Medical Management News in Medical XPRThttps://www.medical-xprt.com/medical-management/newsMedical Management News in Medical XPRThttps://www.medical-xprt.com/images/logo.gifhttps://www.medical-xprt.com/medical-management/newsMedical Management News in Medical XPRTCorify Care participated in the CEI Satellite Meeting CinC 2020: Challenges in the Daily Application of ECGIhttps://www.medical-xprt.com/news/corify-care-participated-in-the-cei-satellite-meeting-cinc-2020-challenges-in-the-daily-application--1057536<![CDATA[ Last 18th of September, Corify Care CEO and co-founder, Dr. Andreu Climent participated in the CEI Satellite Meeting CinC 2020: ECGI Past, Present, and Future: from Engineering to Clinical Application organised by the Consortium for ECG Imaging. The objective was to discuss engineering hurdles for ECGI being incorporated into clinical practice and are partnering with industry leaders to discuss these difficult and important topics.Dr. Climent participated in panel discussion 1 together with Dr. Pietro Bonizzi and Dr. Jo&eacute;l Karel. He highlighted ECGI is an attractive idea and in order to become clinically useful needs (A) to provide useful information in the decision-making process and (B) to facilitate the clinical practice with easy procedures. CEO&rsquo;s Corify presented the technology developed by Corify and explained that our medical device (Acorys) is an ECGI mapping system that uses 3D real time scanning to provide epicardial cardiac maps without the need of CT or MRI scans. Acorys can help clinicians to visualize cardiac activity in a single procedure both in a regular visit and during an ablation.&ldquo;ECGI need to be precise but even more, it needs to be useful and easy to use because clinicians and patients need better and easier to use mapping solutions.&rdquo; Andreu ClimentThe meeting was completely virtual.]]>Fri, 13 Nov 2020 00:00:00 +0100https://www.medical-xprt.com/news/corify-care-participated-in-the-cei-satellite-meeting-cinc-2020-challenges-in-the-daily-application--1057536mapping systemmedical devicepatient needelectrocardiogramMRI scanningclinical practiceclinical useclinical need3D scanningcardiac activitycomputed tomography scanning10 Years of Peer-Reviewed Studies Predicting and Informing the Prognosis Profile of Autoimmune Patientshttps://www.medical-xprt.com/news/10-years-of-peer-reviewed-studies-predicting-and-informing-the-prognosis-profile-of-autoimmune-patie-1055413<![CDATA[ Recent journal publications are fortifying the clinically important role of the 14-3-3&eta; blood test along the whole continuum of RA and autoimmune patient care. From RA meta-analysis data through to 14-3-3&eta; expression in juvenile idiopathic arthritis and secondary Sj&ouml;gren&rsquo;s syndrome in Lupus, the importance of this protein across a spectrum of autoimmune conditions is clear. ]]>Thu, 11 Nov 2021 00:00:00 +0100https://www.medical-xprt.com/news/10-years-of-peer-reviewed-studies-predicting-and-informing-the-prognosis-profile-of-autoimmune-patie-1055413data analysisblood testblood testingpatient careautoimmunearthritisautoimmune conditionlupusarthritis secondaryAdjustability on the gohttps://www.medical-xprt.com/news/adjustability-on-the-go-1073358<![CDATA[Adjustable prosthetics are the future direction for prosthetic technology. Patients are seeking out ways to adjust their prosthetic when their limb changes and prosthetists are taking note of this demand. Many patients report their limb goes through changes during the day and being unable to adjust can lead to skin irritation or even tripping and falling. Persons with recent amputation will experience drastic changes in their limb volume over the first year. Using socks is one way to fill in the missing volume, however too many socks can reduce total contact and therefore a proper fit. iFIT's patented buckle system allows the wearer to adjust their socket whenever and wherever they are. All sockets are further modifiable by the prosthetist so they can accommodate even large changes in volume.]]>Tue, 20 Jul 2021 00:00:00 +0100https://www.medical-xprt.com/news/adjustability-on-the-go-1073358adjustable socketskin irritationskin irritantpatient reportingNeurescue`s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arresthttps://www.medical-xprt.com/news/neurescue-s-breakthrough-intelligent-balloon-catheter-fda-510-k-cleared-for-hemorrhage-control-and-i-1055970<![CDATA[COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market the company&rsquo;s NEURESCUE&reg; device for temporary occlusion of large vessels, including patients requiring emergency control of hemorrhage. The company also announced the FDA approval of its Investigational Device Exemption (IDE) application to conduct a clinical trial of a novel cardiac arrest treatment indication. The NEURESCUE device is the world&rsquo;s first intelligent balloon catheter for aortic occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment. The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the aorta to redirect blood flow towards the upper body. The procedure is performed to provide additional time to control blood loss and bridge patients to additional life-saving treatment options. "The NEURESCUE device represents a significant advancement that could meaningfully improve the survival rates for emergency patients,&rdquo; said Maham Rahimi, M.D., Ph.D., assistant professor of cardiovascular surgery at Weill Cornell School of Medicine. &ldquo;The device gives patients suffering traumatic blood loss a longer window of time to receive appropriate medical interventions, which can directly translate to saved lives.&rdquo; Hemorrhage is a substantial global unmet need, with more than 60,000 deaths per year in the U.S., and an estimated 1.9 million deaths per year worldwide, 1.5 million of which result from trauma, such as car accidents.1 Cardiac arrest represents an even larger unmet need, with more than half a million deaths each year in the U.S. alone. Today, only 1 out of 10 survive a cardiac arrest with the current treatment and it is estimated to be the single largest cause of death worldwide.2 Neurescue aims for its device to help increase the survival rate for these patients. &ldquo;The FDA 510(k) clearance is an incredible milestone towards achieving our mission, saving the hearts and minds of emergency patients worldwide, giving us market authorization in the biggest medical device market in the world. Additionally, we have received FDA IDE approval to investigate a novel indication for the treatment of cardiac arrest,&rdquo; said Habib Frost, M.D., founder and CEO of Neurescue. &ldquo;Today we moved the bar forward for an often underserved, large group of patients. We&rsquo;re excited about the tremendous potential of our device to improve outcomes for millions of patients and look forward to starting our U.S. clinical trial of the cardiac arrest indication.&rdquo; ]]>Thu, 10 Jun 2021 00:00:00 +0100https://www.medical-xprt.com/news/neurescue-s-breakthrough-intelligent-balloon-catheter-fda-510-k-cleared-for-hemorrhage-control-and-i-1055970pressure monitoringpressure regulatorpressure monitorsafety systemmedical devicecardiac arrestcardiac survivalblood flowaortic occlusionblood pressureemergency patientfemoral arteryclinical trialcatheteraortic catheterballoon cathetermedical device industrysurgerycardiovascular surgerycardiovascularmedical device developmentblood pressure deviceadvanced medical deviceinflation deviceresuscitationblood flow braintissue damageblood brainblood losshemorrhage controlblood pressure monitorcatheter basedcatheter devicepatient usepatient bloodartery femoraldrug administrationcatheter positioningconductivityNew device offers a mouthful of data for chronic diseaseshttps://www.medical-xprt.com/news/new-device-offers-a-mouthful-of-data-for-chronic-diseases-1055693<![CDATA[Aidar Health, formerly known as Multisensor Diagnostics, has developed a portable hand-held device that allows patients to measure and track vital signs in a matter of seconds. Roughly the size of an iPhone, MouthLab consists of a hand unit and a mouthpiece that fits between the teeth and lips. The mouthpiece uses special sensors to gather information from breathing patterns, saliva and blood vessels in the lips and hands. Users inhale and exhale into the mouthpiece and, within 30 seconds, MouthLab measures 10 different parameters of their health: temperature, blood pressure, electrical activity of the heart, oxygen saturation, pulse rate, respiratory rate, breathing pattern, heart rate, heart rate variability and lung function. &ldquo;Let&rsquo;s take, for example, a credit report or FICO score,&rdquo; said Sathya Elumalai, president and CEO of Aidar Health. &ldquo;People don&rsquo;t look at it every single day, but if something is wrong and there&rsquo;s a negative effect, they look at it. Those scores are not determined based on your credit card performance. It&rsquo;s based on several other factors. Similarly, when it comes to health, there&rsquo;s a variety of factors responsible for somebody&rsquo;s health. We are collecting only a tiny percentage &hellip; but everything adds value.