Diagnostic technology – Mostobd http://mostobd.com/ Tue, 15 Nov 2022 11:42:12 +0000 en-US hourly 1 https://wordpress.org/?v=5.9 https://mostobd.com/wp-content/uploads/2021/11/favicon-1-120x120.png Diagnostic technology – Mostobd http://mostobd.com/ 32 32 Delphi-MD Breakthrough Diagnostic Technology Promises to Reduce Healthcare Burden by Detecting Brain Abnormalities Before Symptoms, at Point-of-Care US-English US-English https://mostobd.com/delphi-md-breakthrough-diagnostic-technology-promises-to-reduce-healthcare-burden-by-detecting-brain-abnormalities-before-symptoms-at-point-of-care-us-english-us-english/ Mon, 14 Nov 2022 13:00:00 +0000 https://mostobd.com/delphi-md-breakthrough-diagnostic-technology-promises-to-reduce-healthcare-burden-by-detecting-brain-abnormalities-before-symptoms-at-point-of-care-us-english-us-english/ [ad_1] Delphi-MD, the world’s first direct visualization technology of the brain network presented at the HLTH Las Vegas Conference today, provides for the first time objective clinical measurements of neural functions, enabling point-of-care physicians and neurologists to access new diagnostic capabilities. RAANANA, Israel, November 14, 2022 /PRNewswire/ — QuantalX developer of Delphi-MD, an ‘ECG’ for […]]]>

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Delphi-MD, the world’s first direct visualization technology of the brain network presented at the HLTH Las Vegas Conference today, provides for the first time objective clinical measurements of neural functions, enabling point-of-care physicians and neurologists to access new diagnostic capabilities.

RAANANA, Israel, November 14, 2022 /PRNewswire/ — QuantalX developer of Delphi-MD, an ‘ECG’ for the Brain, Debuts its Breakthrough Brain Health Technology at the HLTH Conference in Las Vegas as part of its U.S. Clearance Commercialization Efforts breakthrough expected by the FDA.

The Delphi-MD provides direct visualization of the brain network, enabling clinical measurements of neural functions for the first time in the history of healthcare, targeting the larger neurological paradigm: “brain abnormalities are typically only discovered after patients show symptoms and it’s already late,” the professor said. David Tanne, medical director of QuantalX and president of the IL Neurological association. According to “The Lancet” published study, 90% of strokes and 35% of dementias are preventable if detected early enough, but diagnostic methods available today result in ineffective treatment of brain disorders due to late, inaccurate and under-diagnosis. diagnostic.

For clinicians, such revolutionary technology, accessible at the point of care, greatly supports early and differential diagnosis through objective “real life” data, leading to informed treatment decisions and interventions, as well as improving brain health outcomes for healthcare providers and payers. For patients, earlier diagnosis leads to an optimal care pathway, resulting in a long-term positive effect on quality of life.

35% of the total economic disease burden is attributed to brain disorders, primarily due to repeated hospitalizations and rehabilitation, avoidance of unnecessary CT/MRI scans, and associated accessibility and cost issues. Recent estimates* show that the financial burden of stroke and dementia care alone exceeds $550 billion/ year in the United States only. “The clinical breakthrough of Delphi-MD is that it is a direct, functional, objective test for the brain that does not require patient involvement and provides actionable information to the physician at the point of care,” said Dr. Iftach Dolev, CEO and co-founder of QuantalX. “Making neuro-diagnostics accessible to everyone is a game-changer for brain health management”

I am very excited about QuantalX Delphi-MD technology. Probing the integrity of brain networks in a cost-effective way will allow us to identify patients at increased risk to whom we can provide improved care by optimizing and adapting existing and emerging preventive therapies.“said Prof. Jeff Saver ; Neurologist; UCLA

For more information on the Delphi-MD system, please visit http://www.quantalx.com

* Source: 1. Alzheimer’s Association Facts and Figures About Alzheimer’s Disease 2. Tsao et al, Heart Disease and Stroke Statistics3. Reducing the Impact of Dementia in America: A Decade Survey of Behavioral and Social Sciences 4. AHA Statistical Update Heart Disease and Stroke Statistics – 2022 Update 5. Wang et al Hospitalization costs of stroke patients aged 18-64 years 6. Girotra et al A contemporary and comprehensive analysis of stroke costs in the United States States

About QuantalX Neuroscience

QuantalX is dedicated to providing better patient care and reducing the neurological load on healthcare systems, through differential diagnosis and early detection of brain abnormalities. The Delphi– The MD device solves today’s neurodiagnosis challenges with direct neurodiagnosis, a new technology, revolutionizing the standard of brain healthcare as we know it.

