ProSomnus® Provides Business Update and Preliminary 2022 Revenue Guidance
01 Février 2023 - 11:15PM
ProSomnus, Inc. (“the Company”) (NASDAQ: OSA), a pioneer in
precision medical devices for the treatment of Obstructive Sleep
Apnea (OSA), today announced certain unaudited results for the
quarter and full year ended December 31, 2022.
Preliminary 2022 Revenue Guidance and
Recent Business Highlights
- Revenue for the full year 2022 is
expected to increase over 35% year-over-year from 2021
- Surpassed 187,500 devices
prescribed by healthcare providers
- Commenced execution of multiple
growth initiatives, including the expansion of direct sales team in
the U.S. and Europe, the commercialization of our next generation
sensor device, the relocation to a new manufacturing facility, and
the development of marketing and medical affairs programs
- Announced first patient enrolled in
the Severe Obstructive Sleep Apnea (SOS) study
- Announced full enrollment of
patients with moderate to severe obstructive sleep apnea in the
First Line Obstructive Sleep Apnea Treatment (FLOSAT) study
- Began trading on the Nasdaq Stock
Exchange in December under the ticker “OSA”
“We are extremely pleased with the progress the
ProSomnus team achieved in 2022 across all business segments,
including commercialization, manufacturing, new product
development, and clinical data generation,” said Len Liptak,
Co-Founder and Chief Executive Officer of ProSomnus. “These efforts
were capped by the initial public offering in December 2022, which
we undertook to help advance our vision of making our
patient-preferred precision oral devices a first-line therapy to
treat the global health emergency of obstructive sleep apnea. As we
enter the next phase of growth, we remain highly focused on
executing our global growth strategy and making precision oral
devices a mainstay in treating and managing obstructive sleep apnea
for millions of patients globally.”
The results described in this release are
subject to revision until the Company reports its full financial
results in its earnings announcement planned for late March.
About ProSomnusProSomnus
(NASDAQ: OSA) is the first manufacturer of mass-customized
Precision Oral Appliance Therapy (OAT) devices to treat OSA, which
affects over 74 million people in North America and is associated
with serious comorbidities, including heart failure, stroke,
hypertension, morbid obesity and type 2 diabetes. ProSomnus’s
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. A
growing body of research, including studies published by the
Journal of Clinical Sleep Medicine and Military Medicine, suggests
ProSomnus’s Precision OAT devices are an effective treatment for
mild to moderate OSA. Additional clinical research has shown that
ProSomnus’s Precision OAT devices can mitigate common dental side
effects and improve economics for payers and providers. With more
than 187,500 devices delivered, ProSomnus’s devices are the most
prescribed Precision OAT in the U.S. ProSomnus’s FDA-cleared
devices are authorized by the Department of Defense and the U.S.
Army, and are often covered by medical insurance, Medicare, and
social health programs in key international markets. 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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