Industry Watch

 Published: March 9, 2021

By: Debbie Bunch



Pulse Oximeter Equals ABGs for People with Dark-Pigmented Skin

The CIRCUL Ring pulse oximeter from BodiMetrics has been validated for efficacy and reliability in people with dark-pigmented skin. The study was conducted in China and compared measurements taken by the CIRCUL Ringwith those taken by an arterial blood gas (ABG) test. Four of the 12 participants in the study were black. Results showed an excellent correlation with ABG testing for the 100 CIRCUL Ring measurements taken among the black participants. The mean difference between the two tests was only 1.06%. The company believes these findings can help address concerns found in previous studies that current pulse oximeters provide less accurate measurements for black patients than white patients. The CIRCUL Ringis under FDA review for Emergency Use Authorization. READ MORE 

Two Dose Epinephrine Nasal Spray Found Effective

According to Bryn Pharma, LLC, its two-dose epinephrine nasal spray, BRYN-NDS1C, was found to be as effective as a single dose 0.3 mg epinephrine auto-injector in treating anaphylaxis in a recent studyNo adverse effects were seen in either of the treatments. Bryn Pharma CEO David Dworaczyk, PhD, notes that up to 30% of people experiencing an anaphylactic event will require a second dose of epinephrine and believes his companys bi-dose nasal spray device meets this critical need. These clinical results show that a single spray from our bi-dose nasal spray device delivered epinephrine at levels equaling or exceeding those administered with a single 0.3 mg epinephrine auto-injector, potentially allowing patients to replace two auto-injectors with a single nasal device, he said. The research was presented at the 2021 American Academy of Allergy, Asthma and Immunology annual meeting. READ MORE 

Together COVID-19 Trial to Test Existing Drugs Against the Virus

The Together COVID-19 trial, funded in part by the Bill and Melinda Gates Foundation and Fastgrants, a collaboration of technology philanthropists, has been launched to evaluate the effectiveness of three inexpensive and existing drugs against COVID-19. The study, which investigators from McMaster University in Canada are heading up, will test invermectin, metformin, and fluvoxamine on preventing disease progression in Brazil and South Africa. Up to 3,200 people will be enrolled, and the researchers believe they could have results in as little as three to six months. The trial is especially significant for low and middle-income countries where vaccine rollout may not be as robust as in higher-income countries. The need for treatments in early disease is paramount. Evidence is quickly emerging that suggests several drugs may have a promising effect on reducing COVID-19 disease severity in patients with mild to moderate disease, said lead investigator Edward MillsOur study has been designed to rapidly recruit patients to evaluate these potential therapeutics. READ MORE 

Bronchial Rheoplasty Study Gets Underway

The FDA has issued conditional Investigational Device Exemption approval to Gala Therapeutics, Inc. for the initiation of a clinical trial on its RheOx Bronchial Rheoplasty System for chronic bronchitis. Dubbed RheSolve, the study will randomize 270 COPD patients with moderate to severe chronic bronchitis in a 2:1 ratio at up to 40 U.S. and 10 international centers. The trial will assess the safety and efficacy of the RheOx System, which is performed using a minimally invasive bronchoscopic procedure called bronchial rheoplasty, to treat the symptoms of chronic bronchitis. The primary endpoint will be the change in COPD Assessment Test score from baseline to six months post-procedure. READ MORE 

Regeneron Antibody Cocktail Tackles Cat-Allergic Asthma

The investigational antibody cocktail REGN1908-1909 from Regeneron Pharmaceuticals, Inc. has shown promise in reducing symptoms in asthmatics with cat allergies. The proof-of-concept study met the primary endpoint of preventing early asthma reactionsdefined as a 20% or greater decline in FEV1, and met key secondary endpoints, which included improving lung function and increasing the amount of cat allergen patients could tolerate. These encouraging trial results showed that a single dose of REGN1908-1909 prevented early asthma reactions in cat-allergic patients with mild asthma rapidly and durably  as early as one week after treatment and up to three months, said principal investigator Frederic J. de Blay, MDfrom Strasbourg University. The study was presented at the 2021 American Academy of Allergy, Asthma and Immunology annual meeting. READ MORE 

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Debbie Bunch

Debbie Bunch is an AARC contributor who writes feature articles, news stories, and other content for Newsroom, the AARC website, and associated emailed newsletters. In her spare time, she enjoys reading, traveling, photography, and spending time with her children and grandchildren. Connect with Debbie by email or on AARConnect or LinkedIn.

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