Media Contact

[email protected]
TEL: +972502044934

Photo: https://mma.prnewswire.com/media/1944122/QuantalX_Delphi_MD.jpg

SOURCEQuantalX

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Ground-breaking Delphi-MD diagnostic technology promises to reduce healthcare burden by detecting brain abnormalities before symptoms, at point-of-care https://mostobd.com/ground-breaking-delphi-md-diagnostic-technology-promises-to-reduce-healthcare-burden-by-detecting-brain-abnormalities-before-symptoms-at-point-of-care/ Mon, 14 Nov 2022 13:00:00 +0000 https://mostobd.com/ground-breaking-delphi-md-diagnostic-technology-promises-to-reduce-healthcare-burden-by-detecting-brain-abnormalities-before-symptoms-at-point-of-care/ [ad_1] Delphi-MD, the world’s first direct visualization technology of the brain network presented at the HLTH Las Vegas Conference today, provides for the first time objective clinical measurements of neural functions, enabling point-of-care physicians and neurologists to access new diagnostic capabilities. RAANANA, Israel, November 14, 2022 /PRNewswire/ — QuantalX developer of Delphi-MD, an ‘ECG’ for […]]]>

[ad_1]

Delphi-MD, the world’s first direct visualization technology of the brain network presented at the HLTH Las Vegas Conference today, provides for the first time objective clinical measurements of neural functions, enabling point-of-care physicians and neurologists to access new diagnostic capabilities.

RAANANA, Israel, November 14, 2022 /PRNewswire/ — QuantalX developer of Delphi-MD, an ‘ECG’ for the Brain, Debuts its Breakthrough Brain Health Technology at the HLTH Conference in Las Vegas as part of its U.S. Clearance Commercialization Efforts breakthrough expected by the FDA.

The Delphi-MD provides direct visualization of the brain network, enabling clinical measurements of neural functions for the first time in the history of healthcare, targeting the larger neurological paradigm: “brain abnormalities are typically only discovered after patients show symptoms and it’s already late,” the professor said. David Tanne, medical director of QuantalX and president of the IL Neurological association. According to “The Lancet” published study, 90% of strokes and 35% of dementias are preventable if detected early enough, but diagnostic methods available today result in ineffective treatment of brain disorders due to late, inaccurate and under-diagnosis. diagnostic.

For clinicians, such revolutionary technology, accessible at the point of care, greatly supports early and differential diagnosis through objective “real life” data, leading to informed treatment decisions and interventions, as well as improving brain health outcomes for healthcare providers and payers. For patients, earlier diagnosis leads to an optimal care pathway, resulting in a long-term positive effect on quality of life.

35% of the total economic disease burden is attributed to brain disorders, primarily due to repeated hospitalizations and rehabilitation, avoidance of unnecessary CT/MRI scans, and associated accessibility and cost issues. Recent estimates* show that the financial burden of stroke and dementia care alone exceeds $550 billion/ year in the United States only. “The clinical breakthrough of Delphi-MD is that it is a direct, functional, objective test for the brain that does not require patient involvement and provides actionable information to the physician at the point of care,” said Dr. Iftach Dolev, CEO and co-founder of QuantalX. “Making neuro-diagnostics accessible to everyone is a game-changer for brain health management”

I am very excited about QuantalX Delphi-MD technology. Probing the integrity of brain networks in a cost-effective way will allow us to identify patients at increased risk to whom we can provide improved care by optimizing and adapting existing and emerging preventive therapies.“said Prof. Jeff Saver ; Neurologist; UCLA

For more information on the Delphi-MD system, please visit http://www.quantalx.com

* Source: 1. Alzheimer’s Association Facts and Figures About Alzheimer’s Disease 2. Tsao et al, Heart Disease and Stroke Statistics3. Reducing the Impact of Dementia in America: A Decade Survey of Behavioral and Social Sciences 4. AHA Statistical Update Heart Disease and Stroke Statistics – 2022 Update 5. Wang et al Hospitalization costs of stroke patients aged 18-64 years 6. Girotra et al A contemporary and comprehensive analysis of stroke costs in the United States States

About QuantalX Neuroscience

QuantalX is dedicated to providing better patient care and reducing the neurological load on healthcare systems, through differential diagnosis and early detection of brain abnormalities. The Delphi– The MD device solves today’s neurodiagnosis challenges with direct neurodiagnosis, a new technology, revolutionizing the standard of brain healthcare as we know it.

Media Contact

[email protected]
TEL: +972502044934

Photo: https://mma.prnewswire.com/media/1944122/QuantalX_Delphi_MD.jpg

SOURCEQuantalX

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Asep Inc. Obtains Patent Approval for Its Sepsis Diagnostic Technology in 13 European Countries and Australia https://mostobd.com/asep-inc-obtains-patent-approval-for-its-sepsis-diagnostic-technology-in-13-european-countries-and-australia/ Mon, 07 Nov 2022 12:02:05 +0000 https://mostobd.com/asep-inc-obtains-patent-approval-for-its-sepsis-diagnostic-technology-in-13-european-countries-and-australia/ [ad_1] VANCOUVER, BC, November 7, 2022 /CNW/ – Asep Medical Holdings Inc. (“Asep inc.” or the “Company”) (CSE: ASEP) (OTCQB: SEPSF) is pleased to announce that the company’s sepsis diagnostic technology, called SepsetER TMhas successfully received patent approval in 13 European countries as well as in Australia. The Company received confirmation of its European patent […]]]>

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VANCOUVER, BC, November 7, 2022 /CNW/ – Asep Medical Holdings Inc. (“Asep inc.or the “Company”) (CSE: ASEP) (OTCQB: SEPSF) is pleased to announce that the company’s sepsis diagnostic technology, called SepsetER TMhas successfully received patent approval in 13 European countries as well as in Australia. The Company received confirmation of its European patent (EP) 3117030 from its patent attorneys on August 29, 2022and this patent was then validated in Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Swiss and the UK, representing 400 million people. The Company has also obtained a patent in Australia (Australian Patent No. AU2020201564B2), issued July 16, 2022.

