The coronavirus pandemic has revealed flaws in the global supply chain for oxygen that can put virus patients’ lives at risk. David Cheeseman, Chief Engineer of Oxair Gas Systems, a leading global supplier of on-site gas generating equipment, explains how the latest technology can replace outsourcing conventional oxygen tanks.
The Covid-19 pandemic has resulted in dwindling oxygen supplies as demand soared during the crisis, with deadly consequences for patients, particularly in countries suffering high infection rates. Generating a constant flow of oxygen on site helps hospitals save lives by becoming less reliant on outsourcing conventional canisters.
Severe shortages of this life-saving gas were reported from all corners of the world during the pandemic, raising concerns that fault lines have been exposed in the supply chain with hospitals being forced to ration oxygen to avoid the risk of running out.
Off-the-shelf automated solution
There is an off-the-shelf automated solution to avoid potential shortages in the form of Oxygen Pressure Swing Adsorption (PSA) systems, robust technology which has been designed to deliver consistent, high purity oxygen on tap to hospitals and medical facilities even in the remotest locations around the world.
Medical facilities are often forced to rely on outsourcing oxygen, with failing supply lines posing a potential catastrophe for hospitals, not to mention the added stress on frontline staff associated with the storage, handling and removal of traditional oxygen cylinders.
PSA medical oxygen offers better patient care with a permanent flow of high-quality oxygen to suit the needs of the hospital – and the equipment is capable of piping oxygen around every department as needed. In cases where the hospital does not have a central piping system, suppliers like Oxair will install an onsite cylinder filling system. It’s a highly cost-effective and hygienic alternative to the inconvenience and uncertainty of outsourcing canisters.
Constant oxygen
This automated system delivers constant oxygen of 94-95 percent purity through PSA filtration, a unique process that separates oxygen from compressed air. The gas is then conditioned and filtered before being stored in a buffer tank to be used directly by the hospital on demand.
It’s not just in the middle of a global pandemic when outsourcing conventional canisters can hit a bottleneck. Ensuring a reliable supply to hospitals in remote or troubled locations proves a constant challenge when faced with poor infrastructure, limited resources and haphazard road conditions.
An ideal example, Heal Africa hospital in The Democratic Republic of the Congo (DRC), had been relying on tanker deliveries of oxygen from a neighbouring state, but staff found that patients were being left at risk due to faulty equipment which, upon testing, was discovered to be supplying just 60 percent oxygen purity compared with the standard 93 percent needed for medical grade applications.
Supply difficulties
It was decided that a new oxygen system was vital and the hospital was able to overcome its supply difficulties by having an Oxair OA450 system installed, piping oxygen around the hospital to every department as needed, providing a cost-effective and hygienic alternative to the inconvenience of ordering in traditional carbon steel cylinders which are also prone to corrosion.
Meanwhile, medical facilities on the subcontinent have not only seen the life-saving benefits of turning to automation but cost savings too. The Sunrise Hospital in Hyderabad, India, installed a PSA system to supply its oxygen – saving the hospital almost a thousand pounds a month by reducing its dependence on cylinders.
The multi-specialist facility was going through cylinders at a costly rate of up to 16 a day. Now Sunrise’s owner is happy because the hospital is saving money which can be redirected to improving other services, while the staff are happy because they have more time to care for patients.
By embracing an automated process, Sunrise is following in the footsteps of many other hospitals in the Indian medical sector that have realised the benefits of having their own source of oxygen, helping to eliminate possible future interruptions.
To improve the flow of oxygen, suppliers should be ready to step up and do whatever is necessary to help healthcare services during the current coronavirus crisis – and beyond – by providing life-saving oxygen equipment wherever it is needed.
Plug-and-play
PSA systems that are ‘plug-and-play’ means that they are literally ready to start working as soon as they are delivered and plugged in – with voltage adapted to the country of delivery. Wherever they may be located, hospitals can rely on technology which is tried and tested over many years, coupled with almost instant access to vital oxygen supplies.
- For further information on Oxair’s products and services visit: www.oxair.com.au
PSA Systems safeguard oxygen supplies during crisis
, /in Product News /by panglobalThe coronavirus pandemic has revealed flaws in the global supply chain for oxygen that can put virus patients’ lives at risk. David Cheeseman, Chief Engineer of Oxair Gas Systems, a leading global supplier of on-site gas generating equipment, explains how the latest technology can replace outsourcing conventional oxygen tanks.
