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NUWE

Nuwellis, Inc.

NASDAQ · Healthcare · Medical - Devices · US

$0.78
+6.29%
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Analyst consensus

Next report date
Nov 11, 2026
EPS estimate
-$14
Revenue estimate
$2.5M

Latest reported

Last report date
Aug 13, 2026
EPS actual
-$27
EPS estimate
-$24
Revenue actual
$2.0M
Revenue estimate
$2.4M

Track record

Trailing twelve quarters

EPS beats (12Q)
4
EPS misses (12Q)
8
EPS in line (12Q)
0
Avg surprise (4Q)
-3.5%
Revenue beats (12Q)
3
Earnings call summaryRead the full call →

Q2 FY2026 · Aug 13, 2026

AI summary of management’s prepared remarks and analyst Q&A · For informational purposes only, not investment advice

Management highlights

  • Leadership Transition: Newly appointed CEO Mike McCormick opened the call, thanking former CEO John Erb, who remains chairman of the board. McCormick outlined three core strategic priorities for the company: 1) build on the existing differentiated position in precision fluid management to grow the pediatric segment, 2) expand commercial presence in adult critical care, 3) strategically broaden the cardiorenal platform through complementary technologies and collaborations to drive commercial value.
  • Installed Base Growth: 9 Aquadex consoles were sold in Q2 2026, bringing first half 2026 total console placements to 24, up from only 5 in the first half of 2025. Management is focused on converting new placements to sustained clinical use via training, protocol development, and appropriate patient identification, measuring success by consistent account utilization, patient volume, and recurring circuit revenue from the installed base.
  • Pediatric Segment Progress: New Ellis expanded into two new states (Michigan and Wisconsin) to launch their first ever pediatric Aquadex programs, and added a new placement in a major South Carolina healthcare system. The company strengthened clinical education adoption support, including a highlighted clinical case presentation at the 2026 International Society for Heart and Lung Transplantation Annual Meeting, and marked 5 years of support for the Pediatric Cardiac Critical Care Consortium (PC4). The company completed a pre-submission meeting with the FDA for a proposed Aquadex label expansion (extending eligibility from patients 20kg and above to patients 5kg and above), gained clarity on the regulatory pathway, and plans to submit the expansion in Q4 2026. Software updates to the Aquadex platform were completed to improve workflow efficiency, treatment precision, and reduce adoption barriers.
  • Adult Critical Care Development: New Ellis launched a strategic initiative to expand Aquadex into a broader extracorporeal therapy platform, adding higher flow capabilities to support new filtration technologies for complex, high-pressure critical care environments, and developing the Smart View enhanced user interface to improve usability, workflows, and utilization. More than 280 physicians attended a company-hosted critical care cardiac education summit with hands-on Aquadex training, the largest concentrated physician training initiative in the company's history.
  • Cardiorenal Platform Expansion: The Q1 2026 acquisition of Renditech added the Clarity Prime automated kidney function monitoring system to the company's pipeline. Q2 2026 focus included product development, technology integration, and commercial planning, with Clarity Prime on track to launch in 2007. The product will complement Aquadex by enabling earlier, continuous detection of kidney function changes to support more informed cardiorenal care decisions. Management is selectively evaluating additional complementary pediatric technologies (including urine output monitoring and non-invasive cardiac monitoring) in a capital-efficient manner.
  • Intellectual Property and Balance Sheet: The U.S. Patent and Trademark Office issued a notice of allowance (patent issued mid-July 2026) for New Ellis' dual-lumen midline catheter technology, which supports less invasive peripheral access for extracorporeal therapies and strengthens the company's intellectual property portfolio. As of June 30, 2026, the company had no debt and $3.9 million in cash and cash equivalents. Subsequent to quarter end, the company raised an additional $3.4 million in gross proceeds via a registered direct offering, and received $3.3 million from cash exercise of warrants related to the June 2026 financing.

Guidance

  • New Ellis does not provide formal quarterly or full-year financial guidance.
  • The company has set clear long-term financial objectives: deliver consistent double-digit revenue growth, maintain strong gross margins, increase Aquadex installed base and recurring circuit utilization, advance high-priority development programs, and reduce cash utilization over time.
  • Management confirmed the Aquadex pediatric label expansion submission to the FDA is on track to occur in Q4 2026, and Clarity Prime remains on schedule for a 2027 launch.

Segment performance

New Ellis does not break out results into multiple distinct product segments in this call. Total company revenue for Q2 2026 was $1.97 million, a 14% increase from $1.7 million in Q2 2025. Year-to-date (first half 2026) total revenue was $4.37 million, a 20% increase year-over-year. U.S. revenue grew 17% in Q2 2026 and 24% year-to-date, outpacing overall company growth as lower outside-U.S. service and rental revenue moderated total growth. Gross profit for Q2 2026 was approximately $1.5 million, for a gross margin of 76%, up 20 percentage points from 56% in Q2 2025. Operating expenses for Q2 2026 were approximately $4.7 million, up from $3.9 million in the prior year quarter but down sequentially from $6.3 million in Q1 2026. Reported net loss for Q2 2026 was approximately $4.8 million, compared to a $12.6 million net loss in Q2 2025. Nine U.S. Aquadex consoles were sold in Q2 2026, up from three sold in Q2 2025, bringing first half 2026 console sales to 24, compared to five in the first half of 2025. U.S. circuit average selling prices increased 5% year-over-year, and console average selling prices increased 3% year-over-year, driven by 2025 Q3 pricing adjustments.

Risks & headwinds

  • Management noted that all forward-looking statements involve material risks and uncertainties that could cause actual results to differ materially from anticipated outcomes, in line with the disclosures in New Ellis' SEC filings, including the 10-K. No additional specific operational or financial risks were discussed in detail during the call.

Analyst Q&A

No questions were submitted by participants during the Q&A portion of the call. All prepared remarks on strategy, performance, guidance, and risk are included in the preceding sections of this summary.

Reported results against consensus at the time of each report · Surprise is computed from the estimate on record · Data as of Nov 11, 2026