Nemaura Medical, Inc | January 14, 2022
Nemaura Medical, Inc.(“Nemaura” or the “Company”), a medical technology company focused on developing and commercializing non-invasive wearable diagnostic devices and supporting personalized lifestyle coaching programs, announces the launch for employers and insurers of Miboko, a new metabolic health program using a non-invasive glucose sensor along with an AI mobile application. The Company’s goal is to achieve broad adoption of Miboko as a form of preventative medicine for a wide user base through these commercial channels and is aligned with the general trend in consumer digital healthcare.
“Introducing Miboko to the population at-large through employers and insurers will allow Nemaura to reach a much wider audience in much faster fashion than solely relying on a direct-to-consumer campaign, and in the Western world, these institutions are the most reliable gateway toward wider adoption of preventative health maintenance practices. Being aware of one’s metabolic health and how the body uniquely regulates sugar is key to one’s health. Patients, of course, want to be as informed as possible about their health, and employers and insurers are also aligned with patients in that regard, given the massive productivity losses and healthcare costs at stake on a larger scale across their employee and insured base, respectively. Miboko can help address this substantial market opportunity through our non-invasive, revolutionary approach to healthcare.”
Nemaura CEO Dr. Faz Chowdhury
Nemaura has also submitted a Premarket Approval (PMA) to the United States Food and Drug Administration (FDA) for approval of its glucose monitoring device as a Class 3 medical device. The Company’s PMA was the subject an on-site FDA bioresearch monitoring (BIMO) audit that generated a single Form 483 observation, for which the Company has committed to a full response this quarter. A follow-up BIMO audit of the clinical investigator site has also been scheduled for the current financial quarter.
Miboko has been in development for nearly two years and addresses a significant mass market opportunity that the Company believes could benefit roughly a third to half of the population by using a non-invasive glucose sensor to measure and monitor a user’s metabolic health score, which is based on glucose tolerance or insulin resistance. Those with prediabetes or obesity concerns -- or even those looking to maintain better health through more careful glucose control -- may benefit from such a metabolic health program. How one’s body metabolizes sugar is the main influencer of one’s appetite, weight, sleep quality, and energy and mood levels and even plays a critical factor in chronic diseases (beyond just diabetes), such as heart disease and dementia.
At the heart of the Miboko offering is Nemaura’s non-invasive glucose sensor that is designed to measure insulin resistance, reported as a metabolic health score, and priced to be highly affordable with the program running for an initial two-year period. The program also uses a mobile app to provide users with personalized information by tracking their metabolism. A user can find out how well their body responds to sugar through their metabolic health score — and how what they eat and what they do every day uniquely affects their metabolic health.
Along with the capability to follow metabolic health progress on the app, Miboko users receive weekly and monthly reports that show and explain their body’s unique metabolic health score and a breakdown of how each of their habits are impacting their overall health and wellbeing. Suggestions for small, manageable changes to daily routines, such as eating more or less of a certain kind of food or exercising at a different time of day to coincide with peak energy levels, provide Miboko users with personalized, usable data.
About Nemaura Medical, Inc.
Nemaura Medical Inc. is a medical technology company developing and commercializing non-invasive wearable diagnostic devices. The company is currently commercializing sugarBEAT® and proBEAT™. sugarBEAT®, a CE mark approved Class IIb medical device, is a non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which may help people with diabetes and pre-diabetes to better manage, reverse, and prevent the onset of diabetes. Nemaura has submitted a PMA (Premarket Approval Application) for sugarBEAT® to the U.S. FDA. proBEAT™ combines non-invasive glucose data processed using artificial intelligence and a digital healthcare subscription service and has been launched in the U.S. as a general wellness product as part of its BEAT®diabetes program that is currently undergoing pilot studies.
Additionally, Nemaura has launched Miboko, a new metabolic health and well-being program using a non-invasive glucose sensor along with an AI mobile application that helps a user understand how certain foods and lifestyle habits can impact one’s overall metabolic health and well-being. Nemaura believes that up to half the population could benefit from a sensor and program that monitors metabolic health and well-being.
The Company sits at the intersection of the global Type 2 diabetes market that is expected to reach nearly $59 billion by 2025, the $50+ billion pre-diabetic market, and the wearable health-tech sector for weight loss and wellness applications that is estimated to reach $60 billion by 2023.
Northwell Health | April 13, 2022
Northwell Health, New York’s largest healthcare provider, and Aegis Ventures, a New York-based startup studio announced at their inaugural Healthcare AI Innovation Summit the finalization of definitive agreements to launch Ascertain, a joint company creation platform. Ascertain is a first-of-its-kind partnership that pairs a dynamic venture studio with one of the nation’s largest and most impactful health systems to develop and commercialize breakthrough healthcare AI companies that improve quality and access to care and close health equity gaps.
