Desktop Health Announces First Patients Treated with FDA-Cleared CMFlex™ – an Off-the-Shelf 3D Printed Synthetic Bone Graft Product Pioneered by Dimension Inx on the 3D-Bioplotter®

Rhea-AI Summary

Dimension Inx (DM) has successfully implanted its innovative CMFlex material in multiple patients, marking a significant milestone in regenerative therapeutics. CMFlex, the first 3D printed regenerative bone graft product cleared by the FDA, eliminates the need for invasive bone harvesting and shaping. The product has been used in jaw surgeries and dental socket preservation cases, showcasing its versatility and potential impact on the medical industry. Dimension Inx's co-founders, Dr. Ramille Shah and Dr. Adam Jakus, have been instrumental in the development and manufacturing of CMFlex, demonstrating the company's commitment to cutting-edge medical solutions.

• Chicago-based Dimension Inx, a regenerative therapeutics company, has now had its innovative CMFlex material implanted in multiple patients
• CMFlex is an off-the-shelf, customizable bone graft material indicated for maxillofacial, mandibular, and dental bone defects
• The first 3D printed regenerative bone graft product cleared by the FDA, CMFlex has now been used in two patient jaw surgeries, an upper and lower, and several dental socket preservation cases
• CMFlex eliminates the need for doctors to invasively harvest bone from another area of a patient's body and shape it into a desired anatomy for a bone graft
• Dimension Inx developed and manufactures CMFlex on the Desktop Health 3D-Bioplotter Manufacturing Series model
• The 3D-Bioplotter has now been used for separate in-patient applications in Germany and the United States, as bioprinting applications in development for years begin advancing to the first in-patient applications
• A video showcasing the work done by Dimension Inx on the 3D-Bioplotter is now available at TeamDM.com/CMFlex

BOSTON--(BUSINESS WIRE)-- Desktop Health – the trusted production-grade medical 3D printing brand of Desktop Metal, Inc. (NYSE: DM) – today announced the first patients have been treated with CMFlex™, an off-the-shelf 3D printed synthetic bone graft product developed and manufactured by Chicago-based Dimension Inx on the 3D-Bioplotter®.

CMFlex™ was co-invented by Dimension Inx co-founders, Dr. Ramille Shah, CSO, Head of R&D, (pictured right) and Dr. Adam Jakus, CTO, Head of Technology Strategy, (pictured left). The duo have been developing the material and product since 2009 on the Desktop Health 3D-Bioplotter®. (Photo: Business Wire)

Founded in 2017, Dimension Inx is a regenerative therapeutics company that designs, develops, and manufactures therapeutic products to restore tissue and organ function. The company owns four Desktop Health 3D-Bioplotters – two used for R&D and two used for manufacturing their commercial CMFlex product.

Dimension Inx received FDA clearance of CMFlex in December of 2022. CMFlex is currently available to a limited number of key surgeons with a broader release to follow later in 2024.

The first jaw cases were performed by Dr. Derek Steinbacher, Director of West River Surgery Center (Guilford, CT ), Former Professor Plastic surgery and Chief of Oral and Maxillofacial surgery at Yale New Haven Health, and Dr. Brian Farrell, DDS, MD, of the Carolinas Center for Oral & Facial Surgery (Charlotte, NC). Procedures performed included a mandibular angle augmentation (surgery of the lower jaw) and maxillary segmental osteotomy (surgery of the upper jaw).

CMFlex has also been used in dental socket preservation surgeries for future dental implant placement by Dr. Robert Bosack, DDS, Oral, Maxillofacial & Dental Implant Surgery (Orland Park, IL).

“These first cases are not only indicative of a new generation of biomaterials, but also highlight our technology platform’s unique capability to rapidly create biomaterials that direct cell behavior to restore tissue and organ function. It is a proud moment for us to be able to demonstrate the value of therapeutics derived from integrating novel biomaterial design and 3D-printing approaches,” said Dr. Adam Jakus, CTO, Head of Technology Strategy, and Dimension Inx co-founder.

