Study Published in "Military Medicine" Reports 88% Success Treating Obstructive Sleep Apnea Patients with Precision Oral Appliance Therapy
09 December 2022 - 12:00AM
ProSomnus, Inc. (“the Company”) (NASDAQ: OSA), a pioneer in
precision medical devices for the treatment of Obstructive Sleep
Apnea (OSA), today announced the publication of a peer-reviewed,
independent, study in Military Medicine, in which 88% of patients
with Obstructive Sleep Apnea (“OSA”) were successfully treated
using the Company’s novel precision intraoral medical devices.
Following approval from the Carl R. Darnall Army Medical Center
Institutional Review Board and the Defense Health Agency, the
investigators analyzed the records of active-duty military patients
treated for OSA to determine the success of precision oral
appliance therapy (“OAT”) based on a symptom-driven titration.
“The U.S. military continuously looks for
opportunities to enhance the wellness and readiness of all of its
members,” said the principal investigator, Ryan Kang, DMD, MS,
ABGD. “Sleep is an incredibly important factor in one’s overall
health and daily performance, so we are especially interested in
ways to improve soldiers’ rest. Our primary goal was to evaluate if
OSA can be effectively managed with Precision OAT. This study
suggests that Precision OAT has strong potential in managing
patients’ OSA and makes a case for wider adoption of it throughout
the military.”
The study demonstrated that 88% of patients were
successfully treated with precision OAT to an Apnea-Hypopnea Index
(“AHI”) of less than 10 events per hour, which was noted as better
than previous studies that utilized non-precision, dental products.
The study also reported statistically significant improvements in
respiratory disturbances (“RDI”), oxygen saturation, REM sleep,
sleep efficiency and daytime sleepiness, with a 79.6% mean
reduction in sleep apnea events. For context, previous studies
reported that success rates with traditional, non-precision, OAT
were less than 65%.
“ProSomnus is honored to support the US Military
and for our devices to be associated with high quality, independent
research investigations,” said Len Liptak, Co-Founder and Chief
Executive Officer of ProSomnus. “This study adds to the growing
body of independent research demonstrating the success of ProSomnus
precision oral devices for the treatment of OSA, further
establishing ProSomnus devices as a leading option for patients and
healthcare providers seeking an alternative to CPAP and Hypoglossal
Nerve Stimulation treatments.”
About OSAOSA is the recurring
collapse of the airway during sleep, resulting in oxygen shortages
and abrupt awakenings accompanied by gasping or choking. In
addition to daytime sleepiness, OSA is associated with serious
comorbidities, including heart failure, stroke, hypertension,
morbid obesity and type 2 diabetes. Patients with untreated OSA are
23 times more likely to suffer a heart attack and four times more
likely to have a stroke. It is estimated that more than one billion
people worldwide and over 74 million people in North America suffer
from OSA. Approximately 56 million of those 74 million people in
North America are undiagnosed.
About ProSomnusProSomnus is
the first manufacturer of precision, mass-customized Precision Oral
Appliance Therapy devices to treat OSA, which affects over 74
million Americans and is associated with serious comorbidities,
including heart failure, stroke, hypertension, morbid obesity and
type 2 diabetes. ProSomnus’ patented devices are a more comfortable
and less invasive alternative to Continuous Positive Airway
Pressure (CPAP) therapy, and lead to more effective and
patient-preferred outcomes. With more than 150,000 patients
treated, ProSomnus’ devices are the most prescribed Precision Oral
Appliance Therapy in the U.S. To learn more, visit
www.ProSomnus.com.
Important Notice Regarding Forward-Looking
StatementsThis Press Release contains certain
“forward-looking statements” within the meaning of the Securities
Act of 1933 and the Securities Exchange Act of 1934, both as
amended. Statements that are not historical facts, including
statements about the parties’ perspectives and expectations, are
forward-looking statements. The words “expect,” “believe,”
“estimate,” “intend,” “plan” and similar expressions indicate
forward-looking statements. These forward-looking statements are
not guarantees of future performance and are subject to various
risks and uncertainties, assumptions (including assumptions about
general economic, market, industry and operational factors), known
or unknown, which could cause the actual results to vary materially
from those indicated or anticipated.
