STONY BROOK, NY/PRNewswire-USNewswire/ — Sound
Interventions, Inc. today announced the successful completion of the company’s
First-In-Human clinical trial (SOUND-ITV) to treat resistant hypertension.
The study was performed by Dr. Petr Neuzil and a team of
cardiologists at Holmolka Hospital in Prague,
Czech Republic.
Patients enrolled in the study were selected based on a history of hypertension
which could not be controlled with medical therapy. The SOUND-ITV study is
focused on safety and effectiveness of the company’s volumetric dosimetry-based
application of unfocused ultrasound (patents pending). Patients enrolled in the
study will be followed for 12 months to evaluate the procedure’s effectiveness
in lowering blood pressure.
“This study demonstrated the feasibility of the acute
procedure,” stated Doc. MUDr. Petr Neuzil, CSc., FESC, Chairman,
Department of Cardiology of Holmolka
Hospital. “The
procedures highlighted the ease with which the system and the ultrasound energy
may be delivered, minimizing the number of applications of energy and the
procedure time.”
Dr. Vivek Reddy, of Mt. Sinai Medical Center in New York
City, who is an advisor to Sound Interventions, commented, “In addition to
testing the effectiveness of ultrasound in lowering blood pressure, the study
was designed to evaluate the ability of the technology to deliver a specific
dose of ultrasound which is effective in affecting the renal sympathetic
nerves, while sparing the renal artery from damage. We are encouraged by the
complete lack of ultrasound-induced spasm in the renal arteries during these
procedures. Spasm is a common occurrence when radiofrequency energy is
delivered in the renal arteries.”
“The successful completion of the treatment phase of
the SOUND-ITV study is an important milestone for Sound Interventions, and
brings us closer to our goal of commercialization of the Sound Interventions’
technology,” said David Smith, President & CEO of Sound Interventions.
“While we await the important follow-up data from this series of patients,
we continue to move forward with our plans for an expanded European
trial.”
About Sound Interventions
Sound Interventions is a privately held emerging medical technology company
focused on the development of therapeutic ultrasound for the treatment of
resistant hypertension. Founded in 2010, Sound Interventions is located in the
Long Island High Technology Incubator at Stony
Brook, NY. For more
information, please visit www.sounditv.com.
Dr. Neuzil received financial support from Sound
Interventions for the SOUND-ITV Study.
Dr. Reddy is an equity holder in Sound Interventions.
