SurModics Announces First Patient Enrolled in IDE Study of SurVeil™ Drug-Coated Balloon
April 06 2016 - 8:05AM
Business Wire
SurModics, Inc. (Nasdaq:SRDX), a leading provider of medical
devices and in vitro diagnostic technologies, today announced
enrollment of the first patient in an early feasibility study of
its proprietary SurVeil™ drug-coated balloon (DCB). This study is
part of the company’s strategy to transform its medical device
business from a provider of device coatings, to offering
differentiated whole-product solutions to leading medical device
customers.
SurModics received investigational device exemption (IDE)
approval for the study from the U.S. Food and Drug Administration
(FDA) in late 2015. The SurVeil DCB includes the company’s new,
proprietary coating formulation for interventional vascular
treatment of peripheral artery disease (PAD), and it is the first
complete vascular medical device developed that will be clinically
tested by SurModics.
“First and second generation DCBs demonstrated a biologic effect
and improved patency in patients with PAD,” said Kenneth
Rosenfield, M.D., section head, Vascular Medicine and Intervention
at Massachusetts General Hospital, and chair of the SurModics
Scientific Advisory Board. “The new generation of DCBs, which
includes significant advances in technology, provides a great
opportunity to further enhance patient outcomes.”
“We are pleased with the progress we made enrolling the first
patient in this study of our proprietary SurVeil DCB,” said Gary
Maharaj, president and CEO of SurModics. “We are proud to be on the
path to offering highly differentiated whole-products solutions to
our medical device customers.”
Three clinical sites have been identified to participate in this
early feasibility study for the SurVeil DCB. This study will
include up to 15 patients and allow for the collection of data on
product safety and usability before finalization of the product
design. By undertaking this first-in-human early feasibility study
of the SurVeil DCB in the U.S., SurModics plans to gather
meaningful data that could potentially accelerate future regulatory
approvals.
About Early Feasibility Studies
U.S. medical device companies commonly conduct clinical trials
abroad to expedite time to market. To encourage medical device
innovation in the U.S., in 2013 the FDA introduced new guidelines
under the early feasibility study program to facilitate the early
clinical evaluation of medical devices in small numbers of human
subjects. The guidelines allow companies to collect data on product
functionality and safety before finalization of product design
while still adhering to exacting human subject protections.
About Drug-Coated Balloons
Clinical trials have demonstrated the efficacy of DCBs in
treating PAD. The collective results of these trials have
demonstrated that DCBs lead to decreased late lumen loss – or
increased lumen diameter – six months post intervention as compared
to non-drug-coated balloons. In some cases, DCBs have also led to
decreased need for recurrent intervention. DCBs often deliver
paclitaxel, an antiproliferative drug, to arterial walls to limit
restenosis which may reduce blood flow. The drug is usually
combined with an excipient, which facilitates its transfer into the
arterial wall.
Medical device manufacturers face significant challenges in
optimizing DCB design. The aim of a DCB is to deliver the correct
dosage of antiproliferative drug at the site of a lesion, and apply
the drug uniformly to the arterial wall. To do this, the DCB must
minimize unintended release of the drug into the blood stream
during the procedure. Factors that may affect DCB performance
include the ability of the excipient to preserve and release the
drug at the appropriate time during the procedure, uniformity of
the coating application on the balloon, and consistency of the
paclitaxel drug on the balloon.
About the SurVeil™ Drug-Coated Balloon
The SurVeil DCB design incorporates SurModics’ decades of
experience as a leading supplier of surface modification
technologies to the medical device industry. It includes a
SurModics-proprietary drug-excipient formulation for the balloon
coating, and a new and proprietary manufacturing process for the
coating applications. It also includes the SurModics Serene™
low-friction, low-particulate hydrophilic coating on the catheter
shaft. The SurVeil DCB is not available for sale in the United
States and is for investigational use only.
About SurModics, Inc.
SurModics is known as 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 microassays. Following two recent acquisitions of Creagh
Medical and NorMedix, the company is transforming its medical
device business from being a provider of coating technologies, to
offering whole-product solutions. The combination of proprietary
coatings and application processes, along with enhanced device
design, development and manufacturing capabilities will enable
SurModics to significantly increase the value it offers medical
device customers. The company is focused on leading next-generation
development of highly differentiated total vascular device
solutions, designed and engineered to the most demanding
requirements. Throughout its transformation, SurModics’ mission
remains: to improve the detection and treatment of disease by using
our technology to provide solutions to difficult medical device and
diagnostic challenges. 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 company’s
strategy to transform to a provider of whole-product solutions, and
the timing, impact and success of clinical development (including
future regulatory milestones) of the SurModics 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 develop, obtain
regulatory approval for, and commercialize our SurVeil DCB; (2) the
possibility of unfavorable or delayed clinical trial results,
whether the FDA and other relevant agencies will be satisfied with
those results, even if favorable, and the impact on further trials
and studies that will be required; and (3) other factors, including
those identified under “Risk Factors” in Part I, Item 1A of our
Annual Report on Form 10-K for the fiscal year ended September 30,
2015, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160406005478/en/
SurModics, Inc.Andy LaFrence, 952-500-7000Vice President of
Finance and Chief Financial Officer
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