L2Mtech | February 17, 2021
CE Mark Approval for LimusTrack™, Sirolimus Eluting Coronary Stent System for Cardiovascular Applications.
CE Mark Approval for LomiFlow™, Paclitaxel Drug Eluting Balloon for Cardiovascular Applications
CE Mark Approval for PearlFlow™, Paclitaxel Drug Elutin Balloon for Endovascular Applications
CE Mark Approval for PearlFlow NS™, Self Expandable Nitinol Stent System for Endovascular Applications
CE Mark Approval for FlexiTrack 018™, Peripheral Balloon Catheter for Endovascular Applications
CE Mark Approval for FlexiTrack 035™, Peripheral Balloon Catheter for Endovascular Applications
Bonn, Germany – L2Mtech GmbH has announced the award of its first CE Mark approval on Six (6) products:
LimusTrack™ : Sirolimus Coated Cobalt Chromium Stent with biodegradable polymer for the treatment of coronary artery disease, de novo lesions, restenosis lesions.
LomiFlow™ : Paclitaxel Coated balloon catheter for the treatment of coronary artery disease, small vessels, dilatation of de novo lesions, in-stent restenosis (ISR) cases.
PearlFlow™ : Paclitaxel Coated balloon catheter for the treatment of peripheral arterial disease, PTA, dilatation of stenotic segments or lesions in peripheral arteries.
PearlFlow NS™ : Self-Expanding Nitinol Stent System for the treatment of peripheral arterial disease, de novo lesions, lesions in femoropopliteal arteries.
FlexiTrack 018™ : Peripheral Balloon Dilatation catheter for the treatment of peripheral arterial disease, dilatation of lesions in femoral, popliteal, tibial arteries.
FlexiTrack 035™ : Peripheral Balloon Dilatation catheter for the treatment of peripheral arterial disease, dilatation of lesions in the SFA, femoral arteries.
L2Mtech GmbH Founder and CEO Lalit Mamtani said ‘‘We are very excited to have been awarded our first CE Mark on six products, CE Mark approval represents a key milestone for L2Mtech GmbH and is a testament to the efficacy and safety of our innovative technology products for Cardiovascular and Endovascular applications.“
We now prepare to commercially launch the products in all markets where the CE Mark is recognized. With introduction of our innovative technology products in markets, we will be able to expand treatment options for the benefit of many millions of patients with coronary and peripheral artery disease around the world.
Founded in 2017, L2Mtech GmbH is a privately-owned multinational medical device company headquartered at Bonn, Germany. L2Mtech specializes in design, development, manufacture and commercialization of medical devices that are used by healthcare establishments globally. L2MTech will provide interventional physicians with innovative vascular devices including Drug Eluting Balloon manufactured in Europe.Our Core mission is to build a product portfolio focused on minimally invasive treatment for patients with cardiovascular,endovascular and vascular artery disease. For further information, please visit : L2MTech.de
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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
PRIA Healthcare Management | January 27, 2022
PRIA Healthcare Management (PRIA), a leader in technology-enabled Market Access services that accelerate the adoption and rapid commercialization of innovative devices and procedures, today announced a significant investment fromVirginiabased growth equity firm, Aldrich Capital Partners. With the support of growth capital, PRIA Healthcare will quickly expand its Market Access solutions to innovative Medtech companies facing clinical trials and early reimbursement challenges of novel and life changing therapies.
"After bootstrapping PRIA since our founding in 2012, we could see it was time for us to take the next step as the business grew and the needs in the market continued to expand. After meeting with many potential partners, we chose to work with the team at Aldrich Capital Partners because of their deep experience within our space and enormous set of resources they will bring to the table, outside of just capital."
Mike Simon, Founder and CEO of PRIA Healthcare
PRIA looks to further advance its mission to provide patients and providers across dozens of specialties access to innovative medical devices. PRIA's deep expertise in early reimbursement strategy, clinical trial reimbursement programs, and market-leading patient access programs ultimately enhance the market success of ground-breaking medical device procedures. The investment will be used to develop new products and services, as well as expand its reach to additional medical device manufacturers accelerating PRIA's already impressive growth rate.
PRIA and Aldrich Capital Partners share a common vision around the importance of patient-centric services within the life sciences ecosystem.
"Over the last several years, we have set out to invest in an innovative patient services business serving the life sciences segment and after meeting the PRIA team, we were immediately impressed", saysRaz Zia, General Partner of Aldrich Capital. "The sector-specific expertise, use of technology and vision set PRIA apart from other vendors in the space and we are excited to leverage our resources, relationships and decades of experience in scaling businesses to help the PRIA team realize their full potential."
Informed by clinical data, PRIA partners with leading medical device manufactures and emerging medical device start-ups across the country and uses centralized, data-driven process workflows to deliver coordinated patient access programs that navigate the complexity of coding, coverage and payment for novel procedures. PRIA brings together patients, providers, medical device manufacturers and health insurers to ensure patients receive the best possible care for their situation.
About PRIA Healthcare
PRIA Healthcare Management is a patient access and reimbursement solutions company specializing in patient-based appeals of denied care. PRIA partners with medical device companies, healthcare providers, and healthcare organizations to ensure that patients are afforded appropriate coverage for the care that they are prescribed. Guided by the PRIA Patient Access Process our team of Patient Access Specialists have the experience and expertise to ensure that patient's rights to prescribed care will always be exercised to the fullest extent.
About Aldrich Capital Partners
Aldrich Capital Partners supports disruptive innovation in healthcare IT, fintech, and application software by investing equity capital in privately held growing companies. Founded by experienced investors and operators, who were also successful entrepreneurs, the founders of Aldrich Capital have been responsible for over$1 billionin technology investments since 1999. Both an operations partner and board-level advisor, ACP brings its portfolio companies strategic insight and access to a broad network of relationships built over 50 combined years of entrepreneurship and investing. Aldrich Capital Partners was founded in 2014 and has offices in Silicon Valley and theWashington, DCmetro area.
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.