Anticonvulsant

NeuroPace to Present at 40th Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Donnerstag, Dezember 16, 2021

A live webcast of this event, as well as an archived recording, will be available on the Investors section of the companys website at: https://www.neuropace.com .

Key Points: 
  • A live webcast of this event, as well as an archived recording, will be available on the Investors section of the companys website at: https://www.neuropace.com .
  • The webcasts will be archived and available for replay for at least 90 days after the event.
  • Based in Mountain View, Calif., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy by reducing or eliminating the occurrence of debilitating seizures.
  • Its novel and differentiated RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source.

NeuroSigma Announces a $5 Million Equity Investment by KT Corporation

Retrieved on: 
Mittwoch, Dezember 8, 2021

LOS ANGELES, Dec. 08, 2021 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a bioelectronic medical device company, announced today that KT Corporation has made a $5 million equity investment in NeuroSigma.

Key Points: 
  • LOS ANGELES, Dec. 08, 2021 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a bioelectronic medical device company, announced today that KT Corporation has made a $5 million equity investment in NeuroSigma.
  • KT, an international digital telecommunications company based in Seoul, South Korea, has selected the digital healthcare sector as one of its next leading businesses.
  • The equity investment follows the announcement in June 2021 of a digital health partnership between NeuroSigma and KT.
  • This is another milestone in KT's continuous efforts to deliver essential products and services as it aspires to be DIGICO KT.

Neurona Therapeutics to Present New Preclinical Data and Clinical Trial Plans for Lead Neural Cell Therapy Program, NRTX-1001, at the Annual Meeting of the American Epilepsy Society

Retrieved on: 
Freitag, Dezember 3, 2021

SAN FRANCISCO, Dec. 03, 2021 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing restorative neural cell therapies to treat chronic neurological disorders, today announced that Catherine Priest, Ph.D., Neurona’s head of preclinical development, and David Blum, MD., Neurona’s head of clinical development, will present preclinical data that support the company’s recently cleared investigational new drug (IND) application and the initiation of the first-in-human Phase 1/2 clinical trial to evaluate lead asset, NRTX-1001, in people with drug-resistant mesial temporal lobe epilepsy (MTLE). The data are being presented at the Annual Meeting of the American Epilepsy Society (AES), which is being held December 3-7, 2021, in Chicago, IL.

Key Points: 
  • The data are being presented at the Annual Meeting of the American Epilepsy Society (AES), which is being held December 3-7, 2021, in Chicago, IL.
  • Furthermore, the data show that NRTX-1001 remains restricted to the targeted hippocampus without adverse effects, said Dr.
  • The NRTX-1001 preclinical data package is compelling, supporting clinical development of a novel cell therapy designed to provide targeted inhibition to hyperexcitable neural networks in the epileptic brain, said Dr. Blum.
  • Biodistribution studies with histological and qPCR-based analyses of central and peripheral tissues confirmed that NRTX-1001 cells were restricted to the hippocampus.

Neurelis Announces Partnership With Rick Harrison, Host Of TV's "Pawn Stars" And Epilepsy Advocate, To Raise Awareness Of Epilepsy And Need For More Education Regarding Seizure Emergencies

Retrieved on: 
Freitag, Dezember 3, 2021

SAN DIEGO, Dec. 3, 2021 /PRNewswire/ --Neurelis, Inc., announced today that it is partnering with epilepsy education advocate Rick Harrison, star of TV's "Pawn Stars," to raise awareness of epilepsy and the need for more education regarding seizure emergencies.

Key Points: 
  • SAN DIEGO, Dec. 3, 2021 /PRNewswire/ --Neurelis, Inc., announced today that it is partnering with epilepsy education advocate Rick Harrison, star of TV's "Pawn Stars," to raise awareness of epilepsy and the need for more education regarding seizure emergencies.
  • "There is a high unmet need in the epilepsy community for more education about epilepsy as well as seizure emergencies," said Craig C. Chambliss, President and Chief Executive Officer of Neurelis.
  • We're excited to partner with Rick on initiatives to educate the epilepsy community and general public about seizure emergencies and the importance of seizure action plans and learning seizure first aid."
  • I appreciate Neurelis giving me a platform to tell my story and to educate more people about epilepsy and seizure emergencies."

LivaNova to Present Scientific Data on VNS Therapy for Drug-Resistant Epilepsy at American Epilepsy Society 2021 Annual Meeting

Retrieved on: 
Donnerstag, Dezember 2, 2021

The Company will present seven scientific posters aimed at engaging clinical collaborators and deepening understanding of the LivaNova VNS Therapy System for the treatment of drug-resistant epilepsy.

Key Points: 
  • The Company will present seven scientific posters aimed at engaging clinical collaborators and deepening understanding of the LivaNova VNS Therapy System for the treatment of drug-resistant epilepsy.
  • LivaNova pioneered the VNS Therapy System, which sends mild pulses to the vagus nerve via an implantable device.
  • The seven scientific poster presentations feature the work of LivaNova employees and/or independent investigators using the Companys VNS Therapy System in their research.
  • These statements include, but are not limited to, statements regarding participation in upcoming events and VNS Therapy for drug-resistant epilepsy.

