RAIsonance’s Forced Cough Vocalization (FCV) Signature Analysis Technology is Designed to Diagnose Respiratory Illnesses Via a Cloud-Based Diagnostic Platform and a Mobile App User Interface
DENVER, April 12, 2023 – RAIsonance, Inc., the leader in artificial intelligence-powered analysis of FCV, announced today it has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), a U.S. government agency.
The contract consists of just over $749,000 allocated to the continued development of RAIsonance’s AudibleHealth Dx Software as a Medical Device (SaMD). The device is designed to analyze a user’s Forced Cough Vocalization (FCV) in the diagnosis of illness, with the current focus on both COVID-19 and Influenza. The cloud-based artificial intelligence processing platform uses a mobile app interface for cough collection and is designed to deliver test results in about 2 minutes within the app. The primary objectives of the contract are to complete the execution of the clinical validation studies for COVID-19 and Influenza and to complete a de novo submission to the U.S. Food and Drug Administration before the end of 2023.
“We are elated to have BARDA’s support. Their strategic guidance and extensive expertise will speed our efforts to deliver the best possible diagnostic SaMD to market and help ensure that we fulfill our mission to meaningfully impact global health with such an innovative diagnostic solution,” said Kitty Kolding, Co-Founder and CEO at RAIsonance.
RAIsonance’s SaMD is designed to use only software to diagnose disease, without any wet or biological samples of any kind. The non-invasive test requires just 10 intentional coughs, submitted via a uniquely devised mobile application. Tests can be delivered on-demand electronically, are independent of supply chains, and are not limited by shelf-life expiration. The SaMD is scalable – able to process 20,000 tests per second – an ideal solution for large organizations, colleges and universities, and government agencies.
This award is one component of BARDA's rapidly expanding DRIVe Medical countermeasures portfolio; visit https://drive.hhs.gov to learn more.
“This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00015.”
About RAIsonance, Inc.
RAIsonance is a family of companies headquartered in the Denver Tech Center in Colorado, dedicated to Artificial Intelligence/Machine Learning (AI/ML)-based solutions for the safety, security, and healthcare diagnostics markets. Originally funded with a grant from the National Science Foundation, RAIsonance has developed breakthrough technology innovations that use signal data signature recognition as a biomarker for human medical diagnostics and to support ground-breaking safety applications. To learn more about RAIsonance, please visit RAIsonance AI.
RAIsonance Investor Contact:
Jamie Mariani, CFO
Email: InvestorRelations@raisonance.ai
RAIsonance Media Contact:
Denise Covington
Email: Press@raisonance.ai
MyAdvocate Product Tracks Progress Upon Quitting and Delivers a Personalized Biometric Score for Each User’s Respiratory Wellness Journey
Denver, CO, April 11, 2023 – RAIsonance, Inc., the leader in artificial intelligence-powered analysis of Forced Cough Vocalization (FCV), today announced the launch of two new apps for iOS and Android mobile devices. The apps, MyAdvocate Smoker Recovery and MyAdvocate Vape Recovery, use AI to support cessation by tracking each user’s personal progress, and providing them with personal biometric cough score analyses that measure their journey back to respiratory health. The apps are free to download on the App Store and Google Play, and specially priced 6-month and 12-month packages can be purchased from the MyAdvocate storefront.
“Kicking a nicotine habit is extremely difficult, no matter who you are” said Kitty Kolding, CEO and Co-Founder of RAIsonance, Inc., said, “On average, people make 5 to 7 attempts to quit before they actually succeed. We created this product because we know that being able to see your personal progress and improvement makes a huge difference in a person’s motivation to keep going, and quit for good. Using artificial intelligence, we can provide users with an incredibly detailed, completely customized understanding of their progress back to health.”
In the US, more than 30 million adults smoke cigarettes and more than 2.5 million high school and middle school kids use e-cigarettes. And, at any given moment, approximately 65% of smokers say they want to quit. Recent studies by NIH show that “mobile phone-based interventions, interactive and tailored internet-based interventions, … had modest but significantly increased benefits to smoking cessation at 6 or more months”.
To set up MyAdvocate, the mobile app guides a user through recording several sets of intentional coughs called FCVs. From those recordings, MyAdvocate uses AI to create a baseline - a composite of the user’s FCV signature as unique as their fingerprint. This baseline is a multi-dimensional representation of the imprint representing a user’s respiratory function. With this baseline in place, a user can check their progress any time by coughing again into the app. The MyAdvocate AI compares the current cough to the baseline, and shows an Improvement Score in about 2 minutes, right in the app.
Both apps are designed to work alongside any other smoke or vape cessation products or programs. Similar to dieting, no matter what diet program a person might use, they always use a scale to measure their progress. MyAdvocate is exactly that: the ultimate biometric measure of progress back to health. In testing for more than 2 years, the MyAdvocate FCV tracking technology is the only system that uses AI-powered deep science to track the changes to a user’s unique FCV.
About RAIsonance, Inc.
RAIsonance is a family of companies headquartered in the Denver Tech Center in Colorado, dedicated to Artificial Intelligence/Machine Learning (AI/ML)-based solutions for the safety, security, and healthcare diagnostics markets. Originally funded with a grant from the National Science Foundation, RAIsonance has developed breakthrough technology innovations that use signal data signature recognition as a biomarker for human medical diagnostics and to support ground-breaking safety applications. To learn more about RAIsonance, please visit RAIsonance AI.
RAIsonance Investor Contact:
Jamie Mariani, CFO
Email: InvestorRelations@raisonance.ai
RAIsonance Media Contact:
Denise Covington
Email: Press@raisonance.ai
Ronkonkoma, NY and Denver, CO, March 22, 2023 – RAIsonance Inc., a family of companies dedicated to Artificial Intelligence/Machine Learning (AI/ML)-based solutions for the safety, security, and healthcare diagnostics markets has partnered with Soter Technologies, the Long Island-based creators of the world’s first vape detection and alert system for schools. The companies will work together to bring MyAdvocate, a Forced Cough Vocalization (FCV) Signature Analysis technology app, to schools and parents to support the reduction of youth vaping and smoking.
