Vivani Medical Mergers and Acquisitions Presentation Deck
NPM-119 Clinical + Regulatory Development
Near-Term Plan
Year(s)
2020
4Q2022/102023
2023
.
We expect to utilize the 505(b)(2) pathway, which permits submissions to rely, in part, on the safety and
effectiveness of a previously approved product, which may potentially result in a more expeditious pathway to
FDA approval.
.
Milestone
Progress towards IND-enabling activities:
Development of both low dose and high dose versions of NPM-119 to be used in LIBERATE-1 is complete
Recent extensive studies have confirmed excellent biocompatibility of NPM-119's device constituent
NPM-119 was well tolerated in a preclinical GLP toxicology study
GMP production of LIBERATE-1 clinical supplies is underway
.
Status
.
FDA Pre-IND Meeting
Completed
File IND to support Ph 2 (LIBERATE-1) clinical study On-Track
Deliver LIBERATE-1 top-line results
Projected
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