Urinary Incontinence, Urge

NEWTON, Mass.--( BUSINESS WIRE )--Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, welcomes the Centers for Medicare & Medicaid Services’ (CMS) new Healthcare Common Procedure Coding System (HCPCS) Level II code for the Leva ® Pelvic Health System. The Leva System’s patented, motion-based technology allows women to treat urinary incontinence (UI) and fecal incontinence (FI) through pelvic floor muscle training, also known as Kegels, correctly and in the privacy of their home. Effective on April 1, 2024, the new code makes it easier for clinicians, distributors, payers and, most importantly patients, to access Leva System’s clinically validated, non-invasive treatment. Pelvic floor muscle training (PFMT) is globally recommended as a first-line treatment for urinary and fecal incontinence. A study published earlier this year showed the Leva System yielded superior UI symptom improvement vs. doing typical unsupervised, home PFMT and that just eight weeks of treatment resulted in two years of symptom improvement. The Leva System’s unique accelerometer-based technology allows real-time visualization and guidance during PFMT, helping women perform PFMT correctly. The Leva System’s new HCPCS Level II code simplifies access for patients, eliminating barriers that can delay coverage through their insurance plan. “The new HCPCS code is a significant milestone that accelerates our mission to make Leva more accessible for patients, prescribers and insurance plans,” said Eileen Maus, CEO of Axena Health. “Several years of data across numerous published studies affirm that Leva helps women access first-line, conservative treatment for incontinence and the results they achieve are long lasting. The new code removes barriers that have kept treatment out of reach by defining a clear path as a medical benefit through patients’ durable medical equipment coverage. The Leva System’s HCPCS code along with its previously established pharmacy code, make either channel an option to increase access through insurance. Every woman deserves safe and effective treatment for incontinence. We’re confident clinicians, insurers and medical distributors are now able to help women gain faster, easier access to Leva. ” “UI is a progressive disease that, if left untreated, can severely impact women’s quality of life, imposing enormous physical, psychological, and economic burdens and placing her at risk for disability,” said Samantha Pulliam, M.D., Axena Health’s Chief Medical Officer. “PFMT, commonly practiced via Kegels, is a first-line treatment, but data show achieving effective, consistent practice is challenging. The Leva System makes PFMT accessible by guiding women through their treatment, effectively, enabling supervised PFMT. And this new code is a huge step towards making the Leva System available to all women who need symptom relief.” About the Leva ® Pelvic Health System The Leva Pelvic Health System, recently named a Medical Breakthrough in women’s health by AARP , is a prescription medical device that offers an effective, non-invasive, medication-free way for women to treat urinary incontinence (UI) and chronic fecal incontinence (FI). Combining a small FDA-cleared intra-vaginal probe embedded with multiple motion sensors and integrated software, the Leva System allows women to visualize pelvic floor muscle movement in real-time and guides them to complete their treatment correctly. Available by prescription only, the Leva System gives providers/clinicians the opportunity to treat UI and chronic FI on a broad scale and with continued involvement in patient success. The Leva System has multiple clinical trials with globally recognized medical centers supporting its efficacy in treating UI, including two studies in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG). The U.S. Food and Drug Administration (FDA) granted the Leva System Breakthrough Device Designation in 2021 as a treatment for chronic FI. About Axena Health Axena Health, Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders. Axena Health’s flagship product, the Leva ® Pelvic Health System , offers a novel, effective, first-line treatment for urinary incontinence (UI) and chronic fecal incontinence (FI), underreported conditions affecting over 78 million and 12 million women in the U.S. alone. Axena Health's technology enables non-invasive, drug-free treatment which they can do at home, in just five minutes a day while also allowing clinicians to monitor usage and progress. For more information, please visit www.axenahealth.com or www.levatherapy.com , follow Axena Health on LinkedIn and follow Leva Pelvic Health System on Instagram and TikTok. Important Indication and Other Information for the Leva® Pelvic Health System The Leva ® Pelvic Health System is intended for (1) strengthening of pelvic floor muscles, (2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women and (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence ( > 3-month uncontrolled passage of feces) in women. Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use the Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor. For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levatherapy.com .

