The Evolving Symptoms and Variants

Since the first reported cases in December 2019, SARS-CoV-2 has infected millions of people worldwide, causing varying symptoms and outcomes. The symptoms of COVID-19 have evolved as new viral variants emerged, leading to changes in the clinical presentation and severity. Survivors of COVID-19 often report persistent symptoms that continue to affect their quality of life even after the acute illness phase. Notably, the prevalence and nature of these long-term symptoms have been found to differ across SARS-CoV-2 variants.

Study Design and Methodology

The prospective longitudinal cohort study analyzed data from UK-based adults, aged 18-100 years, who regularly reported their health status through the Covid Symptom Study smartphone app. The study included participants who tested positive for SARS-CoV-2 after being physically normal for at least 30 days. The researchers focused on individuals who developed symptoms lasting longer than 28 days from the initial positive test, defining this as long COVID. Additionally, they examined post-COVID-19 condition, which involved symptoms persisting for at least 84 days after the initial positive test. By employing unsupervised clustering analysis of time-series data, the researchers aimed to identify distinct symptom profiles for vaccinated and unvaccinated individuals across various SARS-CoV-2 variants.

Findings and Implications

The study included a total of 9,804 individuals with long COVID, of whom 15% developed a post-COVID-19 condition. The researchers identified different symptom profiles within and across variants. The wild-type variant (in unvaccinated people) showed four distinct endotypes. Alpha variant (in unvaccinated people) showed seven endotypes, while the vaccinated delta variant group exhibited five endotypes. Across all variants, researchers identified three main clusters of symptoms: cardiorespiratory, central neurological, and multi-organ systemic inflammatory. Gastrointestinal symptoms showed a less diverse clustering pattern across viral variants.

The findings shed light on the heterogeneous nature of post-COVID-19 condition, characterized by varying combinations of symptoms, durations, and functional outcomes.

This classification holds immense potential in enhancing our understanding of the different mechanisms underlying post-COVID-19 conditions, as well as identifying subgroups of individuals at risk of prolonged debilitation. Such insights are invaluable for tailoring personalized care and developing targeted interventions for affected individuals.

Conclusion

The rapid evolution and spread of SARS-CoV-2 have necessitated extensive research to comprehend its impact on human health. This study’s innovative approach, analyzing self-reported symptoms and leveraging clustering analysis, has contributed significantly to unraveling the diverse profiles of post-COVID-19 condition based on viral variants and vaccination status. By understanding the distinct characteristics of this condition, healthcare professionals can provide tailored care to individuals experiencing prolonged symptoms, thereby enhancing their well-being and recovery.

Funding for this study was provided by various organizations, including the UK Government Department of Health and Social Care, Wellcome Trust, and National Institute for Health Research, among others.

FAIRFAX, Va.–(BUSINESS WIRE)–Vibrent Health, a leading software-as-a-service company in the field of precision health research, announced today the publication of a methods paper in JMIR Formative Research (JFR). The prospective cohort study is titled A Digital Health Initiative (COVIDsmart) for Remote Data Collection and Study of COVID-19’s Impact on the State of Virginia.

The peer-reviewed study aims to determine individuals’ social, mental, and physical well-being across the state of Virginia, an area with evidence of a growing rural-urban demographic divide. Increasingly, there are distinct socioeconomic differences between the multiethnic population of Northern Virginia and the predominately white population in rural communities. This unique sociodemographic distribution offers an interesting and important source to examine the multifaceted impact of the COVID-19 pandemic in a broad range of lifestyle, environmental, economic, and social settings.

The study is led by an industry-academic collaboration including Vibrent Health, George Mason University, and the Healthcare Analytics and Delivery Science Institute (HADSI)—a collaboration between Eastern Virginia Medical School and regional healthcare provider Sentara. A study team comprised of experts from these organizations collaboratively designed and deployed a statewide digital health research study called COVIDsmart to understand the effects of COVID-19

COVIDsmart relies exclusively on digital methods for eConsent, participant communication and engagement, and data collection. The study team used the scientifically-validated ResearchCloud Enterprise platform across multiple research domains, including physiological, neurological, social neuroscience, socio-psychological, and behavioral economics.

