Surmodics Announces First Patient Enrolled in TRANSCEND Pivotal Clinical Trial for SurVeil® Drug-Coated Balloon
October 23 2017 - 8:00AM
Business Wire
Comparing SurVeil® DCB to Medtronic IN.PACT®
Admiral® DCB
Plan to enroll up to 446 patients at
approximately 78 sites
Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical
device and in vitro diagnostic technologies, today announced
enrollment of the first patient in TRANSCEND, the pivotal clinical
trial for the SurVeil® drug-coated balloon (DCB). The randomized
trial will evaluate the SurVeil DCB for treatment for peripheral
artery disease (PAD) in the upper leg compared to a commercially
available DCB treatment. Up to 446 patients will be randomized 1:1
to receive either the SurVeil DCB or Medtronic’s IN.PACT® Admiral®
DCB at approximately 60 U.S. sites and 18 sites outside the United
States.
“Based on the preclinical and early feasibility study results we
have seen so far, I am excited about the potential of the Surveil
DCB as a third-generation DCB to improve the treatment of PAD,”
said Kenneth Rosenfield, M.D., section head, Vascular Medicine and
Intervention at Massachusetts General Hospital, chair of the
Surmodics Clinical Advisory Board and U.S. co-principal
investigator for the TRANSCEND trial. “TRANSCEND will be a
rigorous Level One trial that will answer important questions about
DCB technologies.”
The design of the Surveil DCB reflects Surmodics’ long-standing
industry leadership in the development of surface technology for
vascular medical devices. The device includes a proprietary
drug-excipient formulation for the balloon coating and is
manufactured using a proprietary process to improve coating
uniformity. Pre-clinical data have shown a three to five times
higher target tissue drug concentration, a more evenly distributed
and durable drug effect, and lower incidence of downstream drug
particles compared to control DCBs.1
“This is a major step in the right direction for Surmodics, as
we apply and evaluate our unique technology with the goal of
improving clinical outcomes for patients with peripheral artery
disease,” said Gary Maharaj, president and CEO of Surmodics. “We’re
thrilled to be underway with TRANSCEND and look forward to working
with our investigators to execute an efficient and rigorous pivotal
trial.”
About the TRANSCEND Pivotal Trial
The objective of the Surveil DCB pivotal trial, TRANSCEND, is to
evaluate the safety and effectiveness of the device for treatment
of subjects with symptomatic PAD due to stenosis of the femoral
and/or popliteal arteries. The clinical study will be used to
support regulatory approvals (U.S. and Europe) and reimbursement.
The primary efficacy endpoint of the trial is primary patency,
defined as a composite of freedom from restenosis and
clinically-driven target lesion revascularization (TLR) through 12
months post-index procedure. All randomized subjects will be
followed through 60 months post-index procedure.
The trial will be led by national co-principal investigators
Kenneth Rosenfield, M.D., and Gary Ansel, M.D., system medical
chief of the Vascular Program at OhioHealth. Marianne Brodmann,
M.D., substitute head of the Division of Angiology, Department of
Internal Medicine, Medical University of Graz, Graz, Austria, is
the European principal investigator.
The Surveil DCB is not available for sale anywhere in the world,
and is for investigational use only.
About Peripheral Artery Disease
Worldwide, over 200 million people have PAD,2 a serious and
underdiagnosed circulatory condition caused by build-up of arterial
plaque, most commonly in the legs. Twelve to 20 percent of
Americans over 60 years old have PAD.3 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.4
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) tests
and microarrays. Following two recent acquisitions of Creagh
Medical and NorMedix, the Company is executing a key growth
strategy for its medical device business by expanding to offer
total intravascular product solutions to its medical device
customers. The combination of proprietary surface technologies,
along with enhanced device design, development and manufacturing
capabilities, enables Surmodics to significantly increase the value
it offers with highly differentiated intravascular solutions
designed and engineered to meet the most demanding requirements.
With this focus on offering total solutions, Surmodics’ mission
remains to improve the detection and treatment of disease.
Surmodics is headquartered in Eden Prairie, Minnesota. For more
information about the company, 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
statements about beliefs and expectations regarding the impact and
success of the clinical evaluation of the Surveil DCB,
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, and in a timely
fashion, develop, obtain regulatory approval for, and commercialize
our Surveil DCB, and other proprietary products; (2) our
ability to achieve expected benefits from our acquisitions;
(3) possible adverse market conditions and possible adverse
impacts on our cash flows, and (4) 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, 2016, 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.
1 Surmodics data on file2 Fowkes FGR, et al. Lancet 2013,
382(9901):1329-1340.3 Centers for Disease Control and Prevention.
Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.4 National
Institutes of Health. What is Peripheral Artery Disease? n.d.
Web.
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version on businesswire.com: http://www.businesswire.com/news/home/20171023005341/en/
Surmodics, Inc.Andy LaFrence, 952-500-7000ir@surmodics.com
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