Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter
Company received FDA 510(k) clearance
Continued progress in R&D whole-product solutions pipeline
Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare
industry, announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its .018” Low-Profile percutaneous
transluminal angioplasty (PTA) balloon dilation catheter, designed and indicated for a broad range of peripheral vascular
applications. The product is the result of the company’s ongoing investment in a pipeline of highly differentiated whole-product
solutions. Surmodics expects to make the product available for distribution in the coming months.
This new low-profile product combines our most advanced balloon technologies with Surmodics’ proprietary,
low-friction, low-particulate Serene® hydrophilic coating for superb tracking, and unmatched lesion crossing performance, while
delivering high pressures and a broad offering ranging from 2mm to 10mm diameter.
“We are delighted to announce this latest of three recent FDA clearances, adding further depth to our proprietary product
offerings. With the .018” Low-Profile PTA balloon catheter, we continue building upon Surmodics’ portfolio of differentiated
products that are designed to advance the treatment of vascular disease,” said Gary Maharaj, President and CEO of Surmodics. “This
regulatory milestone adds to the recent clearances of the Telemark™ .014” Support Microcatheter and the .014” BTK Balloon
Dilatation Catheter.”
Surmodics’ whole-product solutions strategy leverages its comprehensive, vertically integrated design, development and high
volume commercial production capabilities at its state-of-the-art facility in Ballinasloe, County Galway, Ireland. At this facility
we control every step of the manufacturing process to produce the highest quality medical devices designed to address unmet
clinical needs.
About Peripheral Artery Disease
Worldwide, over 200 million people have peripheral artery disease (PAD),1 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.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 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
statements about beliefs and expectations regarding Surmodics’ strategy to transform to a provider of whole-product vascular
solutions. 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 proprietary products; (2) our ability to achieve expected benefits from our acquisitions; and (3) 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,
2017, and updated in its subsequent reports filed with the SEC. These reports are available in the Investors section of Surmodics'
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 Surmodics undertakes no
obligation to update them in light of new information or future events.
1 Fowkes FGR, et al. Lancet 2013, 382(9901):1329-1340.
2 Centers for Disease Control and Prevention. Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.
3 National Institutes of Health. What is Peripheral Artery Disease? n.d. Web.
Surmodics, Inc.
Andy LaFrence, 952-500-7000
ir@surmodics.com
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