the ERASER® System
The ERASER® System is a wholly new, non-laser-based approach to tattoo removal that employs a next generation scientific and technological advance. The fundamental principle behind the ERASER® System is the dislodgement, at room temperature, of the tattoo ink particles from their biological anchors by a benign, safe reactive energy field that works on any color of tattoo ink and in skin of any color.
A comparison of the ERASER® System to laser tattoo removal is included in the table to the right.
partners in development
ERASER® System research and development has been led by James W. Winkelman, M.D., ClearIT's Cofounder and Chief Medical and Scientific Officer. ClearIT is developing its ERASER® System in collaboration with the following partners, which include research, development and design support from the Boston University School of Engineering, Elbit America – KMC Medical Systems, NK Labs, Tegra Medical, Charles River Laboratories and the Juliana Design Group. Clinical and regulatory support is provided by the Boston University School of Medicine, Department of Dermatology, RCRI, and Hyman Phelps & McNamara PC. Intellectual property development and processing support is provided by Nelson, Mullins, Riley and Scarborough LLP. Currently, the ClearIT team involves twenty-four team members. The research, design and clinical operations of the ERASER® System is also overseen by a world class Medical and Scientific Advisory Board.
ClearIT has filed four U.S. patents covering the ERASER® System with the following reference numbers, titles and application dates. Extensive PCT and other international filings have been submitted to extend patent coverage over all the major markets for tattoo removal. The Company anticipates in-licensing and filing for additional intellectual property protection.
1. Systems and Methods for Tattoo Removal Using Cold Plasma U.S. Patent Application No. CA2986031; May 15, 2015.
2. Methods and Compositions for Simulation of the Dermal Compartment U.S. Patent Application No. 16/242683; January 8, 2019.
3. Systems for Methods for Tattoo Removal Using an Applied Electrical Field U.S. Patent Application No. 62/782172; December 19, 2018.
4. Systems for Methods for Tattoo Removal Using an Electro-Kinetic Applicator U.S. Patent Application No. 62/782208; December 19, 2018.
Regulatory And Timelines
ClearIT is preparing the ERASER® System for US FDA clearance as a medical device and European CE mark approval. US and Europe are expected to be the two largest markets for the ERASER® System. We anticipate that the ERASER® System will be evaluated by the US FDA as a Class 2 device. Accordingly, the ERASER® will be marketed to physicians, mainly dermatologists, for tattoo removal. Treatment of other dermatological disorders and diseases may be approved later. The ERASER® System will not be sold to the general public. Our anticipated time for commercial launch in the US is Q4 2023, EU in Q1 2024 and the rest of the world in mid 2024.