Sells a blood-treatment device to hospitals for critically ill children with kidney injury, and develops the device for adults with kidney and other inflammatory conditions.
10-K for FY2025, filed Mar 25, 2026We are a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and…View ↗
We received Food and Drug Administration (“FDA”) approval on February 21, 2024, under a Humanitarian Device Exemption (“HDE”) for our…View ↗
We are currently commercializing our first product, QUELIMMUNE, under an HDE that was approved by the FDA on February 21, 2024. QUELIMMUNE…View ↗
End-user customers buy each device at the fixed price in their purchase order; the sale is counted when the device reaches the customer's destination.
10-K for FY2025, filed Mar 25, 2026The Company has sold and intends to continue to sell its products either through a combination of distributor(s) and/or directly to…View ↗
Timing of Revenue Recognition – During the brief history (commenced July 2024) of selling QUELIMMUNE, revenue has been recognized based on…View ↗
Transaction Price – based on the above, as currently constructed, the Company’s transaction price is fixed, based on the agreed-upon price…View ↗
$1.2M
10-K for FY2025, filed Mar 25, 2026
$1.2M ↗
The company sells QUELIMMUNE directly to pediatric hospitals through its own sales team and targets additional pediatric medical facilities for adoption.
10-K for FY2025, filed Mar 25, 2026
No. It lost $12.2M in FY2025.
10-K for FY2025, filed Mar 25, 2026
10-Q for Q2 FY2026, filed Aug 12, 2026
−$3.7MView ↗
8-K, filed Apr 28, 2026
On July 5, 2024, Forrest A K Wells, a purported stockholder of ours, filed a putative class action complaint in the United States District…View ↗
Pediatric product reaches market
The older report described the device as investigational and pediatric sales as a future plan; the latest describes an approved pediatric product with commercial hospital sales.
10-K for FY2022, filed Mar 30, 2023 10-K for FY2025, filed Mar 25, 2026
Direct sales replace distributor plans
The older report planned United States pediatric sales through an exclusive distributor; the latest describes direct sales supported by its own commercial team.
10-K for FY2022, filed Mar 30, 2023 10-K for FY2025, filed Mar 25, 2026We intend to continue to shape our commercial and distribution strategy by expanding indications and pursue collaborations with partners in…View ↗
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