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.
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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.
SOURCE Neuspera Medical
The primary endpoint results of the Neuspera Phase II SANS UUI clinical study will be presented during the annual winter meeting of the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU), February 26 – March 1, 2025, in Rancho Mirage, California. These pivotal trial results will support Neuspera’s FDA PMA submission for U.S. regulatory approval and expand the portfolio of clinical evidence Neuspera is building to ensure insurance coding, coverage, and reimbursement. Our presentation, “Podium #46 – TREATMENT OF OAB SYMPTOMS USING NEUSPERA’S ULTRA-MINIATURIZED SYSTEM: 6-MONTH RESULTS OF THE SANS-UUI PHASE II STUDY” is scheduled for 8:00AM during the OAB/Chemodenervation Podium Session, 7:30-9:00AM on Saturday, March 1st. The full SUFU program schedule can be viewed online.
Neuspera is Presenting at the Piper Sandler 36th Annual Healthcare ConferenceNeuspera is looking forward to participating and presenting at the Piper Sandler 36th Annual Healthcare Conference early December. Steffen Hovard will provide an update on the progress and positive momentum for Neuspera in getting PMA approval for our micro-invasive system for treatment of overactive bladder.
Neuspera SANS-UUI Trial ProgressesTrial of SNM device for urinary urgency incontinence progresses.
Check out the information in Urology Times, September 2024.
Volume 52, Number 09, Page 10.
Read the full article here.
Neuspera Attending American Urogynecologic Society PFD WeekOur CEO and CMO, Steffen Hovard and Dr. Steven Siegel will be heading to Washington D.C. for this year’s American Urogynecologic Society PFD Week and are looking forward to connecting with old friends and meeting new ones. Reach out via LinkedIn or email to meet up. Hope to see you there!
Neuspera Featured in MassDevice’s Top 10 Urology Device Stories of the YearDid you know that this week is Urology Week 2024? To commemorate the occasion, MassDevice published an article on the top 10 urology device stories of 2024 so far and it featured our Series D round!
Neuspera Medical, Inc. Welcomes Bunty Banerjee as Its First Chief Operating OfficerThe seasoned life sciences executive will play a key role as the company completes the regulatory process and prepares for commercialization of its Neuspera SNM System
SAN JOSE, Calif., Sept. 12, 2024 /PRNewswire/ — Neuspera Medical, Inc., a neuromodulation company pioneering the Neuspera Sacral Neuromodulation (SNM) System, announced today that Bunty Banerjee has joined the company as its first Chief Operating Officer. He will lead the activities in both research and development, as well as operations, while working closely with all other functions as Neuspera completes the U.S. Food and Drug Administration (FDA) submission for regulatory approval of the Neuspera System to treat OAB symptoms and prepares for commercialization.
“Bunty is joining Neuspera at an incredibly exciting time for the company,” said Steffen Hovard, CEO of Neuspera Medical. “We look forward to his contributions to the team as he deploys valuable skills and insights with the organization.”
The Neuspera SNM System is a discreet, minimally invasive, ultra-miniaturized implant designed to provide patients personal control and relief from urinary urge incontinence (UUI), a symptom of overactive bladder (OAB). Banerjee joins Neuspera following the company achieving a number of significant milestones:
- All implanted patients have completed the 6-month primary endpoint visit in the SANS-UUI pivotal trial. The SANS-UUI multi-center, single-arm clinical study was designed to demonstrate the safety and efficacy of the Neuspera System and gain FDA approval in the U.S.
- The closing of its Series D funding round raising $23 million and led by Vertex Ventures HC and Treo Ventures with participation by Action Potential Venture Capital, Windham Capital Partners, Portfolia, Olympus Innovation Ventures, and another strategic investor.