The patents, granted under exclusive license to of Asep Inc. subsidiary company Sepset Biosciences Inc., validate the company’s unique and clinically feasible AI-based approach to diagnosing sepsis, a disease that causes more than 11 million deaths globally each year. The technology, named SepsetEmergency roomis a blood-based gene expression test developed under the guidance of a leading microbiologist at UBC and of Asep Inc. Founding Director and current CEO, Dr. Robert E. W. Hancock. The test enables early and accurate diagnosis of severe incidences of fatal sepsis, which is also the cause of death in most severe COVID-19 patients.

The patents also provide a solid foundation for the Company’s activities as the test is in advanced development and in preparation for formal 510(k) clinical studies. Since SeptemberEmergency room signature has already been validated and refined in more than 700 patients with sepsis and severe COVID-19 to date, the company is looking to duplicate it in a formal trial. In diagnostics, the 510(k) pathway involves a single clinical study which, if successful, will lead to approval by the US Food and Drug Administration (FDA). Once approved, the test will be marketed for use in emergency rooms and intensive care units around the world, enabling physicians to quickly make informed patient care decisions that will improve prognosis and survival.

The SepsetEmergency room test detects the dysfunctional immune response underlying sepsis when patients first enter the emergency room. The test is a blood-based gene expression test that is simple to perform using equipment available in most hospital laboratories, and results are obtained in approximately 60 to 90 minutes. Current diagnostic tools provide results after approximately 8 to 36 hours, which often delays the start of treatment. SeptemberEmergency room is designed to allow doctors to quickly predict the severity of the disease and thus trigger urgent treatment of the patient. The patent licensing regime gives of Asep Inc. subsidiary company, Sepset Biosciences Inc.exclusive worldwide rights to develop the sepsis severity signature into a diagnostic test and bring the test to market.

CEO dr. Robert E. W. Hancock said, “Patents are the cornerstone of biotechnology. This validates the novelty of our technology in the main markets.

Tim Murphythe COO, commented: “The expansion of of Asep Inc. patent coverage in Europe and Australia represents an important step for the company towards the commercialization of the SepsetEmergency room test.

ON ASEP MEDICAL HOLDINGS INC.

Asep Medical Inc. (asepmedical.com) is dedicated to solving antibiotic failure by developing new solutions for significant unmet medical needs. The Company is a consolidation of two existing private companies (Sepset Biosciences Inc. and ABT Innovations Inc.) who are both in the advanced development of proprietary diagnostic tools, enabling the early and rapid identification of severe sepsis as well as broad-spectrum therapeutic agents to treat multidrug-resistant biofilm infections.

Sepset Biosciences Inc. (sepset.ca) is developing diagnostic technology that involves a patient’s gene expression signature that predicts severe sepsis, one of the leading diseases leading to antibiotic failure since antibiotics are the primary treatment for sepsis. Despite this, sepsis is responsible for almost 20% of all deaths on the planet. The SepsetEmergency room is a blood-based gene expression test that is simple to perform and results are obtained in approximately one hour in the emergency room or intensive care unit. This proprietary diagnostic technology differs from current diagnostic tests in that it can diagnose severe sepsis within 1-2 hours of first clinical presentation (i.e. in the emergency room), while other diagnostics provide a diagnosis only after 24 to 36 hours. Asep inc. believes this will enable physicians to make critical early decisions about appropriate therapies and reduce overall morbidity and mortality from sepsis.

ABT Innovations Inc. (abtinnovations.ca) peptide technology covers a wide range of therapeutic applications, including bacterial biofilm infections (medical device infections, chronic infections, lung, bladder, wound, dental, skin, otolaryngology, sinusitis, orthopaedics, etc.), anti-inflammatories, anti-infective immunomodulators and vaccine adjuvants.

FORWARD-LOOKING STATEMENTS –

This press release contains certain “forward-looking statements” within the meaning of such statements under applicable securities laws. Forward-looking statements are often characterized by words such as “expects”, “plans”, “continues”, “expects”, “projects”, “intends”, “believes”, “expects”, ” believes”, “may”, “will”, “potential”, “proposed”, “positioned” and other similar words, or statements that certain events or conditions “may” or “will occur”. These statements include, but are not limited to, the successful completion of clinical testing of our Sepsis diagnostic test and its anticipated filing for regulatory approval; and conducting preclinical studies on our lead drug, in the hope that this will lead to accelerated clinical trials. Various assumptions were used in drawing conclusions or making the predictions contained in the forward-looking statements throughout this press release. Forward-looking statements are based on the opinions and estimates of management as of the date they are made and are subject to a variety of risks (including the risk factors identified in the Asep Medical Inc. dated flyer November 9, 2021) available for review under the Company’s profile at www.sedar.com and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Asep Medical Inc. has no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law expressly.

