National Institutes of Health Archives - Medical Design Sourcing

Pulmonary embolism startup Flow Medical raises $2M in friends-and-family round

Flow Medical co-founders (from left) Dr. Jonathan Paul, Jennifer Fried and Dr. Osman Ahmed [Photo courtesy of Flow Medical]Flow Medical announced today that it has raised $2 million in a friends-and-family funding round.

Chicago-based Flow Medical is developing a new thrombolysis catheter for treating acute pulmonary embolism (PE). The startup said it will use the funding for R&D and regulatory activities.

Flow Medical is led by co-founder and CEO Jennifer Fried, the co-founder and former CEO of Explorer Surgical. Her co-founders are venous thromboembolism physicians Dr. Jonathan Paul and Dr. Osman Ahmed at The University of Chicago Medical Center.

“This investment not only validates the potential of this groundbreaking technology but also propels us towards our goal of revolutionizing the treatment landscape for PE,” Fried said in a news release. “We are grateful for the confidence our friends and family investors have placed in our t…

Researchers develop wearable monitor that measures ECG and SCG signals simultaneously

A researcher examines the health monitor part of the wearable device under a microscope in Yan’s lab. [Image courtesy of Pate McCuien/University of Missouri]

Researchers at the University of Missouri received a $2.6 million grant from the NIH to develop a multifunctional, wearable heart monitor.

Funding helps the researchers create a breathable material with antibacterial and antiviral properties. This supports their ongoing development of the heart monitor.

According to a post on the university’s website, they designed the device to continuously track human heart health. It does so by monitoring dual signals simultaneously. Its electrocardiogram (ECG) function measures the heart’s electrical signal while a seismocardiogram (SCG) measures vibrations. After the recording on an electronic device, users can share their information with their healthcare provider to identify potential warnin…

New method of cardiac ablation used in first in-human trial for ventricular tachycardia

Thermedical’s Durablate catheter [Photo courtesy of Thermedical]

A new cardiac ablation technique for patients with ventricular tachycardia (VT) has been used in its first in-human multicenter trial involving Mayo Clinic.

The new process — needle ablation using in-catheter, heated, saline-enhanced, radio frequency (SERF) energy — creates lesion scars inside the heart muscle where life-threatening arrhythmias cause VT, Mayo Clinic said. Injecting heated saline at the same time as the RF energy is applied increases heat transfer compared to conventional methods of ablation, which means the ablation can treat tissue deeper in the heart wall than the surface.

Caused by irregular electrical signals in the lower chambers of the heart, VT can trigger heartbeats so rapid that the heart’s chambers don’t fill with blood properly. VT can also stop the heart entirely. Implantable cardioverter-defib…

NIH research backs efficacy of AREDS2 formula in macular degeneration

The National Institutes of Health (NIH) has released a new report analyzing a decade of data related to AREDS2, a vitamin and mineral supplement with lutein, vitamin C, zeaxanthin, zinc and vitamin E.

AREDS2, whose name refers to the second formulation of a supplement used in Age-Related Eye Disease Studies, can slow the progression of age-related macular degeneration.

The AREDS2 formulation replaces the beta-carotene in the original formulation with the carotenoids lutein and zeaxanthin.

NIH decided to move away from beta-carotene after observing an increased risk of lung cancer in smokers in earlier NIH-backed research. “Our goal with AREDS2 was to create an equally effective supplement formula that could be used by anyone, whether or not they smoke,” said Dr. Emily Chew, director of the Division of Epidemiology and Clinical Application at the National Eye Institute (NEI). “This 10-year data confirms that not only is the new formula safer, it’s actuall…

An Amazon cloud conversation with AWS Chief Medical Officer Taha Kass-Hout

Taha Kass-Hout is the chief medical officer and director of machine learning at Amazon Web Services [Photo courtesy of Amazon]

It doesn’t get any bigger than Amazon in the world of cloud computing.

The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google.

Taha Kass-Hout, the chief medical officer and director of machine learning at AWS, spoke with Medical Design & Outsourcing as part of an ongoing series of conversations about cloud computing’s contributions to medtech and the potential ahead.

“The future is bright for anyone who’s trying to solve problems in healthcare and life science globally,” he said.

This conversation has been edited for clarity and length.

MDO: What d…

NIH announces funding for new tuberculosis research centers

The National Institute of Allergy and Infectious Diseases (NIAID) this week announced four new grants to establish tuberculosis research centers in the U.S.

The NIAID, which is part of the National Institutes of Health (NIH), issued four new grant awards to establish Tuberculosis Research Advancement Centers (TRAC) to support the development of the next generation of researchers. The centers will provide focused mentoring and funding support for new investigators, opportunities for multidisciplinary and collaborative research and training in laboratory and clinical settings.

Total funding in the first year of the five-year grants is approximately $4.3 million, according to the NIH.

Awards were made to four research institutions, including: Texas Biomedical Research Institute in San Antonio, Texas; Johns Hopkins University in Baltimore; Emory University in Atlanta and the University of Washington School of Medicine in Seattle.

