April 10 2015 CardiAQ™ Valve Technologies receives FDA IDE

News Release
FOR IMMEDIATE RELEASE
Contact: Ronald Trahan, APR, Ronald Trahan Associates, Inc., +1 508-359-4005, x108
CardiAQ™ Valve T echnologies receives F DA I DE Approval
for a US E arly F eas ibility Study of I ts Second-Generation
T rans fem oral and T rans apical T rans catheter
Mitral Valve I m plantation Sys tem s
For p atien ts s u fferin g from s evere, s ymp tomatic mitral regu rgitation
an d w h o are h igh -ris k can d id ates for op en h eart s u rgery,
Tran s cath eter Mitral V alve I mp lan tation may offer
h op e for a n ovel d efin itive treatmen t
With th is s tu d y ap p roval, U S clin ical in ves tigators w ill n ow b e ab le to
commen ce as s es s in g th e feas ib ility an d s afety of th e tw o C ard iA Q S ys tems
in p rep aration for a fu tu re p ivotal s tu d y
IRVINE, Calif., April 10, 2015—CardiAQ Valve Technologies (CardiAQ), today announced that it has
received a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval
to conduct an early feasibility study using the CardiAQ Second-Generation Transfemoral (TF) and
Transapical (TA) Transcatheter Mitral Valve Implantation (TMVI) Systems. The study will enroll up to
20 patients (10 TF and 10 TA) and multi-disciplinary physician teams at select US sites will start
enrollment once hospital approvals and agreements are in place. CardiAQ also announced that Beth
Israel Deaconess Imaging Core Laboratory will serve as the core lab for its US and OUS studies under
the leadership of Jeffrey Popma, MD, Director, Interventional Cardiology, Beth Israel Deaconess
Medical Center and Professor of Medicine, Harvard Medical School.
“The FDA’s new draft guidance, ‘Investigational Device Exemptions (IDE’s) for Early Feasibility
Medical Device Clinical Studies, including Certain First in Human (FIH) Studies’, is a relatively new
approach to clinical studies conducted in the early stages of development, and is designed to facilitate
early clinical experience with investigational medical devices to reach patients sooner and to create
innovation capabilities within the United States,” said Paul Cornelison, VP Regulatory Affairs, Quality
Assurance & Clinical Affairs at CardiAQ. “Through its application and close collaboration with the
FDA, we are delighted to be able to bring our self-conforming, self-anchoring implant technology to US
patients much earlier.”
“CardiAQ remains the only company on this new medical frontier to have successfully accomplished
both transfemoral and transapical human mitral valve implantations,” said Brent Ratz, Co-Founder,
President and COO. “The approval of this study is a major step forward for the clinical development of
CardiAQ’s groundbreaking TMVI platform and, for the first time ever, will give US heart teams the
choice of a mitral valve that can be delivered either transfemorally or transapically.”
“CardiAQ’s second generation TMVI products are built upon the company’s proprietary method for
anchoring the implant through leaflet engagement, chordal preservation, and annular attachment, while
offering greater durability, improved flow properties, and a novel feature for the prevention of
paravalvular leaks,” said Arshad Quadri, MD, Cardiac Surgeon, Founder, and CMO. “As a practicing
physician who treats patients with mitral regurgitation, I am personally excited that we are now in a
position to bring this technology to high-risk patients in the US.”
“Obtaining an early feasibility IDE approval in the US represents a pivotal milestone in establishing
Transcatheter Mitral Valve Implantation as the next-generation, less-invasive therapy for structural heart
therapy because early participation of US investigative centers will fast-forward clinical understanding
and adoption of CardiAQ’s technology,” added CEO Rob Michiels.
About CardiAQ Valve Technologies
Privately held CardiAQ, headquartered in Irvine, Calif., has developed a proprietary Transcatheter Mitral
Valve (TMV) Implant that can be delivered through multiple delivery systems, including both
Transfemoral and Transapical. Through its unique anchoring mechanism that engages and utilizes the
patient’s native mitral valve anatomy, physicians will be able to accurately and securely implant a new
mitral valve within a beating heart without circulatory support, thus avoiding open-heart surgery. The
CardiAQ TMVI procedures are designed to be performed in a cardiac catheterization laboratory or
hybrid operating room. Ultimately, the procedure will result in less trauma to the patient and substantial
potential cost-savings to the healthcare system.
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C aut ion: The C ar diA Q™ V alve Te c hnologie s Syst e ms f or Tr ansc at he t e r Mit r al
V alve Implant at ion ar e in t he e ar ly phase s of c linic al de ve lopme nt and w ill be
unde r going c linic al t r ials in t he U SA and ove r se as unt il f ur t he r not ic e . The
C ar diA Q TMV I t e c hnology is limit e d by F e de r al law t o inve st igat ional use only
and is N OT available f or sale .