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Asep Inc. Obtains Patent Approval for Its Sepsis Diagnostic Technology in 13 European Countries and Australia https://mostobd.com/asep-inc-obtains-patent-approval-for-its-sepsis-diagnostic-technology-in-13-european-countries-and-australia-3/ Mon, 07 Nov 2022 12:00:00 +0000 https://mostobd.com/asep-inc-obtains-patent-approval-for-its-sepsis-diagnostic-technology-in-13-european-countries-and-australia-3/ [ad_1] VANCOUVER, BC, November 7, 2022 /CNW/ – Asep Medical Holdings Inc. (“Asep Inc.” or the “Company”) (CSE: ASEP) (OTCQB: SEPSF) is pleased to announce that the company’s sepsis diagnostic technology, called SepsetER TMhas successfully received patent approval in 13 European countries as well as in Australia. The Company received confirmation of its European patent […]]]>

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VANCOUVER, BC, November 7, 2022 /CNW/ – Asep Medical Holdings Inc. (“Asep Inc.” or the “Company”) (CSE: ASEP) (OTCQB: SEPSF) is pleased to announce that the company’s sepsis diagnostic technology, called SepsetER TMhas successfully received patent approval in 13 European countries as well as in Australia. The Company received confirmation of its European patent (EP) 3117030 from its patent attorneys on August 29, 2022and this patent was then validated in Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Swiss and the United Kingdom, representing 400 million people. The Company has also obtained a patent in Australia (Australian Patent No. AU2020201564B2), issued July 16, 2022.

Asep Medical Holdings Inc. (CNW Group/ASEP Medical Holdings Inc.)

The patents, licensed exclusively to Asep Inc.’s subsidiary, Sepset Biosciences Inc., validate the company’s unique and clinically feasible AI-based approach to diagnosing sepsis, a disease that causes more than 11 million deaths per year worldwide. The technology, named SepsetEmergency roomis a blood-based gene expression test developed under the leadership of UBC’s Principal Microbiologist and Founding Director and current CEO of Asep Inc., Dr. Robert E. W. Hancock. The test enables early and accurate diagnosis of severe incidences of fatal sepsis, which is also the cause of death in most severe COVID-19 patients.

The patents also provide a solid foundation for the Company’s activities as the test is in advanced development and in preparation for formal 510(k) clinical studies. Since SeptemberEmergency room signature has already been validated and refined in more than 700 patients with sepsis and severe COVID-19 to date, the company is looking to duplicate it in a formal trial. In the area of ​​diagnostics, the 510(k) pathway involves a single clinical study which, if successful, will lead to approval by the United States Food & Drug Administration (FDA). Once approved, the test will be marketed for use in emergency rooms and intensive care units around the world, enabling physicians to quickly make informed patient care decisions that will improve prognosis and survival.

The SepsetEmergency room test detects the dysfunctional immune response underlying sepsis when patients first enter the emergency room. The test is a blood-based gene expression test that is simple to perform using equipment available in most hospital laboratories, and results are obtained in approximately 60 to 90 minutes. Current diagnostic tools provide results after approximately 8 to 36 hours, which often delays the start of treatment. SeptemberEmergency room is designed to allow doctors to quickly predict the severity of the disease and thus trigger urgent treatment of the patient. The patent licensing agreement gives Asep Inc.’s subsidiary, Sepset Biosciences Inc., exclusive worldwide rights to develop the sepsis severity signature into a diagnostic test and bring the test to market.

CEO dr. Robert E. W. Hancock said, “Patents are the cornerstone of biotechnology. This validates the novelty of our technology in the main markets.

Tim MurphyChief Operating Officer, commented, “The expansion of Asep Inc.’s patent coverage in Europe and Australia represents an important step for the company towards the commercialization of the SepsetEmergency room test.

ABOUT ASEP MEDICAL HOLDINGS INC.

Asep Medical Inc. (asepmedical.com) is dedicated to addressing antibiotic failure by developing new solutions for significant unmet medical needs. The company is a consolidation of two existing private companies (Sepset Biosciences Inc. and ABT Innovations Inc.) which are both in the advanced development of the two proprietary diagnostic tools, enabling the early and rapid identification of severe sepsis as well as broad-spectrum therapies. agents for combating multidrug resistant biofilm infections.