Parents and school administrators across the United States have been looking for tools and approaches to stop the youth vaping epidemic. School administrators in particular want to find ways to help students rather than punishing them when they are addicted to nicotine. MyAdvocate gives parents and school leaders mobile technology that young people can connect with and use to monitor their progress as they work to break their nicotine addiction.
MyAdvocate for Vape Recovery and Smoking Recovery is a completely new, biometric tracking app that detects and measures the respiratory improvements users achieve while quitting smoking or vaping. Using artificial intelligence, MyAdvocate technology compares Forced Cough Vocalization (FCV) signatures, which are intentional coughs, to the user’s previously created baseline. With each new cough, MyAdvocate generates a new score that shows the recovery progress.
To create a baseline, users record several sets of FCVs. From those recordings, MyAdvocate uses AI to create a baseline that is as unique as a fingerprint. This baseline is a multi-dimensional composite consisting of dozens of unique cough features from each cough. Each new cough is then compared to this baseline and scored, to show the user’s progress toward recovery. The MyAdvocate product line works on both Android and Apple smartphones, giving schools, parents, and young people an additional set of smart tools to help them stop vaping and smoking.
"Our proprietary AI analyzes these biometric FCV signals, creating a personalized way to capture, track and monitor progress. Young people are drawn to mobile technology and it is our goal to give them a tool that is easy to use, and helps them see the result of their efforts to quit. Providing frequent, direct, and personal feedback is a proven approach to supporting this very difficult journey. Partnering with Soter Technologies is a big win for us – they are a leader in this space and have done tremendous work in supporting young people, their families, and their schools in this critical initiative. We are so proud to be working with them," said Kitty Kolding, CEO and Founder, RAIsonance Group of Companies.
Soter’s experience in the K-12 market, mobile application and backend monitoring technology have been paired with RAIsonance’s AI cough analyzer technology. By combining their technology, MyAdvocate for Vape Recovery app users have real time tracking of their cessation efforts.
"Youth smoking continues to be a problem and the student vaping epidemic is out of control across the USA. Millions of students from middle schools and high schools are vaping, and school administrators need solutions that will help students who are addicted instead of punishing them. Education and awareness help reduce vaping and smoking, but the process of breaking the addiction cycle is difficult and painful for many, especially young people. MyAdvocate for Smoking Recovery and Vape Recovery is a perfect addition to the products and services we offer. With this technology as a key part of anti-vaping efforts, I am certain we will help more young people break the nicotine addiction cycle and quit vaping and smoking," said Derek Peterson, CEO Soter Technologies.
MyAdvocate will be added to Soter Technologies FlySense vape detection and alert system and "NO VAPE" educational awareness program which has been proven to reduce vaping in schools by focusing on the health hazards.
Post-pandemic vaping has reemerged in schools. More and more students are vaping and each vape liquid pod contains the same amount of nicotine as a pack of cigarettes in addition to other harmful chemicals.
For more information about the Vape Recovery app from RAIsonance, please visit our LinkedIn Showcase page
For more information about Soter Technologies, visit Soter Technologies
- END -
About RAIsonance, Inc.
RAIsonance is a family of companies headquartered in the Denver Tech Center in Colorado, dedicated to Artificial Intelligence/Machine Learning (AI/ML)-based solutions for the safety, security, and healthcare diagnostics markets. Originally funded with a grant from the National Science Foundation, RAIsonance has developed breakthrough technology innovations that use signal data signature recognition as a biomarker for human medical diagnostics and to support ground-breaking safety applications. To learn more about RAIsonance, please visit RAIsonance AI
About Soter Technologies
Based in Ronkonkoma, New York, Soter Technologies is committed to protecting the health and wellbeing of students and the general public with advanced technology and creative solutions that fits today’s marketplace and needs. Using advanced sensor, IoT, and software technology, Soter Technologies develops and delivers innovative solutions in two distinct and unique product lines FlySense® and SymptomSenseTM. FlySense® offers environmental intelligence, which makes the world a safer and healthier place, from schools to enterprises to public spaces. The FlySense® Vaping and Elevated Sound Detector is the first in the world to introduce a vape and bullying detection and alert system for schools. SymptomSense™ products are designed to detect illness and protect facilities. Soter Technologies’ name is inspired by Greek mythology wherein Soter is the personification of safety, deliverance, and preservation from harm. For more information about the company and its services and products, visit:
Soter Technologies
RAIsonance Investor Contact:
Jamie Mariani, CFO
Email: InvestorRelations@raisonance.ai
RAIsonance Media Contact:
Denise Covington
Email: Press@raisonance.ai
Soter Media Inquiries:
Bill Corbett
Email: wjcorbett@corbettpr.com
Tel: (516)775-0435
Denver, CO, March 15, 2023 – RAIsonance, Inc., announces the beta testing phase of its innovative, AI-powered tracker for sufferers of Long COVID. Part of the MyAdvocate line of Forced Cough Vocalization (FCV) wellness products, this platform was specially developed to track the unique and complex symptoms experienced by Long COVID sufferers, and to track changes to their FCV score – a key respiratory wellness metric.
“We are thrilled to welcome beta testers to experience our new MyAdvocate for Long COVID application. COVID has been a terrible scourge for so many people around the world – and for some people, COVID never goes away. That’s who we made this product for.” Kitty Kolding, CEO of RAIsonance. “By capturing and analyzing this data-rich FCV signal, our tools can provide Long COVID sufferers with a new, trackable biometric data point as they continue on their journey to recovery.”
The product’s user interface takes the form of a mobile app, which communicates with the cloud-based FCV processing and analytics system. The system enables users to create their unique Baseline FCV profile by coughing into the application multiple times on the first day. Then, users can cough again any time and have the system compare their new cough to their baseline, yielding an FCV change score. This score helps users understand how their FCV score changes over time, and even throughout the day as their symptoms might worsen or subside.
