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Nuwellis, Inc.

NUWEFDA catalysts, PDUFA dates & pipeline intelligence
$0.69
▲ +0.01 · +2.19%

Financials

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52W LOW $0.6752W HIGH $172.90
Volume
103.26 K
Value Traded
894.30 K
Short % Float
1.22%
-0.39%Week
-13.59%1 Month
-77.27%3 Month
-98.18%6 Month
-100%5 Year
-100%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
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  • SEC Filing

Key Stats

Market Cap
2.52 M
EPS (TTM)
-3.57
P/E Ratio
-
Ent. Value
-1.41 M
Total Shares
3.65 M
Float Shares
3.12 M
Insiders
14.52%
Institutions
0.57%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA
2026
Example Drug
Treatment for example condition requiring FDA review
Phase 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

NUWE Catalyst Timeline

Dated clinical, regulatory and corporate events for Nuwellis, Inc.

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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How NUWE actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
-Example Drug Phase 3 data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

No drug pipeline

Nuwellis, Inc. is a medical device company. The clinical trials it takes part in test other companies' drugs, so it has no drug pipeline of its own to score.

Clinical Trial Results

Readouts, endpoints and source filings for every NUWE program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
Example Drug Example indication for clinical evaluationPhase 32025-12-01The study met its primary endpoint demonstrating statistically significant improvement.Read MorePhase 3 Study Results AnnouncementRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
WALLER GREGORY DDirectorGrant/Award 6,744 6,744 held$0.00 04/28/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
No hedge fund reported a 13F position in NUWE for Q2 2026.
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

NUWE Institutional Ownership Trends

Options Data

Option Volume

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Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
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Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Live calls and puts by strike: last price, volume and open interest for every expiry.
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Calls vs Puts by Expiry

CallsPutsLog scale
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Competitive positioning

How NUWE ranks across every disease it competes in

Competitive Position is a premium feature
See how NUWE ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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NUWE News

NUWE
Jun 16, 2026
NUWEGeneral

Nuwellis Appoints Mike McCormick as Chief Executive Officer

Nuwellis, Inc. has announced the appointment of Mike McCormick as the new Chief Executive Officer, effective June 30, 2026, succeeding John Erb, who will remain as Chairman of the Board. McCormick brings over three decades of experience in the medical technology sector, and his leadership is anticipated to drive the company’s expansion in precision fluid management for cardiorenal care. The transition aims to leverage McCormick’s commercial expertise and strategic vision to enhance the company’s product pipeline and overall market position.

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NUWE
May 12, 2026
NUWEGeneral

Nuwellis, Inc. Announces First Quarter 2026 Financial Results MINNEAPOLIS - May 12, 2026 - Nuwellis, Inc.

Nuwellis, Inc. reported its first-quarter 2026 financial results, showcasing a revenue increase of 26% year-over-year, reaching $2.4 million. The company improved its gross margin to 70.1%, supported by enhanced pricing strategies and product mix. However, operating expenses rose significantly, leading to a net loss of approximately $4.3 million. Leadership emphasized the positive effects of a strategic reset initiated in 2025, aimed at focusing on key clinical areas and driving disciplined execution.

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NUWE
Mar 10, 2026
NUWEGeneral

Nuwellis, Inc. Announces Fourth Quarter and Full Year 2025 Financial Results

Nuwellis, Inc. has reported its financial results for the fourth quarter and full year ended December 31, 2025. The fourth quarter saw a revenue increase of 4% year-over-year, with a notable improvement in gross margins. However, the company experienced a 5% decline in total revenue for the full year, despite growth in specific areas such as Heart Failure and Pediatrics. Moving into 2026, Nuwellis plans to integrate its recent acquisition of Rendiatech and focus on advancing its product offerings within the cardiorenal continuum.

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NUWE
Feb 26, 2026
NUWEGeneral

Minneapolis, MN

Nuwellis, Inc. has appointed David A. McDonald and Martin J. Emerson to its Board of Directors, effective February 24, 2026. These appointments are aimed at enhancing the board's expertise, particularly in capital markets and medical device leadership. John Erb, the company's CEO, highlighted the importance of their combined experience for executing the company's strategic priorities. Both new board members bring extensive backgrounds in healthcare and corporate development, which are expected to contribute positively to Nuwellis's goals.

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NUWE
Jan 29, 2026
NUWEGeneral
▲ +8.5%on this news

Nuwellis Announces $5 Million Private Placement and Warrant Inducement Transaction, Priced At-The-Market

Nuwellis, Inc. has announced a $5 million private placement and warrant inducement agreement, aimed at enhancing its capital resources. The agreement involves the sale of 994,537 shares of common stock and warrants, with an effective offering price of $3.09 per share. Additionally, Nuwellis will allow a reduction in the exercise price of existing warrants, encouraging immediate investor activity. The completion of these transactions is expected to close around January 30, 2026, contingent on standard closing conditions.

