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Nauticus Robotics Reports Strong Start to 2025

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Revenue Momentum Builds; Strategic Acquisition Positions Company for Accelerated Growth

HOUSTON, May 14, 2025 /PRNewswire/ — Nauticus Robotics, Inc. (“Nauticus” or the “Company”) (NASDAQ: KITT), a trailblazer in subsea robotics and intelligent automation, today announced its financial and operational results for the quarter ended March 31, 2025.

President and CEO John Gibson commented, “Our offshore season launched in Q1 with solid momentum and continues to gain strength into the second quarter. With the successful integration of SeaTrepid, the combined business is on pace to exceed Nauticus’s full-year 2024 revenue during the first half of 2025.”

Strategic Acquisition Fuels Innovation and Scale

On March 20, 2025, Nauticus completed the strategic acquisition of SeaTrepid International LLC (“SeaTrepid”), a seasoned provider of subsea robotic services. This milestone transaction enhances the Company’s operational capabilities and accelerates the deployment of Nauticus’s autonomy software, ToolKITT, across SeaTrepid’s active ROV fleet.

This powerful integration brings together cutting-edge robotics with intelligent automation, enabling seamless underwater collaboration between ROVs and Aquanaut vehicles. This breakthrough positions Nauticus to deliver industry-first efficiencies and unlock new commercial opportunities in the offshore services market.

The $14.4 million transaction included the acquisition of substantially all assets and select liabilities of SeaTrepid.

Operational Milestones and Project Success

Nauticus launched the 2025 Gulf Coast offshore season with significant activity:

One ROV began a contract with a drill ship, expected to remain active through the summer.A second ROV successfully completed a project in the Northeast and is now operational off the Gulf Coast, conducting detailed subsea inspections.Two Aquanaut® vehicles progressed through rigorous readiness testing; one is fully prepared for deployment, while the other is undergoing final validation.

Advancing Next-Generation Technology

Nauticus’s Software team achieved notable progress this quarter, developing and finalizing new capabilities for Aquanaut and preparing a commercial-ready release of software for work-class ROVs.

Simultaneously, the Electric Manipulator team continued advancing purpose-built electric manipulators designed for seamless integration with both Aquanaut vehicles and ROVs – ushering in a new era of versatile, high-performance subsea tools.

Customer Demand and Outlook

Market response to Nauticus’s expanded service offerings has been overwhelmingly positive. Long-standing customers are engaging with the Company’s new operational model, exploring innovative ways to partner and deploy the latest robotic technologies. The sales team is seeing a meaningful shift in customer mindset, signaling increased openness to autonomous solutions.

With strong demand, innovative products, and a growing platform, Nauticus is well-positioned for a standout 2025. “We are committed to improving our value,” Gibson said. “The foundation we’ve laid is strong, and the opportunities ahead are truly exciting.”

Financial Highlights

Revenue: Nauticus reported first-quarter revenue of $0.2 million, compared to $0.5 million for the prior-year period and $0.5 million for the prior quarter.

Operating Expenses: Total expenses during the first quarter were $6.0 million, a $0.02 million increase from the prior-year period and a $0.4 million decrease from Q4 2024.

Adjusted Net Loss: Nauticus reported adjusted net loss of $6.6 million for the first quarter, compared to an adjusted net loss of $6.4 million for the same period in 2024 and an adjusted net loss of $6.9 million for the prior quarter. Adjusted net loss is a non-GAAP measure which excludes the impact of certain items, as shown in the non-GAAP reconciliation table below.

Net Loss: For the first quarter, Nauticus recorded a net loss of $7.6 million, or basic loss per share of $0.28. This compares with a net loss of $72.8 million from the same period in 2024, and a net loss of $84.5 million in the prior quarter.

G&A Cost: Nauticus reported G&A first-quarter costs of $4.3 million, which is an increase of $0.9 million compared to the same period in 2024 and a $0.4 million increase from the previous quarter.

Balance Sheet and Liquidity

As of March 31, 2025, the Company had cash and cash equivalents of $10.1 million, compared to $1.2 million as of December 31, 2024.

