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€8M Debt Financing for MedTech Scale-Up

Client Background

A MedTech company developing an innovative medical device was in the final stages of regulatory approval. The next step was securing capital to complete the approval process and scale up manufacturing. The company sought €8M in non-dilutive financing to fund these milestones efficiently.

Challenge / Pain Point

  • Regulatory Approval Dependency – Investors were hesitant to commit capital until approval was secured, but approval required funding to complete the necessary compliance steps.
  • Avoiding Equity Dilution – The company wanted to preserve ownership and sought financing options that did not require issuing new shares.
  • Limited Lending Options – Traditional lenders were reluctant to provide debt due to the uncertain timeline of regulatory approval.
  • Manufacturing Constraints – Even with approval, the company needed additional working capital to increase production capacity and meet expected demand.

Solution / Approach

1. Identifying the Right Lenders

  • TULA engaged with venture debt providers and alternative financing partners specializing in healthcare and regulatory-driven business models.
  • We focused on lenders who understood the dynamics of MedTech approvals and post-market adoption.

2. Structuring a Flexible Debt Facility

Instead of a single loan, TULA structured a tranche-based facility that aligned financing with key business milestones:

  • First tranche: Funds released before regulatory approval to complete the final steps of the approval process.
  • Second tranche: Disbursed upon approval to support initial manufacturing scale-up.
  • Third tranche: Available after early commercial traction to ensure sufficient production capacity.

3. De-Risking the Investment Case for Lenders

  • We reframed regulatory approval as a predictable milestone rather than a fundamental risk, backed by clear timelines and previous trial results.
  • By linking capital deployment to business inflection points, we improved lender confidence and secured better terms.

Outcome / Results

  • Secured €8M in non-dilutive debt financing under favorable conditions.
  • Structured financing to minimize cash burden before approval and ensure working capital availability for manufacturing.
  • Allowed the company to move forward with regulatory clearance and production ramp-up without sacrificing equity.

Key Takeaways

  • Strategic debt financing can be structured around business milestones, reducing risk for both borrowers and lenders.
  • Regulatory approval delays do not always mean funding roadblocks—positioning and lender selection are key.
  • Avoiding equity dilution at critical stages preserves long-term value for founders and early investors.

Need non-dilutive financing for your MedTech business?

TULA structures debt solutions that align with your growth milestones.

Let’s discuss your options