Ascertain represents a novel, more targeted approach to the way entrepreneurs and healthcare systems collaborate to solve major healthcare challenges. The platform combines clinical and business leadership, expert technical and product teams, access to Northwell’s leading, diverse datasets, and capital resources within a single ecosystem – with a sole focus on building and validating effective solutions that can be rapidly brought to market.
“Ascertain brings a unique structure, an innovative approach, and a compelling vision to create breakthrough healthcare AI companies that are set up for success. We are all driven by the idea that everyone deserves access to high-quality, affordable healthcare. Our aim is clear: to find new, cost-efficient ways to create and accelerate companies that deliver real, equitable solutions.”
Michael Dowling, President and CEO of Northwell Health
Ascertain has commenced the creation of its first portfolio companies in partnership with Northwell’s clinicians and administrators. One such collaboration is focused on bringing substantive improvements in maternal health, working hand-in-hand with Northwell’s recently launched Center for Maternal Health to develop new approaches to detecting and managing serious complications for expectant mothers and babies. Ascertain’s data science team has been working hand-in-hand with Northwell’s Maternal and Fetal Medicine team to examine tens of thousands of cases of preeclampsia, a hypertensive pregnancy complication that disproportionately affects Black mothers in the United States.
Using cutting-edge data science techniques, the Ascertain team aims to deliver an AI solution that helps clinicians predict the risk of developing preeclampsia, enabling them to intervene earlier than previously possible.
“Existing approaches to the detection of preeclampsia often occur too late in pregnancy, once the condition has begun to manifest. An important enabler for a solution to this challenge is predictive analytics, applying available knowledge of a patient's history to enable action far earlier with simple, yet life-saving, clinical interventions. We believe the AI solution Ascertain is currently developing will enable this,” shared Burt Rochelson, MD, Chief of Maternal Medicine at Northwell Health.
“Aegis and Northwell’s multidisciplinary teams are pursuing innovation through a systematic approach that will bring validated solutions to patients more quickly and at a lower cost,” said Bill Schoenfeld, Aegis Ventures Chairman. “Our skillsets are extraordinarily complementary and enable us to address healthcare’s most entrenched quality, equity, and cost problems far more powerfully than either organization could alone.”
Ascertain is preparing to launch multiple companies in 2022 that focus on maternal health, chronic disease detection and management, and next-generation AI tools.
Ascertain’s Chairman Tom Manning shared, “Together, we’re paving a new way forward, a monumental step toward real, proven AI solutions that can bring impact to the world. It is a bold collaboration to drive AI-backed companies that save lives and resolve long-standing health inequities – and realize results that deliver something greater in healthcare.”
Ascertain is committed to building exceptional teams that will embrace this unique opportunity to create unparalleled impact. To learn more about Ascertain or register your interest, please visit https://ascertain.com/.
Ascertain is a revolutionary new partnership between Northwell Health, New York’s largest healthcare provider, and Aegis Ventures, a dynamic startup studio. This unique partnership assembles leading medical, technology, and business resources to create a first-of-its-kind company creation platform for healthcare innovation to address healthcare’s most challenging quality, equity, and cost problems. Ascertain brings $100M in seed-stage capital to bear in pursuit of a three-pronged approach to company creation: internal ideation, commercialization of scientific breakthroughs, and US market entry partnerships for global ventures. Ascertain creates companies that improve quality of care, patient experience, and long-standing health, placing patient needs at the center of every business model, technology solution, and product.
About Northwell Health
Northwell Health is New York State’s largest healthcare provider and private employer, with 23 hospitals, 830 outpatient facilities and more than 16,600 affiliated physicians. We care for over two million people annually in the New York metro area and beyond, thanks to philanthropic support from our communities. Our 77,000 employees – 18,900 nurses and 4,800 employed doctors, including members of Northwell Health Physician Partners – are working to change healthcare for the better. We’re making breakthroughs in medicine at the Feinstein Institutes for Medical Research. We're training the next generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and the Hofstra Northwell School of Nursing and Physician Assistant Studies.
About Aegis Ventures
Aegis Ventures is a next-generation startup studio that partners with entrepreneurs and industry leaders to originate, launch, and scale transformative companies. Our platform brings together market-shaping ideas, permanent growth capital, and ambitious individuals driven to solve major societal problems. We aim to build companies with the capacity for vast impact, with an initial focus on artificial intelligence and digital health. Within these verticals, Aegis seeks to create companies that leverage technology to better optimize tradeoffs between quality, access, and cost, focusing on innovations that promote seamless continuity of care, patient empowerment, and better-informed clinical decision-making.
