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GROUPE GORGE (EPA:GOE) Prodways Group 3D Materials division (3D Printing subsidiary) recorded major successes in the field of Medical applications

Transparency directive : regulatory news

13/01/2021 07:30

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Groupe Prodways (Euronext Paris: PWG), specialist in digital design and manufacturing, announces major successes in the field of medical applications for its 3D Materials division.

In the continuity of a very successful year 2020 and despite the Covid-19 crisis, Prodways Group's materials division, DeltaMed, recorded outstanding successes in its dental products division by i/ signing an agreement with a leading global player in the dental industry, ii/ successfully implementing new regulatory requirements, iii/ with a solid order backlogs for 2021, in particular multi-tons of resins to support fast growing clients in the aligner market.

DeltaMed signed a four years agreement with a leading global player in the dental industry. Its products, solutions and services are marketed in more than 100 countries through a broad network of distributors and partners. The agreement mainly covers the development and supply of 3D resins. The program includes materials for dental applications like, casting, individual trays, try-ins, surgical guides, or temporary crown & bridges. Another important focus of the partnership is the development of new materials for further medical applications. DeltaMed has decades of distinctive expertise in the development of 3D resins and medical device certification.

Recently, DeltaMed has been certified successfully in accordance with MDSAP, the common standard for regulatory quality management audits, a prerequisite for marketing medical devices in the participating countries Australia, Japan, Brazil, the USA and Canada. In addition, DeltaMed was one of the first companies to be audited by its notified body in accordance with the new European Medical Devices Regulation (2017/745). The new regulation, which will come into force in May 2021, is mandatory for all medical device manufacturers and will replace the current Medical Devices Directive 93/42 EEC.

 “Adapting to the new legal requirements and the associated documentation effort presents a challenge for all medical technology companies and significantly increases the barrier to entry to our 3D printing medical device markets. The expertise we have obtained as a result of this process means we can now provide expert support to our customers and partners through the transition phase”, says Olivier Strebelle Prodways Group CEO.

In addition to these achievements, DeltaMed successfully cleared a new printable dental composite material for the US market within the FDA (Food and Drug Administration). As early as 2011, DeltaMed's pioneering work enabled the world's first printable dental crown and bridge material to be approved by the FDA.

While preparing the future out of advanced medical materials, Prodways Group signed multi-ton firm orders in December to support fast growing clients in the dental aligners application in 2021. To support these developments, an expansion work has been done at DeltaMed GmbH on its site in Friedberg (Hesse) for the second time in three years. In just eight months, the warehousing and production premises have been expanded by 50%.

In 2021, Prodways Group 3D printing machine and material offers will continue to being strengthened out of new/ upgraded products targeting mass customized applications while deploying Group integrated offer in medical applications.

 

About Groupe Gorgé
Groupe Gorgé is a high-tech industrial group driven by a strong entrepreneurial culture.
The Group operates in the fields of 3D printing, drones, engineering and protection systems and employs
around 2,000 people in seven countries. The Group reported revenue of €275 million in 2019.

More information is available at www.groupe-gorge.com
Groupe Gorgé is listed on Euronext Paris Compartment B (GOE).
 
Upcoming releases
• February 23, 2021 (after close of trading): Q4 revenue
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• April 28, 2021 (after close of trading): Q1 2021 revenue


 
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Disclaimer
Groupe Gorgé press releases may contain forward-looking statements regarding the Group's targets. Forward-looking statements reflect current expectations about Groupe Gorgé. Such forward-looking statements and targets depend on known and unknown risks, uncertainties and other factors that could cause actual results, performance or events to differ materially from those anticipated herein. Some of these risk factors are explained in detail in the Universal Registration Document, which may be downloaded from the Groupe Gorgé website (www.groupe-gorge.com). This list of risks, uncertainties and other factors is not limitative. This press release and the information it contains do not constitute an offer to sell or subscribe, or a solicitation to purchase or subscribe shares in Groupe Gorgé or its listed subsidiaries in any country whatsoever.
 
       


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Full and original press release in PDF: https://www.actusnews.com/news/66944-gorge-group_prodways-group_medical-materials_pr_-130121_leadingglobalpayer_veng.pdf

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