Study of New Sleep Apnea Treatment in Ethnic Japanese Subjects Completed Reports Sommetrics

AlixPartners Forecasts: Household Products Could Cost U.S. Manufacturers and Consumers 15% More This Year Due to Resin Shortage

While companies can’t control the market forces at play, they can take action to mitigate the risk and impact of supply chain disruption.

How To Control a Radio Frequency (RF) Process

The radio frequency welding and manufacturing process uses electromagnetic energy and pressure to fuse and permanently bond vinyl, thermoplastic, and coated materials to produce a specific product - all according to customer requirements. Using this RF sealing process, a distinct, one-piece perpetual bond is formulated that is both solid and resistant to ripping or tearing. But how is this process controlled, and with what specific tools? Read on.

June 25, 2019

Sommetrics is a company dedicated to developing state of the art products to treat obstructive sleep apnea (OSA).  Today they announced the completion of clinical study SOM-014.

This trial evaluated the safety, tolerability, and effectiveness of the Sommetrics aerSleep™ product in ethnic Japanese subjects with obstructive sleep apnea (OSA). This was a prospective, observational study conducted at the American Academy of Sleep Medicine accredited Sleep Lab in Kaneohe, Hawaii. In a cohort of subjects with moderate to severe OSA, use of the aerSleep™ device was effective in reducing the frequency of apneas and hypopneas by 75% from baseline levels in responsive subjects. No significant adverse events were observed. During the home use portion of the study, aerSleep™ was well tolerated as evidenced by average nightly usage of 5.7 hours during the second week of therapy.

“We are delighted to verify that aerSleep™ has a treatment profile in ethnic Japanese people that is comparable to what we’ve observed in Caucasian populations,” commented Dr. Richard Rose, President, CEO and Chief Medical Officer of Sommetrics. ”This is an important consideration in view of the differences in configuration of the maxilla-facial structures between some Asians and Caucasians. It is reassuring to observe that such differences do not appear to affect the treatment benefits of aerSleep™ for the large worldwide markets that have a predominately Asian demographic.”

The principal investigator, Dr. Jamil Sulieman, had these remarks: “aerSleep™ proved to be effective and well-tolerated in this small group of ethnic Japanese subjects. It was relatively simple to fit and initiate treatment with this device, which has a number of advantages over current therapies like continuous positive airway pressure (CPAP). I look forward to adding aerSleep to my treatment options for OSA.”

The aerSleep™ system consists of a comfortable silicone collar fitted on the front of the neck which holds the airway open via the application of external negative pressure delivered by a quiet, integrated vacuum pump. This system has a number of advantages over conventional sleep apnea therapies in that it is non-invasive, simple to use and maintain, highly portable and well-tolerated by the majority of users. An earlier version of aerSleep™ has previously received market clearance from HealthCanada.



Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.