In Q1 2025, the Company conducted At The Market offerings, in which it issued and sold almost 7.5 million shares for net proceeds of $19.4 million.

Conference Call Details

Nauticus will host a conference call on May 15, 2025 at 10:00 a.m. Central Time to discuss its results for the quarter ended March 31, 2025. To participate in the earnings conference call, participants should dial toll free at +1-800-549-8228, conference ID: 78839, or access the listen-only webcast at the following link: https://events.q4inc.com/attendee/167622035. A link to the webcast will also be available on the Company’s website (https://ir.nauticusrobotics.com/). Following the conclusion of the call, a recording will be available on the Company’s website.

About Nauticus Robotics

Nauticus Robotics, Inc. is a developer of ocean robots, cloud software and services delivered to the ocean industry. Our portfolio includes fully autonomous underwater vehicles (“AUVs”), robotic manipulators, an open robotic operating system, and related consulting and prototype services with a strong alignment to offshore energy and national security interests. Our technology solutions enable autonomous operations for both the commercial and defense sectors. To effectively enter markets dominated by legacy solutions, we have developed innovative and value-driven technologies. Our flagship autonomous fully electric vehicle, Aquanaut, provides advantages over conventionally tethered Remotely Operated Vehicles (ROVs) and untethered AUVs. Aquanaut represents the next generation of subsea robotics integrating eight independent thrusters to precisely propel and position a hull design to maximize efficiency and speed high-resolution data collection, and autonomous fully electric manipulation comparable to traditional ROV operations. ToolKITT is a sophisticated software platform that governs our suite of robotic products. It enables robots to perceive their environment, navigate in three dimensions, make autonomous decisions, and execute tasks with minimal human intervention. ToolKITT has been deployed on third party commercial ROVs and competing robotic platforms, enhancing our ability to offer advanced inspection and intervention services. This software also plays a critical role in next-generation inspection services, a key industry need for ensuring the integrity of subsea pipelines and offshore infrastructure. The Olympic Arm is a fully electric subsea manipulator designed for complex intervention tasks on both work-class ROVs and Aquanaut. Its patented electric actuators replace traditional hydraulic systems. The strategic acquisition of SeaTrepid International LLC intends to integrate Nauticus AI-driven autonomy software, ToolKITT, into SeaTrepid’s existing remotely operated vehicle (ROV) fleet. The combination will showcase unprecedented advancements in power efficiency and operational performance across the industry. The ability of ROVs and Aquanaut to seamlessly communicate at depth unlocks new service opportunities, enabling two autonomous systems to collaborate in delivering cutting-edge underwater solutions.

Cautionary Language Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Act”), and are intended to enjoy the protection of the safe harbor for forward-looking statements provided by the Act as well as protections afforded by other federal securities laws. Such forward-looking statements include but are not limited to: the expected timing of product commercialization or new product releases; customer interest in Nauticus’ products; estimated operating results and use of cash; and Nauticus’ use of and needs for capital. Generally, statements that are not historical facts, including statements concerning possible or assumed future actions, business strategies, events, or results of operations, are forward-looking statements. These statements may be preceded by, followed by, or include the words “believes,” “estimates,” “expects,” “projects,” “forecasts,” “may,” “will,” “should,” “seeks,” “plans,” “scheduled,” “anticipates,” “intends,” or “continue” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that may cause actual events, results, or performance to differ materially from those indicated by such statements. These forward-looking statements are based on Nauticus’ management’s current expectations and beliefs, as well as a number of assumptions concerning future events. There can be no assurance that the events, results, or trends identified in these forward-looking statements will occur or be achieved. Forward-looking statements speak only as of the date they are made, and Nauticus is not under any obligation and expressly disclaims any obligation, to update, alter, or otherwise revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. Readers should carefully review the statements set forth in the reports which Nauticus has filed or will file from time to time with the Securities and Exchange Commission (the “SEC”) for a more complete discussion of the risks and uncertainties facing the Company and that could cause actual outcomes to be materially different from those indicated in the forward-looking statements made by the Company, in particular the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents filed from time to time with the SEC, including Nauticus’ Annual Report on Form 10-K filed with the SEC on April 15, 2025. Should one or more of these risks, uncertainties, or other factors materialize, or should assumptions underlying the forward-looking information or statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated, or expected. The documents filed by Nauticus with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov.

