Ischemia

Us2.ai Partners with Leading Academic Medical Center to Collaborate on AI-Enabled Echocardiography Software

Retrieved on: 
Wednesday, September 13, 2023

In clinical practice, echocardiography is now firmly established as a central, affordable front-line tool for diagnosis and management of a range of cardiac conditions.

Key Points: 
  • In clinical practice, echocardiography is now firmly established as a central, affordable front-line tool for diagnosis and management of a range of cardiac conditions.
  • Even at the most well-resourced setting, the process of acquiring, measuring, and analyzing the images is time-consuming and labor-intensive, making the routine echocardiography application unsustainable.
  • Advances in deep learning have made automated analysis of medical images possible,” said Dr. Manesh Patel, Chief of Cardiology and Co-Director of the Heart Center at Duke University Health System.
  • This covers the vast majority of standard measurements for adult transthoracic echocardiography recommended by the American Society of Echocardiography, European Association of Cardiovascular Imaging, and British Society of Echocardiography.

Grant Awarded to Newcastle University to Research Athersys’ MultiStem® in Machine Perfusion Prior to Kidney Transplantation

Retrieved on: 
Wednesday, September 6, 2023

Machine perfusion refers to a technology used for limiting the damaging effects of removing and transporting kidneys prior to transplantation.

Key Points: 
  • Machine perfusion refers to a technology used for limiting the damaging effects of removing and transporting kidneys prior to transplantation.
  • It involves a machine that pumps fluid around the organ while it is outside the body, allowing for the potential therapeutic treatments to the kidney after donation.
  • Athersys and Newcastle University researchers previously demonstrated that administration of MAPC cells to donor human kidneys during machine perfusion resulted in healthier organs more suitable for transplantation.
  • “This planned study builds upon the foundation of several publications and early clinical work in solid organ transplant with collaborators.

LifeNet Health LifeSciences partners with CN Bio to set a new standard for cell quality and performance

Retrieved on: 
Wednesday, September 6, 2023

This partnership represents a joint effort to set a new standard for cell quality across the industry.

Key Points: 
  • This partnership represents a joint effort to set a new standard for cell quality across the industry.
  • Both LifeNet Health and CN Bio are global leaders, with a shared commitment to helping researchers bring safer, more effective therapies to patients sooner, with no unnecessary animal testing.
  • LifeNet Health cells have consistently demonstrated higher success rates in CN Bio studies, according to Tomasz Kostrzewski, PhD, the company's Chief Scientific Officer.
  • LifeNet Health LifeSciences offers the largest selection of comprehensively characterized liver cells and tissue in the industry, including healthy and diseased donor-matched samples.

Elucid Appoints Windi Hary to Lead Regulatory Affairs and Quality Management

Retrieved on: 
Wednesday, September 6, 2023

Elucid, Inc ., a leading medical technology company providing physicians with AI-powered imaging analysis software to assess cardiovascular disease, has hired Windi Hary as senior vice president (SVP) of regulatory affairs and quality management.

Key Points: 
  • Elucid, Inc ., a leading medical technology company providing physicians with AI-powered imaging analysis software to assess cardiovascular disease, has hired Windi Hary as senior vice president (SVP) of regulatory affairs and quality management.
  • View the full release here: https://www.businesswire.com/news/home/20230906762108/en/
    Elucid has hired Windi Hary as senior vice president (SVP) of regulatory affairs and quality management.
  • “It is my pleasure to welcome Windi Hary to the Elucid leadership team,” said Blake Richards, chief executive officer, Elucid.
  • “Not only does Windi bring a wealth of expertise, acumen, and experience in regulatory and quality management, but she is also a natural fit with Elucid’s culture.

ACTIMIS Post-hoc Results on Imaging Stroke Data Using Artificial Intelligence Reinforces Glenzocimab Mode of Action in Stroke Patients

Retrieved on: 
Thursday, August 31, 2023

To explore the mode of action of glenzocimab in the reduction of intracranial hemorrhage occurrence, a collaboration has been setup with Brainomix, a UK company specialized in the creation of AI-powered imaging biomarkers, to further analyze imaging stroke results from ACTIMIS study.

Key Points: 
  • To explore the mode of action of glenzocimab in the reduction of intracranial hemorrhage occurrence, a collaboration has been setup with Brainomix, a UK company specialized in the creation of AI-powered imaging biomarkers, to further analyze imaging stroke results from ACTIMIS study.
  • In a post-hoc analysis of the ACTIMIS study results, ischemic injury and hemorrhagic transformation volume measurements were quantified using AI-enabled Brainomix software.
  • Preliminary results seem to show that glenzocimab not only reduces the occurrence of intracranial hemorrhages, but also their volume, compared with placebo.
  • It has shown that glenzocimab reduced brain injury following thrombolysis in stroke, and identified subgroups of patients who appear to benefit most."

