ProSomnus, a pioneer in precision medical devices for the treatment
of Obstructive Sleep Apnea (OSA), today announced that the
ProSomnus EVOTM Sleep and Snore Device is now reimbursable by
Germany’s public health insurance system.
The ProSomnus EVO is an alternative to legacy
oral devices and CPAP machines, and can result in more effective
treatment and superior patient compliance. It repositions and
stabilizes the jaw during sleep, improving airflow through a
patient's pharyngeal space. The ProSomnus EVO consists of maxillary
and mandibular aligner trays for orthodontic treatment that are
precision-manufactured with twin-mated posts, and is digitally
milled to be patient-specific. Prescribed advancements can be
achieved by removing the current upper- or lower-device arch and
inserting the next arch in the mandibular advancement series.
“The German reimbursement update provides an
excellent opportunity to scale treatment for thousands of patients
with OSA,” stated Gregory Vogel, VP International Business for
ProSomnus. “ProSomnus’s precedent of providing first-class products
and services in North America paves the way for growth and
expansion in Europe. We are excited to continue our investment in
the people and resources needed to support our clinical
providers.”
“Validating reimbursement helps establish ProSomnus precision
intraoral devices as an effective, patient-preferred and
economically viable treatment option for healthcare providers in
Germany and the estimated 26 million people in the country
suffering from OSA,” said Len Liptak, Co-Founder and Chief
Executive Officer of ProSomnus.
ProSomnus to Attend Five European Sleep Medicine
Meetings
ProSomnus will also exhibit research pertaining
to its OAT devices at five meetings in Europe in 2022. The company
will provide updates on the First Line Obstructive Sleep Apnea
Treatment study (FLOSAT), and exhibit research pertaining to its
OAT devices. ProSomnus will attend:
- The German Society of Dental Sleep
Medicine’s 22nd (DGZS) Symposium in Frankfurt, Germany, from
September 16-17.
- The Irish Society of Dental Sleep
Medicine (ISDSM) Meeting in Dublin, Ireland, on October 8.
- The European Academy of Dental
Sleep Medicine (EADSM) Annual Meeting in Florence, Italy, on
October 13.
- The Interdisciplinary Belgium
Dental and Surgical Sleep Medicine Academy’s (IBEDSSMA) 2022
Symposium in Genval, Belgium, on October 21.
- The German Society for Sleep
Research and Sleep Medicine’s (DGSM) 30th Annual Conference in
Wiesbaden, Germany, from November 10-12.
About ProSomnusProSomnus is the
first manufacturer of precision, mass-customized 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’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. With more than 150,000 patients treated, ProSomnus’s
devices are the most prescribed oral appliance therapy in the U.S.
To learn more, visit www.ProSomnus.com.
In May 2022, ProSomnus entered a definitive
merger agreement with Lakeshore Acquisition I Corp. (Nasdaq: LAAA),
a special purpose acquisition company. Upon closing, the combined
company is expected to change its name to ProSomnus, Inc. and its
Class A common stock is expected to be traded on the Nasdaq Capital
Market under the symbol “OSA”.