&rdquo; The information is securely stored in the cloud and sent in real time to patients, caregivers and health care providers using technology to connect directly to a 4G network, called LTE-M. Currently, MouthLab aims to help patients manage ongoing diseases, specifically heart failure and chronic obstructive pulmonary disease (COPD), but Elumalai said he plans to add more sensing capabilities to the device in the future to read other biological indicators of health, making it a useful monitoring device for everyone. &ldquo;The ultimate goal is to measure all the different parameters,&rdquo; Elumalai said. &ldquo;Ideally, we want every single individual in the world to use it. It is not just a device for helping patients, but we wanted to have this device as a daily monitoring tool.&rdquo; Aidar Health, which participated under its previous name in the TMC Innovation Institute&rsquo;s TMCx accelerator program, is currently conducting clinical studies at Johns Hopkins University and plans to submit its application for U.S. Food and Drug Administration approval early next year.]]>Wed, 02 Oct 2019 00:00:00 +0100https://www.medical-xprt.com/news/new-device-offers-a-mouthful-of-data-for-chronic-diseases-1055693thickness monitoringheart diseasechronic diseaseblood pressureblood vesselpatient carepatient managementpatient healthpatient trackingclinical studyheart failurepulmonary diseaseCOPDlung functionhealthcarehealthcare technologyheart rateoxygen saturationblood salivablood pressure temperaturediagnostics developmentlung functionalitydisease managementdisease specificpatient specificdisease chronicdrug administrationdrug approvalrespiratory ratelung functionsbreath ratebreath salivaconductivityEmpatica and BARDA Join Forces to Validate Wearable System That Detects COVID-19 Before Symptoms Appearhttps://www.medical-xprt.com/news/empatica-and-barda-join-forces-to-validate-wearable-system-that-detects-covid-19-before-symptoms-app-1056852<![CDATA[ BOSTON, June 19, 2020 /PRNewswire/ -- Digital healthcare company Empatica announces a pioneering new partnership with the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), to validate an early warning system for COVID-19 and other respiratory infections using its wearable sensors and proprietary algorithm. The system, named Aura, is completely noninvasive, utilizing Empatica's medical smartwatches, software, and artificial intelligence capabilities. Aura will enable continuous and real-time insight into the likelihood of SARS-CoV-2 infection before symptoms present, and send a warning to the user and their healthcare provider. In February 2019, Empatica and BARDA's Division of Research, Innovation and Ventures (DRIVe) began to develop a digital biomarker that predicts respiratory infections. Preliminary findings have been promising, showing a strong correlation between viral shedding and changes in a person's physiology. Now Empatica will be sponsored to run a validation trial specific to early detection of COVID-19. The aim is to validate Empatica's algorithm in real-life settings, with the participation of healthcare workers who are exposed to a high viral load while treating hospitalized COVID-19 patients. They will wear the E4, Empatica's medical-grade research wearable wristband, for 30 days, and their physiological data will be reviewed against daily nasopharyngeal (NP) samples and a daily qRT-PCR swab, ensuring the highest ground truth. Empatica CEO Matteo Lai, stated, "We are very proud to join forces with BARDA to help improve the health and safety of millions of Americans going back to work. This product introduces a new paradigm: empowering individuals and institutions with smart health monitoring, so that they will know early when they need to self-isolate and take care of themselves. Without BARDA's leadership and foresight over the past year, our early detection algorithm would not have reached this pivotal stage of clinical validation, which will accelerate our request for FDA's approval of Aura as a medical product for use by people at risk of contracting COVID-19." BARDA Acting Director, Gary Disbrow, Ph.D., added, "We anticipate that access to real-time and actionable health information will empower people to seek medical advice and care sooner, or to adopt behavioral changes such as temporary self-isolation that can help reduce the spread of COVID-19 and similar infections." Early detection can protect frontline workers, reduce spread, and improve the overall public health response as lockdowns ease globally. Recent estimates by CDC suggest that 35% of infections are asymptomatic, making contact tracing and containment of the virus a challenge. Meanwhile, the most infectious period could be 1 to 3 days before symptoms start, so even those patients who eventually display symptoms can still infect their family, colleagues and other people they interact with, before realizing they are ill. Digital biomarkers like Aura can help efficiently triage patients, enabling more effective care and prioritization of cases, and potentially saving lives. Contact care@empatica.com for more info on Aura. Empatica Empatica Inc is an MIT spinoff based in Boston, MA, and a pioneer in physiology-based biomarker development and continuous, unobtrusive patient monitoring driven by AI. Empatica's platform uses a combination of biosensors to detect features of human physiology that are distilled in AI-based algorithms and can remotely monitor autonomic activity, movement, sleep and cardiac activity. Empatica's E4 and Embrace2 smartwatches are CE-marked and have been sold to thousands of institutional partners for research purposes, in trials and studies examining Stress, Sleep, Epilepsy, Migraine, Depression, Addiction and other conditions. HHS/ASPR/BARDA HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures &ndash; vaccines, treatments, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. ]]>Fri, 19 Jun 2020 00:00:00 +0100https://www.medical-xprt.com/news/empatica-and-barda-join-forces-to-validate-wearable-system-that-detects-covid-19-before-symptoms-app-1056852biosensorhealth monitoringremote monitoringearly warning systembiosensor detectionbiomedical researchCOVID-19 detectionmedical caremedical softwaremedical productpatient monitoringpatient monitorepilepsysars-cov-2biomarkerbiomarker developmentmedical researchai platformhealthcarewearable medicalhuman healthrespiratory infectionearly COVID-19health informationcontinuous patient monitoringclinical validationhealth threatphysiological datawearable sensordigital healthcaredepressionsmart healthvaccinationpharmaceutical productionpharmaceutical productbiomedicalcovid 19pharmaceuticalcardiac activityunobtrusive patient monitoringCorify Care Participates In the Atrial Signals Workshop 2021https://www.medical-xprt.com/news/corify-care-participates-in-the-atrial-signals-workshop-2021-1057531<![CDATA[Last week (23-25th September) took place the workshop Atrial Signals 2021 http://www.atrial-signals.kit.edu/ at the Karlsruhe Institute of Technology (KIT), thanks to the joint collaboration of the Institute of Biomedical Engineering (IBT) and the St&auml;dtisches Klinikum Karlsruhe. Andreu Climent, CEO of Corify Care presented Acorys, our Non-invasive Electrocardiographic Imaging device of the electrical activity of the heart, which allows a personalized and optimal diagnosis and treatment to each patient. Mar&iacute;a S. Guillem, professor at ITACA Institute of the Universitat Politecnica de Valencia and Chief Scientific Officer of Corify Care, presented the latest advances of the signal processing. Likewise, Professor Guillem shared the progress of the PersonalizeAF project (https://personalizeaf.net/), a Marie S. Curie action coordinated by her. PersonalizeAF counts on the participation of Karlsruhe Institute of Technology (KIT), the Maastricht University, the Bordeaux University, the Oxford University, the Bologna University, Simula Research Laboratory, the August Pi Sunyer Biomedical Research Institute (IDIBAPS), La Fe Health Research Institute and the Medicine University of Freiburg. The Atrial Signals 2021 agenda comprised more than 60 invited talks by renowned experts in the field. The sessions covered topics like the Arrhythmogenic Substrate, Atrial Signals &ndash; Novel Technologies, the Best Mapping Strategy, the Best Ablation Targets and the Best Ablation Strategy, etc. For Corify Care has been an honour to participate in this workshop together with the best clinicians and engineers to address the posed challenge of treatment of atrial fibrillation.]]