SBIR Phase II: A Mechanical Blood Clot Removal Device for Pulmonary Embolism

该小型企业技术转让（STTR）II期项目的更广泛影响/商业潜力是解决肺栓塞作为住院患者第三大常见死因的问题。目前治疗肺栓塞的方法对大多数病例有效，但急性大块和亚大块患者除外（45%的患者）。 该公司的产品特别适用于大面积和次大面积肺栓塞，分别占PE人群的5%和40%。基于每年约15万例PE患者病例，估计每根QuickFlow导管价值3000美元，该公司在前三年内至少4%渗透率的估计目标市场为1800万美元。QuickFlow解决了严重服务不足的市场;因此，最大限度地提高了患者和医生的价值。更快（不到1小时的手术）、更安全（无血栓溶解、无血管壁损伤和整个凝块清除）、使用简单直观（与现有器械的使用机制相似）和手术成本更低（ICU 1天而不是2-3天）的价值主张使其适用于几个关键市场，到2022年全球市场机会超过15.3亿美元。 该器械对血栓切除术器械市场和医疗保健系统的影响在帮助治疗服务不足的PE患者和降低成本方面具有重要意义。这个小企业创新研究（SBIR）第二阶段项目是开发一种机械血块清除装置，以解决肺栓塞和恢复血流在30分钟的病人？的到来。手术时间缩短、使用非手术过程、易于使用和成本降低使得这种微创机械血栓切除术比目前可用的治疗方法更可取。微创QuickFlow PE基于镍钛合金器械设计和制造中的范式转变技术创新提供了这些独特功能。超级可扩张镍钛合金网篮可完全清除血凝块，同时显著降低与当前治疗方法相关的并发症风险，如内出血和凝块破碎。一项关于先进生物材料和开发新制造技术的多学科研究产生了一种范式转变的医疗器械，该器械正在由一个工程师、医生、销售顾问和商业顾问团队进行研究。该团队具有独特的优势来进行这项多学科研究。QuickFlow的成功商业化将大大提高我们对制造新型镍钛合金医疗器械的理解，使其应用范围更广。该奖项反映了NSF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 Technology Transfer (STTR) Phase II project is about addressing pulmonary embolism as the third most common cause of death for hospitalized patients. Current modalities for treating pulmonary embolism are effective for most cases with the exception of the acute massive and submassive patients (45% of patients). The company's product is particularly suited for the massive and submassive pulmonary embolisms, respectively 5% and 40% of PE population. Based on the approximately 150K PE patient cases per year, with an estimated $3000 per QuickFlow catheter, the company's estimated target market at minimum 4% penetration within the first three years is $18 million. QuickFlow addresses a severely underserved market; hence, maximizing the value to both the patient and physicians. The value propositions of faster (less than one-hour procedure), safer (no thrombolysis, no vessel wall damage and whole clot removal), easy and intuitive to use (similar mechanism of use to the existent device), and less procedure cost (1 day in ICU instead of 2-3 days), make it appropriate for several key markets, with a global market opportunity in excess of $1.53 billion by 2022. The implications of this device for the thrombectomy device market and healthcare system can be significant in helping to treat underserved PE patients and reducing cost. This Small Business Innovation Research (SBIR) Phase II project is to develop a mechanical blood clot removal device to address pulmonary embolism and restore blood flow in 30 minutes of patient?s arrival. Reduced time of procedure, use a nonsurgical process, ease of use, and reduced cost make this minimally invasive mechanical thrombectomy procedure more desirable than the currently available treatment methods. The minimally invasive QuickFlow PE, offers these unique features based on the paradigm shifting technological innovation in Nitinol device design and manufacturing. The super expandable Nitinol baskets completely remove blood clots while significantly reducing the risk of complications associated with the current methods of treatment such as internal bleeding, and clot fragmentation. A multidisciplinary study on an advanced biomaterial and developing a new manufacturing technology has resulted in a paradigm shifting medical device which is being studied by a team of engineers, physicians, a sales consultant, and a commercial advisor. The team is uniquely positioned to conduct this multidisciplinary research. The success in commercializing QuickFlow will significantly advance our understanding of fabricating novel Nitinol medical devices for a wide spectrum of applications.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.