OAB

Urovant Sciences Appoints Betzy Estrada as Executive Vice President and Chief Human Resources Officer

Retrieved on: 
Donnerstag, August 12, 2021

Urovant Sciences, Inc., a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced the appointment of Betzy Estrada as executive vice president and chief human resources officer.

Key Points: 
  • Urovant Sciences, Inc., a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced the appointment of Betzy Estrada as executive vice president and chief human resources officer.
  • In her new role, Estrada reports to Urovant President and Chief Executive Officer Jim Robinson and is based at the companys headquarters office in Irvine, Calif.
  • Most recently, she was vice president, human resources, and chief compliance executive for Nihon Kohden, a leading manufacturer, developer and distributor of medical electronic equipment headquartered in Tokyo, Japan.
  • Sumitovant is the majority shareholder of Myovant Sciences and wholly owns Urovant Sciences, Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences.

BlueWind Medical Reaches 100th Patient for the OASIS Study of the RENOVA™ iStim System

Retrieved on: 
Dienstag, Juli 6, 2021

The Overactive Bladder Stimulation System Study (OASIS) clinical pivotal study is designed to test the safety and efficacy of the RENOVA iStim System in providing tibial neuromodulation (TNM) therapy.

Key Points: 
  • The Overactive Bladder Stimulation System Study (OASIS) clinical pivotal study is designed to test the safety and efficacy of the RENOVA iStim System in providing tibial neuromodulation (TNM) therapy.
  • "I had the privilege of taking part both to the pilot and pivotal trials of the RENOVA iStim System" said Dr. Digesu.
  • "I find the RENOVA iStim a device easy to implant for a surgeon and easy to operate for a patient."
  • BlueWind Medical, founded in 2010, is developing the RENOVA iStim, a miniature, wireless neurostimulator to treat Overactive Bladder (OAB).

Uro Medical Corporation Acquires Micron Medical and Initiates the FDA IDE Approved “Guardian” RCT of the Protect PNS Injectable Tibial Stimulator for Treatment of Overactive Bladder

Retrieved on: 
Dienstag, Juli 6, 2021

Our new organization Uro Medical Corporation reflects our core business focus in urology and improving how neuromodulation is delivered to treat previously under-served urologic conditions," saidMatt Kemp, Chief Commercial Officer of Uro Medical.

Key Points: 
  • Our new organization Uro Medical Corporation reflects our core business focus in urology and improving how neuromodulation is delivered to treat previously under-served urologic conditions," saidMatt Kemp, Chief Commercial Officer of Uro Medical.
  • In addition, Uro Medical announced the initiation of the Guardian clinical trial, a multi-center randomized controlled clinical trial evaluating the safety and efficacy of Protect PNS as compared to traditional medical management for the treatment for OAB.
  • Protect PNS is a wirelessly powered, minimally invasive, microtechnology neurostimulator intended to treat overactive bladder (OAB).
  • Protect PNS is currently being studied for the treatment of OAB and is under regulatory review for market approval by the FDA.

Urovant Sciences Announces U.S. Commercial Launch of GEMTESA® (vibegron) 75 mg Tablets for Patients with Overactive Bladder

Retrieved on: 
Montag, April 12, 2021

\xe2\x80\x9cThe launch of GEMTESA is a significant milestone for Urovant, as we are bringing our first product to market.

Key Points: 
  • \xe2\x80\x9cThe launch of GEMTESA is a significant milestone for Urovant, as we are bringing our first product to market.
  • GEMTESA is designed to reduce the bothersome symptoms of OAB by relaxing the detrusor bladder muscle so that the bladder can hold more urine.
  • GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder.
  • Sumitovant is the majority shareholder of Myovant Sciences and wholly owns Urovant Sciences, Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences.

Micron Medical Issues a Letter to Shareholders

Retrieved on: 
Donnerstag, Januar 7, 2021

BOCA RATON, Fla., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Micron Medical (Micron), a privately-held medical device company engaged in the development, manufacture and early stage commercialization of innovative wireless, minimally invasive, electroceutical solutions for urological conditions, focused on OAB, today published a letter to shareholders.

Key Points: 
  • BOCA RATON, Fla., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Micron Medical (Micron), a privately-held medical device company engaged in the development, manufacture and early stage commercialization of innovative wireless, minimally invasive, electroceutical solutions for urological conditions, focused on OAB, today published a letter to shareholders.
  • Within one year of seeking medical treatment for their bladder control problems, most patients seek out alternative or advanced therapies to manage their symptoms.
  • This is the culture we have at Micron Medical and the principles we are committed to upholding.
  • In 2021, we look forward to continued excellence in execution, solidifying our culture, strengthening your Companys balance sheet, improving the lives of patients with bladder control problems, exploring an IPO, and creating value for all Micron Medical shareholders.

