SBIR-STTR Award

Significance Pediatric patients with pulmonary artery stenosis face treatment options with significant limitations For example metal stents are limited by long term interference with natural vessel growth Patients implanted with metal stents are subject to multiple hospital admissions for interventional stent expansions often requiring fracture of the stent and open heart surgery for removal As such there is an emergent need for pediatric specific devices for this underserved population Approach In response to a solicitation from NHLBI Biomedical developed a self expanding bioresorbable stent to treat pulmonary artery stenosis under a Fast Track SBIR Through the Fast Track project promising animal results were achieved through the device resorption period while in growing vessels On the strength of these Fast Track data we raised $ M of funding from Broadview Ventures This Phase IIB SBIR application will enable advancement of this product towards commercialization application In this project first in human experience with this innovative device will be achieved During Year current bench and animal data will be supplemented to create a data package to enable submission of an Investigational Device Exemption IDE for an Early Feasibility Study EFS This accomplishment will enable enrollment of clinical subjects during Year Year will be focused on mo follow up in the EFS and along with an extensive package of bench and pre clinical data this human data will be submitted to the FDA for marketing clearance This project represents an important step in the commercialization of a therapy that has the potential to be a game changer for pediatric patients with pulmonary artery stenosis Innovation Biomedicalandapos s novel stent couples full bioresorption with self expansion two features that are ideal for the pediatric population This combination of properties is achieved through our unique composite design By utilizing a strong base braid coated with a proprietary elastomer we can achieve properties that are similar to metal in a fully resorbable design The self expansion of this design provides the added benefit of enabling the stent to maintain apposition with the vessel wall as a pediatric patient grows The fast yet safe resorption characteristics of the design will enable the device to andquot growandquot with the vessel without impeding early intervention if required PUBLIC HEALTH RELEVANCE Currently young pediatric patients with congenital heart disease have inadequate treatment options because metal stents will restrict growth of their vessels and will eventually require open chest surgery to remove them The goal of this Phase IIB Small Market SBIR is to further the development of a novel bioresorbable stent for these patients that will provide support while needed then dissolve away to allow normal vessel growth

Significance: Pediatric patients with pulmonary artery stenosis face treatment options with significant limitations. For example, metal stents are limited by long-term interference with natural vessel growth. Patients implanted with metal stents are subject to multiple hospital admissions for interventional stent expansions, often requiring fracture of the stent and open- heart surgery for removal. As such, there is an emergent need for pediatric-specific devices for this underserved population. Approach: In response to a solicitation from NHLBI, 480 Biomedical developed a self- expanding, bioresorbable stent to treat pulmonary artery stenosis under a Fast-Track SBIR. Through the Fast-Track project, promising animal results were achieved through the device resorption period, while in growing vessels. On the strength of these Fast-Track data, we raised $1.2M of funding from Broadview Ventures. This Phase IIB SBIR application will enable advancement of this product towards commercialization application. In this project, first-in- human experience with this innovative device will be achieved. During Year 1, current bench and animal data will be supplemented to create a data package to enable submission of an Investigational Device Exemption (IDE) for an Early Feasibility Study (EFS). This accomplishment will enable enrollment of clinical subjects during Year 2. Year 3 will be focused on 12mo follow-up in the EFS, and along with an extensive package of bench and pre-clinical data, this human data will be submitted to the FDA for marketing clearance. This project represents an important step in the commercialization of a therapy that has the potential to be a game-changer for pediatric patients with pulmonary artery stenosis. Innovation: 480 Biomedical's novel stent couples full bioresorption with self-expansion: two features that are ideal for the pediatric population. This combination of properties is achieved through our unique composite design. By utilizing a strong base braid coated with a proprietary elastomer, we can achieve properties that are similar to metal in a fully resorbable design. The self-expansion of this design provides the added benefit of enabling the stent to maintain apposition with the vessel wall as a pediatric patient grows. The fast, yet safe, resorption characteristics of the design will enable the device to "grow" with the vessel without impeding early intervention, if required.

Public Health Relevance Statement:


Public Health Relevance:
Currently, young pediatric patients with congenital heart disease have inadequate treatment options because metal stents will restrict growth of their vessels and will eventually require open-chest surgery to remove them. The goal of this Phase IIB Small Market SBIR is to further the development of a novel bioresorbable stent for these patients that will provide support while needed then dissolve away to allow normal vessel growth.

NIH Spending Category:
Assistive Technology; Bioengineering; Cardiovascular; Clinical Research; Heart Disease; Lung; Pediatric

Project Terms:
Address; Admission activity; Affect; Age-Years; animal data; Animal Model; Animals; artery stenosis; Award; base; bioresorption; Blood flow; Cardiac Surgery procedures; Catheters; Characteristics; Child; Childhood; Clinic; Clinical; Clinical Data; Clinical Research; commercialization; congenital heart disorder; Coupled; Couples; Data; Data Analyses; Data Collection; design; Development; Device Safety; Devices; Early Intervention; Elastomers; Enrollment; Evaluation; Excision; experience; Face; Feasibility Studies; flexibility; follow-up; Fracture; Funding; Goals; Growth; Heart failure; Hospitals; Human; human data; Implant; innovation; Intervention; Lead; Lung; Marketing; Metals; mortality; National Heart, Lung, and Blood Institute; novel; Pathway interactions; patient population; Patients; pediatric patients; Phase; Population; pre-clinical; preclinical safety; Production; Property; public health relevance; Pulmonary Artery Branch; Pulmonary artery structure; Ramp; Research; response; Safety; Small Business Innovation Research Grant; Stenosis; Stents; success; Support System; System; Testing; Thoracic Surgical Procedures; Underserved Population; United States; Validation