Overactive bladder

Axena Health Receives Positive Insurance Coverage Decision From Cigna Healthcare for Leva Pelvic Health System

Retrieved on: 
Wednesday, March 22, 2023

Axena Health, Inc. (Axena Health), a medical device company relentlessly dedicated to women’s health, today announced that Cigna Healthcare (Cigna), one of the largest healthcare insurance providers in the United States with approximately 15 million members, has added the Leva Pelvic Health System as a covered treatment for stress, urgency and mixed urinary incontinence (UI) in women.

Key Points: 
  • Axena Health, Inc. (Axena Health), a medical device company relentlessly dedicated to women’s health, today announced that Cigna Healthcare (Cigna), one of the largest healthcare insurance providers in the United States with approximately 15 million members, has added the Leva Pelvic Health System as a covered treatment for stress, urgency and mixed urinary incontinence (UI) in women.
  • The positive coverage decision from Cigna follows Axena Health’s recent $25 million Series A fundraising and a new Obstetrics and Gynecology study showing the Leva System’s long-term efficacy for female UI.
  • For our patients, the Leva System makes this training easy, accessible and effective, allowing more women to live leak-free.
  • Cigna’s coverage policy update then states, “a newer at-home biofeedback device and remotely delivered program called Leva® Pelvic Health System was developed to mitigate some of these issues.

American Urological Association Announces Innovation Nexus Showcase Selections

Retrieved on: 
Tuesday, March 14, 2023

BALTIMORE, March 14, 2023 /PRNewswire/ -- The American Urological Association (AUA) is pleased to announce the ten companies chosen through a rigorous and highly competitive selection process for the inaugural Innovation Nexus Showcase. The Showcase gives investigators, startups and mid-size companies the opportunity to pitch their ideas to a panel of individuals and corporations looking to invest in urology.  

Key Points: 
  • BALTIMORE, March 14, 2023 /PRNewswire/ -- The American Urological Association (AUA) is pleased to announce the ten companies chosen through a rigorous and highly competitive selection process for the inaugural Innovation Nexus Showcase.
  • Innovation Nexus is a long-term commitment by the AUA to sustain a urology incubator to advance discoveries with key stakeholders for the benefit of urologic patient care.
  • "Beyond the next generation innovation that these showcase selections represent, we are excited about the international reach as well as the breadth and depth of urologic conditions that this cohort represents."
  • For more information on the Showcase and to register to attend the April 27 event, please visit: https://auanexus.org/

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.

BlueWind Medical Announces Key Milestone as AMA Issues Unique Category III CPT Code for Subfascial Placement of Tibial Neurostimulators

Retrieved on: 
Wednesday, March 8, 2023

This information was released by the AMA in the February 2023 Summary of Panel Actions from the February CPT Editorial Panel Meeting.

Key Points: 
  • This information was released by the AMA in the February 2023 Summary of Panel Actions from the February CPT Editorial Panel Meeting.
  • CPT codes provide a uniform nomenclature for coding medical procedures and services and are granted and maintained by the AMA CPT Editorial Panel.
  • The release of this new CPT code represents a significant reimbursement achievement for BlueWind Medical as physicians, hospitals and surgery centers will be able to submit claims for the BlueWind System using this code.
  • The subfascial procedure described in the CPT code is unique to BlueWind Medical.

Axena Health Commends Obstetrics and Gynecology Publication Showing Leva® Pelvic Health System’s Long-Term Efficacy for Female Urinary Incontinence

Retrieved on: 
Wednesday, March 1, 2023

The Leva Pelvic Health System (the Leva System) is a prescription digital therapeutic (PDT) that offers easy-to-use, at-home treatment for urinary and chronic fecal incontinence (FI) in women.

Key Points: 
  • The Leva Pelvic Health System (the Leva System) is a prescription digital therapeutic (PDT) that offers easy-to-use, at-home treatment for urinary and chronic fecal incontinence (FI) in women.
  • Of the 299 participants, women using the Leva System experienced durable, significantly greater improvement in UI symptoms compared with women who relied on Kegels alone.
  • The 2023 publication announced today shows that UI symptom improvement lasts, even without ongoing use of the Leva System.
  • “Urinary incontinence is common, but it should not be normal,” said Eileen Maus, CEO of Axena Health.

Axena Health Secures $25M Series A Investment to Accelerate Global Adoption of Digital Health Treatment for Female Incontinence

Retrieved on: 
Thursday, February 16, 2023

Axena Health, Inc. (Axena Health), a newly-formed commercial-stage medical device company focused on women’s pelvic health, today announced a $25 million Series A investment from AXA IM Alts through its Global Healthcare Private Equity Strategy.