Sepset Biosciences Inc. (septet.ca) is developing diagnostic technology that involves a patient’s gene expression signature that predicts severe sepsis, one of the important diseases leading to antibiotic failure since antibiotics are the primary treatment for sepsis. Despite this, sepsis is responsible for almost 20% of all deaths on the planet. The SepsetEmergency room is a blood-based gene expression test that is simple to perform and results are obtained in approximately one hour in the emergency room or intensive care unit. This proprietary diagnostic technology differs from current diagnostic tests in that it can diagnose severe sepsis within 1-2 hours of first clinical presentation (i.e. in the emergency room), while other diagnostics provide a diagnosis only after 24 to 36 hours. Asep Inc. believes this will enable physicians to make critical early decisions about appropriate treatments and reduce overall morbidity and mortality from sepsis.

ABT Innovations Inc. (abtinnovations.ca) peptide technology covers a wide range of therapeutic applications, including bacterial biofilm infections (medical device infections, chronic infections, lung, bladder, wound, dental, skin, otolaryngology, sinusitis, orthopedics, etc.), anti-inflammatories, anti-infective immunomodulators and vaccine adjuvants.

FORWARD-LOOKING STATEMENTS –

This press release contains certain “forward-looking statements” within the meaning of such statements under applicable securities laws. Forward-looking statements are often characterized by words such as “expects”, “plans”, “continues”, “expects”, “projects”, “intends”, “believes”, “expects”, ” believes”, “may”, “will”, “potential”, “proposed”, “positioned” and other similar words, or statements that certain events or conditions “may” or “will occur”. These statements include, but are not limited to, the successful completion of clinical testing of our Sepsis diagnostic test and its anticipated filing for regulatory approval; and conducting preclinical studies on our lead drug, in the hope that this will lead to accelerated clinical trials. Various assumptions were used in drawing conclusions or making the predictions contained in the forward-looking statements throughout this press release. Forward-looking statements are based on the opinions and estimates of management as of the date they are made and are subject to various risks (including the risk factors identified in Asep Medical Inc.’s prospectus dated November 9, 2021) available for review under the company profile at www.sedar.com and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Asep Medical Inc. is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. applicable expressly so requires.

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SOURCEASEP Medical Holdings Inc.

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Asep Inc. Obtains Patent Approval for Its Sepsis Diagnostic Technology in 13 European Countries and Australia https://mostobd.com/asep-inc-obtains-patent-approval-for-its-sepsis-diagnostic-technology-in-13-european-countries-and-australia-2/ Mon, 07 Nov 2022 12:00:00 +0000 https://mostobd.com/asep-inc-obtains-patent-approval-for-its-sepsis-diagnostic-technology-in-13-european-countries-and-australia-2/ [ad_1] VANCOUVER, BC, November 7, 2022 /PRNewswire/ – Asep Medical Holdings Inc. (“Asep Inc.” or the “Company”) (CSE: ASEP) (OTCQB: SEPSF) is pleased to announce that the company’s sepsis diagnostic technology, called SepsetER TMhas successfully received patent approval in 13 European countries as well as in Australia. The Company received confirmation of its European patent […]]]>

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VANCOUVER, BC, November 7, 2022 /PRNewswire/ – Asep Medical Holdings Inc. (“Asep Inc.” or the “Company”) (CSE: ASEP) (OTCQB: SEPSF) is pleased to announce that the company’s sepsis diagnostic technology, called SepsetER TMhas successfully received patent approval in 13 European countries as well as in Australia. The Company received confirmation of its European patent (EP) 3117030 from its patent attorneys on August 29, 2022and this patent was then validated in Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Swiss and the United Kingdom, representing 400 million people. The Company has also obtained a patent in Australia (Australian Patent No. AU2020201564B2), issued July 16, 2022.

Asep Medical Holdings Inc. (CNW Group/ASEP Medical Holdings Inc.)

The patents, licensed exclusively to Asep Inc.’s subsidiary, Sepset Biosciences Inc., validate the company’s unique and clinically feasible AI-based approach to diagnosing sepsis, a disease that causes more than 11 million deaths per year worldwide. The technology, named SepsetEmergency roomis a blood-based gene expression test developed under the leadership of UBC’s Principal Microbiologist and Founding Director and current CEO of Asep Inc., Dr. Robert E. W. Hancock. The test enables early and accurate diagnosis of severe incidences of fatal sepsis, which is also the cause of death in most severe COVID-19 patients.

The patents also provide a solid foundation for the Company’s activities as the test is in advanced development and in preparation for formal 510(k) clinical studies. Since SeptemberEmergency room signature has already been validated and refined in more than 700 patients with sepsis and severe COVID-19 to date, the company is looking to duplicate it in a formal trial. In the area of ​​diagnostics, the 510(k) pathway involves a single clinical study which, if successful, will lead to approval by the United States Food & Drug Administration (FDA). Once approved, the test will be marketed for use in emergency rooms and intensive care units around the world, enabling physicians to quickly make informed patient care decisions that will improve prognosis and survival.

The SepsetEmergency room test detects the dysfunctional immune response underlying sepsis when patients first enter the emergency room. The test is a blood-based gene expression test that is simple to perform using equipment available in most hospital laboratories, and results are obtained in approximately 60 to 90 minutes. Current diagnostic tools provide results after approximately 8 to 36 hours, which often delays the start of treatment. SeptemberEmergency room is designed to allow doctors to quickly predict the severity of the disease and thus trigger urgent treatment of the patient. The patent licensing agreement gives Asep Inc.’s subsidiary, Sepset Biosciences Inc., exclusive worldwide rights to develop the sepsis severity signature into a diagnostic test and bring the test to market.

