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Paradigm Medical Industries Receives FDA Approval for P60 UBM Device; Names New Vice-President of Engineering
SALT LAKE CITY--(BUSINESS WIRE)--June 2, 2005--Paradigm Medical Industries, Inc. (OTCBB: PMED.OB/PMEDW.OB) today announced it has received U.S. Food and Drug Administration (FDA) 510(k) premarket approval for its P60 ultrasound biomicroscope (UBM). The Company filed a 510(k) application for the P60 with FDA in late April. The UBM is used for viewing structures in the eye involved with glaucoma pathologies and surgical procedures.
"FDA approval will allow the Company to begin selling the P60 in the U.S. immediately," said Paradigm Medical's Chief Operating Officer, Aziz A. Mohabbat. "Coupled with receiving the CE Mark earlier this year, the Company can now participate in the global market opportunity for UBM devices."
The P60 represents the Company's fourth-generation of UBM devices, and is believed to have better visual clarity and image flexibility than earlier versions. The UBM is Paradigm Medical's largest generator of revenues. UBM accounted for more than 25% of corporate sales in 2004.
Paradigm Medical also announced it has named Fredrick D. Geiger, 36, as Vice-President, Engineering, effective immediately. Mr. Geiger most recently served as director of production, product management, and engineering at Stonebridge Systems and a member of its Executive Council.
"We are extremely pleased to add Fred Geiger to our management team," noted Paradigm Medical's Chief Executive Officer, John Y. Yoon. "He brings a broad array of disciplines, including engineering, product management, and information technology. Fred will be instrumental in retooling Paradigm Medical's product line, as we have done with the P60."
Paradigm Medical Industries, Inc., currently develops, manufactures and markets surgical and diagnostic high-tech, proprietary equipment and consumable products for the medical industry. The Company's corporate headquarters are located at 2355 South 1070 West, Salt Lake City, Utah 84119. Call (801) 977-8970 or visit us at www.paradigm-medical.com.
This press release contains statements that, if not verifiable historic fact, may be viewed as forward-looking statements that could predict future events or outcomes with respect to Paradigm and its business. The predictions embodied in these statements will involve risk and uncertainties and, accordingly, actual results may differ significantly from the results discussed or implied in such forward-looking statements.
Contacts
Paradigm Medical Industries, Inc. Aziz A. Mohabbat, 801-977-8970
posted
Paradigm Medical Industries Receives FDA Approval for P60 UBM Device; Names New Vice-President of Engineering
June 02, 2005 11:33:01 (ET)
SALT LAKE CITY, Jun 02, 2005 (BUSINESS WIRE) -- Paradigm Medical Industries, Inc. (OTCBB: PMED.OB/PMEDW.OB) today announced it has received U.S. Food and Drug Administration (FDA) 510(K, Trade) premarket approval for its P60 ultrasound biomicroscope (UBM). The Company filed a 510(k) application for the P60 with FDA in late April. The UBM is used for viewing structures in the eye involved with glaucoma pathologies and surgical procedures.
"FDA approval will allow the Company to begin selling the P60 in the U.S. immediately," said Paradigm Medical's Chief Operating Officer, Aziz A. Mohabbat. "Coupled with receiving the CE Mark earlier this year, the Company can now participate in the global market opportunity for UBM devices."
The P60 represents the Company's fourth-generation of UBM devices, and is believed to have better visual clarity and image flexibility than earlier versions. The UBM is Paradigm Medical's largest generator of revenues. UBM accounted for more than 25% of corporate sales in 2004.
Paradigm Medical also announced it has named Fredrick D. Geiger, 36, as Vice-President, Engineering, effective immediately. Mr. Geiger most recently served as director of production, product management, and engineering at Stonebridge Systems and a member of its Executive Council.
"We are extremely pleased to add Fred Geiger to our management team," noted Paradigm Medical's Chief Executive Officer, John Y. Yoon. "He brings a broad array of disciplines, including engineering, product management, and information technology. Fred will be instrumental in retooling Paradigm Medical's product line, as we have done with the P60."
