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Pharma R&D and patient advocacy to discuss patient involvement in clinical research at Patients as Partners® Europe 2024

NEW YORK, NY, United States, 12-Mar-2024 — /EPR HEALTHCARE NEWS/ — The Conference Forum today announced the launch of the 8th annual Patients as Partners® Europe meeting, taking place May 14-15, 2024, at Plaisterers’ Hall, in London, England. Patients as Partners® Europe offers an unparalleled opportunity to hear from pharma R&D and patient advocacy on how patient involvement gets done to drive greater efficiencies and inclusivity in clinical research with better outcomes.

“Patients as Partners Europe brings advocates and sponsors together in a unique forum focused on improving collaborations that result in meaningful impact for patients,” said 2024 co-chair, Victoria DiBiaso, MPH, Global Head, Patient Informed Development & Health Value Translation, Sanofi.

The 2024 keynotes and featured speakers include:

  • Patient Advocate Keynote Derek Stewart, OBE on understanding mental health support in clinical research
  • Patient Advocate Keynote Sarah Zenner Dolan, a former biotech executive on navigating clinical trials as a patient
  • GSK’s Andrew Garvey, Global Patient Advocacy Lead, on what has been working, and what has not, in GSK’s effort to advance patient engagement in clinical trials
  • Pfizer’s Patrick Gallogly, Medical Advisor, Pfizer, on the learnings generated from an industry-first LGBTQ+ oncology advisory board
  • Lundbeck’s Anders Lassen, Senior Director, Patient Insights, on using patient-centric integrated evidence approaches to inform drug development decisions
  • Boehringer Ingelheim’s Annie Gilbert, Global Patient Advocacy Lead, on the pilot program bridging the communication gap by sending trial updates to patients
  • Ipsen’s Oleksandr Gorbenko,​​​​​​​ Global Patient Affairs Director, Neurosciences, on how Ipsen partnered with patient advocacy to create robust patient experience mapping
  • AstraZeneca’s Lisa Kerr, Senior Director, R&D Patient Science, on creating a measurement strategy and business investment case to scale patient-centric R&D approaches
  • Astellas’ Stephen Head, Senior Director, Patient Partnerships, on instilling conscious awareness of the patient into everyday work practices
  • Prostate Cancer Research’s David James, Director of Patient Projects, on demystifying and diversifying clinical trials to engage underserved communities

“Patients as Partners® Europe presents case examples on how patient involvement in clinical research can accelerate medicine development, how it can improve better access, inclusivity and diversity,” said Valerie Bowling, Executive Director.

Key topics to be addressed include:

  • ​​​​The future of patient-informed research
  • Understanding patient preferences in decentralized clinical trials
  • Advancing health equity and diversifying clinical trials to engage underserved communities
  • The patient experience data landscape and returning patient data
  • Turning patient insights into action
  • Mapping and measuring patient engagement
  • Patient burden-reducing solutions and technologies
  • Regulatory requirements and patient engagement in drug development

The 2024 meeting is co-chaired by ​​​​​​​Sanofi’s Victoria DiBiaso, MPH, Global Head, Patient Informed Development & Health Value Translation; Patient Advocate, ​​​​​​​​​​​​​​Alfred Samuels; and Parexel’s Rosamund Round, VP, Patient Engagement.

About Patients as Partners® Europe:
Patients as Partners® Europe is co-produced with patients, industry, academia, government and nonprofit organizations to establish a well-rounded program that addresses the needs of all stakeholders seeking to implement and advance patient involvement, access and diversity across the entire clinical development continuum. To learn more about Patients as Partners and access the full agenda, visit PatientsAsPartnersEU.com.

About the Conference Forum:
The Conference Forum is a life science industry research, conference development and marketing firm. The company brings the full spectrum of executives together to share ideas and information on how to advance efficient medicine development and delivery, patient diversity and access. They produce trusted conferences, webinars, podcasts, digital editorial and provide marketing services. To learn more, visit theconferenceforum.org.

SOURCE: EuropaWire

IQ Biozoom, a medtech startup, develops non-invasive home diagnostics to measure biomarker levels in saliva with unmatched accuracy

WARSAW, 13-Nov-2023 — /EPR HEALTHCARE NEWS/ — IQ Biozoom, a medical technology startup focusing on developing non-invasive home diagnostics, is set to make non-invasive home testing more convenient with their innovative technology that allows for the possibility to measure the concentration of biochemical substances in liquid analytes such as saliva, sweat, urine or tears. More people around the world will be empowered to monitor the course of various diseases from the comfort of their own home with laboratory precision using saliva analysis. Currently,  non-invasive home tests measuring glucose and lactate levels in saliva and, in the near future, hormones or CRP proteins, are being developed as part of the technology development.

IQ Biozoom’s technology includes a sophisticated biosensor system that integrates inkjet printing technology with advanced semiconductors, specifically thin-film transistors. Although not yet in commercial use, it allows the concentration of a selected biomarker to be determined based on contact between a disposable test strip and a body fluid such as saliva. According to analyses, when measuring glucose concentration in saliva, IQ Biozoom’s cutting-edge technology is up to ten times more accurate than current market standards. This means that even very low concentrations of selected biomarkers in the analyte can be determined with laboratory precision. This can be particularly relevant in those cases where the physiological concentration of a selected substance is very low, or where the mere presence of a biomarker in an analyte is indicative of a health disorder.

Most current blood glucose meters need a finger prick which is usually uncomfortable for patients. IQ Biozoom’s technology enables biomarker levels to be tested with laboratory precision based on saliva analysis, making it a completely non-invasive and painless method.

The solution will enable people with, for example, metabolic and endocrine disorders, to monitor their health and manage their disease, as well as take appropriate preventive care. The devices being developed based on IQ Biozoom’s technology are intended to be used for self-contained, non-invasive home diagnostics, allowing for precise laboratory-standard results.

Monitoring biomarkers and analysing their data retrospectively can help to select the right therapy for a patient. By monitoring biomarkers before, during and after therapy, it is possible to assess whether a patient is responding to treatment. If biomarker levels improve, this may indicate that the therapies are working. If there is no improvement, the therapy may need to be changed. Retrospective analysis of biomarker data can help to personalise therapy, tailoring it to the individual patient. The technology also has applications in personalised sports medicine, particularly in the context of physical performance assessment, training planning and training unit selection. Different athletes may have different lactate threshold which means their training plans should be tailored to their individual body characteristics. Testing lactate levels allows for precise individualisation of training.

Currently, invasive glucometers are the devices of choice for glucose level monitoring. According to the Polish Family with Diabetes report, published by the Association for Diabetes Education SED – 84% of people with type 1 diabetes would prefer to use non-invasive glucose monitoring methods, while 60% skip part of their daily testing due to the need for fingertip pricks. In addition to the discomfort felt, the disruption of the skin increases the risk of an infection. In 2021, IQ Biozoom started developing their innovative technology to non-invasively monitor glucose and lactate levels. Other biomarkers such as cortisol or CRP proteins in the body are in the R&D pipeline.

In the third quarter of 2023, IQ Biozoom obtained funding from the VC Link fund, which supports Polish companies developing breakthrough technologies with global potential. But the seed round is not closed yet with the startup seeking further investment to implement the technology and go to market.

The company expects an even faster growth rate in the near future. The home diagnostics market is growing at 5.6% year-to-year and is expected to exceed $13.6 million by 2033, according to FutureMarketInsight.com.

About IQ BIOZOOM

IQ BIOZOOM Ltd (https://iqbiozoom.com/) develops technology for non-invasive home diagnostics. The company is working on innovative devices for measuring the concentration of biochemical substances in saliva: glucose, lactates, and hormones, to enable people with metabolic and endocrine disorders to monitor their health and manage their disease, as well as applying appropriate prevention. IQ Biozoom technology will be designed for home self-testing. In the near future, the company intends to focus on expanding the technology usage to measure the levels of other substances important for diabetics (diabetes package) and woman (hormone package) ‒ in saliva.

SOURCE: EuropaWire

A groundbreaking paper: Climate change is a key driver of infectious disease outbreaks in Europe

Increasing threat of vector-borne infectious diseases exacerbated by climate change. (Credit: Ingenious Buddystock.adobe.com)

BRUSSELS, 5-Sep-2023 — /EPR HEALTHCARE NEWS/ — The Lancet Regional Health – Europe journal has published a scientific paper on 7 August 2023 authored by a distinguished team of international researchers as part of their work in the IDAlert project. Titled “Decision-Support Tools to Build Climate Resilience Against Emerging Infectious Diseases in Europe and Beyond“, this paper introduces a transformative approach to tackle the emergence and transmission of climate-sensitive infectious diseases in Europe, informing cross-sectoral policy while improving the long-term climate resilience of health systems to infectious disease risks.

Climate change is one of several drivers of recurrent outbreaks and geographical range expansion of infectious diseases in Europe. This paper proposes a collaborative approach to develop policy-relevant indicators and decision-support tools. These tools are designed to comprehensively track and anticipate climate-induced disease risks across various domains, including environmental hazard, exposure patterns, and vulnerability factors. With a keen focus on the interconnectedness of animals, humans, and the environment, the framework promises a holistic perspective to address this multifaceted challenge.

The lead author and IDAlert project coordinator Joacim Rocklöv highlighted, “Our decision-support tools offer a multi-dimensional perspective that transcends traditional silos. By examining the nexus of animals, humans, and the environment, we’re unlocking a more comprehensive understanding of disease dynamics a pre-requisite for more timely and effective outbreak preparedness.”

