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MedicalCV's Omnicarbon Heart Valve To Launch In August After 15-Year Wait

This article was originally published in The Gray Sheet

Executive Summary

MedicalCV aims to capture 1-2% of the roughly $360 mil. worldwide mechanical heart valve market over the next year after gaining FDA approval of its Omnicarbon pyrolite ceramic-based heart valve on July 26.

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MedicalCV, Inc.

Mechanical heart valve maker plans initial public offering to support marketing of its Omnicarbon 3000 monoleaflet, pyrolytic carbon heart valve following FDA approval July 26 (1"The Gray Sheet" Aug. 6, 2001, p. 12). The offering includes 1.5 mil. units at $4.50 each; the units consist of one share of common stock and a warrant to purchase an additional share at $6.50 per share. Estimated proceeds of $5.6 mil. will primarily be used for sales and marketing initiatives and working capital. MedicalCV also plans to pursue FDA approval of the Omnicarbon 4000 by late 2004, incorporating the firm's UPP Carbon coating technology. Other R&D projects include a bi-leaflet valve. Competing with mechanical valve market leader St. Jude as well as Sulzer Carbomedics, Edwards Life Sciences, Medtronic, Sorin Biomedica, ATS Medical and MCRI in the $580 mil. worldwide heart valve market, MedicalCV's revenues increased 6% to $2.9 mil. for the year ended April 30 and consisted mostly of European sales. The Inver Grove Heights, Minnesota firm had a net loss of $3.2 mil. for the year. Equity Securities Investments is managing underwriter for the offering

MedicalCV, Inc.

Mechanical heart valve maker plans initial public offering to support marketing of its Omnicarbon 3000 monoleaflet, pyrolytic carbon heart valve following FDA approval July 26 (1"The Gray Sheet" Aug. 6, 2001, p. 12). The offering includes 1.5 mil. units at $4.50 each; the units consist of one share of common stock and a warrant to purchase an additional share at $6.50 per share. Estimated proceeds of $5.6 mil. will primarily be used for sales and marketing initiatives and working capital. MedicalCV also plans to pursue FDA approval of the Omnicarbon 4000 by late 2004, incorporating the firm's UPP Carbon coating technology. Other R&D projects include a bi-leaflet valve. Competing with mechanical valve market leader St. Jude as well as Sulzer Carbomedics, Edwards Life Sciences, Medtronic, Sorin Biomedica, ATS Medical and MCRI in the $580 mil. worldwide heart valve market, MedicalCV's revenues increased 6% to $2.9 mil. for the year ended April 30 and consisted mostly of European sales. The Inver Grove Heights, Minnesota firm had a net loss of $3.2 mil. for the year. Equity Securities Investments is managing underwriter for the offering

CV Dynamics to resubmit Omnicarbon PMA to FDA within a few months.

CV DYNAMICS OMNICARBON CARDIAC VALVE PMA RESUBMISSION will come within the next few months, the company estimates. CV Dynamics plans to submit a revised version of a premarket approval application for the heart valve that was rejected by the agency in 1989. The company plans to supplement the filing with information including updated clinical data and comprehensive fatigue data on the Omnicarbon's pyrolite housing.

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