Inhalation of the Unique Nasal Saline Reduced Exhalation of Bioaerosol by 99% in a Human Volunteer Study for up to Six Hours
Testing to Begin in High Risk Covid-19 Environments
CAMBRIDGE, Massachusetts, July 7, 2020 /PRNewswire/ -- Today, Sensory Cloud, a technology startup that designs solutions to problems of human well-being and healthcare through pioneering discoveries at the frontiers of olfaction and respiratory biology, announced the publication of a new peer-reviewed paper in QRB Discovery, an interdisciplinary medical journal of biological function, structure and mechanism. The paper establishes the foundation for understanding the hygienic properties of unique combinations of physiological salts, and particularly the ability of these salts to substantially mitigate expiration of the very small particles humans exhale during natural breathing and that are not captured by conventional masks.
"Airborne infectious disease transmits through the air by particles we exhale during natural breathing," said the lead author, Dr. David Edwards of Harvard University and Founder of Sensory Cloud. "Most of these particles are less than a single micron in size, and not effectively filtered by conventional face masks. Cleaning our airways of these particles is a hygienic measure that complements the wearing of face masks, the washing of hands, and social distancing, and can be of particular value in our current COVID-19 pandemic."
In "A New Natural Defense Against Airborne Pathogens," the authors, including Edwards and Dr. Robert Langer (MIT), and several authors from Pulmatrix and Sensory Cloud, Boston-based healthcare companies co-founded by Edwards, conducted a study of 10 human volunteers to determine the efficacy of a nasal delivery of calcium and sodium salts, each present in sea water, to diminish exhaled particles of 300 nanometers to 5 microns in diameter from human airways. Based on previous research pointing to the roles of age and other factors in the spread of airborne pathogens, the researchers selected five volunteers older than 65, and five younger than 65.
The researchers set out to determine whether nasal delivery of the calcium and sodium salts in a formulation called FEND (Fast Emergency Nasal Defense) by Sensory Cloud's Nimbus, could substantially suppress exhalation of bioaerosols without targeting the entire lungs. The authors found a strong correlation between high numbers of exhaled particles and age, with the group older than 65 exhaling on average 6,641 particles per liter of air, while the group younger than 65 exhaled on average 440 particles per liter. Delivery of FEND by nasal inspiration of the Nimbus cloud reduced exhalation of bioaerosol by 99% for the entire group, for up to 6 hours. Most of the suppressed airborne particles were smaller in size than those effectively filtered by conventional face masks.
Summarizing research conducted over the last 15 years at Pulmatrix, with animal and human studies performed at labs in the UK, US and Canada, the authors document how an aerosol comprised of unique combinations of calcium and sodium salts improves the barrier function of the mucus lining to protect against infection and promotes natural innate immune disinfectant properties suited to defense against a range of bacterial and viral infections, including Influenza A, Influenza B and parainfluenza strains.
The paper also documented, in the case of an influenza swine model, the complete blockage of airborne transmission of the disease through the administration of the saline compound.
For immediate human use as a new purely hygienic intervention, the authors proposed the Nimbus, a hand-held nasal mister developed by Edwards' company Sensory Cloud, given its ability to generate FEND aerosols of approximately 10 microns in diameter, ideally suited for distribution of the FEND composition to the upper airways where bioaerosol is largely generated.
"With today's healthcare crisis we believe a nasal cleanser to be the best and fastest approach as a defensive measure against the rapid spread of COVID-19," the authors wrote in QRB Discovery. "Beyond diminishing viral bioaerosol expulsion into the environment, these particular combinations of calcium and sodium salts delivered to the nose are likely to decrease the same bioaerosols from reaching the lungs via inhaled air, the only route for virus to reach this organ."
Dr. Edwards further explained that the human results suggest that a purely hygienic FEND nasal saline solution, based on salts that have been administered to the nose for centuries while with uniquely high calcium content, can be introduced immediately as a nasal cleansing agent for clearing exhaled air of the very small particles that conventional face masks fail to filter.
"We are very encouraged by these findings and the prospect of providing an additional level of safety for healthcare workers and everyone heading back to work and to school," Dr. Edwards said. "The ease and safety with which FEND can be administered nasally, as demonstrated by the results of our articles, suggests a practical pathway to significantly clean airborne infection from interior air environments where airborne pathogens can accumulate. FEND can be an effective complement to the proper use of face masks, suppressing from the air the airborne particles that conventional face masks do not filter."
About Sensory Cloud Sensory Cloud is a Boston-based technology startup company that designs solutions to problems of human wellbeing and healthcare through pioneering discoveries at the frontiers of olfaction and respiratory biology. Sensory Cloud is developing a proprietary line of consumer products based on its proprietary olfaction and calcium-salt platforms for human health and wellbeing. The Company will launch FEND in the fall 2020 for use as a new hygienic protection against COVID-19 and other airborne infectious diseases, like influenza.
About PulmatrixPulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline is initially focused on advancing treatments for serious lung diseases, including Pulmazole, an inhaled anti-fungal for patients with allergic bronchopulmonary aspergillosis ("ABPA"), and PUR1800, a narrow spectrum kinase inhibitor in lung cancer. Pulmatrix's product candidates are based on iSPERSE™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
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