
| • |
Revenue was $9.6 million, an increase of 9%, or 4% on a constant currency basis, compared to $8.8 million in Q2 2024, driven by 22% year-over-year and sequential sales growth in
Germany.
|
| • |
Gross margin was 70.9% compared to 73.5% in Q2 2024.
|
| • |
Operating loss was $3.6 million, flat compared to Q2 2024.
|
| • |
Net income was $1.9 million or $0.03 per basic and diluted share, compared to a net loss of $4.3 million or $0.08
per basic and diluted share in Q2 2024.
|
| • |
Adjusted net loss was $3.7 million or $0.06 per basic and $0.05 per diluted share, compared to an adjusted net loss of $2.8 million, or $0.05 per basic and diluted
share in Q2 2024.
|
| • |
Adjusted EBITDA loss was $2.6 million compared to a loss of $2.2 million in Q2 2024.
|
| • |
Total cash, cash equivalents, and restricted cash of $11.7 million at June 30, 2025, compared to
$13.1 million as of March 31, 2025, which includes $1.7 million of proceeds received from the sale of its 2023 and amended 2022 Net Operating Loss and R&D tax credits from the Technology Business Tax Certificate Transfer Program,
sponsored by the New Jersey Economic Development Authority (NJEDA).
|
| • |
In July, the Company conducted an in-person appeal hearing with the U.S. FDA for supervisory review (administrative appeal) under 21 CFR 10.75 for its De Novo Request for
DrugSorb™-ATR. The appeal hearing included FDA senior leadership and review team, Company management, our FDA regulatory counsel, and our external cardiac surgery experts. The Company continues to believe that remaining deficiencies in its
DeNovo application can be effectively resolved through this supervisory review process which is expected to be completed by the end of August 2025, and that a final regulatory decision can be achieved in 2025.
|
| • |
The Company continues to work with Health Canada after receipt of their Notice of Refusal in June. As part of Health Canada’s prescribed reconsideration process, and after
discussions with Health Canada, the Company has filed a Level 1 “Request for Reconsideration” and with agreement from the Medical Devices Directorate Bureau Director, will pursue the review following the completion of the Company’s review
with the U.S. FDA.
|
| • |
In May 2025, Prof. Matthias Thielmann, STAR Registry investigator, received the “Best Oral Presentation Award” at the 73rd International Congress of the European Society for Cardiovascular and
Endovascular Surgery for his presentation entitled, “Early CABG with Intraoperative Hemoadsorption in Patients on Ticagrelor: Real World Data from the International Safe and Timely Antithrombotic Removal (STAR) Registry” -
underscoring the importance of our technology and these findings in the international community.
|
| • |
In May 2025, a new comparative real-world data analysis was presented at EuroPCR,
