Siemens, UM System, MU Health Care launch $133M precision medicine alliance

fiercehealthcare | July 15, 2019

Siemens, UM System, MU Health Care launch $133M precision medicine alliance
German healthcare technology company Siemens will provide $133 million worth of medical technology and equipment to boost the University of Missouri's precision medicine efforts.
Three organizations-Siemens Healthineers, the University of Missouri System and the University of Missouri Health Care-will jointly contribute to the establishment of the Alliance for Precision Health in amounts that could reach $40 million.

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HEALTH TECHNOLOGY

Texas Children's Hospital And Baylor College of Medicine COVID-19 Vaccine Technology Secures Emergency Use Authorization In India

Texas Children Hospital | December 29, 2021

Texas Children's Hospital and Baylor College of Medicine announced today that CORBEVAX™, a protein sub-unit COVID-19 Vaccine, whose technology was created and engineered at its Center for Vaccine Development (CVD), has received Emergency Use Authorization (EUA) approval from the Drugs Controller General ofIndia(DCGI)to launch inIndiawith other underserved countries to follow. Dubbed "The World's COVID-19 Vaccine", it uses a traditional recombinant protein-based technology that will enable its production at large scales making it widely accessible to inoculate the global population. The initial construct and production process of the vaccine antigen was developed at Texas Children's Hospital CVD, led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez and in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE). CORBEVAX™ after completing two Phase III clinical trials involving more than 3000 subjects was found to be safe, well tolerated and immunogenic: CORBEVAX™ demonstrated superior immune response in comparison with COVISHIELD™ vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. CORBEVAX™ vaccination also generated significant Th1 skewed cellular immune response. CORBEVAX™ nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies. CORBEVAX™ nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies. While none of the subjects who took CORBEVAX™ or COVISHIELD™ had serious adverse events, CORBEVAX™ had 50 percent fewer adverse events than COVISHIELD™. In the continuous monitoring of phase II studies, CORBEVAX™ showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to >80% drop observed with majority of the vaccines. "Protein-based vaccines have been widely used to prevent many other diseases, have proven safety records, and use economies of scale to achieve low-cost scalability across the world," said Dr. Maria Elena Bottazzi, Professor and Associate Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Our decade-long studies advancing coronavirus vaccine prototypes has led to the creation of this vaccine, which will fill the access gap created by the more expensive, newer vaccine technologies and that today are still not able to be quickly scaled for global production." The need for safe, streamlined, low-cost vaccines for middle- to low-income countries is central to the world's fight against the COVID-19 pandemic. Without widespread vaccination of populations in the Global South, additional virus variants will arise, hindering the progress achieved by currently available vaccines in the United States and other Western countries. "This announcement is an important first step in vaccinating the world and halting the pandemic. Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant," said Dr. Peter Hotez, Professor and Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Widespread and global vaccination with our Texas Children's-Baylor-BE vaccine would also forestall the emergence of new variants. We have previously missed that opportunity for the alpha and delta variant. Now is our chance to prevent a new global wave from what might follow." "Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality. We deeply appreciate Texas Children's Hospital Center for Vaccine Development, Baylor, CEPI, the Bill and Melinda Gates Foundation, and the government of India for their continuous support and cooperation during this journey. The combined efforts & unceasing support demonstrate that we can collectively overcome any challenge". Mahima Datla, Managing Director, Biological E. Limited ABOUT TEXAS CHILDREN'S HOSPITAL Texas Children's Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children's hospital in Texas, and among the top in the nation, Texas Children's has garnered widespread recognition for its expertise and breakthroughs in pediatric and women's health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children's Hospital West Campus, a community hospital in suburban West Houston; and Texas Children's Hospital The Woodlands, the first hospital devoted to children's care for communities north of Houston. The organization also created Texas Children's HealthPlan, the nation's first HMO for children; has the largest pediatric primary care network in the country, Texas Children's Pediatrics; Texas Children's Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that's channeling care to children and women all over the world. Texas Children's Global Health program leads efforts that advance health care equity through innovative collaboration in care, education and research for underserved populations globally. Texas Children's Hospital is affiliated with Baylor College of Medicine. ABOUT TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world. Established in Washington DC as the Sabin Vaccine Institute Product Development Partnership (PDP) in the year 2000 and after relocating to the Texas Medical Center in 2011, it rebranded as Texas Children's Center for Vaccine Development. For the past two decades it has acquired an international reputation as a non-profit PDP, advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. In addition, it builds and strengthens capacity for vaccine development locally and with foreign nations and leads global efforts to guide and influence vaccine policy and advocacy through "vaccine diplomacy" as an international bridge for peace and vaccine development capacity. ABOUT BCM VENTURES Baylor College of Medicine Ventures is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. We do this by engaging university innovators, entrepreneurs and industry to fully develop ideas along their best commercial path. We foster a culture of commercialization and engage with industry to identify market opportunities for collaborative ventures. ABOUT BIOLOGICAL E. LIMITED Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio. In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

