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Thermedical Announces FDA Investigational Device Exemption Approval to Begin US Clinical Study of Durablate Catheter for Treatment of Ventricular Tachycardia

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Thermedical®
announced today that the U.S. Food and Drug Administration (FDA) has
approved its Investigational Device Exemption (IDE) application for the
Early Feasibility Study (EFS) of the groundbreaking Durablate™ ablation
catheter. The single-arm, observational study is designed to evaluate
the safety and effectiveness of the Durablate catheter to treat ventricular
tachycardia
(VT), a leading cause of Sudden Cardiac Death in the U.S.

The target population consists of patients who have already been treated
with medicine, have an Implantable Cardioverter Defibrillator (ICD), and
who have had a conventional ablation procedure to treat VT, yet all
their treatments have failed. The study is scheduled to begin in 2018 at Mayo
Clinic
under the direction of Douglas L. Packer, M.D., Professor of
Medicine, and at Loyola
University of Chicago Stritch School of Medicine, under the direction of
David Wilber, M.D., Medical Director of Clinical Electrophysiology.

"Receiving IDE approval to begin clinical testing of our innovative ablation
therapy
in patients is an important next step to advance treatment
to reduce or potentially eliminate VT episodes," said Michael Curley,
Ph.D., FHRS, co-founder and chief executive officer of Thermedical. "A
successful therapy would significantly improve the quality-of-life for
the more than one million people who develop, or are at high risk for
developing VT annually.

"Ablation therapy for the treatment of VT today is problematic,
resulting in extremely long procedures and a low success rate,"
continued Dr. Curley. "There is significant need for an effective
ablation therapy that can serve as an adjunct to, or as a possible
replacement for ICDs. We believe our solution may be a low-cost
alternative for treating VT, and it might save the US healthcare system
significant costs associated with VT treatment today."

Implantable Cardioverter Defibrillators are the current standard-of-care
treatment for patients suffering from VT; however, this approach does
not stop the progression of the disease or provide a cure. In addition,
ICDs can be costly and painful, and may substantially reduce a patient's
quality of life. VT patients who have ICDs and recurrent VT may be
treated today with conventional RF ablation, which is a lengthy
procedure that has a success rate of approximately 50 percent1.

Thermedical's patented ablation technology uses heat to kill the damaged
heart muscle cells that are causing VT. The heat is delivered by the
Durablate catheter, which simultaneously injects a precise flow of hot
saline together with controlled RF energy into the heart tissue. This
combination is an advanced form of biological heat transport that is 20
times more effective than conventional RF ablation methods. Compared to
conventional VT ablation catheters, Durablate can more accurately
control the ablation size, and it can treat tissue that is deeper in the
heart wall, which is where life-threatening arrhythmias (abnormal, rapid
heart rhythm) that cause VT are often located.

About Thermedical

Thermedical
is a privately held company founded by Massachusetts Institute of
Technology (MIT) Hyperthermia Center alumni, Michael
G. Curley, Ph.D.
and Patrick
S. Hamilton, Ph.D.
, based in Waltham, Mass. Under a Massachusetts
Life Sciences Center Small Business Matching Grant (SBMG) Award,
multiple NIH* Small Business Innovation Research (SBIR) Grants, and
Series A venture funding; the company has developed thermal-ablation
systems to treat VT. The FDA-approved EFS will be the first human use of
the Durablate Catheter Ablation System in the United States. Human
studies began earlier in Canada and continue at three leading Canadian
centers. For more information, visit: www.thermedical.com.

1 http://www.onlinejacc.org/content/accj/67/6/684.full.pdf

* Research reported in this publication was supported by the National
Heart, Lung, And Blood Institute of the National Institutes of Health
under Award Number R44HL132746. The content is solely the responsibility
of the authors and does not necessarily represent the official views of
the National Institutes of Health.

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