The US Food and Drug Administration (FDA) has granted a De Novo request for Zephyr Sleep Technologies Inc’s MATRx plus, an at-home class II medical device to identify obstructive sleep apnea (OSA) patients suitable for oral appliance therapy.
MATRx plus is a multi-function device capable of performing both:
- a standard home sleep test (HST); and
- an oral appliance trial.
Zephyr Sleep says the device is ideally suited for a dentist’s office, and the MATRx plus will also be sold to sleep labs and clinics. The MATRx plus utilizes a tablet-based design and includes instructional videos walking patients through the self-administered test in the comfort of their own home. Offering real-time, cloud connectivity, the MATRx plus simultaneously brings the patient’s study to the dentist’s office, the sleep physician’s office, and Zephyr’s servers—allowing for instant collaboration among health professionals. The MATRx plus technology uses proprietary algorithms, artificial intelligence, and machine learning. The MATRx plus joins the Zephyr’s MATRx, which is installed in over 200 sleep labs and clinics in the United States.
The MATRx plus tells the medical professional if a patient can be treated with oral appliances (reducing the failure rate) and how to treat by offering a therapeutic treatment position. The dentist uses this information to order and configure the oral appliance efficiently and effectively in a patient-friendly matter. “Never before has providing a sleep appliance been so easy” says Shouresh Charkhandeh, DDS, Zephyr’s chief dental officer, in a release.
John Remmers, MD, Zephyr’s chief medical officer, says, “Finally, we are able to confidently prescribe an alternative therapy to CPAP and invasive surgery to treat OSA. Using a MATRx plus to responsibly and confidently select patients for oral appliances is the missing link to effectively treating a broader population.”
Zephyr has partnered with Dentsply Sirona, a manufacturer of professional dental products and technologies, to bring MATRx plus to the United States market. “The FDA clearance for the MATRx plus is a significant achievement for Zephyr Sleep Technologies, our partner in developing the first 3D solution for obstructive sleep apnea therapy,” says Walter Petersohn, Dentsply Sirona’s chief commercial officer. “Details on how The Simple Sleep Solution will deliver better, safer and faster treatment will be announced at Dentsply Sirona World in September.”
“The FDA clearance of MATRx plus as a De Novo Class II medical device is a significant achievement for our company. The process involved three clinical studies, over 280 patients and rigourous testing on safety, effectiveness and usability. The MATRx plus is truly a new class of device that will change this industry,” says Sabina Bruehlmann, PhD, Zephyr Sleep’s director technology and regulatory affairs.
“Our team is very proud of this significant accomplishment, which clearly puts Zephyr Sleep Technologies as the innovation, technology, and now product leader in the dental sleep industry,” says Paul Cataford, CEO. “We share this important milestone with our industry partners and look forward to bringing MATRx plus to every dental practice in the US.”
In Canada, Zephyr received Health Canada approval for MATRx plus in August 2016. The US launch of MATRx plus will be at the Dentsply Sirona World Conference on Thursday, September 13, 2018.