Six-Month Data from the Surmodics SurVeil® Drug-Coated Balloon Early Feasibility Study Presented at VIVA 2017

  • Study met primary endpoint and six-month secondary safety endpoints
  • Results demonstrated primary patency of 100% and significant
    improvement in measured clinical outcomes

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and
in vitro diagnostic technologies, today announced that data from the
PREVEIL early feasibility study (EFS) of the company’s SurVeil®
drug-coated balloon (DCB) was shared in a late-breaking clinical trial
presentation at the Vascular Interventional Advances (VIVA) 2017
conference in Las Vegas. PREVEIL is a prospective, U.S., multi-center,
single-arm trial designed to assess the safety and feasibility of the SurVeil
DCB in the treatment of subjects with symptomatic peripheral artery
disease (PAD) due to de novo lesions of the femoral and popliteal
arteries.

Gary Ansel, MD, system medical chief of the Vascular Program at
OhioHealth, presented six-month results from 13 patients (Rutherford
class 2 to 4) at 3 clinical sites who were treated with the SurVeil
DCB. Average lesion length was 56 mm. Clinical assessments included
primary patency and late lumen loss through six months, plasma
paclitaxel levels, and changes in Rutherford classification, resting
ankle brachial index/toe brachial index (ABI/TBI), 6-minute walk test,
and walking impairment questionnaire (WIQ) at 1, 6, 12, 24 and 36
months. Key secondary safety endpoints included freedom from major
vascular complications, evidence of paclitaxel toxicity, or thrombolysis
in myocardial infarction (TIMI).

Data from the study show that acute success measures of safety were
achieved in 100 percent of subjects. Results also showed primary patency
of 100 percent and mean late lumen loss of 0.27±0.54 mm at six months.
Significant improvement in Rutherford classification, ABI/TBI, 6-minute
walk test, and WIQ were seen at 30 days and six months. Median
paclitaxel plasma concentration peaked immediately post-procedure (Cmax
1.07 ng/mL) and was undetectable at 30 days. Secondary technical,
device, and procedure success criteria were achieved.

“We are encouraged by the early patient data using the Surmodics SurVeil
DCB platform and are excited to continue clinical evaluation of the
product in the U.S. pivotal trial,” said Dr. Ansel, who is a principal
investigator in both the PREVEIL trial and the SurVeil DCB
pivotal trial, TRANSCEND.

“Our goal with the SurVeil DCB is to improve drug transfer and
effect on the arterial wall with a lower drug dose and a reduction in
the amount of drug reaching tissue outside the area of treatment,” said
Gary Maharaj, president and CEO of Surmodics. “We are very satisfied
with the results of the EFS and believe they are consistent with our
encouraging pre-clinical data.”

About the Surmodics SurVeil® DCB

In July 2017, Surmodics received an investigational device exemption
(IDE) from the U.S. Food and Drug Administration (FDA) to initiate a
pivotal clinical trial of the SurVeil DCB. The randomized trial,
TRANSCEND, will evaluate the SurVeil DCB for treatment for PAD in
the upper leg compared to the Medtronic IN.PACT® Admiral® DCB. Surmodics
expects to initiate enrollment in the TRANSCEND clinical trial in the
fourth quarter of calendar 2017.

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 concentrations compared to control
DCBs.1

The development of the SurVeil DCB is a major step forward in
Surmodics’ strategy to transform from a surface modification technology
company to a provider of whole-product solutions for its medical device
customers. In 2015, the company acquired Creagh Medical, an innovative
developer and manufacturer of balloon catheters located in Ireland, and
U.S.-based NorMedix, a manufacturer of differentiated specialty catheter
and device delivery systems. Surmodics now has complete capabilities for
design, development and high-volume manufacturing of a wide variety of
highly differentiated balloon catheter solutions that utilize the
company’s advanced surface technology.

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 company’s strategy to transform to a
provider of whole-product solutions, and the SurVeil DCB and
TRANSCEND clinical trial, including the expected initiation of that
trial, 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, and other
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, 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 file

Contacts

Surmodics, Inc.
Andy LaFrence, 952-500-7000
Vice
President of Finance, Information Systems and Chief Financial Officer