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Neuspera Medical Announces Landmark Six-Month Clinical Trial Results for the First Battery-Free Percutaneous Sacral Neuromodulation (pSNM) System for Urgency Urinary Incontinence Management

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2 years ago

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Pivotal Study Data Show Comparable “Gold Standard” Efficacy to Traditional Sacral Neuromodulation (SNM) Devices – Eliminating Burdens of a Battery Implant

SAN JOSE, Calif., Feb. 26, 2025 /PRNewswire/ — Neuspera® Medical, Inc., the leading developer of wireless energy technology powering the future of bioelectronic medicine, today announced six-month pivotal clinical trial results showing that the efficacy of its battery-free percutaneous sacral neuromodulation (pSNM) system has comparable efficacy to published rates for traditional sacral neuromodulation (SNM) devices,1,2 while aiming to offer a significantly better patient experience for the treatment of urgency urinary incontinence (UUI). The landmark results will be presented at the 2025 winter meeting of the Society of Urodynamics Female Pelvic Medicine & Urogenital Reconstruction (SUFU) on March 1, 2025. 

In a market that has gradually grown to $1 billion worldwide, despite negligible innovation since its inception in 1997, Neuspera has developed the first wireless, battery-free, ultra-miniaturized percutaneous SNM device for the treatment of UUI. The pSNM approach aims to address the most common complaints reported in patient forums: painful infections around the battery pocket, unwanted battery movement, persistent discomfort, visible bulging, and additional required surgeries for battery replacement.

UUI is a major component of OAB (Overactive Bladder), a condition that affects approximately 300 million people worldwide, including 1 in 5 women in the U.S., and has a major impact on quality of life (QOL), driving the demand for more effective and patient-friendly treatment options. 

Results Show Proven Efficacy and Significant UUI Symptom Relief

Six-month data from the Phase II pivotal clinical study of 128 patients implanted with Neuspera’s pSNM therapy found:

84.2% of implanted patients had a 50% or greater reduction in urgent leaks – on par with reported rates in recent SNM studies1,2

84% of patients who responded to treatment were classified as “super responders,” meaning they experienced more than a 75% reduction in UUI symptoms

42% of patients who responded were completely “dry,” with 100% reduction in UUI symptoms

3.5x clinically significant improvement in QOL, with a reduction in voids and urgent episodes

“These results demonstrate that Neuspera’s pSNM technology provides similar effectiveness to traditional SNM devices while offering an alternative to a traditional implanted battery,” said Dr. Colin Goudelocke, MD, Clinical Investigator and Urologist at Ochsner Health System. “Having options available for our patients is so crucial, and pSNM provides consistent relief from UUI while removing what can be an obstacle for some. I look forward to offering this option to my patients once it receives regulatory approval.”

Beyond Legacy Limitations: Wireless Innovation Modernizes a Proven Therapy

Conventional SNM systems require three surgical steps: 1) implanting the neurostimulation device at the sacral nerve, 2) creating a “pocket” in the buttock tissue to house the Oreo-sized metal battery, and 3) surgically creating a “tunnel” from the lower back to the lower abdomen to connect the implanted stimulation device to its battery. Complications related to the implanted batteries include infection at the battery site, battery flipping and movement, chronic pain, battery visibility, and the need for battery replacement surgeries.

“The pivotal trial results validate the founding vision of Neuspera – that we could revolutionize SNM therapy by eliminating the need for an implanted battery,” said Alexander Yeh, Ph.D, Neuspera Founder and Chief Technology Officer. “Our device offers a transformative alternative to traditional SNM, removing the stigma and burden of an invasive surgical implant and eventual battery replacement surgery.”

How the Battery-Free Wireless Sacral Neuromodulation [pSNM] Therapy Works:

Neuspera’s pSNM system has just two components:
1) an ultra-miniaturized neurostimulator – 100x smaller than traditional SNM devices, and

2) a small external therapy disc.

