Axonics, Inc. (Nasdaq: AXNX) today announced that the Patent
Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark
Office has issued written decisions on two Medtronic patents that
Axonics is contesting.
The PTAB issued its decision with respect to Patent Nos.
8,626,314 (“the ‘314 patent”) and 8,036,756 (“the ‘756 patent”).
Medtronic has asserted these patents, which expired in 2021 and
2022, against Axonics’ proprietary tined lead design. Today, the
PTAB invalidated 10 of the 15 challenged claims in Medtronic’s ‘314
patent and declined to invalidate the challenged claims in the ‘756
patent over one Administrative Patent Judge’s dissenting opinion.
The district court case where Medtronic has asserted these patents
is currently stayed based on these IPRs as well as pending IPRs on
other Medtronic asserted patents. Axonics plans to seek review of
the PTAB’s finding that the remaining claims were not
unpatentable.
“We are pleased with the PTAB’s decision finding numerous claims
of the ‘314 patent unpatentable,” said Raymond W. Cohen, chief
executive officer. “Axonics will continue to vigorously defend
itself against Medtronic’s claims while we remain focused on
fulfilling our mission of changing the lives of patients suffering
from bladder and bowel dysfunction.”
About Axonics
Axonics is a global medical technology company that is
developing and commercializing novel products for adults with
bladder and bowel dysfunction. Axonics recently ranked No. 2 on the
2023 Financial Times ranking of the fastest growing companies in
the Americas after being ranked No. 1 in 2022.
Axonics® sacral neuromodulation systems provide adults with
overactive bladder and/or fecal incontinence with long-lived, easy
to use, safe, clinically effective therapy. In addition, the
company’s best-in-class urethral bulking hydrogel, Bulkamid®,
provides safe and durable symptom relief to women with stress
urinary incontinence. In the U.S., moderate to severe urinary
incontinence affects an estimated 28 million women and fecal
incontinence affects an estimated 19 million adults. For more
information, visit www.axonics.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words like “may,” “will,” “likely,”
“should,” “expect,” “anticipate,” “future,” “plan,” “believe,”
“intend,” “goal,” “seek,” “endeavor,” “estimate,” “project,”
“continue,” and variations of such words and similar expressions.
These forward-looking statements are not guarantees of future
performance and involve risks, assumptions, and uncertainties,
including, but not limited to, risks related to: Axonics’ ability
to consummate the transactions contemplated by the Agreement and
Plan of Merger, dated January 8, 2024 (the “Merger Agreement”), by
and among Axonics, Boston Scientific Corporation (“Boston
Scientific”), and Sadie Merger Sub, Inc., a wholly owned subsidiary
of Boston Scientific (“Merger Sub”), providing for the merger of
Merger Sub with and into Axonics with Axonics continuing as the
surviving company and a wholly owned subsidiary of Boston
Scientific (the “Merger”), in a timely manner or at all; the risk
that the Merger Agreement may be terminated in circumstances
requiring the payment by Axonics of a termination fee; the
satisfaction (or waiver) of the conditions to the closing of the
Merger; potential delays in consummating the Merger; the occurrence
of any event, change or other circumstance or condition that could
give rise to termination of the Merger Agreement; Axonics’ ability
to timely and successfully realize the anticipated benefits of the
Merger; the ability to successfully integrate the businesses of
Axonics and Boston Scientific; the effect of the announcement or
pendency of the Merger on Axonics’ current plans, business
relationships, operating results and business generally; the effect
of limitations placed on Axonics’ business under the Merger
Agreement; significant transaction costs and unknown liabilities;
litigation or regulatory actions related to the Merger Agreement or
Merger; FDA or other U.S. or foreign regulatory or legal actions or
changes affecting Axonics or Axonics’ industry; the results of any
ongoing or future legal proceedings, including the litigation with
Medtronic, Inc., Medtronic Puerto Rico Operations Co., Medtronic
Logistics LLC and Medtronic USA, Inc. (the “Medtronic Litigation”);
any termination or loss of intellectual property rights, including
as a result of the Medtronic Litigation; introductions and
announcements of new technologies by Axonics, any commercialization
partners or Axonics’ competitors, and the timing of these
introductions and announcements; changes in macroeconomic and
market conditions and volatility, including the risk of recession,
inflation, supply chain constraints or disruptions and rising
interest rates; and economic and market conditions in general and
in the medical technology industry specifically, including the size
and growth, if any, of Axonics’ markets, and risks related to other
factors described under “Risk Factors” in other reports and
statements filed with the U.S. Securities and Exchange Commission
(“SEC”), including Axonics’ most recent Annual Report on Form 10-K,
which is available on the investor relations section of Axonics’
website at www.axonics.com and on the SEC’s website at www.sec.gov.
