STTR Phase II: Intravitreal oxygen nanobubble technology for treatment of retinal artery occlusions

这个小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力是开发一种氧纳米气泡平台技术，用于治疗眼部缺血性疾病，特别是视网膜中央动脉阻塞(CRAO)。CRAO的预计市场估计为每年6,400例，或每年100万美元。该项目的近期目标是确保CRAO的研究新药(IND)适应症，然后将平台技术扩展到治疗其他缺血性疾病，如视网膜分支动脉阻塞(16,000-50,000例/年)、视网膜静脉阻塞(约100,000例/年)和糖尿病视网膜病变(74,000例/年)。该公司现在已经扩大了氧气纳米泡沫的概念，以治疗慢性伤口，这是一个价值250亿美元的市场，影响着900万至1200万美国人。公司的使命是降低社会医疗成本支出，增加患者的质量调整寿命年，减轻治疗负担。这个小企业创新研究第二阶段项目将开发一种创新技术，以减轻由于视网膜动脉阻塞而造成的缺氧性损伤的严重程度。滩头市场是视网膜中央动脉阻塞(CRAO)，这是一种急性失明孤儿疾病，目前还没有有效的治疗方法。CRAO是一种眼科急症，将血液输送到视网膜内的主要动脉被斑块以中风的方式闭塞，导致突然丧失视力。在人类中，介入的机会窗存在于闭塞后24-36小时之间，大约90%的病例发生在~72小时内。该公司将开发、测试和验证一种安全稳定的纳米氧气输送配方，该配方可以通过平坦部输送，这是一种将治疗药物注入玻璃体腔的标准方法。氧纳米气泡配方将在缺血大鼠眼睛模型中进行持氧能力和释放、组织氧合、低氧缓解和功能保存方面的评估。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to develop an oxygen nanobubble platform technology to treat ischemic diseases of the eye, specifically Central Retinal Artery Occlusion (CRAO). The projected market for CRAO is an estimated 6,400 cases/year or $64 million, annually. The immediate goal of this project is to secure an Investigational New Drug (IND) indication for CRAO and then expand the platform technology to treat other ischemic conditions such as branch retinal artery occlusion (16,000 – 50,000 cases/year), retinal vein occlusions (~100,000 cases/year), and diabetic retinopathy (746,000 cases/year). The company has now expanded the oxygen nanobubble concept to treat chronic wounds, a $25 billion market affecting 9-12 million Americans. The company mission is to reduce the societal expenditures on healthcare costs, increase quality adjusted life years for patients, and reduce the burden of treatment. This Small Business Innovation Research Phase II project will develop an innovative technology to mitigate the severity of hypoxic insult due to retinal artery occlusions. The beachhead market is Central Retinal Artery Occlusion (CRAO), an acute blinding orphan disease for which no effective treatment exists. CRAO is an ophthalmologic emergency wherein the main artery that carries blood to the inner retina is occluded, in a stroke-like fashion by a plaque, resulting in sudden loss of vision. In humans, the window of opportunity for intervention exists between 24-36 hours after the occlusion before spontaneous reperfusion, which occurs in ~72 hours in about 90% of the cases. The company will develop, test, and validate a safe and stable oxygen nanodelivery formulation that can be delivered through pars plana, a standard method for administration of therapeutics into the vitreous cavity. The oxygen nanobubble formulation will be evaluated for oxygen holding capacity and release, tissue oxygenation, hypoxic mitigation, and preservation of function in ischemic rat eye models.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.