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.
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Bellmont Partners
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SOURCE Neuspera Medical, Inc.
Neuspera Medical Raises $23 Million in Series D FinancingCapital from Olympus Innovation Ventures, another strategic investor and several institutional investors will fund through expected PMA approval
SAN JOSE, Calif., July 15, 2024 /PRNewswire/ — Neuspera Medical, Inc., a neuromodulation company pioneering the Neuspera Implantable Sacral Neuromodulation (SNM) System, announced 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 Venture Partners, Olympus Innovation Ventures and another strategic investor. This round will fund the company though expected U.S. Food and Drug Association (FDA) premarket approval (PMA) of the Neuspera System, the 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).
“As a partner of choice for innovators in urology, we are thrilled to invest in the Neuspera team as they bring the Neuspera System through FDA approval and to the market,” said Gabriela Kaynor, President of Olympus Innovation Ventures and Chief Strategy Officer at Olympus Corporation. “Based on critical unmet market need and patient demand, changes in society guidelines, and positive feedback from patients and physicians in clinical trials, we are excited to invest in the Neuspera team as they build their innovative Neuspera System for OAB.”
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.1
“We’re excited to bring new partners on board as we approach the next significant milestone of submitting the Neuspera System for regulatory approval,” said Steffen Hovard, CEO of Neuspera Medical. “The confidence and conviction of our new and existing investors, like Olympus Innovation Ventures, demonstrates the strength and potential of our platform technology.”
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 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, while empowering patients to regain control of their OAB symptoms and life.2
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.
About Olympus
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. For more information, visit olympus-global.com and follow our global X account: @Olympus_Corp.
Olympus Innovation Ventures is the venture capital arm of Olympus. OIV invests in customer driven solutions in medical devices, diagnostics and digital health that complement or extend our market leading endoscopic procedures. Get in touch with OIV at ventures@olympus.com or https://olympusamerica.com/olympus-venture-capital.
About Vertex Ventures HC
Vertex Ventures HC (San Francisco, CA) invests in various sectors of the healthcare industry, including biopharmaceuticals and medical devices. The Vertex portfolio includes companies at all stages of development, from early-stage companies testing transformative technologies to commercial-stage companies seeking additional growth. With a focus on areas with significant unmet need, Vertex seeks to build great companies that improve the health and quality of human life. Vertex will take an active role in their portfolio companies and work with exceptional entrepreneurs, industry partners and fellow venture investors to create value. The global investment professionals at Vertex bring deep scientific, medical and business knowledge to every investment they make.
About Treo Ventures
The Treo team brings more than 90 years of cumulative healthcare experiences as investors, company founders, and operator, investing globally in more than 45 companies through multiple market cycles. The Treo team has been involved in several premium healthcare companies bringing novel technologies to market that have become the standard of care. With their experiences across both early and commercial stage companies, the Treo team has played active and important roles from founding companies to liquidity via trade sales to multiple strategics and IPOs. Treo’s experiences on private and public company boards gives them a unique vantage point in their active involvement with portfolio companies. In addition, their scientific and commercial backgrounds along with global relationships have helped them play an important role in consistently building some of the most successful healthcare companies over last two decades.
1 Stewart et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36.
2 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:
Hyedi Nelson
Bellmont Partners
651-757-7054
hyedi@bellmontpartners.com
SOURCE Neuspera Medical, Inc.
Alex Yeh Neurotech Pub PodcastCheck out this “stimulating” deep-dive conversation into how our respective technologies are shifting the paradigm for how patients with underlying neurological conditions may receive care in the not-too-distant future.
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Neuspera to Participate in the 2024 MedTech Innovator Cohort65 Startups Named to MedTech Innovator 2024 Cohort
Neuspera’s Statement Regarding New AUA/SUFU Guideline for OABThe American Urological Association (AUA) and Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) recently published their 2024 Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder (OAB). 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 completely revised guideline recognizes the difficulties and drawbacks with previous tiered therapies including behavioral interventions and medications, noting that patients may have been worn-out before having the opportunity to try more potentially attractive and effective alternatives. Options including intradetrusor botulinum toxin (botox) injection, sacral neuromodulation (SNM), and percutaneous tibial neuromodulation (PTNM), previously labeled as “third line” therapies, are now classified as “minimally invasive” therapies.
GUIDELINE STATEMENT 24
Clinicians may offer patients with OAB, in the context of shared decision making, minimally invasive therapies without requiring trials of behavioral, non-invasive, or pharmacologic management. (Expert Opinion)
The new guideline can be found here: https://www.auanet.org/guidelines-and-quality/guidelines/idiopathic-overactive-bladder#x21368.
