Neuroprosthetics

NIH Backs Synchron Brain Computer Interface with $10M Grant to Launch First U.S. Clinical Trial

Retrieved on: 
Thursday, August 26, 2021

The FDA granted approval in July to begin this breakthrough trial, paving the way for Synchrons StentrodeTM to become first commercially available implantable brain computer interface.

Key Points: 
  • The FDA granted approval in July to begin this breakthrough trial, paving the way for Synchrons StentrodeTM to become first commercially available implantable brain computer interface.
  • The Stentrode is the only brain computer interface (BCI) implanted without the need for open brain surgery.
  • We are excited to be collaborating with three world-leading U.S. institutions to deliver on the long promise of brain computer interface technology.
  • Synchron, a brain interface platform company, is a leader in the field of implantable neural interface technology.

Synchron Receives Green Light From FDA to Begin Breakthrough Trial of Implantable Brain Computer Interface in US

Retrieved on: 
Wednesday, July 28, 2021

Outcomes will include the use of the brain data to control digital devices and achieve improvements in functional independence.

Key Points: 
  • Outcomes will include the use of the brain data to control digital devices and achieve improvements in functional independence.
  • The FDA granted Breakthrough Device designation to Synchron in August 2020 .
  • We are thrilled to finally be launching a U.S. clinical trial this year, said Synchron CEO Thomas Oxley, MD, PhD.
  • Other implantable BCI approaches involve drilling into the skull and placing needle electrodes directly into the brain tissue, which can result in long term brain inflammation.

MicroPort® Cardiac Rhythm Management Business Announces US$150 Million Series C Investment

Retrieved on: 
Tuesday, July 27, 2021

SHANGHAI, July 27, 2021 /PRNewswire/ -- MicroPort Scientific Corporation ("MicroPort") announced that MicroPort Cardiac Rhythm Management Limited ("MicroPort CRM"), which is MicroPort's subsidiary focused on developing and commercializing implantable pacemaker and defibrillator devices and related technologies to manage cardiac rhythm disorders, has entered into definitive agreements in connection with its Series C financing with total investment proceeds of US$150 million.

Key Points: 
  • SHANGHAI, July 27, 2021 /PRNewswire/ -- MicroPort Scientific Corporation ("MicroPort") announced that MicroPort Cardiac Rhythm Management Limited ("MicroPort CRM"), which is MicroPort's subsidiary focused on developing and commercializing implantable pacemaker and defibrillator devices and related technologies to manage cardiac rhythm disorders, has entered into definitive agreements in connection with its Series C financing with total investment proceeds of US$150 million.
  • Hillhouse Capital Group and MicroPort will co-lead the Series C investment and will invest US$20 million and US$47 million, respectively.
  • After the completion of this transaction, MicroPort will continue to be the majority shareholder of MicroPort CRM.
  • Through its long-standing expertise in CRM, MicroPort CRM develops, manufactures and markets around the world cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure.

Evren Technologies receives FDA Breakthrough Device Designation for the Phoenix® - Revolutionary Transcutaneous Auricular Vagus Nerve Therapy to Treat PTSD

Retrieved on: 
Monday, July 26, 2021

GAINESVILLE, Fla., July 26, 2021 /PRNewswire/ -- Evren Technologies, Inc. announced today that its non-invasive Phoenix earbud device received Breakthrough Device Designation from the U.S. Food and Drug Administration for the treatment of Post-traumatic Stress Disorder (PTSD).

Key Points: 
  • GAINESVILLE, Fla., July 26, 2021 /PRNewswire/ -- Evren Technologies, Inc. announced today that its non-invasive Phoenix earbud device received Breakthrough Device Designation from the U.S. Food and Drug Administration for the treatment of Post-traumatic Stress Disorder (PTSD).
  • 7.5 million Americans seek treatment for PTSD every year and the rates tripled during the COVID shutdown.
  • The Phoenix is an earbud that provides personalized medicine that addresses the underlying autonomic imbalance of PTSD by delivering transcutaneous auricular vagal nerve stimulation (taVNS) in a proprietary closed-loop system.
  • The Phoenix medical device provides personalized medicine in a discreet earbud design that delivers transcutaneous auricular vagal nerve stimulation (taVNS).

Global Cochlear Implants Market Report 2021 Featuring Cochlear Ltd, GN Store Nord, MEDEL Elektromedizinische Gerate, Nurotron Biotechnology, Oticon Medical, Sonova, & William Demant - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 21, 2021

The "Cochlear Implants - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Cochlear Implants - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.
  • Unilateral, one of the segments analyzed in the report, is projected to record 7.8% CAGR and reach US$2.3 Billion by the end of the analysis period.
  • The U.S. Market is Estimated at $409.4 Million, While China is Forecast to Grow at 12.5% CAGR
    The Cochlear Implants market in the U.S. is estimated at US$409.4 Million in the year 2020.
  • Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 4.5% and 7.4% respectively over the 2020-2027 period.