Paradigm Medical Industries, Inc., currently develops, manufactures and markets surgical and diagnostic high-tech, proprietary equipment and consumable products for the medical industry. The Company's corporate headquarters are located at 2355 South 1070 West, Salt Lake City, Utah 84119. Call (801) 977-8970 or visit us at www.paradigm-medical.com.
This press release contains statements that, if not verifiable historic fact, may be viewed as forward-looking statements that could predict future events or outcomes with respect to Paradigm and its business. The predictions embodied in these statements will involve risk and uncertainties and, accordingly, actual results may differ significantly from the results discussed or implied in such forward-looking statements.
SOURCE: Paradigm Medical Industries, Inc.
Paradigm Medical Industries, Inc. Aziz A. Mohabbat, 801-977-8970
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75 was a good entry point if it shakes to 75 or below again it should bounce to 85 or so
-------------------- Choosing individual stocks without any idea of what you're looking for (or without reliable information) is like running through a dynamite factory with a burning match. You may live, but your still an idiot.
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another shake should come just after lunch, jump in and it should run eod IMHO
-------------------- Choosing individual stocks without any idea of what you're looking for (or without reliable information) is like running through a dynamite factory with a burning match. You may live, but your still an idiot.
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that's right jump in in the 7's, this should closed at the HOD, then make a big run again tomorrow once the news come out, and the company announces the start of the orders for their FDA approved product.
I got in at 79 will stay in for a while and buy on the dips, doing more research on it.
For now, riding the wave.
-------------------- Dream Come True if You Truly Believe !!!!
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Company announcement for the FDA aprroval, which today was approved.
Paradigm Medical Industries Files 510k With FDA for Next Generation UBM Device SALT LAKE CITY
Paradigm Medical Industries, Inc. Aziz A. Mohabbat, 801-977-8970
Paradigm Medical Industries, Inc. today announced it has filed a 510(k) with the U.S. Food and Drug Administration (FDA) for its new generation ultrasound biomicroscope (UBM). Last month, the Company was awarded the CE Mark for the P60 UBM, which will enable it to market the device in 19 Western European countries and some parts of the Pacific Rim.
A 510(k) is a formal marketing application to the FDA to gain clearance for specific indications of use for a device. With FDA approval, the new device will be available for sale in the United States.
"The P60 represents the latest generation of our UBM devices," said Paradigm Medical's Chief Operating Officer, Aziz A. Mohabbat. "We believe it has better visual clarity and image flexibility than earlier versions."
The UBM is Paradigm Medical's leading product, accounting for more than 25% of 2004 revenues.
The P60 represents the Company's fourth generation UBM device. The first three devices already have received U.S. FDA approval as well as the CE Mark. The UBM is used for viewing structures in the eye involved with glaucoma pathologies and surgical procedures.
Paradigm Medical Industries, Inc., currently develops, manufactures and markets surgical and diagnostic high-tech, proprietary equipment and consumable products for the medical industry. The Company's corporate headquarters are located at 2355 South 1070 West, Salt Lake City, Utah 84119. Call (801) 977-8970 or visit us at www.paradigm-medical.com.
This press release contains statements that, if not verifiable historic fact, may be viewed as forward-looking statements that could predict future events or outcomes with respect to Paradigm and its business. The predictions embodied in these statements will involve risk and uncertainties and, accordingly, actual results may differ significantly from the results discussed or implied in such forward-looking statements.
-------------------- Dream Come True if You Truly Believe !!!!
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OTCStockExchange.com's "Mid-Day Stock Watch Alert" this afternoon are BICO, Inc. (Pink Sheets: BIKO), Paradigm Medical Industries, Inc. (OTCBB: PMED), The World Golf League, Inc. (OTCBB: WGFL), GLOBAL TRIAD, INC. (Pink Sheets: GTRD).
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