NAUTICUS ROBOTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

March 31, 2025

December 31, 2024

(Unaudited)

ASSETS

Current Assets:

Cash and cash equivalents

$10,054,304

$1,186,047

Restricted certificate of deposit

52,640

52,151

Accounts receivable, net

326,830

238,531

Accounts receivable unbilled

165,256

–

Inventories

955,894

880,594

Prepaid expenses

1,695,991

1,389,434

Other current assets

607,391

573,275

Assets held for sale

750

750

Total Current Assets

13,859,056

4,320,782

Property and equipment, net

22,812,432

17,115,246

Operating lease right-of-use assets

999,496

1,094,743

Other assets

157,701

154,316

Goodwill

10,652,388

–

Total Assets

$48,481,073

$22,685,087

LIABILITIES AND STOCKHOLDERS’ DEFICIT

Current Liabilities:

Accounts payable

$4,892,453

$5,916,693

Accrued liabilities

9,674,282

5,602,721

Contract liability

346,279

346,279

Operating lease liabilities – current

447,292

435,307

Notes payable – current

2,437,744

–

Total Current Liabilities

17,798,050

12,301,000

Warrant liabilities

131,025

181,913

Operating lease liabilities – long-term

653,402

768,939

Notes payable – long-term, fair value option (related party)

3,307,758

2,583,832

Notes payable – long-term, net of discount (related party)

10,955,052

13,820,366

Notes payable – long-term, net of discount

13,219,166

12,531,332

Other liabilities

895,118

895,118

Total Liabilities

$46,959,571

$43,082,500

Stockholders’ Deficit

Series A Convertible Preferred Stock $0.0001 par value; 40,000
     shares authorized,  35,434 shares issued at March 31, 2025 and
     December 31, 2024 and 19,846 and 35,034  outstanding at March
     31, 2025 and December 31, 2024, respectively.

$2

$4

Common stock, $0.0001 par value; 625,000,000 shares authorized,
     35,153,188 and 9,761,895 shares issued, respectively, and
     35,153,188 and 9,761,895 shares outstanding, respectively

3,515

976

Additional paid-in capital

262,825,753

233,342,188

Accumulated other comprehensive loss

(42,229)

(42,229)

Accumulated deficit

(261,265,539)

(253,698,352)

Total Stockholders’ Deficit

1,521,502

(20,397,413)

Total Liabilities and Stockholders’ Deficit

$48,481,073

$22,685,087

 

NAUTICUS ROBOTICS, INC.

Unaudited Condensed Consolidated Statements of Operations

Three Months Ended

3/31/2025

12/31/2024

3/31/2024

Revenue:

Service

$165,256

$471,223

$464,354

Total revenue

165,256

471,223

464,354

Costs and expenses:

Cost of revenue (exclusive of items
shown separately below)

1,238,957

2,114,837

2,093,955

Depreciation

480,376

452,970

426,185

Research and development

–

19,316

63,534

General and administrative

4,309,686

3,867,232

3,430,010

Total costs and expenses

6,029,019

6,454,355

6,013,684

Operating loss

(5,863,763)

(5,983,132)

(5,549,330)

Other (income) expense:

Other income, net

(87,397)

(55,012)

(96,473)

(Gain) loss on lease termination

–

42,618

(15,365)

Foreign currency transaction loss

3,267

40,320

5,147

Loss on extinguishment of debt

–

48,870,991

78,734,949

Change in fair value of warrant liabilities

(50,888)

(211,181)

(8,309,623)

Change in fair value of New Convertible
Debentures

–

28,123,852

(4,504,426)