The heart of this novel framework lies in the co-production of early warning and response systems with stakeholders and end-users, as well as tailored tools to assess the costs and benefits associated with climate adaptation and mitigation strategies across diverse sectors. By fostering greater resilience within regional and local health systems, the framework aims to strengthen Europe’s capacity to respond to health crises, even in the face of changing environmental conditions.

As part of its approach, the IDAlert project will integrate multi-level engagement, innovative methodologies, and novel data streams, and tap into locally generated intelligence and empirical insights through case studies. This strategy empowers experts to quantify the effects of climate-induced disease threats in areas undergoing rapid urban transformation and contending with heterogeneous health risks. The ultimate aspiration is to bridge the gap between knowledge and action, delivering an unparalleled integrated One Health—Climate Risk framework that will empower policymakers, healthcare professionals, and communities to mitigate risks and bolster resilience.

About The Lancet Regional Health – Europe Journal:
The Lancet Regional Health – Europe Journal is a prestigious journal renowned for publishing groundbreaking research on health challenges worldwide. It aims to promote the advancement of the research agenda, clinical practice and health policy in Europe with the goal of improving health outcomes for all people regionally and globally.

About the IDAlert project:
IDAlert – Infectious Disease decision-support tools and Alert systems to build climate Resilience to emerging health Threats – officially started on 1 June 2022 is a € 9.18 million project and lasts for five years. The project is funded by the European Commission under the Horizon Europe programme with Grant Agreement number 101057554. More information: www.idalertproject.eu

Note to Editors:
For more information about the paper or to request an interview with the researchers, please contact the IDAlert project: contact@idalertproject.eu.

The full paper, “Decision-Support Tools to Build Climate Resilience Against Emerging Infectious Diseases in Europe and Beyond,” is available on the Lancet Regional Health Journal website:
https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(23)00120-5/fulltext

SOURCE: EuropaWire

AMBROSIA, a new HORIZON-RIA project, aims to develop a portable diagnostic unit for intelligent sepsis diagnosis

ATHENS, 9-May-2023 — /EuropaWire/ — AMBROSIA (http://ambrosia-h2022.eu/) is a new ambitious HORIZON Research and Innovation Action project that was granted under the call of “Digital and emerging technologies for competitiveness and fit for the green deal” and the topic “HORIZON-CL4-2022-DIGITAL-EMER-GING-01-03: Advanced multi-sensing systems”. AMBROSIA envisions to develop a portable diagnostic unit for intelligent sepsis diagnosis at the point-of-care (PoC).

Sepsis is a life-threatening whole-body inflammatory reaction caused by a severe infection. With mortality rates around 35%, sepsis is responsible for 11 million deaths worldwide every year. In economic terms, sepsis represents a primary cost of hospitalization in developed regions, expending up to €9 billion/year only in Germany. The window of opportunity for sepsis management is in hours: the chance of survival drops by 7.6% each hour of disease progression until an appropriate treatment is started. However, early and accurate sepsis detection is hampered due to: i) complex diagnostic criteria requiring screening of multiple targets, (ii) time-consuming methods for identifying the bacterial causes of sepsis, (iii) specimen transfers in centralized laboratories. Meeting this challenging framework can only be accomplished through the adoption of real-time and label-free sensor technologies incorporated in PoC platforms.

This is exactly where AMBROSIA steps in to transform integrated plasmo-photonic RI sensors into a disruptive solution for sepsis diagnosis at the point of care that will offer multiplexed (within a single test) quantification of multiple protein biomarkers and bacteria within a few minutes, providing also real-time disease stage classification and enabling a rapid and precise decision making for medical actuation. Specifically, AMBROSIA objectives include:

1. Development of multi-channel label-free CMOS plasmo-photonic sensors with high-sensitivity and resilience to noise.
2. Hetero-integration of InP-on-SiN through micro-transfer printing (μTP).
3. Development of an AI-based electro-optical read-out exploiting ultra-low power photonic Deep Neural Networks for disease classification.
4. Development of a PoC sepsis diagnostic unit.
5. Experimental validation of AMBROSIA sepsis diagnostic system with real samples.

The project is coordinated by the Aristotle University of Thessaloniki, Greece, and is scheduled to run for 4 years bringing together 12 partners strategically compiled from strong industrial and academic organizations including: (a) 4 universities, Aristotle University of Thessaloniki (GR), University of Bourgogne (FR), University of Southampton (UK), and University of Ioannina (GR), (b) 2 research institutes, the Catalan Institute of Nanoscience and Nanotechnology (ES), and the Vall d’Hebron Research Institute (ES), and (c) 6 companies, Ligentec (CH), SMART PHOTONICS BV (NL), X-Celeprint (IE), Argotech (CZ), microLIQUID (ES), and Biopix DNA Technology P.C. (GR).

About AMBROSIA

A MULTIPLEXED PLASMO-PHOTONIC BIOSENSING PLATFORM FOR RAPID AND INTELLIGENT SEPSIS DIAGNOSIS AT THE POINT-OF-CARE

Project ID:101093166
Call: HORIZON-CL4-2022-DIGITAL-EMERGING-01
Type of Action: HORIZON-RIA
Start Date: 01 Jan 2023
Duration: 48 months
Estimated Project Cost: €4,999,612.17
Requested EU Contribution: €3,689,509.66

Website: http://ambrosia-h2022.eu/

About BIOPIX-T

BIOPIX DNA TECHNOLOGY P.C. (https://biopix-t.com)  was founded in December 2019 in order to commercialize a novel molecular diagnostic method, developed by the founding team, for the detection of nucleic acids at the point-of-care. The company targets multiple healthcare-diagnostics related markets through the production of standardized assays for detection and monitoring of Infectious Diseases and Companion Diagnostics. Our mission is to offer portable diagnostic devices to every potential end-user, regardless of financial status, geographical location and training.

SOURCE: EuropaWire

Novartis, Lundbeck, and GSK Among Pharmaceutical Companies to Present at Patients as Partners Europe 2023

NEW YORK, NY, United States, 13-Apr-2023 — /EPR HEALTHCARE NEWS/ — The Conference Forum announced that the 7th annual European Patients as Partners® in Clinical Research conference will return to London at the Thistle Hotel Marble Arch on June 12-13, 2023. The event will showcase the progress made by pharma R&D executives with input from patients on achieving greater representation in clinical research, building trust and engagement in communities, and building truly patient-centric R&D organizations.

“We are delighted to be back in person to offer an unparalleled opportunity to hear from pharma R&D and patient advocacy together on how patient involvement gets done to drive greater efficiencies in clinical research with better outcomes,” said Valerie Bowling, Executive Director, Patients as Partners in Clinical Research Europe.

A variety of pharmaceutical companies will report on the progress they’ve made engaging communities and partnering with patients. Sanofi will open with the evolution of patient-informed research and its impact on medicine development. Novartis will be speaking on the organization’s global approach to implementing systematic and consistent patient engagement across the medicine lifecycle with a focus on measurement.

Lundbeck will share how they are generating insights through engagement with patient communities and making patient input actionable for medicines development. CSL Behring will discuss how they are evaluating clinical research sites based on patient-focused principles.

Several companies, including Regeneron, the Center for BME Health and Sanofi, will discuss their progress in increasing diversity amongst underrepresented communities in clinical research. GSK will lead a session on understanding barriers to community engagement in clinical research.

Boehringer Ingelheim will discuss the company’s approach to engaging patients throughout the clinical trial and how to leverage those patient insights to improve the process. Alnylam Pharmaceuticals will share how the organization has developed a top-down approach to integrating the patient perspective.

The conference features incredible patient advocate representation, addressing the realities of underrepresented communities to better serve them. For the first time, Patients as Partners Europe will have a patient-led session on supporting mental health for patients in clinical research.

“I look forward to hearing from patients and industry colleagues about what matters most and what has the greatest impact when partnering with patients and their communities on our efforts to new therapeutic options available,” said Deirdre BeVard, SVP, R&D Strategic Operations, CSL Behring and Patients as Partners Europe co-chair.

Key topics for 2023 include:

  • The evolution of patient informed research
  • Increasing diversity in clinical research
  • Patient access to research through digital innovation
  • Understanding barriers to community engagement in clinical research
  • Turning patient insights into action
  • Navigating patient engagement and compliance
  • Mapping and how to measure patient engagement
  • Regulatory requirements and patient engagement in drug development

To learn more about the event, and a full overview of speakers, please click here (https://theconferenceforum.org/conferences/patients-as-partners-europe/overview/)

About Patients as Partners EU
Patients as Partners is co-produced with patients, industry, academia, government and nonprofit organizations to establish a well-rounded program that addresses the needs of all stakeholders seeking to implement and advance patient involvement across the entire clinical development continuum.

About the Conference Forum
The Conference Forum is a life science industry research firm that develops conferences primarily around how to get therapeutics to patients faster. They examine and challenge the complex ecosystem of drug development and delivery, bringing ideas together from a variety of sources to help advance clinical research with common goals that are patient-focused.

They currently offer conferences for pharma/biotech professionals including R&D leaders, CEOs, business development/licensing, medical affairs/safety, chief patient officers/advocates, clinical innovation champions, investors and drug delivery specialists. The company also publishes six newsletters and produces PharmaTalkRadio and virtual events.

SOURCE: EuropaWire

First patient enrolled in an international multicenter clinical study for non-invasive cardiac resynchronization therapy

BOLZANO/ BOZEN, Italy, 19-Mar-2023 — /EPR HEALTHCARE NEWS/ — XSpline SPA, a start-up company incorporated in Bolzano (Italy) and the Ordensklinikum Linz Elisabethinen Hospital in Linz (Austria) today announced the first patient enrolled in a clinical study (ClinicalTrials.govID: NCT05327062) for the cardiac resynchronization therapy (CRT) guided by non-invasive electrical and venous anatomy assessment.  The international multicenter prospective study will include 150 patients from 16 centers in the U.S. and Europe.

