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Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)

- Name of Small Business Concern (SBC)

- Type of therapeutic or diagnostic device being developed

- Description of the disorder affecting the nervous or neuromuscular systems

- Description of the clinical prototype device

- Non-clinical safety and effectiveness testing plan

- Design verification and validation activities plan

- Planned submission of an Investigational Device Exemption (IDE) to the FDA or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study

- Explanation of why additional non-clinical assessments (e.g., bench top or animal studies) are not practical for obtaining necessary information about device function or final design

- Milestones for the project plan

- Description of any existing collaborations with NIH-funded consultants or device manufacturers

- Plan for collaboration with NIH-funded consultants for assistance with regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships

- Plan for collaboration with NIH contract research organizations for specific specialized testing and services (large animal testing, sterilization testing, biocompatibility assessment, manufacturing, medical monitoring)

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Funding Amount

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Eligible Applicants

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Eligible Activities

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Deadline to Apply

Apply for Funding

88%

Approval rating across all Canadian funding programs

93%

Average time savings to our clients, compared to
businesses that apply for funding in-house
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