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 pending transactions among Lakeshore
Acquisition I Corp. (together with its successors, the
“Purchaser”), LAAA Merger Sub Inc., a Delaware corporation and
wholly-owned subsidiary of Purchaser (the “Merger Sub”), ProSomnus,
HGP II, LLC, a Delaware limited liability company, as the
representative of the stockholders of ProSomnus, and RedOne
Investment Limited, a British Virgin Islands company, as the
representative of the stockholders of Purchaser, and the
transactions contemplated thereby, and 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 risk that the transaction may not be
completed in a timely manner or at all, which may adversely affect
the price of Purchaser’s securities; (ii) the risk that the
transaction may not be completed by Purchaser’s business
combination deadline and the potential failure to obtain an
extension of the business combination deadline if sought by
Purchaser; (iii) the failure to satisfy the conditions to the
consummation of the transaction, including the approval of the
business combination agreement by the stockholders of Purchaser,
the satisfaction of the minimum cash amount following any
redemptions by Purchaser’s public stockholders and the receipt of
certain governmental and regulatory approvals; (iv) the lack of a
third-party valuation in determining whether or not to pursue the
proposed transaction; (v) the occurrence of any event, change or
other circumstance that could give rise to the termination of the
business combination agreement; (vi) the effect of the announcement
or pendency of the transaction on ProSomnus’s business
relationships, operating results and business generally; (vii)
risks that the proposed transaction disrupts current plans and
operations of ProSomnus; (viii) the outcome of any legal
proceedings that may be instituted against ProSomnus or Purchaser
related to the business combination agreement or the proposed
transaction; (ix) the ability to maintain the listing of
Purchaser’s securities on a national securities exchange; (x)
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; (xi) the ability to implement
business plans, forecasts and other expectations after the
completion of the proposed transaction, and identify and realize
additional opportunities; (xii) the risk of downturns in the market
and ProSomnus’s industry including, but not limited to, as a result
of the COVID-19 pandemic; (xiii) 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; (xiv) the inability to complete its convertible debt
financing; (xv) the risk of potential future significant dilution
to stockholders resulting from lender conversions under the
convertible debt financing; and (xvi) 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 Purchaser’s initial public offering
prospectus dated June 10, 2021 and in Purchaser’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 and will be filed with the SEC by the Purchaser in
connection with the proposed transactions, 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 Purchaser, Merger Sub, ProSomnus, and their
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.
Additional Information and Where to Find
ItIn connection with the transaction described herein,
Purchaser has and will file relevant materials with the SEC,
including the Registration Statement on Form S-4 and a proxy
statement. The proxy statement and a proxy card will be mailed to
stockholders as of a record date to be established for voting at
the stockholders’ meeting relating to the proposed transactions.
Stockholders will also be able to obtain a copy of the Registration
Statement on Form S-4 and proxy statement without charge from
Purchaser. The Registration Statement on Form S-4 and proxy
statement, once available, may also be obtained without charge at
the SEC’s website at www.sec.gov or by writing to Purchaser at 667
Madison Avenue, New York, NY 10065.
INVESTORS AND SECURITY HOLDERS OF PURCHASER ARE
URGED TO READ THESE MATERIALS (INCLUDING ANY AMENDMENTS OR
SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION
WITH THE TRANSACTIONS THAT PURCHASER WILL FILE WITH THE SEC WHEN
THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION ABOUT PURCHASER, PROSOMNUS AND THE TRANSACTIONS.
Participants in
SolicitationPurchaser, Merger Sub, ProSomnus, certain
stockholders of ProSomnus, and their respective directors,
executive officers and employees and other persons may be deemed to
be participants in the solicitation of proxies from the holders of
Purchaser common stock in respect of the proposed transaction.
Information about Purchaser’s directors and executive officers and
their ownership of Purchaser’s ordinary shares is set forth in
Purchaser’s Annual Report on Form 10-K for the year ended December
31, 2021 filed with the SEC. Other information regarding the
interests of the participants in the proxy solicitation will be
included in the proxy statement pertaining to the proposed
transaction when it becomes available. These documents can be
obtained free of charge from the sources indicated above.
No Offer or SolicitationThis
press release is not a proxy statement or solicitation of a proxy,
consent or authorization with respect to any securities or in
respect of the potential business combination or any other matter
and shall not constitute an offer to sell or a solicitation of an
offer to buy the securities of Purchaser, ProSomnus or the combined
company, nor shall there be any sale of any such securities in any
state or jurisdiction in which such offer, solicitation, or sale
would be unlawful prior to registration or qualification under the
securities laws of such state or jurisdiction. No offer of
securities shall be made except by means of a prospectus meeting
the requirements of the Securities Act of 1933, as amended.
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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