>Thu, 30 Sep 2021 00:00:00 +0100https://www.medical-xprt.com/news/corify-care-participates-in-the-atrial-signals-workshop-2021-1057531biomedical researchbiomedical engineeringelectrocardiographatrial fibrillationatrial fibrillation treatmenthealth researchbiomedicalatrial fibrilationatrial signalRTsafe and Biomedic Medical Group sign exclusive agreement for distributionhttps://www.medical-xprt.com/news/rtsafe-and-biomedic-medical-group-sign-exclusive-agreement-for-distribution-1056937<![CDATA[RTsafe, a medical technology company focused on improving the safety and accuracy of radiotherapy for cancer and other medical conditions, today announced that Biomedic Medical Group will be the exclusive distributor of RTsafe&rsquo;s products in China. We are delighted to announce this new collaboration and looking forward to provide our products to the Chinese radiotherapy professionals. About Biomedic Medical Group Biomedic Medical Group is an international medical technology group enterprise. The group is committed to connecting the Chinese and international medical technology markets, integrating global related high-quality and advanced product technologies according to the actual needs of doctors and patients, so that medical technology can improve the quality of human life. The main products we provide cover many fields such as minimally invasive tumor intervention, vascular intervention, radiotherapy, radiology and ultrasound diagnosis, surgical operation and interventional consumables, orthopedic rehabilitation consumables. About RTsafe RTsafe is a medical technology company that has developed a unique approach to quality assurance that significantly enhances the safety and accuracy of radiotherapy for cancer and other medical conditions. It combines proven expertise in medical physics with highly accurate 3D printing technology to create pseudo-in-vivo dosimetry phantoms towards End-to-End commissioning, benchmarking and patient-specific quality assurance in SRS, IMRT, VMAT and SBRT applications. The anatomically accurate effigies enable medical professionals to plan more precise treatment interventions for each individual patient and help radiotherapy technology innovators to fine-tune their products. The result is more effective individualized therapy and reduced patient risk.]]>Wed, 28 Jul 2021 00:00:00 +0100https://www.medical-xprt.com/news/rtsafe-and-biomedic-medical-group-sign-exclusive-agreement-for-distribution-1056937orthopedicradiotherapymedical technologycancer radiotherapysurgicalsurgical operationsurgical interventionradiotherapy technologymedical staffmedical technology developmentvascular interventionsurgery ultrasoundradiologysurgery interventionalcancerradiology interventionalvascular interventionalradiotherapy innovationcancerous conditioninterventional radiologypatient specificpatient qualitypatient medicalorthopedic consumablesinterventional treatmentinterventional radiotherapyinterventional vascularbiomedicalWired: This startup wants to stop deaths from cardiac arrest?https://www.medical-xprt.com/news/wired-this-startup-wants-to-stop-deaths-from-cardiac-arrest-1055975<![CDATA[In April 2013, final-year Danish medical student Habib Frost was called out to an emergency: a four-month old girl had just suffered cardiac arrest. Frost&rsquo;s team tried defibrillation, but to no avail. Immediately after, the team was called out again: another case of cardiac arrest, this time a woman in her 30s. Once again, Frost was powerless to save her life. &ldquo;I felt devastated,&rdquo; he says. &ldquo;I knew I was not meant to let myself be affected to such a degree, but I could not give my very best the next day.&rdquo; Cardiac arrest is one the leading causes of death worldwide, killing around 7 to 10 million people every year. This condition can have many underlying causes, such as coronary atherosclerosis, which occurs with tissue plaque builds up and clogs the arteries that feed into the heart. &ldquo;There are a great number of underlying mechanisms that can trigger a cardiac arrest, such as an airway obstruction, a metabolic imbalance, a drug overdose, a critical bleeding, a collapsed lung,&rdquo; says Frost. &ldquo;Prevention is important but unfortunately not enough, as even healthy adults can experience the sudden onset of cardiac arrest.&rdquo; During cardiac arrest, the heart starts beating with an erratic rhythm. As a result, very little blood is flowing throughout the body. Without blood supply, different organs start dying out at different rates. The brain starts deteriorating after 15 minutes, whereas the liver and kidney can last up to two to three hours without blood supply. Current emergency procedures &mdash; like chest compressions and defibrillation &mdash; can partially replace the blood flow but, more often than not, are ineffective: only one out of ten patients are saved. &ldquo;I knew that I wanted to do something about this, but I did not know what,&rdquo; Frost says. In his last semester of medical school &mdash; Frost graduated at the age of 23, becoming the youngest doctor in Denmark &mdash; he invented Neurescue, a small computer-controlled balloon catheter that can be used during CPR. The catheter is inserted into the femoral artery in the leg and moved to the main artery of the body, the aorta, which descends from the left ventricle of the heart down to the abdomen. There, the balloon is inflated, obstructing the artery. &ldquo;This redistributes the blood flow generated by chest compressions to the two most sensitive organs: the heart and brain,&rdquo; Frost says. &ldquo;The blood supply increases the chances of the heart start beating again and protects against brain damage, allowing for more time to treat the underlying cause of the cardiac arrest.&rdquo; According to Frost, this approach can greatly improve the survival rate. Whereas chest compressions can prolong the life of the patient for an average of half an hour before there's damage to the brain, Neurescue can extend that window to a maximum of two hours. Frost is currently running safety tests on the device to comply with regulatory medical approval. The startup has raised $4.75 million and expects to run the first pilot tests in a few European hospitals next year.]]>Mon, 17 Jul 2017 00:00:00 +0100https://www.medical-xprt.com/news/wired-this-startup-wants-to-stop-deaths-from-cardiac-arrest-1055975safety testsafety testingcardiac arrestblood flowdescending aortafemoral arterycatheterballoon cathetersudden cardiac arrestdefibrillatorarterial obstructionmedical studentblood supplybrain damagecatheter insertioncatheter insertedartery cloggingartery femoraldefibrillationcardiac deathcardiac triggerairway obstructionmetabolism drugmedical schoolAioCare system could be successfully applied in primary healthcare Centers.https://www.medical-xprt.com/news/aiocare-system-could-be-successfully-applied-in-primary-healthcare-centers-1057067<![CDATA[The role of spirometry in diagnosing and monitoring chronic obstructive airway diseases is crucial. According to WHO, the demonstration of irreversible airway obstruction is essential for diagnosing chronic obstructive pulmonary disease (COPD), which is the third leading cause of death worldwide. It is estimated that up to 67&ndash;81% of patients with COPD remain undiagnosed. Mobile phone-linked spirometers can be used almost anywhere &ndash; at small primary healthcare centers or even at the patient&rsquo;s home. Improved access to these tools could lead to earlier diagnosis of COPD and asthma, resulting in earlier therapeutic intervention and suppression of disease progression. In cooperation with the Medical University of Warsaw, we have made a study that demonstrated that the AioCare system could be successfully applied in primary healthcare centers that do not have access to a lung function laboratory across all regions of Poland. We have performed 10,936 examinations in 9855 patients. Airway obstruction was found in 17% of correctly performed spirometry examinations, whereas the prevalence of airway obstruction among smokers &gt;40 years was almost 27%.]]