Banerjee is a seasoned life sciences executive with more than 25 years of experience in the medical device industry, holding senior operational leadership positions at Omnicell, Philips Image Guided Therapy, Abbott, and Boston Scientific, which involved the development, commercialization, and scaling of complex medical products. He has served in senior leadership roles in enterprises ranging from early start-ups to Fortune 100 corporations, overseeing operations from pre-clinical to billion-dollar businesses.
“I am absolutely thrilled to join the Neuspera team and contribute to the company’s success at this critical stage,” said Banerjee. “I’m looking forward to being a part of an incredibly innovative team and an amazing technology dedicated to improving the lives of patients with chronic health conditions.”
Banerjee has a Bachelor of Science degree in Electrical Engineering from Jadavpur University, India, and a Master of Science degree in Industrial Management from Clemson University.
The Neuspera System has FDA clearance for treating chronic pain of peripheral nerve origin and is currently an investigational device for treating UUI, a symptom associated with OAB.
About Neuspera Medical
Neuspera Medical, Inc. is committed to developing implantable medical devices that will improve the lives of patients battling chronic illnesses. The Neuspera platform is designed to provide patients and physicians with new, and potentially earlier, treatment options that are less invasive and more adaptable. These therapeutic alternatives aim to help patients restore their health and well-being for a better quality of life. For more information, please visit www.neuspera.com.
Media Contact:
Shelli Lissick
Bellmont Partners
651-276-6922
shelli@bellmontpartners.com
SOURCE Neuspera Medical Inc.
Neuspera Welcomes Two New EmployeesWe’re excited to welcome two new members to our Neuspera team: Douglas Sullivan as Supply Chain Director and Jeff Siegel, CPA as Controller. We are grateful to have their expertise on the team as we continue working to improve sacral neuromodulation options for treating OAB!
Strong Media Interest in NeusperaNeuspera Medical is very excited and grateful for the tremendous interest in our progress towards reinventing sacral neuromodulation for treating OAB. The Neuspera Sacral Neuromodulation System includes innovations designed to significantly impact patient acceptance and satisfaction with this potentially life-changing therapy in a large market that has been largely underserved to date. Our two recent press releases were published by more than 1,000 news outlets around the world! Thank you for helping us spread the word that Neuspera Sacral Neuromodulation is coming! The following is a select sample of the many media outlets that have covered our news in the past two weeks.
Neuspera Medical, Inc. Reaches Significant Milestone: Final Patient Has Completed Primary Endpoint Visit in the SANS-UUI Pivotal Clinical TrialClinical study data to evaluate the safety and efficacy of the Neuspera System for the treatment of urinary urge incontinence (UUI) will support the FDA submission for regulatory approval
SAN JOSE, Calif., July 23, 2024 /PRNewswire/ — Neuspera Medical, Inc., a neuromodulation company pioneering the Neuspera Implantable Sacral Neuromodulation (SNM) System, announced it has reached a significant milestone: All implanted patients have completed the 6-month primary endpoint visit in the SANS-UUI pivotal trial of the Neuspera System. The Neuspera System is a discreet, minimally invasive, ultra-miniaturized implant designed to provide patients personal control and relief from urinary urge incontinence (UUI), a symptom of overactive bladder (OAB). The clinical data will support the U.S. Food and Drug Administration (FDA) submission for regulatory approval of the Neuspera System to treat OAB symptoms.
“We’re grateful to every physician and patient who participated in the clinical trial, and we’re excited that our uniquely differentiated technology will help millions of patients when it is FDA-approved for treatment of OAB symptoms,” said Steffen Hovard, CEO of Neuspera Medical. “The fact that the market is only 5% penetrated at this time is a clear indication that patients are looking for something different than what’s available today. The Neuspera System delivers true innovation.”
OAB is a common medical disorder affecting roughly one in six adults. OAB symptoms include a sudden, uncontrolled need or urge to urinate, urine leakage, and/or the need to pass urine many times during the night and day. These symptoms can make it difficult to work, socialize, exercise and lead a normal, active life which can lead to depression, self-esteem and social stigma issues.
