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Nika · #1 (**permalink**) 04-27-2005, 09:26 PM

Source:
Business Wire

Business Wire; 4/20/2005

FORT MYERS, Fla. -- Frost & Sullivan will present MedicalCV, Inc. (OTCBB:MDCV), with the 2005 Excellence in Technology Award at tonight's Best Practices Awards Banquet for its development of an innovative laser-based surgical ablation platform known as the ATRILAZE(TM) system.

Every year, Frost & Sullivan presents this Award to a company that has pioneered the development/introduction of an innovative technology into the market -- one that is expected to bring significant contributions to the industry in terms of adoption, change, and competitive posture. The Award lauds overall technical excellence and commitment toward technology innovation.

"The ATRILAZE(TM) Surgical Ablation System provides patients with a minimally invasive surgical option to treat atrial fibrillation (AF), and obviates the need for cardiopulmonary bypass (CPB) in many patients," says Frost & Sullivan Research Analyst S. Ravi Shankar. "By allowing stand-alone surgery to be performed, it will help deliver ablation to patients who suffer solely from AF."

AF is a cardiac disorder for which no satisfactory medical treatment exists to date. Treating this condition with antiarrhythmic drug therapy is associated with a failure rate of 50 percent (in one year) to 84 percent (in two years). Besides, currently available antiarrhythmic agents may result in side effects on ventricular function, which may further cause other complications such as ventricular tachyarrhythmias.

The failure of medical therapy to provide a long-lasting solution to AF has spurred efforts to develop surgical treatments. Dr. James Cox's Maze procedure demonstrated the feasibility of treating AF surgically by interrupting the atrial pathways for multiple re-entry circuits. The 'Cox-Maze' procedure has an outstanding success rate (approximately 98 percent) in those patients who suffer only from AF, and a high rate (up to 90 percent) in patients who exhibit concomitant heart conditions. In spite of the attractive success rates, the procedure has not been widely adopted because it is time-consuming, very complex, and requires highly skilled surgeons.

"Efforts are currently focused on reducing the complexity of the procedure and lowering the procedure time," notes Shankar. "But, in general, surgeons do not prefer to use open-heart surgery for those patients who suffer solely from AF."

Therefore, treatment strategies based on the employment of alternate energy sources are being explored because they can ablate the atrial tissue faster, in a minimally invasive manner. One such solution is MedicalCV's ATRILAZE(TM) system that uses laser to ablate cardiac tissue. Laser is a viable alternative to the surgeon's scalpel since it is very accurate and capable of rapidly creating lesions without any collateral damage.

The ATRILAZE's laser is the only energy source that can be adapted to function effectively through port-access type incisions. It can be extended to thoracoscopic as well as robotic surgery. Moreover, since the laser can be delivered through a 600-micron optical fiber, it represents a giant leap toward performing the Maze procedure through the stand-alone, minimally invasive (closed-chest, beating heart) surgery. The ability to perform surgery on a beating heart precludes the need of putting a patient on a heart-lung machine (as regards CPB).

Through this stand-alone, minimally invasive procedure, the operation is complete within two hours and the patient can go home in the next 24 hours. The patient would be able to return to normal activities within one to two weeks, rather than six to eight weeks as required in the case of traditional invasive open-heart surgery. This abbreviated recovery time helps in reducing hospitalization costs and enhancing surgeon productivity.

The market for AF treatment through the concomitant open-chest Maze procedure is close to $250 million, while the minimally invasive treatment market for AF (stand-alone solutions for closed-chest, beating heart treatment) represents a $1.5 billion-a-year opportunity by 2008. MedicalCV's minimally invasive approach would be pivotal in the treatment of patients who suffer solely from AF as a complication, and in the long term, would help it enter the much larger stand-alone, minimally invasive (closed-chest, beating heart) market (the technology is currently being employed in concomitant open-chest procedures).

Overall, MedicalCV's ATRILAZE(TM) system represents a breakthrough technology that improves patient outcomes and comfort, enhances surgeon productivity while simultaneously reducing hospitalization. For this, the company is a worthy recipient of the Frost & Sullivan Award for Excellence in Technology.

Held in Fort Myers, Fla., the Frost & Sullivan banquet honors world-class companies for outstanding performance and achievements in their industries. An annual event, the banquet recognizes the quality and merit of distinguished individuals and companies.

About MedicalCV, Inc.

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 ("AF"). Historically, MedicalCV developed and marketed Omnicarbon(R) mechanical heart valves utilizing its proprietary pyrolytic carbon processes. Although the Company ceased manufacturing new heart valves in September 2004, it had continued to maintain the mechanical heart valve business, supporting customers and distributors during the divestiture process. After April 30, 2005, the Company will discontinue sales of the Omnicarbon(R) heart valve. The Company is concentrating its resources on the AF market. The Company's core technology is the ATRILAZE(TM) Surgical Ablation System, for use in cardiac tissue ablation in surgery, which the Company acquired on August 27, 2003 and for which it received FDA 510(k) clearance on November 30, 2004. The Company's common stock is traded on the OTC Bulletin Board under the symbol "MDCV."

For further information on MedicalCV, Inc., please visit www.medcvinc.com.

INDICATION: The ATRILAZE(TM) Surgical Ablation System is indicated for delivery of 810nm light to soft tissue to include cardiac tissue during surgical procedures.

Indications include incision, excision, dissection, vaporization, ablation, or coagulation of tissue.

About Frost & Sullivan

Frost & Sullivan, a global growth consulting company, has been partnering with clients to support the development of innovative strategies for more than 40 years. The company's industry expertise integrates growth consulting, growth partnership services and corporate management training to identify and develop opportunities. Frost & Sullivan serves an extensive clientele that includes Global 1000 companies, emerging companies, and the investment community, by providing comprehensive industry coverage that reflects a unique global perspective and combines ongoing analysis of markets, technologies, econometrics, and demographics. For more information, visit www.frost.com.

Opinions expressed in the above press release are those of Frost & Sullivan. The statements have been arrived through its own analysis of the market. The organization mentioned in the press release is not responsible for arriving at conclusions that have been incorporated in the above press release.

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MedicalCV Receives Frost & Sullivan's Excellence in Technology Award in the Surgical