Sterling Photonics intends to develop a unique laser instrument for otologic surgical applications. The compact diode pumped fiber laser system will be primarily directed to the treatment of otosclerosis via laser stapes surgery. Secondary applications include mastoid surgery, revision mastoid surgery, and laser myringotomy. The choice of stapedotomy as an """"""""entry point"""""""" surgical application is dictated in part by the ?. unique advantages of a fiber laser for this surgical procedure, and the fact that this is still a sizeable market for a startup company, with limited competition. ,? . .. . : , - . ? . < There are two major efforts for this program. The first, carried out by Sterling Photonics, alone, is to further develop high power, diode pumped 2.7 micron ErZBLAN fiber lasers. The Phase I program has demonstrated feasibility for the 2.7 micron laser system with the desired specifications, and confirmed this feasibility by performing preliminary bone ablation experiments. The Phase II program will develop this laser technology into a packaged product, suitable for undergoing the 510k process for establishing equivalency with currently FDA-approved 2.9 micron ErYAG lasers, with subsequent clinical trials foreseeable upon completion of the 51 Ok process. A continuous-wave (cw) ErZBLAN fiber laser with > 10 Watts of 2.8 micron output power, and a pulsed 2.8 micron fiber laser with > 30 Watts peak power and > 3 millijoules/pulse (of < 100 microsec pulse duration) will be produced. These devices will be packaged for use in a surgical lab environment. A fiber delivery system suitable for use in a medical research lab will be developed and implemented on the final laser system. This delivery system will have the advantage of very high flexibility, with an ability to go around bends of <1 inch radius, in contrast to the less flexible delivery system used with the competitive CO2 (carbon dioxide) 10 micron lasers. The second major effort will be tissue studies needed to verify the performance, ErYAG.equivalence, efficacy, and safety of this laser system for the procedures named above. These detailed studies will be performed primarily by Dr. Brian Wong and Dr. Zeng of the University of California, Irvine. i ? ?