NeuroPace Awarded Five-Year NIH Grant Funding of More than $9M to Study RNS System in Patients with Lennox-Gastaut Syndrome

Retrieved on: 
Wednesday, June 30, 2021

The study funded by the grant will explore the potential of NeuroPaces brain-responsive neuromodulation technology as a new therapy for persons living with LGS.

Key Points: 
  • The study funded by the grant will explore the potential of NeuroPaces brain-responsive neuromodulation technology as a new therapy for persons living with LGS.
  • If the RNS System meets certain criteria, experience from the study will inform the design of a future larger clinical study.
  • The RNS System, a paradigm-shifting treatment for drug-resistant focal epilepsy, is the only brain-responsive neuromodulation system approved by the FDA.
  • In 2013, it introduced the RNS System, the first and only FDA-approved closed-loop, brain-responsive neuromodulation system that delivers truly personalized, data-driven treatment.

AngelMed Announces FDA Approval of the Enhanced Real-Time Cardiac Monitor for Acute Coronary Syndrome (ACS) Events

Retrieved on: 
Monday, June 28, 2021

The AngelMed Guardian System is the world's first implantable cardiac detection monitor and patient-warning system for acute coronary syndrome (ACS) events, including silent heart attacks.

Key Points: 
  • The AngelMed Guardian System is the world's first implantable cardiac detection monitor and patient-warning system for acute coronary syndrome (ACS) events, including silent heart attacks.
  • "The improved AngelMed Guardian devicewill have a meaningful effect on the current standard of patient cardiology care for ACS events.
  • Angel Medical Systems maintains a robust portfolio of U.S. patents relating to detecting cardiac events, including silent heart attacks.
  • Implanted monitor alerting to reduce treatment delay in patients with acute coronary syndrome events.

Outlook on the Electrical Stimulation Devices Global Market to 2027 - Featuring Abbott Laboratories, Boston Scientific & BTL Industries Among Others - ResearchAndMarkets.com

Retrieved on: 
Monday, June 28, 2021

The "Electrical Stimulation Devices - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Electrical Stimulation Devices - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.
  • The U.S. Market is Estimated at $1.5 Billion, While China is Forecast to Grow at 4.3% CAGR
    The Electrical Stimulation Devices market in the U.S. is estimated at US$1.5 Billion in the year 2020.
  • In the global Vagus Nerve Stimulation (VNS) Devices segment, USA, Canada, Japan, China and Europe will drive the 3.9% CAGR estimated for this segment.
  • Led by countries such as Australia, India, and South Korea, the market in Asia-Pacific is forecast to reach US$790.7 Million by the year 2027.

Second Sight Medical Products Announces Pricing of Public Offering

Retrieved on: 
Wednesday, June 23, 2021

Second Sight Medical Products, Inc. (NASDAQ: EYES) (Second Sight or the Company), a leading developer of implantable visual prosthetics that are intended to create an artificial form of useful vision for blind individuals, today announced the pricing of its underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $5.00 per share, for gross proceeds of $50,000,000, before deducting underwriting discounts, commissions and other offering expenses.

Key Points: 
  • Second Sight Medical Products, Inc. (NASDAQ: EYES) (Second Sight or the Company), a leading developer of implantable visual prosthetics that are intended to create an artificial form of useful vision for blind individuals, today announced the pricing of its underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $5.00 per share, for gross proceeds of $50,000,000, before deducting underwriting discounts, commissions and other offering expenses.
  • ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering.
  • The Company intends to use the net proceeds from the offering primarily for development of the Orion device and general corporate purposes.
  • About Second Sight Medical Products, Inc.
    Second Sight Medical Products, Inc. (Nasdaq: EYES) develops implantable visual prosthetics that are intended to deliver useful artificial vision to blind individuals.

FDA Approves First-of-its-Kind SenSight™ Directional Lead System for DBS Therapy

Retrieved on: 
Monday, June 7, 2021

DUBLIN, June 7, 2021 /PRNewswire/ -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the U.S. Food and Drug Administration (FDA) approval and first U.S. implants of the SenSight Directional Lead System used for Deep Brain Stimulation (DBS) therapy.

Key Points: 
  • DUBLIN, June 7, 2021 /PRNewswire/ -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the U.S. Food and Drug Administration (FDA) approval and first U.S. implants of the SenSight Directional Lead System used for Deep Brain Stimulation (DBS) therapy.
  • SenSight is the first-of-its-kind DBS directional lead that combines the benefits of directionality with the power of sensing, allowing physicians to deliver precise, patient-specific DBS therapy for the treatment of some symptoms associated with movement disorders like Parkinson's disease, dystonia and essential tremor, and medically refractory epilepsy.
  • For the SenSight directional lead system, Medtronic reimagined how a lead system could be designed, with the patient, neurosurgeon, and programming neurologist in mind.
  • When paired with the Percept PC device, SenSight expands on BrainSense technology, enabling clinicians to capture and record enhanced, directional LFP information from the implanted lead.