Users can also easily input their symptoms with a few clicks using the app’s symptom diary. The app provides trend analysis and other insights to help users get a clearer picture of their situation and share these details with their healthcare providers if they wish.
The beta testing period opens on March 15, 2023, and is free to Long COVID sufferers. Click HERE for more information about MyAdvocate for Long COVID, and to join the beta testing group, click HERE.
Denver, CO, March 13, 2023 – RAIsonance, Inc., the leader in artificial intelligence powered analysis of Forced Cough Vocalization (FCV), announces expansion into new wellness product categories. This proprietary technology focuses on FCV signature analysis, which uses these intentional coughs as a rich source of biometric and biomarker data to detect changes to an individual’s cough sound signatures, tracking a key respiratory wellness metric.
RAIsonance has incorporated this FCV Wellness technology into 3 new product lines launching over the next 60 days:
Each of the RAIsonance product lines use a mobile app interface to collect a series of intentional coughs which are processed in their cloud-based FCV analysis system. Guided by the app, these initial coughs are collected over a prescribed period of time to build a complex, multi-dimensional FCV profile or baseline for the user. Once established, the user can cough into the mobile app again anytime, and the powerful Artificial Intelligence (AI) rapidly compares that user’s new cough to their previously established baseline. In about 2 minutes, the results are available in the app, designed to track even the smallest changes.
Learn more about RAIsonance’s line of FCV Signature Analysis products HERE.
Investor Contact:
Jamie Mariani, CFO
Email: InvestorRelations@raisonance.ai
Media Contact:
Denise Covington
Email: Press@raisonance.ai
SOURCE RAIsonance, Inc.
Denver, CO, February 14, 2023 – RAIsonance, Inc., a group of Artificial Intelligence – Machine Learning (AI-ML) technology solutions companies, today announced the promotion of Paul McLenaghan to Chief Revenue Officer and the hiring of Kris Hopkins as Chief Product Officer.
Paul McLenaghan, Chief Revenue Officer
Paul McLenaghan joined RAIsonance in July 2021 as SVP of Market Development. He is a market and business development executive with a passion for driving market disruption. Since joining RAIsonance, he has worked with executive leadership to develop strategic relationships, identify new market opportunities, and drive go to market activities across the government, private enterprise, and education sectors.
Prior to RAIsonance, Paul spent close to twenty years in the advertising technology industry. He was most recently with Prohaska Consulting, where he consulted to major ad tech platforms, publishers, and media companies on data strategy and new product strategy. Previously, he spent close to fifteen years at TARGUSinfo and Neustar, where he had a track record of success creating and driving new solutions and lines of business at the intersection of technology, data, and media in executive roles across Product Strategy and Market Development.
Paul completed his MBA at the University of Maryland Robert H. Smith School of Business and has BA degrees in Economics and English from Villanova University. He is a dual citizen of Australia and the United States.
Kris Hopkins, Chief Product Officer
Kris Hopkins is an entrepreneur, inventor, and product leader in software. Previously, Kris has led strategy, product, and engineering as CTO and/or Chief Product Officer at multiple companies including at Perfecta, a cybersecurity, intelligence, and communications technology provider, and led strategic product management for new products at Oracle. As founder and CEO of Newfound Communications, Kris sold the company to Acme Packet (NASDAQ: APKT) and spun out its Software as a Service business into Surgent Networks. A dynamic leader of software product and development teams, Kris brings to RAIsonance 20 years of experience managing mission-critical and high-security software development projects and pipelines. With a focus on the largest enterprise and government customers, his leadership builds robust cloud-based and premise-based software products, SDKs, and APIs for businesses to provide secure and efficient solutions.
Kris is a graduate of Cornell University where he was the recipient of the Dorman Family Award for Entrepreneurship and Personal Enterprise Excellence. He is a dedicated husband, father of two, loves coaching youth sports, and is an active member of his community.
Driving a Revolution in AI-ML Technology for Healthcare
Mr. Hopkins and Mr. McLenaghan join RAIsonance’s executive team at a critical moment in the company’s growth. Founded in March of 2020, the company set out to devise and bring to market the first software only, AI-powered COVID test using only the sound of a person’s cough to render a diagnosis. The device, called AudibleHealth Dx, is designed to diagnose COVID-19 by analyzing the sound of a person’s forced cough vocalization using artificial intelligence.
The user interface takes the form of a mobile app. Once the user downloads and registers on the app, they cough 4 to 6 times into their mobile phone, and in about 2 minutes after submitting a cough, they receive their test result in the app. This all-digital approach allows for fast and easy COVID-19 testing with no swabs, no lines, no waste, no expiration dates, and no waiting. The massively scalable testing platform is capable of processing many thousands of tests per second and is integrated with the company’s TestHub digital test acquisition, distribution, and tracking platform.
The RAIsonance team successfully completed its EUA clinical trials for the COVID test in late 2022 and has filed applications for Emergency Use Authorization in the US and Canada. The company is currently working on its second and third tests on the platform, for Influenza and Tuberculosis.
Of the new hires, RAIsonance Co-Founder and CEO, Kitty Kolding, said, “Kris and Paul are both impressive, accomplished executives. They join our executive team at the perfect moment as we launch several new AI-ML health tech solutions while continuing development on our Software as a Medical Device (SaMD).”
When asked about his role at RAIsonance, Kris Hopkins replied, “Since the onset of the global pandemic, AI and Machine Learning have held great promise for the diagnosis and wellness assessments of respiratory ailments. As Chief Product Officer, I am looking forward to building upon and extending the impressive work by the RAIsonance team. We are in a position to deliver secure, breakthrough products which leverage our experience with AI/ML bio-acoustic markers for the reliable detection of respiratory conditions, leading to improved outcomes and better health equity.”
