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

存在耐药细菌，如MRSA，以及通过空气传播的微生物，如流感和结核病 重大的健康问题，造成重大的医疗和经济后果。紫外线是一种久负盛名的 高效的抗微生物方法，对细菌和病毒都有效。然而，它并不是 在有人在场的情况下使用紫外线灭菌是可能的，因为它既致癌又 会导致白内障的。基于基本物理原理，在我们的初步和第一阶段研究的支持下，FAR- UVC光(~222 nm由KRCL准分子灯产生)具有传统光源的所有抗微生物优势 杀菌紫外线灯，但没有相应的人体安全危害。因此，许多人在空中展示了 杀菌紫外线灯的抗微生物应用，目前不能在人类 现在，在人类在场的情况下，可以被认为是潜在的实际应用。 市场是双重的：最初是为医院，在手术室里，在手术过程中照射伤口上方，以 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、飞机和食品制备业，以减少病毒在空中的传播，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是独立于 耐药性，所以我们的方法解决了日益增长的“超级细菌”问题。 较高(&gt；230 nm)或较低(&lt；200 nm)波长都没有所需的特性。我们的产品将是 价格低廉、寿命长的远紫外线准分子灯，发射波长222 nm，波长最高 排放物。目前没有这样的222 nm灯可用，并且在没有新的技术突破的情况下， 在低于230 nm的相关波长范围内，适当的LED是不实用的。 在第一阶段，我们开发了一种高强度222 nm准分子灯，寿命为&gt；5000小时，最小 更高波长的辐射。在第二阶段，我们将设计、制造和测试大面积(&gt；300平方厘米)222纳米 准分子灯的强度进一步提高了5倍，达到&gt；20 mW/cm2。制造工艺将得到优化 为了降低成本，开发了与之匹配的滤波电源。 根据纯物理原理，222纳米的光对人体曝光是安全的：222纳米的光不能穿透 皮肤外部的死细胞层，既不是眼睛表面的泪膜层，也不是进入皮肤的微生物生物膜。这已经是 我们的短期安全研究证实了这一点，但我们认识到需要确凿的长期安全数据。 在第一阶段，我们证明了222纳米的光不会对皮肤或眼睛造成生物损害，使用 相关的短期体内终点。在第二阶段，我们将把这些体内安全性研究延长到 (60周)远紫外线暴露和长期终点(皮肤癌、皮肤微生物群、眼睛损伤)。 一种用于管理开放伤口细菌的传统杀菌紫外线灯符合FDA 510(K) 批准，并将成为我们最初的510(K)申请的主要判定工具

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