CEO dr. Robert E. W. Hancock said, “Patents are the cornerstone of biotechnology. This validates the novelty of our technology in the main markets.

Tim MurphyChief Operating Officer, commented, “The expansion of Asep Inc.’s patent coverage in Europe and Australia represents an important step for the company towards the commercialization of the SepsetEmergency room test.

ABOUT ASEP MEDICAL HOLDINGS INC.

Asep Medical Inc. (asepmedical.com) is dedicated to addressing antibiotic failure by developing new solutions for significant unmet medical needs. The company is a consolidation of two existing private companies (Sepset Biosciences Inc. and ABT Innovations Inc.) which are both in the advanced development of the two proprietary diagnostic tools, enabling the early and rapid identification of severe sepsis as well as broad-spectrum therapies. agents for combating multidrug resistant biofilm infections.

Sepset Biosciences Inc. (septet.ca) is developing diagnostic technology that involves a patient’s gene expression signature that predicts severe sepsis, one of the important diseases leading to antibiotic failure since antibiotics are the primary treatment for sepsis. Despite this, sepsis is responsible for almost 20% of all deaths on the planet. The SepsetEmergency room is a blood-based gene expression test that is simple to perform and results are obtained in approximately one hour in the emergency room or intensive care unit. This proprietary diagnostic technology differs from current diagnostic tests in that it can diagnose severe sepsis within 1-2 hours of first clinical presentation (i.e. in the emergency room), while other diagnostics provide a diagnosis only after 24 to 36 hours. Asep Inc. believes this will enable physicians to make critical early decisions about appropriate treatments and reduce overall morbidity and mortality from sepsis.

ABT Innovations Inc. (abtinnovations.ca) peptide technology covers a wide range of therapeutic applications, including bacterial biofilm infections (medical device infections, chronic infections, lung, bladder, wound, dental, skin, otolaryngology, sinusitis, orthopedics, etc.), anti-inflammatories, anti-infective immunomodulators and vaccine adjuvants.

FORWARD-LOOKING STATEMENTS –

This press release contains certain “forward-looking statements” within the meaning of such statements under applicable securities laws. Forward-looking statements are often characterized by words such as “expects”, “plans”, “continues”, “expects”, “projects”, “intends”, “believes”, “expects”, ” believes”, “may”, “will”, “potential”, “proposed”, “positioned” and other similar words, or statements that certain events or conditions “may” or “will occur”. These statements include, but are not limited to, the successful completion of clinical testing of our Sepsis diagnostic test and its anticipated filing for regulatory approval; and conducting preclinical studies on our lead drug, in the hope that this will lead to accelerated clinical trials. Various assumptions were used in drawing conclusions or making the predictions contained in the forward-looking statements throughout this press release. Forward-looking statements are based on the opinions and estimates of management as of the date they are made and are subject to various risks (including the risk factors identified in Asep Medical Inc.’s prospectus dated November 9, 2021) available for review under the company profile at www.sedar.com and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Asep Medical Inc. is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. applicable expressly so requires.

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SOURCEASEP Medical Holdings Inc.

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GENFIT Announces Compelling Results for NIS2+™ Next-Generation Noninvasive Diagnostic Technology in NASH to be Showcased at AASLD Liver Meeting® https://mostobd.com/genfit-announces-compelling-results-for-nis2-next-generation-noninvasive-diagnostic-technology-in-nash-to-be-showcased-at-aasld-liver-meeting/ Tue, 25 Oct 2022 20:50:24 +0000 https://mostobd.com/genfit-announces-compelling-results-for-nis2-next-generation-noninvasive-diagnostic-technology-in-nash-to-be-showcased-at-aasld-liver-meeting/ [ad_1] News and research before you hear about it on CNBC and others. Claim your one week free trial for StreetInsider Premium here. NIS2+™ developed and validated inasmuch as optimization NIS4® technology for the detection of NASH patients at risk Data demonstrate robust and improved clinical performance of NIS2+™ allowing effective identification of at-risk NASHregardless […]]]>

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News and research before you hear about it on CNBC and others. Claim your one week free trial for StreetInsider Premium here.


  • NIS2+™ developed and validated inasmuch as optimization NIS4® technology for the detection of NASH patients at risk
  • Data demonstrate robust and improved clinical performance of NIS2+™ allowing effective identification of at-risk NASHregardless of patient characteristics such as age, gender and type 2 diabetes
  • NIS2+™s analytical improvement To allows for bigr large-scale implementation in clinical practice and clinical trials
  • three posterss to be presented to the AASLD Meeting of the Liver®

Lille (France)), Cambridge (Massachusetts, USA), October 252022 – GENFIT (Nasdaq and Euronext: GNFT)a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver disease, today announced that it has developed NIS2+™, a next-generation technology for the diagnosis of non-alcoholic steatohepatitis (NASH) in risk, and will present clinical performance results of NIS2+™ in three poster presentations at the 2022 Liver Meeting® hosted by the American Association for the Study of Liver Diseases (AASLD).

