Market assessment for glucose-responsive microgels and microneedle patch technology

我们实验室发明了一种血糖响应器，它可以感知血糖水平，并在低血糖时实时释放天然胰高血糖素。该装置是一种复合透皮微针贴片，由微针阵列和嵌入的微凝胶颗粒组成。这种微粒由三种类型的单体制成-一种提供葡萄糖响应性体积变化，一种用于稳定天然胰高血糖素，另一种用于促进胰高血糖素的包裹。应用微针贴片后，微针穿透皮肤，在体液中迅速膨胀，使微凝胶与液体和葡萄糖接触。这种微凝胶可以感知葡萄糖浓度，并在低糖水平下收缩，从而将包裹的胰高血糖素挤出。结果，高血糖素从针头扩散到血液循环和肝脏，从而提高血糖水平。整个过程自动进行，无需患者或护理人员的外部干预。本发明的微凝胶系统可以在体温和制作微针阵列的条件下保持胰高血糖素的天然结构和生物活性。在T1D大鼠模型中，我们的实验室已经证明，透皮贴片能够预防因过量胰岛素注射而导致的低血糖，最长可达3小时。这项技术是2018年11月8日提交的美国临时专利第62/757,677号的主题-“装置及其用于预防低血糖的用途”。为了将这些专利技术商业化，创新和伙伴关系办公室(IPO)已与一家咨询公司签约，进行市场分析，以解决各种市场方面的问题。在项目完成时，该公司将提供一份报告，指导我们下一步的商业化活动，包括申请NSERC I2I阶段1拨款，以优化设备的组成和设计，并开发更大规模的方法。这些活动将加强我们在未来吸引战略发展伙伴和投资者的地位。

Our laboratory has invented a glucose-responsive device that can sense glucose levels and release native glucagon in real time in response to hypoglycemia. The device is a composite transdermal microneedle patch comprising a microneedle array and embedded microgel particles. The microparticles are made from three types of monomers - one provides glucose-responsive volume change, one for stabilizing native glucagon, and one for facilitating glucagon encapsulation. After the microneedle patch is applied, the microneedles penetrate the skin, swell quickly in the body fluid, and enable the microgels in contact with the fluid and glucose. The microgels sense the glucose concentrations and shrink at low glucose levels thus squeezing the encapsulated glucagon out. As a result, the glucagon diffuses out of the needles to the blood circulation and to the liver thereby increasing blood glucose levels. The entire process automatically proceeds without external intervention of patients or care givers. The invented microgel system can maintain the native structure and bioactivity of glucagon at body temperature and under the conditions of making microneedle array. In a T1D rat model, our laboratory has demonstrated that the transdermal patch is able to prevent hypoglycemia induced by excess insulin administration for up to 3 hours. This technology is the topic of US Provisional Patent 62/757,677 filed on 11/08/2018 - "Device and Its Use for Preventing Hypoglycemia". To commercialize these proprietary technologies into a product, Innovations and Partnerships Office (IPO) has contracted a consultant company to perform market analysis to address various market aspects. At the completion of the project, the company will provide a report which will guide us next move of commercialization activities including application for an NSERC I2I Phase 1 grant to optimize the composition and design of the device and develop larger scale methods. These activities will strengthen our position of attracting strategic development partners and investors in future.