ProSomnus (“the Company”), a pioneer in precision medical devices
for the treatment of Obstructive Sleep Apnea (OSA), today announced
that it has received 510(k) clearance from the United States Food
and Drug Administration (FDA) for the ProSomnus EVO™ [PH] Sleep and
Snore Device. The device joins the Company’s flagship product, the
ProSomnus EVO™, in its line of FDA-cleared, patient-preferred, less
invasive Precision Oral Appliance Therapy (OAT) devices for the
treatment of OSA.
The ProSomnus EVO [PH] Sleep and Snore Device is
specifically engineered to meet Centers for Medicare Services
coding guidelines, offering Medicare beneficiaries a non-invasive,
comfortable, easy-to-use, and effective alternative to CPAP
machines, surgical procedures, and legacy oral devices. Per
Medicare coding guidelines, the ProSomnus EVO [PH] device uses
mechanical hinge components to precisely reposition and stabilize
the patient’s jaw during sleep, increasing pharyngeal space and
reducing the risk of upper airway collapse. The device is
approximately 13% smaller than predicate devices and features
unique comfort bumps around key components. The device features
unique advancement markings and visual indicators to make it easier
for beneficiaries to communicate with their healthcare providers
throughout treatment.
Every ProSomnus EVO [PH] device is personalized
and digitally manufactured based upon the patient’s unique anatomy
and healthcare provider’s treatment plan for each patient. The
ProSomnus EVO [PH] is the only Herbst-style device made from
engineered, Medical Grade Class VI-rated material, the highest
material quality grade offered by US Pharmacopeia.
“Receiving FDA clearance for the ProSomnus EVO
[PH] is a significant milestone for the Company and for patients
suffering from OSA,” said Len Liptak, Co-Founder and Chief
Executive Officer of ProSomnus. “This expands our industry-leading
suite of FDA-cleared precision medical devices to treat OSA,
offering patients and their healthcare providers yet another
alternative to CPAP, surgery and legacy oral appliances.
Successfully addressing OSA starts with giving patients a treatment
that is safe, effective, and easier to adhere to, and the EVO [PH]
is one more patient-preferred Precision OAT option available to
them.”
“This latest FDA milestone is a big step in
making Precision OAT available to as many patients as possible,”
said John E. Remmers, MD, Chief Scientist of ProSomnus. “Despite
the alarming prevalence of OSA and its dire consequences, legacy
OSA treatments have not improved at a rate that patients deserve,
especially in light of the current issues with CPAP treatment. This
makes our commitment to developing less invasive therapies even
more important, and we look forward to the difference it will make
for patients and providers.”
“Our manufacturing platform allows us to advance
the quality of our materials. We are continuously expanding our
material selection far beyond dental applications and researching
and developing innovative medical grade polymers for our products,”
commented Sung Kim, Co-Founder and Chief Technology Officer of
ProSomnus. “The improved flexibility of the ProSomnus EVO [PH]
makes it even easier for patients to use, while its durability
protects it from accidental drops. In addition to being incredibly
stain-resistant, the EVO [PH] is precision milled in one piece, so
it maintains its fit throughout treatment without deformation,
staining or harboring bioburden, unlike soft liner and nylon
materials.”
Patients interested in learning more about
ProSomnus’ Precision OAT devices for the treatment of OSA can visit
www.ProSomnus.com or speak with their local ProSomnus sleep
dentist.
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’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 Precision 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.
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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