SUFU

Amber Therapeutics announces positive preliminary results from its first-in-human investigation of Amber-UI, its new adaptive implanted pudendal neuromodulation system for urinary incontinence

Retrieved on: 
Tuesday, February 27, 2024

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.

Key Points: 
  • 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.
  • Clinically significant improvements in symptom-related quality-of-life were observed in both mixed and refractory urge UI patients.
  • 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.

AUA Releases Amendment to the Diagnosis and Treatment of Early-Stage Testicular Cancer Guideline

Retrieved on: 
Thursday, September 14, 2023

BALTIMORE, Sept. 14, 2023 /PRNewswire/ -- Today the American Urological Association (AUA) released the 2023 clinical practice guideline amendment for the diagnosis and treatment of early-stage testicular cancer.

Key Points: 
  • BALTIMORE, Sept. 14, 2023 /PRNewswire/ -- Today the American Urological Association (AUA) released the 2023 clinical practice guideline amendment for the diagnosis and treatment of early-stage testicular cancer.
  • Testicular cancer is the most common solid malignancy in young males and is relatively rare, with outcomes defined by specific cancer and patient-related factors.
  • "Since the last testicular cancer guideline was released, the model for management has substantially changed, making an amendment like this critical to effectively treat and manage testicular cancer."
  • Diagnosis and treatment of early-stage testicular cancer: AUA Guideline amendment 2023.

AUA, SUFU Release an Amendment to the Female Stress Urinary Incontinence Guideline

Retrieved on: 
Tuesday, April 25, 2023

Importantly, they also focus on the crucial nature of assiduous counseling regarding the risks, benefits, and alternatives available for treatment.

Key Points: 
  • Importantly, they also focus on the crucial nature of assiduous counseling regarding the risks, benefits, and alternatives available for treatment.
  • This amendment is the result of 24 new studies reviewed since the initial SUI guideline publication in 2017.
  • "This recent amendment to the stress urinary incontinence guideline provides clinicians with the most up to date guidance and recommendations for the evaluation and treatment of women with SUI."
  • Updates to surgical treatment of female stress urinary incontinence (SUI): AUA/SUFU guideline (2023).

Axonics to Participate in the SUFU 2023 Winter Meeting

Retrieved on: 
Tuesday, March 7, 2023

In addition, data highlighting the experience of patients with Axonics SNM therapy will include three poster presentations:

Key Points: 
  • In addition, data highlighting the experience of patients with Axonics SNM therapy will include three poster presentations:
    The Role of Age in the Effectiveness of SNM for OAB – presented by Ayman Mahdy, M.D., Ph.D.
  • Effectiveness of the Axonics SNM System in Improving Sleep Quality of Life for Patients Suffering with Nocturia – presented by Michael Kennelly, M.D.
  • Efficacy and Durability of the Predictive Programming Algorithm of the Axonics SNM System – presented by Ryan Krlin, M.D.
  • “The SUFU 2023 Winter Meeting provides an opportunity for physicians to learn more about Axonics SNM therapy and the durable symptom relief patients are experiencing, directly from their peers,” said Karen Noblett, M.D., chief medical officer of Axonics.

NEUSPERA MEDICAL® ANNOUNCES FIRST SUCCESSFUL IMPLANT OF THE NUVELLA™ SYSTEM IN THE SECOND PHASE OF ITS SANS-UUI IDE CLINICAL TRIAL

Retrieved on: 
Monday, October 10, 2022

SAN JOSE, Calif., Oct. 10, 2022 /PRNewswire/ -- Neuspera® Medical, a medical device company developing implantable devices for patients battling chronic illnesses, today announced the first patient successfully implanted with the Nuvella™ system in its pivotal clinical trial (SANS-UUI). The procedure was performed by Dr. Jodi Michaels of Minnesota Urology, St. Paul, MN. The study will evaluate the safety and efficacy of the Nuvella system, designed to treat overactive bladder (OAB) with sacral neuromodulation (SNM) in patients with urinary urgency incontinence (UUI) symptoms.

Key Points: 
  • The study will evaluate the safety and efficacy of the Nuvella system, designed to treat overactive bladder (OAB) with sacral neuromodulation (SNM) in patients with urinary urgency incontinence (UUI) symptoms.
  • "This system has the ability to treat UUI symptoms with the smallest available implant, significantly improving the patient experience."
  • The Nuvella system delivers neuromodulation therapy through a wireless, less invasive, and more versatile platform than commercially available technology.
  • Kicking off enrollment builds on the strong momentum from our feasibility experience," commented Steffen Hovard, CEO of Neuspera Medical.

Published studies find low documented adherence to guideline-based care for female urinary incontinence

Retrieved on: 
Friday, July 22, 2022

BOSTON, July 22, 2022 /PRNewswire/ -- Renovia Inc. (Renovia), a developer of non-surgical treatments for female pelvic floor disorders and an advocate for women's health, announced today that Neurourology and Urodynamics published two studies demonstrating low rates of documented adherence to treatment guidelines for female urinary incontinence (UI) care for women and the effect on payer costs. One study showed significantly higher costs for payers in the two years following diagnosis for women whose treatment claims did not align with published guidelines for female UI. A second study showed very low use of physical therapy (PT) for UI, a discipline commonly engaged in first-line care for UI.

