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.
 
 
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Unique

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.
 
 

 

1NASAL INTERFACE

Biocompatible medical grade silicone made in ISO13485-certified production facility.

2FRAME

Durable nylon which helps secure the nasal interface through the night.

3HEADGEAR

Comfortable and adaptable.

4TUBE ASSEMBLY

Universal adaptor connects to any existing CPAP machine on the market.

Comfort

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.
 
 
 
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Strap Tension

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.
 

Nasal Cushion

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.

 
Patient Activation
Scanning
Production
Shipping
 
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.
 
 
 

Patient Activation

The application has been designed with efficiency and ease of use in mind. Clinicians simply add the patient in the application and they are ready to order for them.
 

Scanning

Our team of designers has put considerable energy into ensuring the right specifications for the scanning process is highly curated and intuitive. Once the scanner has collected enough data, the software will automatically notify you that the scan has been completed and upload the scan wirelessly to our secure server. The scanning process will take an estimated one to two minutes to complete.
 
 

Production

After a scan is complete, the application will guide the provider to “place an order” for the patient. Once an order is confirmed, our software generates a manufacturing file from the scan, which provides for a 3D mold of the mask based on the patient’s face. Our mask molds are printed, cleaned, inspected, and cast out of medical-grade silicone.
 

Shipping
How it works

The finished order will be shipped back to the providers site where they can dispense to the patient. To ensure that every mask can be reliably matched to the intended patient, each mask will bear a unique ID number embedded into the silicone. Our software provides a check-in process to ensure the clinician can verify without any doubt the mask is the correct patients mask. The entire process for making a custom, 100% unique mask typically takes the same time as receiving a standard mask from a DME provider.
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.