The Covid-19 pandemic has resulted in dwindling oxygen supplies as demand soared during the crisis, with deadly consequences for patients, particularly in countries suffering high infection rates. Generating a constant flow of oxygen on site helps hospitals save lives by becoming less reliant on outsourcing conventional canisters.
Severe shortages of this life-saving gas were reported from all corners of the world during the pandemic, raising concerns that fault lines have been exposed in the supply chain with hospitals being forced to ration oxygen to avoid the risk of running out.
Off-the-shelf automated solution
There is an off-the-shelf automated solution to avoid potential shortages in the form of Oxygen Pressure Swing Adsorption (PSA) systems, robust technology which has been designed to deliver consistent, high purity oxygen on tap to hospitals and medical facilities even in the remotest locations around the world.
Medical facilities are often forced to rely on outsourcing oxygen, with failing supply lines posing a potential catastrophe for hospitals, not to mention the added stress on frontline staff associated with the storage, handling and removal of traditional oxygen cylinders.
PSA medical oxygen offers better patient care with a permanent flow of high-quality oxygen to suit the needs of the hospital – and the equipment is capable of piping oxygen around every department as needed. In cases where the hospital does not have a central piping system, suppliers like Oxair will install an onsite cylinder filling system. It’s a highly cost-effective and hygienic alternative to the inconvenience and uncertainty of outsourcing canisters.
Constant oxygen
This automated system delivers constant oxygen of 94-95 percent purity through PSA filtration, a unique process that separates oxygen from compressed air. The gas is then conditioned and filtered before being stored in a buffer tank to be used directly by the hospital on demand.
It’s not just in the middle of a global pandemic when outsourcing conventional canisters can hit a bottleneck. Ensuring a reliable supply to hospitals in remote or troubled locations proves a constant challenge when faced with poor infrastructure, limited resources and haphazard road conditions.
An ideal example, Heal Africa hospital in The Democratic Republic of the Congo (DRC), had been relying on tanker deliveries of oxygen from a neighbouring state, but staff found that patients were being left at risk due to faulty equipment which, upon testing, was discovered to be supplying just 60 percent oxygen purity compared with the standard 93 percent needed for medical grade applications.
Supply difficulties
It was decided that a new oxygen system was vital and the hospital was able to overcome its supply difficulties by having an Oxair OA450 system installed, piping oxygen around the hospital to every department as needed, providing a cost-effective and hygienic alternative to the inconvenience of ordering in traditional carbon steel cylinders which are also prone to corrosion.
Meanwhile, medical facilities on the subcontinent have not only seen the life-saving benefits of turning to automation but cost savings too. The Sunrise Hospital in Hyderabad, India, installed a PSA system to supply its oxygen – saving the hospital almost a thousand pounds a month by reducing its dependence on cylinders.
The multi-specialist facility was going through cylinders at a costly rate of up to 16 a day. Now Sunrise’s owner is happy because the hospital is saving money which can be redirected to improving other services, while the staff are happy because they have more time to care for patients.
By embracing an automated process, Sunrise is following in the footsteps of many other hospitals in the Indian medical sector that have realised the benefits of having their own source of oxygen, helping to eliminate possible future interruptions.
To improve the flow of oxygen, suppliers should be ready to step up and do whatever is necessary to help healthcare services during the current coronavirus crisis – and beyond – by providing life-saving oxygen equipment wherever it is needed.
Plug-and-play
PSA systems that are ‘plug-and-play’ means that they are literally ready to start working as soon as they are delivered and plugged in – with voltage adapted to the country of delivery. Wherever they may be located, hospitals can rely on technology which is tried and tested over many years, coupled with almost instant access to vital oxygen supplies.
Ziehm Imaging Americas partners with Carestream to distribute Ziehm Vision RFD
, /in Product News /by panglobalIn partnership with Ziehm Imaging, Carestream Health has added a mobile C-arm into its product portfolio. Known as the Ziehm Vision RFD C-arm, this surgical imaging system will further enhance Carestream’s mobile and fluoroscopic product offerings. The system will be available in the U.S. and Canada this year.
