Overactive bladder

RLS takes high toll on health, patients face major gaps in treatment, study shows

Retrieved on: 
Monday, June 6, 2022
People, Woman, Happiness, Restless legs syndrome, Adult, COPD, Time, Quality of life (healthcare), Research, Overactive bladder, Stroke, Man, Doctor of Philosophy, Sleep, Depression, Sleep deprivation, Education, Awareness, Travel, Multimedia, Chronic obstructive pulmonary disease, Physician, FDA, Bed, Patient, RLS, Risk, Diabetes, Psoriasis, Quality of life, Diagnosis, Population, Alzheimer's disease, Inflammatory bowel disease, Foundation, View, Pharmaceutical industry, Health insurance

This study underscores the toll that RLS has on mental and physical health," says Charles E. Phelps, PhD, a health economist and senior author of the study.

Key Points: 
  • This study underscores the toll that RLS has on mental and physical health," says Charles E. Phelps, PhD, a health economist and senior author of the study.
  • "This study underscores the toll that RLS has on mental and physical health," says Charles E. Phelps, PhD, a health economist and senior author of the study.
  • Founded in 1989, the Foundation's goals are to increase awareness, improve treatments and, through research, find a cure for RLS.
  • The RLS Foundation has awarded over $1.8 million in grants for medical research on RLS causes and treatments.

GentiBio Appoints Neely Mozaffarian, MD, PhD as Chief Medical Officer

Retrieved on: 
Wednesday, June 1, 2022
Filgotinib, Albert Einstein College of Medicine, Research, Knowledge, Doctor of Philosophy, Inflammation, Senior, Therapy, University, Autoimmunity, Immunology, Patient, AbbVie, MS, Immune system, University of Washington Department of Global Health, Immune tolerance, Overactive bladder, Degenerative disease, Drug development, Gilead, Adalimumab, Vaccine, Regulatory T cell, MD

CAMBRIDGE, Mass., June 1, 2022 /PRNewswire/ -- GentiBio, Inc., a biotherapeutics company developing engineered regulatory T cells (Tregs) therapies for autoimmunity, autoinflammation and allergic diseases, today announced that Neely Mozaffarian, M.D., Ph.D., has been appointed to the position of Chief Medical Officer. Bringing more than 25 years of clinical and management experience in autoimmunity research, Dr. Mozaffarian will oversee the company's growing clinical and regulatory organization.

Key Points: 
  • CAMBRIDGE, Mass., June 1, 2022 /PRNewswire/ -- GentiBio, Inc., a biotherapeutics company developing engineered regulatory T cells (Tregs) therapies for autoimmunity, autoinflammation and allergic diseases, today announced that Neely Mozaffarian, M.D., Ph.D., has been appointed to the position of Chief Medical Officer.
  • Bringing more than 25 years of clinical and management experience in autoimmunity research, Dr. Mozaffarian will oversee the company's growing clinical and regulatory organization.
  • Neely received her MD and PhD degrees from Albert Einstein College of Medicine and completed her internal medicine residency training and rheumatology fellowship at the University of Washington.
  • "I'm excited to join GentiBio to lead the experienced clinical and regulatory team as we are poised to become a clinical-stage company," stated Dr. Mozaffarian.

Axonics® Files PMA Supplement with FDA for Fourth Generation Rechargeable Neurostimulator

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Tuesday, May 31, 2022
Biotechnology, General Health, Health, Medical Devices, Financial Times, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, Nasdaq, Lead, Patient, Woman, Fecal incontinence, FDA, Urinary incontinence, SUI, Deloitte Technology Fast 500, Awareness, Life, Overactive bladder, SNM, Security (finance), INS, Pharmaceutical industry, Axon Enterprise

Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, has filed a premarket approval supplement with the FDA for its fourth generation rechargeable sacral neuromodulation implantable neurostimulator (INS).

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, has filed a premarket approval supplement with the FDA for its fourth generation rechargeable sacral neuromodulation implantable neurostimulator (INS).
  • The fourth generation rechargeable INS reduces how frequently a patient needs to recharge their implanted device to only once every six months for one hour.1 This compares to the current recharging interval of once a month for one hour with the Axonics third generation rechargeable INS.
  • Axonics expects the new INS to receive FDA labeling for 20 years of useful life in the body.
  • Axonics anticipates receiving FDA approval for the fourth generation rechargeable INS in the fourth quarter of 2022 and expects to begin shipping the new device to customers in the first quarter of 2023.

Urovant Sciences® Presents Interim Data from Phase 2a Study of Investigational Novel Gene Therapy, URO-902, Supporting Safety, Tolerability, and Efficacy Endpoints at 2022 American Urological Association Meeting

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Friday, May 13, 2022
Health, Genetics, Clinical Trials, General Health, Pharmaceutical, Biotechnology, American Urological Association, Urination, Sex, Medicine, Urinary urgency, Urine, Sore throat, Overactive bladder, Vitamin, Neurogenic bladder dysfunction, Female, Nasal congestion, Urinary incontinence, Headache, Twitter, Science, Oakland University, Burden, Allergy, Nausea, Professor, Journal, Liver, Breast milk, Woman, Medical school, Beaumont, Vats, The Journal of Urology, Man, Urinary tract infection, Trial of the century, Diarrhea, NYSE, Department, Urinary retention, Catheter, Kopp, Digoxin, Doctor of Philosophy, I, Micturition syncope, Beaumont Hospital, Patient, OAB, Adult, FDA, Public health, LinkedIn, MD, Kidney, Upper respiratory tract infection, Population, Injection, Nocturia, Cystoscopy, Gesellschaft mit beschränkter Haftung, Safety, Pharmaceutical industry, Dietary supplement, Urology, Sexton

This was a prespecified, 12-week interim analysis of a 48-week multicenter, randomized, double-blind, placebo-controlled, dose-escalation study ( NCT04211831 ).

Key Points: 
  • This was a prespecified, 12-week interim analysis of a 48-week multicenter, randomized, double-blind, placebo-controlled, dose-escalation study ( NCT04211831 ).
  • Treatment-emergent adverse events occurred in 45.5% of patients receiving URO-902 24 mg, 46.2% receiving 48 mg, and 50.0% receiving placebo.
  • We are encouraged by these promising interim safety and efficacy findings for URO-902, said Sef Kurstjens, MD, PhD, Executive Vice President and Chief Medical Officer of Urovant Sciences.
  • UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo, GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.

Valencia Technologies Retains PRIA Healthcare to Improve Patient Access to the eCoin for treatment of Urge Urinary Incontinence (UUI)

Retrieved on: 
Tuesday, May 10, 2022
Private Securities Litigation Reform Act, Insurance, Overactive bladder, Leg, United, Patient, Health policy, Neurogenic bladder dysfunction, FDA, Business development, Urinary incontinence, Medtech, PRIA, VP, Technology, OAB, Medical imaging, Health insurance

VALENCIA, Calif., May 10, 2022 /PRNewswire/ -- Valencia Technologies Corporation ("Valencia" or the "Company"), a privately held company, today announced it has retained PRIA Healthcare to assist in patient access for Valencia's recently FDA approved proprietary product, eCoin.

Key Points: 
  • VALENCIA, Calif., May 10, 2022 /PRNewswire/ -- Valencia Technologies Corporation ("Valencia" or the "Company"), a privately held company, today announced it has retained PRIA Healthcare to assist in patient access for Valencia's recently FDA approved proprietary product, eCoin.
  • eCoin is a leadless tibial nerve neurostimulator for the treatment of urge urinary incontinence (UUI), affecting over 60% of patients who suffer from Overactive Bladder (OAB).
  • PRIA has 10 years of experience assisting MedTech companies improve patient access to new medical devices.
  • The company designed and manufactured its eCoin device for the treatment of urge urinary incontinence (UUI).

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

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Monday, May 9, 2022
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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.

Renovia debuts "Stronger Women" campaign at annual gathering of women's health care leaders

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Friday, May 6, 2022
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SAN DIEGO, May 6, 2022 /PRNewswire/ -- ACOG Annual Meeting — Renovia Inc. (Renovia), a women-led company that develops digital therapeutics for female pelvic floor disorders, has launched a new brand campaign titled, Stronger Women, at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting (ACSM). The campaign is intended to educate clinicians and women about urinary incontinence (UI) and the leva® Pelvic Health System, a convenient, easy-to-use, at-home pelvic health program that can help women strengthen their pelvic floor and decrease the symptoms of stress, mixed and mild to moderate UI, including overactive bladder. Through the campaign, and by launching it at the ACSM, Renovia seeks to make first-line treatment for UI more accessible and accelerate the momentum supporting regular screening for female UI among clinicians.

