Resources will be channeled towards randomized clinical studies and further commercialization.
Keystone Heart will exhibit and present at EuroPCR next week in Paris.
CAESAREA, Israel, May 15, 2014 /CNW/ - Keystone Heart, a medical device company and the developer of CE marked TriGuard™ Cerebral Protection Device, has successfully raised $14M in a series B round of financing led by OrbiMed. OrbiMed is a leading investment firm dedicated exclusively to the healthcare sector, managing approximately $11 billion across public and private company investments.
Keystone Heart's TriGuard™ is the only cerebral protection device specifically designed to provide full coverage to all aortic arch takeoffs. By protecting all brain territories, the TriGuard™ Cerebral Protection Device is designed to minimize the risk of cerebral damage during TAVR (Transcatheter Aortic Valve Replacement) and other cardiovascular procedures.
The current round of financing will be dedicated to conducting a European multi-center, randomized clinical trial during TAVR procedures, as well as a planned FDA IDE study. These studies will enable further assessment of the efficacy and performance of the TriGuard™ and are expected to generate additional clinical data to support the TriGuard™ commercialization globally. Keystone Heart is planning additional studies to leverage the TriGuard™ product pipeline in TAVR and other cardiovascular indications.
Mr. Hank Hauser, formerly VP Clinical Affairs at Vessix Vascular, has recently joined Keystone Heart as VP Clinical Operations, to support these expanding clinical activities.
DEFELCT I clinical data presented at PCR 2013 demonstrated a significant reduction of over 60% of new brain lesion volume during protected TAVR procedures using TriGuard™, compared with historical data on unprotected TAVR procedures. DEFLECT III , a multi-center, randomized clinical trial, conducted in up to 12 centers across Europe and Israel, is currently enrolling patients undergoing TAVR procedures, to evaluate this critical effect further.
"When performing TAVR procedures, we should provide embolic cerebral protection to protect the brain from insult. I strongly believe that TriGuard™ makes a difference" said Prof. Joachim Schofer, Head of Universitāres Herzzentrum in Hamburg, Germany, one of the leading investigators participating in this study.
Keystone Heart will be exhibiting at EuroPCR 2014 next week in Paris, and will review some key activities in clinical presentations at this leading European Cardiology Congress.
The TriGuard™ Cerebral Protection Device is not yet commercially available in the USA.
Keystone Heart Ltd. is a medical device company developing and manufacturing cerebral protection devices to reduce the risk of stroke, neurocognitive decline and dementia caused by brain emboli associated with cardiovascular procedures.
The Company is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, surgical valve replacement, atrial fibrillation ablation and other cardiovascular procedures. The novel TriGuard™ product pipeline is designed to help interventional cardiologists, electrophysiologists and cardiac surgeons to preserve brain reserve while performing these procedures.
Headquartered in Israel, Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research. The Company's management has extensive experience in the fields of interventional cardiology and medical devices.
SOURCE: Keystone Heart
For further information: Mr. Shuki Porath, President and CEO, firstname.lastname@example.org, Tel: +972-4-615-8000, http://www.keystoneheart.com