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的影响/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闭塞（CRAO）。CRAO的预计市场估计为6，400例/年或6，400万美元。该项目的近期目标是确保CRAO的研究性新药（IND）适应症，然后扩展平台技术以治疗其他缺血性疾病，如视网膜分支动脉闭塞（16，000 - 50，000例/年）、视网膜静脉闭塞（约100，000例/年）和糖尿病视网膜病变（746，000例/年）。该公司现在已经扩大了氧气纳米气泡的概念，以治疗慢性伤口，这是一个250亿美元的市场，影响着900万至1200万美国人。该公司的使命是减少医疗保健成本的社会支出，提高患者的质量调整生命年，并减轻治疗负担。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闭塞导致的缺氧损伤的严重程度。滩头阵地市场是视网膜中央动脉阻塞（CRAO），这是一种急性致盲孤儿疾病，目前尚无有效的治疗方法。CRAO是一种眼科急症，其中将血液输送到内部视网膜的主动脉以中风样的方式被斑块堵塞，导致突然丧失视力。在人类中，干预的机会窗口存在于闭塞后24-36小时之间，然后自发再灌注，约90%的病例发生在约72小时内。该公司将开发、测试和验证一种安全稳定的氧气纳米递送制剂，该制剂可以通过睫状体平坦部递送，睫状体平坦部是一种将治疗药物递送到玻璃体腔的标准方法。氧纳米泡配方将被评估的氧容量和释放，组织氧合，缺氧缓解，并在缺血大鼠眼模型的功能保存。这个奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

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.