Case Studies

Learning from Real Outcomes

Anonymized examples showing how our analysis identifies risks that standard due diligence misses.

The Predicate Trap

Regulatory Failure

A promising orthopedic device company built their FDA strategy around a predicate that was later recalled. Without clearance pathway, they ran out of runway.

What We Flagged:

Predicate device had 3 warning letters in 24 months
No backup predicate strategy identified
Regulatory timeline assumptions unrealistic

The Reimbursement Mirage

Negotiated Down

Diagnostic company assumed $200+ reimbursement based on "comparable" tests. Actual CPT code paid $47. Investor negotiated 40% valuation reduction.

What We Flagged:

No payer pre-submission meetings conducted
"Comparable" tests had different clinical utility
Unit economics fatal at actual reimbursement

The Workflow Gap

Adoption Failure

Surgical tool required 15 minutes of physician time per procedure with no reimbursement bump. Achieved less than 2% of target adoption.

What We Flagged:

No time-motion studies with practicing surgeons
Value proposition didn't offset workflow burden
KOL enthusiasm didn't reflect community practice

The Hidden Indication

Successful Exit

Our clinical review identified a secondary indication with 3x the market size. Company pivoted, achieved FDA clearance in 11 months, acquired at 8x return.

What We Identified:

Underappreciated clinical utility in adjacent specialty
Faster regulatory pathway for new indication
Less competitive market with higher ASPs

Don't Let These Patterns Repeat

Our methodology catches these issues before they become expensive lessons.

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