Well, here it is. The IDE was given FDA approval + earnings. Tomorrow should be interesting......
Thursday May 6, 4:30 pm Eastern Time
Company Press Release
SOURCE: Symphonix Devices, Inc.
Symphonix Devices, Inc. Reports First Quarter Financial Results
SAN JOSE, Calif., May 6 /PRNewswire/ -- Symphonix Devices, Inc. (Nasdaq: SMPX - news) today reported a
net loss of $3.9 million, or $0.32 per share, for the first quarter ended March 31, 1999, compared to $2.7 million,
or $0.36 per share for the corresponding quarter of 1998.
Symphonix reported revenues of $115,000 for the quarter from sale of the Company's Vibrant soundbridge in Europe.
In the United States, Symphonix reported that it expects to complete follow-up of its pivotal trial of the Vibrant P soundridge during the second quarter of 1999.
Harry S. Robbins, Symphonix Chief Executive Officer, stated, ''We have now submitted to the FDA, under the modular PMA process, a total of seven
modules, five of which have already been reviewed and accepted by the FDA.''
Symphonix also announced that it had received FDA approval of an IDE supplement permitting the evaluation of the Vibrant D soundbridge, the Company's
latest generation product incorporating 100% digital technology . Harry S. Robbins stated, ''After fitting the device to many of our existing patients, the initial
results from the Vibrant D soundbridge have been encouraging and we anticipate being able to submit data for the Vibrant D and Vibrant P soundbridges
simultaneously to the FDA in a PMA submission.''
Founded in 1994, Symphonix Devices, Inc. is a hearing management company dedicated to developing a family of products to improve communication ability
and quality of life for the millions of hearing-impaired individuals who cannot benefit from current hearing technology. Symphonix's family of Vibrant
soundbridges are surgical implants designed to work with the natural structures of the middle ear, to enhance hearing and communication ability for people with
hearing impairment.
Except for historical information, statements made in this press release are ''forward looking statements'' and are subject to a number of risks and uncertainties
that could cause actual results to differ materially from the statements made. Such risks and uncertainties include but are not limited to the risks that the final
clinical trial results will not be consistent with the initial results or the intended claims of the Vibrant P and Vibrant D soundbridges; that Symphonix will not
finish patient follow-up or submit the remaining modules of the PMA for the Vibrant P and Vibrant D soundbridges in 1999; or that the clinical trial results for
the Vibrant P and Vibrant D soundbridges will not demonstrate the required safety and efficacy to obtain PMA approval. These and other risk factors are
described in the Company's Form 10-K for the year ended December 31, 1998.
Symphonix and Vibrant are registered trademarks of Symphonix Devices, Inc. |