Senator Markey pushes U.S. to develop universal COVID-19 vaccine

Image from www.edmarkey.com

Senator Edward J. Markey (D-Mass.) has sent a letter to the National Institute of Allergy and Infectious Disease (NIAID) asking for a status update regarding ongoing research to develop a universal COVID-19 vaccine.

NIAID had awarded $36.3 million to academic institutions to conduct research that will help develop a coronavirus vaccine that protects against multiple types of coronaviruses.

Coronavirus outbreaks have resulted in three outbreaks in the past two decades. First, there was severe acute respiratory syndrome (SARS) from 2002 to 2004. Then, Middle East respiratory syndrome (MERS) appeared in 2012 and SARS-CoV-2 seven years later.

“Had a universal coronavirus vaccine existed at the onset of the pandemic, hundreds of thousands of American lives could have been saved,” wrote Senator Markey in a press release. “And we remain at risk of variants that have the pot…

NIH to study third dose of COVID-19 vaccine in people with autoimmune disease

The National Institutes of Health (NIH) has launched a study to gauge the antibody response of a third dose of mRNA COVID-19 vaccine in patients with autoimmune disease. Participants in the study had an insufficient immune response to the primary series of vaccination.

The Phase 2 study will also test the impact of pausing immunosuppressive medication to determine if it improves the antibody response.

The study, titled “COVID‐19 booster vaccine in autoimmune disease non‐responders,” will test an additional dose of vaccines from both Pfizer-BioNTech and Moderna.

The National Institute of Allergy and Infectious Diseases (NIAID), an NIH division, is sponsoring the study.

The study will first focus on people with one of the following autoimmune diseases: multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus or systemic sclerosis.

On Aug. 12, FDA authorized an additional dose of Pfizer-BioNTech and Moderna COVID-19 va…

U.S. buys 200 million more Moderna vaccine doses for potential boosters and use in children

Health experts remain divided over the need for COVID-19 vaccine boosters in the coming months, but the U.S. government is preparing for that possibility by purchasing 200 million additional doses of the COVID-19 vaccine from Moderna (NSDQ:MRNA).

The purchase of additional doses will also enable the U.S. government to inoculate children aged 12 to 17 in coming months, assuming FDA authorizes that use. Two doses of the vaccine were 100% effective in that age group, according to a recent Phase 2/3 trial.

In May, FDA amended its EUA for the Pfizer-BioNTech vaccine to include adolescents aged 12 to 15.

The U.S. has committed to buying 500 million doses of Moderna’s vaccine to date. The company expects to deliver 110 million doses in the fourth quarter of 2021 and another 90 million in the first quarter of 2022.

To date, Moderna has provided 217 million doses to the U.S.

The NIH has launched a clinical trial involving fully vaccinated participan…

Adamis Pharmaceuticals’ Tempol shows promise against SARS-CoV-2 in preclinical research

The investigational drug Tempol from Adamis Pharmaceuticals Corp. (NSDQ:ADMP) could be a potent oral antiviral treatment for COVID-19 based on cell culture research, according to scientists at the National Institutes of Health (NIH).

The positive research news caused Adamis Pharmaceuticals’ stock to jump 61% from $0.69 to $1.13 today. The quick jump in its stock valuation triggered a trading halt.

Tempol belongs to a growing class of anti-COVID-19 drugs that aim to stop viral replication.

Pfizer (NYSE:PFE) is also developing a similar potential COVID-19 treatment known as PF-07321332 that is a protease inhibitor. That investigational drug binds to a viral enzyme known as protease to stop viral replication.

Remdesivir, the subcutaneous injectable drug from Gilead Sciences (NSDQ:GILD) that won FDA approval on October 22, 2020, binds to the RNA polymerase and protease of SARS-CoV-2.

Tempol relies on a different mode of action. The drug in…

What are the top COVID-19 vaccine candidates?

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

As of yesterday, five COVID-19 vaccine candidates had begun Phase III clinical trials as they seek to determine the safety and efficacy of their formulas.

Researchers worldwide are testing 132 COVID-19 vaccine candidates, including 42 that are in clinical trials on humans and at least 92 in preclinical or animal trials, according to the New York Times.

With the U.S. alone topping 200,000 COVID-19 deaths this week and continued pressure to deliver a safe and effective vaccine, these companies and several others are working very quickly to make a vaccine that meets regulatory standards. Seven pharma companies have received funding for vaccine development and…

Moderna launches Phase 3 study of its COVID-19 vaccine candidate

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) announced today that it began dosing participants in the Phase 3 clinical study of its mRNA-1273 COVID-19 vaccine candidate.

Cambridge, Mass.-based Moderna’s COVE (coronavirus efficacy) study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Dept. of Health and Human Services.

The company had previously announced on June 11 that it expected to begin the Phase 3 trial at some point this month. At that point, it had already fully enrolled the first cohort of healthy adults between ages 18-53 in the Phase 2 study, 13 days after the first participant was dosed, having prev…