Hekka Labs | January 15, 2022
Hekka Labs launches a game changing decentralized healthcare ecosystem for a far more efficient health record management. The firm will concentrate on the Southeast Asia market, starting with India, where it will establish the largest chronic disease data management network. Hekka then intends to connect to the rest of the world's healthcare market through the design and implementation of proprietary Distributed Ledger Technology (DLT).
Hekka has cemented initial partnerships with 3 Indian healthcare solution providers, Curisin, a healthcare company with a wide network of 30 million patients and 40,000 partnered doctors which as recently agreed to provide a minimum of 1.5 million medical records in 2022. A further agreement to provide up to 20 separate blood biomarkers together with Covid 19 data on 100,000 patients, will form the basis of an initial trial for its blockchain audit trail platform. IMMUNIDEX, a healthcare solution provider offering tests and applications that are driven by proprietary AI that can identify early immune-related risks and is well placed to capture highly valuable data for the Hekka network. TELEMEDICINE INDIAN CO, a start-up offering multi telemedicine services, multiple blood tests, and health screening including COVID-19 testing will form another integral part of data generation for the Hekka ecosystem.
Hekka Labs with the integration of Distributed Ledger Technology (DLT) offers a plug and go solution that allows users to interact with the HEKKA ecosystem without major disruption. This set up can solve the inherent problems that occur on a regular basis in the healthcare industry such as inefficient biomarker management, document hogging and unstructured data management.
Hekka Labs has set out to become the leading chronic illness and immunology platform in India. Hekka's private and public blockchain network solution will generate a new trust in Indian healthcare data management and can open up significant opportunity for both the domestic and global collaboration. This will lead to new levels of ethical standards and excellence for the Indian healthcare market.
In the long run, Hekka plans to evolve as a significant decentralized healthcare ecosystem by connecting the network of medical and associated healthcare providers culminating in a targeted community of over 500 million patients. As a result, tens of billions of chronic disease digital biomarkers can be made available for Deep Learning, potentially speeding up new healthcare discoveries.
HEK is the native token of the Hekka ecosystem, which is launched in the Ethereum network's ERC-20 standards for its intensive security and global reputation, ensuring the confidence of delivering the most sophisticated healthcare data management service.
The HEK token is a token complimented by an ATOM token (Points) system which is the primary source of HEKKA 's data transfers. This ensures the value of the token. The HEK token will be a key component in serving all prospective users' interactions with the platform's different levels of service.
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.
Medtronic | January 11, 2022
Medtronic plc, a global leader in healthcare technology,today announced it has received approval fromJapan'sMinistry of Health, Labor and Welfare for the sale and reimbursement of the Micra™ AV Transcatheter Pacing System (TPS), and the company will launch the product this month.
This approval expands the number of patients inJapan– one of the largest markets in the world – who are eligible to receive the Micra TPS, the world's smallest pacemaker. The Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired. The Micra TPS is the first-ever leadless pacemaker; its first version (the Micra VR) was approved inJapanin 2017 for patients who only require single-chamber pacing.
"Pacemakers have made significant progress over their approximately 60-year history, including miniaturization, improvements in pacing technology, MRI compatibility, and remote monitoring," explainedKyoko Soejima, professor of cardiovascular internal medicine at Kyorin University Hospital and a member of the Micra TPS Global Clinical Trial steering committee. "The first Micra system transformed the concept of pacemakers by eliminating surgical pockets and leads, and Micra AV promises to deliver the benefits of leadless pacing to a larger number of patients because ventricular pacing can be performed synchronously with the atrium."
Historically, patients with AV block have been treated with traditional dual-chamber pacemakers which are implanted in the upper chest, under the skin below the collar bone, and connected to the heart using thin wires called "leads." Identical in size and shape to the original Micra TPS, Micra AV has several additional algorithms which detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, providing "AV synchronous" pacing therapy to patients with AV block.
The Micra AV approval is based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. The study evaluated the ability of the Micra's internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony.
"Since introducing the first battery-powered external pacemaker in 1957 to the innovative Micra leadless pacemaker portfolio, Medtronic continues to pioneer pacing innovations for physicians and their patients."
Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiac Rhythm Management business at Medtronic
About the Micra Transcatheter Pacing Systems (TPS)
The Micra TPS received CE Mark inApril 2015and U.S. FDA approval in 2016. Comparable in size to a large vitamin, Micra is less than one-tenth the size of traditional pacemakers yet delivers advanced pacing technology to patients via a minimally invasive approach. During the implant procedure, the device is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.
Unlike traditional pacemakers, Micra does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to leads and pockets are reduced, and there is no visible sign of the device.
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered inDublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.
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.