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8-K: SeaStar Medical Reports Third Quarter 2024 Financial Results and Provides a Business Update

SEC ·  Nov 14 06:18

Summary by Moomoo AI

On November 13, 2024, SeaStar Medical Holding Corporation, a medical device company listed on Nasdaq under the symbol ICU, reported its financial results for the third quarter ended September 30, 2024. The company announced its first commercial sales of QUELIMMUNE™, a pediatric device for treating acute kidney injury (AKI), which received FDA clearance in February 2024. SeaStar Medical's CEO, Eric Schlorff, highlighted the direct sales to an end-user customer and the transition to a direct sales model expected to significantly increase revenue. The company also reported on the progress of its NEUTRALIZE-AKI pivotal trial for adult AKI patients, with 59 subjects enrolled and an increase in clinical sites to 12. Additionally, SeaStar Medical received FDA Breakthrough Device Designation for the SCD in chronic dialysis...Show More
On November 13, 2024, SeaStar Medical Holding Corporation, a medical device company listed on Nasdaq under the symbol ICU, reported its financial results for the third quarter ended September 30, 2024. The company announced its first commercial sales of QUELIMMUNE™, a pediatric device for treating acute kidney injury (AKI), which received FDA clearance in February 2024. SeaStar Medical's CEO, Eric Schlorff, highlighted the direct sales to an end-user customer and the transition to a direct sales model expected to significantly increase revenue. The company also reported on the progress of its NEUTRALIZE-AKI pivotal trial for adult AKI patients, with 59 subjects enrolled and an increase in clinical sites to 12. Additionally, SeaStar Medical received FDA Breakthrough Device Designation for the SCD in chronic dialysis, marking the fourth such designation. CFO David Green noted the elimination of over $9 million in long-term debt since the start of 2024. The financial results showed a net revenue of $67,500 for the quarter, with R&D and G&A expenses amounting to $2.3 million and $2.2 million, respectively. The net loss for the quarter was reported at $4.5 million, or $1.10 per share. As of September 30, 2024, the company had $2.1 million in cash and no long-term debt.

This announcement is a separate document:

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