Paul McLenaghan said about his promotion to Chief Revenue Officer, “I joined RAIsonance in 2021 to contribute to the company’s mission to have a positive impact on global health and wellness. It has been a privilege to work alongside such a talented and passionate team these past 18 months to develop a suite of innovative, 100% digital diagnostic and wellness solutions that are affordable, reliable, and scalable. I look forward to working with Kitty and the rest of the team to deliver our solutions to health providers, public health officials, employers, and most importantly - individuals in the US and globally.”
About RAIsonance, Inc.
RAIsonance, Inc., a family of AI-powered technology solution companies headquartered in the Denver Tech Center, is focused on meeting today’s critical health and safety challenges. Founded in March of 2020, AudibleHealth AI, Inc. is the SaMD division of RAIsonance, specializing in AI/ML diagnostic solutions and platforms. Originally funded by an SBIR grant by the National Science Foundation, the team of medical, artificial intelligence, technology, and medical device specialists focuses on developing leading-edge AI/ML-based, scalable, cost-effective diagnostic products across a range of acute and chronic health conditions.
For more information visit us at RAIsonance AI and AudibleHealth AI
Investor Contact:
Email: InvestorRelations@raisonance.ai
Media Contact:
Email: Press@raisonance.ai
Greenwood Village, CO, September 26, 2022 – RAIsonance, Inc., today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its AudibleHealth Dx Software as a Medical Device (SaMD). The device is designed to analyze a user’s Forced Cough Vocalization-Signal Data Signature (FCV-SDS) in the diagnosis of COVID-19 illness. Results in the clinical validation study demonstrated a Positive Percent Agreement (PPA) of 84.39% and a Negative Percent Agreement (NPA) of 85.09% when compared to a reverse transcription-polymerase chain reaction (RT-PCR) test.
“I am beyond thrilled to have submitted our EUA Application for AudibleHealth Dx.” said RAIsonance Founder and CEO, Kitty Kolding. “If authorized, we will immediately bring to market a convenient, accessible, inexpensive, and innovative COVID-19 test that will truly allow everyone to test as often as they wish.”
About the Clinical Trial
The submission comes after completion of the Clinical Trial conducted in Florida, and enrolled 515 participants, which included 65 COVID-19 positive cases and 450 COVID-19 negative cases for a prevalence of 12.6%. The study was a prospective, multi-site, non-inferiority trial that compared the AudibleHealth Dx COVID-19 test to a highly sensitive de novo-authorized RT-PCR test to detect COVID-19 infections.
For the clinical validation study, the AudibleHealth Dx SaMD's ability to correctly diagnose COVID-19 was compared to the BioFire RP2.1 Panel (the first FDA de novo-authorized test for COVID-19). The BioFire RP2.1 Panel runs on the BioFire® FilmArray® Torch and the BioFire® FilmArray® 2.0 Systems in laboratories certified to perform CLIA high-complexity or moderate complexity tests.
When compared to this RT-PCR test, the AudibleHealth Dx has results demonstrating a Positive Percent Agreement (PPA) of 84.39% and a Negative Percent Agreement (NPA) of 85.09%.
Study participants included males and females aged 18 and older who presented for elective, outpatient COVID-19 RT-PCR testing and met the indications for use for the RT-PCR nasal swab test for COVID-19 using the comparator test and AudibleHealth Dx. All participants stated their willingness to comply with all trial procedures, and informed consent was obtained prior to testing.
The validation study included symptomatic and asymptomatic COVID-19 patients as well as healthy subjects who each utilized the AudibleHealth Dx SaMD device on a mobile phone and then immediately were swabbed with an RT-PCR test.
Usability Analysis Results
In addition to evaluating the NPA and PPA of the device, the company also conducted a separate, comprehensive Usability Analysis. Total usability enrollment was 443 participants. Participants included those between the ages of 18 and 88 as well as notable diversity in both ethnicity/race and educational level. Key Usability Analysis outcomes:
Mona Kelley, Chief of Clinical and Regulatory Affairs for RAIsonance is also pleased with the results. "Given the novelty of the test, understanding the usability of the test was essential. We are very excited about our Usability Analysis results and how well the device performed in that regard."
Background
The use of signal data signatures is common practice for biometric authentication and other means. A forced cough vocalization (FCV), the sound produced when a person intentionally coughs, is unique to each individual and also takes on unique qualities if the individual has certain illnesses, such as COVID-19. RAIsonance has taken this knowledge and the field of artificial intelligence and machine learning (AI/ML) to design and develop a SaMD that uses these unique signatures to diagnose COVID-19 illness.
A Complete Solution
The device, called the AudibleHealth Dx, is designed to diagnose COVID-19 by analyzing the sound of a person’s forced cough vocalization using artificial intelligence. The user interface takes the form of a mobile app. Once the user downloads and registers the app, they cough 6 to 10 times into their mobile phone, and in about 2 minutes, after submitting a cough, they receive their test result in the app. The (SaMD) approach allows for fast and easy COVID-19 testing with no swabs, no lines, no waste, no expiration dates, and no waiting.
The device is designed so that results are also pushed to a comprehensive Patient Portal where users can learn more about the test, the science, and current public health recommendations regarding COVID-19. Thanks to a technical integration with the Association of Public Health Laboratories (www.APHL.org), the platform is also designed to automatically send any positive results to local public health authorities in all 50 states and 4 U.S. territories.
In addition to the mobile application, the company has also designed a web-based, enterprise class, fully integrated testing solution platform called TestHub, designed for high-volume purchasers. Businesses, employers, universities, sports teams, organizations, and government agencies will be able to use TestHub to acquire any quantity of tests, if authorized by the FDA, and distribute those tests in any quantities to their users, either once or on a recurring basis, with just a few clicks.
The TestHub dashboard is also designed to enable these high-volume customers to monitor test usage and results to manage risks and support whatever testing protocols they may have in place. In response to the evolving nature of the COVID-19 pandemic, this seamless platform is nimble and versatile enough to flex with policy changes and infection rates.