At time of publication of the paper, the study was able to convert nearly 21% of visitors to the study website, using only digital touchpoints. The most successful recruitment modality resulting in study enrollment was the use of newsletters or emails that popularized the study across the target catchment areas within Virginia.

“The preliminary findings of COVIDsmart demonstrate that individuals are willing to participate in fully-remote digital health research, which is promising news for infectious disease research,” said Vibrent Health CEO Praduman “PJ” Jain. “Digital methods not only enable researchers to scale their participant populations over larger areas, but also protect patients and research teams from potential risks of in-person data collection. The high level of engagement in this study confirms the viability of this approach.”

The data collected remotely included mood, social communication and isolation, alcohol dependency, sleep deprivation, and other behavioral risk indicators over time. The study team also implemented incentives, reminders, and other retention strategies for participants.

This concluded study represents a growing priority within the research community to build permanence and sustainability in infectious disease research. Digital health research using platforms like ResearchCloud Enterprise provide a safe, scalable, and speedy model for infectious disease and epidemic monitoring.

“The industry-academic collaboration for COVIDsmart holds great promise for accelerating research in infectious disease, and we hope to do more of it,” said Jain. “We are actively working to support more collaborations and invite other research programs to partner with us in these initiatives to accelerate the benefit to global health.”

To discuss potential collaborations in health or clinical research, visit https://info.vibrenthealth.com/request-a-pilot.

About Vibrent Health

Vibrent Health develops digital health technology and research tools for health organizations, researchers and research participants. Powering the next generation of precision medicine, Vibrent’s scalable technology platform for individual and population health provides actionable insights to help accelerate medical discoveries. Vibrent Health is proud to serve, since 2017, as the Participant Technology Systems Center for the National Institutes of Health’s All of Us Research Program, which aims to collect health data from 1 million or more people to support a wide variety of research studies. Since 2020, Vibrent has also collaborated with numerous organizations to conduct a variety of research initiatives spanning several topics, including precision medicine, cancer, COVID, substance abuse, aging, and fertility, among others. To learn more, visit vibrenthealth.com.

Contacts

Molly Bryant
Vice President
Email – mbryant@vibrenthealth.com
Phone – 843.814.8623

As part of 23andMe’s ongoing research on COVID-19, the findings were first reported in June of last year. The paper offers more detail on the study, which identified variants near two olfactory genes — UGT2A1 and UGT2A2.

We’re delighted to see this manuscript published, said Adam Auton, 23andMe’s Vice President for Human Genetics. It is another example of how data contributed by 23andMe customers can provide unique insights into COVID-19. It really wouldn’t be possible without our customers, and we’re extremely grateful to everyone that participated in this research.

Common Symptoms

Loss of smell and or taste, also called anosmia, is a hallmark symptom of COVID-19. It is often the earliest indication of infection, and in some cases, the only symptom. An individual with one copy of the variant is about 11.5 percent more likely to lose their sense of smell or taste if infected compared to someone with zero copies.

For this work researchers* conducted a genome-wide association study (GWAS) using data from more than 69,000 23andMe customers who consented to participate in research.  Along with identifying variants implicating the two olfactory genes, the study also noted that loss of taste and smell after COVID-19 was most common among women and younger research participants. It was less common among research participants of East Asian or African American ancestry.

Long Haulers

The research is part of ongoing work by 23andMe since the beginning of the pandemic in 2020. Among the areas of study is research on the role blood type plays in severity and susceptibility to the virus, and insights into the genetics that influence different reactions to COVID-19 vaccines. In addition, researchers are currently studying so-called long haulers, individuals with continued health effects weeks, months or longer after infection, to determine whether genetics plays a role.

