Desktop Health Announces CE Mark Certification and International Launch for Flexcera Next Generation 3D Printed Dentures
Desktop Health, recently launched by Desktop Metal, Inc. (NYSE: DM) and committed to developing 3D printing and biofabrication solutions for personalized medicine, today announced Conformité Européenne (CE) Mark certification for its FlexceraTM resin, a proprietary technology for use in 3D fabrication of high-quality dental prosthetics. The CE Mark affirms that Flexcera resins meet the requirements of the European Medical Devices Directive, paving the way for Desktop Health to launch Flexcera resins to dental professionals within the European Union (EU) and other CE Mark geographies. Flexcera Base, which recently received U.S. Food and Drug Administration (FDA) 510(k) clearance, and Flexcera Smile are Desktop Health’s first formulated and optimized digital dental solutions.
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Desktop Health announces CE Mark certification and the international launch of Flexcera, a proprietary resin for use in 3D fabrication of high-quality dental prosthetics. The introduction of Flexcera Base and Flexcera Smile marks the inception of a new era in dentistry, combining advanced science with 3D printing technology to deliver superior strength, aesthetics, and function for patients. (Photo: Business Wire)
“We are very pleased to report CE Mark certification for Flexcera, launching our global expansion to meet the needs of dental professionals and their patients,” said Michael Jafar, President & CEO of Desktop Health. “The introduction of Flexcera marks the inception of a remarkable new era in dentistry, combining advanced Flexcera science with 3D printing technology to deliver superior strength, aesthetics, and function for patients.”
The need for dental prosthetics is on the rise, with the global dentures market estimated to reach $3.8 billion USD by 2027.The European dentures market is a $878 million market1, driven by the advancement of technology which addresses limitation of current 3D printed dental prosthetics in both brittleness and aesthetics.
The Science of Printing Teeth
Flexcera resin was developed with the strength of ceramic coupled with long chain chemistry to ensure optimal denture properties. When used exclusively with EnvisionTEC™ 3D printers, dental providers can print up to eight customized Flexcera dentures in less than two hours, delivering on the promise of same-day, high quality dental prosthetics.
For the first time in dental prosthetics, Flexcera resin offers:
- High fracture resistance, three times more resistant to fracture than select competitive resins;
- Moisture resistance to prevent staining or discoloration, two times more resistant than a leading competitive formulation; and
- An overall natural aesthetic that offers lifelike tooth translucency and a natural-looking smile.
“The ability to deliver beautiful, high-quality, printable dental prosthetics is a powerful new capability made possible by Flexcera and Desktop Health,” said Prof. Patrik Zachrisson, Co-Founder and Vice President of the International Digital Dental Academy and a Partner Dentist at Digital Smile Studio in the United Kingdom. “Until now, the production of dentures has been limited to milling methods which are time-consuming, or 3D printing methods which have been brittle. For the first time, with Flexcera, we now have a complete digital denture solution that delivers on the four cornerstones of what should be expected from 3D printing: strength, high aesthetics, accuracy and speed.”
Flexcera resin is expected to launch commercially in Europe in late summer 2021 and in the U.S. and Canada by the end of June. Healthcare providers who wish to stay updated on product availability, or place a pre-order, can sign up at www.flexcera.com.
About Flexcera Resins
Proprietary Flexcera resins enable the fabrication of beautiful, functional dentures with ceramic-like strength. Flexcera Smile is an FDA Class 1 and CE-marked medical device for the fabrication of lifelike denture teeth, and Flexcera Base is an FDA 510(k)- cleared Class 2 and CE-marked medical device for the fabrication of premium denture bases. Both are formulated exclusively for use with EnvisionTEC 3D printers. For more information, visit www.flexcera.com.
About Desktop Health
Based in Newport Beach, California, Desktop Health develops additive manufacturing solutions and advanced materials for personalized patient care. Founded in March 2021 as a healthcare business within Desktop Metal, Inc., the business is vertically integrated to develop, manufacture, and commercialize applications across a range of healthcare specialties. Desktop Health is rapidly focused on developing applications and uncovering opportunities to leverage its bioprinting capabilities within healthcare. For more information on Desktop Health, visit www.desktophealth.com.
About Desktop Metal, Inc.
Desktop Metal, Inc., based in Burlington, Massachusetts, is accelerating the transformation of manufacturing with an expansive 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 unmet challenges of speed, cost, and quality to make additive manufacturing an essential tool for engineers and manufacturers around the world. Desktop Metal was selected as one of the world’s 30 most promising Technology Pioneers by the World Economic Forum and named to MIT Technology Review’s list of 50 Smartest Companies. For more information, visit www.desktopmetal.com.
FORWARD LOOKING STATEMENTS
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 Desktop Health’s potential and future performance, including its strategic focus, development of new healthcare applications, adoption or success of new technologies and applications, and anticipated results. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including, but not limited to: (i) the ability to implement business plans, forecasts, and other expectations and identify and realize additional opportunities; (ii) the regulatory requirements that will apply to Desktop Health’s technology, products, materials and applications, including by the U.S. Food and Drug Administration and comparable 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 forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward Looking Statements"" in the Annual Report on Form 10-K/A filed by the Company with the U.S. Securities and Exchange Commission (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 included in this press release speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Desktop Metal assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Desktop Metal does not give any assurance that it will achieve its expectations.
1 Fortune Business Insights, Dentures Market Size, Share & Industry Analysis, July 2020
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