CeloNova BioSciences, Inc. | April 08, 2022
CeloNova BioSciences, Inc. developer and manufacturer of a portfolio of novel surfaced coated technologies, including the proprietary Polyzene™-F nanocoating, announced the strategic decision to focus its core business on creating partnership and co-development opportunities with medical device manufacturers seeking to optimize implant interaction within the body. The company's nanocoated innovation is the result of years of rigorous scientific research and engineering and has been extensively published in numerous academic articles to date.
"We are pleased to offer leading medical device manufacturers access to the unique clinical advantages of our Polyzene-F nanocoated technology that has clinically demonstrated low thrombosis, restenosis and inflammation with rapid healing effects," stated Carl St. Bernard, President and Chief Executive Officer of CeloNova. "This technology offers a significant benefit to companies seeking to improve the clinical performance of their implant technologies."
"I fully support CeloNova's new strategic direction which allows medical device manufacturers to benefit from long-term biocompatibility and thromboresistance of Polyzene-F. When my students and I set out to study the hemocompatibility of this inorganic polymer in our lab in Heidelberg Germany, we soon realized its potential to significantly limit a wide range of implant complications and being broadly applied in the human body and in biomedical devices."
Professor Dr. Michael Grunze, Former Chair and Professor (emeritus) at the Institute of Applied Physical Chemistry of the Ruprecht-Karls-University in Heidelberg and co-inventor of Polyzene-F
CeloNova is based on a rich history of medical innovation with two PzF coated medical implants successfully commercialized in the U.S. and the EU. The company's PzF coated embolic microspheres product line was sold to Boston Scientific in 2015 and the COBRA PzF NanoCoated Coronary Stent, was developed to safely and effectively treat patients who may benefit from 1-month of dual antiplatelet therapy. CeloNova's new business direction builds upon the successful application of PzF in interventional oncology and cardiology and expands its opportunities through the development of new surface coating technologies to address important unmet clinical needs.
"In my pre-clinical research at CVPath since 2012, CeloNova's proprietary Polyzene-F coating has consistently demonstrated a unique advantage of allowing an implant to heal quickly and in a functional way, without the need for antiproliferative drug elution," stated Aloke Finn, MD, Medical Director and Chief Scientific Officer at CVPath and Associate Professor of Medicine at the University of Maryland. "I believe Polyzene-F will continue to play an important role in delivering safety and efficacy in clinical practice."
Polyzene-F is a proprietary, ultra-pure and highly elastic surface coating possessing unique mechanical properties that allow an implant to be coated at a nanoscale level. The coating acts as a biocompatible barrier between the implant, intimal surface and circulating elements in the blood and has demonstrated thromboresistant and anti-inflammatory properties with significantly faster, higher quality healing compared to market-leading technologies.1*
About CeloNova BioSciences, Inc.
CeloNova BioSciences, Inc. is a global medical device company that develops, manufactures and markets novel surfaced coated technologies, including its proprietary Polyzene™-F nanocoating. The next generation nanocoating is the result of years of rigorous scientific research and engineering and has been extensively published in numerous academic articles to date.
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
Endonovo Therapeutics, Inc. | April 26, 2022
Endonovo Therapeutics, Inc. announced an agreement with NAMSA – a leading Global Contract Research Organization and medical device reimbursement specialist – as strategic advisors to develop in-patient and out-patient medical reimbursement strategies for Endonovo’s flagship PEMF product SofPulse®.
“Engaging NAMSA as strategy advisors to develop and apply proven medical device reimbursement strategies is a huge advantage for Endonovo and our shareholders, according to Endonovo CEO Alan Collier. “NAMSA is a proven medical device development partner with relevant therapeutic know-how that is critical when seeking acceleration of reimbursement efforts and commercialization objectives,” he pointed out.
NAMSA was founded in 1967 as a scientific research company and later transitioned into a Global CRO and Medtech (Medical Technologies) reimbursement specialist. Today, it has 1,000 strategic associates who provide Medtech reimbursement advisory expertise to more than 300 clients in 15 global regions.
NAMSA offers a full continuum of reimbursement services for medical technologies. Their reimbursement consultants provide: payer relations, medical policy research, coverage advocacy, Healthcare Common Procedure Coding System Current Procedural Terminology code analysis/applications and health economic analysis.
“Our team strives to bring impactful products like the Endonovo SofPulse into higher adoption. With this technology, and its favorable economics, there are multiple opportunities ahead for serving populations in need. We will work together with the Endonovo team to improve market access for this novel device in the very near term.”,
Joseph Sierra, Director, Reimbursement Consulting, North America, NAMSA
NAMSA provides strategic guidance and tactical support to fast-track medical device commercialization and to make an immediate impact on patient healthcare worldwide. NAMSA’s services have grown to include regulatory, reimbursement and quality consulting as well as clinical research. These additions have helped NAMSA to become the pre-eminent 100% medical device-focused Global CRO that offers proven strategic solutions throughout the full development continuum. NAMSA is the only US FDA ASCA accredited medical device biocompatibility laboratory in the world. This allows medical device sponsors to fast-track commercialization efforts, while achieving time and cost efficiencies in every major market of the world.
