ANDOVER, Mass., July 29, 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
U.S. Food and Drug Administration (FDA) 510(k) clearance of its
OCS™ Lung Solution for use in transplants using cold storage
techniques. The solution, which is also cleared as a component of
the company's OCS Lung System, is indicated for hypothermic
flushing, storage and transportation of donor lungs for
transplantation.
"This FDA clearance marks another achievement for TransMedics as
we assemble the most comprehensive, market leading portfolio of
organ preservation products to meet the clinical needs of the organ
transplant market," said Dr. Waleed
Hassanein, President and Chief Executive Officer. "With this
new clinical indication, we are demonstrating our commitment to
establishing TransMedics as the trusted partner to supply
world-class organ preservation products to meet customer needs
across all transplant indications as we execute on our mission to
transform organ transplant therapy for the future."
The OCS Lung System is approved in the U.S. and the Company's
OCS Heart System and OCS Liver System are currently under review by
the FDA after receiving positive votes by the FDA's relevant
advisory panels in April and July respectively.
About the OCS Lung Solution
The OCS Lung Solution is a colorless, sterile, pyrogen-free,
colloid-based extracellular low potassium solution for cold
flushing, storage and transport of donor lungs for transplantation.
The solution is cleared by FDA for use in transplants using
TransMedics' OCS Lung System for warm perfusion as well as in
transplants using cold storage techniques as a standalone product.
It is labeled with a 24-month shelf life.
About the OCS System
The OCS System is the only portable, multi-organ platform for
donor lungs, hearts and livers for transplantation. The OCS System
mimics the human body by providing donor organs with warm,
oxygenated blood perfusion throughout preservation that maintains
the organs in a living, functional state. The assessment
capabilities of the OCS System enable diagnostic evaluation to
allow for the analysis of organ function and viability prior to
transplant. Normothermic perfusion on the OCS System optimizes the
organ conditions and allows for therapeutic intervention through
replenishing oxygen and nutrients.
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. 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, 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.
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SOURCE TransMedics Group, Inc.