SeaStar Medical, a commercial stage medical technology company, reported its financial performance and business developments in its latest quarterly report. The company has not generated significant revenue from commercialized products as of June 30, 2024, but it has made strides in its business development. SeaStar Medical received FDA approval for its pediatric Selective Cytopheretic Device (SCD) under a Humanitarian Device Exemption in February 2024 and made its first commercial sale in July 2024. The company also entered into a securities purchase agreement on July 10, 2024, for a registered direct offering and concurrent private placement, expecting to raise approximately $10.0 million before expenses. Additionally, SeaStar Medical is involved in a class action lawsuit alleging misstatements regarding FDA approval of product candidates, which the company intends to defend...Show More

SeaStar Medical, a commercial stage medical technology company, reported its financial performance and business developments in its latest quarterly report. The company has not generated significant revenue from commercialized products as of June 30, 2024, but it has made strides in its business development. SeaStar Medical received FDA approval for its pediatric Selective Cytopheretic Device (SCD) under a Humanitarian Device Exemption in February 2024 and made its first commercial sale in July 2024. The company also entered into a securities purchase agreement on July 10, 2024, for a registered direct offering and concurrent private placement, expecting to raise approximately $10.0 million before expenses. Additionally, SeaStar Medical is involved in a class action lawsuit alleging misstatements regarding FDA approval of product candidates, which the company intends to defend vigorously. Looking forward, SeaStar Medical is focused on the development of its SCD technology for various indications and is currently evaluating its adult SCD device in a pivotal clinical trial for FDA pre-market clearance. The company has incurred net losses, with a net loss of $15.9 million for the six months ended June 30, 2024, compared to $9.5 million for the same period in 2023. As of June 30, 2024, SeaStar Medical had cash reserves of $1.2 million and an accumulated deficit of $130.7 million. The company acknowledges the need for additional capital to fund operations and may seek further financing through equity or debt offerings.