ProSomnus, Inc. (“the Company”), a pioneer in precision
medical devices for the treatment of Obstructive Sleep Apnea (OSA),
today announced the completion of its previously announced business
combination with Lakeshore Acquisition I Corp. (“Lakeshore”)
(Nasdaq: LAAA), a publicly traded special purpose acquisition
company. ProSomnus will commence trading on the Nasdaq Global
Market under the symbol “OSA” on Dec. 7, 2022. The business
combination, which was approved by Lakeshore’s shareholders on Dec.
2, 2022, along with the convertible debt issued in connection with
the transaction, provides access to capital that will be used to
drive the Company’s multi-faceted commercial expansion.
A key reason for going public was to bring to
fruition ProSomnus’ ambitious growth plans. ProSomnus will use the
capital to scale up its business by expanding and investing in
three key areas: technology, sales and manufacturing. ProSomnus is
planning to open its new design and manufacturing facility next
month, which will be optimized for mass-customized manufacturing,
AI-driven design and 3D robotic milling This will enable the
Company to increase manufacturing capacity four-fold for its Oral
Appliance Therapy (“OAT”) devices to meet the rising demand of
providers and patients. Additional capital also will allow the
Company to grow its international presence as it continues to
attract providers in the multi-billion dollar North American
market, as well as globally, representing a $50 billion dollar
market opportunity.
ProSomnus will continue to be led by Len Liptak,
Co-Founder and Chief Executive Officer, and Laing Rikkers,
Co-Founder and Executive Chair, William Johnson, Audit Chair and
Director, and Len Hedge, Director. Mr. Johnson continues to
contribute his financial expertise in medical technology and public
company management, and Hedge remains invaluable to the team
offering experience from his thirteen years managing the operations
of Align Technology’s Invisalign products.
Effective today, ProSomnus will add to its Board
of Directors including the appointment of the following individuals
who bring a depth and breadth of talent to the team:
- Heather Rider will serve as
Compensation Committee Chair. Ms. Rider is currently on the Board
of Directors of publicly traded companies including Inogen, Inc.,
an oxygen therapy technology manufacturer, and served on the Board
of Directors of Intricon Corporation, a micro-medical technology
component manufacturer, until its sale earlier this year.
- Steve Pacelli will serve as
Nominating and Governance Committee Chair. Mr. Pacelli is Executive
Vice President and Managing Director of Dexcom Ventures, a leader
in continuous glucose monitoring for people with diabetes.
- Jason Orchard is the Managing
Director of Spring Mountain Capital, an investment management firm
specializing in alternative asset investing.
“We are pleased to welcome a new group of
carefully selected directors who bring diverse and pertinent
experience to ProSomnus’ leadership team at an important inflection
point in the Company’s history. Heather Rider has spent eight years
in the respiratory sector and has significant human resources
capabilities, which we will leverage as we scale our team for
future growth. Steve Pacelli’s seventeen years at
Dexcom will provide key insights into remote patient monitoring as
ProSomnus develops and launches its next-generation device, which
will be the first precision OAT with remote monitoring – a key
innovation for sleep physicians seeking improved disease management
capabilities. Finally, Jason Orchard’s extensive experience on Wall
Street offers valuable perspectives into the capital markets as we
accelerate our growth. We are fortunate to have such a strong group
of leaders and I am confident that they will be important
contributors in the development and maturation of the Company in
the coming years,” said Laing Rikkers, ProSomnus Co-Founder and
Executive Chair.
ProSomnus’ FDA-cleared, Precision OAT devices
are a practical alternative to legacy oral devices and CPAP
machines, and can result in more effective treatment and superior
patient compliance. They reposition and stabilize the jaw during
sleep, improving airflow through a patient's pharyngeal space.
ProSomnus Precision OAT devices consist of maxillary and mandibular
aligners that are precision-manufactured with twin-mated posts, and
are 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.
“With more than 175,000 devices prescribed and a
growing network of over 4,000 medical providers, ProSomnus is
actively disrupting the massive OSA treatment market and, as a
public company, we will now have the ability to fuel even more
growth,” said Len Liptak, ProSomnus Co-Founder and Chief Executive
Officer. “With an estimated one billion people suffering from OSA
worldwide, this is a tremendous population in need of a viable
therapy, as untreated OSA is known to exponentially increase
mortality. Becoming publicly traded will help fund expanded
infrastructure and groundbreaking clinical studies – including our
FDA-reviewed, landmark Severe OSA Study (SOS) and Frontline OSA
Treatment (FLOSAT) study – that will help us further address OSA on
a global scale.”
“In addition to a growing body of research, the
increased adoption of ProSomnus Precision OAT devices suggests that
this type of therapy is a patient-preferred alternative to legacy
OSA treatment options,” continued Liptak “In 2022, we achieved
several important product milestones, receiving FDA 510(k)
clearance for our EVO [PH] Sleep and Snore device, and continuing
the development of our next-generation device, which will feature
remote patient monitoring. Access to the public capital markets
will allow us to continue innovating and providing patients with
cutting-edge features that can fundamentally improve the treatment
and management of OSA.”
AdvisorsSolomon Partners and
Gordon Pointe Capital, LLC acted as financial advisors to
ProSomnus. Nelson Mullins Riley & Scarborough acted as legal
advisor to ProSomnus and Loeb & Loeb acted as legal advisor to
Lakeshore. Craig-Hallum Capital Group LLC and Roth Capital
Partners, LLC acted as joint placement agents on the private
investment in public equity. Craig-Hallum Capital Group LLC acted
as M&A advisor to Lakeshore.
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 proposed
transaction 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 ContactSean LeousICR WestwickePhone:
+1.646.866.4012Email: Sean.Leous@westwicke.com
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