Toronto healthtech startup Mesosil has received clearance to sell its bacteria-fighting dental technology to the US dental industry through a partnership with one of its clients.
Mesosil is pursuing Health Canada clearance for its customers, but that requires slightly different data than the FDA submission.
Mesosil investor GreenSky Ventures announced on Wednesday that the startup’s antimicrobial additive technology was granted 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA). The technology is integrated into an undisclosed company’s dental products, and the clearance gives Mesosil’s global manufacturing partners a pathway to sell their “advanced anti-infective” products to dental and medical clinics across the US. Mesosil did not share the client’s name, citing a confidentiality agreement.
Cameron Stewart, CEO and founder of Mesosil, said in a statement that the milestone “represents four years of product development, refinement, and rigorous testing.” The clearance is “a massive validation of Mesosil’s technology and our approach to infection control,” he said.
Spun out of Stewart’s University of Toronto Faculty of Dentistry master’s research project, the startup has developed a tiny, “hard materials sponge” filled with an antimicrobial drug designed to be released slowly over a long period of time. The nanomaterials are designed to kill bacteria, prevent disease, and make dental fillings and other medical implants last longer.
RELATED: Mesosil secures $2.2 million to develop infection-fighting biomaterials for medical devices
Dental manufacturers can add the material into products like composites or cements to give them bacteria-fighting properties. Mesosil claims its dental materials can reduce recurrent tooth decay by 80 percent.
Mesosil filed its first patent in 2017 and spun out as an independent business in 2018. It began fundraising in earnest in 2021 and has raised more than $3 million CAD in venture capital from investors GreenSky Ventures, the Centre for Aging + Brain Health Innovation, and NorthSpring Capital Partners.
To obtain FDA clearance, Mesosil’s client had to issue a 510(k) premarket notification demonstrating that its device is as safe and effective, or substantially equivalent, to a legally marketed device.
In an email, Stewart told BetaKit that Mesosil is pursuing Health Canada clearance for its customers, which requires slightly different data than the FDA submission.
“We see this approval as the first of many,” Stewart said, adding that Mesosil is working on applications for non-medical sectors and for medical devices within the body.
The company said that with the FDA greenlight, it’s scaling its manufacturing capacity in Toronto to meet demand from global partners.
Feature image courtesy Steve Gschmeissner via Science Photo Library.