Medical Device Strategy from Investment to Market

Start-ups

The challenges you're facing

You need a credible clinical story to raise your next round. You need the most efficient, smallest and fastest trial FDA will accept. Enrollment may be slower than planned. And you probably don't have a full-time CMO yet.

How Axelmed helps

A fractional or full-time CMO who builds your clinical, regulatory and reimbursement strategy from first-in-human through pivotal. That covers investor presentations, FDA pre-submissions and breakthrough designation, protocols and SAPs, and early payment planning (NTAP, TPT, C-codes).

Proven results

• Helped two start-ups close Series A rounds of approximately $15M with VCs and strategic investors.
• Negotiated IDE trials with FDA that used much smaller sample sizes than originally planned, including a 50-patient study with no hypothesis testing.
• Sped up enrollment through early screen-log analysis and changes to inclusion/exclusion criteria. In heart failure trials, pre-screened candidates so few were rejected at Patient Review Committee review from the onset.
• Prepared a C-code application for a sham-controlled RCT.

Established Device Companies

The challenges you're facing

A pivotal trial is at risk because of CRO performance, data quality or questionable event adjudication. You face an FDA panel or interactive review with tight deadlines. Post-market commitments are expensive. Reimbursement lags behind approval. A growing trial portfolio needs senior leadership.

How Axelmed helps

Hands-on leadership that steps into complex programs, quickly finds what's going wrong, and fixes it, while managing FDA, notified bodies, PMDA, CMS and KOL relationships directly.

Proven results

• Rescued a PMA at risk. Found and fixed critical CRO failures in monitoring, data management and safety oversight within three months. The clinical module was accepted by FDA on its due date, and the device was approved.
• Improved the reported outcomes through rigor. Strengthened adjudication with an independent neuro-interventional expert and standard definitions, and revised the SAP. The final results were among the lowest event rates reported in a pivotal carotid stent trial.
• Won a split FDA advisory panel. Designed and performed the three analyses central to the panel's favorable vote (7–3–1), leading to approval of a carotid stent for patients at standard surgical risk, the only one with that indication.
• Corrected the label. Found a core lab measurement error; FDA accepted the corrected technical success rate (98.4% vs. 92.7%) for the IFU.
• Cut post-market costs. Persuaded FDA to accept extended follow-up of the pivotal cohort in place of a new post-approval study.
• Built and ran a large trial portfolio. Obtained approval of 9 IDEs in 3.5 years (5 EFS, 4 RCTs), including a two-phase, win-ratio RCT that led to FDA approval and an NEJM publication.
• Secured approvals worldwide. Delivered EU approvals ahead of schedule for three indications and negotiated the PMDA strategy that led to approval in Japan for a structural heart device.
• Advanced reimbursement. Led a request to CMS to reconsider a national coverage policy, engaged CMS early on a new structural heart therapy, and secured Category B trial coverage for several devices.
• Generated real-world evidence. Led a 60-million-record EHR and claims analysis that helped define the disease burden in a new therapeutic field.