XSpline Cloud provides a cloud-based non-invasive cardiac panoramic mapping technology to select individual CRT treatment strategy and predict outcomes.

Fast and fully automatic Artificial Intelligence based epi- and endocardial segmentation of cardiac structures, including coronary sinus veins, provides clear understanding of individual patient’s anatomy. The electrical assessment is based on a 3D panoramic electro-anatomical map based on 12 -lead ECG only, without requiring multichannel ECG recording or any kind of body surface potential mapping. XSpline Cloud is the first system in the world with AI based identification of the correct target zone for LV lead implantation.

The cloud-platform guarantees full operability with existing clinical standards and data formats; it supports IHE profiles, HL7 FIHR, DICOM, and a broad range of ECG formats. The platform also provides embedded medical grade visualization tools, such as an integrated multimodality DICOM viewer, an ECG viewer with measurement capabilities, a high-performance 3D viewer for segmented cardiac structures and electro- anatomical maps as well as an interactive navigator for LV lead placement.

Dr. Georgios Kollias, M.D., is the principal investigator for the clinical trial in Austria and performed the first procedure on a 71-year-old patient with ESV LV of 154 ml and EF LV of 20%.

“The XSpline Cloud software provides a unique approach to selecting an individualized CRT treatment strategy. It is a comprehensive tool for successful CRT implantation that can also predict outcomes, making the implantation procedure faster, easier, and safer for the patient. We are very pleased to start using this tool in our clinic”, said Dr. Kollias.

“XSpline SPA is supported by an international R&D team of skilled clinicians, mathematicians, and biomedical engineers with the shared goal of improving patient care. We think that the real-time visualization of each patient’s individual anatomy, the precise non-invasive electro-anatomical endo- and epicardial activation map and the interactive navigator will help to increase CRT responders”, said Mr. Werner Rainer, CEO of the company.

XSpline Cloud is an investigational device and not yet approved for commercial use.

SOURCE: EuropaWire

MIGUN LIFE, the original brand of K healthcare, to participate at CES 2023

SEOUL, Korea, 20-Dec-2022 — /EPR HEALTHCARE NEWS/ — MIGUN LIFE (CEO Jacob Hun Cheol Chang), the originator of home medical appliance, will participate in CES 2023 world’s largest exhibition of home appliances which will be held on January at Las Vegas Convention Center in USA, and will unveil year 2023 new products.

MIGUN LIFE set up exhibition booth in Convention Center at Venetian Expo Hall and will introduce MIGUN LIFE’s products and brand to global buyers. The year 2023 new products to be unveiled this time are Re:ach RH01 and Re:ach RH02.

Product Information

Re:ach RH01 is product in a form of mat that allows us to enjoy relaxation and spine treatment. Re:ach RH02 is product in a form of mattress that allows us to enjoy both sleeping and spinal treatment which looks like a regular bed. The main feature of these products is that hidden jade massager comes out and starts spinal massage from one’s neck to hip. More than 10 acupressure rods stimulate blood spots exactly next to spine line. Once the operation is stopped, jade and acupressure rods return to inside of the mat or mattress, then you can have comfortable relaxation and sleep. Each product has leg cuffs exclusively for lower body which has functions for massaging legs and acupressure for soles of the foot. Also, they are evenly equipped with all convenient functions necessary for massage and relaxation such as thermal function, body scanning function, massage function tailored to individual’s body shape, intensity modulation massage function, relaxing music.

Personal thermal therapy appliance which was upgraded through MIGUN LIFE’s unrivaled technology Re:borne, personal ultrasound stimulating appliance Re:vive, high-frequency foot stimulator DAY:RE, these 3 products will be also exhibited.

Exhibition Booth

In the booth, products are placed in relaxed space so that visitors can experience the products comfortably and reception space for business talk are prepared separately. Furthermore, key component which shows MIGUN’s advanced technology, 2 sets of 5 thermo jades (10 thermo jades) will be exhibited with an emphasis on visitors to experience and understand MIGUN LIFE. 2 sets of 5 thermo jades (10 thermo jades) are made of 10 processed natural jades which have thermal function and it moves along the spine line and provides compression and heat.

Purpose of Participation

MIGUN LIFE has purpose to achieve from participating CES 2023. First of all, it is to promote brand and products worldwide to expand our global business in earnest from 2023 which we established 50 countries and for about 30 years. Also, it is to increase sales across the US since the establishment of US corporation in 2000. MIGUN LIFE has export record more than 5 million US dollars in the US, proceeded FDA (Food AND Drug Administration) for approval but also clinical trial at UC Irvine in the US. It explains that if MIGUN LIFE meets demand from American customers, the products will be recognized as differentiated product by going beyond global standards.

An official from MIGUN LIFE said “MIGUN LIFE, the original brand of K-healthcare, will participate CES 2023 to introduce 2023 new products and is asking for interest of MIGUN LIFE’s active role in Korea market but also in global market as well”

Homepage : http://www.migunlife.co.kr
Inquiry : +82-2-6951-2886 / Sales Rep: Andrew Yoon (migunlife_gsales@migunlife.co.kr)
Sales Rep: Andrew Yoon (migunlife_gsales@migunlife.co.kr)

SOURCE: EuropaWire

A British Girl Creates a Special Sign for Women’s Periods to Say “No” to Period Shaming

NEW YORK, 2022-Nov-21 — /EPR HEALTHCARE NEWS/ — In recent years, “menstrual shame” has become one of the most searched topics on the Internet, which caused heated discussion among netizens. Some women said they had never felt ashamed of menstruation and they even could talk about it openly. Some others said they felt period-shame when they were young; however, this feeling gradually disappeared as they grew older…

It is believed that most girls feel embarrassed or even ashamed to talk about periods when they are young. They hesitate to tell others when they feel sick during the periods; they even feel uncomfortable buying sanitary essentials from shops and try to “cover up” the embarrassment with black plastic bags.

Periods shouldn’t be taboo!

Sophia McKinstry, a girl from a university in UK, has exquisitely made a “Special Sign for Women’s Periods” to call on people to break the taboo around menstruation, remove the shame and stigma, and urge the society to face women’s physiological periods squarely. The overall outline of the Special Sign for Women’s Periods is like a drop of blood. The upper part is mainly composed of rosebuds, which shows a curling-up female who is lying on her side. The hollow part showing a few bat totem elements combines with the red shadow below to express that the woman is on her period.

When talking about the chance for the creation of the Special Sign, Sophia McKinstry said that she initially just wanted to help girls with period discomfort by designing a special sign, for example, when others see a girl wearing this sign, they will know that she is on her period and may feel tired and uncomfortable. In some cases, she probably needs a little care and understanding like a hot drink for her when eating meals together or avoiding persuading her to drink wine. She saw a piece of news that Melinda Gates liked the Chinese swimmer Fu Yuanhui for her bravely smashing period taboo during the Rio Olympics and noticed various hot discussions triggered by the Indian film Padman. After that, she gradually realized that period shame is a common phenomenon in many countries. Menstruation is perceived as unclean or shameful by girls and other people, which can be seen in all aspects of our lives. Therefore, she began to pay more attention to the topic of menstrual shame.

Sophia McKinstry stated that she wanted to make people understand through her own way that menstruation is a normal and healthy part of life for women and the traditional idea that periods are dirty should be bravely broken. Female periods should be treated equally as other physical phenomena in the society and they should not be taboo. For this purpose, she “encourages people to abandon the traditional secular ideas such as ‘menstrual taboo’ and ‘ menstrual shame’”, and integrate “may every girl does not feel embarrassed or ashamed any more when talking about menstruation” as well as other concepts and appeals into the design concept of the Special Sign.

The Special Sign for Women’s Periods has become globally accepted to mark women’s menstruation and periods. It encourages women to break the taboo of “menstrual shame”, calls on the society to stop hating “menstruation”, and represents care and understanding for women on periods.

The small sign contains infinite power. We believe that it will promote a great spirit, end the long-standing discrimination, and arouse people’s courage to challenge the secular ideas and break taboos, just like the Olympic Rings and Red Ribbons.

Via EPR Network
More Healthcare press releases

Diabeloop presents the results of the use of its Automated Insulin Delivery (AID) over the past 12 months by 4,162 patients

PARIS, 21-Sep-2022 — /EPR HEALTHCARE NEWS/ — Diabeloop, a leader in therapeutic AI applied to insulin delivery, reports today on 12 months of use of its hybrid closed-loop DBLG1 System on a large, multi-country patient cohort. While Time in Range (70-180 mg/dL) still shows constant improvement, time spent in hypoglycemia stays significantly low. Users share how these clinical results, combined with a growing trust in the algorithm has led to fewer interactions with the device and improved quality of life.

New data2: one year living with DBLG1 System
Cohort of over 4,000 patients in 5 European countries

The innovative company Diabeloop, which will be present this week at the EASD Annual Meeting 2022, shares new real-world data on its first Automated Insulin Delivery system use.

DBLG1 System reached the European market a little over a year ago with consistent utilization throughout this period, with merely 1% of users discontinuing use of the product3.

In line with previously presented data4, significant improvement in Time in Range is observed here on a much larger population. The cohort gathers 4,162 patients in five countries: Germany, Italy, Spain, The Netherlands and Switzerland. TIR gain is 17.6 percentage points over a year of real life use.