The first poster highlights NIS2+™ as an optimization of NIS4® technology to identify NASH at risk. This next-generation technology addresses unmet needs for identifying at-risk NASH patients using non-invasive tests (NIT) that are unaffected by critical patient characteristics. NIS2+™ demonstrated strong clinical performance in detecting at-risk NASH, while its composite scores were not impacted by the status of important subpopulations such as type 2 diabetes, age, and gender . Although the performance of NIS4® was convincing, the distributions of the composite scores were significantly affected in certain subpopulations. In addition, the increased robustness and simplicity of the NIS2+™ technology (from a panel of 4 to 2 biomarkers) allows a broader and easier application in the clinical setting.

The second poster demonstrates that NIS2+™ is an effective screening tool for recruiting at-risk NASH patients into clinical trials, reducing liver biopsy failure rates and associated costs without inflating the number of patients to be screened .

Data from the third poster highlights NIS2+™ as a valuable prognostic tool for early detection of fibrosis progression in at-risk NASH patients with significant fibrosis (F2) to advanced fibrosis (F3) and cirrhosis (F4). ).

In November 2021, the utility of NIS4® technology was validated in a Phase 11 study undertaken by the Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) Initiative of the Foundation for the National Institutes of Health’s Biomarkers Consortium as demonstrating strong and unique performance in identifying at-risk NASH patients.2

Dr. Vlad Ratziu, Professor at Sorbonne University and Pitie-Salpetriere Hospital in Paris, France commented : “Rapid diagnosis of at-risk NASH patients is a critical unmet medical need, and so we welcome this next-generation diagnostic tool. NIS2+™ simplifies the analytical process with only two biomarkers, is more robust in terms of composite scores in critical subpopulations of interest, and can be widely implemented in clinical practice. I anticipate that in clinical practice, NIS2+™ will be a diagnostic test of choice to select NASH patients requiring pharmacotherapy, eliminating the need for a liver biopsy – a real progress for the management of patients. Moreover, there is a need for noinvasive tests for facilitate enrollment in NASH clinical trialsso that the number of liver biopsies, with their many challenges, can be reduced.

POSTER PRESENTATIONS

Poster number 1: #2484

Title: Derivation and validation of the NIS2+™ blood biomarker panel, an enhancement of NIS4® technology for the identification of at-risk NASH

Authors: Harrison SA, Ratziu V et al.

Poster number 2: #2503

Title: NIS2+™ Technology as a Screening Tool for Recruiting At-Risk NASH Patients into Clinical Trials

Authors: Ratziu V et al.

Poster number 3: #2522

Title: NIS2+™, an enhancement of NIS4® technology for the early detection of fibrosis progression in patients with at-risk NASH proven by liver biopsy and F2

Authors: Ratziu V et al.

ON THE LIVER REUNION®

The Liver Meeting® organized by the AASLD is one of the most important hepatology congresses for the medical and scientific community. It brings together more than 10,000 scientists, gastroenterologists and hepatologists from all over the world. Liver Meeting® 2022 will be held November 4-8, 2022 at the Walter E. Washington Convention Center in Washington DC.

ABOUT GENFIT

GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver disease characterized by significant unmet medical needs. GENFIT is a pioneer in the research and development of therapeutic and diagnostic solutions in liver disease, with a rich history and a strong scientific heritage spanning more than two decades. Thanks to its expertise in bringing high-potential early-stage actives to advanced development and pre-marketing stages, GENFIT now has a growing and diversified pipeline of innovative therapeutic and diagnostic solutions.

Its R&D is centered on three franchises: cholestatic diseases, Acute on Chronic Liver Failure (ACLF) and NASH diagnostics. In its cholestatic disease franchise, ELATIVE™, a global Phase 3 trial evaluating elafibranor3 in patients with primary biliary cholangitis (PBC) is well underway after a successful Phase 2 clinical trial. The first data is expected to be announced in the second quarter of 2023. In 2021, GENFIT signed an exclusive license agreement with IPSEN to develop, manufacture and commercialize elafibranor in PBC and other indications.4 GENFIT is also developing GNS5611 in cholangiocarcinoma following acquisition of rights in this indication from Genoscience Pharma in 20215. In ACLF, a Phase 1 clinical program with nitazoxanide was initiated in 2021, and GENFIT further expanded its ACLF pipeline in 2022 through the acquisition of Swiss clinical-stage company Versantis, with a Phase 2-ready Program evaluating liposome technology and a preclinical-stage small molecule. As part of its diagnostic solutions franchise, the Company entered into an agreement with Labcorp in 2021 to commercialize NASHnext®, powered by GENFIT’s proprietary NIS4® diagnostic technology, and recently developed NIS2+™, a scalable diagnostic tool and optimized to identify at-risk NASH.