The mini neurostimulator is implanted percutaneously near the sacral nerve through a tiny 2.3mm canula — requiring no stitches and minimal recovery. Patients activate the therapy by placing the Neuspera disc against their lower back for generally just two hours daily, using a discreet wearable belt compatible with most activities. When not in use, the therapy disc charges wirelessly, like a smartphone. Neuspera’s pSNM eliminates all battery complications and associated body image concerns voiced by many patients.

“Sacral neuromodulation has delivered life-changing symptom relief for decades, but implanted batteries remain a significant limitation,” said Dave Van Meter, Neuspera Executive Chairman. “Neuspera is poised to offer a more patient-friendly solution to the millions of patients waiting for a better option. With FDA approval expected this year, we believe the pSNM technology will establish a new standard in UUI therapy.”

Neuspera submitted its Premarket Approval (PMA) to the FDA in September 2024 and, pending regulatory review, anticipates approval later this year.

About Neuspera Medical 
Neuspera® Medical, Inc. is the leading developer of wireless, directionally adaptive energy systems that power tiny medical implants deep within the body. Their technology is enabling a new class of bioelectronic medicine. The company’s initial innovation is the first battery-free percutaneous sacral neuromodulation (pSNM) device for urgency urinary incontinence (UUI), currently pending FDA approval. Neuspera’s pSNM device stands to expand the $1 billion overactive bladder market by providing a less-invasive, battery-free option to millions more UUI patients within the next 10 years. Learn more at neuspera.com and LinkedIn.

Media Contact 
media@capwellcomm.com 
949-999-3303

References

Axonics Artisan Study: McCrery, Rebecca, et al. “Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study.” The Journal of Urology, vol. 203, no. 1, 2020, pp. 185-192.

Medtronic Interstim Micro Study: Goudelocke, Colin, et al. “Evaluation of Clinical Performance and Safety for the Rechargeable InterStim Micro Device in Overactive Bladder Subjects: 6-Month Results from the Global Postmarket ELITE Study.” Neurourology and Urodynamics, vol. 42, no. 4, 2023, pp. 761-769.

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SOURCE Neuspera Medical

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LEAP Group Relaunches HumanView, a Growth Intelligence System Built to Explain Why Customers Behave the Way They Do

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7 hours ago

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October 24, 2026

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Reimagined from the ground up, HumanView pairs statistical modeling with expert analysts to turn millions of real-world customer signals into business decisions

LOUISVILLE, Ky., Oct. 23, 2026 /PRNewswire/ — LEAP Group today announced the relaunch of HumanView, its growth intelligence service. The new version has been rebuilt from the ground up and now has a dedicated home at leapgroupnetwork.com/humanview.

HumanView analyzes what customers say and do across social platforms, e-commerce sites, review platforms, search behavior and user-generated content, including signals from Reddit, TikTok, YouTube, Meta, Amazon and Walmart+ that general AI tools cannot always access. Because the data reflects unprompted, real-world behavior, it avoids the response bias built into surveys and focus groups.

The service works in three layers. HumanView captures signals at scale, decodes millions of records through validated statistical models such as regression, correlation and clustering, and then relies on experienced analysts to interpret the patterns. Clients receive clear, human-validated insights instead of another dashboard.

“Machines find the patterns. Humans find the point,” said Alan Gilleo, CEO at LEAP Group. “The first version of HumanView showed us how much customers reveal when nobody is asking them questions. This version is built to explain why they act the way they do, and to put those answers in front of everyone making decisions, from product to service to marketing.”

HumanView focuses on three areas:

Growth Intelligence: customer motivations and how people perceive a brand and its competitors

Market and Category Intelligence: product pain points, service friction, unmet needs and competitive gaps

Audience Intelligence: new segments, positioning opportunities and gaps in the market

Every model is designed and validated by data scientists and benchmarked before it informs a recommendation.

To learn more about HumanView, visit leapgroupnetwork.com/humanview.

About LEAP Group
LEAP Group is a boutique marketing agency holding company with offices in Louisville, Indianapolis, Cincinnati and Chicago. Guided by the belief that brands should “Market Less. Matter More.,” LEAP gives clients access to specialized experts across its entire network. Learn more at leapgroupnetwork.com.

