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.
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
MERU HEALTH | January 18, 2022
Meru Health, the most comprehensive mental health solution in the market with industry-leading outcomes, and Evry Health, a modern business-to-business health insurance company announced today that they will partner on delivering Meru Health's solution to Evry Health's members in Dallas, Texas starting January 2022.
The Meru Health online mental health solution will be embedded as part of Evry Health's tailored wellness plans that come at no cost to the employer or their employees. These specialized, optional wellness solutions provide a wide range of resources, tools and rewards that are different from other health insurance plans, including benefits such as mental health support through Meru Health. Members will be recommended to the program based on pre-screening criteria as well as Evry Health's data analysis.
For example, if Evry Health receives a claim for cancer screening and oncologist claims, this is a flag to proactively loop the member into Meru Health's mental health program and support cycles. The partnership will focus on delivering outcomes-based mental healthcare and it rewards members for following their personalized care pathways. A member who completes Meru Health's 12-week Therapy program can get up to $100 reward for doing so.
"This is a completely new way of delivering mental healthcare and we are proud to partner with Meru Health to together change how the system works," said Chris Gay, Evry Health CEO. "Focusing on outcomes is the way mental healthcare – and healthcare in general – should be delivered now and in the future. We are confident our members will get the best possible value-based care, and see their mental health improve as they go through the Meru Health program."
Incentivizing members to take care of their mental health can lead to major cost savings down the line. According to data from BCBS, people with major depression are on average nearly 30 percent less healthy than those without depression. This decrease in overall health translates into increased costs: a depressed person has $6,390 more healthcare costs than nondepressed people every year.
Evry Health incentivizes participants to focus on better mental health through its voluntary wellness plans. Rewards are deposited to an Evry Health Reward Card that members use like any other credit card.
Meru Health is focused on delivering the best long- and short-term outcomes in the market. After program completion, 75% of people are in depression or anxiety symptom remission and 85% of people show clinically significant improvement, measured on industry standard PHQ-9 (depression) and GAD-7 (anxiety) scales. The Meru Health Program is one of only digital mental health interventions with published research that shows that these treatment gains last 12 months after the end of treatment.
"We could not be more excited to partner Evry Health, who is changing health insurance just like we are transforming mental healthcare. Together we can really deliver patient-centric care that ensures that people prioritize their mental health. Health plans and employers would benefit a lot focusing more on outcomes. The question we should be asking is are people getting better and staying better after the treatment? I believe trailblazers like Evry Health will be a role model in the industry to start focusing more on care outcomes."
Kristian Ranta, the CEO of Meru Health
About Meru Health
Meru Health is setting the new standard in mental healthcare with the most comprehensive online solution that combines licensed therapists and psychiatrists, a smartphone-based treatment program, biofeedback training, anonymous peer support, and habit-changing activities for sleep, nutrition, and more.
The company is committed to evidence-based care and has published groundbreaking clinical outcomes with Stanford, Harvard, and UC Davis that show promising clinical effectiveness and lasting results. Meru Health offers a convenient, accessible, side-effect-free mental health treatment option in contrast to the standard of care in the U.S. today. Meru Health partners with major health insurance providers like Cigna, Humana, and Moda Health, as well as leading businesses that want to provide best-in-class mental health care for their employees or members.
About Evry Health
Headquartered in Dallas, Evry Health is not your standard health plan. We're on a mission to make healthcare affordable, transparent and high quality again by providing expanded benefits at an affordable price, lowering premiums by up to 20%. We're building the health insurance we've always wanted for ourselves, with a high-tech, mobile-first experience focused on helping people live better, healthier lives.
AdhereHealth | December 18, 2021
AdhereHealth, a healthcare technology leader in medication adherence insights and health outcomes, has entered into a strategic partnership with Hero, the market leader in digital in-home care. This new agreement enables AdhereHealth to deploy Hero's digital in-home care platform to help high-risk, high-cost, chronically ill patients adhere to complex medication regimens.
Hero's platform includes a connected smart pill dispenser, which automatically sorts and dispenses medications according to a patient's unique medication schedule. Hero's connected app then tracks what a patient took and when, and sends real-time alerts to the patient's care team if a dose is missed or a medication is ready for refill. Hero continually monitors the patient's medication inventory and facilitates real-time medication reconciliation and synchronization.
"Combining Hero's industry-leading medication management platform with AdhereHealth's advanced technologies and its nationwide AdhereRx digital pharmacy creates the first complete lifecycle medication management service," said Kal Vepuri, founder and CEO of Hero. "Our partnership will also simultaneously improve patient safety by focusing on medication management, further support caregivers and help people take more control of their health," added Mr. Vepuri.
AdhereHealth's digital pharmacy, AdhereRx, leverages data analytics to identify and prioritize vulnerable populations most at risk for nonadherence or drug safety problems. Trained pharmacists then connect via phone with patients to conduct comprehensive medication reviews and address social determinants of health (SDOH) that might get in the way of medication adherence.
"Hero's patient-centric technology will enable care managers, providers and health plans to remotely monitor medication intake, providing real-time visibility into how patients are adhering to medication regimens at home. Combined with our medication synchronization technologies and our nationwide AdhereRx digital pharmacy solution, we can drive better patient experience and improve value-based outcomes for vulnerable populations."
Jason Z. Rose, CEO of AdhereHealth
Poor medication adherence is a leading cause of re-hospitalizations and ER visits, especially among the elderly and those with chronic conditions. The financial impact is significant: medication nonadherence accounts for 16% of U.S. healthcare spending annually, accounting for more than half a trillion dollars.
Hero is a leading digital in-home care platform delivering the first end-to-end medication management service for patients and caregivers. Hero's solution includes its award-winning smart pill dispenser, medication management app, automatic refills with free delivery and 24/7 live support. Since launching in 2018, Hero has dispensed more than 70 million medications. Hero is used as a care management solution by individuals, caregivers and medical providers.
AdhereHealth delivers purpose-built, innovative technology solutions to improve quality of care, medication adherence, and cost outcomes – all with an emphasis on overcoming social determinants of health (SDOH) and improving patient experience. AdhereRx, an AdhereHealth digital pharmacy, provides high-risk, underserved patients with personalized pharmacy services that drive medication compliance and reduce unnecessary utilization costs. This unique combination of predictive analytics, intelligent clinical workflow software and proactive telepharmacy outreach performed by a nationwide team of licensed clinicians addresses an estimated half a trillion dollars of unnecessary annual medical costs attributed to medication adherence issues. Today, the Adhere™ Platform touches nearly 30 million patients across dozens of health plans, self-insured employers and other risk-bearing entities.