SAN FRANCISCO, June 23, 2021 /PRNewswire/ -- ProSomnus Sleep Technologies, the leading Oral Appliance Therapy medical device for the treatment of Obstructive Sleep Apnea (OSA), today announced their plan to support patients affected by the Philips Respironics Bi-Level Positive Airway Pressure (Bi-Level PAP) and Continuous Positive Airway Pressure (CPAP) recall.
ProSomnus oral appliances are a relevant treatment alternative for patients with sleep apnea. ProSomnus devices are uniquely made from a medical grade, low porosity, biocompatible, hygienic material. Numerous studies have shown that precision Oral Appliance Therapy (OAT) is a proven, effective treatment option that should be considered for adult patients who are intolerant of CPAP therapy or prefer alternate therapy. OAT can be used to treat all levels of OSA severity and has been proven to reduce AHI and improve OSA co-morbidities, such as blood pressure, fatigue and fatigue-related accidents and cardiovascular mortality. ProSomnus is offering the following programs to help affected patients get into effective, safe and comfortable therapy;
Find a Qualified Provider
ProSomnus offers sleep professionals two links to make it easy to refer patients to experienced, qualified, dental sleep medicine providers in their areas. The first is ProSomnusDentists.com the second is AADSM.org.
Expedited Production/Capacity
ProSomnus has a scalable rapid, seven-day, production schedule to get patients into therapy faster. Capacity can be expanded easily to accommodate this crisis. The American Academies of Sleep Medicine (AASM) and Dental Sleep Medicine (AADSM) recommend custom, titratable, oral appliance therapy devices fitted by qualified dentists, and not do-it-yourself mouthguards. Prescription oral appliance therapy devices are made-to-order, which historically took several weeks. ProSomnus uses a unique manufacturing process that speeds up the process and is more precise.
Extended Warranty
ProSomnus standard three-year warranty, fewer interventions and excellent efficacy, adherence and effectiveness, make it a robust and cost-effective solution for the medical insurance reimbursement payer and patients.
Recent ProSomnus Studies
A recent IRB study published at the AASM meeting, demonstrated 96% strongly prefer ProSomnus EVO™ over their previous predicate devices and PAP therapy. Other recent poster abstracts at the AASM and AADSM showed excellent AHI improvements, less dose and fewer side effects and treatment interruptions using ProSomnus devices.
"The objective is to help sleep physicians and dental sleep providers to get affected patients back into safe, comfortable and effective therapy," stated Len Liptak, CEO of ProSomnus. "It is understandable that many affected patients may prefer non-CPAP alternatives. We want the sleep medicine community to know that ProSomnus is a partner they can trust for oral appliance therapy."
"Because of the current limited availability of machines and a complex payment structure for replacing them, ProSomnus OSA Therapy is an exceptional solution," stated Sleep Physician Edward T. Sall, MD, DDS, MBA. "This California medical device manufacturer can scale their artificial intelligent design and robotic manufacturing. This includes a best-in-class 7-day manufacturing timeframe even though each appliance is custom made. My recent AASM poster abstract also demonstrates the efficacy and effectiveness of these devices for mild moderate and select severe patients."
"The AASM and AADSM joint guidelines on the treatment of OSA along with recently published posters at the AASM and AADSM annual meetings clearly demonstrates the efficacy, adherence, and effectiveness of ProSomnus oral appliances as an alternative to PAP therapy," commented Mark T. Murphy, DDS, DABDSM. "Never has there been a better time to utilize this valuable alternative solution to enhance the lives of so many affected by this recall. Treating physicians should engage ProSomnus qualified providers to quickly solve this crisis."
Additional Resources:
AASM Guidance in Response to Philips Recall
Related Files
AASM_Preference Study EVO_Murphy.pdf
Related Images
prosomnus-evo-sleep-and-snore.jpg
ProSomnus® EVO™ Sleep and Snore Device
ProSomnus EVO, for preferred OSA therapy. ProSomnus EVO is the first OAT device to incorporate advanced materials, manufacturing robotics and artificial intelligence to advance the treatment of OSA.
SOURCE ProSomnus Sleep Technologies