Change in fair value of November 2024
Debentures

723,926

435,864

–

Interest expense, net

1,114,516

1,309,931

1,475,397

Total other expense, net

1,703,424

78,557,383

67,289,606

Net loss

$(7,567,187)

$(84,540,515)

$(72,838,936)

Basic and diluted loss per share

$(0.28)

$(21.59)

$(58.75)

Basic and diluted weighted average
shares outstanding

27,447,425

3,915,684

1,239,881

 

NAUTICUS ROBOTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Three months  ended March 31,

2025

2024

Cash flows from operating activities:

Net loss

$(7,567,187)

$(72,838,936)

Adjustments to reconcile net income (loss) to net cash used in operating activities:

Depreciation

480,376

426,185

Amortization of debt discount

9,895

381,592

Amortization of debt issuance cost

173,447

142,821

Capitalized paid-in-kind (PIK) interest

166,882

–

Accretion of RCB Equities #1, LLC exit fee

24,152

24,212

Stock-based compensation

312,679

530,655

Change in fair value of warrant liabilities

(50,888)

(8,309,623)

Change in fair value of New Convertible Debentures

–

(4,504,426)

Change in fair value of November 2024 Debentures

723,926

–

Loss on extinguishment of debt

–

78,734,949

Non-cash lease expense

95,247

115,778

Gain on disposal of assets

–

(4,231)

Gain on lease termination

–

(15,365)

Changes in current assets and liabilities:

Accounts receivable

(115,200)

55,101

Inventories

–

(15,930)

Other assets

(282,031)

1,196,413

Accounts payable and accrued liabilities

(517,629)

(222,104)

Contract liabilities

–

(2,289,834)

Operating lease liabilities

(103,552)

(67,539)

Net cash used in operating activities

(6,649,883)

(6,660,282)

Cash flows used in/from investing activities:

Capital expenditures

(47,989)

(324,147)

Acquisition of business, net of cash acquired

(3,871,992)

–

Proceeds from sale of property and equipment

–

384,708

Proceeds from sale of short-term investments

–

7,921

Net cash from investing activities

(3,919,981)

68,482

Cash flows from financing activities:

Proceeds from notes payable

–

13,305,000

Payment of debt issuance costs on notes payable

–

(1,279,291)

Proceeds from ATM offering

20,141,905

–

Payment of ATM commissions and fees

(703,784)

–

Net cash from financing activities

19,438,121

12,025,709

Net change in cash and cash equivalents

8,868,257

5,433,909

Cash and cash equivalents, beginning of year

1,186,047

753,398

Cash and cash equivalents, end of year

$10,054,304

$6,187,307

NAUTICUS ROBOTICS, INC.

Unaudited Reconciliation of Net Loss Attributable to Common Stockholders (GAAP) to Adjusted Net Loss Attributable to Common Stockholders (NON-GAAP)

Adjusted net loss attributable to common stockholders is a non-GAAP financial measure which excludes certain items that are included in net loss attributable to common stockholders, the most directly comparable GAAP financial measure. Items excluded are those which the Company believes affect the comparability of operating results and are typically excluded from published estimates by the investment community, including items whose timing and/or amount cannot be reasonably estimated or are non-recurring.

Adjusted net loss attributable to common stockholders is presented because management believes it provides useful additional information to investors for analysis of the Company’s fundamental business on a recurring basis. In addition, management believes that adjusted net loss attributable to common stockholders is widely used by professional research analysts and others in the valuation, comparison, and investment recommendations of companies such as Nauticus.

Adjusted net loss attributable to common stockholders should not be considered in isolation or as a substitute for net loss attributable to common stockholders or any other measure of a company’s financial performance or profitability presented in accordance with GAAP. A reconciliation of the differences between net loss attributable to common stockholders and adjusted net loss attributable to common stockholders is presented below. Because adjusted net loss attributable to common stockholders excludes some, but not all, items that affect net loss attributable to common stockholders and may vary among companies, our calculation of adjusted net loss attributable to common stockholders may not be comparable to similarly titled measures of other companies.

