Surmodics Provides Update Regarding TRANSCEND Clinical Trial

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and
in vitro diagnostic technologies to the healthcare industry, has resumed
patient enrollment into its TRANSCEND clinical trial and is nearly 75
percent of the way to its goal of 446 randomized patients.

Patient enrollment in TRANSCEND, the pivotal clinical trial for the
SurVeil™ drug-coated balloon (DCB), was temporarily paused following the
March 15 publication of a Food & Drug Administration (FDA) letter to
physicians. The letter included an update on the Agency’s preliminary
analysis of a potentially concerning signal of increased long-term
mortality with paclitaxel-coated devices and recommended that physicians
consider alternative treatment methods until additional analysis has
been performed.

“Immediately following publication of the March 15 FDA communication, we
reached out to the Agency seeking guidance on the recommendations and
the impact on TRANSCEND,” said Gary Maharaj, Surmodics President and
CEO. “Following multiple conversations, we’ve taken several actions in
response to the Agency’s recommendations, including updates to
investigator communications, patient Informed Consent Forms (ICF), and
data safety review and patient follow-up procedures. A number of our
trial sites have already secured IRB or Ethics Committee approval of the
updated ICF and are actively enrolling and randomizing patients.”

     
FDA Recommendations: Surmodics Action:
 
Follow device recommendations from March 15 letter Communicated FDA recommendations to trial investigators
 
Update patient informed consent form (ICF) Initiated process to update ICF at sites worldwide
 
Include ongoing independent Data Safety Monitoring Board (DSMB)
review
Ongoing Clinical Events Committee (CEC) and DSMB reviews were
initiated at trial onset
 
Take measures to increase follow-up with patients Establishing an aggressive patient follow-up program for both new
patient randomizations and those already treated
 

The TRANSCEND randomized trial will evaluate the SurVeil DCB for
treatment of peripheral artery disease (PAD) in the upper leg compared
to a commercially available DCB treatment. The results of the trial will
also include long-term, patient-level data out to 5 years. The Company
continues to assess the impact of the March 15 FDA communication on its
expectations regarding the timing of completion of patient enrollment in
the TRANSCEND clinical trial and related regulatory approvals for the SurVeil
DCB.

“Patient safety is the top priority in every study, so pausing trial
enrollment while implementing the recommendations from the FDA was in
the best interest of both our patients and this trial,” said William
Gray, MD, the national Co-Principal Investigator of the TRANSCEND study.
“We’re pleased to see many sites enthusiastically resuming enrollments.
The TRANSCEND trial comes at a critical time in the endovascular field
and will provide important safety and efficacy data for the next
generation SurVeil DCB as it compares to the Medtronic IN.Pact®
DCB and will ultimately be useful for physicians and the patients that
they treat.”

Worldwide, over 200 million people have PAD, 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. 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.

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 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 are forward-looking statements,
including statements and beliefs about the TRANSCEND clinical trial and
the SurVeil DCB. Forward-looking statements involve inherent
risks and uncertainties, and important factors could cause actual
results to differ materially from those anticipated, including 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, 2018, 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.

Contacts

Surmodics, Inc.
Tim Arens, 952-500-7000
ir@surmodics.com