Embecta Corp

There have been no material changes to Embecta’s risk factors from those described in “Risk Factors” included within the 2023 Form 10-K, except for the addition of the following risk factor:

In the first quarter of Embecta’s fiscal year 2024, Embecta submitted its first 510(k) premarket filing to the FDA for its proprietary disposable insulin delivery system. We cannot predict when, if ever, such submission will be cleared by the FDA, as the FDA can refuse to grant a 510(k) clearance for many reasons, including the system may not be deemed by the FDA to be substantially equivalent to appropriate predicate devices under the 510(k) pathway, the system may not satisfy the FDA’s safety or effectiveness requirements, or changes in FDA clearance policies or adoption of new regulations may require additional data. Even if cleared by the FDA or foreign regulatory agencies, future generations of our systems, expanded indications for use of future systems, our software platforms or any other system under development, may not be cleared for the indications that are necessary or desirable for successful commercialization.