About the AudibleHealth Dx submission and the TestHub platform, Mark Fogarty, Chief Technical Officer (CTO) and Chief Biotechnical Engineer (CBTE) said, “This submission is the next step towards potentially transforming how organizations scale their COVID testing programs. Our enterprise-class TestHub platform has a comprehensive set of features, from bulk purchasing to one-click distribution and easy monitoring of test results, and it stands ready if the FDA authorizes the device.”
Lead Series A investor and Chairman of the Board, Rudy Karsan, details AudibleHealth Dx’s next steps. “RAIsonance’s journey has been remarkable and submitting the application for the EUA is an important next step. If authorized, the test will revolutionize COVID testing for businesses, organizations, and individuals.”
About RAIsonance, Inc.
RAIsonance, Inc., a family of AI-powered technology solution companies headquartered in the Denver Tech Center, is focused on meeting today’s critical health and safety challenges. Founded in March of 2020, AudibleHealth AI, Inc. is the SaMD division of RAIsonance, specializing in AI/ML diagnostic solutions and platforms. Originally funded by an SBIR grant by the National Science Foundation, the team of medical, artificial intelligence, technology, and medical device specialists focuses on developing leading-edge AI/ML-based, scalable, cost-effective diagnostic products across a range of acute and chronic health conditions.
For more information visit us at RAIsonance AI and AudibleHealth AI
Investor Contact:
Email: InvestorRelations@raisonance.ai
Media Contact:
Email: Press@raisonance.ai
Updated as of September 6, 2022
Greenwood Village, CO, August 26, 2022 – RAIsonance, Inc., a group of AI-powered technology solutions companies, today reported the preliminary results of its AudibleHealth Dx clinical validation study. The purpose of the trial was to evaluate the AudibleHealth Dx Software as a Medical Device (SaMD) using Forced Cough Vocalization-Signal Data Signature (FCV-SDS) in the diagnosis of COVID-19 illness.
Clinical Study Results
In Q2 of 2022, RAIsonance commenced its Clinical Trial in Florida to validate the AudibleHealth Dx device’s efficacy. Enrollment was 514 participants, with a prevalence of 12.8%. The results of this study will be used to support an Emergency Use Authorization (EUA) submission to the U.S. Food and Drug Administration in the coming weeks.
The study was a prospective, multi-site, non-inferiority trial that compared the AudibleHealth Dx COVID-19 test to a highly sensitive de novo-authorized RT-PCR COVID-19 test when using the AudibleHealth Dx SaMD to detect COVID-19 infections.
For the clinical validation study, the AudibleHealth Dx SaMD’s ability to correctly diagnosis COVID-19 was compared to the BioFire RP2.1 Panel (the first FDA de novo-authorized test for COVID-19). The BioFire RP2.1 Panel runs on the BioFire® FilmArray® Torch and the BioFire® FilmArray® 2.0 Systems in laboratories certified to perform CLIA high complexity or moderate complexity tests.
When compared to this highly sensitive reverse transcription-polymerase chain reaction (RT-PCR) test, the AudibleHealth Dx has results, updated as of September 6, 2022, demonstrating Positive Percent Agreement (PPA) of 84% and a Negative Percent Agreement (NPA) of 85%.
Study participants included males and females aged 18 and older who presented for elective, outpatient COVID-19 RT-PCR testing and met the indications for use for the RT-PCR nasal swab test for COVID-19 using the comparator test and AudibleHealth Dx. All participants stated their willingness to comply with all trial procedures, and informed consent was obtained prior to testing.
The validation study included symptomatic and asymptomatic COVID-19 patients as well as healthy subjects who each utilized the AudibleHealth Dx SaMD device on a mobile phone and then immediately were swabbed with an RT-PCR test.
Usability Analysis Results
In addition to evaluating the NPA and PPA of the device, the company also conducted a separate, comprehensive Usability Analysis. Total net usability enrollment was 443 participants. Demographics included those between the ages of 18 and 88 as well as notable diversity in both ethnicity/race and educational level. Key Usability Analysis outcomes:
Background
The use of signal data signatures is common practice for biometric authentication and other means but has not yet been used within the medical community. A forced cough vocalization (FCV), the sound produced when a person intentionally coughs, is unique to each individual and also takes on unique qualities if the individual has certain illnesses, such as COVID-19. RAIsonance has taken this knowledge and the field of artificial intelligence and machine learning (AI/ML) to design and develop a SaMD that uses these unique signatures to diagnose COVID-19 illness.
A Complete Solution
The device, called the AudibleHealth Dx, is designed to diagnose COVID-19 by analyzing the sound of a person’s forced cough vocalization using artificial intelligence. The user interface takes the form of a mobile app. Once the user downloads and registers the app, they cough 4 to 6 times into their mobile phone, and in about 2 minutes, after submitting a cough, they receive their test result in the app. The (SaMD) approach allows for fast and easy COVID-19 testing with no swabs, no lines, no waste, no expiration dates, and no waiting.
The device is designed so that results are also pushed to a comprehensive Patient Portal where users can learn more about the test, the science, and current public health recommendations regarding COVID-19. Thanks to a technical integration with the Association of Public Health Laboratories (www.APHL.org), the platform is also designed to automatically send any positive results to local public health authorities in all 50 states and 4 U.S. territories.
In addition to the mobile application, the company has also designed a web-based, enterprise class, fully integrated testing solution platform called TestHub, designed for high-volume purchasers. Businesses, employers, universities, sports teams, organizations, and government agencies will be able to use TestHub to acquire any quantity of tests, if authorized by the Food and Drug Administration (FDA), and distribute those tests in any quantities to their users, either once or on a recurring basis, with just a few clicks.
The TestHub dashboard is also designed to enable these high-volume users to monitor test usage and results to manage risks and support whatever testing protocols they may have in place. In response to the evolving nature of the COVID-19 pandemic, this seamless platform is nimble and versatile enough to flex with policy changes and infection rates.
