OAB

AUA/SUFU Guideline on the Treatment of Overactive Bladder Allows Access to ReviTM System Earlier in Treatment Journey

Retrieved on: 
Monday, April 29, 2024
FDA, Commercial software, Society, Risk, Urinary incontinence, Food, De novo, American Urological Association, Paruresis, Pharmacotherapy, MMHC, Guideline, OAB, Deficit spending, Prescription, Patient, Neuromodulation, Physician, AUA, Ankle, Diagnosis, SUFU, Anticholinergic, Female

The revised guidelines are a major affirmation of the importance of Revi as a therapy for patients with UUI.

Key Points: 
  • The revised guidelines are a major affirmation of the importance of Revi as a therapy for patients with UUI.
  • First, the guidelines were updated to include iTNM as an acceptable minimally invasive therapy.
  • "We are delighted to witness the transformation of the new OAB treatment guideline by the AUA/SUFU.
  • This guideline represents a significant turning point in physicians' approach to OAB management," commented Dan Lemaitre, Chief Executive Officer of BlueWind Medical.

AUA, SUFU Release Guideline on Diagnosis and Treatment of Overactive Bladder

Retrieved on: 
Tuesday, April 23, 2024
Society, Phenotype, Woman, American Urological Association, MD, Partnership, Pelvic floor dysfunction, Guideline, OAB, Obesity, Patient, Overactive bladder, AUA, Constipation, Diagnosis, SUFU, Quality of life, Prevalence, Systematic review, Medical device

BALTIMORE, April 23, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), released the 2024 clinical practice guideline for the diagnosis and treatment of overactive bladder (OAB).

Key Points: 
  • BALTIMORE, April 23, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), released the 2024 clinical practice guideline for the diagnosis and treatment of overactive bladder (OAB).
  • As OAB is a symptom-based diagnosis, the impact of the symptoms on quality of life is critical to the condition.
  • The degree of bother caused by OAB symptoms directly affects OAB care-seeking, treatment intensity, and satisfaction with treatment.
  • The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder.

Zydus launches Mirabegron Extended-Release Tablets in the US

Retrieved on: 
Monday, April 22, 2024
Biotechnology, General Health, Pharmaceutical, Health, Zydus Lifesciences, USP, Patient, Overactive bladder, USFDA, Mirabegron, Urinary incontinence, OAB, Generic drug

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market.

Key Points: 
  • Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market.
  • The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq® Extended-Release Tablets).
  • Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is prepared to launch Mirabegron Extended-Release Tablets, 50mg imminently.
  • Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.

Vuzix Establishes Ophthalmic Advisory Board to Better Serve Human Vision Correction Needs with AR Glasses

Retrieved on: 
Monday, January 29, 2024
School, Research, Cataract, IP, Heart, OAB, OEM, Wireless, Knowledge, Software as a service, Medical school, Consumer Electronics Show, FDA, CES, Wayne State University, Kent State University, Smartglasses, Retina, Augmented reality, Management

The Company also announces the appointment of Doctor Shabbir Khambati to this board as the chair and a founding board member.

Key Points: 
  • The Company also announces the appointment of Doctor Shabbir Khambati to this board as the chair and a founding board member.
  • Coming up with new and implementable methods and techniques to compensate for human vision issues is critical for the ultimate success of HUDs and AR glasses.
  • Increased knowledge and oversight in vision correction will allow Vuzix to better serve its customers and offer vision correction solutions that still allow the benefits of AR glasses and HUDs in as seamless a way as possible, as most industry observers state that vision correction solutions must be found for AR glasses to succeed.
  • Numerous technology and healthcare firms maintain medical and scientific advisory boards to support various needs.

Anthem Blue Cross and Blue Shield Announces Coverage for the eCoin System for Urinary Incontinence

Retrieved on: 
Tuesday, January 9, 2024
Patient, Blue Shield, OAB, Leg, Health, Food and Drug Administration, TNS, Urinary incontinence, Quality of life, Food, CPT, Safety, FDA, Physician, Elevance Health, PMA, Clinical trial, United, Tibial nerve

VALENCIA, Calif., Jan. 9, 2024 /PRNewswire/ --Valencia Technologies Corporation announced today that Anthem Blue Cross and Blue Shield published a coverage policy for the eCoin® System procedure effective December 28, 2023.

Key Points: 
  • VALENCIA, Calif., Jan. 9, 2024 /PRNewswire/ --Valencia Technologies Corporation announced today that Anthem Blue Cross and Blue Shield published a coverage policy for the eCoin® System procedure effective December 28, 2023.
  • The eCoin system is an innovative, implanted, leadless tibial neurostimulator for the treatment of urgency urinary incontinence (UUI), secondary to overactive bladder (OAB).
  • Effective December 28, 2023, Anthem Blue Cross and Blue Shield announced in a published medical policy their decision to cover the eCoin® System implantable tibial nerve stimulation (TNS) procedure when medical necessity criteria are met.
  • We couldn't be more pleased that our efforts resulted in early coverage adoption from an influential health plan like Anthem Blue Cross and Blue Shield."

EG427 Announces New Preclinical Results from Multiple Studies of EG110A in Neurogenic Detrusor Overactivity (NDO) and Overactive Bladder (OAB)

Retrieved on: 
Thursday, January 4, 2024
Overactive bladder, Biotechnology, IND, Sphincter, Drug discovery, OAB, DNA, MD, Human, Animal, Effectiveness, Gene expression, NDO, Urinary tract infection, Patient, Neurology, Vaccine

In the first non-clinical pharmacology study comparing bladder injections of EG110A to botulinum toxin A in OAB, EG110A showed comparable efficacy, and further showed no increase in post-void residual urine volume.

