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

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是开发一种氧纳米泡平台技术来治疗眼睛的缺血性疾病，特别是视网膜中央动脉闭塞（CRAO）。cro的预计市场估计为每年6400箱或每年6400万美元。该项目的近期目标是获得cro的IND适应症，然后将平台技术扩展到治疗其他缺血性疾病，如视网膜分支动脉闭塞（1.6万- 5万例/年）、视网膜静脉闭塞（~10万例/年）、糖尿病视网膜病变（74.6万例/年）。现在，该公司已经将氧气纳米气泡的概念扩展到治疗慢性伤口，这是一个价值250亿美元的市场，影响着900万至1200万美国人。公司的使命是减少医疗保健费用的社会支出，增加患者的质量调整生命年，减轻治疗负担。这个小企业创新研究二期项目将开发一种创新技术，以减轻视网膜动脉闭塞引起的缺氧损伤的严重程度。市场的阵地是视网膜中央动脉闭塞（CRAO），这是一种急性致盲孤儿病，目前尚无有效的治疗方法。cro是一种眼科急症，其中向视网膜内输送血液的大动脉被斑块阻塞，类似中风，导致视力突然丧失。在人类中，干预的机会窗口存在于闭塞后24-36小时，然后再灌注，大约90%的病例发生在~72小时。该公司将开发、测试和验证一种安全稳定的氧气纳米输送配方，该配方可以通过pars plana输送，这是一种将治疗药物注入玻璃体腔的标准方法。将在缺血大鼠眼模型中评估氧纳米泡配方的持氧能力和释放、组织氧合、缺氧缓解和功能保存。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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.