Dental: 3DIO, Inc.

3Dio, Inc. builds upon Dr. Turner’s success with Aribex and the battery-operated, handheld NOMAD device. Only NOMAD is limited in its ability to help the dentist diagnose cavities because it delivers only 2D images. The dentist might be able to see the cavity, but the lack of true depth to the image leaves a fair amount of uncertainty on the location of the cavity within the tooth. What is truly needed is a 3D image.

There have been advancements in X-ray technology since the sale of Aribex to Danaher in 2012. What is available now is a technology called Cone Beam Computed Tomography (CBCT), a specialized technique that provides a low-resolution 3D view of the oral and maxillofacial region, allowing for more detailed and comprehensive analysis compared to traditional 2D dental X-rays. CBCT utilizes a cone-shaped X-ray beam that rotates around the patient's head, capturing a series of 2D X-ray images from different angles. These images are then reconstructed using computer algorithms to generate a comprehensive 3D representation of the patient's oral structures, and it results in significantly enhanced X-ray images, especially in showing the relationships of the teeth to each other.  This is particularly interesting for orthodontists to do treatment planning.

3Dio has developed Lumos 3DX, an intra-oral sensor chairside X-ray machine that constructs a 3D image using 30 2D X-ray pulses in about three seconds from multiple locations at the side of the patient’s head. Lumos 3DX captures these images roughly 12 times faster than traditional 2D devices but with a much lower radiation dose than CBCT. The data is uploaded to a local server, and the software reconstructs the high-resolution 3D image for analysis of the oral and maxillofacial region. The software allows the dentist to fly through the tooth, front to back, and be able to see within the tooth to identify cavities or cracks or, more precisely apply files for root canals. With a 2D image, the endodontist is never really sure; Lumos 3DX solves that problem.

Lumos was FDA-cleared in July 2023 and is now doing limited launch to collect clinical data from selected sites prior to a full launch at the end of 2024. SBIR grants from the NIH funded the foundational technology. 3Dio is now looking for outside investors.

A number of our early investors that came in on our convertible notes are dentists, oral surgeons, or endodontists. And we think those specialists are really probably the early adopters because the endodontists do root canals. And typically, when they get to where they think they're finished with the root canal, they will take a 2D image and make sure that the file is at the bottom of the tooth. What they’ve told us is that the ability to do 3D with the patient in the chair mid-procedure is really a game changer. So, our vision for this company is that this will replace the 2D X-ray

3Dio has tremendous market potential, likely exceeding that of Smart C. Dr. Turner likens the pending paradigm shift to what has taken place in mammography over the last decade. Mammograms used to be 2D images, but Hologic advanced the diagnostic standard roughly a decade ago by utilizing tomosynthesis technology to create a 3D image of the breast. The Hologic product also uses artificial intelligence to improve the accuracy and speed of the 3D image, and it has been shown to be more effective at detecting breast cancer than traditional 2D mammography.

The Hologic product is now the standard of care. They have over 80% market share because it’s more sensitive and has better diagnostic quality than 2D products. That’s what we envision for dentistry with Lumos 3DX.

There are approximately 200,000 dentists in the U.S. There is over $9 billion in 2D X-ray technology sold in the U.S. each year. Much of this is service and replacement for existing units. Dr. Turner believes that the market opportunity for 3D machines is in the hundreds of millions of dollars, and dentists will eventually adopt the 3D technology. Early adopters might be the endodontists and oral surgeons noted above, but slowly these 2D units will give way to 3D platforms in the long run.

As a point of reference, right now, Danaher, who bought the NOMAD from me, is selling 6,000 units a year, and they have roughly 30% market share. We think 3Dio can do 3,000 units per year, about half as many as the 2D, and that would generate nearly $150 million in revenues

Just like Aribex, the future of 3Dio might be to get acquired by a larger player in the dental imaging market. Danaher has spun out Envista, which is now one of the largest players in dental imaging. Other major players include Dentsply Sirona, Progeny, Finland’s Planmeca, Germany’s Duerr Dental, and many smaller companies.