Pr. Pierre-Yves Benhamou, CMO and President of Diabeloop’s scientific committee and US advisory board, commented:

“When initiating a treatment with DBLG1, it can be expected that the recommended outcomes (i.e., a TIR>70%, a TBR<4% and a GMI< 7%) will be achieved in about half of patients. Currently in Europe, the rate of achievement with standard treatment is only 27%.”

Another significant result is that this improvement in time spent in the target range is combined with a still extremely low occurrence of hypoglycemia: 0.2% < 54 mg/dL, 1.1% < 70 mg/dL. For the patients’ clinical picture and for their overall quality of life, this means less than 20 minutes per day spent in hypoglycemia, whereas the maximum accepted in the international recommendations is 60 mins.

Andrea and Martin, users of DBLG1 System share the benefit they derived from DBLG1 System on their hypoglycemia:

“Before I started using the system, I always had restless nights, because I often got hypoglycemia at night. Now the nights are great, I have to say.”

“I feel safer knowing that I’m not going to start sweating at some point, somewhere, because I have a low. That always made me feel kind of weak. I used to work as a nurse in three shifts, so I wish DBLG1 had been available, because I didn’t really have a daily routine then, where DBLG1 would have supported me.”

Algorithm performance leads patients to entrust it with fuller meal management

In the current commercial version of DBLG1, thanks to the initial parameter (meal ratio) and intuitive food logging functionality, patients:

– have access to meal size pre-configurations (small – medium – large)
– can quickly declare their meal
– personalize the carb intake declaration.

Based on the declaration, the glucose trend at time of meal and incremental patient data, the algorithm will recommend the insulin dose to deliver and manage post-prandial time period.

Diabeloop has already announced it was working on new versions to allow optimal management without declaration. Testimonials and data5 of DBLG1 real-life use however tend to show that patients trust the currently available device’s performance enough to skip some meal declarations and/or to declare approximative carbs quantities, and still get satisfying results.

For example, for the three main daily meals (breakfast, lunch and dinner), the patients used the shortcut (small-medium-large) for half of the 45 million meals declared on DBLG1.

It has also been observed that the longer the patients use DBLG1, the less likely they tend to declare meals altogether and the system will regulate itself. On average, one less meal is declared per day after 6 months of use.

Throughout the first 12 months of commercialization, feedback from users has been tremendous, highlighting time-saving, mental load alleviation and overall quality of life improvement.

Eva shares:

“I would definitely say that the mental burden has become less, or that I have to put in less effort to get good values (…) My sleep in general has gotten much better. The blood sugar levels are much more stable. I remember when I would wake up at night or set my own alarm. That has become much better since I have the Diabeloop system. The nights are fantastic.”

Erik Huneker, co-founder and CEO of Diabeloop reacts to these new real-world data and users comments:

“There is nothing more fueling for us than seeing DBLG1 perform over many months while it contributes to people with diabetes various lifestyles and needs. We have now equipped 10,000 patients and look forward to providing more personalization, ever more simplicity of use and more choices…to more and more people with diabetes.”

DIABELOOP AT EASD, September 20-23:
Booth M06
Meet the Expert session, September 21, 10:00 – 10:30 am
Supporting patient empowerment and improving glycemic outcomes with connected pens and artificial intelligence – From DBLG1 to DBL-4pen.
Networking Hub – with Erik Huneker, Pr. Lutz Heinemann & Pr. Pierre-Yves Benhamou
Platinum sponsor of #dedoc voices program

SOURCE: EuropaWire

New AI-powered predictive algorithm offers unprecedented accuracy in diagnosing NASH and liver fibrosis staging

BOSTON, MA, United States, 18-Jul-2022 — /EPR HEALTHCARE NEWS/ — Metadeq Inc., a global NASH and metabolic diseases diagnostics company, today announced a breakthrough non-invasive blood test that utilizes two novel circulating proteins to accurately diagnose Non-alcoholic steato-hepatitis (NASH) and liver fibrosis, and can score the stages of both diseases, without the need for invasive liver biopsy. The study which details the new blood test – just revealed in Gut, a leading hepatology and gastroenterology journal published by BMJ – was led by King’s College London Professor Geltrude Mingrone, in collaboration with Metadeq.

Approximately one in four people worldwide, or approximately two billion people, have Non-alcoholic fatty liver disease (NAFLD) and therefore are at risk of developing NASH. NASH is the most severe form of NAFLD, a silent disease associated with fatty deposit build-up of the liver. NASH leads to advanced liver diseases such as liver fibrosis (scarring), cirrhosis, and liver cancer, and may ultimately result in death. The annual cost to the US healthcare system alone has been estimated to be over $100 billion per year.

Currently, the only way to diagnose NASH is through the standard of diagnosis, invasive liver biopsy, which is expensive and is associated with significant complications and discomfort. Until now, no reliable blood test has been developed for NASH, nor liver fibrosis. Most importantly, no available test can define the severity (stage), or monitor the progression, of either NASH or liver fibrosis.

Professor Geltrude Mingrone from the School of Cardiovascular and Metabolic Medicine & Sciences at King’s College London, who is one of the most widely cited and influential researchers globally for metabolic diseases and disorders, set out to discover a more accurate liquid biopsy test in support of patient care and in collaboration with Metadeq. The resulting study was published today in leading journal, Gut.

This study identified two novel protein biomarkers, PLIN2 and RAB14, to assist in the diagnosis of patients with NASH and/or liver fibrosis. The ability of these proteins to detect both diseases was tested in cohorts with either NASH and/or liver fibrosis that were confirmed with liver biopsy, the current standard of diagnosis.

“This blood test will allow researchers and clinicians to define the prevalence of NASH across populations, including children and adolescents, avoiding the need for invasive liver biopsy,” said Professor Mingrone. “Critically, it will allow care-givers to monitor the efficacy of NASH treatments over time, reducing screen failures and helping generate better drugs.”

“Since HEPAR-QTM is the only diagnostic modality that can diagnose NASH and fibrosis staging we expect it to be instrumental in the development of new therapeutics for the management of patients,” said Frank Jaksch, Chairman of Metadeq. “We believe that HEPAR-QTM will advance for the benefit of patients the problem of regular screening, that has resulted in late drug failures during clinical trials, since it is now possible to accurately measure the severity of disease in a non-invasive manner.”

 

The Metadeq predictive algorithm, which uses A.I., provided unprecedented sensitivity (88-95%), specificity (90-100%), and overall accuracy (92-93%) for NASH, and also has near-perfect sensitivity (99%-100%), specificity (90%-96%), and accuracy (98%-99%) for liver fibrosis.

The test results show that the proteins can provide rapid and cost-effective testing to combat the growing epidemic of NASH and liver fibrosis. This could be an invaluable tool in diagnosing and monitoring cases of liver diseases, allowing people to receive earlier treatment, from lifestyle adjustments to surgical and pharmacological interventions.

Currently no NASH drug has been approved by either the FDA or EMA, which may be a direct result of the lack of an accurate, reliable, and non-invasive test. More than 65% of patients who enroll in clinical trials for NASH-related therapies are found to be ineligible for the trial due to screen failure, which causes major monetary losses to companies developing and testing NASH drugs. The improved accuracy and ability to detect NASH staging will help in identifying and enrolling the appropriate people in clinical trials, speeding up the development of NASH drugs.

About Metadeq
Metadeq Corp. is a diagnostics company that provides innovative liquid biopsy solutions for liver and metabolic diseases. For the first time, Metadeq allows people to measure the whole spectrum of liver diseases – from NAFLD, to NASH, and liver fibrosis – with a blood test. www.metadeq.com

SOURCE: EuropaWire

Diabeloop, a high-growth health tech firm that automates the treatment and the management of diabetes, announces EUR 70 million funding

PARIS, 2-Jun-2022 — /EPR HEALTHCARE NEWS/ — Diabeloop secures 70 million euros to pursue its solid and sustained growth strategy.

The company, an Automated Insulin Delivery pioneer, develops machine-learning software for diabetes treatment. Its highly sophisticated algorithms are integrated into easy-to-use products helping facilitate chronic disease management impacting patients’ clinical outcomes and their quality of life.

Diabeloop has seen impressive growth in the last few years with two products on the European market, rapidly approaching 10,000 equipped patients one year after commercial launch and major developments with various device partners.

The first closed-loop solutions commercialized by Diabeloop offer personalized management for Type 1 (DBLG1) and highly unstable Type 1 diabetes (DBL-hu). By connecting a Continuous Glucose Monitoring device (CGM) and an insulin pump, Diabeloop’s world-leading algorithms analyze data in real time and automate insulin delivery. It transforms the lives of people with diabetes by taking over many of the therapeutic decisions that used to fall to patients.

Erik Huneker, founder & CEO of Diabeloop, declares: “Being able in 2021 to bring the benefits of our products to thousands of patients and hearing their enthusiasm, is why all of us at Diabeloop work so hard. The financing round announced today recognizes the team’s successes, and more importantly, the great opportunities ahead.”

The financing round is led by prominent private equity player LBO France. The Venture division of the sustainability-conscious private equity fund is a European leader in digital health, supporting young companies with ambitious projects showing international footprints.

“Diabeloop’s team has developed a unique data driven product that has the potential to revolutionize the daily life of millions of diabetic patients by taking away most of their daily mental burden and significantly improving the control of their disease. We are eager to join the investor base and help the company become a global leader in diabetes closed-loop software solutions,” says Valery Huot, Partner, Head of Venture at LBO France.

International healthcare leader Terumo Corporation also participates in Diabeloop’s Series C round. After entering into development agreements with one another in 2020, Terumo extended this to a comprehensive strategic partnership agreement with Diabeloop in 2021.