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DIGITAL HEALTHCARE

Nemaura Medical Launches Metabolic Health Program for Employers and Insurers

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.

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HEALTH TECHNOLOGY

Stryker, One of the World’s Leading Medical Technology Companies, announces definitive agreement to acquire Vocera Communications

Stryker | January 07, 2022

Strykerannounced today a definitive merger agreement to acquire all of the issued and outstanding shares of common stock of Vocera Communications, Inc.for $79.25 per share, or a total equity value of approximately $2.97 billion and a total enterprise value of approximately $3.09 billion (including convertible notes). Vocera, which was founded in 2000, has emerged as a leading platform in the digital care coordination and communication category. The importance of this growing segment has continued to expand throughout the pandemic as it aims to reduce cognitive overload for caregivers and enables them to deliver the best patient care possible. Vocera brings a highly complementary and innovative portfolio to Stryker’s Medical division that will address the increasing need for hospitals to connect caregivers and disparate data-generating medical devices, which will help drive efficiencies and improve safety and outcomes. Vocera’s highly developed software competency, unique and innovative hardware solutions, and the ability to securely enable remote communication between patients and their families, complements Stryker's Advanced Digital Healthcare offerings. The combined business will further advance Stryker’s focus on preventing adverse events throughout the continuum of care. “This acquisition underscores our commitment and focus on our customer. Vocera will help Stryker significantly accelerate our digital aspirations to improve the lives of caregivers and patients.” Kevin Lobo, Chair and Chief Executive Officer, Stryker “Today’s milestone represents an exciting opportunity for Vocera given the clear alignment of mission, goals and culture between our two organizations and our ability to drive even greater economic and clinical value for our customers,” said Brent Lang, Chairman and Chief Executive Officer, Vocera. Under the terms of the merger agreement, Stryker will commence a tender offer for all outstanding shares of common stock of Vocera for $79.25 per share in cash. The boards of directors of both Stryker and Vocera have unanimously approved the transaction. The closing of the transaction is subject to expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, completion of the tender offer and other customary closing conditions. The acquisition is expected to close in the first quarter of 2022 and is expected to have a neutral impact to net earnings per diluted share in 2022. About Stryker Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. About Vocera The mission of Vocera Communications, Inc. is to improve the lives of healthcare professionals, patients, and families. Founded in 2000, Vocera provides clinical communication and workflow solutions that help protect and connect team members, increase operational efficiency, enhance quality of care and safety, and humanize the healthcare experience. More than 2,300 facilities worldwide, including nearly 1,900 hospitals and healthcare facilities, have selected Vocera solutions to enable their workforce to communicate and collaborate with co-workers and engage with patients and families. Mobile workers can choose the right device for their role or task, including smartphones or one of the company’s wearable communication devices, and use voice commands to easily reach people by name, role, or group. The hands-free Vocera Smartbadge was named to TIME’s list of the 100 Best Inventions of 2020. Vocera solutions can integrate with more than 150 clinical and operational systems, including electronic health records, nurse call systems, ventilators, physiological monitors, and more. In addition to healthcare, Vocera solutions are found in aged care facilities, veterinary hospitals, schools, luxury hotels, retail stores, power facilities, and more.

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HEALTH TECHNOLOGY

Microbot Medical Announces Strategic Collaboration with Stryker Corporation to Develop the LIBERTY® Robotic System for Neurovascular Applications

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.

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