>Wed, 16 Jun 2021 00:00:00 +0100https://www.medical-xprt.com/news/aiocare-system-could-be-successfully-applied-in-primary-healthcare-centers-1057067spirometerchronic diseaseasthmapulmonary diseaseCOPD patientCOPDlung functionspirometryhealthcarelung functionalityhealthcare centersdisease accordinglung functionsairway obstructionairway diseaseALung Announces Commercial Development of its Breakthrough Next Generation Artificial Lunghttps://www.medical-xprt.com/news/alung-announces-commercial-development-of-its-breakthrough-next-generation-artificial-lung-1057960<![CDATA[PITTSBURGH&ndash;(BUSINESS WIRE)&ndash; April 4, 2020 &ndash; ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced the recent initiation of commercial development of its next generation artificial lung, which expands the Company&rsquo;s focus on highly efficient gas exchange devices and also broadens its applicable market. The Company&rsquo;s current product, the Hemolung&reg; Respiratory Assist System (RAS), is the only fully comprehensive extracorporeal carbon dioxide removal (ECCO2R) system specifically designed and manufactured for this therapy, as compared to complex competitive products that are modifications of existing technologies designed for other purposes. The Hemolung continues to be the most highly efficient and simple to use ECCO2R system on the market today. The next generation Hemolung RAS is based upon intellectual property recently licensed to ALung from the University of Pittsburgh. Developed by Professor William Federspiel, PhD and colleagues at the Swanson School of Engineering and the McGowan Institute for Regenerative Medicine, this new technology platform significantly enhances gas exchange efficiency while reducing the deleterious hematologic effects from extracorporeal blood circulation. The licensed research was supported in part by the National Institutes of Health and the Coulter Translational Research Partners II Program at the University of Pittsburgh. Dr. Federspiel has an equity holding in the company and is compensated as an advisory board member. &ldquo;The next generation Hemolung RAS is a direct result of the continued collaboration between the University of Pittsburgh and ALung Technologies. This collaboration, spanning 20+ years, has resulted in a rich pipeline of innovation for ALung that will accelerate the development of highly efficient, simple to use artificial lung devices for the treatment of acute respiratory failure. The foundation of our next generation system is an integrated artificial lung cartridge/blood pump that will be unparalleled in the industry as the most efficient carbon dioxide removal and oxygen delivery system, which will address the needs of acute respiratory failure patients that require ECCO2R and/or ECMO (extracorporeal membrane oxygenation). All of this will again be consolidated in a comprehensive, easy to use system without all of the complexities represented in competitive systems,&rdquo; stated Peter M. DeComo, Chairman and CEO of ALung Technologies. Jeremy Kimmel, PhD, Vice President of New Technology at ALung Technologies stated, &ldquo;Professor Federspiel and colleagues at the University of Pittsburgh have rapidly advanced this technology toward commercial readiness through state of the art computational, in vitro and in vivo testing, including successful 7-day and 30-day large animal studies. ALung has initiated commercial development of the next generation Hemolung RAS to provide clinicians with the flexibility to support patients across the full spectrum of acute and acute-on-chronic respiratory failure using a single integrated device. The system design will accommodate bedside therapy as well as portability and wearability, further enhancing device usability and expanding potential clinical indications.&rdquo; Key features and benefits of the next generation Hemolung RAS will include: Patent-pending technology that generates superior blood flow uniformity to maximize gas exchange efficiency. A custom designed centrifugal pump integrated with a low surface area (0.65 m2) gas exchange membrane without the need for additional components (e.g. heat exchanger, pressure ports) that will reduce operational complexity of the system. Low flow ECCO2R (250 &ndash; 700 mL/min) as well as full ECMO (2 &ndash; 4 L/min) using a single integrated pump and gas exchange membrane. The highest efficiency oxygenation of any ECMO device on the market providing full oxygen saturation at &le;4 L/min blood flow with membrane surface area of 0.65 m2. COPD affects 30 million Americans1 and is the third leading cause of death in the United States behind cancer and heart disease.2 Acute exacerbations, defined as a sudden worsening of COPD symptoms, are a major cause of morbidity and mortality in COPD patients. ARDS is estimated to affect more than 10% of intensive care unit patients globally, has a mortality rate as high as 45% and requires invasive mechanical ventilation in the majority of cases.3,4 Combined, these disorders represent a significant need and a global market for innovative respiratory assist devices. The COVID-19 pandemic is a recent example of such a dramatic need. Currently, the Hemolung RAS has European marketing clearance (CE Mark). In addition, it is the only system that has been studied for safety and efficacy in two large landmark pivotal trials; the FDA approved VENT-AVOID trial and the U.K. REST trial. The Hemolung RAS was recently granted Emergency Use Authorization (EUA) by FDA for the treatment of acute respiratory failure caused by COVID-19. About ALung Technologies ALung Technologies, Inc. is a privately held Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung RAS as a dialysis-like alternative or supplement to mechanical ventilation. ALung is backed by Philips, UPMC Enterprises, Abiomed, The Accelerator Fund, Allos Ventures, Birchmere Ventures, Blue Tree Ventures, Eagle Ventures, Riverfront Ventures, West Capital Advisors, and other individual investors. For more information about ALung and the Hemolung RAS, visit www.alung.com. For more information on the VENT-AVOID trial, and a list of enrolling sites, please visit clinicaltrials.gov. For more information about the REST Trial, please visit UK National Institute for Health Research (NIHR) &ndash; REST Trial Project Website. CAUTION: The Hemolung RAS is an Investigational Device and limited by United States law to investigational use. This press release may contain forward-looking statements, which, if not based on historical facts, involve current assumptions and forecasts as well as risks and uncertainties. Our actual results may differ materially from the results or events stated in the forward-looking statements, including, but not limited to, certain events not within the Company&rsquo;s control. Events that could cause results to differ include failure to meet ongoing developmental and manufacturing timelines, changing GMP requirements, the need for additional capital requirements, risks associated with regulatory approval processes, adverse changes to reimbursement for the Company&rsquo;s products/services, and delays with respect to market acceptance of new products/services and technologies. Other risks may be detailed from time to time, but the Company does not attempt to revise or update its forward-looking statements even if future experience or changes make it evident that any projected events or results expressed or implied therein will not be realized.]]>Sat, 04 Apr 2020 00:00:00 +0100https://www.medical-xprt.com/news/alung-announces-commercial-development-of-its-breakthrough-next-generation-artificial-lung-1057960centrifugal pumpheat exchangercentrifugecarbon dioxide removalrespiratory systemin vitrocentrifugal pumpingcarbon removal technologycarbon dioxide removal systemhematologycarbonate removal systemcarbon removalheart diseaseGood Manufacturing Practicesblood flowblood circulationregenerative medicineintensive careCOPD patientCOPDpatient respiratoryacute respiratory failurerespiratory failureoxygen delivery systemblood pumpoxygen saturationrespiratory deviceintensive care unitcancerhealth researchintensive care patientcovid 19covid pandemicin vivo testin vivo testingin vivo testscarbonizationrespiratory patientmembrane gas exchangermechanical ventilationA Phase Ii Trial Of Onapristone In Combination With Fulvestrant For Patients With Er-Positive And Her2-Negative Metastatic Breast Cancer After Progression On Endocrine Therapy And Cdk 4/6 Inhibitorshttps://www.medical-xprt.com/news/a-phase-ii-trial-of-onapristone-in-combination-with-fulvestrant-for-patients-with-er-positive-and-he-1098371<![CDATA[Antiprogestins act as Progesterone Receptor (PgR) antagonists. Novel and promising class of drugs to overcome endocrine resistance associated with ESR1 mutations. SMILE STUDY is a multi-institutional phase II clinical trial to determine the efficacy