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EnvisionTEC’s 3D-Bioplotter gets medical-grade materials for implantation in humans

Among other big news from one of the 3D printing market’s leaders participation at this year’s RAPID show in Texas, EnvisionTEC also unveiled two new medical-grade materials that make printing parts for safe implantation in humans.

EnvisionTEC’s two new ready-to-print Medical Grade (MG) materials – a liquid silicone rubber and a biodegradable PCL polyester ― are manufactured with the highest purity and can be implanted in humans after 3D printing on the company’s 3D-Bioplotter series printers.

The world’s leading bioprinter since 2002, EnvisionTEC’s 3D-Bioplotter is offered in three models ― Starter, Developer and Manufacturer ― that make bioprinting accessible to educators, medical researchers and global manufacturing companies.

EnvisionTEC 3D-Bioplotters
From left to right, the Manufacturer, Developer and Starter series of the 3D-Bioplotter

Demonstration parts 3D printed in the new materials will be on display this week in Fort Worth, Texas, at RAPID + TCT, the premier event for 3D manufacturing in North America. EnvisionTEC is sponsoring the event’s Medical Manufacturing Innovations conference and will also be showcasing other innovations in Booth 1304.

“These new materials show that EnvisionTEC continues to work closely with our customers and partners to develop materials that can be easily used on our highly accurate and reliable 3D-Bioplotter,” said CEO Al Siblani.

FDA Master Files are available upon request for the two new materials, which are now available for purchase:

EnvisionTEC UV Silicone 60A MG material

  • UV Silicone 60A MG ― a biocompatible, bio-inert, non-biodegradable liquid silicone rubber that is cured with a UV light and delivers a Shore A hardness of 60. A transparent material, it can also be mixed with pigments. Approved only for short-term use in the body (29 days or less). Sold by the kilogram. Suitable applications include microfluidics, wound dressings, bio-sensor housings and prototyping.
  • HT PCL MG ― a biodegradable thermoplastic polyester that is processed at high temperatures. To be offered in two molecular weights that affect stiffness, flexibility and degradation time: 80 kDa and 120 kDa. Available in 1 kg or 100 g packages. Suitable for both short-term and long-term use in the body (longer than 29 days). Suitable applications include bone regeneration, cartilage regeneration, drug release and hybrid scaffolds.

EnvisionTEC PCL-MG material

Additionally, EnvisionTEC is also now offering an additional wavelength for its photo curing head, which operates independently of the printing head. Customers can change between 365 nm and 405 nm light sources just as quickly and easily as changing material cartridges on a low temperature printing head.

History of Ready-to-Print Biomaterials

The 3D-Bioplotter is EnvisionTEC’s only open-source materials printer ― a feature designed to give medical researchers and manufacturers the flexibility to develop their own materials for unique research or a specific patient.

For more than 15 years, 3D-Bioplotter users have been printing silicones, thermoplastics, hydrogels and more, to advance groundbreaking research in regenerative medicine, drug delivery and materials science, among other topics.

As the 3D-Bioplotter has become ever more popular, however, with more than 200 citations in peer-reviewed journals, there has been increasing demand for standard 3D printing materials.

For convenience, EnvisionTEC now sells three grades of materials, with varying levels of purity and cost, to expedite research and manufacturing, such as printing supports for tissue engineering applications or structures for soft implants:

  • Technical Grade (TG)
  • Research Grade (RG)
  • Medical Grade (MG)

Several of EnvisionTEC’s standard bioprinting materials also come with low-temperature (LT) or high-temperature (HT) designations, to meet different printing needs. For example, EnvisionTEC offers LT and HT versions of its Support RG material. These research-grade materials can be used to create sacrificial supports that are dissolved in distilled water after the support is no longer needed. The LT version is cellulose-based and has a processing temperature of 23°C or 73°F, while the HT version is sugar-based and can be processed at 150°C or 302°F.

As the world leader in bioprinting solutions, EnvisionTEC continues to develop bioprinting materials with its global partners as the field of regenerative medicine evolves and bioprinting expands in the coming years into clinical trials and manufacturing production.

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