Dr. Ramille Shah, CSO, Head of R&D, and co-founder of Dimension Inx, added, "We’re excited by the interest we’ve already received from surgeons who recognize the importance of a ready-to-use solution with great handling characteristics and the ability to cut and shape the graft to match the defect site.”

About CMFlex

CMFlex is comprised primarily of hydroxyapatite, a naturally occurring mineral found in bone, combined with biodegradable polylactide-co-glycolide (PLG) polymer. Both materials have an extensive history demonstrating biocompatibility and clinical utility. Dimension Inx combines these base materials into a proprietary, microstructurally porous composite material, Hyperelastic Bone®, as first published in Science Translational Medicine in 2016.

This unique, easily deployable bone repair material is then 3D printed into CMFlex. which has an engineered architecture with nano, micro, and macro-level features designed to promote natural bone regeneration after implantation, without the need for an invasive autograft.

The resulting product is one that surgeons can size for each patient and is uniquely capable of absorbing fluid, which enables it to control bleeding during surgery while assisting the bone remodeling process once implanted.

“After many years of research and development, we’re proud to see the first bioprinting applications move into clinical use with patients,” said Ric Fulop, Founder and CEO of Desktop Metal. “We are especially proud that our 3D-Bioplotter platform is accurate, reliable, and robust enough to take customer inventions all the way from R&D to commercial manufacturing on the same platform.”

The 3D-Bioplotter is a sophisticated extrusion-based 3D printer that processes liquids, melts, pastes, gels, or other materials, including cells, through a needle tip on a Swiss-made, 3-axis gantry system with high accuracy and repeatability, along with tight controls for temperature, sterility, and design. 3D-Bioplotter offers eight printheads with the widest range of temperatures in bioprinting – from 2°C to 500°C (35.6°F to 932°F) – enabling complex, multi-material medical parts.

3D-Bioplotter is also the world’s most cited and researched bioprinter in peer-reviewed scientific and medical journals, with more than 2,490 citations and more than 640 research papers directly produced with the system. To learn more, visit TeamDM.com/3DBioplotter.

About Desktop Metal

Desktop Metal (NYSE:DM) is driving Additive Manufacturing 2.0, a new era of on-demand, digital mass production of industrial, medical, and consumer products. Our innovative 3D printers, materials, and software deliver the speed, cost, and part quality required for this transformation. We’re the original inventors and world leaders of the 3D printing methods we believe will empower this shift, binder jetting and digital light processing. Today, our systems print metal, polymer, sand and other ceramics, as well as foam and recycled wood. Manufacturers use our technology worldwide to save time and money, reduce waste, increase flexibility, and produce designs that solve the world’s toughest problems and enable once-impossible innovations. Learn more about Desktop Metal and our #TeamDM brands at www.desktopmetal.com.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. 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 the risks and uncertainties set forth in Desktop Metal, Inc.'s filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Desktop Metal, Inc. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231129556039/en/

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Source: Desktop Health

FAQ

What is the name of the company that developed CMFlex?

Dimension Inx (DM) is the Chicago-based company that developed and manufactured CMFlex, the innovative 3D printed synthetic bone graft product.

What is the FDA clearance status of CMFlex?

CMFlex, developed by Dimension Inx, received FDA clearance in December of 2022, making it the first 3D printed regenerative bone graft product to gain this approval.

Who were the first surgeons to use CMFlex in jaw surgeries?

Dr. Derek Steinbacher and Dr. Brian Farrell were the first surgeons to use CMFlex in jaw surgeries, highlighting the product's clinical application and potential impact in the field of oral and maxillofacial surgery.

What is the unique feature of CMFlex that sets it apart from traditional bone graft materials?

CMFlex eliminates the need for invasive bone harvesting and shaping, offering surgeons a ready-to-use solution with great handling characteristics and the ability to cut and shape the graft to match the defect site.

Who are the co-founders of Dimension Inx and what role did they play in the development of CMFlex?

Dr. Ramille Shah and Dr. Adam Jakus are the co-founders of Dimension Inx and have been instrumental in the development and manufacturing of CMFlex, showcasing their expertise and dedication to innovative medical solutions.