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.
FUTURE OF HEALTHCARE
Trinity Health | April 20, 2022
Trinity Health and CommonSpirit Health announced they have signed an agreement for Trinity Health to acquire all facilities and assets of MercyOne, a regional health system based in Iowa. Since 1998, MercyOne has operated under a joint operating agreement between not-for-profit Catholic health care organizations Trinity Health and Catholic Health Initiatives, which is now CommonSpirit.
MercyOne is a leading health system in Iowa and serves more than 3.3 million patients each year. The system includes 16 medical centers, 27 affiliate organizations and more than 420 care sites offering a range of health and wellness services, including provider services and urgent care, and more than 20,000 colleagues including 2,000 of the state's most talented doctors and providers.
"True to our shared Catholic mission, our goal is to provide high-quality, compassionate care with the best patient/member experience possible. We will accomplish that goal through a holistic approach, with a range of health services and technologies that are fully connected and coordinated. This agreement creates a fully integrated MercyOne to care for more people in a unified way."
Mike Slubowski, president and chief executive officer at Trinity Health
After months of analysis and due diligence, Trinity Health and CommonSpirit determined a sole parent is the best path forward for MercyOne and for the communities it serves. Trinity Health, a national health system spanning 25 states, will bring unified strategies and operations to MercyOne's care sites, including one set of system services.
As an example, MercyOne will transition to Trinity Health's common platforms, including a single electronic health record (EHR), ultimately allowing patients to easily manage their care across all MercyOne services and facilities. The result is a more convenient and consistent care experience for MercyOne's communities.
"After two decades of successful collaboration, we are immensely proud of our partnership with Trinity Health and our efforts to advance health care statewide," said Marvin O'Quinn, president and chief operating officer at CommonSpirit Health. "While the current structure has been instrumental in growing our health care services in Iowa, we believe this decision is ultimately what is best for our patients, colleagues, and our communities."
"We strongly believe this transition to become a full member of the Trinity Health family will result in a stronger, more cohesive health system better able to offer a convenient and personalized circle of care for all we serve," said Bob Ritz, president and chief executive officer at MercyOne. "We are delighted to have the agreement in place as we plan for the future of our mission. We are grateful to CommonSpirit for more than 20 years of partnership."
Trinity Health and CommonSpirit will now plan for integration, complete regulatory filings, and take other steps necessary to finalize the transaction, which is expected to be completed summer 2022. This process will be seamless for the communities MercyOne serves, and patients can continue to expect the same compassionate care they have always received.
About Trinity Health
Trinity Health is one of the largest not-for-profit, Catholic health care systems in the nation. It is a family of 115,000 colleagues and nearly 26,000 physicians and clinicians caring for diverse communities across 25 states. Nationally recognized for care and experience, Trinity Health's network of care includes 88 hospitals, 131 continuing care locations, the second largest PACE program in the country, 125 urgent care locations, and many other health and well-being services. Based in Livonia, Michigan, its annual operating revenue is $20.2 billion with $1.2 billion returned to its communities in the form of charity care and other community benefit programs. For more information, visit www.trinity-health.org or follow us on LinkedIn, Facebook or Twitter.
About CommonSpirit Health
CommonSpirit Health is a nonprofit, Catholic health system dedicated to advancing health for all people. It was created in February 2019 by Catholic Health Initiatives and Dignity Health. With its national office in Chicago and a team of over 150,000 employees and 25,000 physicians and advanced practice clinicians, CommonSpirit operates 140 hospitals and more than 1,500 care sites across 21 states. In FY 2021, CommonSpirit had revenues of $33.3 billion and provided $5.1 billion in charity care, community benefit, and unreimbursed government programs. Learn more at www.commonspirit.org.
MercyOne is a connected system of health care facilities and services dedicated to helping people and communities live their best life. MercyOne's care providers and staff make health the highest priority. The system's clinics, medical centers, hospitals and affiliates are located throughout the state of Iowa and beyond. Headquartered in central Iowa, MercyOne was founded in 1998 through a collaboration between Catholic Health Initiatives, now CommonSpirit Health, and Trinity Health - two of the country's foremost, not-for-profit Catholic health organizations.
FUTURE OF HEALTHCARE
Optum | April 06, 2022
Optum, a diversified health services company, and Change Healthcare a health care technology leader, have agreed to extend their merger agreement to December 31, 2022.