Three Months Ended

3/31/2025

12/31/2024

3/31/2024

Net loss attributable to common
stockholders (GAAP)

$(7,567,187)

$(84,540,515)

$(72,838,936)

Loss on extinguishment of debt

–

48,870,991

78,734,949

Change in fair value of warrant liabilities

(50,888)

(211,181)

(8,309,623)

Change in fair value of New Convertible
Debentures

–

28,123,852

(4,504,426)

Change in fair value of November 2024
Debentures

723,926

435,864

–

Stock compensation expense

312,679

430,550

530,655

Adjusted net loss attributable to common
stockholders (non-GAAP)

$(6,581,470)

$(6,890,439)

$(6,387,381)

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SOURCE Nauticus Robotics, Inc.

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CHIME and ScaleHealth Announce Joint Venture to Expand Healthcare’s Innovation Ecosystem

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ScaleHealth, powered by CHIME, creates new pathways connecting healthcare leaders, innovators, technology partners, and investors to accelerate the future of digital health.

ANN ARBOR, Mich., Oct. 27, 2026 /PRNewswire/ — The College of Healthcare Information Management Executives (CHIME) today announced a strategic joint venture with ScaleHealth, Inc. to create ScaleHealth, powered by CHIME, LLC, a new innovation ecosystem designed to connect healthcare’s most pressing challenges with the innovators, leaders, organizations, and partners capable of solving them. By combining CHIME’s trusted digital health community with ScaleHealth’s expansive innovation ecosystem, the venture creates a unique environment where healthcare organizations, entrepreneurs, established technology companies, and investors can discover, connect, validate, and advance the ideas shaping the future of healthcare.

For 35 years, CHIME has evolved alongside the digital health leaders it serves. What began as a community centered on healthcare CIOs has grown into a global network of digital health leaders supported through education, events, research, policy initiatives, media platforms, executive collaboration, and professional communities. The creation of ScaleHealth, powered by CHIME represents the next chapter in that evolution, expanding CHIME’s ecosystem to include the innovators, entrepreneurs, and emerging technology companies helping define what comes next in healthcare.

As healthcare organizations face increasing pressure to improve outcomes, strengthen operations, address workforce challenges, improve cybersecurity, and realize the promise of emerging technologies including artificial intelligence, the need for stronger connections across the innovation ecosystem has never been greater. ScaleHealth, powered by CHIME was created to help build those connections.

“CHIME has spent 35 years bringing together the leaders responsible for solving healthcare’s most important technology and transformation challenges,” said Russ Branzell, President and CEO of CHIME. “As the pace of innovation continues to accelerate, we have an opportunity to expand that trusted community even further. ScaleHealth, powered by CHIME, extends our ecosystem to include entrepreneurs, innovators, investors, and emerging technology companies so that healthcare leaders can engage earlier, collaborate more effectively, and help shape the innovations that will define the future of healthcare.”

The opportunity emerged through CHIME’s growing innovation programming, particularly its Innovation Summit series, where healthcare leaders and technology companies increasingly expressed a desire to engage more directly with innovators and entrepreneurial organizations. At the same time, startups and growth-stage companies were seeking trusted pathways into healthcare and stronger connections to leaders who understand the industry’s real-world operational challenges.

“Healthcare has no shortage of innovation. The challenge is creating trusted pathways that connect innovators with the healthcare leaders who understand the industry’s most urgent problems,” said Taylor McPartland, CEO of ScaleHealth and leader of the new venture. “By combining ScaleHealth’s innovation ecosystem with CHIME’s trusted community of digital health leaders, we’re creating an environment where meaningful connections can lead to validation, partnership, and real-world impact. This is about bringing together everyone who has a role to play in the future of healthcare innovation and helping them move great ideas forward.”