This milestone comes on the heels of the American Urological Association (AUA) and Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction’s (SUFU) recently published 2024 Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder. The guideline promotes a shared decision-making process between the patient and physician that weighs the patient’s comorbidities along with expressed values, preferences, and treatment goals in order to help them make an informed decision regarding treatment. This new guideline will facilitate OAB patient access to the therapy that best meets their particular needs and goals without requiring a lengthy stepwise approach through multiple levels of therapy. SNM is recognized as the “gold standard” neuromodulation therapy for OAB. With a dramatically smaller implant and incision size than anything else on the market, and efficacy comparable to the best SNM data[1], Neuspera is expected to benefit greatly from the new guideline’s consultative approach providing accelerated patient access to minimally invasive therapies that were previously considered “third line.”
The SANS-UUI multi-center, single-arm clinical study was designed to demonstrate the safety and efficacy of the Neuspera System and gain FDA approval in the U.S. Patients were screened and implanted with the device at 26 centers across the U.S. and Europe. Patients who participated in the Phase One clinical trial – and who have been finding relief using the Neuspera System to successfully control their UUI symptoms for up to 3.5 years – have called the Neuspera System “life-changing,” “the miracle,” and “easy to do.”
“I love that there is no battery implant compared to traditional devices and that it’s outside of my body and I’m in charge of it,” said one patient who participated in the Phase One clinical trial.
“It’s improved my life so much that I tell everybody about it,” another patient said.
“Reaching the final patient’s primary endpoint visit for the clinical trial is an important milestone in Neuspera’s journey towards revolutionizing the way physicians utilize SNM therapy,” said Dr. Steve Siegel, chief medical officer of Neuspera Medical. “This will be a great solution for patients who want a high degree of symptom control with the smallest implantable neurostimulator available, designed to empower patients and provide ultimate discreetness putting control of life-altering symptoms in patients’ hands.”
“As the coordinating investigator for the SANS-UUI clinical trial, based on my experience with the Neuspera System and how patients are responding, I’m excited to soon be able to offer an OAB treatment option that truly gives patients control of their bladders in the least invasive way with the ability to self-administer their therapy when it’s convenient for them, and nobody else can see or feel it,” said Dr. Osvaldo Padron with Florida Urology Partners.
The Neuspera System has FDA clearance for treating chronic pain of peripheral nerve origin and is currently an investigational device for treating UUI, a symptom associated with OAB.
About Neuspera Medical
Neuspera Medical, Inc. is committed to developing implantable medical devices that will improve the lives of patients battling chronic illnesses. The Neuspera platform is designed to provide patients and physicians with new, and potentially earlier, treatment options that are less invasive and more adaptable. These therapeutic alternatives aim to help patients restore their health and well-being for a better quality of life. For more information, please visit www.neuspera.com.
The Neuspera System is the least invasive sacral neuromodulation device and includes an ultra-miniaturized pulse generator attached to an electrode array. It is designed to be discreet and fit within the protected space of the sacral foramen, so patients typically don’t feel any lump or bulge and the tiny 4-5 mm scar from the implant procedure is usually barely perceptible, even if you know where to look. This design eliminates the need for more invasive tunneling and a separate pocket for an implanted battery, avoiding issues that negatively affect patient satisfaction with traditional SNM systems while empowering patients to regain control of their OAB symptoms and life.
1 Based on outcomes of the SANS-UUI Phase I clinical data; Padron et al. (2021). TREATMENT OF URINARY URGENCY INCONTINENCE (UUI) WITH AN ULTRA-MINIATURIZED SACRAL NERVE MODULATION (SNM) SYSTEM: PRELIMINARY OUTCOMES OF THE SANS-UUI STUDY. Journal of Urology. 2021 Sep 1;206(Supplement 3):e1158.
Media Contact:
Shelli Lissick
Bellmont Partners
651-276-6922
shelli@bellmontpartners.com
SOURCE Neuspera Medical, Inc.
