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Vitacore Announces World-First Custom-Fit CPAP Mask Following Health Canada MDL Approval
FormFit™ is the world’s first end-to-end custom-fit medical grade silicone CPAP mask, creating a precision fit for each individual face.
VANCOUVER, British Columbia, May 21, 2026 (GLOBE NEWSWIRE) -- Vitacore, a deep technology company, today announced that it has received a Medical Device Licence (MDL) from Health Canada for FormFit™, the world’s first fully custom-fit medical-grade silicone CPAP mask. With regulatory approval secured, Vitacore is officially launching FormFit™ across Canada, direct-to-consumer at vitacore.com/formfit and through participating sleep clinics and healthcare providers nationwide.
The proprietary technology converts a short smartphone facial scan into a high-resolution 3D facial model, which is then used to produce a precisely fitted mask that is manufactured in Canada. FormFit™ is compatible with CPAP, APAP, and BiPAP therapy devices.
Solving One of the Biggest Failures in CPAP Therapy
CPAP therapy is the gold standard for treating obstructive sleep apnea (OSA), a condition affecting an estimated 5.4 million Canadian adults and nearly 1 billion people worldwide. Yet adherence remains the single biggest barrier to clinical benefit: roughly half of patients abandon therapy within the first year, and poor mask fit — leading to air leaks, noise, pressure marks, and skin irritation — is consistently identified as the leading cause. Standard CPAP masks are produced in a handful of sizes and shapes. Human faces are not.
FormFit™ directly addresses this challenge through a fully custom-designed and manufactured mask, individually engineered for a single patient and produced at scale. Vitacore’s proprietary design engine translates each patient's facial topography into a unique design, automatically optimizing seal geometry, contact-pressure distribution, structural integrity, and airflow dynamics for an individual face. The completed mask is then manufactured using medical-grade silicone at Vitacore's ISO 13485 certified facility in Port Coquitlam, BC.
The result is a personalized seal that reduces air leaks, minimizes noise, eliminates facial pressure marks, and improves overall therapy effectiveness and comfort.
A New Model for Personalized Medical Devices
“One of the fundamental problems in CPAP therapy is that we’ve been trying to fit an extremely diverse range of facial shapes into a small number of generic mask designs,” said Mikhail Moore, President of Vitacore. “The medical device industry has long assumed that mass production and true personalization are incompatible. FormFit™ proves they are not. We've built a platform that translates each patient's unique anatomy into a manufactured, medical-grade product with no compromises, no generic shells, no 'best available size.' FormFit™ is the first product on this platform, and I believe it represents the future of how personalized medical devices will be designed and built.”
Vitacore plans to extend the same technology stack behind FormFit™ to develop additional personalized medical devices and products in the future, targeting applications where anatomical fit, comfort, and precision are critical to clinical outcomes.
Availability
FormFit™ is available immediately:
- Direct-to-consumer via vitacore.com/formfit
- Through participating sleep clinics and healthcare providers across Canada
With the Canadian launch underway, Vitacore is also preparing a submission to the U.S. Food and Drug Administration (FDA)
About Vitacore
Vitacore Industries Inc. is a Canadian deep technology innovation company. Vitacore develops and manufactures next-generation products at the intersection of advanced computational systems, materials science, and precision manufacturing. Operating from ISO-certified facilities in British Columbia, Vitacore develops proprietary technologies and domestically manufactured solutions for healthcare and other high-impact industries, supplying products to customers worldwide. For more information visit www.vitacore.com.
Media Contact
Amy Tunnicliffe
Media@vitacore.com
778-650-0339
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