Toronto, ON – Mesosil Inc., a Toronto-based material science company and a portfolio company of GreenSky Accelerator Fund V, announced that its proprietary antimicrobial additive technology has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This regulatory milestone marks a major commercial turning point for the company and a significant breakthrough for the dental and medical device industry. It clears the regulatory pathway for Mesosil’s network of global manufacturing partners to launch a new generation of “advanced anti-infective” dental and medical materials in the United States. The clearance represents the first regulatory approval of a diffusive dental antimicrobial system and the first time mesoporous silica has been cleared for use as a carrier within an internal medical device.
“The whole company is extremely proud of this achievement, which represents four years of product development, refinement, and rigorous testing with regulatory and key-opinion-leader input,” said Cameron Stewart, CEO and founder of Mesosil. “This FDA clearance is a massive validation of Mesosil’s technology and our approach to infection control.”
Current dental materials often fail due to secondary caries as bacteria colonize the microscopic interface between the tooth and the filling. Mesosil has engineered a nanostructured silica additive that dental manufacturers integrate directly into their own product lines such as composites and cements, granting materials the ability to actively resist infection and degradation without altering clinician workflow or final product aesthetics.
Mesosil is currently working with forward-thinking manufacturers to co-develop highly differentiated products that are expected to hit the market in the coming quarters. With this clearance, the regulatory pathway for Mesosil and its partners has been effectively de-risked. The company is now leveraging its ability to produce highly controlled, customizable silica nanomaterials efficiently and at scale for both medical and non-medical applications. “We see this approval as the first of many,” added Stewart. “We have opened the door to broad application of Mesosil in medicine and dentistry. We continue to develop multiple applications for in-dwelling medical devices prone to infection, as well as leveraging our manufacturing scale for non-medical sectors.”
With the backing of its investors and the green light from the FDA, Mesosil is poised for rapid expansion. The company is now actively scaling its manufacturing capabilities in Toronto to meet the demand from its global OEM partners, ensuring that its vision for next generation of dental and medical materials is not just a concept, but a clinical reality available to patients worldwide.
About Mesosil Inc.:
Spun-out of the University of Toronto’s Faculty of Dentistry, Mesosil is venture-backed by prominent deep-tech investors including GreenSky Ventures, Greyhill Capital Partners, Archangel Network of Funds, and the Centre for Aging + Brain Health Innovation (CABHI). Mesosil develops and supplies nanostructured antimicrobial and bioactive additives that allow medical and dental manufacturers to “upgrade” their materials. By integrating Mesosil’s technology, manufacturers can offer devices that actively prevent infection and degradation at the tissue biomaterial interface. For more information, visit mesosil.com.
About GreenSky Ventures:
GreenSky Ventures is a venture capital firm that invests in early-stage Canadian technology startups. Through its six affiliated GreenSky Accelerator Funds I–VI, the firm provides capital and strategic guidance to high-growth potential companies. Learn more at greensky.vc
