Unique centralized service helps increase the supply of lungs
for transplant, addressing a critical unmet need
United Therapeutics Corporation (Nasdaq: UTHR), a public
benefit corporation, and its subsidiary Lung Bioengineering Inc.
(LBE) announced that the 500th lung transplant utilizing
LBE’s centralized ex vivo lung perfusion (EVLP) service was
completed last month. These 500 transplants were the result of
evaluating over 800 donated lungs using centralized EVLP since
2014.
The 500th transplant was completed in Jacksonville at Mayo
Clinic in Florida. “We are honored to work with United
Therapeutics in this important collaboration that continues to
increase the number of lungs that can be transplanted and is a
significant step forward for transplant patients,” said John
Haney, M.D., M.P.H., Chair of the Department of Cardiothoracic
Surgery at Mayo Clinic in Florida. “Mayo Clinic is committed to
using and developing the latest medical advances and innovations
that will have tremendous benefits not only for our patients, but
other patients at institutions throughout the U.S.”
“At United Therapeutics, our founding purpose has always been to
save and improve lives through innovative technologies like those
that expand the availability of transplantable organs and organ
alternatives,” said Martine Rothblatt, Ph.D., Chairperson
and Chief Executive Officer of United Therapeutics. “We are proud
of the groundbreaking accomplishments at LBE, and this important
milestone serves as a testament to directly fulfilling our public
benefit purpose by providing life-changing opportunities for those
in need. This critical effort would not be possible without the
tireless dedication of the LBE staff, the skilled physicians and
hospital teams with whom we partner, and the patients and families
we serve. Together, we are making a profound difference in the
lives of so many, and we are deeply grateful for the trust placed
in us.”
Lungs are among the most fragile and difficult organs to
transplant. They are susceptible to injuries and infections, with
only about 20 percent of donor lungs in the U.S. initially meeting
the standard for transplant. About 300 people die every year
waiting for a lung transplant – and this number only includes
patients who can get on the waiting list. Close to 1,400 people are
waiting for a lung transplant, and many thousands more could
benefit from a transplant if more viable lungs were available,
according to the United Network for Organ Sharing, the organization
that oversees the nation's organ transplant system.
EVLP is a technique used to evaluate donor lungs outside of the
human body. It has emerged as an important tool for transplant
physicians to increase the number of lungs available for
transplant. EVLP involves flushing, ventilating, and heating donor
lungs to normal body temperatures while gathering data on the lungs
for real-time transmission for review by transplant physicians and
other transplant program team members. For example, when lungs do
not meet standard direct-to-transplant criteria, they are often
discarded. With the help of EVLP, lungs can be monitored and
clinically assessed to help transplant centers determine transplant
suitability.
In each case, LBE clinical specialists review donor information
with transplant centers and organ procurement organizations to
determine whether the proposed organ is suitable for EVLP. LBE
clinical specialists then use an FDA-approved EVLP device, or
alternatively as part of a clinical trial, an EVLP device under
development by LBE called the Centralized Lung Evaluation System
(CLES), to gather data. LBE transmits EVLP data and
communicates with transplant practitioners in real time using its
proprietary OrganVue™ software.
LBE’s staff of more than 30 professionals provide EVLP services
at facilities located in Silver Spring, Maryland, and Jacksonville,
Florida. Since 2014, LBE has received lungs from donor institutions
as far afield as Alaska and Puerto Rico for centralized EVLP
evaluation. Following EVLP, lungs have been accepted for transplant
at 25 centers in North America spanning from a southernmost point
of Miami to Toronto to the north, and St. Louis to the west.
Added Dr. Rothblatt: “As we look ahead at the unmet need, we are
committed to building on the success of our centers of excellence
in Maryland and Florida and are planning to open additional
centralized EVLP centers in North America.”
LBE’s centralized EVLP service is part of the broader xeno and
organ alternative development platform at United Therapeutics. This
platform consists of four key technologies – xenotransplantation,
bio-artificial organ alternatives, regenerative medicine, and 3D
bioprinting – providing manufactured alternatives for four human
organs – heart, kidney, liver, and lung. United Therapeutics’
Miromatrix subsidiary recently initiated a phase 1 study of
miroliverELAP™, the first bioengineered organ alternative to enter
human clinical studies. United Therapeutics plans to initiate the
first clinical study of the UKidney™ xenokidney in 2025, contingent
on satisfactory FDA review of an investigational new drug
application and concurrent investigational new animal drug
application.
About Lung Bioengineering
Lung Bioengineering Inc. (LBE) owns and operates the
first and only full-service ex-vivo lung perfusion (EVLP)
centers in the United States. The company was formed as a
subsidiary of United Therapeutics in 2014 to be a leading provider
of EVLP services. Our EVLP centers are driven by data and powered
24/7, 365 days a year, by the expertise of our LBE clinical
specialists. LBE’s integrated EVLP service aims to reduce resource
burdens from donation to transplant and increase organ utilization.
LBE’s vision is a world where no one waits for a lifesaving
transplant to become a reality. The organization is dedicated to
achieving this vision one organ at a time.
www.lungbioengineering.com
United Therapeutics: Enabling Inspiration
At United Therapeutics, our vision and mission are one. We use
our enthusiasm, creativity, and persistence to innovate for the
unmet medical needs of our patients and to benefit our other
stakeholders. We are bold and unconventional. We have fun, we do
good. We are the first publicly-traded biotech or pharmaceutical
company to take the form of a public benefit corporation
(PBC). Our public benefit purpose is to provide a brighter
future for patients through (a) the development of novel
pharmaceutical therapies; and (b) technologies that expand the
availability of transplantable organs.
You can learn more about what it means to be a PBC here:
unither.com/pbc.
Forward-Looking Statements
Statements included in this press release that are not
historical in nature are “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include, among others, our goals for
LBE’s integrated EVLP service to reduce resource burdens from
donation to transplant and increase organ utilization; our plans to
open additional centralized EVLP centers in North America; our plan
to initiate the first clinical study of the UKidney™ xenokidney in
2025, and future regulatory activities related to these plans; and
our efforts to innovate for the unmet medical needs of our
patients, to benefit our other stakeholders, and to pursue our
public benefit purpose of developing novel pharmaceutical therapies
and technologies that expand the availability of transplantable
organs. These forward-looking statements are subject to certain
risks and uncertainties, such as those described in our periodic
reports filed with the Securities and Exchange Commission, that
could cause actual results to differ materially from anticipated
results. Consequently, such forward-looking statements are
qualified by the cautionary statements, cautionary language, and
risk factors set forth in our periodic reports and documents filed
with the Securities and Exchange Commission, including our most
recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q,
and Current Reports on Form 8-K. We claim the protection of the
safe harbor contained in the Private Securities Litigation Reform
Act of 1995 for forward-looking statements. We are providing this
information as of October 23, 2024, and assume no obligation to
update or revise the information contained in this press release
whether as a result of new information, future events or any other
reason.
ORGANVUE, MIROLIVERELAP, and UKIDNEY are trademarks of United
Therapeutics Corporation and its subsidiaries.
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version on businesswire.com: https://www.businesswire.com/news/home/20241023762679/en/
For Further Information Contact:
Dewey Steadman at (202) 919-4097 (investors/media) Catherine
Sheehy at (202) 352-4995 (sustainability/responsibility) Harry
Silvers at (301) 578-1401 (investors)
https://ir.unither.com/contact-ir/
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