MDD

Neuronetics Launches Innovations To NeuroStar® Advanced Therapy’s Proprietary TrakStar® Platform

Retrieved on: 
Monday, September 26, 2022

Continuing Neuronetics commitment to innovation, this release represents the third TrakStar upgrade in 2022.

Key Points: 
  • Continuing Neuronetics commitment to innovation, this release represents the third TrakStar upgrade in 2022.
  • We continue to innovate our TrakStar platform to be a smarter, better tool, stated Keith J. Sullivan, President, and CEO of Neuronetics Inc.
  • The latest updates can streamline the patient journey by bridging our proprietary PHQ-10 platform with our HIPAA-compliant TrakStar patient data management system making it easier to identify new patients and those needing re-treatment.
  • As a global leader in neuroscience, Neuronetics is redefining patient and physician expectations with its NeuroStar Advanced Therapy for Mental Health.

EQS-News: PRECISIS GmbH: EASEE – ­­­World's first minimally invasive brain pacemaker for the treatment of epilepsy receives CE-certification and is available immediately

Retrieved on: 
Friday, September 23, 2022

Heidelberg, 23.09.2022 after seven years of development work, Precisis GmbH, headquartered in Heidelberg, has received the CE certification for its minimally invasive brain pacemaker EASEE.

Key Points: 
  • Heidelberg, 23.09.2022 after seven years of development work, Precisis GmbH, headquartered in Heidelberg, has received the CE certification for its minimally invasive brain pacemaker EASEE.
  • These drug-refractory patients wait an average of 22 years before they are offered further technical or surgical treatment options.
  • With this new, risk-minimized EASEE method, the treatment spectrum is expanded in the early phases of the disease."
  • EASEE is an acronym for Epicranial Application of Stimulation Electrodes for Epilepsy.

Alzamend Neuro Has Regained Compliance with Nasdaq's Minimum Bid Price Requirement

Retrieved on: 
Thursday, September 22, 2022

As previously announced, on June 22, 2022, Alzamend received a notification letter from Nasdaq stating that the Company was not in compliance with the Minimum Bid Price Requirement because the bid price for the Companys common stock had closed below $1.00 per share for the previous 30 consecutive business days.

Key Points: 
  • As previously announced, on June 22, 2022, Alzamend received a notification letter from Nasdaq stating that the Company was not in compliance with the Minimum Bid Price Requirement because the bid price for the Companys common stock had closed below $1.00 per share for the previous 30 consecutive business days.
  • To regain compliance with the Minimum Bid Price Requirement, the Company was required to maintain a minimum closing bid price of the Company's common stock of at least $1.00 for a minimum of ten consecutive business days.
  • The Compliance Notice confirmed that the closing bid price of the Company's common stock has been at $1.00 per share or greater for 10 consecutive business days from September 7 through September 20, 2022, the Company has regained compliance with the Minimum Bid Price Requirement.
  • Alzamend is an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimers, bipolar disorder, MDD and PTSD.

Small Pharma Completes Enrollment in Phase IIa DMT-Assisted Psychotherapy Clinical Trial in Patients With Major Depressive Disorder

Retrieved on: 
Monday, September 19, 2022

In addition, all participants are rolled into a second phase of the study where they receive a dose of SPL026 with psychotherapy.

Key Points: 
  • In addition, all participants are rolled into a second phase of the study where they receive a dose of SPL026 with psychotherapy.
  • Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma, said: The enrollment completion of our Phase IIa trial is an exciting milestone in the development of SPL026.
  • Following encouraging results from our Phase I trial on the safety and tolerability profile of SPL026, the main focus for Phase IIa is exploring treatment efficacy in MDD patients.
  • Small Pharma initiated a clinical program into DMT assisted psychotherapy in February 2021.

BVI Announces Certification for its Intraocular Lens Portfolio under the European Medical Device Regulation

Retrieved on: 
Thursday, September 15, 2022

WALTHAM, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- BVI, a diversified global ophthalmic device company, today announced certification for its intraocular lens (IOL) portfolio under the European Medical Device Regulation (MDR, (EU) 2017/745) from its Notified Body, the British Standards Institution (BSI).

Key Points: 
  • WALTHAM, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- BVI, a diversified global ophthalmic device company, today announced certification for its intraocular lens (IOL) portfolio under the European Medical Device Regulation (MDR, (EU) 2017/745) from its Notified Body, the British Standards Institution (BSI).
  • The new regulatory criteria came into effect in May 2021, replacing the prior Medical Device Directive (MDD).
  • The MDR, representing the most significant change to European regulatory framework in decades, ensures a consistently high level of health and safety for medical devices.
  • Achieving and maintaining MDR certification is a major effort that requires a tremendous amount of investment, capabilities, and hard work, said Shervin Korangy, BVI President and CEO.