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 these
forward-looking statements. Therefore, you should not rely on any
of these forward-looking statements.
The forward-looking statements included in this press release
are made only as of the date of this press release, and except as
otherwise required by federal securities law, Axonics does not
assume any obligation nor does it intend to publicly update or
revise any forward-looking statements to reflect new information,
changed circumstances or unanticipated events.
Additional Information and Where to Find It
In connection with the contemplated Merger, Axonics filed on
February 22, 2024 with the SEC a definitive proxy statement
relating to a special meeting of Axonics’ stockholders to be held
for the purpose of obtaining stockholder approval of the Merger
Agreement and other related matters (the “Proxy Statement”). The
Proxy Statement was mailed to Axonics’ stockholders on or about
February 22, 2024. Axonics may also file other documents with the
SEC regarding the contemplated Merger. This document is not a
substitute for the Proxy Statement or any other document that
Axonics has filed or may file with the SEC in connection with the
contemplated Merger. BEFORE MAKING ANY VOTING DECISION, INVESTORS
AND SECURITY HOLDERS OF AXONICS ARE URGED TO READ THE PROXY
STATEMENT, ANY AMENDMENTS OR SUPPLEMENTS THERETO, ANY OTHER
SOLICITING MATERIALS AND ANY OTHER DOCUMENTS THAT ARE FILED OR WILL
BE FILED WITH THE SEC IN CONNECTION WITH THE CONTEMPLATED MERGER OR
INCORPORATED BY REFERENCE IN THE PROXY STATEMENT BECAUSE THEY
CONTAIN OR WILL CONTAIN, AS APPLICABLE, IMPORTANT INFORMATION ABOUT
AXONICS, BOSTON SCIENTIFIC AND THE CONTEMPLATED MERGER. Investors
and security holders may obtain free copies of the Proxy Statement
and other filings containing important information about Axonics on
the SEC’s website at www.sec.gov, on Axonics’ website at
www.axonics.com or by contacting Axonics’ Investor Relations
department via email at IR@axonics.com.
Participants in the Solicitation
Axonics and its directors and executive officers may, under SEC
rules, be deemed participants in the solicitation of proxies from
the stockholders of Axonics in connection with the contemplated
Merger. Information regarding the identity of potential
participants in the solicitation of proxies in connection with the
proposed Merger, and their direct or indirect interests, by
security holdings or otherwise, is included in the Proxy Statement.
Additional information regarding Axonics’ directors and executive
officers is contained in the Proxy Statement, Axonics’ Definitive
Proxy Statement on Schedule 14A for Axonics’ 2023 Annual Meeting of
Stockholders, which was filed with the SEC on May 1, 2023 (and
specifically, the following sections: “Security Ownership of
Certain Beneficial Owners, Executive Officers and Directors”,
“Certain Relationships and Related-Party Transactions”, “Executive
Officers”, “Proposal 1–Election of Directors”, “Director
Compensation”, and “Executive Compensation”) and in Axonics’
Current Report on Form 8-K, which was filed with the SEC on October
4, 2023. To the extent holdings of the Company’s securities by the
directors or executive officers have changed since the amounts set
forth in the Proxy Statement, such changes have been or will be
reflected on Initial Statement of Beneficial Ownership of
Securities on Form 3, Statement of Changes in Beneficial Ownership
on Form 4, or Annual Statement of Changes in Beneficial Ownership
on Form 5 filed with the SEC, which are available at EDGAR Search
Results (sec.gov). These documents (when available) are available
free of charge as described in the preceding section.
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version on businesswire.com: https://www.businesswire.com/news/home/20240321796123/en/
Neil Bhalodkar IR@axonics.com
Axonics (NASDAQ:AXNX)
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