Surmodics Completes Enrollment in Pivotal TRANSCEND Clinical Trial
August 28 2019 - 8:30AM
Business Wire
Study designed to evaluate safety, efficacy of
the company’s next-generation SurVeil™ drug-coated balloon
Company Raises 2019 Revenue and EPS
Guidance
Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical
device and in vitro diagnostic technologies to the health care
industry, today announced it has completed enrollment in TRANSCEND,
its pivotal clinical trial for the SurVeil™ drug-coated balloon
(DCB).
“TRANSCEND is a rigorous level one, randomized controlled trial
that comes at a very important time for the vascular and
interventional community,” said Kenneth Rosenfield, MD, a principal
investigator of the TRANSCEND study. “By providing a head-to-head
comparison with today’s market leading DCB, this trial will provide
data regarding the relative performance of the SurVeil DCB, which
represents a new generation of DCB. Beyond the device itself, the
new trial design will ultimately provide insight into clinically
important questions regarding long-term results. There is great
promise that this third-generation DCB will further improve upon
current outcomes for this technology and provide additional benefit
for clinicians and the patients that they treat.”
The TRANSCEND trial enrolled 446 patients at 65 global sites.
The randomized study will evaluate the safety and efficacy of the
SurVeil DCB compared with a commercially available DCB in treating
peripheral artery disease (PAD) in the upper leg. The results of
the trial will also include long-term, patient-level data out to
five years.
“I am excited about the potential of the SurVeil DCB to improve
the treatment of PAD,” said Professor Marianne Brodmann, a
TRANSCEND Principal Investigator and the trial’s leading enroller
with 44 randomizations. “Our focus now shifts to follow-up and
monitoring of these patients and the collection of high-quality
data.”
"Completing enrollment in the TRANSCEND trial marks an important
milestone and brings us one step closer to bringing this
next-generation treatment to PAD patients,” said Gary Maharaj,
Surmodics' president and chief executive officer. “I would like to
thank our Principal Investigators—Dr. Kenneth Rosenfield, Professor
Marianne Brodmann and Dr. William Gray—our trial advisor, Dr. Peter
Schneider, and the entire Steering Committee for their leadership
and guidance, all our investigators, support teams and,
importantly, the patients we enrolled. Without their participation,
we wouldn’t be here today.”
In February 2018, Surmodics entered into an agreement with
Abbott (NYSE: ABT) that provided Abbott with exclusive worldwide
commercialization rights for the SurVeil DCB. Pursuant to the terms
of the agreement, Surmodics received a $25 million upfront payment
and will receive a $10 million milestone payment in connection with
the completion of patient enrollment in the TRANSCEND trial.
Approximately $5 million from this milestone payment will be
recognized as revenue in the Company’s fiscal fourth quarter.
Surmodics may earn an additional $57 million for other various
product development milestones.
Upon the regulatory approval of the device, Surmodics will be
responsible for manufacturing clinical and commercial quantities of
the product and will realize revenue from product sales to Abbott
as well as a share of profits resulting from sales to third
parties.
2019 Guidance Update With the completion of this
milestone, Surmodics now expects fiscal 2019 revenue to be in a
range of $97.0 million to $99.0 million, this compares to the
Company’s previous expected revenue range of $92.0 to $94.0
million. Surmodics is also increasing fiscal 2019 diluted GAAP EPS
guidance to a range of $0.52 to $0.60 per share, compared with the
Company’s previous expectations of $0.24 to $0.32 per share.
Diluted non-GAAP EPS is now expected to be in the range of $0.69 to
$0.77 per share, compared with previous expectations of $0.41 to
$0.49 per share.
About PAD PAD is a serious and often underdiagnosed
circulatory condition caused by a build-up of arterial plaque, most
commonly in the legs. Drug-coated balloons are recognized as an
important treatment option in treating PAD, which affects an
estimated 200 million people worldwide.1 Between 12-20 percent of
Americans over 60 years old have PAD.2 PAD increases risk of
coronary artery disease, heart attack and stroke, and can impair
the ability to walk. If left untreated, PAD can lead to gangrene
and limb amputation.3
About the SurVeil™ DCB The SurVeil DCB includes a
proprietary drug-excipient formulation for a durable balloon
coating and is manufactured using an innovative process to improve
coating uniformity. Pre-clinical data have shown a more evenly
transferred and durable drug effect, and lower incidence of
downstream drug particles compared to the control drug-coated
balloon.4 The design of the SurVeil drug-coated balloon reflects
Surmodics' industry leadership in the development of surface
technology for vascular medical devices. The SurVeil DCB is not
available for sale anywhere in the world and is for investigational
use only.
About Surmodics, Inc. Surmodics is the global leader in
surface modification technologies for intravascular medical devices
and a leading provider of chemical components for in vitro
diagnostic (IVD) immunoassay tests and microarrays. Surmodics is
pursuing highly differentiated whole-product solutions that are
designed to address unmet clinical needs for its medical device
customers and engineered to the most demanding requirements. This
key growth strategy leverages the combination of the Company’s
expertise in proprietary surface technologies, along with enhanced
device design, development and manufacturing capabilities. The
Company mission remains to improve the detection and treatment of
disease. Surmodics is headquartered in Eden Prairie, Minnesota. For
more information, visit www.surmodics.com. The content of Surmodics
website is not part of this press release or part of any filings
that the company makes with the SEC.
Safe Harbor for Forward-Looking Statements This press
release contains forward-looking statements. Statements that are
not historical or current facts, including certain statements about
beliefs and expectations regarding the SurVeil DCB and the
TRANSCEND clinical trial, are forward-looking statements.
Forward-looking statements involve inherent risks and
uncertainties, and important factors could cause actual results to
differ materially from those anticipated, including (1) our ability
to successfully obtain regulatory approval for and commercialize
our SurVeil DCB; and (2) the factors identified under “Risk
Factors” in Part I, Item 1A of our Annual Report on Form 10-K for
the fiscal year ended September 30, 2018, and updated in our
subsequent reports filed with the SEC. These reports are available
in the Investors section of our website at www.surmodics.com and at
the SEC website at www.sec.gov. Forward-looking statements speak
only as of the date they are made, and we undertake no obligation
to update them in light of new information or future events.
References:
- Fowkes FGR, et al. Lancet 2013, 382(9901):1329-1340.
- Centers for Disease Control and Prevention. Peripheral Arterial
Disease (PAD) Fact Sheet. n.d. Web.
- National Institutes of Health. What is Peripheral Artery
Disease? n.d. Web.
- Surmodics data on file
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version on businesswire.com: https://www.businesswire.com/news/home/20190828005149/en/
Surmodics, Inc. Tim Arens, 952-500-7000 ir@surmodics.com
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