The Vision RFD C-arm offers a 25kw generator, in either a 20.5 x 20.5 cm or 31 x 31 cm field of view flat-panel CMOS digital detector, allowing for broad procedural work including vascular, cardiac, spine ortho-trauma and pain management, in addition to many general surgical applications. The system’s Advanced Active Cooling enables extended case times beyond traditional air-cooled systems. It also provides an intuitive graphical interface that benefits technologists with reduced training time as well as improved productivity.
“The partnership with Carestream confirms Ziehm Imaging’s industry-leading technology,” said Nelson Mendes, President and CEO of Orthoscan and Ziehm Imaging Inc. “As a result of this partnership, we’re able to provide Carestream and its customers with one of the most innovative C-arms on the market. The Ziehm Vision RFD delivers advanced surgical care with the Ziehm Usability Concept, provides exceptional image quality and helps to reduce exposure significantly with the next-generation SmartDose, thereby providing a very unique package.”
Ziehm Vision RFD systems will be available for sale and service through Carestream.
RESPIRE trial of therapeutic for all strains of COVID-19 gets underway in Germany
, /in Corona News, E-News /by panglobalInvestigators hope ATR-002 drug will also be effective against ‘Long-Covid’
Tübingen, Germany-based Atriva Therapeutics, a biopharmaceutical company that is pioneering the development of host-targeting antiviral therapies, has enrolled its first patient in its Phase II RESPIRE [1] trial in COVID-19. Prof. Martin Witzenrath, M.D., Vice Director Department of Infectious Diseases and Respiratory Medicine, supervised the first administration of study medication (MEK inhibitor ATR-002 or placebo) at the Charité – Universitätsmedizin Berlin, Germany.
Dr Rainer Lichtenberger, CEO of Atriva Therapeutics, commented: “We are excited to assess the efficacy of ATR-002 in treating COVID-19 and are looking forward to the results of the clinical trial. We can now test our lead candidate against SARS-CoV-2 because our pharmacological target is a common cellular mechanism that RNA viruses use. ATR-002 leaves the virus itself untouched but blocks a cellular factor that the virus needs for its replication and has the potential to reduce the viral load in the infected host.
“Host-directed approaches maintain efficacy also against mutated viruses – a problem that we are commonly seeing in the influenza virus and, unfortunately, in SARS-CoV-2 as well. If we were to see the positive outcomes of the trial we hope for, ATR-002 could provide efficient help against COVID-19 regardless of the given genetic subtype of the underlying viral strain.”
Prof. Gernot Rohde, M.D., Head of Pneumology and Professor for Respiratory Medicine and Allergology at the Goethe University Hospital, Frankfurt am Main, Germany and Global Coordinating Investigator of the RESPIRE trial, said: “While we have been lucky that SARS-CoV-2 vaccines were developed at unprecedented speed, we still are in desperate need for effective therapies against COVID-19. The pandemic situation remains very critical and is far from being under control.
“Being able to contribute to the development of a COVID-19 therapy, I am very much looking forward to the effects that we may see with ATR-002. I am convinced that a medication that can prevent hospitalized patients with a moderate to severe stage of COVID-19 from deteriorating and requiring ICU admission and ventilator support would mean huge progress and could also play a role in impeding the severe long-term effects that are being described as “Long COVID” Syndrome (PASC).”
RESPIRE trial
RESPIRE is a randomized, double-blind, placebo-controlled, international, multi-center Phase II clinical trial in 220 adult patients with moderate to severe COVID-19, requiring hospitalization, but not requiring ICU admission or ventilator support at the time of screening or randomization. On top of standard of care, half of the patients will receive ATR-002 900 mg, administered as tablets once daily on day 1, followed by ATR-002 600 mg once daily on days 2 to 6. Patients in the control group will receive placebo in a matching scheme, on top of standard of care.
The primary objective of the study is to demonstrate the efficacy of ATR-002 versus placebo in addition to standard of care; secondary endpoints include the measurement of changes in clinical signs and symptoms as well as other relevant clinical parameters. Outcomes will be assessed based on the clinical severity status on day 15, using a 7-point ordinal scale as suggested by the WHO COVID-19 Therapeutic Trial Synopsis [2]. All patients will be followed-up for 90 days. The study will also evaluate the pharmacokinetics of ATR-002.
ATR-002’s mode of action
Atriva’s lead product ATR-002 is developed specifically to treat diseases such as influenza and COVID-19, caused by RNA viruses. ATR-002 is a clinical stage MEK inhibitor drug candidate targeting the intracellular Raf/MEK/ERK signaling pathway. This pathway is central for replication of many RNA viruses, such as the influenza virus, hantavirus or respiratory syncytial virus (RSV) and also SARS-CoV-2, the virus that causes COVID-19.
