Business Wire

Desktop Health Announces CE Mark Certification and International Launch for Flexcera Next Generation 3D Printed Dentures

Share

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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210610005323/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

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

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Lynda McKinney
Lyndamckinney@desktopmetal.com
978-224-1282

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Celltrion Healthcare presents the first real-world data for Truxima ® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress12.6.2021 17:45:00 CEST | Press release

Celltrion Healthcare today presented new data from its post-approval study evaluating the real-world clinical effectiveness and safety of Truxima® (biosimilar rituximab, CT-P10) in patients with diffuse large B-cell lymphoma (DLBCL) at the European Hematology Association (EHA) 2021 Virtual Congress.1 CT-P10 was granted European Medicines Agency approval in 2017 for the treatment of rheumatoid arthritis (RA) and specific blood cancers, including non-Hodgkin’s lymphoma (NHL).2 DLBCL is the most common subtype of NHL, representing an estimated 30-40% of adult cases.3,4,5,6 This non-interventional post-authorisation safety study (PASS) involved the collection of patient-level data from hospital medical records for patients with DLBCL who received CT-P10 treatment in five European countries (United Kingdom, Spain, France, Germany and Italy). CT-P10 treatment pattern data were collected retrospectively during the 30-month observation period and patients were selected based on the treatment t

Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX ® ▼ (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible12.6.2021 09:01:00 CEST | Press release

The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 MAIA (NCT02252172) study showing the addition of DARZALEX® ▼(daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression.1 These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefing and will be presented as a late-breaking abstract during the EHA Virtual Congress (Abstract #LB1901). The prespecified interim analysis for OS found that after a median follow-up of nearly five years (56.2 months), a 32 percent reduction in the risk of death was observed in the D-Rd treatment arm vs. Rd arm.1 Median OS was not reached in either arm [hazard ratio (HR): 0.68, 95 percent confidence interval (CI),

New Phase 3 Study Results Show IMBRUVICA ® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia12.6.2021 09:00:00 CEST | Press release

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced primary results from the pivotal Phase 3 GLOW study (NCT03462719) evaluating fixed-duration IMBRUVICA® (ibrutinib) plus venetoclax (I+V) compared to chlorambucil plus obinutuzumab (Clb+O) for first-line treatment of elderly or unfit patients with chronic lymphocytic leukaemia (CLL). The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duration of remission and significantly improved depth of remission.1 With I+V, undetectable minimal residual disease (uMRD) in peripheral blood (PB) was sustained by 85 percent of patients one year after end of treatment.1 The safety and tolerability profile of I+V was consistent with CLL treatment in an older population with comorbidities.1 These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefing an

Alluzience ® , the first ready-to-use BoNT-A neuromodulator, receives positive decision for use in Europe11.6.2021 11:53:00 CEST | Press release

Galderma today announced that Alluzience® has completed its European decentralized procedure resulting in a positive decision for the first ready-to-use neuromodulator, a wrinkle relaxing injection, in Europe. National approvals will now take place across the region in line with local processes in each country. Designed for precision, Alluzience® is a liquid form of botulinum toxin type A intended for use in adult patients as a treatment to temporarily improve the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows), when the severity of these lines has an important psychological impact on the patient.1 "The introduction of Alluzience® marks a new era in treatment innovation for upper facial lines in Europe. Like many aspects of physical appearance, glabellar lines can have a significant impact on patients’ confidence and wellbeing. I’ve heard first-hand that the transition to living and working in a virtual world has only exacerbated these issues. As

Secure Communities Forum: Behavioural Insights Can Assist Governments in the Post-Pandemic World11.6.2021 10:15:00 CEST | Press release

The Secure Communities Forum, a global collaboration of security professionals, has convened a leading panel of experts to discuss how behavioural science can impact positive social cohesion, build on the concept of positive citizenship, and encourage positive individual behaviours. The virtual event was attended by 134 people from 18 countries. The Secure Communities Forum convened the webinar in response to the ongoing Covid-19 pandemic. Governments and law enforcement agencies have used behavioural science to encourage adherence to public health measures like social distancing and mask-wearing. Lindsay Juarez, Director at Irrational Labs, USA, opened the session, offering the view that we assume humans are rational, which is not the case. She said: “Behavioural science is about setting people up for success and breaking through the noise. Information isn't enough to change behaviour, the decision-making context matters. “People don’t always act in their own long-term best interests,

Luxembourg’s Supercomputer MeluXina is Operational11.6.2021 09:18:00 CEST | Press release

Luxembourg’s high performance computer MeluXina was officially launched on June 7 putting the country on the global map of computer super powers. MeluXina is capable of executing more than 10 Petaflops, the equivalent of 10 million billion calculations per second, which will rank it among the world’s top 50 supercomputers. The petascale computer is powered by green energy and is part-funded under the European High Performance Computing Joint Undertaking. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210611005115/en/ Minister of State Xavier Bettel; His Royal Highness Henri, Grand Duke of Luxembourg; Minister of the Economy Franz Fayot; EuroHPC Joint Undertaking Executive Director Anders Jensen (Photo: Business Wire) In a series of 8 high-performance computers in the EU, MeluXina joins Vega, another petascale supercomputer located in Slovenia, as the first EuroHPC machines to go live. Its innovative modular architecture allo

Vertex and CRISPR Therapeutics Present New Data in 22 Patients With Greater Than 3 Months Follow-Up Post-Treatment With Investigational CRISPR/Cas9 Gene-Editing Therapy, CTX001™ at European Hematology Association Annual Meeting11.6.2021 09:05:00 CEST | Press release

Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) and CRISPR Therapeutics (Nasdaq:CRSP) today announced new data on 22 patients,with follow-up of at least 3 months, and ranging from 4 months to 26 months, treated with the investigational CRISPR/Cas9-based gene-editing therapy, CTX001, that show a consistent and sustained response to treatment. CTX001 is being investigated in two ongoing Phase 1/2 clinical trials as a potential one-time therapy for patients suffering from transfusion-dependent beta thalassemia (TDT) and severe sickle cell disease (SCD). In total, more than 40 patients have been dosed across both studies to date. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210611005069/en/ All 15 patients with TDT, including six who have the beta zero/beta zero or other severe genotypes, were transfusion-free at last follow-up, and all seven patients with severe SCD were free of vaso-occlusive crises (VOCs) from CTX001 infu

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom