- Important milestone in moving toward
DCB clinical trials in the U.S.
- SurVeil™ DCB design includes new,
proprietary coating for interventional treatment of PAD
- Advances SurModics’ strategic
transformation to a whole-product solutions provider
SurModics, Inc. (Nasdaq:SRDX), a leading provider of medical
device and in vitro diagnostic technologies, today announced that
it has received U.S. Food and Drug Administration (FDA)
Investigational Device Exemption (IDE) approval to move forward in
pursuing its first-in-human early feasibility study using the
SurModics SurVeil™ drug-coated balloon (DCB).
The development of the SurVeil DCB is a major step forward in
the company’s strategy to transform from a surface modification
technology company to a provider of whole-product solutions to the
medical device industry. This approval allows the company to take
the steps required to start an early feasibility clinical trial.
The company has identified its clinical investigators and is
developing plans for up to three clinical sites in the U.S. and
expects to enroll the first patient in the second quarter of fiscal
2016.
“We are excited to have reached this milestone for the SurVeil
DCB. Our decision to conduct the early feasibility study in the
U.S. reflects our confidence in the advanced drug delivery
capability of the device that has been demonstrated in promising
pre-clinical research,” said Gary Maharaj, president and CEO of
SurModics. “We are proud to use the early feasibility study pathway
established by the FDA and have been very satisfied with the
interactions and responsiveness of the Agency. This IDE approval
allows us to start the process of working with U.S. clinical sites
and investigators.”
“While the utilization of DCB therapy is growing rapidly and the
clinical results for patients with lower extremity PAD are very
encouraging, there are real opportunities to improve upon the early
generation DCB technologies that are currently available,” said
Kenneth Rosenfield, M.D., section head, Vascular Medicine and
Intervention at Massachusetts General Hospital, and chair of the
SurModics Clinical Advisory Board. “We are excited about SurModics’
technology, and their efforts to improve upon the performance of
existing DCBs in the interest of further enhancing patient
outcomes.”
Though SurModics has long provided surface modification and drug
delivery solutions to medical device companies, the SurVeil DCB
will be the first complete vascular medical device developed and
tested clinically by SurModics.
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
efficacy and safety before finalization of product design while
still adhering to exacting human subject protections.
“Some may see SurModics’ decision to initiate human trials on
their drug-coated balloon in the U.S. as a bold move,” said Renu
Virmani, M.D., president and medical director of CVPath Institute.
CVPath has performed the histopathological assessment of all
pre-clinical studies involving the SurVeil DCB since the inception
of the program. “Those of us who have followed the development of
this product are confident in its potential given its performance
in pre-clinical studies.”
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 (LLL) – 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.1-6
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 US and is
for investigational use only.
About SurModics, Inc.
SurModics partners with the world's leading and emerging
medical device, diagnostic and life sciences companies to develop
and commercialize innovative products designed to improve lives by
enabling the detection and treatment of disease. Our mission is to
be a trusted partner to our customers by providing the most
advanced surface modification technologies and in
vitro diagnostic chemical components that help enhance the
well-being of patients. The company’s core offerings include
surface modification coating technologies that impart lubricity,
prohealing and biocompatibility characteristics and components
for in vitro diagnostic test kits and microarrays.
SurModics’ strategy is to build on the product and technical
leadership within these fields, and expand the core offerings to
generate opportunities for longer term sustained growth. 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 SurModics SurVeil 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 Drug-Coated
Balloon product; (2) our ability to successfully receive the
required institutional approvals and satisfy other conditions
required to initiate the clinical trial; (3) 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 (4) 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, 2014, 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.
1Fanelli F, Cannavale A, Boatta E, Corona M, Lucatelli P, Wlderk
A, Cirelli C and Salvatori FM. Lower limb multilevel treatment with
drug-eluting balloons: 6-month results from the DEBELLUM randomized
trial. Journal of endovascular therapy: an official journal of the
International Society of Endovascular Specialists.
2012;5:571-580.
2Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U,
Eschenbach G, Hartmann H, Lange C, Schnorr B, Stiepani H, Zoccai GB
and Hanninen EL. Paclitaxel-coated balloons reduce restenosis after
femoro-popliteal angioplasty: evidence from the randomized PACIFIER
trial. Circulation Cardiovascular interventions. 2012;5:831-40.
3 Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U,
Beregi JP, Claussen CD, Oldenburg A, Scheller B and Speck U. Local
delivery of paclitaxel to inhibit restenosis during angioplasty of
the leg. The New England journal of medicine. 2008;358:689-99.
4Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz
U, Hosten N, Hamm B, Speck U and Ricke J. Inhibition of restenosis
in femoropopliteal arteries: paclitaxel-coated versus uncoated
balloon: femoral paclitaxel randomized pilot trial. Circulation.
2008;118:1358-65.
5Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers
M, Tepe G, Naisbitt S and Rosenfield K. The LEVANT I (Lutonix
paclitaxel-coated balloon for the prevention of femoropopliteal
restenosis) trial for femoropopliteal revascularization:
first-in-human randomized trial of low-dose drug-coated balloon
versus uncoated balloon angioplasty. JACC Cardiovasc Interv.
2014;7:10-9.
6Rosenfield K, Jaff M, White C, Rocha-Singh C, Mena-Hurtado C,
Metzger C, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R,
Müller-Hülsbeck S, Nehler M, Benenati J, Scheinert D. Trial of a
Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. The
New England journal of medicine. 2015; 373:145-153.
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SurModics, Inc.Andy LaFrence, 952-500-7000Vice President of
Finance and Chief Financial Officer
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