highlighting the intraoperative use of our technology to significantly and safely reduce the severity of bleeding in urgent coronary artery bypass grafting (CABG) patients on the blood thinner, ticagrelor (Brilinta®, AstraZeneca) who had not
completed the recommended drug washout period, reinforcing the clinical value of our therapy.
|
| • |
The first CytoSorb septic shock meta-analysis from Steindl et al., from the well-respected Charité Berlin Hospital in Germany, showing a statistically significant reduction of mortality with CytoSorb, in the Journal of Clinical Medicine (2025)
|
| • |
A large
retrospective 175 patient septic shock study from Berlot and team emphasizing high survival with early and intensive CytoSorb treatment, in the
Journal of Intensive Care Medicine (2025),
and
|
| • |
The positive clinical outcomes from the first 150 patients (58% had septic shock) enrolled in the international, prospective COSMOS (CytOSorb
treatMent Of critically ill patientS) critical care registry, reported by Ferrer et al. in the Journal of Intensive Medicine
(2025)
|
| 1) |
Break the vicious cycle of uncontrolled inflammation
|
| 2) |
Reverse shock and restore oxygenated blood flow
|
| 3) |
Promote the repair of leaky blood vessels
|
| 4) |
Actively remove excessive fluid and reduce fluid overload in organs
|
| 5) |
Prevent or treat multiple organ failure
|
|
June 30,
|
December 31,
|
|||||
|
2025
|
2024
|
|||||
|
|
(unaudited)
|
|
||||
|
|
|
|
||||
|
|
|
|
||||
|
$
|
10,204
|
$
|
3,280
|
|||
|
—
|
5,000
|
|||||
|
|
7,743
|
|
7,320
|
|||
|
|
3,710
|
|
2,733
|
|||
|
|
1,330
|
|
3,271
|
|||
|
|
22,987
|
|
21,604
|
|||
|
|
|
|||||
|
|
8,466
|
|
9,002
|
|||
|
1,522
|
1,484
|
|||||
|
11,223
|
11,511
|
|||||
|
|
3,792
|
|
3,771
|
|||
|
$
|
47,990
|
$
|
47,372
|
|||
|
|
|
|
||||
|
|
|
|
|
|||
|
|
|
|
|
|||
|
$
|
3,394
|
$
|
3,340
|
|||
|
5,953
|
6,032
|
|||||
|
495
|
453
|
|||||
|
|
9,842
|
|
9,825
|
|||
|
12,185
|
12,444
|
|||||
|
14,377
|
13,996
|
|||||
|
|
36,404
|
|
36,265
|
|||
|
|
|
|
|
|||
|
|
|
|||||
|
|
|
|
|
|||
|
—
|
—
|
|||||
|
|
63
|
|
55
|
|||
|
|
319,023
|
|
310,809
|
|||
|
|
(3,960)
|
|
4,252
|
|||
|
|
(303,540)
|
|
(304,009)
|
|||
|
|
11,586
|
|
11,107
|
|||
|
$
|
47,990
|
$
|
47,372
|
|||
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||
|
|
2025
|
|
2024
|
2025
|
2024
|
|||||||
|
$
|
9,617
|
$
|
8,842
|
$
|
18,344
|
$
|
17,831
|
|||||
|
2,803
|
$
|
2,339
|
5,323
|
4,455
|
||||||||
|
|
6,814
|
|
6,503
|
13,021
|
13,376
|
|||||||
|
|
|
|
|
|||||||||
|
|
1,262
|
|
1,519
|
2,924
|
3,766
|
|||||||
|
|
9,167
|
|
8,554
|
17,599
|
17,837
|
|||||||
|
|
10,429
|
|
10,073
|
20,523
|
21,603
|
|||||||
|
|
(3,615)
|
|
(3,570)
|
(7,502)
|
(8,227)
|
|||||||
|
|
|
|
|
|||||||||
|
|
(616)
|
|
(180)
|
(1,221)
|
(187)
|
|||||||
|
6,178
|
(544)
|
9,192
|
(1,970)
|
|||||||||
|
|
5,562
|
|
(724)
|
7,971
|
(2,157)
|
|||||||
|
|
|
|
|
|||||||||
|
$
|
1,947
|
$
|
(4,294)
|
$
|
469
|
$
|
(10,384)
|
|||||
|
|
||||||||||||
|
$
|
0.03
|
$
|
(0.08)
|
$
|
0.01
|
$
|
