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9725 South Robert Trail
Inver Grove Heights, MN 55077-4424 USA
phone:(651) 452-3000
fax:(651) 452-4948
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| Symbol |
MCVI |
| Exchange |
OTC |
| Founded |
1992 |
| Employees |
17 |
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| www.medcvinc.com
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| Research Sector |
Medical Devices & Tech |
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| Summary Description |
| Surgical ablation tools designed for use in treatment of atrial fibrillation |
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| Management |
| Marc P. Flores, President & CEO; Eapen Chako: CFO; Adam L. Berman, VP of R&D; Robert W. Clapp, VP of Operations |
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| Keywords |
| cardiovascular, atrial fibrillation, arrhythmia, Cardiology, cardiac, heart tissue ablation, Cardiology, cardiac, heart, valve, ablation, heart, cardiovascular, advamed, j2008 |
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| Description |
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BUSINESS CLOSED
MedicalCV, Inc., a cardiovascular surgery device manufacturer, focuses on the design, development and commercialization of new, improved and enhanced technologies, products, methods and techniques to treat cardiovascular disorders and disease, including products targeting the treatment of atrial fibrillation. |
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| Products / Services |
The ATRILAZE Surgical Ablation System is used in cardiac tissue ablation procedures. The system consists of: the ATRILAZE Laser Unit, a cardiac tissue specific wavelength diode laser, and the ATRILAZE Delivery Device, a hand-held laser delivery device. The company acquired this technology in August 2003 and received FDA 510(k) clearance for its first generation product in December 2004 and its second generation product in October 2005 for the ablation of soft tissue to include cardiac tissue. The ATRILAZE system, and its platform of laser technology, is currently being utilized as a potential means to treat atrial fibrillation (AF) in a concomitant, open-heart surgical procedure.
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| Technology / Differentiation |
| Maze surgery is one of the standard treatment options for atrial fibrillation. It uses an intricate pattern of incisions on cardiac tissue to disrupt the electrical pathways that generate AF. MedicalCV's ATRILAZE Surgical Ablation System allows surgeons to make those cuts in a rapid and highly precise manner. The company believes that because the laser can be delivered through very small incisions, it could enable closed-chest, beating heart procedures. There are several competitors in the space and they utilize different energy sources for their ablation devices including cryothermy, radiofrequency, microwave, high-intensity ultrasound and laser. |
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| Market / Customers |
Atrial fibrillation is the most commonly occurring cardiac arrhythmia and its prevalence increases with age. Approximately 5.5 million people worldwide and nearly 2.5 million Americans are afflicted with AF. Globally, 320,000 new diagnoses made each year. The company belieives the addressable market for ATRILAZE is more than $2 billion. The disease reduces cardiac output, is a major precursor to congestive heart failure and is associated with an increased incidence of stroke. There are several treatment options for AF including medications, electrical cardioversion, radiofrequency ablation, pacemakers and surgery. Surgical procedures are complex and performed at only a few medical centers.
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| Strategy |
In May 2006, Medical CV submitted a 510 (k) application for the ATRILAZE Minimally Invasive System. This system is designed for use in closed-chest, beating heart treatment of AF and MedicalCV hopes to be the first FDA approved standalone, minimally invasive ablation treatment for AF. MedicalCV's competitors are also developing standalone treatments. The company is aggressively working to increase its penetration through its sales team and physician and patient education programs that attempt to show the benefits of laser over other technologies.
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| Status |
| The ATRILAZE Surgical Ablation System received 510(k) clearance on November 30, 2004 for use on cardiac tissue in surgery. It was introduced to the market in January 2005. May 2007, the United States Patent and Trademark Office "USPTO" issued three additional Notices of Allowance to MedicalCV on patent applications pertaining to various aspects of MedicalCV's proprietary laser-based surgical ablation technology. MedicalCV currently markets both the ATRILAZE(TM) and SOLAR(TM) Surgical Ablation Systems. |
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