In influenza virus infected cells, the interaction of ATR-002 with MEK (MAPK/ERK kinase) prevents export of the viral genome protein complexes (ribonucleoprotein, RNP) from the nucleus to the cytoplasm, thus blocking the formation of functional new viral particles. This ultimately reduces the viral load in the body. In addition, ATR-002 has the potential to modulate the pro-inflammatory cytokine response of the body, avoiding overshooting cytokine response that can be caused by such viral infections. MEK inhibition can reduce the gene expression of some of the cytokines involved, like TNF-α, IL-1ß, IP-10, IL-8, MCP-1 and MIP-1a, and thus mitigate the overactive inflammatory response in the lungs of patients who are severely ill with influenza or COVID-19.
References
[1] RESPIRE – A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19.
[2] https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis.
New iCare HOME2 self-tonometer enables easy, accurate eye pressure measurement by glaucoma patients
, /in Product News /by panglobalIcare Finland, a specilist in providing fast, easy-to-use, and reliable tools for ophthalmic diagnostics, is launching their next generation self-tonometer, the iCare HOME2.
iCare HOME2 provides unsurpassed ease of use and accuracy in monitoring real-world intraocular pressure behaviour outside of the doctor’s office and clinical hours, supporting glaucoma management. Glaucoma is a chronic, progressive disease of the optic nerve. As intraocular pressure (IOP) is the only modifiable risk factor for glaucoma progression, disease management is centred around the reduction of IOP. Therefore, comprehensive and accurate information on peak IOPs and IOP fluctuation patterns is crucial.
Most patients can utilize iCare HOME2 simply by following the advice and guidance in the instruction materials, freeing up health care professionals’ precious time. iCare HOME2’s smart light guide helps the patient in positioning the device correctly and in making the measurements effortlessly and accurately, every time. It is now easier than ever for doctors to provide glaucoma management based on real-world IOP information, from finding the optimal medication and instillation schedule, to assessing the need for and effectiveness of surgery.
iCare PATIENT2 mobile app
With the novel iCare PATIENT2 mobile app, the patients can follow their own IOP trends from an iOS or Android mobile device and send the IOP measurement results easily for healthcare professional’s review in the cloud based iCare CLINIC software. Using iCare HOME2 and PATIENT2, the patient can actively participate in the care process by providing valuable information to the healthcare professional. Patient motivation for medication compliance can improve, and knowledge of the real-time IOP levels provides daily reassurance.
HORIBA Medical receives CE Mark for new generation Microsemi CRP haematology analyser
, /in Product News /by panglobalThis new generation analyser Microsemi CRP LC-767G is more compact and proposes enhanced software and network connectivity providing higher memory, usability plus a new parameter: Granulocytes-to-Lymphocytes Ratio (GLR). The incredible robustness and ease of use of the Micros range are further improved for this new generation analyser.
Developed by HORIBA Medical in Japan, ‘emi’ means ‘smile’ in Japanese and stands for easy to use, maintenance free and Intelligent. After a highly successful release in Japan, this unique instrument is now available in Europe. This compact, easy to use addition to the Micros range, simultaneously provides a Complete Blood Count (CBC) and C-Reactive Protein (CRP) from just 18 µL of blood – all in just 4 minutes.
Point of Care
The Microsemi CRP LC-767G provides information of great clinical value enabling quicker and more accurate medical decisions at the Point of Care to ultimately reduce hospitalization times and patient costs. Its powerful and accurate CRP analysis allows the screening of patient samples to quantify the presence of inflammation caused by bacterial, viral (e.g. Covid-19), parasitic infections (e.g. malaria) and other treatable inflammatory diseases.
The simultaneous access to Lymphocytes, GLR and CRP provided on this analyser is helpful for Covid-19 patient screening, monitoring and triage. Measurement is possible immediately after blood sample collection from capillary sample, making this analyser the ideal choice for emergency testing situations.
This new Microsemi CRP LC-767G can also be used to assess infection and inflammatory conditions that require progressive observation. Furthermore, its micro-sampling capabilities are ideal for paediatric blood analysis, at the Point of Care requiring just 10µL for CBC and 18 µL for CBC+CRP, and can be used with capillary, as well as venous blood samples.
