Startup Initiates FDA Approval Process for Custom PAP Masks Made Via 3-D Printing
A Pasadena, Calif-based startup is working on harnessing 3-D technology to create custom CPAP masks for sleep apnea patients via 3-D scanning, smart geometry, and 3-D printing. Metamason has just completed prototyping the Respere Secure CPAP Mask and the Respere Freedom CPAP Adapter. The company is initiating the regulatory FDA 510(k) process, with clinical trials commencing soon, and is seeking investment in their customized healthcare solutions.
“We’re at the crossroads of 3-D technology and personalized medicine,” says Metamason founder and CEO Leslie Oliver Karpas, in a release. “There are many medical products that would be infinitely more comfortable and effective with a customized fit. CPAP therapy is the perfect example….Our design also gets rid of the undignified front-facing elephant tube most CPAP masks have, and redirects airflow around to the crown of the head, where it won’t interfere with your or your partner’s sleep.”
Industry blog 3Dprintingindustry.com reported, “Metamason hasn’t just developed a 3-D printed CPAP mask…they’ve developed an entire workflow for scanning, processing, and creating the custom masks.” Metamason’s “Scan•Fit•Print” process for creating their custom Respere masks translates a 3-D scan of the patient’s face into a 3-D printed custom mask that is a perfect individual fit. To print the masks in soft, biocompatible silicone, Metamason invented a proprietary 3-D printing process called Investment Molding, which creates wholly integrated products that were previously considered “unmoldable.”
Karpas says, “3-D technology is changing how products are made. We are thrilled to be at the front lines as changemakers, ushering in customization through parametric design and on-demand 3-D manufacturing.”
Watch the video pitch embedded above or on the Karpas’ YouTube channel.