a uniquely fitting device
for every patient.
Product not for sale and subject to FDA approval
A challenging treatment
In terms of treating sleep apnea, CPAP therapy is a resounding success. In spite of its effectiveness, CPAP remains a challenging treatment, with more than 50% of patients quitting within the first three months. Overwhelmingly, these patients cite dissatisfaction with their CPAP mask as the reason for their non-compliance. Various attempts at design improvements have failed to address the central problem: poor fit.
Finally, the world’s first matched respiratory mask for the treatment of Sleep Apnea. Each mask is generated from a 3D scan of the patient’s face resulting in a uniquely fitting device for every patient.
the world’s first ‘perfectly fit’ respiratory mask
Features & Design
3D scan-fit-print addresses these issues by providing patients with a comfortable and easy to use device with the ultimate goal of a higher quality of life.
Biocompatible medical grade silicone made in ISO13485-certified production facility.
Durable nylon which helps secure the nasal interface through the night.
Comfortable and adaptable.
Universal adaptor connects to any existing CPAP machine on the market.
Every human face is different...Shouldn’t every CPAP mask be custom? Our nasal interface is made from a highly accurate 3D scan of the patient so our mask fits perfectly.
Ease of use
To get a one-size fits all masks to be effective a delicate dance of adjustments needs to done. Because the mask is a model of you, it fits perfectly for every patient resulting in less adjustments and a more accepting mask system.
CPAP masks are prone to leaks and often result in the over tightening of the headgear straps. The tightening is not only uncomfortable but may cause abrasions and leave marks on the face. By using a 3D scan, patient specific adjustments can be made to the mask to ensure the headgear sits naturally, reducing any tension needed.
Our software creates a unique patient nasal air seal, which allow our mask to fit naturally on the face. The precise fit is also more forgiving to movement during the night, maintaining a secure seal.
The Scanning Application
Our scanning application is an integrated platform for the creation, manufacturing, and distribution of patient ‘matched’ respiratory devices.
How it works.
Using tablets with an attached 3D scanner, our software can guide any clinician through the process of taking a scan, uploading it to our server and tracking the mask from creation to delivery.
How it works
Will the mask really be that much better than existing CPAP interfaces?
It's called the Goldilocks problem: most currently available CPAP masks come in standard sizes, but human faces do not. This leaves you with the problem of having to overtighten a mask too large for you, or cramming your face into one that's too small. By building each mask around a scan of your individual face, our mask takes the painful guesswork out of finding a mask, letting you focus on getting to sleep.
When will it be available?
We're currently in the process of submitting our device to the FDA for clearance in anticipation of receiving clearance later this year. Once our device has been cleared, you'll be able to purchase it from participating sleep providers and durable medical equipment retailers.
Will there be an opportunity to try the mask before it hits the market?
Other than during sanctioned clinical trials, while our mask is moving through the FDA approval process, we are unfortunately not permitted to pre-release versions to the public.
Will you be releasing a full-face version or other mask styles?
The first model we will be releasing is the nasal cushion. We have plans to offer several 3D versions including a nasal and full-face model, so that each patient can receive the best mask for their needs.
Will it be available outside of the United States?
OSA affects large portions of the population regardless of their residence. Our goal is to ensure as many people as possible have access to our 3D print masks, and as soon as possible. The fastest way to do that is to release in America first, and then move it through the regulatory agencies for the rest of the world soon thereafter.