To attract investment, founders must translate their science into a business case. This involves articulating the target customer, go-to-market strategy, cost structure, and value proposition. Investors back ventures that connect three key elements: strong science, a clear clinical need, and a credible business model.
By defining their implant as a mechanical support for the body's natural healing rather than a living tissue, the company gained a significant regulatory advantage. This allows them to focus on well-understood quality attributes like sterility, dimensions, and stability, which are easier to control and validate for batch-to-batch consistency.
Beyond establishing safety and efficacy, first-in-human trials provide crucial, practical insights unavailable from preclinical models. They reveal how a product fits into real surgical practice: if it's easy for surgeons to use, integrates into existing procedures, and requires additional training. This real-world validation is invaluable.
When the COVID-19 pandemic halted their first-in-human trial for two years, the team pivoted from clinical activities to internal improvements. They focused on development, process optimization, and strengthening other company functions. This strategy of reallocating resources to what can be controlled maintains progress and ensures better preparation for when external blockers are removed.