Eisai To Present Real-World Evidence And Convulsive Seizure Freedom Data Evaluating FYCOMPA® (perampanel) Across Patient Types At 75th American Epilepsy Society (AES) Annual Meeting

Retrieved on: 
Mittwoch, Dezember 1, 2021

These effects in FYCOMPA-treated patients led to dose reduction,interruption,anddiscontinuationmorefrequentlythanplacebo-treatedpatients.Homicidalideationand/orthreat have also been reported postmarketing in patients treated with FYCOMPA.

Key Points: 
  • These effects in FYCOMPA-treated patients led to dose reduction,interruption,anddiscontinuationmorefrequentlythanplacebo-treatedpatients.Homicidalideationand/orthreat have also been reported postmarketing in patients treated with FYCOMPA.
  • Patients should be monitored during treatmentandforatleastonemonthafterthelastdoseofFYCOMPA,andespeciallywhentakinghigherdosesandduring the initial few weeks of drug therapy (titration period) or at other times of dose increases.
  • Antiepileptic drugs (AEDs), including FYCOMPA, increase the risk of suicidal thoughts or behavior inpatients.
  • Anyone considering prescribing FYCOMPA or any other AED must balance the risk of suicidalthoughts or behavior with the risk of untreated illness.

CLS Again Releases TRANBERG® Sterile Disposable Products into the US Market

Retrieved on: 
Donnerstag, November 18, 2021

LUND, Sweden, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems AB (publ) (CLS), developer of high precision, image-guided focal laser ablation (FLA) systems, today announced the company is once again releasing its complete range of TRANBERG sterile disposable products into the US market via its subsidiary CLS Americas Inc.

Key Points: 
  • LUND, Sweden, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems AB (publ) (CLS), developer of high precision, image-guided focal laser ablation (FLA) systems, today announced the company is once again releasing its complete range of TRANBERG sterile disposable products into the US market via its subsidiary CLS Americas Inc.
    As a result of the intensive work of recent months to develop a new solution for sterilizing the company's disposable products, CLS is now releasing its complete range of TRANBERG sterile disposable products into the US market through its subsidiary CLS Americas Inc.
  • It is with great satisfaction that I can now state that we again have sterile disposable products on the market.
  • In a next step, we will also release the complete range of our sterile disposable products for the European market.
  • Release and resumption of deliveries of sterile disposable products in Europe will take place after final approval by CLS's notified body, TV Sd.

CLS Again Releases TRANBERG® Sterile Disposable Products into the US Market

Retrieved on: 
Donnerstag, November 18, 2021

IRVINE, Calif., Nov. 18, 2021 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems AB (publ) (CLS), developer of high precision, image-guided focal laser ablation (FLA) systems, today announced the company is once again releasing its complete range of TRANBERG sterile disposable products into the US market via its subsidiary CLS Americas Inc.

Key Points: 
  • IRVINE, Calif., Nov. 18, 2021 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems AB (publ) (CLS), developer of high precision, image-guided focal laser ablation (FLA) systems, today announced the company is once again releasing its complete range of TRANBERG sterile disposable products into the US market via its subsidiary CLS Americas Inc.
    As a result of the intensive work of recent months to develop a new solution for sterilizing the company's disposable products, CLS is now releasing its complete range of TRANBERG sterile disposable products into the US market through its subsidiary CLS Americas Inc.
  • It is with great satisfaction that I can now state that we again have sterile disposable products on the market.
  • In a next step, we will also release the complete range of our sterile disposable products for the European market.
  • Release and resumption of deliveries of sterile disposable products in Europe will take place after final approval by CLS's notified body, TV Sd.

NeuroPace Reports Third Quarter 2021 Financial Results

Retrieved on: 
Mittwoch, November 10, 2021

MOUNTAIN VIEW, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy, today reported financial results for the quarter ended September 30, 2021.

Key Points: 
  • MOUNTAIN VIEW, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy, today reported financial results for the quarter ended September 30, 2021.
  • Total revenue was $10.3 million in the third quarter of 2021, a 19% decrease from $12.8 million in the prior year period.
  • Gross margin for the third quarter of 2021 was 72.6% compared to 75.0% in the third quarter of 2020.
  • NeuroPace will host a conference call to discuss the third quarter 2021 financial results after market close on Wednesday, November 10, 2021, at 4:30 P.M. Eastern Time.

NeuroPace Receives IDE Approval to Initiate NAUTILUS Pivotal Study of its RNS System for Idiopathic Generalized Epilepsy

Retrieved on: 
Mittwoch, November 10, 2021

MOUNTAIN VIEW, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- NeuroPace, Inc., a medical technology company dedicated to transforming the lives of people suffering from epilepsy, today announced that it has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to study the company’s RNS® System in patients with drug-resistant idiopathic generalized epilepsy.

Key Points: 
  • The NAUTILUS pivotal study will be the first in the United States to evaluate use of brain-responsive neuromodulation for the treatment of IGE.
  • We are pleased with FDAs decision to grant IDE approval for the pivotal study, allowing us to evaluate the safety and effectiveness of the RNS System in patients who are living with drug-resistant, idiopathic generalized epilepsy, said Martha Morrell, MD, Chief Medical Officer of NeuroPace.
  • In March 2021, the company received Breakthrough Device Designation status from the FDA for the potential use of its RNS System to treat idiopathic generalized epilepsy.
  • The RNS System, a paradigm-shifting treatment for drug-resistant focal epilepsy, is the only brain-responsive neuromodulation system approved by the FDA.