Our 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.
Capital 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.
Neuspera to Participate in the 2024 MedTech Innovator CohortNeuspera’s Statement Regarding New AUA/SUFU Guideline for OAB
The 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