“The extended agreement reflects our firm belief in the potential of our combination to improve health care, and in our commitment to contesting the meritless legal challenge to this merger.”
In a joint statement, the companies
Change Healthcare and Optum share a vision for achieving a simpler, more intelligent and adaptive health system for patients, payers and providers. The combination of Optum and Change Healthcare will connect and simplify the core clinical, administrative and payment processes health care providers and payers depend on to serve patients. Increasing efficiency and reducing friction will benefit the entire health system, resulting in lower costs and a better experience for all stakeholders.
Change Healthcare and Optum will detail the benefits of this combination at a two-week trial scheduled to begin on August 1. The U.S. Department of Justice’s attempt to block the combination is without merit and serves only to delay improving the experience and outcomes for all participants in the health system.
As part of the extension, Optum will pay a $650 million fee to Change Healthcare in the event the merger is unable to be completed because of the court’s decision. Change Healthcare will pay a special cash dividend of $2.00 per share to its shareholders at or about the time of the closing.
Optum is a leading information and technology-enabled health services business dedicated to helping make the health system work better for everyone. With more than 190,000 people worldwide, Optum delivers intelligent, integrated solutions that help to modernize the health system and improve overall population health. Optum is part of UnitedHealth Group.
About Change Healthcare
Change Healthcare is a leading healthcare technology company focused on insights, innovation, and accelerating the transformation of the U.S. healthcare system through the power of the Change Healthcare Platform. We provide data and analytics-driven solutions to improve clinical, financial, administrative, and patient-engagement outcomes in the U.S. healthcare system.
Ivenix | April 01, 2022
Ivenix, Inc. announced that it has entered into a definitive agreement to be acquired by Fresenius Kabi, a global health care leader specializing in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Ivenix’s advanced infusion system combined with Fresenius Kabi’s intravenous fluids and infusion therapy offerings will bring a comprehensive portfolio of infusion products to U.S. hospitals. The purchase price will be a combination of US$240 million upfront payment and milestone payments linked to achievements of commercial and operating targets.
The transaction is subject to regulatory approvals and other customary closing conditions and is expected to close by mid-2022.
The transaction is designed to
Create a comprehensive portfolio that joins the industry’s most advanced infusion pump technology with the newest source of intravenous fluids, infusion supplies and accessories.
Accelerate operational and commercial growth and scale providing a platform for rapid expansion.
Build on a shared culture of exceptional customer service.
Establish Fresenius Kabi as a leader in the approximately $5 billion infusion segment.
This pivotal transaction will accelerate innovation, expand our combined infusion therapy portfolio and enhance our infusion capabilities, resulting in improved medication safety and operational efficiency.
“We’re very pleased to partner with Fresenius Kabi, a leading global health care company. Together, we intend to transform the standard of care for North American health care providers and patients by providing the highest level of safe and effective integrated infusion care,”
Jorgen B. Hansen, Ivenix’s Chief Executive Officer
The Ivenix Infusion System includes a large-volume infusion pump with administration sets, infusion management tools, and analytics to inform care and advance efficiency. Ivenix centered the system around the patient and clinician and designed it to reduce infusion-related errors and drive down the total cost of ownership. After receiving U.S. Food and Drug Administration (FDA) clearance, Ivenix successfully launched the infusion system in 2021.
“Combining Ivenix’s expertise in pump technology and software with our infrastructure, portfolio, and presence in hospital settings represents an ideal opportunity. We intend to scale the launch of Ivenix’s next-generation infusion system while driving growth opportunities in the United States. With today’s announcement, Fresenius Kabi expects to create a leading, comprehensive infusion therapy offering,” said Michael Sen, President and CEO, Fresenius Kabi.
Ivenix, Inc. is a medical technology company with a vision to eliminate infusion-related patient harm. The company was founded to develop innovative solutions that transform infusion delivery. Ivenix designed an infusion system from the ground up to streamline medication delivery and bring infusion technology into the digital age. The Ivenix Infusion System includes a large-volume infusion pump supported by a robust infusion management system designed to set new standards in simplicity, intelligence, and reliability. For more information, visit ivenix.com. The Ivenix Infusion System is cleared by the FDA.