Of the results, RAIsonance Founder and CEO, Kitty Kolding, said, “We are incredibly proud of the results of these studies. We spent two years refining this technology and building the device itself and were met with dozens of significant challenges along the way. And to ensure that this test can meet the complex testing needs of organizations, we also built a fully integrated, easy to use ecosystem to ensure that users– individuals, businesses, medical professionals, universities, and government agencies – can experience the full benefits of a totally digital COVID-19 testing solution. The combination of our convenient, mobile-app testing interface and our TestHub portal for high-volume purchasers, we believe, is nothing short of revolutionary.”
“We are delighted at the results of this study, which was the culmination of two years of intense work and intentional design. As a physician, the utility of a testing solution like this is a dramatic step forward in terms of scale, innovation, ease of use, convenience, and efficiency. We believe it will be an impressive and impactful tool for mitigating the spread of COVID-19, if authorized by FDA,” added Karl Kelley, MD, FAADM, RAIsonance’s Chief Medical Officer.
Mona Kelley, Chief of Clinical and Regulatory Affairs for RAIsonance is also pleased with the results. “Given the novelty of the test, understanding the usability of the test was essential. We are very excited about our Usability Analysis results and how well the device performed in that regard.”
“I am so proud of the SaMD that we’ve built. Not only is it a complete solution, but it’s also almost infinitely scalable, cost-effective, and user-friendly. Seeing these study results is incredibly gratifying as the validation for all of our work over the past two years,” said Mark Fogarty, Chief Technical Officer (CTO) and Chief Biotechnical Engineer (CBTE).
Lead Series A investor and Chairman of the Board, Rudy Karsan, details AudibleHealth Dx’s next steps. “Our SaMD has the potential to add a powerful new tool to conduct COVID-19 testing. With this novel technology, we can facilitate mass testing without supply-chain headaches, inventory issues and excessive costs. We expect this integrated platform, if authorized by FDA, to become indispensable for businesses, healthcare providers, universities, government bodies and any other type of organization that would benefit from routine COVID-19 testing. The scalability is virtually limitless.”
About RAIsonance, Inc.
RAIsonance, Inc., a family of AI-powered technology solution companies headquartered in the Denver Tech Center, is focused on meeting today’s critical health and safety challenges. Founded in March of 2020, AudibleHealth AI, Inc. is the SaMD division of RAIsonance, specializing in AI/ML diagnostic solutions and platforms. Originally funded by an SBIR grant by the National Science Foundation, the team of medical, artificial intelligence, technology, and medical device specialists focuses on developing leading-edge AI/ML-based, scalable, cost-effective diagnostic products across a range of acute and chronic health conditions.
Learn more about AudibleHealth AI
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Denver, CO, June 10, 2022 – RAIsonance, Inc., a group of AI-powered technology solutions companies that is revolutionizing the COVID-19 testing space and helping to meet today’s critical global health challenges, is proud to announce the appointment of Rudy Karsan as its new Chairman of the Board.
“As a company, we are truly thrilled to announce this appointment,” said Kitty Kolding, Founder and CEO of RAIsonance. “It’s especially gratifying for me personally as well, given the powerful advantages Rudy has already brought us as our lead Series A investor and Board Member.”
Mr. Karsan has a long track record as a highly successful entrepreneur and investor who thrives on building companies from the ground up, whether directly or by actively supporting the entrepreneurs he backs. Mr. Karsan led RAIsonance’s Series A investment in March of 2022 to support the company’s anticipated Emergency Use Authorization filing for its groundbreaking new Software as a Medical Device (SaMD) called AudibleHealth Dx. This new software is designed to diagnose COVID-19 in about 2 minutes by conducting an artificial intelligence-powered analysis of the sound of a user’s cough via a mobile application.
“After working closely with him for nearly a year, I realized Rudy would bring a powerful, additional set of capabilities, relationships, and experience to our team in the role of Chairman,” said Kolding. “I’m so pleased that he’s accepted this role. We have significant global health ambitions for this company, and as my partner, Rudy will help us do exactly what we set out to do: change the face of diagnostic testing and meaningfully impact global health.”
Before joining RAIsonance, Mr. Karsan founded and led Kenexa, a leading global provider of business solutions for human resources. The firm completed an IPO in 2005 and was acquired by IBM in December 2012 for $1.3 billion to provide a platform for its Smarter Workforce initiative.
Since 2014, Mr. Karsan has served as managing director of Karlani Capital, a fund devoted to one main objective: enabling the growth and success of ideas that are original, interesting, and useful to people. Karlani Capital wields the expertise and experience of developing companies from one employee to a 1,000 staff and of growing companies from a single dollar to more than a $1 billion in valuation. The firm has assisted entrepreneurs taking their company into the public markets. This is yet another reason why RAIsonance is excited to have Mr. Karsan on board as the company sets its sights on building out its global health operations.
“RAIsonance and Kitty captured my imagination from the word ‘cough’” said Karsan. “This novel technology is designed to allow you to carry a COVID-19 test in your pocket wherever you go, cutting costs and bypassing or solving supply chain challenges, with the goal of revolutionizing COVID testing as we’ve come to know it over the last several years. I am very blessed and fortunate that Kitty honored me with this position. I look forward to serving to the best of my ability and will work diligently to help bring forth her vision to meaningfully impact global health.”
About RAIsonance, Inc.
RAIsonance, Inc., a family of AI-powered technology solution companies headquartered in the Denver Tech Center, is focused on meeting today’s critical health and safety challenges. Founded in March of 2020, AudibleHealth AI, Inc. is the Software as a Medical Device (SaMD) division of RAIsonance specializing in AI/ML diagnostic solutions and platforms. Originally funded by an SBIR grant by the National Science Foundation, the team of medical, artificial intelligence, technology, and medical device specialists focus on developing leading-edge AI/ML-based, scalable, cost-effective diagnostic products across a range of acute and chronic health conditions.
