Inspira announced a strategic shift to accelerate the commercialization of its U.S. FDA-cleared INSPIRA ART100 system, while maintaining the development and regulatory pathways of its portfolio of products. The Company is currently engaged in active sales discussions in multiple locations. This development follows the initial clinical implementation of the ART100 system in medical centers in the U.S., where the device has been used to treat patients in real-world clinical settings. Several of these discussions are in advanced stages and involve structured procurement frameworks. Based on the current ongoing discussions, deliveries are expected to begin in the second half of 2025, subject to logistical and regulatory alignment, and the finalization of commercial and legal terms.
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