University of Chicago Researchers Conduct Study of Unique Device to Lower High Blood Pressure

CALM-2 Clinical Trial, sponsored by VDI, Focuses on Drug-Resistant
Hypertension

CHICAGO–(BUSINESS WIRE)–The University of Chicago Medicine’s Comprehensive Hypertension Center
is participating in an FDA-approved pivotal trial of a novel
catheter-based, non-surgical procedure to treat patients with
drug-resistant hypertension. This study, called CALM-2 (Controlling
And Lowering blood pressure with MobiusHD®),
continues the study of the investigational MobiusHD device which was
evaluated in an earlier proof-of-concept CALM-FIM which showed
significant reductions in blood pressure through six months.

The new, larger, multi-center CALM-2 clinical trial has been designed to
assess the safety and effectiveness of this unique device as a possible
solution for patients whose blood pressure is not controlled with
prescribed medications.

The research team at the Comprehensive Hypertension Center, led by
world-renowned hypertension expert, professor of medicine and Center
Director George
Bakris, MD, specializes in the assessment and treatment of
hard-to-treat hypertension. This includes the assessment of studies
examining innovations in resistant hypertension.

Specialized stretch-sensitive nerves called baroreceptors are located in
the walls of the carotid arteries and play an essential role in the
body’s natural blood pressure regulation. The MobiusHD system is used in
the first minimally invasive procedure to utilize the baroreceptor
mechanism to address uncontrolled hypertension.

“Patients with high blood pressure who are non-responsive to multiple
medications have very few treatment options,” said Bakris. “Based on our
experience, device-based approaches targeting baroreceptors as a
therapeutic option have promise. The initial results using the MobiusHD
implant to reshape the carotid sinus and stretch baroreceptors to
modulate the body’s natural blood pressure regulation are impressive,
and we are excited to participate in the CALM-2 clinical trial to fully
evaluate the safety and effectiveness of this new treatment.”

The CALM-2 clinical trial, sponsored by Vascular Dynamics Inc., is
targeting up to 300 drug-resistant hypertension patients at select
medical centers around the U.S. and in the UK and Europe, including
UChicago Medicine.

To learn more about the CALM-2 study, visit www.calm2study.com.
To explore further background on the MobiusHD device, visit www.vasculardynamics.com.

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 Breakthrough Devices
Program (formerly known as the Expedited Access Pathway (EAP) program).
The MobiusHD implant system has received a CE Mark for the treatment of
hypertension in the European Union; however, the MobiusHD® system is not
commercially available in the United States. More information is
available at www.vasculardynamics.com.

CAUTION: In the United States, the MobiusHD® device is limited by
law to investigational use only.

Contacts

Media Contact:
Paul Williams
310-569-0023
[email protected]