Desktop Health Announces CE Mark Certification and International Launch for Flexcera Next Generation 3D Printed Dentures
NEWPORT BEACH, California – (BUSINESS WIRE) – Desktop Health, recently launched by Desktop Metal, Inc. (NYSE: DM) and dedicated to developing 3D printing and biofabrication solutions for personalized medicine, today announced Conformité Européenne ( CE) mark for Flexcera. knownTM Resin, a proprietary technology used in the 3D fabrication of high quality dentures. The CE mark confirms that Flexcera resins meet the requirements of the European Medical Device Directive and paves the way for Desktop Health to bring Flexcera resins to market for dentists within the European Union (EU) and other CE marked regions. Flexcera Base, which recently received 510 (k) clearance from the US Food and Drug Administration (FDA), and Flexcera Smile are Desktop Health’s first formulated and optimized digital dental solutions.
“We are very excited to announce CE certification for Flexcera, marking our global expansion to meet the needs of dentists and their patients,” said Michael Jafar, President and CEO of Desktop Health. “The introduction of Flexcera marks the beginning of a remarkable new era in dentistry that combines advanced Flexcera science with 3D printing technology to provide patients with superior strength, aesthetics and function.”
The need for dental prosthetics is growing and the global dental prosthesis market is estimated at $ 3.8 billion by 2027. The European dentures market is a $ 878 million market1, driven by advances in technology addressing the limitations of current 3D printed dental prosthetics in terms of both brittleness and aesthetics.
The science of printing teeth
Flexcera plastic was developed with the strength of ceramics in conjunction with long-chain chemistry to ensure optimal prosthetic properties. When used exclusively with EnvisionTEC ™ 3D printers, dentists can print up to eight customized Flexcera prostheses in less than two hours, delivering on the promise of high quality dentures in the same day.
For the first time in dental prosthetics, Flexcera resin offers:
High breaking strength, three times more resistant to breaking than selected competitive plastics;
Moisture resistance to prevent staining or discoloration, twice as tough as a leading competitor formulation; and
An overall natural aesthetic that offers lifelike tooth translucency and a natural-looking smile.
“The ability to deliver beautiful, high-quality, printable dentures is a powerful new skill enabled by Flexcera and Desktop Health,” said Prof. Patrik Zachrisson, Co-Founder and Vice President of the International Digital Dental Academy and Partner Dentist at the Digital Smile Studio in Great Britain. “Until now, the manufacture of dentures has been limited to time-consuming milling processes or brittle 3D printing processes. With Flexcera, we now have for the first time a complete digital prosthesis solution that fulfills the four cornerstones of what one should expect from 3D printing: strength, high aesthetics, accuracy and speed. ”
Flexcera resin is expected to launch in Europe in late summer 2021 and in the US and Canada in late June. Healthcare providers who want to stay up to date on product availability or place a pre-order can register at www.flexcera.com.
About Flexcera resins
Proprietary Flexcera resins enable the production of beautiful, functional prostheses with ceramic-like strength. Flexcera Smile is an FDA class 1 medical device with CE marking for the production of lifelike denture teeth and Flexcera Base is an FDA 510 (k) approved medical device of class 2 with CE marking for the production of high quality denture bases. Both are formulated exclusively for use with EnvisionTEC 3D printers. For more information visit www.flexcera.com.
About desktop health
Desktop Health, based in Newport Beach, California, develops additive manufacturing solutions and advanced materials for personalized patient care. Founded in March 2021 as a healthcare company within Desktop Metal, Inc., it is vertically integrated to develop, manufacture, and market applications for a range of healthcare areas. Desktop Health is rapidly focusing on developing applications and uncovering ways to leverage its bioprinting capabilities in healthcare. For more information on Desktop Health, see www.desktophealth.com.
About Desktop Metal, Inc.
Desktop Metal, Inc., based in Burlington, Massachusetts, is accelerating manufacturing transformation with an extensive portfolio of 3D printing solutions, from rapid prototyping to mass production. Founded in 2015 by leaders in advanced manufacturing, metallurgy and robotics, the company is addressing the unresolved challenges of speed, cost and quality to make additive manufacturing an indispensable tool for engineers and manufacturers around the world. Desktop Metal was selected as one of the 30 Most Promising Technology Pioneers in the World by the World Economic Forum and was included in the MIT Technology Review’s list of 50 Smartest Companies. For more information visit www.desktopmetal.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements generally relate to the potential and future performance of Desktop Health, including strategic direction, new health application development, introduction or success of new technologies and applications, and expected results. Forward-looking statements are predictions, forecasts and other statements about future events that are based on current expectations and assumptions and are therefore subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements contained in this document, including, but not limited to: (i) the ability to implement business plans, projections and other expectations and to identify and realize additional opportunities; (ii) the governmental requirements that apply to Desktop Health’s technology, products, materials, and applications, including the United States Food and Drug Administration and similar agencies in other countries; (iii) risks associated with products manufactured by Desktop Health, including product liability or warranty claims; and (iv) other risks and uncertainties set out in the “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” section of the Annual Report on Form 10-K / A filed by the Company with the SEC (the “SEC “) on April 30, 2021 and the company’s other filings with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. The forward-looking statements contained in this press release speak only as of the date of their publication. Readers are cautioned not to place undue reliance on forward-looking statements, and Desktop Metal assumes no obligation and does not intend to update or revise them. Forward-looking statements, whether based on new information, future events, etc. Desktop Metal makes no representation that it will meet its expectations.
1 Fortune Business Insights, Dentures Market Size, Share, and Industry Analysis, July 2020