Mindset Pharma Receives Scientific Advice from UK Regulator Facilitating Advancement of Phase 1 First-In-Human Clinical Trial Plan for Its Lead Clinical Candidate, MSP-1014

Retrieved on: 
Wednesday, September 14, 2022

The MHRA has agreed with the Companys position and confirmed that, subject to CTA review, MSP-1014 will not require additional preclinical studies at this time.

Key Points: 
  • The MHRA has agreed with the Companys position and confirmed that, subject to CTA review, MSP-1014 will not require additional preclinical studies at this time.
  • The MHRA has also provided specific valuable guidance on potential clinical trial design regarding dosing, patient selection criteria, and safety endpoints.
  • Given its differentiation and improved pharmacological profile, Mindset prioritized moving MSP-1014 to first-in-human clinical studies.
  • We are thrilled to have received this favorable written guidance from the MHRA, confirming the readiness of MSP-1014 for Phase 1 first-in-human clinical development.

Click Therapeutics Announces Participation in Upcoming Investor Conferences

Retrieved on: 
Wednesday, September 14, 2022

Click Therapeutics, Inc. (Click), a leader in Digital Therapeutics as prescription medical treatments, today announced that Randall Stanicky, Chief Financial Officer, will present at the following virtual investor conferences in September.

Key Points: 
  • Click Therapeutics, Inc. (Click), a leader in Digital Therapeutics as prescription medical treatments, today announced that Randall Stanicky, Chief Financial Officer, will present at the following virtual investor conferences in September.
  • Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for patients with unmet medical needs.
  • Through cognitive and neurobehavioral mechanisms, Clicks Digital Therapeutics enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments.
  • Click is progressing a broad pipeline of Digital Therapeutics across a variety of high-burden therapeutic areas, including MDD, Schizophrenia, Migraine, Chronic Pain, Atopic Dermatitis, Acute Coronary Syndrome (ACS), Obesity and more.

Bipolar Disorder Therapeutics Global Market Report 2022: Increase in the Prevalence of Bipolar Disorder to Drive Growth - ResearchAndMarkets.com

Retrieved on: 
Tuesday, September 13, 2022

The regions covered in the bipolar disorder therapeutics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

Key Points: 
  • The regions covered in the bipolar disorder therapeutics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
  • The increase in the prevalence of bipolar disorder is expected to propel the growth of the bipolar disorder therapeutics market going forward.
  • As a result, an increase in the prevalence of bipolar disorder increases the demand for the bipolar disorder therapeutics market.
  • Therefore, the increase in the prevalence of bipolar disorder is driving the growth of the bipolar disorder therapeutics market.

ABVC Biopharma Announces Letter to Shareholders

Retrieved on: 
Tuesday, September 13, 2022

FREMONT, CA, Sept. 13, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- ABVC BioPharma, Inc. (Nasdaq: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced a letter to shareholders.

Key Points: 
  • FREMONT, CA, Sept. 13, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- ABVC BioPharma, Inc. (Nasdaq: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced a letter to shareholders.
  • When Dr. Jiang created what is now ABVC BioPharma in 2016, he had a vision to deliver promising botanical medicines developed in the Asia Pacific region to patients in the West.
  • Each of these partnerships has been essential in spurring the growth of the ABVC pipeline.
  • Please accept my thanks and the gratitude of our entire executive team for your support and confidence in ABVC.

Neuronetics, Inc. Announces Grand Opening of NeuroStar® University with Ribbon-Cutting Ceremony

Retrieved on: 
Tuesday, September 13, 2022

The curriculum offered at NeuroStar University has three components: Learn, Connect, and Grow.

Key Points: 
  • The curriculum offered at NeuroStar University has three components: Learn, Connect, and Grow.
  • Currently, NeuroStar University is offering two-day classes at no charge to existing NeuroStar practices.For more information about NeuroStar, please visit neurostar.com .
  • As a global leader in neuroscience, Neuronetics is redefining patient and physician expectations with its NeuroStar Advanced Therapy for Mental Health.
  • NeuroStar Advanced Therapy is the leading transcranial magnetic stimulation (TMS) treatment for MDD in adults with over 4.8 million treatments delivered.