The Microsemi CRP is easy to use and does not require specialist staff. Comprehensive and efficient on-board software with colour touchscreen and easy to access patient and control results are features of the Microsemi CRP. It is compact, lightweight and quiet.
MedUni Vienna and Vienna General Hospital develop criteria for selecting COVID-19 patients for lung transplantation
COVID-19, Lung transplant, Surgery, /in Corona News, E-News /by panglobalIn a study published in The Lancet Respiratory Medicine, the consortium has now proposed the first general selection criteria for lung transplantation in Covid-19 patients.
“We have collated the first experiences in the world of performing lung transplants on Covid-19 patients. It is clear that such a complex intervention should only be considered for patients who, by virtue of their age and good general health, have a good chance of recovery with new lungs,” explaindc Konrad Hoetzenecker, Head of the lung transplantation programme at MedUni Vienna and Vienna General Hospital. The Vienna team performs around 100 lung transplants a year, making it one of the largest programmes in the world, alongside Toronto, Cleveland and Hanover.
Candidates for a lung transplant
The following factors were established as criteria for potential transplantation: exhaustion of all conservative treatment options, no recovery of the Covid-19-damaged lungs despite at least four weeks of ventilation/ECMO, evidence of advanced and irreversible lung damage in several consecutive CT scans, age below 65 and no relevant comorbidities. In addition to this, candidates for a lung transplant must be in good physical condition and have a good chance of complete physical rehabilitation following the transplant.
“These guidelines can be applied worldwide for making a sound selection of patients who are suitable for a lung transplant following a Covid-19 infection,” according to a statement released by MedUni Vienna.
The surgical team at MedUni Vienna and Vienna General Hospital has meanwhile carried out 12 lung transplantations on Covid-19 patients, demonstrating that even the most seriously ill patients, who would otherwise die, can survive with a lung transplant.
Patient No. 1
In March 2020, patient number one suffered total pulmonary failure as a result of Covid-19, so that artificial ventilation was no longer possible. She could only be kept alive by the circulation pump. At the time of the transplant, the PCR test showed that virus particles were still present but were no longer infectious. The MedUni Vienna/Vienna General Hospital thoracic surgeons and surgical team managed to replace the patient’s completely destroyed lungs with new donor lungs.
Reference:
Early outcomes after lung transplantation for severe COVID-19: a series of the first consecutive cases from four countries.
The Lancet Respiratory Medicine, 2021
https://doi.org/10.1016/S2213-2600(21)00077-1
https://www.sciencedirect.com/science/article/pii/S2213260021000771
Implantable sensor made of gold nanoparticles could revolutionize medical diagnostics
, /in E-News /by panglobalGold nanoparticles embedded in a porous hydrogel can be implanted under the skin and used as medical sensors. The sensor is like an invisible tattoo revealing concentration changes of substances in the blood by colour change.
— © Nanobiotechnology Group, JGU Department of Chemistry
Scientists at Johannes Gutenberg University Mainz (JGU) have developed a novel type of implantable sensor which can be operated in the body for several months to detect concentrations of substances or drugs in the body. Until now implantable sensors have not been suitable to remain in the body permanently but had to be replaced after a few days or weeks.
On the one hand, there is the problem of implant rejection. On the other hand, the sensor’s colour which indicates concentration changes has been unstable and faded over time.
The newly developed sensor is based on colour-stable gold nanoparticles that are modified with receptors for specific molecules. Embedded into an artificial polymeric tissue, the nanogold is implanted under the skin where it reports changes in drug concentrations by changing its colour.
Invisible tattoo
Professor Carsten Sönnichsen’s research group at JGU has been using gold nanoparticles as sensors to detect tiny amounts of proteins in microscopic flow cells for many years. Gold nanoparticles act as small antennas for light: They strongly absorb and scatter it and, therefore, appear colourful. They react to alterations in their surrounding by changing colour. Prof. Sönnichsen’s team has exploited this concept for implanted medical sensing.
To prevent the tiny particles from swimming away or being degraded by immune cells, they are embedded in a porous hydrogel with a tissue-like consistency. Once implanted under the skin, small blood vessels and cells grow into the pores. The sensor is integrated in the tissue and is not rejected as a foreign body.
