- The company’s FDA-cleared INSPIRA ART100 system is approved for cardiopulmonary bypass in the U.S.
- With this step, ART100 moves from regulatory clearance to active commercial availability, the company said.
- Earlier, Inspira announced a non-binding term sheet for a proposed two-part deal to acquire an advanced liquid biopsy diagnostics business
Shares of Inspira Technologies OXY (IINN) popped over 28% in pre-market trading on Monday after Israel’s largest health services provider approved the procurement of its FDA-cleared ART100 platform.
IINN shares gave up premarket gains and fell around 3% after the opening bell.
The company secured approval from Clalit Health Services’ Medical Equipment Committee, allowing its INSPIRA ART100 system to be immediately procured and deployed across a healthcare network serving roughly 4.9 million members.
ART100 Regulatory Clearance
With this step, ART100 moves from regulatory clearance to active commercial availability, marking a significant growth opportunity for Inspira and strong clinical validation.
“By securing this approval, we are laying the foundation for potentially long-term, high-quality revenue. This validation from a world-class, data-driven health ecosystem serves as a powerful reference case as we accelerate our commercialization efforts in the U.S. and other global markets,” said Dagi Ben-Noon, CEO of Inspira Technologies.
The company’s FDA-cleared INSPIRA ART100 system is approved for cardiopulmonary bypass in the U.S. and for (Extracorporeal Membrane Oxygenation) ECMO procedures outside the U.S.
Top U.S. Medical Center Clears ART100
In January, Inspira Technologies’ ART100 system completed clinical evaluation at a top U.S. academic medical centre and moved into the budgeted procurement stage. The system successfully treated about 30 patients across surgeries, transplants, and other critical procedures, leading to its adoption into routine clinical workflows.
With the evaluation phase now closed, the hospital has begun an internal process to purchase multiple ART100 units, pending final budget approval.
Earlier, Inspira announced a non-binding term sheet for a proposed two-part deal to acquire an advanced liquid biopsy diagnostics business. The transaction also includes a planned $15 million strategic equity investment.
How Did Stocktwits Users React?
Retail sentiment on Stocktwits turned ‘extremely bullish’ from ‘bullish’ a day earlier, amid ‘extremely high’ message volumes.
The stock has shed around 25% so far this year.
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