Investor Contact:
Email: InvestorRelations@raisonance.ai
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Email: Press@raisonance.ai
Multi-Factor Authentication with Signal Data Signatures is a perimeter security game-changer
Denver, CO, August 5, 2021 – RAIsonance, Inc., a family of Artificial Intelligence/Machine Learning (AI/ML)-based technology companies headquartered in the Denver Tech Center, announced the launch of one of its newest and most innovative products, SoundPass.
SoundPass is a non-medical, biometric tool using multi-factor authentication (MFA) for establishing and maintaining a bubble of perimeter security around the premises or a group of people.
Captured by the mobile app and sent to the AI/ML algorithms, a forced cough vocalization creates a signal data signature or SDS. Our proprietary AI/ML system compares the incoming SDS to the user's personal Baseline SDS for multi-factor authentication. Within minutes, if the new SDS matches the Baseline, the user receives an “Authenticated” message. SoundPass Plus users also receive a QR code for verification at locations using the SoundPass Access software.
"This simple-to-use phone app makes it easy for anyone to conduct a self-check at any time.” said Kitty Kolding, CEO of RAIsonance, Inc. "Our goal is to allow everyone to create a bubble around themselves, their loved ones, friends, even their customers and employees based on individual biometrics. No questionnaires, no medical screenings, no lab testing, no chemical sniffers, no waiting. This is exactly what SoundPass technology delivers.”
Via Apple App Store and Google Play store, SoundPass is available now to businesses, educational campuses, entertainment venues, and any facility seeking to enable smarter in-person interactions.
For more information on SoundPass please visit SoundPass.ai/.
About RAIsonance, Inc.
RAIsonance is a family of companies headquartered in the Denver Tech Center in Colorado, dedicated to Artificial Intelligence/Machine Learning (AI/ML)-based solutions for the biometrics, security, and healthcare diagnostics markets. Funded in part with a grant from the National Science Foundation, RAIsonance has developed technology innovations that use Signal Data Signature recognition as a biomarker for non-medical software and a new generation of diagnostic software as medical devices.
For more information on RAIsonance, please visit RAIsonance.ai/.
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SoundPass uses artificial intelligence to create a biometric perimeter security bubble around workplaces, entertainment and consumer venues, and college campuses.
By Nathan Eddy | August 16, 2021 | mobihealth news
RAIsonance, a group of AI-powered companies focused on natural language processing and AI/ML, announced the release of SoundPass, a trio of AI apps that transform sound data signatures into biometric signal data signatures.
SoundPass uses artificial intelligence to create a biometric perimeter security bubble around workplaces, entertainment venues, public-facing businesses, and college campuses.
The product was designed to bring students back to school and employees back to the office this fall with scalable, efficient controls in place that address the challenges society is currently encountering.
The app learns the unique forced cough signature of each user, which is then securely stored as that user’s baseline for future comparison. If the signature is the same, the user gets an “authenticated” message.
However, if the signatures do not match, the user gets a “not authenticated” message, providing an early warning of a possible problem. Conditions that can alter a baseline forced cough sound include illness and environmental exposure.
The apps come in three editions, Personal, Plus and Access. Personal is free of charge. Plus costs $25 per person, per year, and generates a scannable QR code each time a user authenticates a new forced cough signature to their baseline. The Access app is used to scan the QR code of anyone using SoundPass Plus.
Founded in 2020 in response to COVID-19, and partially funded by National Science Foundation, RAIsonance’s solutions target safety, security and healthcare diagnostics markets, using signal-data signature recognition as a biomarker for human medical diagnostics and in support of safety applications.
"We see a significant opportunity going forward for many different players, some of which we’re actively working to partner with,” Kitty Kolding, CEO of RAIsonance, told MobiHealthNews. “For ourselves, given the approach we take to using AI/ML for security and health purposes, the opportunities are wide open.”
She noted RAIsonance has at least two new products in development to be released on their 2021 road map, all using the same basic capabilities they’ve developed, but serving specific, timely needs in the U.S. and the world.
RAIsonance also has a second product under development, an AI software-as-a-medical device (SaMD) diagnostic for a range of respiratory conditions.
The company recently joined Microsoft for Startups program, giving RAIsonance access to the tech giant’s technologies, including Azure, and to a streamlined path to selling alongside Microsoft and its global partner ecosystem.
“The Microsoft for Start Ups program is really incredible for a start-up,” Kolding said. “Part of the value is the series of credits they offer for software and Azure server utilization which is direct savings for us, and has allowed us to expedite our extensive AI/ML testing with very high capacity CPU and GPU servers.”
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Email: InvestorRelations@raisonance.ai
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Paul McLenaghan Joins RAIsonance as Head of Market Development
Denver, CO, July 23, 2021 – RAIsonance, Inc., a group of AI powered technology solutions companies which help to meet today’s critical health and safety challenges, is proud to announce Paul McLenaghan to its team as Senior Vice President, Market Development.
Before joining RAIsonance, McLenaghan spent 20 years in the advertising technology industry, most recently at Prohaska Consulting, where he worked with major ad tech platforms, publishers, and media companies on data and new product strategy. A market and business development executive with a passion for driving market disruption and transformation, McLenaghan is a versatile leader who combines an ability to generate revenue growth through interaction with external stakeholders, the ability to influence internal product innovation, and the know-how in developing go-to market strategies for new products and technology solutions.
In this role with RAIsonance, McLenaghan will be responsible for influencing adoption and utilization of RAIsonance solutions through partnerships with commercial and non-commercial organizations, as well as identifying new market opportunities for the company.
"We are thrilled to have Paul join our team," said Kitty Kolding, CEO of RAIsonance, Inc. "His background and experience with market development will help expose our company and our offerings to the key partners and markets we’re focused on as we roll out our AI/ML technology solutions."
McLenaghan also spent 15 years of his career at companies such as TARGUSinfo and Neustar where he had a track record of success creating new solutions and lines of business at the intersection of technology, data, and media.
