Complication of medical care

The 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 . Media Contact: Hyedi Nelson Bellmont Partners 651-757-7054 [email protected] SOURCE Neuspera Medical, Inc.

The 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 . Media Contact: Hyedi Nelson Bellmont Partners 651-757-7054 [email protected] SOURCE Neuspera Medical, Inc.

Digital therapeutics (DTx) continue to gain momentum as a promising form of treatment for various diseases. While they are widely considered to be behavioral interventions, the reality is that these therapeutics are used for a wide variety of conditions. DTx are software-based medical treatments that treat various medical conditions. As defined by the Digital Therapeutics Alliance: DTx “delivers evidence-based therapeutic interventions that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.” Those familiar with DTx are likely aware of its potential to provide behavioral interventions, including support for conditions like ADHD, substance abuse, and depression. But DTx can also support physical intervention via neuro-motor training for conditions such as multiple sclerosis, stroke, and amblyopia. By utilizing software-based solutions, DTx offers targeted approaches to address a wide variety of healthcare needs. Despite its growing interest, the subset of DTx prescribed by a physician, known as PDTs (Prescription Digital Therapeutics), are facing substantial challenges. PDTs have the potential to act as a solution to not only reduce rising healthcare costs but also to accelerate clinical outcomes. In fact, it has the potential to revolutionize the way healthcare is delivered across the country. Demand is increasing, yet many payers are still hesitant to cover them – in large part thanks to laws that govern coverage, a lack of clarity regarding coverage approaches, and questions regarding evidence generation for these solutions. Consider these obstacles: – Unlike traditional drugs, PDTs are not required to be covered by payers; as a result, payers must make a conscious decision to cover them. This distinction is important because since their inception, payers have not typically covered PDT solutions. Recall when legislation like Medicare was first created in the 1960s, lawmakers could not anticipate innovations like the existence of PDTs and defined covered benefits in a narrow manner relative to our understanding today. Unfortunately, laws on the books have lagged behind technological advancements. Consider the similarities to the past situation with pharmaceutical drug coverage. Before the introduction of Medicare Part D in 2006, drugs were not universally covered. A growing population of seniors helped lead the way for change. Similarly, with PDTs, there will come a time when the evidence supporting their effectiveness becomes undeniable, and a larger population will require access to these treatments. Legislation to include PDT coverage is not an impossible task, as we consider similar reforms from our past. Beyond improved patient outcomes and real-time data collection, the adoption of PDTs can lead to significant cost savings in the healthcare industry. By empowering patients to take control of their own healthcare and manage their conditions using safe and effective digital treatments, the trajectory of healthcare costs can be altered. – Payers also encounter logistical challenges when it comes to implementing PDTs. As they navigate this new territory, payers find themselves grappling with several questions that require careful consideration. How to assess the quality of evidence supporting PDTs? And should PDTs adhere to the same standards as pharmaceuticals to be reimbursed? Many perceive PDT coverage as complicated, but it may not be as complex as it initially appears. The challenge lies in the fact that payers are accustomed to making decisions for treatments via well-defined pathways; however, these pathways are not yet agreed upon for PDTs. The unfamiliarity and lack of a clear roadmap can make them seem like a logistical nightmare from the payer’s perspective. It’s, therefore, crucial to demonstrate that incorporating PDTs into the reimbursement process can be similar to the current practices for traditional treatments. Experiences in this area are still in their infancy, but feedback from payers shows that existing processes do not need to be entirely revamped for these products. – Finally, another key issue is the expectation of demonstrating outcomes and tangible results – drugs have a clear pathway for this requirement, but PDTs do not. In addition, smaller PDT companies do not have the same level of resources as biopharma to invest in large-scale, costly clinical trials. This has led many to question whether PDTs should be required to follow the same clinical development pathway as drugs. We all know that movement is beneficial to health outcomes. The question is, does a PDT need to prove the outcomes from motor training? Or does it just need to demonstrate that the training is delivering the requisite heart rate and that the range of motion for the patient is changing? The same question applies for behavioral interventions There is a large body of evidence that training the mind can help reduce pain, anxiety, and other conditions. Given those results, where does the burden of proof lie for a PDT – to demonstrate that behavioral interventions work or to demonstrate that the delivery mechanism of the PDT works? Given that many treatments are often criticized for being too expensive, is there a way to reduce the cost burden of clinical trials? If the goal is to reduce the cost of the healthcare system and improve outcomes, we must also create a pathway for pragmatic clinical trials. Let’s recognize that change is hard – but we should be encouraged by the questions that payers are asking. The fact that questions exist means that there is an inherent value in the dialogue. Where there are questions, there will be answers. Today, many insurance companies are creating innovation arms – a welcome step in the right direction, including their emphasis on exploring pathways to develop value-based agreements that are aligned with generating evidence. These pilot approaches linking early access to the development of real-world evidence to positive outcomes will be critical in ultimately offsetting the cost of PDT products – a win-win situation for all stakeholders involved. There’s a reason to be optimistic about the future of PDTs. Innovation can and should be disruptive. The challenges that are initially met with resistance will almost always turn into viable, sustainable solutions. The key is that we continue to engage in dialogue that leads to real change.