“We are excited that Diabeloop successfully completed this important milestone and the great opportunities will continue to expand for all corners of the world. Together with Diabeloop, we are committed that we will be able to contribute to all stakeholders by providing patient-centric and personalized solutions,” comments Hikaru Samejima, President of Terumo’s Medical Care Solutions Company.

Innovacom, a key player in the French and European startup community specialized in deep-tech and industrial projects, joins LBO France and Terumo Corporation as new investors.

Comforted by the commercial launch of Diabeloop first devices and the break-through potential of its projects to address a 10-million patients market in the mid-term, previous investors CERITD, CEMAG invest, Kreaxi, Supernova Invest, AGIR A DOM., Crédit Agricole, Odyssée Venture, UI Investissement (Sofimac) and Promontoires all have decided to reinvest.

Additionally, Bpifrance and the historical bank pool are supporting Diabeloop via debt financing.

“We are grateful for the confidence of our existing investors and proud of our distinguished new financial and industrial shareholders. I have full trust in the talent and commitment of the Diabeloop teams to pursue their groundbreaking value creation path for patients and become a trusted leader and partner in the highly reactive diabetes market,” concludes Catherine Dunand, Diabeloop’s Chairman of the Board.

In 2019, Diabeloop secured the highest recorded European financing round in Therapeutic Artificial Intelligence and went on to commercially launch two products, with several thousand patients equipped in less than a year. Their CE-marked data visualization platform accompanies healthcare professionals and patients as a telemedicine and remote patient monitoring solution. High-impact projects such as the adaptation of the core-algorithm to the multi-million users Connected Pen market and development of smart-watch devices also have contributed to Diabeloop’s tremendous momentum.

About Diabeloop
Diabeloop’s mission: Making innovation accessible to people living with diabetes, improving clinical results while relieving them of their constant mental burden.

Created in 2015, Diabeloop is a high-growth company that offers AI-based, personalized solutions to automate the treatment and the management of diabetes. DBLG1 System, Diabeloop’s first medical device for automated insulin delivery (AID) and DBL-hu, its solution for highly unstable Type 1 diabetes management, are both CE-marked and being deployed in Europe. Diabeloop just completed its Series C financing round, securing 70 million euros, to accelerate its commercial roll-out, support its sustained growth strategy and its high-impact projects.

Today, Diabeloop gathers the personality, passion, and skills of over 160 talented individuals who work hard to improve the quality of life for every person living with diabetes.

About LBO France
With €6.6 billion of capital raised since its inception, as a key player in private equity, LBO France is supporting growing French and Italian companies for more than 30 years.

Its investment strategy is based on five distinct segments managed by dedicated teams:

(i) Mid Cap Buyout through the White Knight funds, and Small Cap Buyout through the Small Caps Opportunities funds,
(ii) Venture capital through the Digital Health funds,
(iii) Real estate through the French White Stone funds, OPCI Lapillus, impact fund Newstone and the Italian management company Polis Fondi SGR
(iv) Debt, notably in Italy through the Vita Superbonus program to finance energy efficiency in real estate assets
(v) Public Equity through the France Développement fund

LBO France is 100 % owned by its management and employs nearly 70 professionals.

SOURCE: EuropaWire

Diabeloop, a medtech firm that automates T1D treatment, presented new real-life results for its DBLG1® System at ATTD2022 in Madrid

PARIS, 28-Apr-2022 — /EPR HEALTHCARE NEWS/ — ATTD 2022 – Diabeloop, pioneer in therapeutic artificial intelligence for diabetes management, presents today new results from a real-life cohort in Germany. The data show a constant improvement in Time In Range (70-180 mg/dL) combined with a significant reduction of hypoglycemia.

DBLG1, Diabeloop’s hybrid closed-loop, showed improvement of Time In Range and reduction of hypoglycemic episodes which allows for better diabetes management and improved quality of life.

Time In Range: a continuous improvement, with even more people equipped

Presented today at ATTD, the latest data from DBLG1¹ real-life cohort demonstrates an increase of 18.4 percentage point in Time In Range (TIR 70-180 mg/dL) on 974 patients.

This significant gain confirms the constant improvement in Time In Range, a key indicator of glucose control, in people living with Type 1 diabetes equipped with DBLG1 System since the WP7² pivotal trial (+12 points), the commercial pre-launch³ (+16.7 points) and the results of the first real-life cohort in Germany4 (+17.1 points).

With several thousand people equipped, Diabeloop’s solution continues to increase the Time In Range and thus improves the associated clinical benefits, such as better glucose control, less complications and improved quality of life.

These significant performances confirm the ability of Diabeloop’s solutions to improve glycemic control of people with T1D, in real-life, in a less controlled environment than in hospital supervised studies.

DBLG1 users in Germany, included in the real-life cohort, benefit from basic support at initialization. This demonstrates the ease of use of Diabeloop’s automated and personalized insulin delivery system and its interface.

Prof. Pierre-Yves Benhamou comments: “From the first study – WP7 which showed an increase in Time In Range of 12 points, to today with +18.4 points following the European commercial launch of DBLG1, the continuous improvement of the TIR is significant. The results observed on the new real-life cohort of nearly 1000 people in Germany are very impactful, with patients with a baseline TIR (70-180 mg/dL) of 54.6% reaching 73% TIR in closed-loop with DBLG1. The other very positive result observed in this cohort is the significant reduction in hypoglycemia”.

A significant reduction of hypoglycemia combined with improvement in TIR

Associated with the increase in TIR, the retrospective data of the real-life DBLG1 cohort show a very significant reduction in time spent in hypoglycemia. Users of DBLG1 whose HbA1c was available at initiation spent only 0.9% of the time below 70 mg/dL and 0.1% of the time below 54 mg/dL5.

This variable has been constantly improving since the real-life WP72 study, which had already demonstrated a halving of the time spent below 70 mg/dL, a gain of more than 30 minutes less spent in hypoglycemia each day. More recently, the first real-life cohort in Germany demonstrated a time spent below 70 mg/dL at 1% and 0.2% below 54 mg/dL(4).

Thus, DBLG1 strongly contributes to reducing the short-term risks associated with hypoglycemia, such as discomfort, dizziness or even life-threatening situations. Diabeloop’s technology, based on artificial intelligence, allows an optimal diabetes management with less glycemic variations responsible for complications, and a life without interruption associated with the chronic disease.

“It is a great satisfaction to see that these new data extracted from an even larger cohort of patients show a simultaneous performance on TIR and reduction of hypoglycemia. Combined with the positive and very concrete feedback from the people equipped, this motivates us to go even further, to address more and more populations affected by diabetes” states Erik Huneker, CEO and co-founder of Diabeloop.

Testimonials: positive impacts in diabetes management, quality of life and mental burden

Since the commercial launch of its first solution in Europe last year, Diabeloop has received numerous feedback on the improvement of diabetes management and clinical benefits.

“I was skeptical about letting my diabetes be controlled by technology. But my diabetologist advised me to try it. My HbA1c dropped from 10% to 7% within two months. DBLG1 has improved my quality of life. I sleep better, I’m fitter, I’m very curious about what the next updates of DBLG1 will bring.” says Martin, living with diabetes for 45 years, equipped in Germany.

“My life has definitely changed with DBLG1. I have much less mental burden. I really noticed that I can have more time for other things and don’t have to concentrate on my diabetes all the time, as long as I take everything responsibly and estimate the carbs of my meals correctly. When I go to parties or some birthdays or other events, I know that DBLG1 always corrects me automatically. I’m really happy!” comments Eva, T1D using DBLG1 in Germany.

“DBLG1 has a “high-fat meal” feature that I use very often, even though I don’t eat that much fat but I don’t eat a lot of carbs either. It allows the delivery of biphasic boluses, adapted to the blood sugar level before meals and it works magically on me to avoid postprandial hyperglycemia!” says Stéphanie, equipped with DBLG1 in France.

Listen to all the testimonials in the first episode of the exclusive podcast Diabeloop Stories on Spotify : https://open.spotify.com/show/3GNcl…

Come and meet the Diabeloop team at ATTD, booth n°34 in the TechFair area.

CEO Erik Huneker and Pr Pierre-Yves Benhamou will present these results at Diabeloop session “AID pipeline perspectives & clinical outcomes” on Thursday, 28th April from 12:10 in the Exhibition Area.

About Diabeloop
Created in 2015, Diabeloop is a high-growth company that offers AI-based, personalized solutions to improve clinical outcomes for people with diabetes while relieving them of their constant mental burden. DBLG1 System, Diabeloop’s first medical device for automated insulin delivery (AID) and DBL-hu, its solution for highly unstable Type 1 diabetes management, are both CE-marked and being deployed in Europe.

A second round of financing of 31 million euros, concluded at the end of 2019, supported the international commercial rollout of DBLG1 iController and Diabeloop’s ambitious R&D program. Today, Diabeloop gathers the personality, passion, and skills of over 160 talented individuals who work hard to improve the quality of life for every person living with diabetes.

——————
References:

1 Real-life internal data (YourLoops data extract, from September 1, 2021, to December 31, 2021): 974 patients from Germany, who gave consent, equipped with DBLG1 System with Accu-Chek® Insight (Roche) insulin pump, with HbA1c available at initiation.

