Ischemia

Revive Therapeutics Announces Update for Type C Meeting to Discuss Amended Protocol Agreement of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Thursday, November 24, 2022

Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.

Key Points: 
  • Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.
  • The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
  • Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

Revive Therapeutics Announces FDA Recommendation for Type C Meeting to Discuss Amended Protocol Agreement of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Tuesday, November 22, 2022

The FDA has now requested additional information, which would include clinical data, for them to agree on the Studys revised endpoints.

Key Points: 
  • The FDA has now requested additional information, which would include clinical data, for them to agree on the Studys revised endpoints.
  • The Company plans to go over with the FDA the overall development plan for Bucillamine in COVID-19 and further review the Pre-Dose selection data that would support the appropriate endpoints.
  • Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

Diabetic Retinopathy Drug Pipeline Market Insights Report 2022 - Comprehensive Insights About 60+ Companies and 60+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Wednesday, November 16, 2022

This report provides comprehensive insights about 60+ companies and 60+ pipeline drugs in Diabetic Retinopathy pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 60+ companies and 60+ pipeline drugs in Diabetic Retinopathy pipeline landscape.
  • This segment of the Diabetic Retinopathy report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery.
  • The companies which have their Diabetic Retinopathy drug candidates in the mid to advanced stage, i.e.
  • Phase III include, Kodiak Sciences
    Diabetic Retinopathy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

HeartBeam Reports Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 10, 2022

HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform for heart attack detection anytime, anywhere, has reported its financial and operational results for the third quarter ended September 30, 2022.

Key Points: 
  • HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform for heart attack detection anytime, anywhere, has reported its financial and operational results for the third quarter ended September 30, 2022.
  • Research and development expenses for the third quarter of 2022 were $1.6 million, compared to $105,000 for the third quarter of 2021.
  • General and administrative expenses for the third quarter of 2022 were $2.0 million compared to $341,000 for the third quarter of 2021.
  • Net loss for the third quarter of 2022 was $3.6 million, compared to a net loss of $1.2 million for the third quarter of 2021.

Global Coronary Heart Disease Diagnostic Imaging Devices Market Report 2022 to 2028: Rising Number of Applications of Imaging Devices Along With Increasing R&D Investments are Encouraging Growth - ResearchAndMarkets.com

Retrieved on: 
Tuesday, November 8, 2022

The "Global Coronary Heart Disease Diagnostic Imaging Devices Market Size, Share & Industry Trends Analysis Report By Modality, By Regional Outlook and Forecast, 2022 - 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Coronary Heart Disease Diagnostic Imaging Devices Market Size, Share & Industry Trends Analysis Report By Modality, By Regional Outlook and Forecast, 2022 - 2028" report has been added to ResearchAndMarkets.com's offering.
  • The Global Coronary Heart Disease Diagnostic Imaging Devices Market size is expected to reach $2.1 billion by 2028, rising at a market growth of 6.7% CAGR during the forecast period.
  • Chest pain, heartburn, and soreness in the shoulder, arm, back, and neck are all symptoms of coronary artery disease.
  • Coronary heart disease diagnostic imaging devices are prohibitively expensive for low-budget healthcare organizations to purchase.

NYU Langone's Leading Cardiac Specialists Present Latest Research at the American Heart Association's Scientific Sessions 2022

Retrieved on: 
Monday, November 7, 2022

NEW YORK, Nov. 7, 2022 /PRNewswire/ -- Experts from NYU Langone Health presented their latest clinical findings and research discoveries at the American Heart Association's Scientific Sessions 2022, from Nov. 4 to Nov. 7, in Chicago.

Key Points: 
  • NEW YORK, Nov. 7, 2022 /PRNewswire/ -- Experts from NYU Langone Health presented their latest clinical findings and research discoveries at the American Heart Association's Scientific Sessions 2022, from Nov. 4 to Nov. 7, in Chicago.
  • Lead presentations covered cardiovascular outcomes data, women and heart disease, COVID-19 outcomes, and updated outcomes from the landmark ISCHEMIA trial.
  • At this year's meeting, NYU Langone's cardiac specialists presented more than 40 papers, posters, videos, symposia, courses, and special sessions.Notable research from this year's conference includes the following.
  • The initial ISCHEMIA trial randomized more than 5,000 patients across 38 countries with chronic coronary disease and moderate or severe ischemia.

Nicox Outlines Future Development and Partnering Plans for NCX 470 in Glaucoma

Retrieved on: 
Monday, November 7, 2022

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced future development and partnering plans for NCX 470, a novel nitric oxide (NO)-donating bimatoprost eye drop, currently in Phase 3 development for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Key Points: 
  • Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced future development and partnering plans for NCX 470, a novel nitric oxide (NO)-donating bimatoprost eye drop, currently in Phase 3 development for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • We look forward to continuing the collaboration with Nicox to bring NCX 470 to market, said Liu Ye, Chief Executive Officer of Ocumension Therapeutics.
  • To complement our strong Chinese partnership, and maximize the potential future value of NCX 470, we are actively exploring commercial partnerships for NCX 470 in both the United States and Japanese markets, said Gavin Spencer, EVP, Chief Business Officer of Nicox.
  • NCX 470 is currently in Phase 3 development for the lowering of intraocular pressure in patients with open-angle glaucoma or elevated intraocular pressure.

Ocelot Bio Presents Phase 1 Data Highlighting Activity and Safety of OCE-205 at AASLD The Liver Meeting®

Retrieved on: 
Friday, November 4, 2022

Across the dose range studied, OCE-205 serum levels (AUC and Cmax) were dose proportional.

Key Points: 
  • Across the dose range studied, OCE-205 serum levels (AUC and Cmax) were dose proportional.
  • The Phase 1 data presented at AASLD provide valuable information that will inform our clinical development strategy for OCE-205.
  • These data support further clinical development of OCE-205 as a potential treatment for conditions such as HRS-AKI and ascites.
  • Ocelot Bio is a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics designed to significantly improve outcomes for patients with liver disease.

Revive Therapeutics Announces Finalization of Amended Phase 3 COVID-19 Study Protocol to FDA

Retrieved on: 
Friday, October 14, 2022

Additional secondary endpoints may include the time to the polymerase chain reaction resolution, clinical outcome (death or hospitalization), disease severity, supplemental oxygen use, and progression of COVID-19.

Key Points: 
  • Additional secondary endpoints may include the time to the polymerase chain reaction resolution, clinical outcome (death or hospitalization), disease severity, supplemental oxygen use, and progression of COVID-19.
  • Should the FDA agree with the revised protocol, the Data Safety Monitoring Board (DSMB) will review the completed Post-Dose selection data of approximately 500 subjects in the context of the new primary endpoint.
  • Regardless of the outcome, the Company would proceed to seek a meeting with the FDA to agree on a proposed plan for potential regulatory approval.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

EQS-News: Mighty Mitochondria: This Company is Developing A Novel Drug for Kidney Disease By Targeting The Powerhouse Of Human Cells

Retrieved on: 
Wednesday, October 12, 2022

While kidney cells make up only 1% of our body weight, they consume over 10% of our daily energy supply.

Key Points: 
  • While kidney cells make up only 1% of our body weight, they consume over 10% of our daily energy supply.
  • When either acute or chronic disease strikes these vital organs, the health of the mitochondria can literally be the difference between life and death.
  • The company is now beginning its next milestone, filing to begin Phase 1 human trials of the drug.
  • Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases.