Photo Release -- Harvard Apparatus Regenerative Technology's "InBreath"
Scaffold and Bioreactor Used in First U.S. Transplant of a Regenerated Trachea
Surgery Successfully Implanted Trachea Into Two-Year-Old
HOLLISTON, Mass., April 30, 2013 (GLOBE NEWSWIRE) -- Harvard Bioscience, Inc.
(Nasdaq:HBIO), a global developer, manufacturer and marketer of a broad range
of tools to advance life science research and regenerative medicine, announces
that the "InBreath" tracheal scaffold and bioreactor system manufactured by
Harvard Apparatus Regenerative Technology, Inc. (HART), its wholly owned
regenerative medicine technology subsidiary, were used in the first successful
transplant of a regenerated trachea in the United States. The recipient of the
implant, two-year-old Hannah Genevieve Warren, is recovering at Children's
Hospital of Illinois, where the surgery was performed on April 9, 2013. The
surgery was also the world's first successful pediatric regenerated trachea
transplant using a synthetic scaffold.
The "InBreath" tracheal
scaffold made for
two-year-old Hannah Warren.
(C) Harvard Apparatus
Scaffold in Bioreactor
The "InBreath" bioreactor used to
create the regenerated trachea for
Hannah Warren. (C) Harvard Apparatus
Photos accompanying this release are available at
Hannah was born on August 22, 2010 in Seoul, South Korea with tracheal
agenesis (lack of a trachea), and was only able to breathe through a tube
inserted in her esophagus that connected to her lungs. Tracheal agenesis is
100 percent fatal, and no child born with the condition has ever lived beyond
six years. Hannah had lived in the intensive care unit for two and a half
years at Seoul National Hospital before being transported to Illinois for the
This was the first regenerated trachea transplant surgery using a scaffold
manufactured by HART and the implant used in the procedure was grown in one of
HART's "InBreath" bioreactors. The scaffold and bioreactor were custom-made to
Hannah's dimensions. The scaffold was seeded with bone marrow cells taken from
the patient and incubated in the bioreactor for two days prior to implant.
Because Hannah's own cells were used, her body has accepted the transplant
without the use of immunosuppressive (anti-rejection) drugs.
The procedure was performed by a team led by Dr. Paolo Macchiarini of
Karolinska University Hospital and Karolinska Institutet in Huddinge,
Stockholm and Drs. Mark J. Holterman and Richard Pearl both of Children's
Hospital of Illinois. The surgery was approved by the FDA under an
Investigational New Drug application made by Dr. Holterman.
Dr. Mark Holterman, Professor of Surgery and Pediatrics at University of
Illinois College of Medicine at Peoria, commented: "The success of this
pediatric tracheal implantation would have been impossible without the Harvard
Bioscience contribution. Their team of engineers applied their talent and
experience to solve the difficult technical challenge of applying regenerative
medicine principles in a small child."
David Green, President of Harvard Bioscience, commented: "We would like to
congratulate Dr. Macchiarini, Dr. Holterman, Dr. Pearl and their colleagues
for accomplishing the world's first transplant of a regenerated trachea in a
child using a synthetic scaffold and giving Hannah a chance at a normal life.
We also wish Hannah a full recovery and extend our best wishes to her family."
This surgery is the seventh successful implant of a regenerated trachea in a
human using HART technology. Prior successes included the first ever
successful regenerated trachea transplant in 2008, the first successful
regenerated trachea transplant using a synthetic scaffold in 2011 and the
commencement of the first clinical trial of regenerated tracheas in 2012. HART
intends to begin discussions with the FDA and EU regulatory authorities in the
near future regarding the clinical pathway necessary to bring this new
therapeutic approach to a wider range of patients in need of a trachea
A subsequent press release will be issued to provide a link to an
archivedvideo of thispress conference.
Video footage and additional still images pertaining to the surgery are
available for media upon request.
About Harvard Bioscience
Harvard Bioscience, or HBIO, is a global developer, manufacturer and marketer
of a broad range of specialized products, primarily apparatus and scientific
instruments, used to advance life science research and regenerative medicine.
HBIO sells its products to thousands of researchers in over 100 countries
primarily through its 850 page catalog (and various other specialty catalogs),
its website, through distributors, including GE Healthcare, Thermo Fisher
Scientific and VWR, and via our field sales organization. HBIO has sales and
manufacturing operations in the United States, the United Kingdom, Germany,
Sweden and Spain with additional facilities in France and Canada. For more
information, please visit www.harvardbioscience.com.
The Harvard Bioscience, Inc. logo is available at
About Harvard Apparatus Regenerative Technology, Inc.
Harvard Apparatus Regenerative Technology, Inc., a wholly owned subsidiary of
Harvard Bioscience, develops and manufactures devices for use within the
emerging field of regenerative medicine. These devices include bioreactors and
synthetic scaffolds for growing tissue and organs outside the body; and
injectors for stem cell therapy.
Registration Statement of Harvard Apparatus Regenerative Technology, Inc.
A registration statement including a prospectus relating to the common stock
of Harvard Apparatus Regenerative Technology, Inc. has been filed with the SEC
but has not yet become effective. These securities may not be sold nor may
offers to buy these securities be accepted before the time the registration
statement becomes effective. This press release shall not constitute an offer
to sell or a solicitation of an offer to buy these securities, nor shall there
be any sale of these securities in any state or jurisdiction in which such an
offer, solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or jurisdiction.
Some of the statements in this press release are "forward-looking" and are
made pursuant to the safe harbor provision of the Private Securities
Litigation Reform Act of 1995. These "forward-looking" statements include
statements relating to, among other things, activities of Harvard Bioscience
and the postponed IPO and other activities of Harvard Apparatus Regenerative
Technology. These statements involve risks and uncertainties, including among
other things, market conditions that may cause results to differ materially
from the statements set forth in this press release. The forward-looking
statements in this press release speak only as of the date of this press
release. Harvard Bioscience expressly disclaims any obligation or undertaking
to release publicly any updates or revisions to such statements to reflect any
change in its expectations with regard thereto or any changes in the events,
conditions or circumstances on which any such statement is based.
Photosare also available at Newscom, www.newscom.com, and via AP
CONTACT: David Green, President
Tom McNaughton, CFO
Chane Graziano, CEO
Tel: 508 893-8999
Fax: 508 892-6135
Dian Griesel Inc.
Harvard Bioscience, Inc. Logo
Press spacebar to pause and continue. Press esc to stop.