Financial ConcernsManagement is making early progress extending the cash runway with ~$850MM currently in hand, but there is potential for ~$400MM in annual burn, which is well above management targets.
Operational RisksA massive RIF cuts costs but also commercial heft, with potential margin impacting ASP pressures and a multi-year timeline to a potential FDA and CMS regulatory and reimbursement pathway raising concern.
Regulatory ChallengesThere are inherent risks associated with broadly commercializing novel technologies such as MCEDs, including an uncertain regulatory and reimbursement pathway.