Collier stated: “We are fortunate to be working directly with Joseph Sierra, at NAMSA. With over 10 years of reimbursement experience, and his proven track-record in developing successful medical device reimbursement strategies is exemplary and will be helpful in developing the path toward reimbursement for our main product SofPulse®. Joseph is an adjunct instructor at USC Masters of Health Administration Program, and his prior professional work includes successful stints with NeoFect USA and Medtronic Ltd. where he demonstrated a record of success leading roles in reimbursement programs, analysis, and strategies for their medical devices.”
NAMSA’s reimbursement expertise and track-record in the introduction and adoption of medical devices into multiple medical specialties includes: orthopedics, cardiovascular surgery, general surgery, plastic surgery, neurology, robotic surgery and wound care. Collaborating with NAMSA on global reimbursement allows Endonovo to explore reimbursement for the U.S. medical markets as well as the European Union market adoption through SofPulse® medical CE Mark. Additional target markets would be Taiwan and other Asian countries.
About Endonovo Therapeutics Inc.
Endonovo Therapeutics is a commercial-stage developer of noninvasive wearable Electroceuticals® therapeutic devices for pain relief, general wellness and wound curatives. The Company's current portfolio of commercial and clinical-stage wearable Electroceuticals® therapeutic devices addresses wound healing, pain, post-surgical pain and edema, cardiovascular disease, chronic kidney disease, and central nervous system disorders, including traumatic brain injury, acute concussions, post-concussion syndrome and multiple sclerosis. The Company's noninvasive Electroceutical® therapeutic device, SofPulse®, which uses pulsed short-wave radiofrequency at 27.12 MHz, has been FDA-cleared and CE marked for the palliative treatment of soft tissue injuries and post-operative pain and edema. It also has CMS national coverage for the treatment of chronic wounds. The Company's current portfolio of preclinical-stage Electroceuticals® therapeutic devices addresses chronic kidney disease, liver disease, non-alcoholic steatohepatitis cardiovascular and peripheral artery disease and ischemic stroke. The Company's noninvasive, wearable Electroceuticals® therapeutic devices work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur.
Alkem Laboratories Ltd. | January 13, 2022
Alkem Laboratories Ltd. (Alkem) hereby announces to launch a unique patented technology for the treatment of Diabetic Foot Ulcer (DFU) in India. The solution would be based on disruptive 4D Bioprinting technology, which would be used to treat deep, non-healing chronic wounds and is expected to be launched in the Indian market in the latter half of 2022 post regulatory approval. This advanced technology for DFU management has a high scope of preventing amputations in diabetic patients. This technology will be available at affordable rates to Indian patients at a time when there is no definitive treatment for DFU in India.
India currently has approximately 77 mn diabetes patients, the second highest in the world. A diabetic foot ulcer is one of the most significant and devastating complications of diabetes and is defined as a foot affected by ulceration that is associated with neuropathy and/or peripheral arterial disease of the lower limb in a patient with diabetes. Approximately, 12-15% with diabetes suffer from DFU at least once in a lifetime. 5–24% of them will finally lead to limb amputation within 6–18 months after the first evaluation. The risk of foot ulceration and limb amputation increases with age and the duration of diabetes. Alkem has collaborated with Rokit Healthcare Inc. to commercialize the technology in India to help reduce amputation amongst DFU patients considering the negative impact of amputation on a patient's quality of life and the associated economic burden on the healthcare system.
"In India, Diabetes is one of the major healthcare challenges. The challenge in itself is so huge that diabetic foot ulcers often get ignored. Approximately 1 lac people have to undergo amputation every year and compromise on their quality of life. To address the problem, Alkem has collaborated with Rokit Healthcare Inc., a global regenerative solutions company, to bring out novel solutions for the management of diabetic foot ulcers."
Mr. Sandeep Singh, Managing Director, Alkem Laboratories Ltd
Adding further, Mr. Sandeep asserted, "Alkem, over the years, has always been at the forefront in delivering high-quality patient care, through its innovation and patient-centric initiatives."
About Alkem Laboratories Ltd
Established in 1973 and headquartered in Mumbai, Alkemis a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture, and sale of pharmaceutical and nutraceutical products. The Company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs), and nutraceuticals, which it markets in India and International markets. With a portfolio of more than 800 brands in India, Alkem is ranked the fifth largest pharmaceutical company in India in terms of domestic sales. The Company also has presence in more than 40 international markets, with the United States being its key focus market.