of an antiprogestin, Onapristone +fulvestrantas second line therapy for patients with HR+/HER2- metastatic breast cancer (MBC). Hypothesis: The proposed combination of therapy with onapristone + fulvestrant is effective for patients with metastatic ER+, and or, PR+/-, HER-2 negative breast cancer with disease progression on Endocrine therapy and CDK 4/6 Inhibitors]]>Mon, 30 Jan 2023 00:00:00 +0100https://www.medical-xprt.com/news/a-phase-ii-trial-of-onapristone-in-combination-with-fulvestrant-for-patients-with-er-positive-and-he-1098371clinical trialpatient positioningbreast cancerclinical phaseprogesteronecancerdisease progressioncancerous breastcancer progressioncancer breastcancer diseasedrug resistantdrug resistanceAARP Names Its Innovator in Aging Prize Winnerhttps://www.medical-xprt.com/news/aarp-names-its-innovator-in-aging-prize-winner-1055692<![CDATA[En espa&ntilde;ol | A wristband that helps you cool off or warm up quickly, offering relief from hot flashes or increasing your comfort, won AARP&rsquo;s Innovator in Aging prize Tuesday morning. AARP CEO Jo Ann Jenkins presented the award to the company, Embr Labs, for its Wave device during a live segment on Good Morning America. The advocacy group for older adults increasingly is looking to boost the development of new technologies that can improve lives. &ldquo;We want to spark new ideas and creation so that more people can choose how they want to live as they age, and that aging is really fueling economies all over the world,&rdquo; Jenkins says. &ldquo;In the U.S. alone, $7.6 trillion of annual economic activity is sparked every year by people over the age of 50.&rdquo; Sam Shames, chief operating officer and cofounder of Embr Labs, says he invented the Wave wristband, in part, to help his mother. &ldquo;My mom is always cold, and her friends have been experiencing hot flashes for years,&rdquo; Shames says. &ldquo;Temperature is personal, but the world doesn&rsquo;t treat it that way.&rdquo; Embr Labs launched in September 2017 with the Wave, a device you wear like a wristwatch. Instead of telling time, though, the accessory uses algorithmically designed waves of thermal energy so the wearer feels the sensation of being warmer or cooler. The Wave can offer relief from hot flashes, improve sleep and help manage stress. By focusing on one small part of the body &mdash; the wrist &mdash; the device is able to make you feel more comfortable. Shames compares the effect to that of putting an ice cube on your wrist on a hot summer day. &ldquo;When one part of your body is uncomfortable, you can counterbalance that effect by creating opposite sensations on another part of your body,&rdquo; he says. &ldquo;It&rsquo;s just like how warming your feet by the fire can make your cold feet feel better on a fall night, or dipping your toes in the ocean can make you feel cooler on a hot day.&rdquo; The Wave currently sells for $300 and requires a smartphone for the mobile app that adjusts the temperature settings. The other company that was a finalist for the Innovator in Aging prize was Aidar Health. Its product, MouthLab, could help people with chronic conditions, along with the caregivers and health care workers who assist them. The device can measure and record a wide variety of data about a person&rsquo;s health through one quick step. You hold the device to your mouth and breathe into it for roughly one minute. MouthLab tracks your respiratory rate, pulse, oxygen saturation and other vital signs in real time and digitally transmits the information so that doctors and caregivers can see the statistics in real time on a secure website or smartphone app. Sathya Elumalai, cofounder and CEO of Aidar Health, says he saw the technology as a way to help him care for his mother, Viji Elumalai, who is 63 and living with multiple chronic conditions, including diabetes, a heart condition and hypertension. Using the MouthLab device has become part of her normal daily routine, like brushing her teeth. &ldquo;It&rsquo;s the check-engine light for humans,&rdquo; her son says. &ldquo;We&rsquo;re trying to build something you use every single day, without thinking too much. But then one day, it will light up and say, &lsquo;Hey, sorry, something&rsquo;s wrong.&rsquo; So, that&rsquo;s what we really wanted to bring to this world, and then, hopefully, save some lives.&rdquo; Elumalai says the company hopes to start distributing MouthLab, which has been under development for roughly 10 years, next summer. The Innovator in Aging prize is part of AARP&rsquo;s long-term commitment to finding solutions that help people live better. &ldquo;The pace of technological advancements in both hardware and software, coupled with the decrease in production costs, creates the perfect environment for innovative companies to develop new disruptive solutions that empower older adults to take control of their health and well-being,&rdquo; says Andy Miller, senior vice president of innovation and product development at AARP.]]>Tue, 15 Oct 2019 00:00:00 +0100https://www.medical-xprt.com/news/aarp-names-its-innovator-in-aging-prize-winner-1055692wave energythermal energythickness monitoringlaboratory devicediabeteshealthcareoxygen saturationchronic diabeteshealth productheart conditionstress managementsleep managementrespiratory rateAARP Names Its Innovator in Aging Prize Winnerhttps://www.medical-xprt.com/news/aarp-names-its-innovator-in-aging-prize-winner-1055694<![CDATA[En espa&ntilde;ol | A wristband that helps you cool off or warm up quickly, offering relief from hot flashes or increasing your comfort, won AARP&rsquo;s Innovator in Aging prize Tuesday morning. AARP CEO Jo Ann Jenkins presented the award to the company, Embr Labs, for its Wave device during a live segment on Good Morning America. The advocacy group for older adults increasingly is looking to boost the development of new technologies that can improve lives. &ldquo;We want to spark new ideas and creation so that more people can choose how they want to live as they age, and that aging is really fueling economies all over the world,&rdquo; Jenkins says. &ldquo;In the U.S. alone, $7.6 trillion of annual economic activity is sparked every year by people over the age of 50.&rdquo; Sam Shames, chief operating officer and cofounder of Embr Labs, says he invented the Wave wristband, in part, to help his mother. &ldquo;My mom is always cold, and her friends have been experiencing hot flashes for years,&rdquo; Shames says. &ldquo;Temperature is personal, but the world doesn&rsquo;t treat it that way.&rdquo; Embr Labs launched in September 2017 with the Wave, a device you wear like a wristwatch. Instead of telling time, though, the accessory uses algorithmically designed waves of thermal energy so the wearer feels the sensation of being warmer or cooler. The Wave can offer relief from hot flashes, improve sleep and help manage stress. By focusing on one small part of the body &mdash; the wrist &mdash; the device is able to make you feel more comfortable. Shames compares the effect to that of putting an ice cube on your wrist on a hot summer day. &ldquo;When one part of your body is uncomfortable, you can counterbalance that effect by creating opposite sensations on another part of your body,&rdquo; he says. &ldquo;It&rsquo;s just like how warming your feet by the fire can make your cold feet feel better on a fall night, or dipping your toes in the ocean can make you feel cooler on a hot day.&rdquo; The Wave currently sells for $300 and requires a smartphone for the mobile app that adjusts the temperature settings. The other company that was a finalist for the Innovator in Aging prize was Aidar Health. Its product, MouthLab, could help people with chronic conditions, along with the caregivers and health care workers who assist them. The device can measure and record a wide variety of data about a person&rsquo;s health through one quick step. You hold the device to your mouth and breathe into it for roughly one minute. MouthLab tracks your respiratory rate, pulse, oxygen saturation and other vital signs in real time and digitally transmits the information so that doctors and caregivers can see the statistics in real time on a secure website or smartphone app. Sathya Elumalai, cofounder and CEO of Aidar Health, says he saw the technology as a way to help him care for his mother, Viji Elumalai, who is 63 and living with multiple chronic conditions, including diabetes, a heart condition and hypertension. Using the MouthLab device has become part of her normal daily routine, like brushing her teeth. &ldquo;It&rsquo;s the check-engine light for humans,&rdquo; her son says. &ldquo;We&rsquo;re trying to build something you use every single day, without thinking too much. But then one day, it will light up and say, &lsquo;Hey, sorry, something&rsquo;s wrong.