For the loss of taste and smell study, the researchers found that about two-thirds of participants who tested positive for the virus reported loss of smell or taste. In addition, the researchers working on this study also ran separate GWAS for individuals of European, Latino, African American, East Asian, and South Asian ancestries, and then combined the data via a meta-analysis. The researchers found the risk variants for loss of taste or smell most common among people of European ancestry, and least common among those of East Asian ancestry.

Because the novel coronavirus SARS-CoV-2 first enters the body and accumulates in olfactory support cells, the findings may offer researchers important insights into the biological pathway for infection.

To read the full paper go to Nature Genetics.  You can learn more about 23andMe’s COVID-19 study here.

The use of digital medicine platforms and anonymous user data collected online can help predict the spread of an infectious disease, identify geographical locations of higher or lower prevalence, and support pandemic responders.

This insight emerged from a study recently published in the Journal of Medical Internet Research (JMIR) led by digital experts in collaboration with the Predictive and Preventive Medicine Research Unit of the Bambin Gesù Hospital in Rome, the largest pediatric hospital and research center in Europe, and Paginemediche, an innovative digital medicine startup.

During a pandemic, users accessing a digital system are a valuable source of information that can facilitate traditional surveillance activities, allow for earlier prediction of a spike in the incidence of disease, and support preventive strategy decisions. For example, the Ministry of Health used the data from positive COVID-19 swabs along with other indicators to plan preventive strategies, including restrictions on travel and social activities, and to predict possible outcome scenarios.

As disease surveillance is affected by the time needed to make a diagnosis and communicate the associated data, epidemiologists are interested in evaluating information complementary to traditional surveillance that can provide early predictions. However, the availability of rapid information has to be weighed against the reliability of that information. As a result, internet user data has often been regarded as ancillary to disease surveillance; an area giants such as Google have explored with varying success.

The team of researchers examined a total of 75,557 sessions in the online decision support system (chatbot) developed by Paginemediche, a simple tool available that aims to answer user questions about COVID-19 and recommend the most appropriate behavior in accordance with the Ministry of Health.

The recommendations particularly concerned users with symptoms or those in close contact with a COVID-19 positive person. This user decision-support system, freely accessible in an algorithm-driven chat room, has been in place since the start of the pandemic in March 2020 across the country and has now been extended to assess other conditions and support early identification of additional diseases beyond COVID-19.

The study was conducted by accessing data from Paginemediche’s assisted decision-making system and comparing it with surveillance data distributed by the Ministry of Health in order to assess the degree of concordance over time. Although the assisted decision-making system could not accurately predict the number of cases that were notified to the Ministry of Health, it was able to predict the upward or downward trend of cases across the country one week in advance of the Ministry of Health’s surveillance data. The accuracy in anticipating pandemic trends was better when it considered users who had been in contact with a patient positive for COVID-19.

Specifically, 65,207 sessions were recorded from users with symptoms, 19,062 from contacts with individuals with COVID-19. The highest number of sessions in the online decision support system was recorded in the early stages of the pandemic. A second peak was observed in October 2020 and a third peak was observed in March 2021, in parallel with the wave of reported cases. The online decision support system session peaks preceded the wave of reported COVID-19 cases by approximately one week.

The results of the study are consistent with the consideration that awareness of contact with a positive individual or having respiratory symptoms anticipates the possible diagnosis by nasal swab and subsequent notification to the Ministry of Health by a few days. Although data from an open, uncontrolled system may fluctuate for different, unpredictable reasons and are not as robust as those based on laboratory tests, these systems represent a source of information that can complement traditional surveillance activities, allow for earlier prediction of possible increases in disease cases, and support decisions for preventive strategies by public health institutions.

The World Health Organization (WHO) and the Federal Republic of Germany will establish a new global hub for pandemic and epidemic intelligence, data, surveillance and analytics innovation. The Hub, based in Berlin and working with partners around the world, will lead innovations in data analytics across the largest network of global data to predict, prevent, detect prepare for and respond to pandemic and epidemic risks worldwide.

