EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Apr. 6, 2016--
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
“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
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
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
SurmodicsSurVeil 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
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Source: Surmodics, Inc.
Andy LaFrence, 952-500-7000
Vice President of
Finance and Chief Financial Officer