ANDOVER, Mass., Sept. 7, 2021 /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 announced that the
U.S. Food and Drug Administration (FDA) has granted premarket
approval (PMA) of its OCS Heart System for use with organs from
donors after brain death (DBD).
The OCS Heart System is indicated for the preservation
of DBD donor hearts deemed unsuitable for procurement and
transplantation at initial evaluation due to limitations
of prolonged cold static cardioplegic
preservation (e.g., > 4 hours of cross-clamp time).
This indication is based on the results of the OCS Heart EXPAND
Trial, the associated OCS Heart EXPAND Continued Access Protocol
(CAP) and the OCS Heart PROCEED II Trial.
"We are thrilled to achieve this important milestone for heart
transplantation in the United
States. This was the culmination of several years of
collaboration with leading heart transplant experts and FDA to
bring our lifesaving OCS technology to help more heart transplant
patients in the U.S.," said Waleed
Hassanein, MD, President and Chief Executive Officer. "We
are honored and humbled that the OCS Heart System is now the only
FDA approved device indicated for ex-vivo perfusion and assessment
of both donor hearts and lungs as an alternative to the antiquated
cold storage preservation. We take this responsibility very
seriously, and we are looking forward to the next phase of
commercial activities, the initiation of the OCS Heart Perfusion
(OHP) Registry, and potentially expanding our clinical indications
in the future."
"The approval of this revolutionary technology marks a critical
step forward for heart transplantation," said Dr. Jacob Schroder, surgical director of heart
transplantation at Duke University
Medical Center and the principal investigator for the OCS Heart
EXPAND Trial. "The OCS Heart System allows surgeons to assess donor
heart's viability in real time and minimizes the negative effects
of cold storage. This will increase utilization of donor hearts
that are rarely used due to limitations of cold storage
preservation. By expanding the donor pool of acceptable
hearts, the OCS will enable us to better meet the growing demand
for heart transplantation in the U.S. and save lives."
The approval of the OCS Heart System follows FDA approval and
subsequent commercialization of the OCS Lung System. TransMedics is
also seeking FDA approval for its OCS Liver System, which received
a favorable vote in support its approval by a panel of experts
during an FDA Advisory Committee Meeting on July 14th, 2021.
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 future events, including the commercialization and
market opportunity of the OCS Heart and potential regulatory
approvals for our OCS Liver System. These forward-looking
statements are subject to a number of risks, uncertainties and
assumptions. Moreover, we operate in a very competitive and rapidly
changing environment and new risks emerge from time to time. It is
not possible for our management to predict all risks, nor can we
assess the impact of all factors on our business 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, uncertainties and assumptions, 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 or implied in the forward-looking statements. Some of
the key factors that could cause actual results to differ include:
that we continue to incur losses; our need to raise additional
funding; 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 to until maturity,
and our ability to obtain additional financing on favorable terms
or at all; the fluctuation of our financial results from quarter to
quarter; our ability to use net operating losses and research and
development credit carryforwards; our dependence on the success of
the OCS; the rate and degree of market acceptance of the OCS; our
ability to educate patients, surgeons, transplant centers and
private and public payors of benefits offered by the OCS; the
impact of the outbreak of the novel strain of coronavirus and
associated containment, remediation and vaccination efforts; our
ability to improve the OCS platform; our dependence on a limited
number of customers for a significant portion of our net revenue;
the timing of and our ability to obtain and maintain regulatory
approvals or clearances for our OCS products; our ability to
adequately respond to FDA follow-up inquiries in a timely manner;
the timing of and our ability to commercialize and market our OCS
products; the performance of our third-party suppliers and
manufacturers; the timing or results of 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 attract and
retain key personnel; 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; and the risks identified under
the heading "Risk Factors" and elsewhere in our annual report on
Form 10-K for the year ended December 31,
2020, our quarterly reports on Form 10-Q and in any
subsequent filings with the Securities and Exchange Commission
("SEC"). Additional information will be made available by our
annual and quarterly reports and other filings that we make from
time to time with the SEC. These forward-looking statements 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 it is not possible for us 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
631-807-1986
Investors@transmedics.com
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SOURCE TransMedics Group, Inc.