H.E. German Federal Chancellor Dr Angela Merkel said:

The current Covid-19 pandemic has taught us that we can only fight pandemics and epidemics together. The new WHO Hub will be a global platform for pandemic prevention, bringing together various governmental, academic and private sector institutions. I am delighted that WHO chose Berlin as its location and invite partners from all around the world to contribute to the WHO hub.

The WHO Hub for Pandemic and Epidemic Intelligence is part of WHO’s Health Emergencies Programme and will be a new collaboration of countries and partners worldwide, driving innovations to increase availability and linkage of diverse data; develop tools and predictive models for risk analysis; and to monitor disease control measures, community acceptance and infodemics. Critically, the WHO Hub will support the work of public health experts and policy-makers in all countries with insights so they can take rapid decisions to prevent and respond to future public health emergencies.

We need to identify pandemic and epidemic risks as quickly as possible, wherever they occur in the world. For that aim, we need to strengthen the global early warning surveillance system with improved collection of health-related data and inter-disciplinary risk analysis, said Jens Spahn, German Minister of Health. “Germany has consistently been committed to support WHO’s work in preparing for and responding to health emergencies, and the WHO Hub is a concrete initiative that will make the world safer.

Working with partners globally, the WHO Hub will drive a scale-up in innovation for existing forecasting and early warning capacities in WHO and Member States. At the same time, the WHO Hub will accelerate global collaborations across public and private sector organizations, academia, and international partner networks. It will help them to collaborate and co-create the necessary tools for managing and analyzing data for early warning surveillance. It will also promote greater access to data and information.

One of the lessons of COVID-19 is that world needs a significant leap forward in data analysis to help leaders make informed public health decisions, said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. This requires harnessing the potential of advanced technologies such as artificial intelligence, combining diverse data sources, and collaborating across multiple disciplines. Better data and better analytics will lead to better decisions.

These data are really appreciated, especially when it comes to decision-making — should we adopt the app or not? says epidemiologist Viktor von Wyl at the University of Zurich, who has been evaluating Switzerland’s SwissCovid app.

Researchers say that contact-tracing apps won’t by themselves bring the pandemic under control. But the results show they are useful, providing that they have adequate political backing and are properly integrated into public-health systems.

Read the full article at nature.com

If you are coming to Helsinki from abroad by plane these days, you will be welcomed not only by the airport crew, but also the four-legged guardians: Finland is running a pilot program using dogs to detect passengers infected with Covid-19.

Different countries are performing research on the coronavirus-sniffing dogs, whose sharp noses have already made the headlines on Time, BBC and other media. However, Finland is the first in Europe to get to the actual trials at the airport: the project started at Helsinki-Vantaa airport at the end of September 2020, following Dubai International Airport that came up with the same innovation this summer.

The Finnish sniffing dogs working are trained by Wise Nose, Finland’s Smell Detection Association and Nose Academy, a start-up company responsible for operational activities at the airport. The research part is led by Anna Hielm-Bjorkman, Adjunct Professor of clinical research on companion animals at the University of Helsinki.

Digital Health Global talked to Soile Turunen, Project Planner at Nose Academy Oy, to shed some light (or sniff out the truth?) on the initiative.

Soile, behind every project there is a story. Could you share one about how it was discovered that dogs can detect Covid? How much time did it take to train the first dogs and to launch the project?

The idea came almost a year ago, in spring 2020 when the pandemic started to spread It belongs to Susanna Paavilainen, Executive Director at Wise Nose, and Anna Hielm-Bjorkman, professor at the Helsinki University.

Susanna is also a dog trainer, so she started to investigate whether her dog, Kössi, could sniff coronavirus. Susanna tried with some of the relatives and it turned out that the dog, in fact, could successfully detect Covid. Finland has been known for the low rates of coronavirus spread, hence it was even difficult to find enough positive samples for the training.