He completed his MBA at the University of Maryland Robert H. Smith School of Business and has BA degrees in Economics and English from Villanova University. He is a dual citizen of Australia and the United States.
About RAIsonance, Inc.
RAIsonance is a family of companies headquartered in the Denver Tech Center in Colorado, dedicated to Artificial Intelligence/Machine Learning (AI/ML)-based solutions for the safety, security, and healthcare diagnostics markets. Originally funded with a grant from the National Science Foundation, RAIsonance has developed breakthrough technology innovations that use Signal Data Signature Recognition as a biomarker for human medical diagnostics and to support ground-breaking safety applications. To learn more about SoundPass go to SoundPass.ai/.
Investor Contact:
Email: InvestorRelations@raisonance.ai
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Email: Press@raisonance.ai
RAIsonance Selected for Microsoft for Startups Program Designed to Help the World’s Most Promising B2B Startups Quickly Scale
Denver, CO, July 1, 2021 – RAIsonance, Inc., a family of Artificial Intelligence/Machine Learning (AI/ML)-based technology companies headquartered in the Denver Tech Center, dedicated to solving today’s critical health and safety challenges, announced today that they have been named the newest member of Microsoft for Startups. This global program provides the tools and resources B2B startups need to rapidly build their business. As a member in the program, RAIsonance will have exclusive access to Microsoft's technologies, including Azure, as well as a streamlined path to selling alongside Microsoft and its global partner ecosystem.
Founded in 2020 in response to COVID-19, and partially funded by National Science Foundation, RAIsonance is a family of companies dedicated to Artificial Intelligence/Machine Learning (AI/ML) based solutions for the safety, security, and healthcare diagnostics markets.
One of the company’s newest products, SoundPass, is a trio of artificial intelligence applications that transforms sound data signatures into biometric signal data signatures.
Users establish a baseline by producing a “forced cough vocalization” multiple times into the app, teaching it to recognize their unique baseline signature. Once this baseline is established, SoundPass users can conduct a self-check at any time to verify whether a change has taken place compared to their own unique baseline.
If nothing has changed, Sound-Pass generates an “authentication” message in under 2 minutes. Users of SoundPass Plus also receive a QR code that can be read by SoundPass Access software at businesses, places of worship, entertainment venues or educational campuses using the SoundPass technology to enhance their safety protocols.
If a user attempts a self-check with SoundPass and is unable to obtain an authentication, this indicates a potential risk. The most common reason for an authentication failure is that the user experienced a change in their cough signature. Conditions that can create such a change to a forced cough sound include illness and environmental exposure, among others.
With support from the Microsoft for Startups program, SoundPass will be able to roll out the SoundPass Access technology rapidly to businesses, educational campuses, entertainment venues, houses of worship or any facility seeking to enable smarter in-person interactions. This rigorous, scientific approach helps employees, customers, visitors and congregants feel more confident and comfortable when returning to in-person interactions and activities.
"We are thrilled to become a part of the Microsoft for Startups program," said Kitty Kolding, CEO of RAIsonance, Inc. "This program will provide us with exposure to thousands of businesses who will utilize our technology solutions to work toward a new normal. Our entire platform has been Azure-based from the start, so we are incredibly excited to collaborate with, and learn from the experts at Microsoft to help build our business faster and better."
"Now is the time to provide peace of mind about returning to in-person activities, and Microsoft is looking forward to working with RAIsonance to make that happen in a bigger way," said Sally Frank, WW Lead, Health & Life Sciences, Microsoft for Startups.
For more information on SoundPass, please visit SoundPass.ai/. For more information on the Microsoft for Startups Program, please visit Microsoft for Startups.
About RAIsonance, Inc.
RAIsonance is a family of companies headquartered in the Denver Tech Center in Colorado, dedicated to Artificial Intelligence/Machine Learning (AI/ML)-based solutions for the safety, security, and healthcare diagnostics markets. Originally funded with a grant from the National Science Foundation, RAIsonance has developed breakthrough technology innovations that use Signal Data Signature Recognition as a biomarker for human medical diagnostics and to support ground-breaking safety applications. To learn more about SoundPass go to SoundPass.ai/.
Investor Contact:
Email: InvestorRelations@raisonance.ai
Media Contact:
Email: Press@raisonance.ai
AI Technology Company Brings Together Revered Team of Healthcare Professionals from Around the Country
Denver, CO, July 1, 2021 – RAIsonance, Inc., a group of AI powered technology solutions companies which help to meet today’s critical health and safety challenges headquartered in the Denver Tech Center, is proud to announce that it has seated its very first Medical Advisory Board to commence its two-year term starting June, 2021.
The distinguished members include:
“We are incredibly gratified to have attracted such an esteemed team of brilliant medical professionals to serve on our Medical Advisory Board,” said RAIsonance’s Chief Medical Officer and Chief Strategy & Planning Officer Maurice Ramirez, DO, Ph.D. “With their guidance and support, we will be extremely well-positioned to bring our groundbreaking AI/ML technologies to market. As we seek to make a meaningful impact on the markets we serve, our Advisory Board will provide us with the essential insights we’ll need to make products that serve practitioners and patients all over the US, and indeed around the world.”
Founded in 2020 in an effort to impact COVID-19, and partly funded by National Science Foundation, RAIsonance is structured as a group of separate companies dedicated to Artificial Intelligence/Machine Learning (AI/ML) based solutions for the safety, security, and healthcare diagnostics markets. “We’re incredibly fortunate to have the opportunity to work with and learn from these expert clinicians,” said Kitty Kolding, CEO of RAIsonance, Inc. “Each individual brings unique perspective and invaluable expertise that will shape our product concepts and specialized technologies as we continue our work in health, wellness, biometrics and safety. It’s hard to overstate how thrilled we are to be working with a team of advisors like this one.”
For more information on RAIsonance, please visit RAIsonance.ai/
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