelets will release proteins, which have been reported to trigger cell migration, proliferation and differentiation over time.

With over 45,000 procedures performed world-wide, this technology has been extensively used for soft tissue regeneration in cosmetics and plastic surgery and in orthopedics.

Reproducible and Easy-to-Use 3 Step System:

The three-step turnkey procedure to prepare SELPHYL PRFM takes approximately 20 minutes.

SELPHYL Kit

Step 1: A small volume of blood is collected.

First, the patient's treatment site may be numbed using your preferred local anesthetic. Then 9cc of venous blood is collected in the yellow-stoppered collection tube using the butterfly needle and placed in Aesthetic Factors provided centrifuge.

With a single blood collection of 9cc, four 1cc syringes of PRFM can be prepared – enough for a facial rejuvenation procedure.

Step 2: The patient's platelets and fibrin are separated and concentrated into PRFM

The yellow-stoppered tube is centrifuged for 6 minutes in our custom centrifuge, pre-programmed for the correct speed and time. The tube is then removed and can be stored at the physician's convenience under room temperature conditions for up to 2 hours.

SELPHYL Tube - After 6 minute Centrifuge

Step3: Matrix Formation

The blood collection tube (yellow) is inverted ten times to ensure homogeneous dispersion of all active ingredients into the plasma supernatant. The plasma is then transferred to a second tube (with red top) containing a fibrin forming catalyst, using the provided transfer device. This catalyst activates the polymerization of fibrin and platelets into PRFM.

PRFM can be aspirated from the red-top tube into four 1cc syringes (not provided) for application.

Take note: Extensive polymerization of fibrin renders the PRFM too viscous to inject after 10 minutes following the transfer.

SELPHYL PRFM should be administered using your preferred technique.

Physicians and patients have seen promising and lasting results, with visible effects noted as early as 3 weeks after injection.

Procedure Note: Standard blood collection procedures and universal precautions should be followed when performing the SELPHYL procedure.

What does PRFM do?

Alpha granules in intact platelets contain many tissue regenerating proteins. In vitro studies have shown that PRFM continues to release these growth and regeneration factors for up to seven days. Several of these factors have been shown to stimulate cell migration, proliferation and differentiation; known to initiate the production of collagen and trigger other biological responses.

The fibrin matrix produced in-situ serves to maintain the intact platelets at the site of injection and provide a scaffold for the cells migrating under the influence of the released chemotactic factors.

Growth Factors and Proteins Release from PRFM

A variety of growth factors are produced at a steady rate. Key factors present are bFGF, PDGF-BB, EGF, TGF-beta and VEGF.

Clinical Injection Sites

Deep Rhytids / Glabella Lines
Nasolabial Folds
Acne / Traumatic Scars
Post Operative Scars
Full Face Contouring and Volumizing
Dermal Defects

SELPHYL System

The SELPHYL system is available in two presentations:
1. SELPHYL kit to prepare 4 cc of PRFM
2. SELPHYL kit to prepare 8 cc of PRFM

FDA cleared Class 2A device - 510(k) #BK020051 & BK060006) and CE mark

SELPHYL is intended 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 can also be mixed with fat during Fat Transfer.

Selphyl is Distributed by Aesthetic Systems - (215)822-7722