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NUWE
Jan 23, 2026
NUWEGeneral

Nuwellis Announces Changes to Board of Directors

Nuwellis, Inc. announced the appointment of Katharyn Field and Mika Grasso to its board of directors, effective January 21, 2026. Both appointees bring significant experience in medical technology and finance. The company also disclosed the resignation of three board members, which was not linked to any disagreements with the company's operations. This change is expected to strengthen Nuwellis' governance as it pursues its strategic priorities in precision cardiorenal care.

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NUWE
Nov 12, 2025
NUWEGeneral

Nuwellis Reports Third Quarter 2025 Results and Continued Operational Momentum

Nuwellis, Inc. reported its financial results for the third quarter of 2025, demonstrating operational momentum in various therapeutic areas. The company experienced a sequential revenue growth of 29%, bolstered by increased utilization of its products. While total revenue decreased from the previous year, management remains optimistic about the launch of new therapies and their growing focus on the U.S. market. However, rising operating expenses present potential challenges in maintaining profitability.

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NUWE
Aug 14, 2025
NUWEGeneral

Nuwellis, Inc. Reports Second Quarter 2025 Financial Results and Business Highlights

Nuwellis, Inc. reported its financial results for the second quarter of 2025, highlighting a revenue decline to $1.7 million compared to $2.2 million the previous year. This decrease was attributed mainly to an industry-wide sterilization vendor issue that caused product backorder disruptions. Despite challenges, the company is strategically realigning its focus towards pediatric and cardiac surgery, and remains debt-free with $4.5 million in cash. Nuwellis aims to bolster its operational discipline and improve patient care as it enters the latter half of the year.

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NUWE
May 13, 2025
NUWEGeneral

Nuwellis, Inc. Announces First Quarter 2025 Financial Results and Business Highlights

Nuwellis, Inc. has reported its financial results for the first quarter of 2025, showing a 3% increase in revenue compared to the same quarter in 2024, reaching $1.9 million. The company recognizes advancements in its Aquadex therapy adoption due to improved reimbursement rates and performance in pediatric services. While the operating loss has improved to $3.1 million, net losses remain high at $3.0 million. The overall financial health appears cautiously optimistic as the company continues to navigate market opportunities.

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NUWE
Apr 3, 2025
NUWEConferences/Events

Investor Presentation April 2025 Making Aquadex the Standard of Care for Fluid Management Aquadex SmartFlow is a registered trademarks of Nuwellis, Inc. Aquadex is a trademark of Nuwellis, Inc. Safe Harbor Statement Fina

Nuwellis, Inc. plans to make Aquadex the standard of care for fluid management, emphasizing its strategic focus on critical care and pediatrics. The company highlights a significant increase in outpatient reimbursement rates, which enhances the financial viability of Aquadex treatments and aims to reduce hospital readmissions. Nuwellis is nearing critical milestones in its REVERSE-HF trial, which seeks to validate the effectiveness of Aquadex therapy compared to traditional IV loop diuretics in heart failure management. The company's focused growth strategy aims to expand its market presence and improve patient care standards.

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NUWE
Mar 11, 2025
NUWEGeneral

Nuwellis, Inc. Announces Fourth Quarter and Full Year 2024 Financial Results

Nuwellis, Inc. recently reported its financial results for Q4 2024, revealing a 9% decrease in revenue to $2.3 million. However, the company experienced significant growth in consumables utilization and revenue in its Critical Care segment, indicating positive market trends. The overall operating loss improved due to reduced operating expenses and a one-time gain from a contract termination. The company remains optimistic about 2025, anticipating expansion due to improved awareness and favorable reimbursement changes.

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NUWE
Feb 24, 2025
NUWEGeneral

NUWELLIS ANNOUNCES RETIREMENT OF NESTOR JARAMILLO, JR. AS PRESIDENT AND CEO JOHN ERB, CURRENT CHAIR OF THE BOARD, APPOINTED INTERIM PRESIDENT AND CEO

Nuwellis, Inc. announced the retirement of President and CEO Nestor Jaramillo, Jr., effective February 18, 2025. John Erb, Chairman of the Board, has been appointed as the Interim President and CEO, taking on the responsibilities of Mr. Jaramillo. The company plans to engage an executive search firm to find a permanent successor. Jaramillo is recognized for his strategic contributions during his tenure with the company.

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NUWE
Dec 19, 2024
NUWEGeneral

Nuwellis Regains Compliance with Nasdaq Listing Requirements MINNEAPOLIS - Dec. 19, 2 024 - Nuwellis, Inc. (Nasd aq: NUWE) (the "Company" or "Nuwellis"), today announced that the Company received formal written notice fr

Nuwellis, Inc. announced that it has regained compliance with Nasdaq's listing requirements for minimum bid price and stockholders' equity. The company improved its financial standing through equity raises and restructuring liabilities. As a result, Nuwellis will continue to trade on Nasdaq under the symbol "NUWE". Additionally, a mandatory panel monitor will oversee the company for a year from the date of compliance confirmation.