Participants now being recruited for RESTORE study to expand the evidence base for Revi, a minimally invasive, FDA-authorized, patient-centric tibial neuromodulation therapy PARK CITY, Utah, Feb. 28, 2024 /PRNewswire/ -- BlueWind Medical, Ltd. today announced that Dr. Osvaldo Padron of Florida Urology Partners in Tampa, Florida, has treated the first patient in the RESTORE study, a prospective, multi-center, open label, post market, randomized controlled trial. The RESTORE study will recruit 150 patients at up to 20 centers in the United States. Revi is an innovative implantable Tibial NeuroModulation (iTNM) device that offers safe and effective treatment for UUI, as demonstrated in the OASIS pivotal study. Revi is placed near the ankle in a single predictable procedure under local anesthesia and is powered by a lightweight external wearable that is used at the patient's convenience once or twice daily to provide therapy. When activated, the Revi Implant stimulates the posterior tibial nerve to provide relief from UUI. Revi received FDA marketing authorization in August 2023, with no conditions of approval or post market study requirements. Revi is the only neuromodulation therapy on the market that allows physicians to use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System rather than mandating "step-therapy." "Urge urinary incontinence is disruptive, embarrassing, and causes undue stress in people's lives. Current treatments work for some people, but not most. There has been a real need for a more patient-centric and minimally invasive treatment option for people," said Dr. Padron. "I am pleased to have treated the first patient with the Revi System as part of the RESTORE study, an important clinical study that will help advance treatment options for people who suffer from urge urinary incontinence. Our site is recruiting additional qualifying study participants, and I encourage people to apply." "This is a great day in our collective journey to bring more convenient, comfortable, and patient-centric treatment options to people suffering from the debilitating symptoms of urge urinary incontinence," said Dan Lemaitre, Chief Executive Officer of BlueWind Medical. "We are so grateful to Dr. Padron for treating the first patient in this critical research effort to help transform the treatment paradigm for UUI." About the RESTORE study: RESTORE is a post market randomized control trial to compare the efficacy of the Revi™ System Therapy On versus Off in Reducing Urinary Urge Incontinence Episodes. BlueWind Medical elected to initiate this trial to build on the body of evidence supporting the efficacy of the Revi System in reducing urge urinary incontinence (UUI) symptoms. The study is currently recruiting participants. To determine if you may qualify, please visit BlueWind Medical's study webpage. You can also find more details about the RESTORE study (NCT06217328) on clinicaltrials.gov. About BlueWind Medical Ltd. BlueWind Medical is transforming the field of neuromodulation therapy through the development of innovative, patient-centric medical technology for the treatment of disease. BlueWind is committed to enhancing the quality of life and overall wellbeing of patients with an initial focus on those living with urgency urinary incontinence (UUI). BlueWind's Revi System is the first and only implantable tibial neuromodulation device activated by a battery-operated external wearable to receive FDA marketing authorization for patients with UUI. For additional information about BlueWind Medical, please visit . SOURCE BlueWind Medical

Key initial results from AURA-2 study highlight good safety and scalability of Amber-UI therapy A strong efficacy signal was seen in the form of complete resolution of incontinence episodes six months post implant in 80% (4 of 5) evaluable women with mixed urinary incontinencePreliminary data from the study were presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) annual meeting (February 2024) London, UK, 27 February 2024 – Amber Therapeutics (‘Amber’ or the ‘Company’), an innovative medical technology company developing next-generation, intelligent bioelectrical therapies to transform clinical outcomes in patients with functional disorders of the peripheral nervous system, announces the presentation of the first data from its AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study evaluating Amber-UI. Amber-UI is the first fully implantable closed-loop bioelectrical therapy in clinical development for urinary incontinence (UI), which is made possible by being able to access and target the pudendal nerve – the nerve that directly controls continence – through a novel, minimally invasive surgical procedure. Leveraging Amber’s expertise in closed-loop neuromodulation concepts, the Amber-UI multi-modal therapy can both directly regulate the urge to void the bladder (urge incontinence or overactive bladder) and augment resistance to urine