Richard
This just posted on PRN. I have no idea of the extent to which quick approval for the hydrobrush has already been discounted in the current price, but its nice to see MDJT getting some publicity.
Friday May 2 10:10 AM EDT
Medjet announces 510(k) filing for HydroBrush Keratome
EDISON, N.J.--(BW HealthWire)--May 2, 1997--Medjet Inc. (NASD: MDJT common; MDJTW warrants), a leading
developer of surgical cutting devices based on high-velocity water jets, today announced that the United States Food and Drug
Administration is processing the company's Section 510(k) application for permission to market its HydroBrush(TM)
Keratome.
The intended use is the removal of the epithelium from the cornea over a defined circular area.
Removing (debriding) the epithelium, or outer surface of the cornea, is the first step in excimer laser refractive surgery, known
as photo-refractive keratectomy, or PRK. Removal of the epithelium is also required in treating various corneal problems
associated with disease, infection, dystrophy and physical damage to the epithelium. The new technique is substantially quicker
than currently used techniques. Based on animal studies, the company has shown that the new procedure leaves the corneal
surface cleaner, less damaged and better defined than currently used techniques. In addition, the corneal surface heals
significantly faster. Those are important advantages for PRK.
The company cautioned that there can be no assurance that the ruling of substantial equivalence will be made (thereby allowing
marketing in the U.S.) or that the ruling would be made on a timely basis.
As part of the process of bringing the HydroBrush(TM) Keratome to market in the U.S., the company is currently engaged in
discussions with four research institutions for clinical tests of the HydroBrush(TM) Keratome, to be performed solely for the
purpose of establishing ease of use.
The HydroBrush(TM) Keratome is a surgeon-controlled cutting tool that utilizes a hair-thin, high-speed waterjet beam
activated by compressed gas.
All statements regarding the anticipated or expected benefits of the HydroBrush(TM) Keratome and the timetable for testing
the HydroBrush(TM) Keratome are merely projections and may not be realized.
CONTACT: Medjet Inc.
Eugene I. Gordon, 908/738-3990
or
Lobsenz Stevens Inc.
Mark Perlgut, 212/684-6300, ext. 309
______________________________________________________________________
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