Micron Medical to Participate in the LifeSci Partners 10th Annual Healthcare Corporate Access Event

Retrieved on: 
Dienstag, Januar 5, 2021

BOCA RATON, Fla., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Micron Medical (Micron), a privately-held medical device company engaged in the development, manufacture and early stage commercialization of innovative wireless, minimally invasive, electroceutical solutions for urological conditions, focused on OAB, today announced that it will participate in the 10thAnnual LifeSci Partners Corporate Access Event,January 6-8and 11-14, 2021.

Key Points: 
  • BOCA RATON, Fla., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Micron Medical (Micron), a privately-held medical device company engaged in the development, manufacture and early stage commercialization of innovative wireless, minimally invasive, electroceutical solutions for urological conditions, focused on OAB, today announced that it will participate in the 10thAnnual LifeSci Partners Corporate Access Event,January 6-8and 11-14, 2021.
  • Mark Landy, Chief Executive Officer, will host 1x1 meetings and will present a corporate update on Wednesday, January 6th at 3:30pm EST.
  • Microns goal is to evolve its patented, cutting-edge platform for neuromodulation to standard of care, increasing the accessibility for patients worldwide while lowering the economic impact of urology care management.
  • www.micronmed.com

Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)

Retrieved on: 
Mittwoch, Dezember 23, 2020

This approval marks the first new oral branded OAB medication approved by the FDA since 2012, and it is the first product approval for Urovant Sciences.

Key Points: 
  • This approval marks the first new oral branded OAB medication approved by the FDA since 2012, and it is the first product approval for Urovant Sciences.
  • The FDAs approval of GEMTESA is an important milestone for the tens of millions of patients living with overactive bladder and for Urovant, as it is our first drug approval.
  • By successfully treating clinical symptoms, GEMTESA may allow patients to overcome the devastating impact that OAB can have on their daily lives.
  • Sumitovant is the majority shareholder of Myovant Sciences and Urovant Sciences, and wholly owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences.

Micron Medical to Present at the 13th Annual LD Micro Main Event Virtual Conference

Retrieved on: 
Donnerstag, Dezember 10, 2020

BOCA RATON, Fla., Dec. 10, 2020 (GLOBE NEWSWIRE) -- Micron Medical (Micron or the Company), a privately-held, commercial stage medical device company preparing to launch a revolutionary minimally invasive neurostimulator for treating patients suffering with an overactive bladder (OAB), today announced that it will be presenting at the 13th Annual LD Micro Main Event virtual investor conference on Monday, December 14, at 3:00 PM EST / 12:00 PM PST.

Key Points: 
  • BOCA RATON, Fla., Dec. 10, 2020 (GLOBE NEWSWIRE) -- Micron Medical (Micron or the Company), a privately-held, commercial stage medical device company preparing to launch a revolutionary minimally invasive neurostimulator for treating patients suffering with an overactive bladder (OAB), today announced that it will be presenting at the 13th Annual LD Micro Main Event virtual investor conference on Monday, December 14, at 3:00 PM EST / 12:00 PM PST.
  • Microns lead product, Protect PNS, is a revolutionary minimally invasive neurostimulator for treating OAB, a debilitating condition that affects more than 37 million people in the U.S., with 7 million patients seeking medical treatment each year.
  • Micron has submitted a De Novo 510(k) application for PROTECT PNS and, pending receipt of FDA classification, the product is expected to be commercially available in the U.S. in 2021.
  • Mark Landy, Microns Chief Executive Officer, will be presenting to a live, virtual audience.

Micron Medical Receives FDA 510(k) Clearance for MOVENTIS PNS, a Drug-Free Wireless Peripheral Nerve Stimulator System for Common Urological Conditions; Commercial Launch Underway

Retrieved on: 
Montag, September 14, 2020

The Company has already commenced a limited U.S. commercial launch of the product.

Key Points: 
  • The Company has already commenced a limited U.S. commercial launch of the product.
  • In addition, Micron has submitted a De Novo 510(k) application for PROTECT PNS in the significant market indication of overactive bladder (OAB).
  • The Micron device, at only 7 cm long, is smaller than any PNS implant currently available on the market today, at a volume of only 0.10 cc.
  • Moreover, it provides power levels up to 23.3 mA, which is also more powerful than any other currently available PNS device.

BlueWind Initiates U.S. Enrollment in Clinical Trial of the RENOVA iStim to Treat Overactive Bladder

Retrieved on: 
Dienstag, August 11, 2020

OAB affects women of all ages, and can impact quality of life including work performance, family life and social interactions.

Key Points: 
  • OAB affects women of all ages, and can impact quality of life including work performance, family life and social interactions.
  • RENOVA is a tiny, battery-less and lead-less neurostimulation implant that provides a patient-centric, home-based alternative therapy option for women with OAB.
  • The OverActive Bladder Stimulation System Study (OASIS), a prospective, interventional, multi-center study, will evaluate the safety and efficacy of RENOVA to improve urinary urgency incontinence (UUI) episodes.
  • The CE Marked RENOVA system is an investigational device and not cleared for marketing in the United States.