Susanna and Anna, with the support of the City of Vantaa Deputy Mayor, Timo Aronkytö, who found the idea innovative and noted a great potential for the country, started to work on the project mid of summer and managed to launch the dog training by August. Considering we are actively using the dogs now, we can say that the training takes 2-3 months but we need to keep in mind that we are still at a pilot stage, hence we don’t have enough data to estimate this time period in a more precise way.

Is there a specific dog breed that deals with such task better?

Most of the dogs we use have previous history of sniffing diseases – for example, Kössi, the dog of Susanna, was trained to detect cancer samples. In fact, Kössi has a history of his own: he is a mixed breed, he was found as a puppy in Spain and brought to Finland.

In general, any dog is capable of doing this kind of nose work. We have Labrador retrievers, German shepherds and White shepherds. The success of the dog depends more on his or her personality: it’s very important that a dog really enjoys the job! A dog should be enthusiastic about carrying out this kind of tasks. It’s crucial, the same as with people going to their job every day!

After a couple of weeks of training one can usually tell whether a dog would be capable of doing the task. At the moment we have 5 dogs working at a daily basis at the airport with 3 dogs under the training. One more dog is also working at the laboratory because not any dog is capable to do the job in the field – some get distracted with noises and people. We are renting the space at one of the schools in Vantaa where we have rooms for training, sample preparation and storage facilities, and dogs that need more peaceful environment work there.

It has beenclaimed that a dog’s ability to find positive patients is about 94-100 %. Can you already share some results of the pilot project? According to the earlier comments of Timo Aronkytö, less then 1% of passengers at the Helsinki airport turn out to be positive.

First of all, we always note that dogs don’t replace the PCR test, it’s a complementary method with a promising potential to screen people in a fast way.

We are advising all passengers who got tested by the dogs to take a PCR test as well, it is available for free for all foreign arrivals. In such way we can compare the results delivered by the dogs to the PCR results and it is also one of the scientific parts of the project. PCR is considered a gold standard right now, however, we know that it may also give false positive or false negative results – this is the puzzle we need to solve.

Our pilot project with the sniffing dogs was initially scheduled for 4 months, till the end of December 2020, but we already confirmed that we will continue in 2021. Until the official results are published by the beginning of the next year, I am not able to announce any percentage but I can say that in most of the times the results of the dogs are consistent with PCRs and we are very satisfied with the dogs.

It’s true that, luckily, a very slight percentage of arriving passengers is infected – in fact, we even give the dogs extra positive samples to sniff so that dog performs the odor separation between positive and negative ones often enough.

The pilot has been very important for us to figure out main logistics and operations details: how many dogs do we need, how much time can a dog spend at the airport vs the time for rest and so on. For example, we can currently screen around 100 customers per day.

By the way, after having finished the training, our dogs have an ‘internship’ phase at the airport before starting the actual work.

How do people react to the dogs? I can assume that not many are familiar with this project, especially the foreigners.

Everyone loves the dogs! The passengers, the Finavia crew – everyone comes to say hello and take pictures, we even started our Instagram account. I think it’s very important to have these positive and cheerful colleagues at the airport.

Turning to the comments of Timo again: he mentioned the costs of the program being equal to 300 000 euros which is relatively low compared to the cost of deploying other preventive measures against coronavirus. Is the whole project funded by the Finnish government?

Yes, mostly it is supported by the government and the City of Vantaa. was to build the facilities at the airport and employ eight people for this project. Then goes dogs training, and at Wise Nose we have rent, supplies, materials and also training costs for the people who work with the dogs.  We take a very good care of the dogs and starting next year we will make sure the dog owners have some resources for physiotherapy and other related costs.

As you can see, the project consists of 3 stakeholders: Wise Nose, which is responsible for the dog training, Nose Academy, where I work, responsible for operations and R&D represented by Anna from the University of Helsinki. Apart from state funding, Wise Nose gets donations from private persons  and companies such as Evidensia Veterinary services Ltd. The research team received contribution from the Finnish Kennel Club.

Are you planning to share your experience with other countries considering that Finland is pioneering Europe?