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NUWE
Nov 11, 2024
NUWEGeneral

Nuwellis, Inc. Announces Third Quarter 2024 Financial Results and Recent Highlights Minneapolis, MN

Nuwellis, Inc. announced its financial results for the third quarter of 2024, reporting a revenue of $2.4 million, a slight decline from the previous year. Despite this, the company highlighted significant growth in the Pediatric customer category and a major reimbursement increase from CMS that will expand its market potential effective January 2025. The gross margin improved to 70%, showing efficient operational management. However, a decrease in revenue and R&D expenses raises some concern about future growth and innovation.

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NUWE
Nov 7, 2024
NUWEGeneral

Nuwellis Announces Exercise of Warrants for $5.1 Million of Gross Proceeds MINNEAPOLIS, November 5 , 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) ("Nuwellis" or the "Company"), a commercial-stage medical device

Nuwellis, Inc. has announced the immediate exercise of certain outstanding warrants, generating approximately $5.1 million in gross proceeds. The exercise of warrants allows for the purchase of common stock at $2.10 per share, along with the issuance of new Series I and Series II warrants at an exercise price of $1.94. This move supports the company’s focus on advancing its Aquadex SmartFlow system for treating patients suffering from fluid overload. The company plans to file a registration statement with the SEC regarding the resale of shares stemming from the new warrants.

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NUWE
Aug 23, 2024
NUWEGeneral

Nuwellis Announces Pricing of $916,000 Registered Direct Offering Priced At-The-Market Under Nasdaq Rules MINNEAPOLIS

Nuwellis, Inc. has announced a registered direct offering priced at-the-market under Nasdaq rules, aiming to raise approximately $916,000. The company will sell 496,901 shares at a price of $1.8450 per share, alongside warrants for the same number of shares with a lower exercise price. The proceeds are intended for working capital and general corporate purposes. The transaction is expected to close on or about August 26, 2024, subject to customary conditions. This offering reflects the company's ongoing strategy to support its operations and commercialization efforts in addressing fluid overload in patients.

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NUWE
Aug 13, 2024
NUWEGeneral

Nuwellis, Inc. Announces Second Quarter 2024 Financial Results Minneapolis, MN

Nuwellis, Inc. reported its financial results for the second quarter of 2024, showing a 6% increase in revenue to $2.2 million, mainly due to growth in consumables usage in Critical Care and Heart Failure. The gross margin improved to 67.2%, reflecting manufacturing efficiencies. Though the company has expanded its Pediatric product offerings, it observed a decline in Pediatric utilization by 25%. Despite these advancements, Nuwellis recorded a higher net loss of $7.7 million compared to the prior year.

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NUWE
Jul 24, 2024
NUWEGeneral

Nuwellis Announces Pricing of $2.0 Million Offering Priced At-The-Market Under Nasdaq Rules MINNEAPOLIS

Nuwellis, Inc. has announced the pricing of a $2.0 million public offering under Nasdaq rules. The offering involves the sale of 469,340 shares of common stock at a price of $4.24 per share, along with warrants for an additional purchase of shares. The transaction is expected to close on or about July 25, 2024, and the funds will primarily be used for working capital and corporate objectives. Roth Capital Partners is acting as the exclusive placement agent for this offering.

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NUWE
Jul 17, 2024
NUWEConferences/Events

July 2024 Investor Presentation Aquadex FlexFlow and Aquadex SmartFlow are registered trademarks of Nuwellis, Inc. Aquadex is a trademark of Nuwellis, Inc. Safe Harbor Statement Financial and Statistical DataThis present

Nuwellis, Inc. delivered an investor presentation highlighting their Aquadex FlexFlow and SmartFlow systems aimed at addressing fluid overload in patients. The presentation outlined the significant public health challenges, particularly for heart failure patients, noting that fluid overload contributes to high hospitalization rates and costs. It also emphasized the limitations of current standard care with diuretics, suggesting a need for innovative solutions. Risks mentioned include uncertainty in market performance and potential fund-raising challenges.

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NUWE
Jul 17, 2024
NUWEGeneral

Nuwellis Marks First Commercial Sale of QUELIMMUNE Therapy to Cincinnati Children's MINNEAPOLIS

Nuwellis, Inc. has reported its first commercial sale of QUELIMMUNE therapy to Cincinnati Children's Hospital, marking a significant step in pediatric critical care. This novel treatment, which targets children with uncontrolled inflammatory responses, offers a promising 77% survival rate for patients suffering from acute kidney injury due to sepsis. The therapy is now available through a Humanitarian Device Exemption granted by the FDA, emphasizing Nuwellis' commitment to improving outcomes in pediatric care. With the integration of QUELIMMUNE into treatment options, healthcare professionals express optimism for its potential impact on critically ill patients.

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About Nuwellis, Inc.

Eden Prairie, MN 38 employees nuwellis.com
Headquarters12988 VALLEY VIEW ROAD, EDEN PRAIRIE, MN, 55344
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