FDA Pathway

We are subject to general controls and pre-market approval (PMA) before we can receive FDA approval. The PMA will require significant clinical information and scientific analysis which will require years of testing. We project our device will be prepared to file the application in early 2022. See our project timeline for more details on how we plan to get to this point.

IP Protection

We are currently working with Johns Hopkins Tech Ventures to file a provisional patent on our atherectomy device. Together we feel confident in the novel aspects of our device. We plan to file the provisional in August of 2016. This gives us one year before we file for our full patent. In this time we plan to continue design improvements and begin discussions with licensing partners. This will lead us to find the optimal design parameters before filling .

Continued Prototyping

Our team plans to continue building upon benchtop models through the summer. The results from testing of scaled up prototypes will guide to scale manufacturing of our system. We plan to have our first to scale prototype manufacutred by August 2016 for excissed vessel and animal model testing. 

Funding

Continued funding for our team will come from sources like business plan competitions and funds like VentureWell, Maryland Innovation Initiative, and the Coulter Translational Partnership. 

Animal & Cadaver Testing

Our team is working with Dr. Caroline Garrett from the Johns Hopkins Medical Institution to submit an ACUC protocol with plans to begin testing on rabbit atherosclertotic models by the end of 2016. 

Pursue Industry Sponsorship

We are looking to pursue established industry partners like Boston Scientific and Medtronic for a sponsorship to take our device through clinical trials. 

Clinical Trials

We plan to prove the increased ease and safety profile of our device through clincial trials starting in 2018. 

Market Penetration

Following FDA approval, we will leverage the support of key opinion leaders Dr. Peter V Johnston and Dr. Chao-Wei Hwang and our industry sponsor to promote sales and widespread adoption by interventional cardiologists.