Indeed, we are contacted by many researchers and right now keeping contact with more than 10 countries. I know that France and Germany have done some research in the area, Italy and Spain are also discussing about dog training and usage of the sniffer dog. We are willing to help, however we have quite limited number of people working on this project so we cannot allocate too much time for this experience transfer.

We started thinking on how we can share our takeaways from the pilot project and first, we thought about hosting research groups from other countries that could come for a week or two to Finland when epidemiological situation in Europe gets better. Then, we also came up with the idea to record videos of the training. It could be a scalable option, but the limitation here is that each dog is very individual: you record the training video with the one and then the next dog would be different.

MRC Epidemiology Unit launches study to monitor COVID-19 in 12,000 Cambridgeshire residents – MRC Epidemiology Unit

SAFE2GO Contact Tracing App to Help UK Businesses Open Safely – digit.fyi

Emotional empathy is driving brand equity – pharmaphorum

Smell and taste loss could help identify COVID-19 at airports, say researchers – pharmaphorum

HealthTunes launches iOS APP to deliver stress and anxiety relief to healthcare workers and beyond – Healthware Group

European investment and regulation

The fast-tracking of global regulations on digital health has enabled wide roll-outs of solutions and in turn encouraged greater investment into the sector. European companies operating in the space have raised $11.8 billion, with France playing a leading role, both on the investors’ and funded companies’ side^[1].
We all know that reimbursement is a key challenge for many new digital health solutions. Since late last year Germany’s Digital Healthcare Act (Digitale–Versorgung–Gesetz) started to chart an important course for other European countries, even though some issues are yet to be resolved^[2].
Consequently, the pandemic period has seen France reimburse its first digital therapy in the form of Sivan’s Moovcare, which targets lung cancer^[3], while Belgium recently fully reimbursed moveUP, an mHealth app for the follow-up of patients after hip and knee replacement operations^[4].

Partnerships

On the companies’ side we have witnessed the establishment of a number of promising partnerships between digital health firms and pharma companies or other institutions.
One of these is a collaboration between Kaiku Health and Roche to co-develop novel digital patient monitoring and management modules in oncology.
The renewed partnership linking mobile care coordination and patient engagement platform Buddy Healthcare with Tampere University Hospital is another example, and will see Tampere implement Buddy’s platform to streamline its patient services and provide transparent and clear care pathways^[5].

Mental Health

The field’s next steps will be ensuring digital health is used today to deliver the best care to a global population in face of a mental health spike following the global emergency.
Digital therapy programmes that can offer courses of evidence-based treatments also have a role in the crisis, given their unique potential for scalability. In the first half of 2020, digital behavioural health start-ups scored $588 million, roughly the annual funding for this segment in any previous year^[6].

The clinical trial collaboration focuses on utilizing remote diagnostic monitoring through the use of precision medicine clinical-grade, cloth-based wearable technology. The goal is to monitor patients with confirmed or suspected COVID-19 with Nanowear’s proprietary and patented cloth-based nanosensors which detect physiological and biomarker changes indicative of clinical deterioration that may require further intervention from the hospital systems.

Nanowear’s digital platform enables a radical leap forward in telemedicine and remote patient diagnostics. When a patient wears SimpleSENSE, Nanowear’s one-size-fits-all adjustable undergarment, physicians can remotely capture and assess multiple physiological signals – including real-time ECG, systolic and diastolic blood pressure, blood flow hemodynamics, respiration, lung volume and fluid, and temperature trends – without the need for an in-person visit or physical touch.

When we talk about telemedicine, we often talk about video conferencing, said Venk Varadan, Co-founder and CEO. But to truly enable remote diagnostics we must incorporate clinical-grade remote monitoring that is affordable, comfortable, and simple for patients to use. Nanowear’s SimpleSENSE replaces a stethoscope, blood pressure cuff, multi-channel Holter monitor, and Capnogram (End-tidal CO2), providing a diagnostic quality monitoring system in a form factor that is easy to ship, easy to wear, and easy for the patient to use. Nanowear’s garment captures 120 million data points per patient per day across cardiac, pulmonary, and circulatory biomarker data, which is transmitted to clinical staff, so that they may make informed and quicker decisions remotely.