&rsquo; So, that&rsquo;s what we really wanted to bring to this world, and then, hopefully, save some lives.&rdquo; Elumalai says the company hopes to start distributing MouthLab, which has been under development for roughly 10 years, next summer. The Innovator in Aging prize is part of AARP&rsquo;s long-term commitment to finding solutions that help people live better. &ldquo;The pace of technological advancements in both hardware and software, coupled with the decrease in production costs, creates the perfect environment for innovative companies to develop new disruptive solutions that empower older adults to take control of their health and well-being,&rdquo; says Andy Miller, senior vice president of innovation and product development at AARP.]]>Tue, 15 Oct 2019 00:00:00 +0100https://www.medical-xprt.com/news/aarp-names-its-innovator-in-aging-prize-winner-1055694wave energythermal energythickness monitoringlaboratory devicediabeteshealthcareoxygen saturationchronic diabeteshealth productheart conditionstress managementsleep managementrespiratory rateEmpatica partnering with U.S. Army MRDC to deploy COVID-19 early detection wearablehttps://www.medical-xprt.com/news/empatica-partnering-with-us-army-mrdc-to-deploy-covid-19-early-detection-wearable-1056851<![CDATA[ BOSTON, Nov. 6, 2020 /PRNewswire/ -- Empatica has been selected by the U.S. Army Medical Research and Development Command (USAMRDC) to deploy a wearable and algorithm that enable the early and pre-symptomatic detection of COVID-19. The project's focus is on protecting the health of the general population by preventing outbreaks via early detection and alerting. Empatica's Aura algorithm gives a daily risk-indication of an individual having contracted COVID-19, using physiological data collected by Empatica's medical smartwatch, EmbracePlus. The initiative is multi-phased, beginning with the clinical validation of Empatica's algorithm on healthy participants at risk of contracting SARS-CoV-2. FDA submissions for regulatory approvals will run in parallel, with the project concluding in a virtual clinical study on participants opting-in to test and validate the entire platform. The tested hardware will consist of EmbracePlus, a medical device in a smartwatch form-factor, with clinical-grade sensors that measure heart rate, heart rate variability, temperature, respiratory rate, and electrodermal activity. The device unobtrusively monitors a person's vitals, and sends in-app alerts for patterns suggestive of COVID-19 infection, helping wearers self-isolate and seek testing without unwittingly infecting others. "Use of wearable tech to prevent rapid spread of COVID-19 within our units is an important capability," says Commander Christopher Steele, Director of the Military Operational Medicine Research Program at USAMRDC. "Key Industry partners are well positioned to help the DoD in this regard." Empatica CEO, Matteo Lai expressed the importance of this collaboration, "It is a privilege for our team to participate in the effort to combat COVID-19 together with the USAMRDC. The department arguably has the world's best track record in sponsoring and fostering groundbreaking technologies. Their inspiration to intervene and act with this initiative brings into sharp focus the impact COVID-19 has had in our daily lives, as well as the need to work together to face the challenge. This is not only a technological race against time, but also a civic responsibility in employing our experience against a threat to our health and economy." Empatica is the only manufacturer of a medical device system combining a wearable, app, and algorithm to provide a daily COVID-19 risk assessment to users. Earlier this year, Empatica partnered with HHS to validate Aura's COVID-19 detection capabilities on at-risk healthcare workers. Furthering this work with the USAMRDC provides additional resources to deploy Aura to the general population. Empatica Inc is a pioneer in continuous, unobtrusive, and remote health monitoring driven by AI. Empatica's platform combines accurate biomarkers, software and wearables to monitor multiple conditions. Empatica's products are used by thousands of institutional partners for research purposes, in trials and studies examining Stress, Sleep, Epilepsy, Migraine, Depression, Addiction, and other conditions. The USAMRDC is the Army's medical materiel developer, with responsibility for medical research, development, and acquisition. USAMRDC produces medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical and biological defense, and clinical and rehabilitative medicine. ]]>Fri, 06 Nov 2020 00:00:00 +0100https://www.medical-xprt.com/news/empatica-partnering-with-us-army-mrdc-to-deploy-covid-19-early-detection-wearable-1056851risk assessmentcondition monitoringdata acquisitionhealth monitoringthickness monitoringremote monitoringpersonal monitoringcondition monitorpersonal monitorbiomedical researchCOVID-19 detectionmedical deviceclinical medicineepilepsysars-cov-2biomarkerclinical studymedical researchai platformhealthcaremedical systemheart rateearly COVID-19clinical validationrehabilitation clinicrespiratory activityphysiological datadepressionvirtual clinicbiomedicalrespiratory raterehabilitation medicineepilepsy sleepcovid 19covid riskinfection isolationcontinuous health monitoringheart rate measurementphysiological data collectionMobile Mammographyhttps://www.medical-xprt.com/news/mobile-mammography-1060708<![CDATA[bout two years after the outbreak of COVID-19, many resources are still being used in the fight against this new virus. Nevertheless, the number of breast cancer cases in Italy are still very high: according to the report &ldquo;The numbers of cancer in Italy&rdquo;, published by AIRTUM and AIOM, in 2020 about 55.000 new cases were diagnosed in Italy among women (as of today, estimates for 2021 are not available). But the numbers are destined to grow, since the pandemic has caused significant delays in screening and, on average, a 37.6% reduction in mammography scans [Source: Gisma: Mammography screening after the pandemic] It is therefore essential to have valid alternatives to make up for the delay in the prevention and early diagnosis of the most common diseases, including breast cancer. Rosa: an all-Italian project for the prevention of breast cancer A valuable aid comes from an all-Italian project: Rosa is the mobile unit for mammography scans and breast screening born from the collaboration between CVS Srl and Metaltronica. It is a highly technological and innovative medical vehicle, designed to support radiology and senology units with the best mammography screening and diagnostic tools. Main characteristics The mobile clinic weighs less than 3.5 tonnes and can therefore be driven with a standard driving license. In this way, it can be driven directly by the radiology technician performing the scan on the patient. The interior spaces have been designed to guarantee comfort for the patient and to ensure that the healthcare worker can move easily. The vehicle is equipped with a Helianthus DBT digital mammography system, a precision diagnostic equipment that provides 2D or 3D mammograms. Bringing scans where they are most needed This is the philosophy behind the project developed by Metaltronica with CVS Srl: to offer qualified medical personnel a vehicle that is easy to drive and fully equipped according to the highest quality standards in the health sector, so that they can perform mammography scans and breast screening even in small towns, in isolated areas or on the outskirts, thus bringing prevention and check-ups where they are most needed and promoting local awareness campaigns. Advantages and benefits for the health service The use of a mobile mammography unit to implement screening programs for the early diagnosis of breast cancer makes it possible, first of all, to increase the supply of prevention services where, for example, there are no (or there are a limited number of) fixed radiology facilities. This results in advantages for the hospital in terms of productivity, and improves its reputation. Expanding the offer and allowing greater access to mammography scans on mobile vehicles also has a positive impact on reducing waiting lists in hospitals and, more generally, on economic and social inequalities in healthcare. Developments in mammography: tomosynthesis in screening Although it is not yet included in the Italian guidelines, tomosynthesis (or 3D mammography) is a method whose use can also be considered