Key Points: 
  • The Stronger Women campaign centers on the importance of a strong pelvic floor in women's overall health and well-being.
  • The campaign also humanizes the issues associated with UI and, thus, seeks to make UI less taboo.
  • "While ACOG recommends annual screening for UI, treatment options often require drugs, surgery or access to physical therapy.
  • Renovia Inc. and levaare trademarks or registered trademarks of Renovia Inc. in the United States and other countries.

Axonics® Reports First Quarter 2022 Financial Results

Retrieved on: 
Thursday, May 5, 2022
Biotechnology, General Health, Medical Devices, Other Health, Health, U.S. Securities and Exchange Commission, Private Securities Litigation Reform Act, Financial Times, Omicron, Nasdaq, Woman, Deloitte Technology Fast 500, Fecal incontinence, Incontinence, Urinary incontinence, Patient, Stigma, Security (finance), Webcast, SNM, SUI, Overactive bladder, Event, Solution, Awareness, Pharmaceutical industry, Video game, Axon Enterprise

Net revenue was $48.4 million in first quarter 2022, an increase of 41% compared to $34.4 million in the prior year period.

Key Points: 
  • Net revenue was $48.4 million in first quarter 2022, an increase of 41% compared to $34.4 million in the prior year period.
  • Gross margin was 68.7% in first quarter 2022 compared to 59.3% in the prior year period.
  • Net loss was $22.7 million in first quarter 2022 compared to net loss of $22.5 million in the prior year period.
  • Axonics will host a conference call today at 4:30 p.m. Eastern Time to discuss financial results and recent business developments.

May is Women's Health Month

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Monday, May 2, 2022
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BALTIMORE, May 2, 2022 /PRNewswire/ -- May marks the start of Women's Health Month, a time dedicated to the health and wellness of women throughout the world. The Urology Care Foundation, the official Foundation of the American Urological Association and the world's leading nonprofit urological health foundation, utilizes the month of May to educate and raise awareness of urology-related conditions and diseases that affect women, such as overactive bladder, urinary tract infections, incontinence, interstitial cystitis and bladder cancer.

Key Points: 
  • BALTIMORE, May 2, 2022 /PRNewswire/ -- May marks the start of Women's Health Month, a time dedicated to the health and wellness of women throughout the world.
  • "Women's Health Month reminds women to take control of their own health," said Harris M. Nagler, MD, president of the Urology Care Foundation.
  • "The Urology Care Foundation serves as a source of trusted resources to help empower women to improve their urologic health, and therefore, their overall health.
  • About the Urology Care Foundation:The Urology Care Foundation is the world's leading nonprofit urological health foundation, and the official foundation of the American Urological Association.

Ventus Therapeutics Appoints Stuart Green, M.D., as Chief Medical Officer

Retrieved on: 
Monday, May 2, 2022
Health, Infectious Diseases, Clinical Trials, General Health, Pharmaceutical, Biotechnology, NLRP3, COVID-19, Duke University Hospital, University, Critical Care Medicine (journal), Duke, University of Texas Health Science Center at Houston, Pain scale, Merck, Stuart, Â, COPD, Asthma, Merck & Co., Inflammation, Therapy, Overactive bladder, Industry, Outline of health sciences, MD, Multimedia, Leadership, Neurology, Internal medicine, Duke University, CMO, LinkedIn, Stuart Green, Chronic cough, CEO, Protein, Resolve, Rheumatoid arthritis, Pharmaceutical industry, Fine chemical, Ventus, Chemistry

Ventus Therapeutics , Inc., a biopharmaceutical company utilizing structural biology and a proprietary computational platform to identify and develop small molecule therapeutics across a broad range of diseases, announced today the appointment of Stuart Green, MD, as Chief Medical Officer.

Key Points: 
  • Ventus Therapeutics , Inc., a biopharmaceutical company utilizing structural biology and a proprietary computational platform to identify and develop small molecule therapeutics across a broad range of diseases, announced today the appointment of Stuart Green, MD, as Chief Medical Officer.
  • We are excited to welcome Stuart to the Ventus team at this pivotal time in our evolution toward a clinical-stage company.
  • Dr. Green brings more than twenty years of experience in clinical development to Ventus.
  • Ventus Therapeutics is a biopharmaceutical company utilizing structural biology and computational tools to identify and develop small molecule therapeutics across a broad range of disease indications, with an initial focus on immunology, inflammation and neurology.