Desktop Health Receives FDA Clearance for Flexcera for Next Generation 3D Printed Dentures

Rhea-AI Summary

Desktop Health, launched by Desktop Metal, has received FDA 510(k) clearance for its Flexcera^TM Base, a proprietary resin for 3D fabrication of dental prosthetics. This marks the company's entry into the digital dental solutions market alongside Flexcera^TM Smile. The global dentures market is projected to reach $3.8 billion by 2027, driven by the increasing edentulous population in the U.S. Flexcera promises enhanced strength, aesthetics, and moisture resistance, making it suitable for same-day dental prosthetics, with commercialization expected by June.

Positive

• Received FDA 510(k) clearance for Flexcera Base, indicating regulatory approval for market entry.
• Flexcera offers high fracture resistance and moisture resistance, enhancing product competitiveness.
• Projected growth in the global dentures market to reach $3.8 billion by 2027, signaling increased demand.

Negative

• None.

Desktop Health, recently launched by Desktop Metal, Inc. (NYSE: DM) and committed to developing 3D printing and biofabrication solutions for personalized medicine, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of Flexcera^TM Base, a proprietary resin for use in 3D fabrication of high-quality dental prosthetics. Flexcera Base along with the new Flexcera^TM Smile are Desktop Health’s first formulated and optimized digital dental solutions.

Desktop Health has received FDA 510(k) clearance of Flexcera Base, 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 remarkable new era in dentistry, combining advanced science with 3D printing technology to deliver superior strength, aesthetics, and function for patients. (Photo: Business Wire)

“Three years ago, we set out to create a product that addressed the limitations of current 3D printed dental prosthetics – brittleness and poor aesthetics,” 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. We are pleased to bring this innovative product to market as it represents our commitment to meet the needs of dental professionals and their patients.”

The need for dental prosthetics is on the rise, with the global dentures market estimated to reach $3.8 billion USD by 2027¹. In the U.S. alone, more than 36 million are edentulous, meaning they have no natural teeth, with 90 percent of those wearing dentures². According to the American Association of Oral and Maxillofacial Surgeons, 69 percent of adults ages 35 to 44 have lost at least one permanent tooth to an accident, gum disease, a failed root canal or tooth decay³.

The Science of Printing Teeth
Flexcera 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 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.

“Desktop Health has changed my approach to personalized dentistry,” said Dr. Ryan Dunlop, DMD of Full Arch Masters, one of the leading experts in dental implants and digital dentistry. “The Flexcera resin delivers on the four cornerstones of why 3D printing works so well: strength, high aesthetics, accuracy and speed. With Flexcera, I am now able to deliver beautiful, high-quality and same-day dental prosthetics in record time, customized to the patient, while they are in the chair.”

Desktop Health will present the details of this new technology to dental professionals for the first time at the LAB DAY Online Spring meeting on May 12 and May 14, 2021. More Information about the LAB DAY program is available at: https://lmtmag.com/shows/lab-day-online-spring-2021.

Flexcera is expected to launch commercially 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
Flexcera is comprised of proprietary resins for the fabrication of beautiful, functional dentures with ceramic-like strength. Flexcera Smile is an FDA Class 1 Medical Device for the fabrication of lifelike denture teeth and Flexcera Base is an FDA Cleared Class 2 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 bio-printing 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 filed by the Company with the U.S. Securities and Exchange Commission (the "SEC") on March 15, 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}

^{2 American College of Prosthodontics, 2021 Facts and Figures, Tooth Loss, https://www.gotoapro.org/facts-figures/}

^{3 Source: American Association of Oral and Maxillofacial Surgeons https://www.aaoms.org}

View source version on businesswire.com: https://www.businesswire.com/news/home/20210512005510/en/

FAQ

What is Flexcera Base and its significance for Desktop Metal (DM)?

Flexcera Base is a proprietary resin approved by the FDA for 3D printing high-quality dental prosthetics, marking Desktop Health's entry into digital dental solutions.

When is Flexcera expected to launch commercially?

Flexcera is expected to launch commercially in the U.S. and Canada by the end of June.

What are the key features of Flexcera compared to other dental materials?

Flexcera offers three times greater fracture resistance and twice the moisture resistance compared to leading competitive resins.

How does the global dentures market affect Desktop Metal (DM)?

The increasing demand in the global dentures market, projected to reach $3.8 billion by 2027, presents significant growth opportunities for Desktop Metal.

What are the applications of Flexcera resin in dentistry?

Flexcera resin is used for creating customized, high-quality dental prosthetics efficiently, allowing same-day delivery for patients.