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SOURCE LEAP Group

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STEPHEN A. SMITH ADDRESSES WHITE HOUSE DINNER ATTENDANCE, REAFFIRMS COMMITMENT TO HBCUs AND PROTECTING CORPORATE INVESTMENT IN BLACK EDUCATION

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8 hours ago

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October 24, 2026

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NEW YORK, Oct. 23, 2026 /PRNewswire/ — Stephen A. Smith, media mogul, New York Times bestselling author, and proud 1991 graduate of Winston-Salem State University, is addressing the public discussion surrounding his decision to attend a White House dinner with President Donald Trump, emphasizing his commitment to the long-term financial stability of Historically Black Colleges and Universities (HBCUs).

For Smith, the decision was rooted in a commitment to institutions that have educated generations of Black leaders, professionals, entrepreneurs, and public servants.

“I will always advocate for HBCUs and the students whose futures depend on them,” Smith said. “My reason for attending the White House dinner was to discuss the challenges these institutions face in securing long-term funding and to make the case that corporate America must continue to invest in them.”

Smith acknowledged federal support through the FUTURE Act while expressing concern that political tensions surrounding diversity, equity, and inclusion (DEI) could discourage private companies from supporting HBCUs. He maintains that these institutions deserve sustained corporate partnerships, philanthropic contributions, and public investment.

“If we truly believe in free-market capitalism, businesses should be able to support educational institutions and charitable causes without fear of criticism or repercussions,” Smith said. “HBCUs have made extraordinary contributions to this country. They deserve sustained public and private investment.”

Ashley Christopher, Esq., Founder and CEO of the HBCU Week Foundation, recognized Smith’s advocacy and decision to engage with the administration.

“Stephen A. Smith has been a powerful advocate for HBCUs, using his platform and influence to shine a national spotlight on our institutions,” expressed Christopher, “His continued support of HBCU Week helps advance our mission of connecting students with life-changing educational opportunities, and we are proud to have him as our ambassador.”

Since Smith became an HBCU Week Ambassador in 2019, the initiative has facilitated more than 15,000 on-the-spot college acceptances and raised and awarded more than $150 million in scholarships, according to the HBCU Week Foundation.

As public discussion continues, Smith is emphasizing the importance of ensuring HBCUs have the resources and partnerships needed to educate future generations and expand opportunities for students.

CLICK HERE to watch Smith’s full response to his White House visit.

MEDIA CONTACT:

media@mrsasinc.com

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SOURCE Straight Shooter Media

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Advantex Announces Completion of Financing and Extension of Maturity Date of Previously Issued Debentures

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8 hours ago

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October 24, 2026

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TORONTO, Oct. 23, 2026 /CNW/ — Advantex Marketing International Inc. (CSE: ADX) (“Advantex”), a leader in the merchant cash advance and loyalty marketing products for merchants, today announced the completion of a $250,000 secured debt financing. Advantex issued a $250,000 non-convertible debenture which bears an interest rate at 12% per annum and matures December 15, 2027. The proceeds raised from this issuance of the Debenture will be used for working capital purposes.

Advantex has also extended the maturity of its existing $700,000 in 12% secured debentures from October 10, 2026 to December 15, 2027.

About Advantex Marketing International Inc.

Advantex provides working capital to merchants. Advantex also provides specialized marketing programs that enable members of Aeroplan to earn Aeroplan points at participating merchants.

Advantex shares trade on the Canadian Securities Exchange under the symbol ADX. For more information go to Advantex’s profile on www.sedar.com

Forward-Looking Information

This news release contains “forward-looking statements” within the meaning of applicable securities laws relating to the future business and operations of Advantex. Actual results and developments may differ materially from those contemplated by these statements. The business and operations of Advantex described herein is dependent on a number of factors and is subject to a number of risks and uncertainties. Factors that could cause actual results to differ material include, but are not limited to, changes in Advantex’s economic and competitive conditions including but not limited to the industry sectors in which Advantex operates.

The statements in this news release are made of the date of this release. Forward-looking statements are made based on management’s beliefs, estimates and opinions on the date the statements are made and Advantex undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as required by applicable law.

SOURCE Advantex Marketing International Inc.

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