for screening. In fact, tomosynthesis is a three-dimensional mammogram that eliminates the overlapping of tissue typical of 2D scans and allows a clearer and more accurate study of the individual &ldquo;layers&rdquo; of the breast. The high diagnostic reliability of tomosynthesis images makes it possible to detect even small lesions or changes that may be a symptom of a tumour process. ]]>Mon, 14 Mar 2022 00:00:00 +0100https://www.medical-xprt.com/news/mobile-mammography-1060708mammography systemmammographydigital mammographybreast screeningbreast cancermedical staffhealthcaremammography unitmammography tomosynthesisradiologydigital mammography systemmedical supportcancermammography screeningbreast mammography3D mammographycancerous breastmedical vehicle3D scanningcancer breastcancer diseasecovid 19ARAI-2PAM Barda Procurement Awardhttps://www.medical-xprt.com/news/arai-2pam-barda-procurement-award-1088710<![CDATA[Broomfield, Colorado, 10/3/2022. Aktiv Pharma Group (Aktiv) today announced a procurement contract award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Under this contract (number 75A50122C00082), awarded under the 2004 Project BioShield Act, Aktiv will supply emergency autoinjectors containing pralidoxime chloride (2-PAM) to the CHEMPACK program, targeting proposed indications related to organophosphate poisoning including nerve agents. The total value of the contract, including options to continue supplying the product until 2029, is up to $220 million. &ldquo;We are humbled by the opportunity to support the U.S. government to enhance its readiness and preparedness to protect the U.S. civilian population and provide peace-of-mind to the emergency first responders if they have to use these products&rdquo; said the company founder and CEO, Amir Genosar. The ARAI autoinjector has been developed by Aktiv with the support of BARDA and the Department of Defense (DoD) as a next generation autoinjector platform to address the shortfalls of previous autoinjectors, by improving usability, reliability, robustness, and drug stability. ARAI is a versatile platform that can deliver up to 5 ml dose volumes, perform simultaneous injections of multiple, separately stored drug formulations, and automatically reconstitute drugs formulated in dry form. Aktiv is currently expanding the ARAI platform to include a consumer market autoinjector for biopharmaceuticals that will feature the same reliability, robustness, and usability benefits in a smaller form factor and with added data connectivity. Aktiv is leveraging its superior autoinjector technology to advance the strongest emergency treatment pipeline in the industry, which currently includes atropine, pralidoxime chloride (2-PAM), atropine/2-PAM dual-injection, scopolamine, and tranexamic acid (TXA). Aktiv is also collaborating with another pharmaceutical company to develop a reconstitution autoinjector for a long-acting formulation of naloxone. ]]>Mon, 03 Oct 2022 00:00:00 +0100https://www.medical-xprt.com/news/arai-2pam-barda-procurement-award-1088710laboratory equipmentfirst responseemergency responderbiomedical researchbiopharmaceuticalGood Manufacturing Practicesoperating roomhuman healthhealth departmentpharmaceutical productionpharmaceutical developmentpharmaceutical productnerve agentdrug formulationdrug stabilitybiomedicalemergency treatmentpharmaceuticalinjectable productbiomedical developmentFDA Emerging Technology Programhttps://www.medical-xprt.com/news/fda-emerging-technology-program-1088711<![CDATA[ Broomfield Colorado 6/16/2022. Aktiv Pharma Group (Aktiv) announced today the acceptance of its novel glass-free, film-based flexible primary drug container (PDC) technology for sterile injectables named ARCH, into the US Food and Drug Administration (FDA) Emerging Technology Program (ETP). The ETP is a collaborative effort which supports the FDA&rsquo;s mission to facilitate modernization in the pharmaceutical industry and helps pharmaceutical companies reduce the time and cost requirements of introducing new, innovative solutions. The ETP will enable the FDA to establish better understanding of the unique aspects of film-based PDCs and use this insight to develop guidelines and regulations ahead of a broader adoption by the industry. It will also allow Aktiv to communicate with the FDA to create alignment on regulatory, technical, and scientific matters associated with gaining regulatory approvals for Aktiv&rsquo;s products. &ldquo;We are excited to participate in this important program and delighted that our technology was recognized by the Agency for its broad potential to improve quality and safety of sterile injectable products&rdquo; said Patricia Brown, Aktiv&rsquo;s VP of Quality and Regulatory. ARCH uses high-barrier polymer films to provide superior performance and increased functionality over conventional glass packaging, either as substitute to vials or when incorporated into prefilled drug delivery systems. ARCH was developed by Aktiv to address potential interactions between biologics and glass-based containers, improve aseptic barriers, provide a superior solution for drugs that require reconstitution at the time of use, and create a foundation for more functional and user-friendly combination products. The first products to feature the flexible ARCH containers are emergency-use autoinjectors currently being advanced to FDA approval. Aktiv&rsquo;s autoinjector pipeline includes tranexamic acid (TXA), atropine, pralidoxime chloride (2-PAM), atropine/2-PAM dual-injection, and scopolamine. The flexible container is crucial for achieving the unprecedented ruggedness and reliability of the ARAI autoinjector platform. Aktiv is additionally developing a biologic combination product in collaboration with a leading biopharmaceutical company and planning new products with integrated reconstitution capability. ]]>Thu, 29 Sep 2022 00:00:00 +0100https://www.medical-xprt.com/news/fda-emerging-technology-program-1088711laboratory equipmentflexible containmentglass containerheadspacesafety productcontainment technologybiopharmaceuticaldrug delivery systemGood Manufacturing Practicesdrug delivery devicebiopharmaceutical productiondrug deliverybarrier solutionbiopharmaceutical productcryogenic temperaturepharmaceutical industrysubcutaneous injectionsubcutaneous intramuscularpharmaceutical productionpharmaceutical productdrug administrationdrug formulationdrug devicedrug stabilitydrug packagingpharmaceuticalinjectable productintramuscular injectionintramuscular subcutaneousCorify Care raises €2.35M to translate its cardiac mapping technology to the market. .https://www.medical-xprt.com/news/corify-care-raises-235m-to-translate-its-cardiac-mapping-technology-to-the-market-1057533<![CDATA[ - Corify Care is developing ACORYS&reg;, a non-invasive cardiac mapping medical device to transform the cardiac arrhythmia treatment process. - The investment round is led by Clave Capital, counting with investment from CDTI through its Innvierte program and the support from Genesis Biomed. Corify Care, the developer of an innovative and completely non-invasive cardiac mapping system, has announced today the closing of a successful &euro;2.35 million investment round. The round has been led by Clave Capital with the participation of the Mondrag&oacute;n Corporation, Bexen Cardio and the Centre for the Development of Industrial Technology (CDTI), through its Innvierte program, which co-invested &euro;1.22 million together with 465 individual investors who contributed with a &euro;1.13 million investment raised through crowdfunding campaigns organized together with Capital Cell. The company thus concludes negotiations with Clave Capital, which aroused its interest in 2020, thus confirming of the venture capital commitment to technology transfer projects at national level. This investment has been channelled through the fund Mondrag&oacute;n Fondo de Promoci&oacute;n FCR, in which the Mondrag&oacute;n Corporation is the majority private investor. The corporation constitutes a group of cooperatives and companies, such as Bexen Cardio, a medical company in the cardiology sector and part of the Mondrag&oacute;n Group cooperative, which has also invested in Corify Care. This set of investments will bring high value to Corify Care in the industrial and market access area and will provide the company with essential economic resources for its activity. This investment complements the funds raised through the Spanish crowdfunding platform Capital Cell, through which Corify Care has been able to raise &euro;1.13 million in two campaigns with the participation of 465 investors, including professionals in the field of cardiology, various