VesicoUreteral Reflux Biopolymer GmbH & Co.KG - Germany

Treatment Options: 1. Medications: antibiotics such as cephalosporins, Bactrim, Amoxicillin. 2. Surgical Procedures: laparoscopic, open procedures ( cohen procedure, leadbetter-politano procedure) 3. Minimal surgery procedures: bulking agents – Ureteral injection of implant material. Biopolymer GmbH & Co.KG - Germany

Treatment Options: Urethral Injections – Bulking Agents: Is a minimal surgical procedure providing An alternative in treatment options: The Ideal Bulking agent of choice must include following charecteristics: 1. Biocompatible. 2. Biodegradable. 3. Bio-stable: no deformation after injection. 4. No Migration after implantion. 5. No erosion after implantion. 6. Easy to applicate – without the need to apply pressure when injecting. Biopolymer GmbH & Co.KG - Germany

Treatment Options: Available Bulking Agents for VUR: 1. Vantris: polyacrylate polyalcohol copolymer immersed in 40% glycerol solution carrier. It is non-resorbable – permanent treatment. 2. Deflux: dextranomere microspheres 50mg/ml in a carrier gel of non-animal stabilized hyaluronic acid 15mg/ml. 3. CRM Vurdex: DEAE-Sephadex – dextran positively charged dextranomere. 4. CRM Vurdex composition: Sodium hyaluronate cross linked 17mg DEAE Sephadex Dextran + charge 50mg Sodium chloride 6.9mg Water for injection 1.0ml Biopolymer GmbH & Co.KG - Germany

CRM Vurdex designed Technolgy: Why to use Urodex ? What is the added Benefits of CRM Vurdex ? In order to realize the added benefits of CRM Vurdex, a summary explaining the designation technology of the product will answer many questions that may arise. 1. In VUR and as the condition is resulting from mechanical failure of valvular mechanism of ureter to prevent urine reflux, basically a material that acts as a bulking agent is needed in order to act in increased tissue thickness at injection site that will aid in complete closure when muscles plays its normal role to prevent reflux. and accordingly, the material of choice was DEAE-DEXTRAN ( Diethylaminoethyl- Dextran), the choice was based upon that Dextran is a Biocompatible, Biodegradable, non-immunogenic molecule. Dextran: consists of linked glucan with side chains attached to the 3-position of the backbone glucose units, and it is produced by bacterial fermentation process ( non- animal origin ). Biopolymer GmbH & Co.KG - Germany

CRM Vurdex designed Technolgy: 2. DEAE-Dextran Biomaterial cannot be introduced by injection And as the concept of the products is based upon – minimal Surgical procedure – a carrier material is needed to carry the DEAE-DEXTRAN to site of implantation, the choice of carrier material was the specially designed cross linked hyaluronic acid Technically adjusted to play the role of a ( carrier ), again the choice was upon that HA is a biocompatible, biodegradable, Non-immunogenic molecule. 3. After that and as a long duration effect is favorable in treatment of VUR the Specially designed cross linking process was applied to DEAE-DEXTRAN to obtain a cross Linked DEAE-DEXTRANOMERE or what is called a DEAE-Sephadex-Dextran, Sephadex Is a trade mark for cross linked dextran, where cross linking process results in a long term Duration of the implant to be degraded gradually. Biopolymer GmbH & Co.KG - Germany

CRM VURDEX designed Technolgy: 4. Finally, a ( fine tuning ) process was created by Biopolymer GmbH – Germany to ensure maximum effect results outcome for the product ( CRM Vurdex ) to be unique and distinguished in VUR Treatment options, the ( fine tuning ) was made by creating a positive charge on DEAE-Sephadex – Dextran which stimulates collagen formation in site of implantation and leading by that for optimum results in treatment of VUR by stimulating tissue regeneration process. Accordingly, DEAE-Sephadex-Dextran is a polycationic cross linked dextran with tissue regeneration stimulating effect. 5. Accordingly, the benefits of CRM Vurdex are summarized as following: A.Biocompatible: as the used materials is a natural component of human body tissues, it is non-immunogenic ( non-animal origin ), and biocompatibility is optimal due to formation of fibroblast and collagen fibers that surrounds the microparticles. B.Biodegradable: the used materials are completely degradable with safe clinical profile. C.Long action duration: due to cross linking process that extends up to 5 five years. D.No Migration from implant site: due to positively charged microparticles – the positive charge plays a role in ( ancoring ) the implant through inter-cellular interactions leading to fibroblasts and collagen fibers surrounding the implant material as well that microparticles size used ensures no migration ( safe particles size – 80 micron ). E.Stimulation of collagen formation: due to positive charges. Biopolymer GmbH & Co.KG - Germany

CRM Vurdex: 1 syringe – 1.0ml sterile needle 350mm 3.7Fr Implantation procedure: Video is available. Biopolymer GmbH & Co.KG - Germany

Clinical trials Biopolymer GmbH & Co.KG - Germany

Clinical trials Biopolymer GmbH & Co.KG - Germany

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