Key Points: 
  • BOSTON, July 22, 2022 /PRNewswire/ -- Renovia Inc. (Renovia), a developer of non-surgical treatments for female pelvic floor disorders and an advocate for women's health, announced today that Neurourology and Urodynamics published two studies demonstrating low rates of documented adherence to treatment guidelines for female urinary incontinence (UI) care for women and the effect on payer costs.
  • A second study showed very low use of physical therapy (PT) for UI, a discipline commonly engaged in first-line care for UI.
  • Numerous studies show PFMT isan effective treatment for urinary incontinence and that PFMT, commonly referred to as Kegels, is challenging for women to implement effectively on their own.
  • The study determined that documented care not sequenced in adherence to guidelines increasedpayers' cost burden.

American Urological Association Announces Updates to Clinical Guidance for Interstitial Cystitis

Retrieved on: 
Tuesday, May 10, 2022

"An important component of that clinical framework is discussion of treatments that should and should not be offered.

Key Points: 
  • "An important component of that clinical framework is discussion of treatments that should and should not be offered.
  • This approach reinforces that the clinical approach for IC/BPS needs to be individualized ad based on the unique characteristics of each patient.
  • A summary of the guideline also appears at:
    Clemens JQ, Erickson DR, Varela NP et al: Diagnosis and treatment of interstitial cystitis/bladder pain syndrome.
  • About the American Urological Association: Founded in 1902 and headquartered nearBaltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology and has nearly 24,000 members throughout the world.

BlueWind Medical Raises $64 Million to Fund Innovative Technology for Overactive Bladder (OAB) Treatment

Retrieved on: 
Monday, May 9, 2022

PARK CITY, Utah and HERZLIYA, Israel, May 9, 2022 /PRNewswire/ -- BlueWind Medical, Ltd., developer of the innovative RENOVA iStim implantable tibial neuromodulation device under investigation for the treatment of urgency incontinence alone or in combination with urinary urgency and/or urinary frequency, today announced the closing of a $64 million Series B funding round. This round of financing was led by ConvaTec, a global medical products and technologies company focused on therapies for the management of chronic conditions including continence care.

Key Points: 
  • BlueWind Medical will submit an application for U.S. Food & Drug Administration (FDA) marketing clearance in the United States later in 2022 based on the OASIS pivotal study.
  • RENOVA iStim is implanted near the ankle in a single short outpatient procedure of approximately 30 minutes utilizing local anesthesia.
  • BlueWind Medical was founded in Israel in 2010 and has an extensive patent portfolio including 15 patent families, 35 filings and 24 issued patents.
  • BlueWind Medical obtained CE Mark for RENOVA iStim in the treatment of overactive bladder in 2016.

Versameb to present at the Female Pelvic Medicine and Urogenital Reconstruction 2022 Winter Meeting

Retrieved on: 
Thursday, February 17, 2022

BASEL, Switzerland, Feb. 17, 2022 /PRNewswire/ -- Versameb AG ("Versameb"), a pre-clinical stage company focused on discovering and developing innovative RNA-based therapeutics, today announces that its Chief Scientific Officer, Friedrich Metzger will be presenting data on the Company's mRNA engineering technology and lead therapeutic candidate, VMB-100,at the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) 2022 Winter Meeting , taking place on 22-26 February 2022 in San Diego, California.

Key Points: 
  • BASEL, Switzerland, Feb. 17, 2022 /PRNewswire/ -- Versameb AG ("Versameb"), a pre-clinical stage company focused on discovering and developing innovative RNA-based therapeutics, today announces that its Chief Scientific Officer, Friedrich Metzger will be presenting data on the Company's mRNA engineering technology and lead therapeutic candidate, VMB-100,at the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) 2022 Winter Meeting , taking place on 22-26 February 2022 in San Diego, California.
  • Versameb has developed a groundbreaking, proprietary technology platform which optimizes the application of functional RNA in different disease contexts.
  • These findings support the therapeutic potential of this treatment for Stress Urinary Incontinence as well as other muscle-related disorders, by restoring muscle functionality."
  • Title: Regeneration of Muscle Tissue and Function In Stress Urinary Incontinence Using Engineered RNA, #NM20
    Klaas Zuideveld, Chief Executive Officer, said: "We are delighted to be presenting at the prestigious SUFU 2022 Winter Meeting.

Versameb to present at the Female Pelvic Medicine and Urogenital Reconstruction 2022 Winter Meeting

Retrieved on: 
Thursday, February 17, 2022

BASEL, Switzerland, Feb. 17, 2022 /PRNewswire/ -- Versameb AG ("Versameb"), a pre-clinical stage company focused on discovering and developing innovative RNA-based therapeutics, today announces that its  Chief Scientific Officer, Friedrich Metzger will be presenting data on the Company's mRNA engineering technology and lead therapeutic candidate, VMB-100, at the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) 2022 Winter Meeting, taking place on 22-26 February 2022 in San Diego, California.

Key Points: 
  • BASEL, Switzerland, Feb. 17, 2022 /PRNewswire/ -- Versameb AG ("Versameb"), a pre-clinical stage company focused on discovering and developing innovative RNA-based therapeutics, today announces that its Chief Scientific Officer, Friedrich Metzger will be presenting data on the Company's mRNA engineering technology and lead therapeutic candidate, VMB-100,at the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) 2022 Winter Meeting , taking place on 22-26 February 2022 in San Diego, California.
  • Versameb has developed a groundbreaking, proprietary technology platform which optimizes the application of functional RNA in different disease contexts.
  • These findings support the therapeutic potential of this treatment for Stress Urinary Incontinence as well as other muscle-related disorders, by restoring muscle functionality."
  • Title: Regeneration of Muscle Tissue and Function In Stress Urinary Incontinence Using Engineered RNA, #NM20
    Klaas Zuideveld, Chief Executive Officer, said: "We are delighted to be presenting at the prestigious SUFU 2022 Winter Meeting.