“Our sensor is like an invisible tattoo, not much bigger than a penny and thinner than one millimetre,” said Prof Sönnichsen, head of the Nanobiotechnology Group at JGU. Since the gold nanoparticles are infrared, they are not visible to the eye. However, a special measurement device can detect their colour noninvasively through the skin.
In their study published in Nano Letters, the JGU researchers implanted their gold nanoparticle sensors under the skin of hairless rats. Colour changes in these sensors were monitored following the administration of various doses of an antibiotic. The drug molecules are transported to the sensor via the bloodstream. By binding to specific receptors on the surface of the gold nanoparticles, they induce colour change that is dependent on drug concentration. Thanks to the colour-stable gold nanoparticles and the tissue-integrating hydrogel, the sensor was found to remain mechanically and optically stable over several months.
Ideal platform for implantable sensors
“We are used to coloured objects bleaching over time. Gold nanoparticles, however, do not bleach but keep their colour permanently. As they can be easily coated with various different receptors, they are an ideal platform for implantable sensors,” explained Dr Katharina Kaefer, first author of the study.
The novel concept is generalizable and has the potential to extend the lifetime of implantable sensors. In future, gold nanoparticle-based implantable sensors could be used to observe concentrations of different biomarkers or drugs in the body simultaneously. Such sensors could find application in drug development, medical research, or personalized medicine, such as the management of chronic diseases.
Reference:
Implantable Sensors Based on Gold Nanoparticles for Continuous Long-Term Concentration Monitoring in the Body, Nano Letters, 30 March 2021. DOI: 10.1021/acs.nanolett.1c00887
https://pubs.acs.org/doi/10.1021/acs.nanolett.1c00887
Graphene nanotech neural implant company – INBRAIN Neuroelectronics – receives €14.35 million investment
, /in E-News /by panglobalINBRAIN Neuroelectronics, a spin-off Graphene Flagship partners the Catalan Institute of Nanoscience and Nanotechnology (ICN2) and ICREA, Spain, has received a €14.35 million Series A investment, one of the biggest rounds in the Spanish MedTech industry. The investment will allow INBRAIN to bring their novel neurotechnology to humans for the first time.
INBRAIN Neuroelectronics was established in 2019, at the intersection between MedTech, DeepTech and Digital Health, with a mission to decode brain signals to develop medical solutions for patients with epilepsy, Parkinson’s disease and other neurological disorders. The company designs small implantable brain intelligent systems – built around an innovative nanoscale graphene electrode – with the ability to interpret brain signals with unprecedented high fidelity, producing a therapeutic response adapted to the clinical condition of each patient.
Disruptive technology based on graphene
Existing brain interfaces are based on metals such as platinum and iridium, which impose significant restrictions in terms of miniaturisation and signal resolution, and therefore cause considerable side effects. For this reason, there is a 50% rejection rate in candidate patients. INBRAIN Neuroelectronics uses a disruptive technology based on graphene which will overcome the current limitations of metal-based neural interfaces.
INBRAIN is now a Graphene Flagship partner and is directed by Carolina Aguilar, who was the former Medtronic Deep Brain Stimulation European and Global Commercialization Director. The spin-off was founded, among others, by Graphene Flagship researchers in Spain and the UK, including Jose Garrido, researcher at Graphene Flagship partners ICN2 and ICREA; Kostas Kostarelos, researcher at Graphene Flagship partners ICN2 and the University of Manchester and Graphene Flagship Work Package Leader for Biomedical Technologies; and Anton Guimerà, researcher at Graphene Flagship partner IMB-CNM-CSIC. The technology development team consists of neurotechnology experts such as Bert Bakker (CTO) and Michel Decre (Technology Advisor & Board Member) from Philips, and other European successful neurotechnology start-ups.
According to a 2010 study commissioned by the European Brain Council, the cost of brain disorders in Europe alone is approximately €800 billion per year, with more than one-third of the population affected. Around 30% of patients with a neuronal disease are resistant to pharmacological treatment and do not have an effective therapy. The high incidence of brain-related diseases worldwide, and their huge social cost, call for greater investments in basic research in this field, with the aim of developing new and more efficient therapeutic and diagnostic tools.
