Monochromatic 222 nm UV light: Development of a safe, cost-effective technology for the efficient reduction of bacterial and viral infection and transmission

耐药性细菌如MRSA，以及空气传播的微生物如流感和结核病， 严重的健康问题，造成重大的医疗保健和经济后果。紫外线是一种公认的 高效抗微生物形式，对细菌和病毒都有效。但它不是 可能在有人的情况下使用紫外线消毒，因为它既致癌， 引起白内障的基于基本的物理学原理，并在我们的初步和第一阶段研究的支持下， UVC光（由KrCl准分子灯产生的~222 nm）具有常规紫外线的所有抗微生物优点。 紫外线杀菌灯，但没有相应的人体安全隐患。因此，许多人在空中展示了 紫外线杀菌灯的抗菌应用，目前还不能应用于人类 现在，可以认为在人类存在的情况下是潜在实用的。 市场是双重的：最初用于医院，在手术室中，在手术期间照射切口上方， 降低手术部位感染率。其次是公共场所，如学校、医院、医生办公室， 机场、飞机和食品加工业，以减少病毒的空气传播，包括 流感和麻疹，以及结核病等细菌。一个关键的优点是紫外线杀菌不依赖于 耐药性，因此我们的方法解决了日益增长的“超级细菌”问题。 更高（> 230 nm）或更低（<200 nm）的波长都不具有期望的性质。您购买的方便面内将 廉价、长寿命的远紫外线受激准分子灯，发射波长为222 nm，具有最小的较高波长 排气中目前还没有这样的222纳米灯，如果没有新的技术突破， 合适的LED在低于230 nm的相关波长范围内是不实用的。 在第一阶段，我们开发了一种高强度的222 nm准分子灯，寿命> 5，000 h， 在更高的波长下发射。在第二阶段，我们将设计，制造和测试大面积（> 300平方厘米）222纳米 受激准分子灯的强度进一步增加5倍，达到> 20 mW/cm 2。制造工艺将得到优化 为了降低成本，开发了匹配的滤波电源。 基于纯物理学，222 nm的光对于人体暴露是安全的：222 nm的光不能穿透 皮肤外层的死细胞层，也不是眼睛表面的泪膜层，也不是皮肤微生物生物膜。这是 我们的短期安全性研究证实了这一点，但我们认识到需要证实性的长期安全性数据。 在第一阶段，我们证明了222 nm的光不会对皮肤或眼睛造成生物损伤， 相关短期体内终点。在第二阶段，我们将延长这些体内安全性研究， (60周）远紫外线暴露和长期终点（皮肤癌、皮肤微生物组、眼损伤）。 用于管理开放性伤口中细菌的传统杀菌紫外线灯具有FDA 510（k） 批准，并将成为我们初始510（k）申请的主要等同器械

Drug resistant bacteria such as MRSA, and airborne-transmitted microbes such as influenza and TB, present significant health issues, with major healthcare and economic consequences. UV light is a well-established highly-efficient anti-microbial modality, effective both against both bacteria and viruses. However it is not possible to use UV sterilization in scenarios where people are present because it is both carcinogenic and cataractogenic. Based on basic physics principles and supported by our Preliminary and Phase I Studies, far- UVC light (~222 nm generated from a KrCl excimer lamp) has all the anti-microbial advantages of conventional germicidal UV lamps, but without the corresponding human safety hazards. Thus the many demonstrated in-air anti-microbial applications of germicidal UV lamps, which cannot currently be applied when humans are present, can now be considered as potentially practical in the presence of humans. The market is twofold: Initially for hospitals, in operating rooms for irradiating above incisions during surgery to reduce surgical site infection rates. Secondly for public locations such as schools, hospitals, doctors offices, airports, airplanes and the food preparation industry, to reduce airborne transmission of viruses including influenza and measles, and bacteria such as TB. A key advantage is that UV bacterial killing is independent of drug resistance, so our approach addresses the ever-growing issue of “superbugs”. Neither higher (>230 nm) nor lower (<200 nm) wavelengths have the desired properties. Our products will be inexpensive, long-lived far-UVC excimer lamps, emitting at 222 nm and with minimal higher-wavelength emission. No such 222 nm lamp is currently available and, without a new technological breakthrough, appropriate LEDs are not practical in the relevant wavelength range below 230 nm. In Phase I we developed a high-intensity 222 nm excimer lamp with a lifetime of >5,000 h, and minimal emissions at higher wavelengths. In Phase II we will design, fabricate and test large area (>300 cm2) 222 nm excimer lamps with a further 5-fold intensity increase to >20 mW/cm2. Fabrication processes will be optimized to reduce costs and a matching filtered power supply developed. 222 nm light is safe for human exposure based on pure physics: 222 nm light cannot penetrate through the skin outer dead cell layer, nor the eye's surface tear film layer, nor into skin microbiome biofilms. This has been confirmed with our short-term safety studies, but we recognize the need for confirmatory long-term safety data. In Phase I we demonstrated that 222 nm light does not cause biological damage to the skin or eye, using relevant short-term in-vivo endpoints. In Phase II we will extend these in-vivo safety studies to prolonged (60 weeks) far-UVC exposures and long-term endpoints (skin cancer, skin microbiome, ocular damage). A conventional germicidal UV lamp designed for management of bacteria in open wounds has FDA 510(k) approval and will be the primary predicate device for our initial 510(k) application