Key Points: 
  • Axena Health, Inc. (Axena Health), a newly-formed commercial-stage medical device company focused on women’s pelvic health, today announced a $25 million Series A investment from AXA IM Alts through its Global Healthcare Private Equity Strategy.
  • The investment will support and expand access to the Leva® Pelvic Health System, a prescription digital therapeutic (PDT) that offers easy-to-use, at-home treatment for urinary incontinence (UI) and chronic fecal incontinence (FI) in women.
  • “We believe the Leva® Pelvic Health System combines high-quality clinical data with novel technology that harnesses the vast opportunity of digital health to offer a breakthrough, at-home treatment for incontinence.
  • We believe female incontinence is a significant unmet health need for millions of women worldwide and Axena Health will be uniquely able to address this need.

Amber Therapeutics announces successful first-in-human implants of Amber-UI: an intelligent, closed-loop bioelectrical therapy for urge and mixed urinary incontinence

Retrieved on: 
Tuesday, January 24, 2023

To explore the clinical potential of Amber-UI, the Company initiated its ground-breaking AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study in late 2022 (clinicaltrials.gov identifier: NCT05241379).

Key Points: 
  • To explore the clinical potential of Amber-UI, the Company initiated its ground-breaking AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study in late 2022 (clinicaltrials.gov identifier: NCT05241379).
  • AURA-2 is designed to evaluate the safety and pilot efficacy of Amber-UI in 15 women.
  • Aidan Crawley, CEO of Amber commented: "Reaching this first-in-human milestone in under two years demonstrates our ability to rapidly prototype new bioelectrical therapy concepts.
  • With our Amber-UI adaptive therapy, we finally have the potential to control both forms of incontinence: relaxing the bladder to treat urge and closing the sphincter to treat stress incontinence."

Amber Therapeutics announces successful first-in-human implants of Amber-UI: an intelligent, closed-loop bioelectrical therapy for urge and mixed urinary incontinence

Retrieved on: 
Tuesday, January 24, 2023

To explore the clinical potential of Amber-UI, the Company initiated its ground-breaking AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study in late 2022 (clinicaltrials.gov identifier: NCT05241379).

Key Points: 
  • To explore the clinical potential of Amber-UI, the Company initiated its ground-breaking AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study in late 2022 (clinicaltrials.gov identifier: NCT05241379).
  • AURA-2 is designed to evaluate the safety and pilot efficacy of Amber-UI in 15 women.
  • Aidan Crawley, CEO of Amber commented: "Reaching this first-in-human milestone in under two years demonstrates our ability to rapidly prototype new bioelectrical therapy concepts.
  • With our Amber-UI adaptive therapy, we finally have the potential to control both forms of incontinence: relaxing the bladder to treat urge and closing the sphincter to treat stress incontinence."

Urovant Sciences® Announces Collaboration with Holly Robinson Peete to Help Raise Awareness for Overactive Bladder and Treatment Options

Retrieved on: 
Thursday, January 19, 2023

Urovant Sciences , a wholly-owned subsidiary of Sumitovant Biopharma, Ltd. , today announced its partnership with actress and overactive bladder (OAB) patient Holly Robinson Peete as part of its Time To Go ™ campaign – an educational program to raise awareness of OAB.

Key Points: 
  • Urovant Sciences , a wholly-owned subsidiary of Sumitovant Biopharma, Ltd. , today announced its partnership with actress and overactive bladder (OAB) patient Holly Robinson Peete as part of its Time To Go ™ campaign – an educational program to raise awareness of OAB.
  • “I noticed I was going to the bathroom a lot and had a sudden urge to go, like now.
  • With my OAB symptoms, there was a lot of added stress and worry before I traveled either for work or for fun.
  • On average, patients waited 3.5 years between noticing OAB symptoms and seeking a doctor’s help.

Axonics Receives Health Canada Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System

Retrieved on: 
Tuesday, December 13, 2022

Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that Health Canada has approved the companys fourth-generation rechargeable sacral neuromodulation system.

Key Points: 
  • Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that Health Canada has approved the companys fourth-generation rechargeable sacral neuromodulation system.
  • Since Axonics founding, delivering superior patient experiences has been at the forefront of our development efforts, said Raymond W. Cohen, chief executive officer of Axonics.
  • The Axonics R20 represents a significant breakthrough for rechargeable neuromodulation devices and underscores our commitment to continuous innovation.
  • Axonics has commenced sales of the R20 sacral neuromodulation system to customers in Canada.