Market Overview

Vascular Dynamics Announces Initial Enrollment in Rigorously Designed Hypertension Trial


CALM-2 Trial Studies Effectiveness of Unique Endovascular
Baroreceptor Amplification Device

Vascular Dynamics, Inc. (VDI), a privately held medical device company
focused on innovative, minimally invasive device-based solutions for
cardiovascular conditions, today announced enrollment of the first
patients in an FDA-approved best-in-class pivotal clinical trial. The
CALM-2 study is designed to establish safety and efficacy of the novel
endovascular baroreceptor amplification (EVBA) procedure using the
unique MobiusHD® device as a treatment for drug-resistant

Over 100 million people in the U.S. have hypertension, which is
recognized as the most important single risk factor for cardiovascular
morbidity and death. Existing pharmacological interventions are
effective for some, but more than half of those treated with
antihypertensive medications continue to have uncontrolled high blood

"I am optimistic that device-based treatments, such as EVBA with the
MobiusHD implant, may be able to provide effective solutions for
patients who have not benefited from drug-based treatments," said
Professor Bryan Williams, Co-Principal Investigator of the trial and
Chair of Medicine at University College London, Director of Research at
UCL Hospitals, and Chairman-elect of the European Council on
Hypertension of the European Society of Cardiology.

About Endovascular Baroreceptor Amplification

Baroreceptors are specialized nerves located in the carotid artery,
which detect changes in stretch of the arterial wall and signal the
brain to control blood pressure. The baroreceptor mechanism, or
baroreflex, is an essential component for the body's natural regulation
of blood pressure. VDI is developing the first minimally invasive
technology designed to use this natural blood pressure control system to
address uncontrolled hypertension. The MobiusHD is a flexible
self-expanding device that reshapes the carotid sinus following
endovascular implantation. It is intended to amplify the baroreflex
while maintaining pulsatility.

Results published in The Lancet from an open-label,
proof-of-concept trial (CALM-FIM) using VDI's EVBA approach to treat
patients with resistant hypertension were positive, showing significant
reductions in blood pressure through six months, greater than the
24-hour ambulatory blood pressure reductions reported to date for
alternative devices used to treat hypertension.1 These
encouraging results led to the design and development of a rigorous
pivotal clinical trial intended to generate conclusive evidence
confirming the safety and efficacy of this unique device for resistant
hypertension patients.

The CALM-2 (Controlling And
Lowering blood pressure with MobiusHD)
pivotal trial is a prospective, randomized, sham-controlled,
double-blinded study targeting patients with drug-resistant
hypertension. Lessons learned from numerous clinical trials of
first-generation device-based approaches to hypertension were
incorporated into the CALM-2 study protocol to provide a best-in-class
clinical trial design. The CALM-2 trial is targeting enrollment of up to
300 patients at leading institutions across the U.S. and Europe. The
first patients were enrolled in July 2018 at the Center for Clinical
Research at Southern Illinois University Medicine and The Lindner
Research Center at The Christ Hospital Health Network.

"Enrolling the first patients in the CALM-2 trial is an important step
toward offering a new treatment option for this large patient population
with resistant hypertension and the associated health risks," stated
Gregg Stone, MD, Co-Principal Investigator of the CALM-2 trial and
Director of Cardiovascular Research and Education for
NewYork-Presbyterian Hospital/Columbia University Medical Center and
Co-Director of Medical Research and Education at the Cardiovascular
Research Foundation.

As VDI's recently appointed President and CEO, Ed Roschak is focused on
expanding the organization to execute on the CALM-2 trial. Roschak
commented, "We are putting the right team and processes in place to
successfully complete this landmark trial and to develop compelling
clinical evidence to support future FDA approval."

About Vascular Dynamics, Inc.

Vascular Dynamics develops innovative, minimally invasive platform
technologies to offer compelling treatment options for patients at risk
of life-threatening cardiovascular events and underserved by
conventional treatments. Focused initially on uncontrolled hypertension,
VDI was approved to participate in the FDA's Expedited Access Pathway
(EAP) program. EVBA treatment with the MobiusHD implant system has
received a CE Mark for the treatment of hypertension in the European
Union. The MobiusHD system is not commercially available in the United
States. More information is available at

CAUTION: Investigational Device: The MobiusHD® device is limited
in the United States to investigational use only.

1Spiering, W, Williams, B, Van der Heyden,
J…, Endovascular baroreflex amplification for the resistant
hypertension: a safety and proof-of-principle clinical study, The

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