We've taken devices through the regulators, not just built them.
20 years hands-on in drug-delivery devices and combination products. Mor Tsabar, founder, led the device at NeuroDerm and systems engineering at Medingo and Roche, and supported the regulatory submissions, some of them through Four Milestones.
4FDA clearances for drug-delivery devices
4CE marks, 2 of them led at NeuroDerm
6INDs across 4 drug programs
1NDA submission, NeuroDerm
Companies we worked with, and where they went.
Each of these companies was acquired. The outcomes belong to the companies. Our contribution was on the engineering and regulatory side.
NeuroDermAcquired by Mitsubishi Tanabe Pharma, $1.1B.
SipNoseAcquired by Aptar Pharma.
Medingo
MedingoAcquired by Roche, up to $200M.
What that experience covers.
- Device platforms. Patch pumps, belt pumps, injectors and inhalers.
- Self-use design. Elderly, pediatric and lay-caregiver users, with self-training built in.
- Regulatory. FDA submissions and responses, CE marking, INDs and NDA preparation.
- Systems and software. System architecture, board design, software lifecycle and update strategy.
- Transactions. Technical due diligence for investors and acquirers.