Such risks and uncertainties include, but are not limited to:
(i) the effect of the announcement or the business combination on
ProSomnus’s business relationships, operating results and business
generally; (ii) risks that the business combination disrupts
current plans and operations of ProSomnus; (iii) the outcome of any
legal proceedings that may be instituted against ProSomnus or
Purchaser related to the business combination; (iv) changes in the
competitive industries in which ProSomnus operates, variations in
operating performance across competitors, changes in laws and
regulations affecting ProSomnus’s business and changes in the
combined capital structure; (v) the ability to implement business
plans, forecasts and other expectations after the completion of the
business combination, and identify and realize additional
opportunities; (vi) the risk of downturns in the market and
ProSomnus’s industry including, but not limited to, as a result of
the COVID-19 pandemic; (vii) costs related to the transaction and
the failure to realize anticipated benefits of the transaction or
to realize estimated pro forma results and underlying assumptions,
including with respect to estimated stockholder redemptions; (viii)
the risk of potential future significant dilution to stockholders
resulting from lender conversions under the convertible debt
financing; and (ix) risks and uncertainties related to ProSomnus’s
business, including, but not limited to, risks relating to the
uncertainty of the projected financial information with respect to
ProSomnus; risks related to ProSomnus’s limited operating history,
the roll-out of ProSomnus’s business and the timing of expected
business milestones; ProSomnus’s ability to implement its business
plan and scale its business, which includes the recruitment of
healthcare professionals to prescribe and dentists to deliver
ProSomnus oral devices; the understanding and adoption by dentists
and other healthcare professionals of ProSomnus oral devices for
mild-to-moderate OSA; expectations concerning the effectiveness of
OSA treatment using ProSomnus oral devices and the potential for
patient relapse after completion of treatment; the potential
financial benefits to dentists and other healthcare professionals
from treating patients with ProSomnus oral devices and using
ProSomnus’s monitoring tools; ProSomnus’s potential profit margin
from sales of ProSomnus oral devices; ProSomnus’s ability to
properly train dentists in the use of the ProSomnus oral devices
and other services it offers in their dental practices; ProSomnus’s
ability to formulate, implement and modify as necessary effective
sales, marketing, and strategic initiatives to drive revenue
growth; ProSomnus’s ability to expand internationally; the
viability of ProSomnus’s intellectual property and intellectual
property created in the future; acceptance by the marketplace of
the products and services that ProSomnus markets; government
regulations and ProSomnus’s ability to obtain applicable regulatory
approvals and comply with government regulations, including under
healthcare laws and the rules and regulations of the U.S. Food and
Drug Administration; and the extent of patient reimbursement by
medical insurance in the United States and internationally. A
further list and description of risks and uncertainties can be
found in Lakeshore’s initial public offering prospectus dated June
10, 2021 and in the Company’s quarterly reports on Form 10-Q and
annual reports on Form 10-K filed with the Securities and Exchange
Commission (the “SEC”) subsequent thereto and in the Registration
Statement on Form S-4 and proxy statement that has been filed with
the SEC by Lakeshore in connection with the business combination,
and other documents that the parties may file or furnish with the
SEC, which you are encouraged to read. Should one or more of these
risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those indicated or anticipated by such forward-looking
statements. Accordingly, you are cautioned not to place undue
reliance on these forward-looking statements. Forward-looking
statements relate only to the date they were made, and the Company
and its subsidiaries undertake no obligation to update
forward-looking statements to reflect events or circumstances after
the date they were made except as required by law or applicable
regulation.
Investor ContactMike CavanaughICR
WestwickePhone: +1.617.877.9641Email:
Mike.Cavanaugh@westwicke.com
Media ContactKyle EvansICR WestwickePhone:
+1.646.277.1295Email: Kyle.Evans@westwicke.com
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