Template:AfC submission/doc
 | This article contains promotional content. (June 2020) |
| [[Image:]] | |
| Company type | Public |
|---|---|
| Industry | Medical Technology Medical Devices Medical Equipment |
| Founder | Antoine Turzi |
| Headquarters | Brooklyn, New York , United States of America |
Area served | Worldwide |
Number of employees | 200 (2020) |
| Website | www |
RegenLab USA is a certified leading innovator of medical products in the PRP&HA regenerative field for more than 15 years. Since 2003, RegenLab has been committed to the development of a unique expertise for the design, the manufacturing and the validation of high-quality medical devices, intended for cellular therapies and for the preparation of fresh and autologous platelet-rich plasma (PRP) from the patient's own blood. The company's cellular therapies allow medical professionals to prepare PRP and freshly collected cells, safely, rapidly, and efficiently for multiple medical disciplines.
At the core of RegenLab's business model is the Research and Development department which has enabled the development of advanced technologies such as preparation of 100% autologous fibrin glue, isolation of bone marrow mononuclear cells, and combination of PRP with adipose tissue that can be used in clinical settings.
RegenLab's sterile and non-pyrogenic class II and class III medical devices fully guarantee patient safety thanks to the patented close-circuit system. They fully comply with the international applicable regulatory requirements and their manufacturing process is in full compliance with current Good Manufacturing Practice. The main quality of RegenLab is a devoted team composed of 60% with scientific profile collaborators.
RegenLab USA is headquartered in Brooklyn, New York.
RegenKit Product Families
Device Description
RegenKits are defined as "hematology tubes and accessories packaged for a bedside and extemporaneous and medical single use. The RegenKit devices allow for the preparation of autologous PRP and of other plasma-derived products, such as autologous serum, in a closed-circuit system with minimal steps by a trained physician. RegenLab offers different devices for the preparation of platelet-rich plasma and other plasma-derived products. These devices differ from each other by the composition of the separator gel, the volume of blood withdrawn, the presence or not of sodium citrate solution and the color of the cap.
All Regen tubes consist of pharmaceutical-grade class I borosilicate and use vacuum for automated blood collection. The hallmark of the Regen technology is a thixotropic separating gel composed of a mixture of polymers for gravimetric plasma separation. Besides the tubes, RegenKits contain off the shelf material intended for phlebotomy or bone marrow aspiration and PRP transfer, necessary to maintain the close-circuit system.
CuteCell-PRP
Recently, RegenLab launched CuteCell, a new set of products to prepare PRP (CuteCell-PRP), serum (CuteCell-serum), and MNC (CuteCell-MNC) to be used exclusively in vitro in a research laboratory setting. These new products offer an autologous alternative to Fetal Bovine Serum in culture media for cell therapies.
Device History and Regulatory Status
RegenKits
The RegenKits are CE-marked since 2003 and patented final versions were introduced in the market in 2006 after three years of clinical evaluation, in Europe and outside of Europe. At that time, RegenKits were exclusively composed of RegenTHT tubes and accessories.
In 2009, the Regen BCT tubes and RegenATS tubes were CE-marked and commercialized. In 2011, the A-CP tubes were CE-marked and commercialized.
Cellular Matrix
A-CP-HA Kit and BCT-HA Kit are CE-marked since July 2013 and February 2014, respectively, and have been sold in Europe since those dates. Since the devices first commercialization in Europe and in over 38 countries worldwide, no reportable incident has occurred.
BioBridge Foundation
The BioBridge Foundation was created with the goal of promoting scientific research in the field of regenerative medicine. The foundation uses an online educational platform in the field of PRP and cell therapy. The BioBridge Knowledge Platform contains recordings of scientific lectures, webinars, and workshops offered by BioBridge worldwide. Access to this platform is available to RegenLab customers via an authentication code, which can be obtained via sales representatives.
BioBridge Books
• Standardization of Platelet Rich Plasma (PRP) and Cell Therapy This book (178 pages) was written to help professionals involved in regenerative medicine better understand PRP and the use of cell therapies.
• Standardized Platelet-Rich Plasma for Musculoskeletal Disorders This book (179 pages) was written to help professionals involved in the treatment of patients with musculoskeletal disorders to better understand PRP and its combination with hyaluronic acid.
• RegenPRP®: Standardized Platelet Rich Plasma for Skin, Hair & Genitourinary Disorders This book (211 pages) was written to help professionals involved in the management of patients suffering from skin, hair and genitourinary disorders to better understand the use of PRP and cell therapies.
Based on 20 years of experience, these three books are intended for physicians practicing and conducting research in disciplines where PRP is a therapeutic option, as well as anyone seeking reliable and up-to-date information about this technology.
References