ANDOVER,
Mass., Jan. 13, 2025 /PRNewswire/ -- TransMedics
Group, Inc. ("TransMedics") (Nasdaq: TMDX), a medical technology
company that is transforming organ transplant therapy for patients
with end-stage lung, heart and liver failure, today addressed what
we believe are inaccurate and misleading claims made in a
short-seller report issued by Scorpion Capital on January 10, 2025.
In response, the company issued the following statement:
We strongly believe that the claims made in the Scorpion Capital
report have no merits, and were primarily intended to manipulate
the market for financial gains. The report fails to accurately
represent TransMedics' business, technology, diverse culture and
steadfast focus on delivering exceptional products and services to
meet the needs of the global transplant community.
We stand by the high integrity of our practices, our world-class
team, our compliance with all applicable laws and our unwavering
commitment to improving clinical outcomes in organ transplantation.
Our OCS™ technology and NOP™ program have enabled over 7,000
organ transplants while allowing surgeons to confidently use donor
organs that would have otherwise been unutilized due to historical
technology and logistics limitations. Critically, our technology
and services have driven an expansion in overall U.S. transplant
volumes and exceptional post-transplant clinical outcomes for
patients, which have been repeatedly validated across our extensive
and unrivaled clinical data set.
TransMedics is engaged with our legal advisor at Kirkland &
Ellis LLP to consider all available legal options.
"We are grateful for the support and trust of our clinical
collaborators and users, OPO partners, donor families, and the
transplant recipients we serve," said Waleed Hassanein, MD, President & Chief
Executive Officer. "We remain laser focused on executing our
growth plans, including the launch of our next-gen OCS Heart and
OCS Lung programs as well as several other strategic initiatives,
in 2025. We look forward to discussing these initiatives and
our business at the upcoming J.P. Morgan Healthcare
Conference."
43rd Annual J.P. Morgan Healthcare
Conference
Members of the TransMedics management team will present
at the upcoming 43rd Annual J.P. Morgan Healthcare
Conference. The presentation will take place on Monday,
January 13, 2025, at 2:15 p.m. Pacific Standard Time.
A live and archived webcast of the presentation will be
available on the "Investors" section of
the TransMedics website
at https://investors.transmedics.com/. The Company's standard
investor presentation is also available through this link.
About TransMedics Group, Inc.
TransMedics is the
world's leader in portable extracorporeal warm perfusion and
assessment of donor organs for transplantation. Headquartered in
Andover, Massachusetts, the
company was founded to address the unmet need for more and better
organs for transplantation and has developed technologies to
preserve organ quality, assess organ viability prior to transplant
and potentially increase the utilization of donor organs for the
treatment of end-stage heart, lung and liver failure.
Forward-Looking Statements
This press release contains
forward-looking statements with respect to, among other things, our
growth plans, including our next-gen OCS Heart and OCS Lung
programs and other strategic initiatives in 2025. For this purpose,
all statements other than statements of historical facts are
forward-looking statements. The words "believe," "may," "will,"
"estimate," "continue," "anticipate," "intend," "expect," "should,"
"could," "target," "predict," "seek" and similar expressions are
intended to identify forward-looking statements. These
forward-looking statements are subject to a number of risks and
uncertainties. Our management cannot predict all risks, nor can we
assess the impact of all factors or the extent to which any factor,
or combination of factors, may cause actual results to differ
materially from those contained in or implied by any
forward-looking statements we may make. In light of these risks and
uncertainties, the forward-looking events and circumstances
discussed in this press release may not occur and actual results
could differ materially and adversely from those anticipated in or
implied by the forward-looking statements. Some of the key factors
that could cause actual results to differ include: our ability to
maintain profitability on a sustained basis; our ability to
attract, train and retain key personnel; our existing and any
future indebtedness, including our ability to comply with
affirmative and negative covenants under our credit agreement to
which we will remain subject until maturity; the fluctuation of our
financial results from quarter to quarter; our need to raise
additional funding and our ability to obtain it on favorable terms,
or at all; our ability to use net operating losses and research and
development credit carryforwards; our dependence on the success of
the Organ Care System or OCS; our ability to expand access to the
OCS through our National OCS Program or NOP; our ability to scale
our manufacturing and sterilization capabilities to meet increasing
demand for our products; the rate and degree of market acceptance
of the OCS; our ability to educate patients, surgeons, transplant
centers and private and public payors on the benefits offered by
the OCS; our ability to improve the OCS platform and develop the
next generation of the OCS products; our dependence on a limited
number of customers for a significant portion of our revenue; our
ability to maintain regulatory approvals or clearances for our OCS
products in the United States, the
European Union, and other select jurisdictions worldwide; our
ability to adequately respond to the Food and Drug Administration
or FDA, or other competent authorities, follow-up inquiries in a
timely manner; the performance of our third-party suppliers and
manufacturers; our use of third parties to transport donor organs
and medical personnel for our NOP and our ability to maintain and
grow our logistics capabilities to support our NOP and reduce
dependence on third party transportation, including by means of
attracting, training and retaining pilots, and the acquisition,
maintenance or replacement of fixed-wing aircraft for our aviation
transportation services or other acquisitions, joint ventures or
strategic investments; our ability to maintain Federal Aviation
Administration or FAA or other regulatory licenses or approvals for
our aircraft transportation services; price increases of the
components of our products and maintenance, parts and fuel for our
aircraft; the timing or results of post-approval studies and any
clinical trials for the OCS; our manufacturing, sales, marketing
and clinical support capabilities and strategy; attacks against our
information technology infrastructure; the economic, political and
other risks associated with our foreign operations; our ability to
protect, defend, maintain and enforce our intellectual property
rights relating to the OCS and avoid allegations that our products
infringe, misappropriate or otherwise violate the intellectual
property rights of third parties; the pricing of the OCS, as well
as the reimbursement coverage for the OCS in the United States and internationally;
regulatory developments in the United
States, European Union and other jurisdictions; the extent
and success of competing products or procedures that are or may
become available; our ability to service our 1.50% convertible
senior notes, due 2028; the impact of any product recalls or
improper use of our products; our estimates regarding revenues,
expenses and needs for additional financing; and other factors that
may be described in our filings with the Securities and Exchange
Commission (the "SEC"). Additional information will be made
available in our annual and quarterly reports and other filings
that we make with the SEC. The forward-looking statements in this
press release speak only as of the date of this press release.
Factors or events that could cause our actual results to differ may
emerge from time to time, and we are not able to predict all of
them. We undertake no obligation to update any forward-looking
statement, whether as a result of new information, future
developments or otherwise, except as may be required by applicable
law.
Investor Contact:
Brian
Johnston
Laine Morgan
332-895-3222
Investors@transmedics.com
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SOURCE TransMedics Group, Inc.