(0.19)
|
|||||
|
$
|
0.03
|
$
|
(0.08)
|
$
|
0.01
|
$
|
(0.19)
|
|||||
|
|
62,608,598
|
54,306,041
|
61,675,447
|
54,284,416
|
||||||||
|
67,166,377
|
54,306,041
|
66,255,298
|
54,284,416
|
|||||||||
|
|
||||||||||||
|
|
(5,476)
|
421
|
(8,212)
|
1,644
|
||||||||
|
$
|
(3,529)
|
$
|
(3,873)
|
$
|
(7,743)
|
$
|
(8,740)
|
|||||
|
Accumulated
|
|||||||||||||||||
|
Additional
|
Other
|
||||||||||||||||
|
Common Stock
|
Paid-In
|
Comprehensive
|
Accumulated
|
Stockholders’
|
|||||||||||||
|
|
Shares
|
|
Par value
|
|
Capital
|
|
Income (Loss)
|
|
Deficit
|
|
Equity
|
||||||
|
62,529,466
|
$
|
63
|
$
|
318,452
|
$
|
1,516
|
$
|
(305,487)
|
$
|
14,544
|
|||||||
|
80,910
|
—
|
571
|
—
|
—
|
571
|
||||||||||||
|
—
|
—
|
—
|
(5,476)
|
—
|
(5,476)
|
||||||||||||
|
—
|
—
|
—
|
—
|
1,947
|
1,947
|
||||||||||||
|
62,610,376
|
$
|
63
|
$
|
319,023
|
$
|
(3,960)
|
$
|
(303,540)
|
$
|
11,586
|
|||||||
|
54,830,146
|
$
|
55
|
$
|
310,809
|
$
|
4,252
|
$
|
(304,009)
|
$
|
11,107
|
|||||||
|
|
113,231
|
1
|
1,390
|
—
|
—
|
1,391
|
|||||||||||
|
6,249,791
|
6
|
5,386
|
—
|
—
|
5,392
|
||||||||||||
|
1,417,208
|
1
|
1,438
|
—
|
—
|
1,439
|
||||||||||||
|
|
—
|
—
|
—
|
(8,212)
|
—
|
(8,212)
|
|||||||||||
|
|
—
|
—
|
—
|
—
|
469
|
469
|
|||||||||||
|
|
62,610,376
|
$
|
63
|
$
|
319,023
|
$
|
(3,960)
|
$
|
(303,540)
|
$
|
11,586
|
||||||
|
Accumulated
|
|||||||||||||||||
|
Additional
|
Other
|
||||||||||||||||
|
Common Stock
|
Paid-In
|
Comprehensive
|
Accumulated
|
Stockholders’
|
|||||||||||||
|
|
Shares
|
|
Par value
|
|
Capital
|
|
Income
|
|
Deficit
|
|
Equity
|
||||||
|
54,293,555
|
$
|
54
|
$
|
307,200
|
$
|
1,752
|
$
|
(289,380)
|
$
|
19,626
|
|||||||
|
—
|
—
|
989
|
—
|
—
|
989
|
||||||||||||
|
—
|
—
|
691
|
—
|
—
|
691
|
||||||||||||
|
—
|
—
|
—
|
421
|
—
|
421
|
||||||||||||
|
12,860
|
—
|
(6)
|
—
|
—
|
(6)
|
||||||||||||
|
—
|
—
|
—
|
—
|
(4,294)
|
(4,294)
|
||||||||||||
|
54,306,415
|
$
|
54
|
$
|
308,874
|
$
|
2,173
|
$
|
(293,674)
|
$
|
17,427
|
|||||||
|
54,240,265
|
$
|
54
|
$
|
306,187
|
$
|
529
|
$
|
(283,290)
|
$
|
23,480
|
|||||||
|
|
—
|
—
|
1,949
|
—
|
—
|
1,949
|
|||||||||||
|
—
|
—
|
691
|
—
|
—
|
691
|
||||||||||||
|
|
—
|
—
|
—
|
1,644
|
—
|
1,644
|
|||||||||||
|
53,290
|
—
|
53
|
—
|
—
|
53
|
||||||||||||
|
12,860
|
—
|
(6)
|
—
|
—
|
(6)
|
||||||||||||
|
|
—
|
—
|
—
|
—
|
(10,384)
|
(10,384)
|
|||||||||||
|
|
54,306,415
|
$
|
54
|
$
|
308,874
|
$
|
2,173
|
$
|
(293,674)
|
$
|
17,427
|
||||||
|
Six
|
Six
|
|||||
|
Months Ended
|
Months Ended
|
|||||
|
June 30,
|
June 30,
|
|||||
|
2025
|
2024
|
|||||
|
|
|
|||||
|
$
|
469
|
$
|
(10,384)
|
|||
|
|
||||||
|
—
|
111
|
|||||
|
381
|
—
|
|||||
|
773
|
|
798
|
||||
|
72
|
92
|
|||||
|
—
|
|
250
|
||||
|
253
|
—
|
|||||
|
9
|
29
|
|||||
|
1,391
|
1,949
|
|||||
|
(9,192)
|
|
1,970
|
||||
|
|
||||||
|
257
|
|
(1,952)
|
||||
|
(925)
|
|
(1,030)
|
||||
|
1,897
|
|
574
|
||||
|
—
|
|
1
|
||||
|
(360)
|
|
(2,032)
|
||||
|
(4,975)
|
|
