Data Published by Cureus Journal of Medical Science Shows Successful Treatment of Obstructive Sleep Apnea with ProSomnus Precision Oral Appliance Devices
December 19 2023 - 8:00AM
ProSomnus, Inc. (NASDAQ: OSA) (the “Company”), the leading non-CPAP
Obstructive Sleep Apnea (OSA) therapy™, today announced the
publication of a study by the Cureus Journal of Medical Science, in
which the Company’s precision oral appliance therapy (OAT) devices
successfully treated patients’ OSA.
“The study underscored what we see daily in our
practice at Star Sleep & Wellness. Our team continues to favor
the ProSomnus® EVO® Sleep and Snore Device, as it not only garners
the fewest number of patient complaints regarding fit and comfort,
but also shows to be superior in resolving chief complaints such as
partner discontent, fatigue and daytime sleepiness,” said Dr. Kent
Smith, D-ABDSM, ASBA, a co-author of the study.
Key findings from the study, titled “Evaluating
the Clinical Performance of a Novel, Precision Oral Appliance
Therapy Medical Device Made Wholly from a Medical Grade Class VI
Material for the Treatment of Obstructive Sleep Apnea,”
include:
- 89% of all patients and 98.5% of mild
to moderate OSA patients were treated to an apnea-hypopnea index
(AHI) of fewer than 10 events per hour.
- 80% of severe OSA patients were
treated to an AHI of fewer than 20 events per hour with a 50%
improvement.
- After a minimum one-year follow-up
period, 96% of patients continued using their precision OAT
devices.
“Oral appliance success is traditionally evaluated
with the AHI metrics. My experience with the ProSomnus® EVO®
precision oral appliance is that it exceeds the American Academy of
Sleep Medicine (AASM) and the American Academy of Dental Sleep
Medicine (AADSM) standards for efficacy. This study shows that
residual AHI using an EVO device is superior to other oral
appliances, and superior to hypoglossal nerve stimulation in
reducing the AHI. Clinically speaking, I have delivered over 300
EVO devices. I find EVO to have great patient compliance, minimal
delivery adjustments, and overall better patient comfort than other
traditional oral appliances for sleep apnea,” said John A. Carollo,
DMD, D-ABDSM, D-ASBA, a co-author of the study.
“My experience with ProSomnus began in 2019 and
since that time, I have come to appreciate the benefit to my
patients in delivering precision oral appliances such as these. The
study irrefutably demonstrates this,” said Dr. Aditi Desai, BDS,
MSc, FCGDent, a co-author of the study. “The ethos of the company
has certainly helped drive the field of oral appliance therapy as a
most credible alternative to CPAP.”
ProSomnus also announced additional clinical
research highlighting the efficacy, decreased AHI incidents, and
strong therapy adherence associated with the Company’s precision
OAT devices:
- In a six-center study assessing the
efficacy, repeatability and predictability of treating 58 moderate
to severe OSA patients with ProSomnus® EVO® and a standard
treatment protocol, participants’ median obstructive AHI decreased
from 20.54 to 3.9 events per hour, while 90% of patients
experienced fewer than 15 events per hour. The data were presented
at the 2023 Interdisciplinary Belgian Dental and Surgical Sleep
Medicine Academy meeting by Prof. Dr. Marc Braem, DDS, PhD., in an
abstract titled “Oral Appliance Treatment in General Hospital
Setting: Effects on Obstructive Apnea-hypopnea Index (oAHI)
Measured with Polygraphy, at Multiple General Hospitals.”
- In a study of 22 mild to moderate
OSA patients, the ProSomnus® EVO® was associated with a decreased
AHI and strong compliance. After being treated with the EVO,
patients’ median AHI decreased from 21 to 4 events per hour, while
95% of patients experienced fewer than 10 events per hour.
Patients’ compliance with the EVO, reported in the first three
months of therapy, was 100%. These findings were presented at the
2023 World Sleep Congress by Dr. Raquel Silva, in an abstract
titled “New Generation Oral Appliances for Treatment of Obstructive
Sleep Apnea.”
“In an effort to offer patients an effective
titration schedule, the bite registration is generally made at the
so called maximal comfortable protrusion, minus 2.0 mm after DISE
investigation. In a retrospective analysis of this procedure at 6
general hospitals, the reduction in Obstructive Apnea-Hypopnea
index, as measured with type 3 polygraphy, was highly significant
lowered to 3.9 events/hr sleep, irrespective of the sleep center
methodology used,” said Prof. Dr. Marc Braem, DDS, PhD.
“These studies demonstrate that precision oral
devices offer consistent efficacy across multiple clinical and
hospital settings, and are associated with reliable adherence.
Traditional oral devices are typically associated with inconsistent
efficacy due to imprecise repositioning and stabilization of the
jaw and unreliable durability due to side effects and mechanical
issues,” said Len Liptak, ProSomnus Chief Executive Officer. “This
new data adds to a body of evidence underscoring that ProSomnus
devices are a safe and efficacious option for millions of OSA
patients who have terminated or refused CPAP, or been impacted by
the CPAP recall.”
About ProSomnusProSomnus
(NASDAQ: OSA) is the leading non-CPAP therapy for the treatment of
Obstructive Sleep Apnea, a serious medical disease affecting over 1
billion people worldwide, that is associated with comorbidities
including heart failure, stroke, hypertension, morbid obesity, and
type 2 diabetes. ProSomnus intraoral medical devices are engineered
to precisely track the treatment plan and anatomy for each patient.
Non-invasive, patient preferred and easy to use, ProSomnus devices
have demonstrated excellent efficacy, safety, adherence, and
overall outcomes in a growing body of clinical investigations.
ProSomnus precision intraoral devices are FDA-cleared, patented,
and covered by commercial medical insurance, Medicare, TRICARE and
many Government sponsored healthcare plans around the world,
representing over 200 million covered lives. To learn more, visit
www.ProSomnus.com.
Investor ContactMike
CavanaughICR WestwickePhone: +1.617.877.9641Email:
Mike.Cavanaugh@westwicke.com
Media ContactElizabeth
ColemanICR WestwickePhone: +1.203.682.4783Email:
Elizabeth.Coleman@westwicke.com
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