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Sundance™ Sirolimus Drug-Coated Balloon exhibits excellent safety pro > Primary patency maintained at 24 months in 71.4% of per protocol analysis population EDEN PRAIRIE, Minn.--(BUSINESS WIRE)-- SurModics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced today that 24-month data from the SWING Trial, a first-in-human study of the safety and performance of the Sundance™ Sirolimus Drug-Coated Balloon (DCB) was presented at the 50th annual VEITH Symposium in New York, New York. The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance Sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries. The SWING Trial enrolled subjects with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter of 2 mm to 4 mm, and a total lesion length of ≤230 mm for treatment with the Sundance Sirolimus DCB at eight sites in Australia, New Zealand, and/or Europe. Study subjects will be followed for 36 months post index procedure. The primary safety endpoint is defined as the number of subjects with a composite of freedom from Major Adverse Limb Event (MALE) and perioperative death at 30 days following the index procedure. The primary efficacy endpoint is the rate of late lumen loss at 6 months, as assessed by quantitative vascular angiography. Both primary endpoints of the SWING Trial were achieved. Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major re-intervention was reported among the 35 trial subjects. The per protocol (PP) population reported an 8.3% rate of major adverse events (two clinically driven target limb revascularizations) at 6 months, with no additional adverse events reported for PP subjects in the 12 or 24-month data. Primary efficacy data show late lumen loss of 1.0 mm (±.79 mm) across 35 lesions at 6 months, indicating that the large luminal gain achieved immediately after the procedure was sustained post procedure. Target lesion primary patency rate, defined as freedom from target vessel occlusion or target lesion revascularization associated with deterioration of Rutherford Clinical Classification and/or increase in size of pre-existing wounds (or occurrence of new wounds), and lesion restenosis >50%, was 71.4% at 24 months in the PP population. The Rutherford Clinical Classification describes 7 categories of peripheral artery disease, including both the patient's clinical symptoms as well as objective findings, and is used to assess disease progression. "The two-year safety and performance results of the SWING trial continue to show promise for the Sundance Sirolimus DCB in treating below the knee disease in a challenging CLTI patient population where options are currently limited," said Professor Andrew Holden, MBChB, FRANZCR, EBIR, ONZM, Director of Northern Region Interventional Radiology Service (Auckland City Hospital, Auckland, New Zealand), co-lead investigator. “We need to continue to strive for better treatments for treating infrapopliteal disease,” added Professor Varcoe. “These results are promising and will inform future trials, which we hope will continue to advance improved treatments for our patients.” About the Sundance™ Sirolimus Drug Coated Balloon The Sundance Sirolimus Drug-Coated Balloon utilizes a next-generation coating technology consisting of microcrystalline Sirolimus and a proprietary excipient designed to maximize drug transfer, enhancing Sirolimus delivery and sustaining therapeutic levels in the artery. Sirolimus, a potent anti-inflammatory and anti-proliferative compound, has been used successfully in coronary drug-eluting stents. The delivery of Sirolimus to the vessel wall during mechanical balloon dilatation provides an ancillary action of inhibiting the proliferation of cells, with the intended purpose of reducing restenosis. The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only. About Surmodics, Inc. Surmodics is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays. Surmodics also develops and commercializes highly differentiated vascular intervention medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with its device design, development and manufacturing capabilities. The Company’s mission is to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit . 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 Sundance™ Sirolimus Drug-Coated Balloon, 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 drug-coated balloon products; 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, 2022, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at and at the SEC website at . 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.

SOPHIA ANTIPOLIS, FRANCE--(Marketwire - March 31, 2009) - Highlighted Links companynewsgroup Home Page Oral presentation focused on blood pressure data for naproxcinod in osteoarthritis patients taking commonly used antihypertensive therapies NicOx S.A. (NYSE Euronext Paris: COX) today announced that important new results on naproxcinod's blood pressure pro presented yesterday at the American College of Cardiology (ACC) Annual Meeting in Orlando, Florida, by Professor William B. White, MD from the University of Connecticut School of Medicine, Farmington. The new analyses included detailed assessments of the systolic blood pressure (SBP) changes from baseline in the overall population and hypertensive sub-groups, in addition to statistical modeling figures that describe the probability of developing an SBP < > =140 mmHg in patients who had normal SBP when they entered the study. The presentation focused on the SBP data for naproxcinod in an important subgroup of hypertensive patients taking renin-angiotensin system (RAS) blockers. Naproxcinod is a Cyclooxygenase-Inhibiting Nitric Oxide Donating (CINOD) anti-inflammatory agent, which completed a phase 3 clinical program in 2008 in patients with osteoarthritis (OA). The submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) is planned for mid-2009. The objective of these analyses of the 301 phase 3 study was to assess the impact of naproxcinod 750 mg bid and 375 mg bid, as well as naproxen 500 mg bid, a widely used traditional non-steroidal anti- inflammatory drug (NSAID), and placebo on the SBP of patients with OA of the knee. Pascal Pfister MD, Chief Scientific Officer and Head of Research & Development at NicOx, commented: "The results presented yesterday by Professor White show a favorable blood pressure pro naproxcinod in a large OA population. Given that approximately half of OA patients also have hypertension, these findings may have important clinical implications. We were very pleased that these data were accepted for an oral presentation at the prestigious American College of Cardiology annual conference." Naproxcinod shows no detrimental impact on blood pressure in a sub-group of hypertensive patients taking RAS blockers Traditional NSAIDs and COX‑2 selective inhibitors have been shown to destabilize systolic blood pressure control in patients on RAS blockers, with increases of 3 to 8 mmHg being reported in the literature. RAS blockers comprise a number of antihypertensive classes that target the renin-angiotensin system: Angiotensin Converting Enzyme (ACE) inhibitors, Angiotensin-II Receptor Blockers (ARBs) and direct Renin Inhibitors. Together, these drugs represented more than 50% of the antihypertensive sales in the seven major pharmaceutical markets in 2007 [Datamonitor 2008]. In the patients with controlled hypertension who were treated with RAS blockers, naproxcinod 750 mg bid showed a mean reduction in SBP of 5.0 mmHg from baseline at week-13, while naproxen 500 mg bid showed an increase of 1.5 mmHg, resulting in a statistically significant difference of 6.5 mmHg in favor of naproxcinod (p < 0.02, post hoc analysis). Likewise, the SBP reduction from baseline was 2.7 mmHg in the naproxcinod 375 mg group and 4.6 mmHg in the placebo group. Categorized SBP changes of individual patients from baseline Dr. White also presented bar graphs which categorize the SBP changes in individual patients from baseline. These showed the proportion of patients who developed an increase or decrease in SBP of between 0 and 10 mmHg, of between 10 and 20 mmHg and exceeding 20 mmHg, for each treatment group in the overall population and hypertensive sub-groups. In the abstract it was disclosed that in the hypertensive population, 23.3% of the patients receiving naproxen saw their SBP increased by 10 mmHg or more over the 13 weeks of the study. The percentage of hypertensive patients experiencing an increase of SBP < > =10 mmHg was significantly lower in the naproxcinod 750 mg group (11.5%, p < 0.04 vs. naproxen, post hoc analysis). This proportion was 16.0% for the 375 mg dose and 15.3% in the placebo group. Probability of developing an SBP < > =140 mmHg In addition, statistical modeling figures were presented, which describe the probability of the different treatments leading to an SBP < > =140 mmHg in patients with normal or borderline SBP at baseline (SBP < 140 mmHg), showing that the probability of becoming uncontrolled was lowest for both doses of naproxcinod. William B. White MD, Professor of Medicine and Chief, Division of Hypertension and Clinical Pharmacology in the Cardiology Center at the University of Connecticut School of Medicine, Farmington, stated: "The increase in blood pressure seen in OA patients receiving NSAID treatment is believed to be partly due to the indirect inhibition of the vasodilator prostacyclin. The sustained release of nitric oxide from naproxcinod may prevent the induction of blood pressure increase in both normotensive and hypertensive patients and this effect may be particularly useful in patients taking renin-angiotensin blocking agents. The impressive results seen in the RAS blocker subgroup support the notion that RAS blocking agents may depend in part on vascular prostacyclin and nitric oxide for their mechanism of action." William B. White MD is a consultant to NicOx who has provided advice on clinical study design. He was the principal investigator of the 112 study for naproxcinod. NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven biopharmaceutical company dedicated to the development and future commercialization of investigational drugs for unmet medical needs. NicOx is applying its proprietary nitric oxide-donating technology to develop an internal portfolio of New Chemical Entities (NCEs) in the therapeutic areas of inflammatory and cardio-metabolic disease. Resources are focused on the development and pre-commercialization activities for naproxcinod, a proprietary NCE and a Cyclooxygenase- Inhibiting Nitric Oxide-Donating (CINOD) anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis. Naproxcinod has completed three pivotal phase 3 studies with positive results and the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) is projected for mid-2009. Beyond naproxcinod, NicOx has a pipeline containing multiple nitric oxide- donating NCEs, which are in development internally and with partners, including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalent and underserved diseases, such as atherosclerosis, hypertension and widespread eye diseases and respiratory conditions. NicOx S.A. is headquartered in France and is listed on the NYSE Euronext Paris (Compartment B: Mid Caps). This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated in the forward-looking statements. For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of NicOx S.A. to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference filed with the AMF, which is available on the AMF website ( ) or on NicOx S.A.'s website ( ). CONTACTS: NicOx: Karl Hanks Director of Investor Relations and Corporate Communication Tel +33 (0)4 97 24 53 42 - hanks@nicox.com Media in the United States - FD Robert Stanislaro - Tel +1 212 850 5657 - robert.stanislaro@fd.com Irma Gomez-Dib - Tel +1 212 850 5761 - irma.gomez-dib@fd.com Media in Europe - Citigate Dewe Rogerson David Dible - Tel +44 (0)207 282 2949 - david.dible@citigatedr.co.uk Nina Enegren - Tel +44 (0)207 282 1050 - nina.enegren@citigatedr.co.uk NicOx S.A., Les Taissounières - Bât HB4 - 1681 route des Dolines - BP313, 06906 Sophia Antipolis cedex, France. Tel. +33 (0)4 97 24 53 00 - Fax +33 (0)4 97 24 53 99 This information is provided by HUGIN