2 P.Y. Benhamou et al., «Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial», The Lancet Digital Health, Vol 1 (1), E17 – E25, 2019. DOI: 10.1016/S2589-7500(19)30003-2

3 C. Amadou et al., «Diabeloop DBLG1 Closed-loop system enables patients with Type 1 diabetes to significantly improve their glycemic control in real-life situations without serious adverse events», Diabetes Care 2021 Jan; dc201809. doi:org/10.2337-dc20-1809

4 Data from 152 patients equipped with DBLG1 System with Accu-Chek® Insight (Roche) insulin pump in Germany from April to September 2021 with available HbA1c at initiation, based on [Beck and al. 2019] equation for hb1Ac <=9% and hb1Ac>=6%”

5 Real-life internal data (YourLoops data extract, from September 1, 2021, to December 31, 2021): 1914 patients from Germany, who gave consent, equipped with DBLG1 System with Accu-Chek® Insight (Roche) insulin pump..

SOURCE: EuropaWire

Diabeloop to integrate insulin pens into its hybrid closed-loop system using a unique app

PARIS, 12-Apr-2022 — /EPR HEALTHCARE NEWS/ — Diabeloop, a pioneer in the field of therapeutic artificial intelligence, leverages the potential of its diabetes technology to enable the integration of insulin pens into its hybrid closed-loop system using a unique app. With DBL-4pen, Diabeloop offers new opportunities for personalized diabetes management for people with Type 1 and Type 2 diabetes, further advancing the quality of patient care.

Diabeloop opens a new segment in the insulin therapy market

Several tens of millions of people worldwide require insulin everyday. However, only 2 million of them1 are equipped with insulin pumps, because of their relative complexity and significant cost. Most diabetes patients in Europe and the U.S. on intensive insulin therapy are multiple daily insulin injections (MDI) pen users.

Diabeloop is developing a product for people living with diabetes who do not have access or want to wear an insulin pump. Using self-learning algorithms, DBL-4pen will bring most of the clinical improvement from DBLG1’s closed-loop to insulin pen users, while the overall cost will be significantly lower for the payer.

DBL-4pen: real-time mobile insulin dosing and telemedicine solution

People on multiple daily insulin injections using pens face the challenge of determining the correct amount and timing of insulin depending on individual blood glucose levels, physiology and lifestyle. To reduce hypoglycemia, risks of associated complications while lowering the mental burden of managing diabetes for patients using insulin pens, Diabeloop is developing a unique smartphone app that embeds its self-learning algorithm. The app is connected via Bluetooth® to a connected insulin pen and a CGM that measures blood glucose levels every 5 minutes.

On the way to more automation, DBL-4pen requires a minimal input from users. They only need to enter meals and physical activities into the app. DBL-4pen then automatically recommends the ideal insulin dose in real time, which can be delivered via the pen with no more calculation to do.

In addition, the measured data can be transmitted to the physician, healthcare providers or family members via YourLoops, the cloud based data visualization platform, if the patient so desires.

Strong partnerships to foster interoperability

DBL-4pen complements Diabeloop’s existing product line with another user-friendly and personalized solution that offers more control and customization possibilities regarding diabetes management.

“The integration of insulin pens into hybrid closed-loop systems is a substantial progress. Especially diabetes patients for whom pump therapy is a hurdle can benefit from this new solution. Moreover, diabetes therapy with insulin pens can be a viable solution for different healthcare systems,” said Prof. Hélène Hanaire of the University Hospital of Toulouse.

Diabeloop announces the extension of its partnership with BIOCORP, a French company specialized in the development and manufacturing of medical devices and connected healthcare solutions, to integrate Mallya®, their smart cap for insulin injection pens into Diabeloop’s technological environment.

This and other planned partnerships are expected to create new opportunities to bring Diabeloop’s interoperable technologies to people with diabetes who use insulin pens for their daily multiple injections.

“With DBL-4pen, we are able to bring the power of self-learning algorithms and connectivity to the majority of people who can not or do not want to wear an insulin pump. The combination of smart sensors for insulin pens with our self-learning algorithm gives us the opportunity to integrate a wide range of insulin pens into our hybrid closed-loop system in the future. Our goal is for this innovative solution to be compatible with almost all pens on the market,” said Erik Huneker, CEO and co-founder of Diabeloop.

Dynamic bolus insulin titration doses

DBL-4pen is currently a unique solution for MDI patients to dynamically titrate bolus insulin doses. Personalization is at the core of this solution because the app takes into account both entered meals and physical activities, as well as glucose trend, and uses the entire patient history to fine-tune bolus amounts based on the patient’s response to previous boluses.

“DBL-4pen offers a customized solution for MDI patients that can be integrated into hybrid closed-loop systems. Currently, we are in the process of launching a clinical trial in France to strengthen Diabeloop’s positioning in the insulin pen therapy market,” said Marc Julien, Chief Operating Officer of Diabeloop.

About Diabeloop
Created in 2015, Diabeloop is a high-growth company that offers AI-based, personalized solutions to improve clinical outcomes for people with diabetes while relieving them of their constant mental burden. DBLG1 System, Diabeloop’s first medical device for automated insulin delivery (AID) and DBL-hu, its solution for highly unstable Type 1 diabetes management, are both CE-marked and being deployed in Europe.

A second round of financing of 31 million euros, concluded at the end of 2019, supported the international commercial rollout of DBLG1 iController and Diabeloop’s ambitious R&D program. Today, Diabeloop gathers the personality, passion, and skills of over 160 talented individuals who work hard to improve the quality of life for every person living with diabetes.
——————
Reference:
1 2021 internal extrapolation based on Seagrove Partners and Simon-Kucher reports data

——————–
Meet Diabeloop at ATTD 2022 (27-30 April 2022, Barcelona, Spain) or contact us for further information at: partnership@diabeloop.fr

SOURCE: EuropaWire

European public-private project to advance precision psychiatry by introducing biology into clinical routine

PARIS AND MONTPELLIER, 30-Mar-2022 — /EPR HEALTHCARE NEWS/ — ALCEDIAG announces the launch of the EDIT-B Consortium, supported by the European Institute of Innovation and Technology for Health (EIT Health). This newly formed European public-private partnership aims at advancing precision psychiatry by introducing biology into clinical routine.

Around 300M people in the world are affected by depression. Studies show that up to 40% of them may be misdiagnosed and potentially bipolar. As a result, diagnosis is often delayed by an average of 7.5 years, worsening patients’ mental and physical conditions as well as their loved ones’ quality of life.

The EDIT-B Consortium aims to solve this diagnostic challenge by using specific RNA editing based biomarkers and artificial intelligence to validate and commercialize an accurate, reliable, and quick blood test to diagnose bipolar disorder.

The Consortium brings together prominent members from across Europe who will be working over the next three years to achieve this goal: Alcediag, Alcen, Capital Region of Denmark, Fundació Clinic per la Recerca Biomèdica, Fundació Sant Joan de Déu, GHU Paris Psychiatrie & Neurosciences, Hospital Clínic de Barcelona, Parc Sanitari Sant Joan de Déu, ProductLife Group and Synlab. With a total budget of € 5.2 million, EDIT-B is co-funded by the EIT Health (€ 2.5M) and the partners.

“This project will accurately separate bipolar disorder from unipolar disorder. This distinction is extremely important clinically, because the treatments are different. EDIT-B Consortium gathers all relevant expertise and as the principal investigator in the clinical trial, I hope we will be able to validate a test that will improve the lives of many people living with bipolar disorder”, says Prof. Eduard Vieta from the Hospital Clínic de Barcelona.

SYNLAB is the first diagnostic service provider in Europe, present in 36 countries in 4 continents and committed to developing high value solutions for patients  focusing on medical excellence and customer centricity.

Maurizio Ferrari, SYNLAB Italy Chief Medical Officer says: “innovation in healthcare is a key pillar for the customer centricity and  we are very proud to be part of this European research project that really may help patients with psychiatric disorders”.

“I am proud to see that the EDIT-B consortium led by our partner Alcediag – a subsidiary of Alcen – will tackle the challenge of improving the diagnosis of bipolar disorder. In doing so, they support EIT Health main mission which is to help citizens live healthier and longer lives and at the same time put the spotlight on mental health which is key to the proper care management and wellbeing of our communities”, adds Jean Marc Bourez, interim CEO of EIT Health.

“On this World Bipolar Day, Alcediag team is happy to announce its contribution to solving the bipolar disorder diagnostic issue.  We are proud and grateful to our partners and the EIT Health for this opportunity to advance science while having a positive impact on people’s lives”, said Alexandra Prieux, CEO of Alcediag.

SOURCE: EuropaWire

Silencil Reviews: A Scam Supplement Or Does It Really Treat Tinnitus – Critical Silencil Review

NEW YORK, 2022-Mar-24 — /EPR HEALTHCARE NEWS/ — It is no news that tinnitus has been considered an incurable health condition ever since it was discovered. Hence, whereas doctors and clinicians usually prescribe antidepressants or anxiety-relieving medications to assist reduce the internal noise, there are no medications specifically designed to help put an end to it. But can Silencil really cure tinnitus? A YES OR A NO!

The fact that no one believes tinnitus has a cure stems from the story that some people have attempted numerous approaches in an attempt to get rid of their ringing in the ears without success. Nonetheless, recent advancements in medical science are taking us one step closer to finding a cure – brain inflammation as the cause of tinnitus. Fortunately, the Silencil team has rallied around this cause (brain inflammation), and they are determined to see it through.

MUST SEE: VISIT THE OFFICIAL WEBSITE TODAY FOR YOUR OWN SUPPLEMENT
According to the manufacturer, Silencil was designed to be almost your one and only true protection against tinnitus of all forms. It is a new nutritional supplement that is intended to reduce ringing in the ears as well as any associated symptoms that may occur as a result of the condition by reducing brain inflammation. Silencil is believed to really solve tinnitus by targeting the underlying problem. This Silencil Review is meant to explain everything about this supplement. Real-world customers and doctors have endorsed it as being tested, dependable, approved, effective, potent, legitimate and reliable.

What Is Silencil?
Silencil is a natural tinnitus supplement made up of 28 clinically approved plant extracts and vitamins that have been shown to be effective in treating tinnitus by reducing brain inflammation. It improves overall brain function, as well as strengthening the immune system and repairing any damage that has occurred, thereby curing tinnitus.

CLICK HERE TO BUY THIS NUTRITIONAL SUPPLEMENT FOR YOUR TINNITUS ON THE OFFICIAL WEBSITE
Silencil is a brain-health supplement / vitamin for tinnitus which works to restore your brain and body’s normal function, ultimately treating you of the condition. Simultaneously providing users with a natural blend of plant and vitamin extracts that work on nerve cells and brain tissue, Silencil’s primary purpose is to improve the user’s ability to hear in all ramifications. While Silencil does assist to decrease the ringing in the ears, it does so primarily through the reduction of inflammation and the re-establishment of neural connections inside the brain.

Truly, Silencil should not be seen as a miracle solution for curing tinnitus, and thus, it should not be expected to produce results overnight. It is rather a dietary supplement which is vested with totally lowering the symptoms of tinnitus as a whole. It accomplishes relief to tinnitus sufferers by identifying and resolving the fundamental root of the problem known as brain inflammation. This is only possible if you have adhered to the manufacturer’s prescription and procedure.

According to general consensus, tinnitus is caused by an issue with one’s hearing. However, the inventor of Silencil believes that electrical misfires (inflammation) in the brain are responsible for a considerable percentage of the ringing in one’s ears and the Silencil pills are designed to address it as effectively as possible.

Is Silencil a legitimate treatment for tinnitus, or does it come with potentially serious side effects and allergies? Of course, this Silencil pill addresses and heals brain inflammation, which is the underlying cause of tinnitus in most cases. It is 100 percent legitimate, and the success stories that have been shared are genuine. Because the components in Silencil have all been approved by the FDA and professionally evaluated, there are no known negative side effects from using it. When the supplement is taken as directed, the pills are delivered directly to the brain, where they work to repair the damaged chain, alleviating the continual ringing sound in the ear.

This natural supplement is now widely acknowledged as one of the most effective natural remedies available for the treatment of tinnitus on a global scale. Millions of real clients all over the world have benefited from this superior supplement and have stated that the ringing or buzzing in their ears has been eliminated completely.

Via EPR Network
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Kenneth Research: Increasing Concern for Mental Health Disorders to Drive Market Growth for Mental Health Software and Devices

NEW YORK, 21-Mar-2022 — /EPR HEALTHCARE NEWS/ — Every year, over 7 Million people are known to die by suicide, one of the major concerns of mental health, according to the statistics by the World Health Organization (WHO). Calculatedly, this comes to one person every 40 seconds. Moreover, in the year 2019, suicide accounted for 1.3% of the total number of deaths around the globe. On the other hand, mental health disorders, such as depression, affected 3.8% of the global population, or around 280 Million people. This included 5.0% adults and 5.7% aged adults above 60 years of age.

Kenneth Research recently released a report titled “Global Mental Health Software and Devices Market” which includes a detailed analysis of the market dynamics along with the impact of COVID-19 on the market growth during the forecast period, i.e., 2021-2030. The report also includes the regulatory and standard landscape, and in-depth research about the market growth across the five major regions, i.e., North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

In Europe, Austria (24 males, 5.6 females), Belgium (23 males, 8.6 females), France (22 males, 5.9 females), Finland (22.9 males, 7.6 females), Germany (17.3 males, 4.8 females), Sweden (17.7 males, 7.0 females), Netherlands (15.7 males, 7.0 females), has shown the highest number of death rates and self-harms per 100,000 inhabitants.

As COVID19 sweeps the global economies, Europe is one of the worst hit since 2020. As new COVID guidelines, lockdown and restriction comes into force, economies have reported elevated cases of anxiety and stress. Especially quarantine and its ill impacts have pushed levels of loneliness, depression, drug use, alcohol consumption, suicidal behavior and self-harm are pushed to another level.

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Mental health is a major concern globally and with the rising prevalence of different types of such disorders in recent years, as well as with the growing awareness for these diseases by governmental bodies, the disease has been included in the list of 17 Sustainable Development Goals (SDGs) of the United Nations. Moreover, the situation for the disease has also gained massive focus, especially to treat the elderly population. This can be attributed primarily to the increasing elderly population count over the past few years, and the growing awareness for mental health and well-being amongst these age groups. In the other statistics by the WHO, the proportion of the population of age 60 years and over around the world is expected to double from 12% to 22% between 2015 and 2050. The statistics further stated that over 20% of these adults suffered from a mental or neurological disorder, and 6.6% of all disabilities amongst these population groups accounted for such disorders. Additionally, around 5% and 7% of these populations had been affected with dementia and depression respectively, which are the two most common mental and neurological disorders.

The global mental health software and devices market generated a revenue of USD 3883.94 Million in the year 2020 and is further expected to grow with a CAGR of 13.28% during the forecast period and touch a value of USD 13367.12 Million by the end of 2030. The growth of the market can primarily be attributed to the growing need for advanced patient monitoring and patient management applications amongst healthcare service providers for those treating mental disorders, backed by the surge in the number of mental health patients worldwide. Besides this, the increasing number of these patients is expected to drive the need for advanced devices which can help for early diagnosis and treatment, therefore contributing to the market growth in the coming years. For instance, the prevalence of dementia, which is known for deteriorating the memory, thinking, behavior, and the ability of the patients to perform everyday activities, is expected to increase to 82 Million by 2030, and further touch 152 Million by 2050, according to the statistics by the WHO. On the other hand, according to the statistics by United Nations Children’s Fund (UNICEF), in the year 2019, between the ages 10 and 14, 34,840,000 female adolescents and 44,647,000 male adolescents suffered from mental disorders. Moreover, between the ages 15 and 19, 41,712,000 female adolescents and 44,563,000 male adolescents had suffered from the same disorder. The surge in these cases is expected to boost the demand for diagnostic devices for the treatment of the disorder, and in turn, drive the market growth.

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The growth of the global mental health software and devices market can also be attributed to the increasing number of government initiatives that focus on maintaining good mental health and well-being of the individuals of nations worldwide. For instance, in May 2013, during the 66th World Health Assembly, the Comprehensive Mental Health Action Plan 2013-2020 developed by the WHO was adopted by the Ministers of Health of the 194 Member States. This action plan was further extended until 2030 in the year 2019, during the 72nd World Health Assembly. On the other hand, according to the statistical report titled “Mental Health Atlas 2020”, published by the WHO, 75% of the Member States had a stand-alone policy or plan for mental health. This was an increase from 68% in the year 2014.

Additionally, the statistics also stated that 57% of the Member States had a stand-alone mental health law. This was an increase from 51% in the year 2014. Besides this, since 2017, 46% of the WHO Member States had updated their health policy or plan, while 27% of them had updated their law regarding mental health.

The global mental health software and devices market is segmented on the basis of region into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Out of the market in these regions, the market in North America generated the largest revenue of USD 1557.47 Million in the year 2020 and is further expected to touch USD 5382.17 Million by the end of 2030. One of the major factors anticipated to drive the growth of the market in the region is the increasing awareness for mental health and the rising need amongst healthcare service providers to improve their services to patients who are suffering from the disease. For instance, according to the statistics by the National Alliance on Mental Illness (NAMI), in the United States, in the year 2020, 1 in 5 U.S. adults experiences a mental illness, while 1 in 20 experienced a serious one, and 1 in 15 experienced both a substance use disorder and mental illness. In addition to this, 26.3 Million adults in the nation received virtual mental health services during the COVID-19 pandemic. Amongst those who received these services, 17.7 Million people experienced delays or cancellations in appointments, while 7.3 Million experienced delays in getting prescriptions. Moreover, 4.9 Million people were unable to access needed care. The market in the region is segmented by country into the United States and Canada. Out of the market in these countries, the market in the United States is expected to hold the largest revenue by the end of 2030 and also grow with the highest CAGR of 13.36% during the forecast period.

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On the other hand, the mental health software and devices market in Europe generated a revenue of USD 1265.71 Million in the year 2020 and is further expected to touch USD 4360.54 Million by the end of 2030, by growing with a CAGR of 13.31% during the forecast period. One of the major factors anticipated to drive the growth of the market in the region is the growing reforms in the diagnosis of mental health. For instance, on the 13th of May, 2019, the Parliamentary Assembly of the Council of Europe (PACE) on Social Affairs, Health, and Sustainable Development, had urged the member States of the Council of Europe to end coercive practices in mental health settings and further adopt a human rights-based approach which is respectful of medical ethics. The market growth in the region can also be attributed to the increasing government initiatives to improve behavioral health services and the surge in the adoption of electronic health records (EHR). The market in the region is further segmented by country into Germany, France, United Kingdom, Italy, Spain, Russia, Netherlands, and the Rest of Europe. Amongst the market in these countries, the market in France is expected to generate the largest revenue of USD 988.54 Million by the end of 2030 and further grow with a CAGR of 13.75% during the forecast period. Additionally, the market in the nation generated a revenue of USD 275.93 Million in the year 2020. Furthermore, the market in Germany registered the second-largest revenue of USD 249.35 Million in the year 2020 and is further expected to touch USD 911.35 Million by the end of 2030.

The study further incorporates Y-O-Y Growth, demand & supply and forecast future opportunity in North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC [Finland, Sweden, Norway, Denmark], Poland, Turkey, Russia, Rest of Europe), Latin America (Brazil, Mexico, Argentina, Rest of Latin America), Asia-Pacific (China, India, Japan, South Korea, Indonesia, Singapore, Malaysia, Australia, New Zealand, Rest of Asia-Pacific), Middle East and Africa (Israel, GCC [Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman], North Africa, South Africa, Rest of Middle East and Africa).