Unlike traditional accelerators, startup showcases, or innovation marketplaces, ScaleHealth, powered by CHIME is designed as a trusted innovation ecosystem. Healthcare organizations bring forward meaningful challenges. Innovators and startups contribute cutting-edge ideas and technologies. Established technology organizations bring expertise, infrastructure, and scale. Investors provide capital and growth pathways. Together, these stakeholders create an environment where innovation can move from discovery and connection to validation, partnership, and measurable impact.

“Throughout its history, CHIME has grown by bringing the right people together around the challenges that matter most,” said Tressa Springmann, Senior Vice President and Chief Information and Digital Officer at LifeBridge Health and Chair of the CHIME Foundation Board of Directors. “Today, innovation is essential to every aspect of healthcare transformation. ScaleHealth, powered by CHIME extends that trusted community into a broader innovation ecosystem, creating new opportunities for healthcare leaders, entrepreneurs, technology partners, and investors to collaborate, learn from one another, and accelerate meaningful progress across healthcare.”

The venture reflects CHIME’s belief that the next era of digital health will be co-created by healthcare leaders, technology partners, entrepreneurs, investors, and innovators working together to solve the challenges that matter most. By creating a trusted environment for discovery, collaboration, validation, and advancement, ScaleHealth, powered by CHIME aims to become the connective layer between healthcare’s needs and the innovation being built to address them.

Read the full release here.

About CHIME
The College of Healthcare Information Management Executives (CHIME) is the leading professional organization for digital health executives and leaders. CHIME provides a trusted, collaborative environment where members and partners connect, share best practices, advance professional development, and advocate for the effective use of information and technology to improve health and care in the communities they serve. For more information, please visit chimecentral.org.

For media inquiries, please contact:

Contact

Calli Dretke
Executive Vice President & Chief Digital and Marketing Officer
CHIME                                                                                                           
734.412.6255
cdretke@dhinsights.org

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SOURCE College of Healthcare Information Management Executives (CHIME)

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In HelloNation, Prenatal Imaging Expert Erika Lambright Explains Ultrasound Differences Between 2D, 3D, And 4D Imaging

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The article outlines how each type of pregnancy ultrasound supports fetal development and family understanding.

DENISON, Texas, Oct. 27, 2026 /PRNewswire/ — What is the difference between 2D, 3D, and 4D ultrasound imaging during pregnancy? HelloNation has published an article that clearly explains the differences between ultrasound and other prenatal imaging modalities and how each supports fetal development.

The HelloNation article explains that a 2d ultrasound is the most common form of prenatal imaging used during routine pregnancy ultrasound appointments. It produces flat, black-and-white images that allow medical providers to assess fetal development, monitor growth, and evaluate vital structures. The article notes that 2D ultrasound plays a central role in identifying potential concerns early and remains the foundation of prenatal diagnostic imaging.

According to the article, a 3d ultrasound builds on the same technology but creates a more detailed still image with depth. This form of prenatal imaging allows families to see clearer views of the baby’s face, hands, and feet. While 3d ultrasound can support certain medical evaluations, the article describes its primary value as helping parents better visualize fetal development in a more lifelike way.

The article further describes how a 4D ultrasound adds motion to the 3d ultrasound image. This allows families to view real-time video of the baby moving, stretching, or making facial expressions. The article explains that this type of pregnancy ultrasound creates a more engaging experience and helps strengthen the emotional connection, while still using the same safe, noninvasive prenatal imaging technology.

The HelloNation article emphasizes that understanding ultrasound differences helps families set clear expectations before imaging sessions. Each type of pregnancy ultrasound serves a distinct purpose. 2D ultrasound focuses on medical accuracy and fetal development monitoring, while 3D and 4D ultrasound provide enhanced visualization and connection. The article highlights that medical professionals typically rely on 2D ultrasound for diagnostic purposes, while 3D and 4D ultrasound are often optional.

The article also notes that several factors can affect the quality of prenatal imaging results. Baby position, gestational age, and fluid levels all play a role in how clearly images appear, especially during 3D and 4D ultrasound sessions. The article explains that providers often guide families on the best timing for ultrasound visits during pregnancy to improve image clarity and achieve better results.