UniDoc | February 04, 2022
UniDoc Health Corp., an innovator in the telehealth sector, is pleased to advise on a commercial master distribution agreement (the “Agreement”) with Massachusetts-based AMD Global Telemedicine Inc. (“AMD Global”) for the provision of specialized products and services critical to ongoing commercialization efforts.
As a pioneer of virtual care technology, and an industry leader in telehealth solutions, AMD Global has been providing quality healthcare solutions for over 30 years with product sales and registered deployments in 100+ countries. The agreement adds AMD Global as a UniDoc key supplier of telehealth solutions including virtual care software platforms, integrated medical devices, and telemedicine bundled kits.
The products and services will be purposed and integrated into the UniDoc Virtual Care Solutions Model (“VCSM”), which will offer a proprietary, customizable, and comprehensive telehealth solution based on a variety of integrated physical enclosures, kiosks, and related configurable packaging designed to deliver web-based services and analytical tools in combination with access to a developing network of healthcare providers, pharmacies, and hospitals.
All AMD Global products and telehealth technologies are built to provide high performance and quality, are easy to use and maintain, and operate dependably even in difficult environments. AMD Global is ISO 13485:2003 certified and runs an FDA registered facility operating within good manufacturing telemedicine best practices guidelines. The AMD platform provides UniDoc with immediate access to FDA & Health Canada approved devices (FDA Certified; ISO 13485; and FDA GMP – including all HIPPAA privacy and compliance) which support and help propel the Company’s fast-track plans for commercialization.
Mr. Eric Bacon, President of AMD Global Telemedicine Inc. states, we are very pleased to have this opportunity to work with the UniDoc team. Their dedication, passion and commitment are outstanding and adds great value to their ability to drive ahead, overcome obstacles, and keep focused on achieving results. Their offering is unique in its vision and feasibility to scale. We are excited to have been chosen as UniDoc’s provider of choice for their telehealth technology needs today as well as help them extend and develop their telehealth portfolio going forward.”
“We are so very delighted to have this opportunity to work with AMD Global as a key vendor of critical components and services. When we began this venture, we found a very short list of suppliers who so clearly fit our needs and timelines. It didn’t take long to determine that AMD’s medical grade instruments are integrated into high quality software. Additionally, AMD completely met our needs when it came to ensuring all required certification and compliance requirements were already in place. To everyone’s credit on both sides, the synergies were readily apparent, and it didn’t take long to come to an agreement. I’m confident that this arrangement will prove instrumental in unlocking the value of this exciting venture together.”
UniDoc CEO Antonio Baldassarre
About UniDoc Health Corp.
UniDoc is developing a telehealth solution which is being designed as a self-contained remote virtual clinic within a private kiosk for patients to undergo full consultations as if they were present in a physician’s office. Telehealth opens the doors to a large segment of the population challenged by access, experience or understanding of online computer technology. It is the Company’s belief that physical accessibility is the key to its business proposition. UniDoc is dedicated to unlocking shareholder value by delivering an excellent product and sophisticated commercial network within an expedited timeframe.
Microbot Medical | December 28, 2021
Microbot Medical Inc.announced that it has entered into a strategic collaboration agreement with Stryker, a leading global medical technology company. The company will collaborate with Stryker’s Neurovascular division to integrate its neurovascular instruments with Microbot’s LIBERTY Robotic System to develop the world’s first dedicated robotic procedural kits for use in certain neurovascular procedures.
“We have already ensured that the LIBERTY Robotic System has a strong and sustainable competitive advantage, and the collaboration with Stryker will allow us to further expand in the neurovascular space. I believe the similarities in our innovation culture, as well as our complementary core capabilities, will allow us to establish a truly differentiated solution that will benefit all stakeholders and accelerate our goal of changing the way robotic surgery is viewed and adopted.”
Harel Gadot, Chairman, CEO and President of Microbot Medical
The company will continue to develop the LIBERTY Robotic System independently for use in peripheral and coronary procedures. The animal feasibility studies to date support the company’s assertion that it will potentially allow physicians to safely and efficiently conduct remote catheter-based vascular procedures, and reduce the risk for radiation exposure, physical strain on the user and Hospital Acquired Infections (HAIs), without the need for cumbersome and expensive capital equipment.
About Microbot Medical
Microbot Medical Inc.is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, focused primarily on both natural and artificial lumens within the human body. Microbot’s current proprietary technological platforms provide the foundation for the development of a Multi Generation Pipeline Portfolio (MGPP).
Microbot Medical was founded in 2010 by Harel Gadot, Prof. Moshe Shoham, and Yossi Bornstein with the goals of improving clinical outcomes for patients and increasing accessibility through the use of micro-robotic technologies.