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

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.