Neuspera Medical is encouraged by the new guideline, which will facilitate OAB patient access to their most desired and appropriate option through shared decision making with their caregiver. SNM is recognized as the “gold standard” neuromodulation therapy for OAB. The Neuspera Sacral Neuromodulation system is designed to be minimally invasive, ultra-miniaturized and to eliminate the need for an implanted battery, which we believe will be an important option for patients in their shared decision-making process.
Note: The Neuspera Sacral Neuromodulation System is currently limited to Investigational Use Only.
Steven W. Siegel, MD
Neuspera Medical CMO
Meet at the Jefferies Global Healthcare Conference 2024We are looking forward to presenting the Neuspera Medical journey update at the Jefferies Global Healthcare Conference in New York early June 2024.
Neuspera Medical, Inc. Completes Patient Enrollment and Implants for the SANS-UUI Pivotal Clinical TrialThe international study is evaluating the safety and efficacy of the Neuspera System for the treatment of urinary urge incontinence (UUI), a symptom of overactive bladder (OAB)
SAN JOSE, Calif., Dec. 6, 2023 /PRNewswire/ — Neuspera Medical, Inc., a neuromodulation company pioneering the Neuspera Implantable Sacral Neuromodulation (SNM) System, today announced it has completed patient enrollment and implant procedures for the pivotal clinical trial (SANS-UUI) of its Neuspera System, a discreet, minimally invasive implant designed to provide patients personal control and relief from urinary urge incontinence (UUI), a symptom of overactive bladder (OAB).
“We are pleased to have reached the target patient enrollment in our pivotal SANS-UUI trial,” said Steffen Hovard, CEO of Neuspera Medical. “The completion of patient implants builds on the progress and strong momentum from our previously reported positive clinical outcomes.”
The SANS-UUI multi-center, single-arm clinical study is designed to demonstrate the safety and efficacy of the Neuspera System and gain U.S. Food & Drug Administration (FDA) approval in the U.S. Patients were screened and implanted with the device at 26 centers across the U.S. and Europe.
“Completing patient enrollment and implants is an important milestone in Neuspera’s journey towards revolutionizing the way physicians utilize SNM therapy,” commented Dr. Steve Siegel, Chief Medical Officer of Neuspera Medical. “We’re grateful to the patients and physicians partnering with us in this study, and we look forward to finalizing the data that will support our FDA submission of the Neuspera System.”
OAB is a common medical disorder affecting roughly 1 in 6 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.
Neuspera’s unique system is designed to provide patients who have failed medication management a minimally invasive, more approachable way of benefiting from sacral neuromodulation, a clinically proven effective treatment that’s been used for more than 30 years to treat UUI associated with OAB.
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, to provide patients with freedom from inconvenient and visible batteries, and to empower them to regain control of their life.
“As the coordinating investigator for the SANS-UUI clinical trial, I’m excited at the prospects of the Neuspera System for treating patients with OAB symptoms in the least invasive manner,” said Dr. Osvaldo Padron with Florida Urology Partners.
The Neuspera System has FDA clearance for treating chronic pain of peripheral nerve origin and is undergoing clinical trials as an investigational device for the use of 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:
Hyedi Nelson
Bellmont Partners
651-757-7054
hyedi@bellmontpartners.com
SOURCE Neuspera Medical, Inc.
Neuspera Medical, Inc. Announces Milestone Completion of 100th Implant in Its SANS-UUI Phase II Clinical TrialThe nationwide study is evaluating the safety and efficacy of the Neuspera System for the treatment of urinary urge incontinence (UUI), a symptom of overactive bladder (OAB)
SAN JOSE, Calif. , Nov. 14, 2023 /PRNewswire/ — Neuspera Medical, Inc., a neuromodulation company pioneering the Neuspera Implantable Sacral Neuromodulation (SNM) System, today announced the completion of the 100th implant of its Neuspera System as part of the SANS-UUI Phase II clinical trial. SANS-UUI is an international study that’s evaluating the safety and efficacy of the Neuspera System, a discreet, minimally invasive implant designed to provide patients personal control and relief from urinary urge incontinence (UUI), a symptom of overactive bladder (OAB).
“I’m always looking for the most advanced and effective treatment methods to offer my patients suffering from overactive bladder that will provide them relief and help them get back to living their lives as normally as possible,” said Dr. Derrick Sanderson, D.O. Urogynecology at Women’s Health Advantage in Fort Wayne, IN. “I’m excited to be a part of this clinical trial and the potential of this minimally invasive and discreet sacral neuromodulation therapy option.”
OAB is a common medical disorder affecting roughly 1 in 6 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.
Neuspera’s unique system is designed to provide patients who have failed medication management a minimally invasive, more approachable way of benefitting from sacral neuromodulation, a clinically proven effective treatment that’s been used for more than 30 years to treat UUI associated with OAB.
