Vitacore Announces World-First Custom-Fit CPAP Mask Following Health Canada MDL Approval

(MENAFN- GlobeNewsWire - Nasdaq) FormFitTM 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 FormFitTM, the world's first fully custom-fit medical-grade silicone CPAP mask. With regulatory approval secured, Vitacore is officially launching FormFitTM across Canada, direct-to-consumer at vitacore/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. FormFitTM 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.

FormFitTM 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. FormFitTM 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.' FormFitTM 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 FormFitTM 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

FormFitTM is available immediately:

• Direct-to-consumer via
• 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 .

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