ANDOVER, Mass., April 6, 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, announced today that
after the review of TransMedics' clinical evidence from the OCS
Heart EXPAND trial, the associated Continued Access Protocol
("CAP") results, as well as the OCS Heart PROCEED II trial, the
Circulatory Systems Device Advisory Panel convened by the U.S. Food
and Drug Administration ("FDA") has issued a favorable vote in
support of approval of the OCS Heart System to the
FDA's Office of Health Technology 2 (Cardiovascular
Devices). The panel voted 12 to 5, with 1 abstaining, that the
benefits of the OCS Heart System outweigh its risks. The panel
voted 10 to 6, with 2 abstaining, that there is reasonable
assurance that the OCS Heart System is effective. The panel voted 9
to 7, with 2 abstaining, that there is reasonable assurance of the
OCS Heart System's safety.
Panel votes 12 to 5 that benefits of OCS Heart System outweigh
risks
FDA Advisory Committees provide the FDA with independent
opinions and non binding recommendations from outside medical
experts. While the FDA will consider the opinions and
recommendations expressed at the Advisory Committee, the FDA will
make a decision regarding whether to approve the premarket approval
application for the use of the OCS Heart System for donor hearts
currently utilized and unutilized for transplantation after
completion of its review of the application.
"This is a critical milestone for the OCS Heart technology on
the path to a potential FDA approval, which I am confident would
benefit patients in need of heart transplantation in the U.S.
We are looking forward to working collaboratively with the FDA as
it completes its review," said Waleed
Hassanein, MD, President and Chief Executive Officer. "We
are grateful for the help and support of our investigators, the
patients who enrolled in our trials, and the donor families who
gave our patients the gift of life by supporting organ donation. In
addition, we want to thank the respected members of the Advisory
Panel and the FDA review team for their thoughtful discussion and
deliberations on this important PMA. We are now laser focused and
looking forward to our next important business milestones planned
for 2021: the scheduling the OCS Liver FDA Advisory Panel Meeting,
the final readout of the OCS Heart DCD trial and the filing of the
DCD Heart PMA supplement to eventually expand our OCS Heart
indication into DCD heart transplantation in the U.S."
"For decades we have talked about heart transplant being supply
limited. If approved by the FDA, with the use of OCS Heart System
for extended criteria donors, and DCD hearts, we can access to a
significantly greater suitable donor poll, said Dr. Jacob Schroder, surgical director of heart
transplantation at Duke University
Medical Center and the principal investigator for the OCS Heart
EXPAND Trial. "As the donor pool expands, more patients can have
access to this life saving therapy. If the OCS Heart System is
approved, I believe the industry will reverse its thinking
and open up the 'demand' to a greater patient population that never
had a chance at a new heart and a better life."
"The potential opportunity to expand the donor pool for our
heart transplant candidates using the TransMedics device in select
patients would be a major advance in the field of heart
transplantation," said Dr. Maryjane
Farr, medical director of the transplant program at
Columbia University Irving Medical
Center.
EXPAND and CAP Trial
The OCS Heart EXPAND trial met
its primary effectiveness endpoint. It showed that the use of the
OCS Heart System resulted in successfully transplanting 84% - more
than 8 out 10 of the extended-criteria donor hearts that are seldom
used for transplant today in the U.S. using cold ischemic storage
preservation. The post-transplant rate of severe Primary Graft
Dysfunction was 8%, which is well below the rates reported in the
literature and there were no unexpected safety findings. Patient
survival at 30-days post-transplant was 97%. All-cause survival was
92% at 6 months and 87% at 12 months. Importantly, cardiac-related
survival was 96% at both 6 and 12 months, these survival rates are
comparable to U.S. standard heart transplant outcomes.
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
those that affect potential regulatory approvals for our OCS Heart
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 payors
of benefits offered by the OCS; the impact of the outbreak of the
novel strain of coronavirus and associated containment and
remediation 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 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; our ability to obtain and maintain
regulatory approvals or clearance for our OCS products; 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, 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.
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SOURCE TransMedics Group, Inc.