leakage caused by activities such as coughing or lifting (stress incontinence), allowing for restoration of normal bladder function. The AURA-2 trial (clinicaltrials.gov identifier: NCT05241379) recruited 13 women with either severe refractory urge UI or mixed UI and was conducted at the University Hospital Antwerp (Belgium) by Stefan De Wachter, Professor of Urology, a leading expert in pelvic floor disorders and a co-founder of Amber. The study fulfilled its primary aim of demonstrating safety and feasibility of Amber’s new surgical procedure, validating a scalable approach to accurately implant two electrode leads on the pudendal nerve. The therapy showed strong evidence of initial efficacy, especially in women with mixed urinary incontinence of whom four out of five study completers (at six months follow up) achieved complete resolution of their incontinence episodes (dry). Clinically significant improvements in symptom-related quality-of-life were observed in both mixed and refractory urge UI patients. Using state-of-the-art serial intra-operative and awake electrophysiological and urodynamic data, the AURA-2 study is generating promising clinical proof of principle evidence for the advanced capabilities of the Amber-UI therapy. Acute stimulation showed clear effects on both barrier muscle functions (sphincter and pelvic floor contraction and EMG measurements) and on suppression of detrusor overactivity leading to increased mean cystometric (bladder) capacity. In patients with mixed UI, this was manifest as reductions in both stress and urge incontinence events. The study also demonstrated the utility of patient-controlled adaptive algorithms using Amber-UI’s integrated sensors. Relevant physiological biomarkers of pelvic neuromuscular activity could be detected real-time, in vivo, and classified to execute a control policy for fully adaptive (closed-loop) stimulation in the next planned trial. Stefan De Wachter, Professor of Urology at Antwerp University, co-Founder of Amber Therapeutics and lead investigator for the AURA-2 study, commented: “I am very excited to see these excellent preliminary results with Amber-UI in a very difficult to manage patient group with mixed urinary incontinence, and for whom no single therapy exists. With these data, Amber’s pioneering technology is demonstrating its promise to be a safe and scalable solution for patients that personalises therapy to their needs and helps them regain control of their bladder and their lives. We look forward to completing the follow-up period with the remaining patients and presenting final data that we hope will further reinforce Amber-UI’s potential to have a meaningful impact for patients dealing with this common and debilitating condition.” - ENDS - About Amber Therapeutics Amber Therapeutics is developing a closed-loop neuromodulation therapy able to treat mixed urinary incontinence for the first time and transform the clinical outcomes of a very large untreated patient population. Amber’s approach leverages the intelligent capability of its next-generation neuromodulation platform, the Picostim DyNeuMo, to create ‘synthetic reflex arcs’ that can sense, interpret, adapt and respond to a patient’s individual signals thereby restoring normal physiological function. This principle can be used in broader functional disorders of the nervous system that the Company’s academic partnerships are exploring. Amber Therapeutics was founded by a multidisciplinary team of clinicians, translational neuroengineers, medtech industry professionals and experienced entrepreneurs focused on developing transformational therapy innovation for major unmet medical conditions. The Company was spun out from the University of Oxford in 2021 and is backed by Oxford Science Enterprises, 8VC, and Innovate UK through a Biomedical Catalyst grant. www.amber-tx.com About Urinary Incontinence and the Current Neuromodulation Market Urinary incontinence (UI) is a debilitating medical condition that affects many millions of women and men globally. Common consequences that sufferers can experience include falls and fractures, hospitalisations, and can bring about a sense of loss of control and shame, leading to isolation and depression. Many patients do not actively seek treatment, with symptoms of UI found in 40 million individuals in the US but only 16 million currently managed on any form of therapy. It is estimated that 6.8 million patients in the US are eligible for the existing sacral neuromodulation therapy, a patient population which is still highly underpenetrated (c.50,000 implants a year) and only treats urge incontinence. Mixed urinary incontinence is more than three times more common than urge but until now there is no single therapy available on the market or in development. ContactsAmber TherapeuticsAidan Crawley, CEOpress@amber-tx.com MEDiSTRAVA ConsultingSandi Greenwood, Mark Swallow+44 203 928 6900ambertherapeutics@medistrava.com