(9,624)
|
||||
|
|
|
|||||
|
(39)
|
|
(63)
|
||||
|
(140)
|
|
(183)
|
||||
|
(179)
|
|
(246)
|
||||
|
|
|
|||||
|
—
|
15,000
|
|||||
|
—
|
|
(5,000)
|
||||
|
—
|
(150)
|
|||||
|
—
|
|
(640)
|
||||
|
—
|
53
|
|||||
|
1,439
|
—
|
|||||
|
5,392
|
—
|
|||||
|
6,831
|
9,263
|
|||||
|
285
|
|
(64)
|
||||
|
1,962
|
|
(671)
|
||||
|
9,764
|
|
15,615
|
||||
|
$
|
11,726
|
$
|
14,944
|
|||
|
|
||||||
|
$
|
1,018
|
$
|
538
|
|||
|
|
||||||
|
$
|
556
|
$
|
691
|
|||
|
|
Three Months Ended
|
|
Six Months Ended
|
|||||||||
|
June 30,
|
June 30,
|
|||||||||||
|
|
2025
|
|
2024
|
|
2025
|
|
2024
|
|||||
|
|
(amounts, in thousands)
|
|||||||||||
|
Net income (loss) attributable to common stockholders
|
|
$
|
1,947
|
|
$
|
(4,294)
|
|
$
|
469
|
|
$
|
(10,384)
|
|
Depreciation and amortization expense
|
$
|
404
|
$
|
401
|
$
|
773
|
$
|
798
|
||||
|
Income tax expense (benefit)
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
Interest expense (income)
|
$
|
616
|
$
|
180
|
$
|
1,221
|
$
|
187
|
||||
|
EBITDA – non-GAAP measure
|
|
$
|
2,967
|
|
$
|
(3,713)
|
|
$
|
2,463
|
|
$
|
(9,399)
|
|
Non-cash stock-based compensation expense
|
|
$
|
571
|
|
$
|
989
|
|
$
|
1,391
|
|
$
|
1,949
|
|
(Gain)/Loss on foreign currency transactions
|
|
(6,178)
|
|
544
|
|
(9,192)
|
|
1,970
|
||||
|
Adjusted EBITDA – non-GAAP measure
|
|
$
|
(2,640)
|
|
|
(2,180)
|
|
$
|
(5,338)
|
|
$
|
(5,480)
|
|
Net income (loss) attributable to common stockholders
|
|
$
|
1,947
|
|
$
|
(4,294)
|
|
$
|
469
|
|
$
|
(10,384)
|
|
Non-cash stock-based compensation expense
|
571
|
989
|
1,391
|
1,949
|
||||||||
|
(Gain)/Loss on foreign currency transactions
|
|
$
|
(6,178)
|
|
$
|
544
|
|
$
|
(9,192)
|
|
$
|
1,970
|
|
Adjusted net income (loss) – non-GAAP measure
|
$
|
(3,660)
|
$
|
(2,761)
|
$
|
(7,332)
|
$
|
(6,465)
|
||||
|
Weighted average common shares outstanding
|
|
|
|
|
|
|
|
|
||||
|
Basic
|
62,608,598
|
54,306,041
|
61,675,447
|
54,284,416
|
||||||||
|
Diluted
|
|
|
67,166,377
|
|
|
54,306,041
|
|
|
66,255,298
|
|
|
54,284,416
|
|
Basic net income (loss) per common share
|
$
|
0.03
|
$
|
(0.08)
|
$
|
0.01
|
$
|
(0.19)
|
||||
|
Diluted net income (loss) per common share
|
|
$
|
0.03
|
|
$
|
(0.08)
|
|
$
|
0.01
|
|
$
|
(0.19)
|
|
Non-cash stock-based compensation expense - basic
|
|
$
|
0.01
|
|
$
|
0.02
|
|
$
|
0.02
|
|
$
|
0.04
|
|
Non-cash stock-based compensation expense - diluted
|
$
|
0.01
|
$
|
0.02
|
$
|
0.02
|
$
|
0.04
|
||||
|
(Gain)/Loss on foreign currency transactions - basic
|
|
$
|
(0.10)
|
|
$
|
0.01
|
|
$
|
(0.15)
|
|
$
|
0.04
|
|
(Gain)/Loss on foreign currency transactions - diluted
|
$
|
(0.09)
|
$
|
0.01
|
$
|
(0.14)
|
$
|
0.04
|
||||
|
Adjusted net income (loss) per common share – basic – non-GAAP measure
|
|
$
|
(0.06)
|
|
$
|
(0.05)
|
|
$
|
(0.12)
|
|
$
|
(0.12)
|
|
Adjusted net income (loss) per common share – diluted – non-GAAP measure
|
$
|
(0.05)
|
$
|
(0.05)
|
$
|
(0.11)
|
$
|
(0.12)
|
||||