XyloCor Therapeutics Presents Phase 2 Data Highlighting Safety and Efficacy of XC001 at the European Society of Cardiology (ESC) Congress 2023

Retrieved on: 
Friday, August 25, 2023

The findings underscore its strong potential as a novel therapeutic approach for the treatment of this disabling condition.

Key Points: 
  • The findings underscore its strong potential as a novel therapeutic approach for the treatment of this disabling condition.
  • XC001 met all of its safety and exploratory objectives and showed potential transformative benefits for the patient population.
  • Among the notable topline results presented at the ESC Congress 2023 included:
    VEGF gene therapy with XC001 administered via minimally invasive transepicardial delivery was generally well tolerated.
  • “We are excited to share data that provides evidence for angiogenesis and a promising efficacy and tolerability profile for XC001.

Humacyte Presents Clinical Performance of Human Acellular Vessel™ (HAV™) From Ukrainian Humanitarian Program

Retrieved on: 
Tuesday, August 15, 2023

DURHAM, N.C., Aug. 15, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, presented yesterday at MHSRS the clinical results of a year-long humanitarian program in Ukraine. The Company’s investigational Human Acellular Vessel (HAV) was provided to five hospitals on the frontlines to treat traumatic vascular injuries beginning in June 2022.   

Key Points: 
  • The Company’s investigational Human Acellular Vessel (HAV) was provided to five hospitals on the frontlines to treat traumatic vascular injuries beginning in June 2022.
  • Humacyte’s humanitarian program was initiated in May 2022, when the company provided investigational HAVs to hospitals in Vinnytsia, Dnipro, Odessa, Kyiv, and Kharkiv, in response to Ukrainian surgeon requests.
  • Humacyte worked closely with the International Office of the U.S. Food and Drug Administration (FDA) and the Ukrainian Ministry of Health to obtain approval for the program.
  • Humacyte then subsequently trained Ukrainian surgeons by video conference on how to implant the HAV.

TheracosBio and SmithRx Collaborate to Offer Newly Approved Diabetes Drug Brenzavvy™ (bexagliflozin) to Members with Type 2 Diabetes

Retrieved on: 
Thursday, August 17, 2023

Working with TheracosBio and Cost Plus Drugs, SmithRx now provides BRENZAVVY as an option following its launch in July 2023.

Key Points: 
  • Working with TheracosBio and Cost Plus Drugs, SmithRx now provides BRENZAVVY as an option following its launch in July 2023.
  • BRENZAVVY is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
  • Diabetes is the most expensive chronic condition in the U.S. and accounts for 1 of every 4 dollars spent on healthcare.
  • In patients with type 1 diabetes mellitus, BRENZAVVY significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond background rate.

HeartBeam Announces Publication of Foundational Study on the Detection of Heart Attacks

Retrieved on: 
Wednesday, August 9, 2023

It demonstrated that HeartBeam’s VECG technology detects the presence of a coronary occlusion, the cause of heart attacks, with the same accuracy as a standard 12 lead electrocardiogram (12L ECG).

Key Points: 
  • It demonstrated that HeartBeam’s VECG technology detects the presence of a coronary occlusion, the cause of heart attacks, with the same accuracy as a standard 12 lead electrocardiogram (12L ECG).
  • Readings were taken before and after a 90 second balloon inflation that occluded the artery, a surrogate for a heart attack.
  • “This is the first peer-reviewed publication based on our novel VECG technology,” Branislav Vajdic, Ph.D., CEO and Founder of HeartBeam.
  • “It demonstrates the potential for an easy-to-use, patient-held device to be employed in the detection of heart attacks at home.

Humacyte Completes Enrollment in Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) for Vascular Trauma Repair

Retrieved on: 
Wednesday, July 26, 2023

DURHAM, N.C., July 26, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced completion of enrollment of its Phase 2/3 vascular trauma trial (V005) that is expected to support a BLA filing for Humacyte’s HAV in vascular trauma repair. The HAV, an innovative regenerative medicine product candidate, is designed to provide surgeons with an off-the-shelf bioengineered human artery that has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries. The HAV has the potential to assist healthcare professionals in saving life and limb in some of the most difficult circumstances. The results from the Phase 2/3 vascular trauma trial are intended to support a BLA filing with the Food and Drug Administration (FDA), planned for the fourth quarter 2023.

Key Points: 
  • The results from the Phase 2/3 vascular trauma trial are intended to support a BLA filing with the Food and Drug Administration (FDA), planned for the fourth quarter 2023.
  • The V005 trial is a single-arm, open-label, pivotal study of patients suffering from vascular trauma injuries, conducted at Level 1 Trauma Centers in the U.S. and Israel.
  • Humacyte, the clinical trial sites, and contracted service providers are preparing for locking of the trial database in order to report the V005 results.
  • “The completion of the target enrollment in Humacyte’s Phase 2/3 vascular trauma trial is expected to enable BLA submission, and is another important landmark moment for our groundbreaking science.