In June last year, INBRAIN received a first-seed investment from a syndicate of investors led by Asabys Partners (through Sabadell-Asabys Health Innovation Investment) and Alta Life Sciences, including the Institut Català de Finances (ICF), Finaves (IESE Business School) and BStartUp. The most recent investment was co-led by Asabys Partners and Alta Life Sciences, and joined by Vsquared Ventures, a DeepTech-focused early-stage venture capitalist based in Munich; TruVenturo GmbH, Germany’s most successful tech and life science company builders; and CDTI, at the Spanish Ministry of Science and Innovation.
Cinzia Spinato, Graphene Flagship Business Developer for Biomedical Applications, said: “INBRAIN is leading the way in the field of graphene-based implantable brain devices, and I hope that this success will raise the interest of new stakeholders and corporates towards the opportunities graphene offers in the healthcare domain. I remember when INBRAIN was born, and it is impressive how they have grown so fast: transforming a laboratory technology into a product – an outstanding milestone. This investment will be fundamental to speed up the development of graphene-based medical devices, which will be tested on patients much earlier than everyone expected.”
Technological transformation
INBRAIN Neuroelectronics is bringing a complete technological transformation to the treatment of neurological diseases. Its brain implantable intelligent systems are based on graphene electrodes, which allow miniaturisation to nanoscale fabrication, with the potential to reach single-neuron resolution. The extraordinary properties of graphene – which is light, biocompatible, flexible and extremely conductive – are harnessed in much smaller devices that are safer to implant and can be programmed, upgraded and recharged wirelessly.
Driven by artificial intelligence, the implant can learn from the brain of each patient and trigger adaptive responses to deliver personalised neurological therapy. In addition, the use of big data management will permit remote monitoring of the device and data processing.
The technology has already been validated in in vitro and in vivo, and biocompatibility and toxicity tests have been successful. Studies on large animals have been completed and the investment will bring the technology to human patients, in collaboration with key neurosurgical and neurological groups in Europe.
“This substantial investment exemplifies the growing interest and ever-expanding opportunities to exploit graphene and layered materials in the biomedical domain. Due to its unique properties, graphene has the potential to transform this application area. The Graphene Flagship has chosen biomedical applications as a focus area for commercialisation, and continues to support efforts to foster new innovations – from research to the factory floor, now and into future.”
— Kari Hjelt, Graphene Flagship Head of Innovation
The Graphene Flagship, Funded by the European Commission, aims to secure a major role for Europe in the ongoing technological revolution, helping to bring graphene innovation out of the lab and into commercial applications.
REGEnLIFE’s trial of photobiomodulation technology for Alzheimer’s shows promising results
, /in E-News /by panglobalGuillaume Blivet, co-founder and president of REGEnLIFE
REGEnLIFE, a company specialized in the research and development of innovative photo-medical technologies for the prevention and treatment of neurodegenerative diseases, has seen promising results of the pilot clinical trial evaluating its technology in Alzheimer’s disease (AD). The results were presented by Professor Jacques Touchon, scientific advisor on the trial, at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2021), held online from March 9 to 14, 2021.
REGEnLIFE’s innovative non-invasive technology is based on photobiomodulation, targeting both the brain and gut via a helmet and abdominal device. This cutting-edge medical device, RGn530, stimulates cells in the brain and gut and regulates inflammation – to improve cognitive functions and behaviour. It targets inflammation of the gut-brain axis, which is believed to be linked to the development of AD and other neurodegenerative diseases.
“There are increasing scientific data to endorse the hypothesis that the gut-brain axis is involved in the development of AD and other neurodegenerative disorders. We also believe that some forms of electromagnetic emissions could prevent and treat this disease. Our initial clinical data, coupled with all our preclinical proof of concept studies, led us to pursue a pivotal clinical study in AD and to consider working on other neurological diseases,” said Guillaume Blivet, co-founder and president of REGEnLIFE. “To accelerate this new phase in our development and to shortly gain early market access, we are preparing a new funding round before the end of 2021.”
REGEnLIFE’s technology safe and well-tolerated
The trial enrolled adult volunteers aged 55 to 85, with mild to moderate Alzheimer’s disease. They were equipped with a helmet and a photobiomodulation abdominal belt; the patients benefited from a total of 40 sessions; these lasted for 25 minutes and were spread over a two-month period. The volunteers were evaluated in a series of tests during the trial and up to one month after treatment ended. This double-blind, randomized, monocenter, placebo-controlled clinical trial began in 2018; it ended prematurely in 2020 due to the COVID-19 pandemic. Out of the 64 planned patients, 53 were randomized into two groups (treated and placebo) and 43 patients benefited from the full duration of the treatment.
