SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : BEAM, BOL, KERA, LASE, LCAV, LVCI, LZRC, VISX, SNRS, STAA

 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: HerbVic who wrote (226)2/24/2000 1:09:00 PM
From: MangoBoy   of 253
 
[SurgiLight Submits IDE Application for New Procedure of Laser Presbyopia Correction]

ORLANDO, Fla.--(BUSINESS WIRE)--Feb. 24, 2000--SurgiLight Inc., (OTCBB:SRGL) announced today that it has submitted an Investigational Device Exemption (IDE) to the Food and Drug Administration (FDA) for the new procedure of Laser Presbyopia Reversal using its patent pending technology. The Company also expects to obtain the IRB approval from Mt. Sinai Hospital in New York for this new IDE clinical trial soon.

In the IDE submission, the Company includes the results of 19 cases of laser presbyopia correction to support the application for an additional 30 cases. The reported data shows more than 6 months follow-up for patients with age range of 42 to 65 with little or no regressions. Details of the first group of clinical results were reported by the Company at the 1999 World Refractive Surgery Symposium earlier.

The Company is concluding the acquisition of IR Vision, Inc. and one of their OPO-IR laser systems was delivered to the Company for clinical studies including LASIK procedures. Adding the IR technology developed by IR Vision, Inc. the Company believes that it will become the leader of IR lasers for LASIK procedures as well as the pioneer of laser presbyopia reversal. The Company also believes that it is the only company not suffering price competition, legal issues and licensing fees related to Excimer UV laser technology currently used by its competitors including VISX (NASDAQ:VISX), Summit (NASDAQ:BEAM), LaserSight (NASDAQ:LASE), Nidek (Japan) and Bausch & Lomb (NYSE:BOL).

After the acquisition of IR Vision, the Company will own three (3) different IR laser technologies and two (2) ultraviolet (UV) lasers for vision correction and skin disorders and more than nine (9) pending patents in the U.S. and other countries. These patents cover a wide range of IR lasers for medical applications including vision correction (LASIK and presbyopia), dermatology and microsurgery.

The Company will also have 3 clinical trials ongoing in Canada, Venezuela and Mount Sinai Hospital in New York. The Company is currently selecting Institutions and ophthalmologists to start more IDE clinical sites for various Phase studies and applications. The Company is also in the process of developing a world renown Medical Advisory Panel that will include 5 ophthalmologists and 2 dermatologists to assist with various clinical trials and to assist with product enhancements.

In addition to the on-going IDE clinical trials, the Company expects to obtain two market approvals within few months under the 510(K) applications for UV-laser psoriasis and WaterJet for eye surgery.

surgilight.com
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext