Signifier Medical Technologies Announces Upcoming Publication of Randomized Controlled Trial Results Examining High-Intensity (Active) Vs. Low-Intensity (Sham) Neuromuscular Electrical Stimulation in Patients for 6 Weeks

BOSTON & LONDON–(BUSINESS WIRE)–Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, is pleased to announce that the publication of AEGIS clinical trial results is in press at the ERJ Open Research. The objective of the trial was to determine whether patients with mild obstructive sleep apnea (OSA) would adhere to eXciteOSA, a daytime neuromuscular electrical stimulation (NMES) therapy. Results showed high adherence, with approximately 90% of participants in each arm adherent to NMES. This trial demonstrates the potential of Signifier Medical’s innovative medical technology to significantly improve the lives of individuals suffering from obstructive sleep apnea (OSA).

“The encouraging results from our first randomized controlled trial further validate the data from our previous studies, and we’re thrilled to see how well patients accept the therapy,” says Co-founder and Director, Akhil Tripathi.

The current standard of care for treating mild OSA, positive airway pressure (PAP), has long been plagued with low adherence and low patient satisfaction. Clinical trials and observational studies indicate 25-46% of patients are not adherent to PAP.^1-3 There is also evidence that those with mild OSA are 34% less likely to adhere to PAP than those with moderate/severe OSA.⁴ Given that adherence to positive airway pressure (PAP) therapy in OSA is suboptimal, alternative strategies are needed, particularly for patients with mild OSA.

The AEGIS clinical trial was a randomized, double-masked, sham-controlled study to assess the adherence and overall impact of Signifier Medical’s innovative medical device, eXciteOSA, in managing and treating obstructive sleep apnea. Using NMES to “exercise” the upper airway muscles, eXciteOSA improves tongue muscle endurance and reduces the occurrence of airway collapse during sleep. The trial involved 40 patients and was conducted in collaboration with a network of renowned medical institutions and healthcare professionals.

Key findings of the AEGIS trial include:

High adherence: eXciteOSA for 20 minutes a day for 6-weeks in mild OSA was well accepted, with approximately 90% of the participants adhering to the required days of use.

Improvement in OSA severity: eXciteOSA was associated with approximately a 33% improvement in OSA severity after accounting for patient-related factors such as age, sex, race, body mass index, and the time in the supine position. In contrast, OSA severity remained unchanged in participants who received the sham device.

Improvement in Daytime Sleepiness: Participants in the active arm experienced improvements in daytime sleepiness, whereas no such change was noted in the sham arm.

“We are immensely pleased with the positive outcomes observed in the AEGIS clinical trial,” said Dr. Naresh Punjabi, the trial’s principal investigator. “This publication underscores our commitment to advancing healthcare and developing solutions that can make a meaningful difference in the lives of patients.”

Signifier Medical Technologies remains dedicated to further research, development, and collaboration with healthcare professionals to continue advancing medical technology and improving patient outcomes.

For further information about the AEGIS clinical trial please visit:

Neuromuscular Electrical Stimulation for Obstructive Sleep Apnea: Comparing Adherence to Active and Sham Therapy | European Respiratory Society (ersjournals.com)

About Signifier Medical Technologies

Signifier Medical is a pioneer in addressing the root causes of sleep-disordered breathing. The Company is focused on developing and commercializing innovative and non-invasive solutions to help people breathe normally and naturally all night – without needing to use a wearable medical device or a surgical implant. Founded in 2015, Signifier is at the forefront of sleep therapy, with a mission to develop therapies to improve population health, increase the quality of patients’ healthcare experience, and generate healthcare savings. Signifier has offices in London (UK) and Needham (Massachusetts, USA).

About eXciteOSA®

eXciteOSA is a revolutionary daytime therapy for sleep-disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA uses neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, working the intrinsic and extrinsic tongue muscles to improve endurance and prevent airway collapse during sleep. Unlike other devices which are used while patients sleep, eXciteOSA is the first commercially available device used while awake.

Signifier is dedicated to engaging with the sleep research community to produce high-quality evidence from rigorous clinical trials. Randomized trials are in progress to understand the impact of therapy relative to usual care without treatment (NCT05183009; NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

To learn more about eXciteOSA, please visit www.signifiermedical.com or www.exciteosa.com.

References:

1. Hwang D, Chang JW, Benjafield AV, Crocker ME, Kelly C, Becker KA, Kim JB, Woodrum RR, Liang J, Derose SF. Effect of Telemedicine Education and Telemonitoring on Continuous Positive Airway Pressure Adherence. The Tele-OSA Randomized Trial. Am J Respir Crit Care Med 2018;197(1):117-126.
2. Cistulli PA, Armitstead J, Pepin JL, Woehrle H, Nunez CM, Benjafield A, Malhotra A. Short-term CPAP adherence in obstructive sleep apnea: a big data analysis using real world data. Sleep Med 2019;59(114-116.
3. Patel SR, Bakker JP, Stitt CJ, Aloia MS, Nouraie SM. Age and Sex Disparities in Adherence to CPAP. Chest 2021;159(1):382-389.
4. Jacobsen AR, Eriksen F, Hansen RW, Erlandsen M, Thorup L, Damgard MB, Kirkegaard MG, Hansen KW. Determinants for adherence to continuous positive airway pressure therapy in obstructive sleep apnea. PLoS One 2017;12(12): e0189614.

Contacts

Media:

Jay Cranston

Signifier Medical Technologies LLC

[email protected]

Investors and Partners:

Mujtaba Chohan

Signifier Medical Technologies LLC

[email protected]