The primary efficacy endpoint was measured by the evolution of the total ADAS-Cog score, (Alzheimer’s Disease Assessment Scale), between inclusion and the end of the two-month period of treatment. The REGEnLIFE RGn530 device was shown to be safe; no major side effects were reported. Compliance with treatment sessions was very high for the vast majority of patients (92%). This level of compliance also confirms the good tolerance of the device. While the primary efficacy endpoint was not statistically met, there was a clear improvement trend in a set of cognitive functions. The results of this pilot study showed that REGEnLIFE’s technology is safe and well-tolerated by patients. These very encouraging safety and efficacy results will now be confirmed in a pivotal or phase III clinical trial.
“The therapeutic strategy for AD should involve several targets. Drug treatments targeting the two characteristic proteins of the Alzheimer’s process (beta-amyloid and tau proteins) must be supplemented by other therapies – targeting less specific but very important mechanisms in the pathophysiological AD cascade, such as inflammation and oxidative stress,” said Professor Jacques Touchon, neurologist and psychiatrist, scientific advisor on the clinical trial. “REGEnLIFE’s photobiomodulation technology acts at the early stages of this cascade, (mitochondria, inflammation, oxidative stress), and could be the non-drug complement to the next-generation therapeutic strategy. This technology also makes it possible to act on both the brain and the gut, a significant advantage when we know the important role of the gut-brain axis and microbiota in neurodegenerative pathologies.”
Photobiomodulation technology
Photobiomodulation is based on photonic emissions in the near-infrared, it has already shown analgesic, anti-inflammatory and healing properties. One of the most reproducible effects is the overall reduction in inflammation, especially in the brain < https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1016/j.trci.2017.12.003 >. REGEnLIFE’s technology could therefore be used on brain diseases and on pathologies linked to neuroinflammation. REGEnLIFE developed this device employing this scientific approach, using medical technology never before applied to neurology.
According to Alzheimer’s Disease International, 35 million patients worldwide have AD. The annual cost of the disease worldwide is estimated at €850bn. Currently, there are no treatments to cure Alzheimer’s.
In order to address public health issues related to a disease that affects elderly and vulnerable people, REGEnLIFE chose to develop a non-invasive technology with low constraints for patients. The cost of this device is expected to be reasonable for patients and national healthcare systems.
Virtual events – does the industry like them?
, /in E-News /by panglobalVirtual events are likely to remain a firm fixture for some time, but do industry professionals like them? A recent survey found that while more than three quarters of survey respondents from the pharmaceutical and medical device sectors felt that virtual events would become much more popular in future – rivalling face-to-face events in number – they also highlighted aspects which have been unsatisfactory and need to be re-appraised by event organisers.
The survey by Owen Mumford Pharmaceutical Services which presents the impressions and predictions of industry professionals to date, serves as a wake-up call to event organisers.
Before COVID-19, the business events industry was economically massive, generating over $600 billion in GDP. The pandemic presented organisers with the challenge of rapidly reproducing events on online platforms. As we come to the end of a year of virtual conferences, webinars and podcasts, the question remains: ‘Are virtual events a suitable replacement for their face-to-face equivalents?’
To provide some early insight into this question specifically in the pharmaceutical and medical device industry, Owen Mumford Pharmaceutical Services commissioned research among top manufacturers. Respondents were asked to give their opinion, based on experience of virtual events throughout 2020, of what has worked and what has not.
Their responses make valuable reading for event organisers, as the benefits of virtual events – reduced travel time, reduced environmental impact and financial savings – will remain attractive even after the pandemic. Though the respondents have been underwhelmed by many virtual events so far (in terms of content, technical platforms, interactivity, price etc.), they remained positive about the potential for creating better experiences in the future. In fact, criticism of virtual events was most vehement where face-to-face methods had simply been ported online, with little thought about whether this would work satisfactorily for delegates.
“There are some areas of the in-person experience which are highly difficult to replace, especially the networking element which is so critical at conferences, and the ability to demonstrate a device and let delegates see how it works. But we see scope for innovative thinking from event organisers and this survey suggests that there is an appetite for this in our industry,” said Denis Marteau, General Manager at Owen Mumford Pharmaceutical Services.
A survey of professional opinion on virtual events in the medical device and pharmaceutical industries