SINTX Technologies Inc. began through a collaboration between materials scientist Ashok Khandkarand orthopedic surgeon Aaron Hoffman. The initial goal was to develop a ceramic bearing joint for artificial hips made from silicon nitride. At the time, metal bearings produced more wear than ceramics. Khandkar and Hoffman had experimental data showing that silicon nitride would be tougher and produce less wear, so they sought to introduce the new bearing for a hip joint, barring an FDA-required clinical trial.
The company also made a submission for a product for spinal fusion, as silicon nitride heals very quickly to bone. The company received approval for the spine fusion device, and began to sell spine products. In 2014, it went public while selling these spinal-related products, including fusion implants made of silicon nitride. Around this time, it decided to invest heavily in the basic research and development related to silicon nitride, since additional properties, such as possible bacterial resistance, were becoming known.
The company is now material-focused and wants to have several applications and products developed for downstream retailers and partners that are focused on silicon nitride ceramics, under the direction of Chief Executive Officer B. Sonny Bal.
In the more nascent stages of the company (2014-2015), it had only a handful of scientific publications and validation, relying on industrial, historical, and animal data to make the case for its material. It began to make a concerted effort toward investing in research and development which ultimately paid off, validating the properties of silicon nitride and discovering more. The company recently published metadata from a data pool of the four original clinical centers to show the outcomes of materials in cervical and lumbar fusion, a milestone for its development.
Bal separates SINTX from other companies of its ilk by noting that the workforce “asks how the material works and why it works, what are its limits,” because no material is the ultimate answer to every problem. “The biggest feather in our cap is that we go out of our way to find the limitations of our material and publish it,” Bal continues. “Honesty and integrity go a long way to our credibility in the scientific and technical world.”
Thus far, the only product SINTX offers in the retail space is its silicon nitride spinal implants, specifically for replacing disc material during surgery and promoting fusion. The material competes with other polymers and metals, but its distinctive properties make it more desirable than its alternatives. It gives ease of imaging on MRI, has a bioactive surface that promotes bone healing and fusion, and anti-bacterial behavior that inherently repels bacterial fusion.
Hip and knee replacements and dental implants are also being developed with the material. Opportunities exist beyond the biomaterial space, so the company has hired Don Bray as its Vice President of Business Development to investigate such non-medical ventures. Silicon nitride is also used in screens and electronics, “making modern life possible from here to outer space” as Bal tells it, with a huge opportunity in industry as well. Industrial orders, such as for specific components and tools targeted at precise non-medical applications, are just starting to come in, making 2020 a very promising year for SINTX.
Overseas, ceramics are far more accepted as implants than in the U.S., so the company is also looking to grow its overseas partnerships. Silicon nitride also has uses within the aerospace, defense, and transportation industries, making it a sought-after material for a great many business sectors.
Bal notes that the older technologies and platforms made by the company are for anyone to use now, since SINTX does not hold onto patents. The company is “busy focusing on tomorrow’s technologies and challenges, by constantly pushing the envelope.”
Don Bray adds that the advent of silicon nitride is relatively recent, having been used since the 1980s onward, with the overall market sitting at well over $5 billion. Bray has found new customers for materials, as SINTX stands on the cutting edge of biomedical materials that are an improvement over current offerings. The fact that SINTX’s silicon nitride is competitive with industrial formulations is an added bonus.
At this point, SINTX’s primary clientele come from the CTL Amedica Corporation, a downstream retail customer, with which the company has a relationship that Bal describes as phenomenal. As the corporation’s biomaterials partner, it manufactures for CTL, sometimes on short timelines, keeping it abreast of new developments in technology that might take advantage of the extremely versatile nature of the material.
The company’s aim is to keep customers up to date on its developments and to publish its findings; so far, the company has published over 130 peer-reviewed papers – approximately two every month – and continues to heighten its presence by attending trade shows. Bal describes the relationship as one built on “trust, support, communication, and strategic planning… we help our clientele do better at what they do.”
Throughout the company’s phases, the relationship between workforce and management has remained loyal and strong. A style of flat communication, where every person’s opinion is valid, is combined with a lack of vertical hierarchy and an open architecture in the office. This has promoted creativity among the workforce that is the core identity of SINTX. It is the number one developer in the world of silicon nitride, and the only silicon nitride medical device manufacturing facility in the world to be FDA and ISO approved, so open creative collaboration is necessary to its continued success. As Bal clarifies on the company’s communication-based approach: “There is no way to promote innovation through control.”
Financially speaking, the company requires a lot of investor cash to make its services possible, as it is described by Bal as “a highly disciplined company, especially in terms of spending.” Supporting a new technology platform takes time and money, but as a publicly-traded company, it can raise capital through a disciplined and incremental approach.
The biggest challenge beyond this that SINTX faces is conveying the complex, underlying science to its audience, as its solutions can seem almost too good to be true. Company heads must ask investors for patience as technology is constructed and analyzed, but Bal feels that 2020 will be the company’s breakout year and will “deliver a number of strategic pathways that have been in development for the last five years.”
Last year was an excellent one for SINTX from both revenue and a projection standpoint, with expenses tracking below budget. Bal credits this to the team as they do not waste money, vet every project extensively, and target those projects to a specific output. The company also downsized its building, saving money as a result, and made use of the revenue gained from selling its spine division in 2018 to Dallas-based partner CTL Amedica. The end of the year saw sales stabilizing further, and the debt-free company looks ahead to an even better 2020.
SINTX’s primary objective remains to ask questions, seek innovation, and figure out the how and why. The company will be keeping this in mind as it seeks feedback from external partners. The pursuit of new technology and solutions, combined with a communicative and honest approach, looks to keep SINTX in business for the foreseeable future and make it a boon to the ever-growing field of medical technology.