The system is comprised of a minimally invasive, ultra-miniaturized pulse generator that is 100 times smaller than the smallest commercially available sacral neuromodulation pulse generator. It is designed to be discreet, to provide patients with freedom from inconvenient and visible batteries, and to empower them to regain control of their quality of life. The device works together with a convenient external wearable to activate the system that is designed to fit into patients’ lifestyles and give them the personal control and relief from their symptoms that have been controlling them and their life for some time.
“We’re grateful to all of the physicians and patients for their enthusiastic participation in this study,” said Steffen Hovard, CEO of Neuspera Medical. “We have positive feasibility data from phase one of SANS-UUI, and this phase two pivotal study is an important step in getting closer to being able to potentially fill a gap in the sacral and tibial neuromodulation market that meets patient demand for a discreet, effective solution.”
The Neuspera System has FDA approval for peripheral nerve stimulation (PNS) and is undergoing clinical trials as an investigational device for the use of 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:
Hyedi Nelson
Bellmont Partners
651-757-7054
hyedi@bellmontpartners.com
SOURCE Neuspera Medical, Inc.
Neuspera Medical® Announces FDA Clearance of its System for Peripheral Nerve StimulationFirst-of-its-kind, leadless micro-implant for chronic peripheral nerve pain management
SAN JOSE, Calif., April 18, 2023 /PRNewswire/ — Neuspera® Medical, a medical device company developing implantable devices for patients battling chronic illnesses, today announced it received U.S. Food and Drug Administration (FDA) clearance for the next-generation Neuspera ultra-miniaturized system. The system is comprised of a micro-implant that delivers neurostimulation therapy through a wireless platform including a wearable transmitter and iPad-based clinician programmer.
The Neuspera system delivers peripheral nerve stimulation (PNS) through a wireless, less invasive, and more versatile platform than commercially available technology. It is the first PNS device that offers an ultra-miniaturized option, which may allow for a better patient experience and greater procedural flexibility. It is 75x smaller than the smallest commercial implantable pulse generator and provides physicians the opportunity for deeper anatomical targets compared to current technologies available today.
“We look forward to bringing this innovative technology to physicians and patients in the U.S.,” commented Steffen Hovard, CEO of Neuspera Medical. “The Neuspera ultra-miniaturized system has the potential to revolutionize the way physicians treat patients battling chronic pain while restoring patients’ health and quality of life.”
In recent years, the growth of PNS technology and treatment has been significant, with advances in implantable device technology and an increasing number of clinical studies focused on developing new PNS therapies. PNS is becoming an increasingly important treatment option for managing chronic pain conditions, with the market expecting to experience significant growth due to factors including the increasing prevalence of chronic pain, advances in implantable device technology, and rising demand for alternative pain management therapies.
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
Investor Relations and Media Contacts
Josh Cohen
Vice President, Market Development & Commercialization
Josh.Cohen@neuspera.com
SOURCE Neuspera Medical Inc.
Neuspera Hires Courtney Lane to Lead Clinical and Regulatory AffairsSAN JOSE, CA – February 1, 2023 — Neuspera® Medical, a medical device company developing miniaturized neuromodulation technology for patients with chronic illnesses, announces the hiring of Courtney Lane as Vice President, Clinical and Regulatory Affairs. The fast-growing early-stage company is progressing through enrollment of the second stage of its pivotal study (SANS-UUI) to evaluate the safety and efficacy of Neuspera’s technology in patients with urinary urgency incontinence associated with overactive bladder.
Dr. Courtney Lane has over 20 years of experience in neuromodulation device development and clinical trials. For the last 10 years, Dr. Lane worked as an independent consultant, working with cutting-edge medical device companies in the development of their devices and clinical and regulatory programs. Dr. Lane also served as Vice President of Clinical Affairs for Axonics Modulation Technologies, where she was responsible for the design and execution of the clinical program of a sacral neuromodulation device. Courtney was instrumental in the development of the Deep Brain Stimulation program at Boston Scientific, where she worked on all aspects of device development, from R&D and test designs to clinical trial designs and regulatory submissions. She then served as the Director of Clinical Science and Strategy, overseeing the development of Boston Scientific Neuromodulation’s clinical trial portfolio.
Steffen Hovard, CEO of Neuspera said: “We are excited to have Courtney Lane join Neuspera. Courtney brings a unique combination of skills and experiences that will help propel Neuspera forward – not to mention that she has a personality that makes it a pleasure to work with her.”
Dr. Lane earned her B.S.E.E. from Rice University, cum laude, and obtained her Ph.D. at the Massachusetts Institute of Technology in the Division of Health Sciences and Technology; she also worked as a researcher at Rice University, focusing on the development of hearing aid algorithms.
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, which will include the Nuvella system, will provide patients and physicians 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.
Investor Relations and Media Contacts
Josh Cohen
Vice President, Market Development & Commercialization
Josh.Cohen@neuspera.com
