Commercialization RisksThere are inherent risks associated with broadly commercializing novel technologies such as MCEDs, including an uncertain regulatory and reimbursement pathway.
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.
Regulatory ChallengesBroad reimbursement and adoption hinge on the NHS-Galleri readout and subsequent FDA approval, which are several years away.