Prenatal Imaging Experts emphasize through the article that learning about ultrasound differences can reduce uncertainty and help families feel more prepared. By understanding how each type of prenatal imaging contributes to monitoring fetal development, expectant parents can approach each pregnancy ultrasound appointment with clearer expectations.

The article concludes that while 2D ultrasound remains essential for medical care, the added perspectives of 3D and 4D ultrasound offer families a broader, more personal understanding of fetal development. Together, these forms of prenatal imaging provide both clinical insight and meaningful connection throughout pregnancy.

What Is the Difference Between 2D, 3D, and 4D Ultrasounds Explained Simply features insights from Erika Lambright, Prenatal Imaging Experts of Denison, Texas, in HelloNation.

About HelloNation
HelloNation is America’s Good News Network, a premier media platform built on the idea that good news travels faster when real people tell real stories. Through its community-focused digital publications and innovative “edvertising” approach, HelloNation delivers expert-driven, good-news content that informs, inspires, and spotlights the leaders making a meaningful impact in their communities. HelloNation maintains partnerships with the U.S. Conference of Mayors and the United States First Responders Association.

View original content to download multimedia:https://www.prnewswire.com/news-releases/in-hellonation-prenatal-imaging-expert-erika-lambright-explains-ultrasound-differences-between-2d-3d-and-4d-imaging-302792440.html

SOURCE HelloNation

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Grünenthal presents Phase III results for Qutenza® in post-surgical neuropathic pain at IASP 2026 World Congress on Pain

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Late-breaking data from the Phase III RISE trial further strengthen the well-established efficacy and safety profile of Qutenza®. Post-surgical neuropathic pain is a debilitating complication of surgery affecting millions of patients every year.1 

AACHEN, Germany, Oct. 27, 2026 /PRNewswire/ — Grünenthal, a global leader in pain management and research, today announced new data from the Phase III RISE trial (NCT04967664), evaluating Qutenza® versus control in people with post-surgical neuropathic pain. These data were shared today as late-breaking poster presentations at the 2026 International Association for the Study of Pain (IASP) World Congress on Pain in Bangkok, Thailand.

The trial (n=409) showed that Qutenza® achieved a statistically significantly greater reduction in average pain intensity (API) than the control treatment over weeks 2-12, meeting one of its pre-specified primary endpoints. When evaluating API at week 12 specifically, at the point when patients would typically return for retreatment, the numerical difference favoured Qutenza® but did not reach statistical significance. In the extension phase of the trial, in which up to 4 retreatments were allowed, Qutenza® achieved a statistically significantly greater reduction in API than the control treatment over weeks 2-42. Safety findings were consistent with previous Qutenza® trials and no new safety signals were observed. These data support the well-established efficacy and safety profile of Qutenza®.2,3

“Post-surgical neuropathic pain can be difficult to manage with current treatment options, and there is an urgent need for patient-centred, effective solutions. The RISE trial provides encouraging evidence that Qutenza® can deliver clinically meaningful and sustained pain reduction for up to 42 weeks, having shown a greater reduction in average pain intensity than the control,” said Prof. Patrice Forget, MD, PhD, FFPMRCA, Clinical Chair (full professor) in Anaesthesia, University of Aberdeen, and Honorary Consultant, NHS Grampian, Aberdeen, UK. “As IASP shines a global spotlight on neuropathic pain at this year’s congress, findings such as these are important to help improve outcomes for patients and reduce the burden of pain on families and healthcare systems.”

“Post-surgical neuropathic pain has been relatively understudied and continues to go under-recognised in clinical practice,” said Uli Brödl, Chief Scientific Officer, Grünenthal. “These results build on the robust body of evidence for Qutenza® and reinforce its potential to provide meaningful, long-lasting pain relief for people living with pain.”

