About

Business Description

Cardious, Inc. is intent on providing the Cardiac Surgeon with the implant and associated tool needed to safely and effectively relieve aortic valve disease without stopping the heart while still using the same trusted clinically proven prosthetic heart valve the surgeon has historically implanted.

Product

The AvA™ Aortic Valve Bypass Graft System is a minimally invasive alternative to traditional aortic valve replacement therapy. avbg Requiring only a small incision between the ribs to expose the beating heart, the device is implanted by a surgeon using the system’s innovative cutting tool to bloodlessly connect two custom designed grafts between the left ventricle of the beating heart and the descending aorta.  The surgeon then inserts a commercially available artificial heart valve into the device to form an alternative pathway for blood to flow out of the heart.

Benefits

Patients benefit due to the elimination of the life threatening risks and potential serious side effects associated with the use of a heart-lung machine.  Surgeons and hospitals benefit because the cost effective therapy easily fits into current practice, is a safer “off pump” aortic valve therapy compared to unproven transcatheter heart valves being promoted by interventional cardiologists, and has a clearly defined reimbursement path.  Finally, investors will love the AvA System for its excellent profit potential, minimal direct competition, and its first to market product development strategy

Market

The AvA Valve Bypass System will enter the aortic valve replacement market by providing the surgeon with a tool to address the large pool of currently identified No Option patients with severe aortic valve stenosis who are not well enough to withstand the rigors of traditional valve surgery.  Once the AvA System is established in this large no option, non-surgical pool of patients, its use will naturally expand as the surgeon gains confidence and begins to consider it a safer alternative for many currently defined High Risk surgical candidates.  Once reduced risks and additional benefits are demonstrated through use in higher risk surgical candidates, surgeons will consider its use in the remaining large pool of Low Risk patients.  Surgeons will realize the “beating heart” nature of the AvA procedure will generate fewer complications while delivering the same therapeutic effects as traditional “stopped heart” valve surgery.