family offices and other investors with extensive experience in the health sector. Both campaigns were closed with an incredible speed within their first day of opening, setting one of the records for the speed of fundraising with a crowdfunding model in Spain in the health sector. Founded in 2019, Corify Care has created ACORYS&reg;, its first device, which is set to transform the process of treating cardiac arrhythmias. ACORYS&reg; is based on the technology developed in collaboration between Hospital General Universitario Gregorio Mara&ntilde;&oacute;n and Universitat Polit&egrave;cnica de Val&egrave;ncia. This first Corify Care device will allow personalization in treatment of cardiac arrhythmias. Worldwide, 33.5 million people suffer from cardiac arrhythmia, a figure that is expected to be doubled by 2050. In the EU, 500,000 people die each year due to a cardiac arrhythmia. With an increasingly ageing population, it is estimated that cardiac arrhythmia will affect more than 50 million people by 2050. In 2021, treatment of patients with cardiac arrhythmias is ineffective and expensive (2% of the European healthcare system budget, accounting for &euro;13.5B per year). Antiarrhythmic drugs only work in 30% of patients, and invasive interventions such as cardiac ablation have a low success rate: more than 50% of patients require re-intervention, which can be offered to only 4% of patients. The main reason for this is that clinicians lack the technology to identify the origin of the arrhythmia and to select the most appropriate treatment for each patient. To address this unmeet need, Corify Care has developed ACORYS&reg;, a non-invasive mapping system that can map any heart rhythm in less than 2 minutes in both the clinical office and operating room. To date, the company has brought the product to final design and validated the technology with more than 300 patients. In 2020, ACORYS&reg; received the European Institute of Innovation and Technology (EIT-Innovation Award) for the best innovation with a prize of &euro;50,000. In addition, Corify Care has initiated pre-commercial activity for ACORYS&reg; through agreements and research projects with national hospitals such as Hospital Cl&iacute;nic de Barcelona, which will generate early traction in the market. The current investment round will enable ACORYS&reg; to complete the clinical validation, to obtain the regulatory approval in Europe and the United States in 2023, and its launch on the domestic and international markets. These milestones have been backed and supported by the collaboration that Corify Care has with the consulting firm GENESIS Biomed, receiving support since before its foundation. GENESIS Biomed has contributed to the process of creating Corify Care as the first spin-off of the Hospital General Universitario Gregorio Mara&ntilde;&oacute;n and has given support in the preparation of the business plan, has facilitated the closing of the first round of investment in 2019 in which &euro;300,000 were raised from a local family office, and has contributed to the public fundraising helping to obtain the CDTI-Cervera grant of about &euro;1M. Finally, GENESIS Biomed and Corify Care have jointly obtained the AF-FINE project, valued at &euro;750,000 and awarded by EIT Health, and have jointly applied for the SAVE-COR project, valued at &euro;2.5M in the EIT Health BP2022 call. Andreu Climent, CEO of Corify Care, said, "We are excited to be able to complete our ambitious development plan and conclude clinical validation and go-to-market. Thanks to this round, we are confident that ACORYS&reg; will be able to help clinicians optimize both efficacy and efficiency when performing complex procedures to treat cardiac rhythm disturbances". From GENESIS Biomed, Josep Llu&iacute;s Falc&oacute; (CEO) adds "we are deeply proud to have seen the birth of Corify Care and to have been able to contribute to its growth in these early stages of its life cycle. We are tremendously grateful to the Corify Care team for appointing us as Board Members in this new stage that we are now opening". According to Alberto Bermejo, investment director at Clave Capital: "ACORYS&reg; has the potential to improve the quality of life of many patients with arrhythmias who currently have no clear treatment. We are excited to be able to support the Corify team, even more knowing that the technology comes from centers such as the Gregorio Mara&ntilde;&oacute;n Hospital and the UPV". About CDTI The CDTI is the body of the General State Administration that supports knowledge-based innovation, advising and offering public aid for innovation through grants or partially reimbursable aids. The CDTI also contributes to the internationalization of the R&amp;D and innovation business projects of Spanish companies and entities and manages Spanish participation in international R+D+i organizations, such as Horizon 2020 and Eureka, and in the Science and Space industries. In addition, through the Innvierte Econom&iacute;a Sostenible initiative, it supports and facilitates the capitalization of technology companies ]]>Wed, 07 Jul 2021 00:00:00 +0100https://www.medical-xprt.com/news/corify-care-raises-235m-to-translate-its-cardiac-mapping-technology-to-the-market-1057533mapping systemmedical devicecardiac rhythm managementoperating roomcardiologyhealthcare systemcardiac ablationhealthcarecardiac systemcardiac arrhythmiaheart rhythmcardiac deviceclinical validationnon-invasive medical devicecardiac patientOnapristone Extended Release: Safety Evaluation from Phase I–II Studies with an Emphasis on Hepatotoxicityhttps://www.medical-xprt.com/news/onapristone-extended-release-safety-evaluation-from-phase-i-ii-studies-with-an-emphasis-on-hepatotox-1098372<![CDATA[Introduction Anliprogestins have demonstrated promising activity against breast and gynecological cancers, but liver-related safety concerns limited the advancement of this therapeutic class. Onapristone is a full progesterone receptor antagonist originally developed as an oral contraceptive and later evaluated in phase II studies for metastatic breast cancer. Because of liver enzyme elevations identified during clinical studies, further development was halted. Evaluation of antiprogestin pharmacology and pharmacokinetic data suggested that liver enzyme elevations might be related to off-target or metabolic effects associated with clinical drug exposure. Objective We explored whether the use of a pharmaceutic strategy targeting efficacious systemic dose concentrations, but with diminished peak serum concentrations and/or total drug exposure would mitigate hepatotoxicity. Twice-daily dosing of an extended-release formulation of onapristone was developed and clinically evaluated in light of renewed interest in antiprogestin therapy for treating progesterone receptor-positive breast and gynecologic cancers. The hepatotoxic potential of extended-release onapristone was assessed from two phase I&mdash;II studies involving patients with breast, ovarian, endometrial, and prostate cancer. Results Among the 88 patients in two phase I&mdash;11 studies in progesterone receptor-positive malignancies treated with extended-release onapristone, elevated alanine aminotransferase/aspartate aminotransferase levels were found in 20% of patients with liver metastases compared with 6.3% without metastases. Of five patients with grade 3 or higher alanine aminotransferase elevations with or without bilirubin elevations (four with breast cancer and one with endometrial cancer), four were assessed as unrelated to extended-release onapristone by the safety data review committee. Furthermore, while the fifth patient's liver enzyme elevations were considered possibly drug related by the study investigator, they were adjudicated as unlikely to be related (&lt;25% likelihood) by a subsequent independent hepatologist. Conclusions These results suggest that the extended-release formulation by reducing drug exposure may be associated with a reduced risk of hepatotoxicity, and supports the continued clinical evaluation of extended-release onapristone for treating progesterone receptor-positive cancers.]]>Mon, 29 Jun 2020 00:00:00 +0100https://www.medical-xprt.com/news/onapristone-extended-release-safety-evaluation-from-phase-i-ii-studies-with-an-emphasis-on-hepatotox-1098372dosing systemsafety dataliver enzymeliver cancerprostate cancergynecologyclinical studybreast cancergynecological cancerclinical developmentprostateprogesteroneliver metastasescancerovarian cancerendometrial cancermetabolic clinicalcancerous breastcancer breastdrug exposuredrug associationpharmacokineticpharmaceuticalmetabolism effectivelybreast positioning