Key Points: 
  • In the first non-clinical pharmacology study comparing bladder injections of EG110A to botulinum toxin A in OAB, EG110A showed comparable efficacy, and further showed no increase in post-void residual urine volume.
  • In the second study, which evaluated EG110A transgene expression over time in the dorsal root ganglia of treated animals, EG110A demonstrated persistent gene expression out to the final six-month time point.
  • These results strongly support the potential for EG110A to provide long-term relief for patients suffering from NDO and OAB.
  • EG 427 will be filing an Investigational New Drug (IND) application for EG110A in the first quarter of this year.

Sumitomo Pharma America and Actress Holly Robinson Peete Extend Time To Go™ Campaign to Empower People with Overactive Bladder

Retrieved on: 
Tuesday, November 21, 2023
Signs and symptoms, Embarrassment, Senior, Prevalence, Risk, OAB, Vibegron, FDA, SMPA, Weakness, Urination, Overactive bladder, Urinary incontinence, Diagnosis, Partnership, Leakage, Holly, Human, Education, Pharmaceutical industry, Nursing

CAMBRIDGE, Mass., Nov. 21, 2023 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), today announced the expansion of its partnership with actress and overactive bladder (OAB) patient Holly Robinson Peete to reach people living with overactive bladder (OAB) through the Time To Go™ campaign. Time To Go is a platform designed to highlight the impact of OAB symptoms and provide education on disease management, including information on treatment options, such as GEMTESA® (vibegron), a FDA-approved prescription medication for the treatment of OAB in adults with symptoms of urge urinary incontinence, urgency, and frequency.

Key Points: 
  • "For years, OAB symptoms kept me from fully enjoying the things I love.
  • Talking to my girlfriends about my symptoms helped me realize I wasn't alone, and that seeking help isn't a sign of weakness, rather it's a step towards taking control," said Holly Robinson Peete.
  • That's why I'm thrilled to continue my partnership with SMPA to educate and empower others to address their OAB."
  • There is no shame in speaking up about OAB, talking to your doctor, and asking for the help you deserve."

Multi-center study published in Urology confirms efficacy and safety of Avation Medical's noninvasive Vivally® System for OAB

Retrieved on: 
Wednesday, November 15, 2023
Sale, Calibration, Incontinence, Safety, OAB, Quality of life, Ankle, Patient, FDA, Urinary incontinence, Urination, EMG, Sir Vival, QOL, Diary, Pharmaceutical industry, Dietary supplement, Urology, COLUMBUS

COLUMBUS, Ohio, Nov. 15, 2023 /PRNewswire/ -- Avation Medical, Inc., an innovative neuromodulation and digital health company with a mission to make wearable peripheral neuromodulation accessible to patients across a variety of clinical conditions, today announced the publication of safety and efficacy results from a  multi-center study, "FREEOAB", for its novel Vivally System in Urology, a leading, peer–reviewed journal for urologists.

Key Points: 
  • "In our study, significant reductions in symptom burden were observed at 12 weeks which, notably, persisted out to 12 months, even with a reduction in frequency of therapy sessions."
  • "We are grateful to the investigators and patients that participated in the study for helping us bring the Vivally System to market."
  • Worn on the ankle, Vivally is used at-home with therapy sessions lasting only 30 minutes, as little as once per week.
  • Results of the FREEOAB Study demonstrated significant reductions in three-day diary parameters for daily void, incontinence, and urgency episodes at 12 weeks.

Neuspera Medical, Inc. Announces Milestone Completion of 100th Implant in Its SANS-UUI Phase II Clinical Trial

Retrieved on: 
Tuesday, November 14, 2023
Urine, Safety, Depression, SAN, Woman, Exercise, SNM, OAB, Clinical trial, Patient, PNS, FDA, Overactive bladder, Disease, Freedom, Physician, Quality of life, Medical device

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).

Key Points: 
  • 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.
  • "I'm excited to be a part of this clinical trial and the potential of this minimally invasive and discreet sacral neuromodulation therapy option."
  • "We're grateful to all of the physicians and patients for their enthusiastic participation in this study," said Steffen Hovard, CEO of Neuspera Medical.
  • 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.

Valencia Technologies Corporation announced today that the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS), published the 2024 Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment

Retrieved on: 
Tuesday, November 7, 2023
Patient, FDA, ASC, Health, Ambulatory Surgery Center Association, Medicare, OAB, The Final Rule, PMA, United, AMA, Addendum, Quality of life, Leg, APC, Physician, Safety, CPT, Outpatient surgery, Hospital, Urinary incontinence, CMS

VALENCIA, Calif., Nov. 7, 2023 /PRNewswire/ -- As outlined in the 2024 Medicare Program: HOPPS and ASC Payment Systems Final Rule, CMS has confirmed that new Category III CPT code 0816T for reporting the eCoin system implantable tibial nerve stimulation procedure across all service locations has been assigned to Medicare Hospital Outpatient Prospective Payment System Ambulatory Payment Classification (APC) 5464 beginning CY'24. In the hospital outpatient site of service, APC 5464 has been assigned a Medicare unadjusted, national average payment rate of US$20,865, as referenced in Addendums A and B of the Final Rule. 

Key Points: 
  • Furthermore, CPT code 0816T describing the eCoin system procedure has been categorized as device-intensive by CMS.
  • This categorization ensures a more comprehensive Medicare payment in the Ambulatory Surgery Center (ASC) in comparison to procedures not deemed device-intensive.
  • Ann Decker, VP of Reimbursement for Valencia Technologies, commented, "The payment Rules for Hospital outpatient (HOPPS) and Ambulatory Surgery Center (ASC) by CMS are a testament to the constructive discussions between Valencia Technologies and CMS.
  • Patients are encouraged to visit Valencia's patient website at www.eCoin.us for more information about this novel therapy for UUI.