Clinical investigators achieve significant
milestone by enrolling 150 patients with hypervascular tumors in
pivotal randomized study.
BEDFORD,
Mass., May 14, 2024 /PRNewswire/ -- Instylla,
Inc., a privately held clinical-stage company focused on developing
liquid embolics for peripheral vascular embolotherapy, today
announced the completion of patient enrollment in the ongoing
Instylla HES Hypervascular Tumor Pivotal Study.
"Tumors treated in the study included
primary and metastatic liver tumors, metastatic bone tumors, and
renal tumors."
The Instylla HES Hypervascular Tumor Pivotal Study is a
prospective, multicenter, randomized clinical study to evaluate the
safety and effectiveness of Instylla's Embrace™ Hydrogel Embolic
System (HES) compared with standard of care transcatheter arterial
embolization or transcatheter arterial chemoembolization for the
vascular occlusion of hypervascular tumors. A wide variety of
tumors were treated in the study including primary and metastatic
liver tumors, metastatic bone tumors, and renal tumors.
Dr. Nadine Abi-Jaoudeh, the study's National Principal
Investigator and Chief of Interventional Radiology at the
University of California, Irvine, said,
"Congratulations to all the investigators, study coordinators, and
the Instylla team on the completion of enrollment for the Instylla
HES Hypervascular Tumor Pivotal Study. This marks an exciting
milestone in the field of embolization of hypervascular tumors. We
hope the study will be positive and demonstrate that this
next-generation liquid embolic technology will improve the lives of
our patients who have to navigate their challenging clinical
conditions. We want to thank all the patients that
participated."
"Enrollment completion represents a significant milestone for
Instylla and cancer patients diagnosed with hypervascular tumors,"
said Amar Sawhney, CEO of Instylla,
Inc. and Managing Director of Incept, LLC. "We look forward to
continuing to work with the study investigators to maintain the
high quality of patient follow-up as we continue on our pathway to
a PMA for Embrace HES."
About Embrace Hydrogel Embolic System:
Embrace HES is
an investigational device intended to embolize hypervascular tumors
in vessels ≤ 5 mm. Embrace HES consists of two injectable liquid
precursors that solidify when simultaneously delivered into blood
vessels, forming a soft hydrogel that fills the vessel lumens
during embolization. The Embrace HES embolization uses no organic
solvents, does not need sizing to the vessel diameter, and
eliminates the possibility of catheter entrapment. Its main
components are water and polyethylene glycol (PEG).
About Instylla:
Instylla, Inc. is a privately held
company based in Bedford, MA,
focused on developing next-generation liquid embolics for
interventional radiology, with initial clinical applications in
interventional oncology and peripheral hemostasis. The company's
first product, Embrace HES, is designed for controlled, complete,
and persistent embolization in these clinical conditions. Instylla
was founded in 2017 by Incept LLC and is funded by several leading
venture capital groups.
To learn more, please visit
https://www.instylla.com/
Caution: Investigational Device. Limited by Federal (or US) law
to investigational use only. Not available for sale.
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SOURCE Instylla, Inc.