Post-surgical neuropathic pain is a poorly recognised potential complication of surgery that can result in devastating outcomes. It affects millions of patients every year, with pain lasting for months or years post-procedure.1 It can also have a significant mental health impact, with patients reporting feeling extremely depressed or anxious, and having problems with daily activities.4

Qutenza® is already approved in Europe for the treatment of peripheral neuropathic pain in adults, either alone or in combination with other medicinal products for the treatment of pain.5 It is also approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults.6

About the RISE trial2,3
The RISE (AV-001) trial is a Phase III multi-centre, randomised, double-blind, parallel-group trial to confirm the efficacy and safety of Qutenza 179mg cutaneous patch versus a low-dose capsaicin control patch in people with moderate to severe post-surgical neuropathic pain.

It included eligible adults with a 24-hour average pain intensity (API) score of 4 or more, a pain duration of 6 to 60 months after index surgery and a DN4 (Douleur Neuropathique 4) Interview score of 3 or more.

Participants were randomly assigned to receive treatment with either a 60-minute Qutenza patch (8%) or a low-dose capsaicin control patch (0.04%).

The trial had two primary endpoints:

Change in 24-hour API from baseline to the average score of the entire period between Week 2 and Week 12.Change in 24-hour API from baseline to the average score at Week 12.

The primary sponsor of the trial is Averitas Pharma, Inc., Grünenthal’s U.S. subsidiary.

About post-surgical neuropathic pain
Post-surgical neuropathic pain (PSNP) is defined as chronic pain with neuropathic characteristics that develops or increases after surgery and persists beyond the normal healing process. It is thought to arise, at least in part, from nerve injury and pain sensitisation associated with surgery.7

The signs and symptoms of peri- and post-surgical pain can vary based on the person and the severity of the injury caused in surgery. Reported symptoms include pain caused by stimuli that are normally painless (allodynia), abnormally increased sensitivity to pain (hyperalgesia), tingling, numbness, phantom pain and scar pain.8,9,10 

About Qutenza®
In Europe, Qutenza® (capsaicin) is indicated for the treatment of peripheral neuropathic pain in adults, either alone or in combination with other medicinal products for the treatment of pain.5

Qutenza® (capsaicin) 8% topical system is approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Important US safety information is available at www.qutenza.com.6

Qutenza® is a topical TRPV1 agonist, designed to provide neuropathic pain relief for up to three months through defunctionalisation of nociceptors and nerve fibre regeneration.

About Grünenthal
Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We focus all our activities and efforts on working towards our vision of a World Free of Pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2025, Grünenthal employed around 4,100 people and achieved revenues of €1.8 billion.

More information: www.grunenthal.com

Follow us on LinkedIn & Instagram

For further information, please contact:

Matt Crabb, Head of Global Communications (Interim) at Grünenthal

matt.crabb@grunenthal.com 

References

1 Gregory P & Settles K. Pract Pain Manag. 2013;13(9):1–6.
2 Wallace M et al. Efficacy of high-concentration capsaicin patch in post-surgical neuropathic pain (RISE). Presented at the International Association for the Study of Pain World Congress 2026.
3 Wallace M et al. Safety and tolerability of high-concentration capsaicin patch in post-surgical neuropathic pain (RISE). Presented at the International Association for the Study of Pain World Congress 2026.
4 Santos MP, Lemos F, Gomes J, Romao JM, Veiga D. Br J Pain 2024;18(1):42–56.
5 European Medicines Agency. Qutenza 179 mg cutaneous patch SmPC. Available at: https://www.medicines.org.uk/emc/product/573/smpc
6 US Food and Drug Administration. Qutenza® Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022395s019lbl.pdf
7 Correl D. F1000Res. 2017;6:1054.
8 Werner MU & Kongsgaard UE. Br J Anaesth. 2014;113(1):1–4.
9 Macrae WA. Br J Anaesth. 2008;101:77–86.
10 Searle RD & Simpson KH. Contin Educ Anaesth Crit Care Pain. 2010;10:12–14.

View original content:https://www.prnewswire.com/news-releases/grunenthal-presents-phase-iii-results-for-qutenza-in-post-surgical-neuropathic-pain-at-iasp-2026-world-congress-on-pain-302921015.html

SOURCE Grünenthal Group

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