The COVID-19 pandemic has transformed healthcare delivery and diagnosis; the traditional experience of a physician physically examining or touching a patient in-person has been altered, perhaps forever, and could have a lasting impact on the future of patient-physician physical interactions expansively from primary care to chronic disease cases.

As New York City, the epicenter of the global coronavirus pandemic, emerges from coronavirus lockdown, health systems are looking for novel technologies like Nanowear to better understand and combat the unprecedented severity of COVID-19. Nanowear is being used to aid in COVID-19 diagnosis to ensure the health and safety of patients and medical professionals.

What we need to understand about COVID-19 is why certain patients develop a cytokine mediated immune response from the virus, said national Principal Investigator of the collaboration, Sameer Jamal, MD, of Hackensack Meridian Health, the largest health system in New Jersey. This resulting inflammation within the circulatory system often leads to severe complications or death, which we have seen first-hand in New York City and the surrounding area. Diagnosis and co-morbidities alone is not enough to determine risk to admitted patients before they need to be transferred to ICU. Nanowear’s SimpleSENSE is giving us an exponential amount of relevant data metrics about the heart and lungs from an all-in-one product that should ultimately enable us to triage lower risk patients and stratify high risk patients.

While the immediate need for hospitals across the US is to remotely diagnose and assess worsening COVID-19 instances from home-to-hospital and hospital-to-home, the virus itself has changed the paradigm for healthcare delivery in general.

The COVID-19 paradigm shift has accelerated healthcare systems’ need to implement staff-contactless monitoring involving acute and chronic disease-related hospitalizations, said John Marshall, MD, Head of Emergency Department at Maimonides Medical Center in Brooklyn, New York. “The continuity of in-patient monitoring, patient-to-home monitoring, and at-home monitoring across 8-10 biomarkers with a very easy-to-use product is what makes Nanowear’s solution compelling and unique.

Unlike consumer-grade wearable garments, smartwatches, smartrings or limited-metric adhesive patches, Nanowear’s textile-embedded multi-parameter nanosensors are clinical-grade, analyzing multiple cardiac, pulmonary, and circulatory biomarkers, creating a holistic personalized digital signature for each patient. The garment transmits these diagnostic health signals to a mobile application and physician portal, enabling healthcare professionals to assess a wide range of medical conditions, from diabetes, high blood pressure and congestive heart failure (CHF), to acute illness, discomfort, and stress.

Nanowear’s core of cloth-nanotechnology sensors is a differentiator from smartwatches, adhesive patches, and other medical or consumer wearables, said Suraj Kapa, MD, of Mayo Clinic. With billions of touchpoints per centimeter and large vectors across the heart and lungs, Nanowear’s skin-to-impedance barrier is lower than other wearable sensors, resulting in location-agnostic, high signal-to-noise raw data from basic skin contact. The breadth of metrics, quality and quantity of data, and comfortable user experience are key for machine learning algorithms in various diagnostic verticals, even beyond healthcare.

Nanowear’s proprietary and patented cloth-based nanotechnology was invented by Co-founder and Chief Innovation Officer, Dr. Vijay Varadan and founding engineers, Dr. Pratyush Rai, Prashanth Shyam Kumar, Mouli Ramasamy and Dr. Gyanesh Mathur. SimpleSENSE achieved first-on-man status in late 2019 in the NanoSENSE Heart Failure validation study led by national Principal Investigator John Boehmer, MD, Director of Penn State Hershey Medical Center’s Heart and Vascular Institute. Hackensack Meridian Health Systems and Medical University of South Carolina are also participating in the NanoSENSE Heart Failure study.

Nanowear has submitted its SimpleSENSE device and mobile platform to FDA for Class II 510(k) clearance. SimpleSENSE is not yet FDA-cleared and currently not intended to mitigate, prevent, treat, cure or diagnose any disease or condition.