The global mental health software and devices market is segmented by delivery model into subscription model and ownership model. Amongst these segments, the subscription model segment is projected to garner the largest revenue of USD 2442.34 Million by the end of 2022. Further, the segment is also expected to grow with the highest CAGR of 11.82% during the forecast period. In North America, the segment is expected to garner the highest market share by the end of 2030, while in Europe, the segment is projected to garner the largest revenue of USD 762.37 Million by the end of 2022.

The global mental health software and devices market is further segmented by end user into community clinics, hospitals, private practices, and home care settings. Among these segments, the community clinics segment registered the largest revenue of USD 1644.62 Million in the year 2020 and is further expected to touch a revenue of USD 5667.35 Million by the end of 2030. In North America, the segment generated the largest revenue of USD 660.52 Million in the year 2020 and is further projected to reach USD 2285.27 Million by the end of 2030, by growing with a CAGR of 13.35% during the forecast period. On the other hand, in the Asia Pacific, the segment is anticipated to garner the largest revenue of USD 1124.71 Million by the end of 2030, up from a revenue of USD 317.70 Million in the year 2020. Moreover, in Japan, the segment is expected to garner the largest revenue of USD 244.73 Million and further grow with a CAGR of 14.34% during the forecast period.

The global mental health software and devices market is also segmented on the basis of component, functionality, and mode of access.

Global Mental Health Software and Devices Market, Segmentation by Component

  • Software
    o Integrated Software
    o Standalone Software
  • Devices

Global Mental Health Software and Devices Market, Segmentation by Functionality

  • Clinical Functionality
    o Electronic Health Records (EHR)
    o Clinical Decision Support (CDS)
    o Care Plans/Health Management
    o E-Prescribing
    o Telehealth
  • Administrative Functionality
    o Patient/Client Scheduling
    o Document/Image Management
    o Case Management
    o Workforce Management
    o Business Intelligence
  • Financial Functionality
    o Revenue Cycle Management
    o Managed Care
    o Accounts Payable/General Ledger

Global Mental Health Software and Devices Market, Segmentation by Mode of Access

  • Desktops/Laptops
  • Tablets/Smartphone

Some of the prominent industry leaders in the global mental health software and devices market that are included in our report are Cerner Corporation, Netsmart Technologies, Inc., Qualifacts Systems, Inc., Valant, NXGN Management, LLC, Core Solutions, Inc., Holmusk USA, Inc., The Echo Group, Welligent, Inc., Credible Behavioral Health, Inc., IBM, and others.

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SOURCE: EuropaWire

Cole & Van Note Announces Mon Health Data Breach Investigation

Oakland, California, USA, 2022-Mar-05 — /EPR HEALTHCARE NEWS/ — Cole & Van Note, a leading consumer rights law firm, announces today its investigation of Monongalia Health System, Inc. on behalf of its consumers/clients, arising out the company’s recent data breach. According to the company, the private information of a massive number of people may have been stolen in the hacking of its information network. It is currently unknown how many people have had their information used for criminal purposes.

If you received a notice of this alarming data breach and/or have transacted in any way with Monongalia Health System, Inc., your information may already be in the hands of cybercriminals, making your urgent attention to this situation very important.

Cole & Van Note is ready to discuss your options and can be contacted at (510) 891-9800, by email at sec@colevannote.com or through its  website by clicking below:

Cole & Van Note has been successfully handling consumer and employee rights matters since 1992. The firm has recovered compensation for millions of individuals and stands ready to help you get paid for your losses.

Attorney Advertisement. Our previous results do not guarantee or predict a similar outcome.

Full Name: Scott Cole
Organization Name: Cole & Van Note
Phone: (510) 891-9800
Email Address: sec@colevannote.com
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Cole & Van Note Announces SAC Health System Data Breach Investigation

Oakland, California, USA, 2022-Mar-05 — /EPR HEALTHCARE NEWS/ — Cole & Van Note, a leading consumer rights law firm, announces today its investigation of SAC Health System on behalf of its consumers/clients, arising out the company’s recent data breach. According to the company, the private information of a massive number of people may have been stolen in the hacking of its information network. It is currently unknown how many people have had their information used for criminal purposes.

If you received a notice of this alarming data breach and/or have transacted in any way with SAC Health System, your information may already be in the hands of cybercriminals, making your urgent attention to this situation very important.

Cole & Van Note is ready to discuss your options and can be contacted at (510) 891-9800, by email at sec@colevannote.com or through its  website by clicking below:

Cole & Van Note has been successfully handling consumer and employee rights matters since 1992. The firm has recovered compensation for millions of individuals and stands ready to help you get paid for your losses.

Attorney Advertisement. Our previous results do not guarantee or predict a similar outcome.

Full Name: Scott Cole
Organization Name: Cole & Van Note
Phone: (510) 891-9800
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Cole & Van Note Announces Logan Health Medical Center Data Breach Investigation

Oakland, CA, USA, 2022-Mar-03 — /EPR HEALTHCARE NEWS/ — Cole & Van Note, a leading consumer rights law firm, announces today its investigation of Logan Health Medical Center on behalf of its consumers/clients, arising out the company’s recent data breach. According to the company, the private information of a massive number of people may have been stolen in the hacking of its information network. It is currently unknown how many people have had their information used for criminal purposes.

If you received a notice of this alarming data breach and/or have transacted in any way with , Logan Health Medical Center your information may already be in the hands of cybercriminals, making your urgent attention to this situation very important.

Cole & Van Note is ready to discuss your options and can be contacted at (510) 891-9800, by email at sec@colevannote.com or through its  website by clicking below:

Cole & Van Note has been successfully handling consumer and employee rights matters since 1992. The firm has recovered compensation for millions of individuals and stands ready to help you get paid for your losses.

Attorney Advertisement. Our previous results do not guarantee or predict a similar outcome.

Full Name: Scott Cole
Organization Name: Cole & Van Note
Phone: (510) 891-9800
Email Address: sec@colevannote.com
Facebook Page
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8-year follow up results revealed for the ELIOS® Excimer Laser Trabeculostomy procedure combined with cataract surgery

LOS ANGELES, CA, United States, 17-Feb-2022 — /EPR HEALTHCARE NEWS/ — Elios Vision Inc. announced today 8-year follow up results of its novel ELIOS® Excimer Laser Trabeculostomy procedure combined with cataract surgery.

Key study findings:

  • 161 eyes of 128 patients with glaucoma or ocular hypertension and cataract received Phaco-ELIOS, and were followed over an 8-year period
  • Significant mean IOP reduction from 19.3 mmHg at baseline to 15.4 mmHg after 8 years of follow-up (p=0.0040)
  • Significant reduction in medication requirements
  • Only 3.7% of patients required secondary surgical glaucoma intervention during the 8-year follow-up period
  • No serious intra- or post-operative events were observed

“This large cohort study provides encouraging evidence that the ‘implant free’ Phaco-ELIOS procedure causes minimal trauma, appears to show lasting IOP control with no serious intra- or post-operative complications, and low rate of incisional secondary surgical intervention over a period of at least 8 years,” said Thomas W. Samuelson, MD, founding partner of Minnesota Eye Consultants and an Adjunct Professor of Ophthalmology at the University of Minnesota. Dr Samuelson added that, “it is encouraging for patients that the number of topical medications required to control IOP was reduced significantly up to 4 years and remained below baseline levels across the entire 8-year follow-up period.”

About the ELIOS procedure:

  • The ELIOS procedure creates ten ‘microchannels (210µm)’ in the trabecular meshwork using an excimer laser.
  • The microchannels facilitate aqueous outflow into Schlemm’s canal, the eyes natural outflow pathway, reducing IOP2 and preserving the integrity, structure, and function of the trabecular meshwork.
  • Combining ELIOS with phacoemulsification is an ‘implant free’ minimally invasive glaucoma procedure with a rapid learning curve for ophthalmic surgeons.
  • The ELIOS procedure is approved in Europe for use in adults with glaucoma, with or without cataract, and is undergoing clinical trials in the US under an investigational device exemption (IDE).
  • Data on the ELIOS procedure has been published in 12 clinical studies2 with over 850 eyes treated showing an IOP reduction of 20-40% from baseline, a significant reduction of medication for up to 4 years, and up to 81% of patients ‘medication free’ at 1 year,3 and a favorable safety profile.

Over the past decade minimally invasive glaucoma surgeries (MIGS) have transformed the treatment of mild to moderate glaucoma and are an attractive alternative to more invasive incisional procedures such as trabeculectomy and tube shunts. Despite the growing popularity of MIGS, combining cataract and glaucoma surgery is not yet the preferred choice by most surgeons.

This clinical study shows that the ELIOS procedure is attractive to all ophthalmic surgeons for patients with glaucoma that are not controlled by medications or SLT because it reduces IOP to mid-teens for at least 8 years, minimizes postop inflammation, avoids intraocular implants, has a favorable safety profile, with or without cataract surgery.

Why are these findings relevant?

  • In 2022 it is estimated that around 29 million people globally will undergo cataract removal and around 20% also have glaucoma or ocular hypertension4.
  • These findings demonstrate a sustained reduction of IOP that is longer than any other currently available MIGS procedure.
  • Routinely combining cataract and glaucoma treatment is appealing since it can reduce the undesirable burden and side effects of drops and it can avoid patients undergoing two separate surgical procedures which also is more efficient for healthcare systems.

SOURCE: EuropaWire