GENFIT has facilities in Lille and Paris, France, and in Cambridge, MA, USA. GENFIT is a listed company listed on the Nasdaq Global Select Market and on compartment B of the regulated market of Euronext in Paris (Nasdaq and Euronext: GNFT). In 2021, IPSEN became one of the first shareholders of GENFIT and holds 8% of the company’s capital. www.genfit.com

ABOUT NIS2+™

NIS2+™ is a blood diagnostic test specially designed to detect at-risk NASH in patients with metabolic risk factors based on an independent panel of 2 biomarkers. It has been developed and validated by GENFIT as a robust NIT on characteristics of interest such as type 2 diabetes, age and sex, allowing large-scale implementation in clinical practice.

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements regarding GENFIT, including those within the meaning of the Private Securities Litigation Reform Act of 1995, relating to the clinical performance of NIS2+™ and its suitability for use as a prognostic assessment of progressive fibrosis. The use of certain words, including “consider”, “contemplate”, “think”, “aim”, “expect”, “understand”, “should”, “aspire”, “estimate”, “believe “, “wish”, “may”, “could”, “allow”, “seek”, “encourage” or “trust” or (as applicable) the negative forms of these terms or any other variations of these terms or other similar terms their meaning is intended to identify forward-looking statements. Although the Company believes that its projections are based on reasonable expectations and assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially. of those expressed, implied or intended by the forward-looking statements. These risks and uncertainties include, among others, uncertainties inherent in research and development, including with respect to safety, biomarkers, the progress and results of its ongoing and planned clinical trials, the review and approval by regulatory authorities of its drugs and diagnostic candidates, the impact of the COVID-19 pandemic, fluctuations in exchange rates and the Company’s continued ability to raise capital to finance its development, as well as the risks and uncertainties discussed or identified in the public documents filed by the Company with the AMF, including those listed in Chapter 2 “Principal risks and uncertainties” of the Company’s 2021 Universal Registration Document filed with the AMF on April 29, 2022 under number D.22-0400, available on the Company’s website (www.genfit.com) and on the AMF website (www.amf-france.org) and public filings and reports filed with the United States Securities and Exchange Commission (“SEC”), including the Company’s 2021 Annual Report on Form 20-F filed with the SEC on April 29, 2022 and the 2022 half-year commercial and financial report. Furthermore, even if the results, performance, financial situation and liquidity of the Company, as well as the development of the sector in which it operates are in line with these forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of the publication of this document. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACT

GENFIT | Investors

Tel: +33 3 2016 4000 | [email protected]

PRESS RELATIONS | Media

Stéphanie Boyer – Press Relations | Tel: +333 2016 4000 | [email protected]

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com

1 https://fnih.org/sites/default/files/2021-11/CWS_NIMBLE_Abstract.pdf2 https://ir.genfit.com/news-releases/news-release-details/genfit-fnih-nimble-study-demonstrates-nis4r-technologys-unique3 Elafibranor and GNS561 are investigational compounds that have not been reviewed or approved by any regulatory authority4 With the exception of China, Hong Kong, Taiwan and Macao where Terns Pharmaceuticals holds the exclusive license to develop and commercialize elafibranor5 The agreement includes commercialization and development in the United States, Canada and Europe, including the United Kingdom and Switzerland

Source: GENFIT SA

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GENFIT Announces Compelling Results for NIS2+™ Next-Generation Noninvasive Diagnostic Technology in NASH to be Showcased at AASLD Liver Meeting® https://mostobd.com/genfit-announces-compelling-results-for-nis2-next-generation-noninvasive-diagnostic-technology-in-nash-to-be-showcased-at-aasld-liver-meeting-2/ Tue, 25 Oct 2022 20:10:00 +0000 https://mostobd.com/genfit-announces-compelling-results-for-nis2-next-generation-noninvasive-diagnostic-technology-in-nash-to-be-showcased-at-aasld-liver-meeting-2/ [ad_1] NIS2+™ developed and validated inasmuch as optimization NIS4® technology for the detection of NASH patients at risk Data demonstrate robust and improved clinical performance of NIS2+™ allowing effective identification of at-risk NASHregardless of patient characteristics such as age, gender and type 2 diabetes NIS2+™’s analytical improvement To allows for bigr large-scale implementation in clinical […]]]>

[ad_1]

  • NIS2+™ developed and validated inasmuch as optimization NIS4® technology for the detection of NASH patients at risk

  • Data demonstrate robust and improved clinical performance of NIS2+™ allowing effective identification of at-risk NASHregardless of patient characteristics such as age, gender and type 2 diabetes

  • NIS2+™s analytical improvement To allows for bigr large-scale implementation in clinical practice and clinical trials

  • three posterss to be presented to the AASLD Meeting of the Liver®

Lille (France)), Cambridge (Massachusetts, USA), October 252022 – GENFIT (Nasdaq and Euronext: GNFT)a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver disease, today announced that it has developed NIS2+™, a next-generation technology for the diagnosis of non-alcoholic steatohepatitis (NASH) in risk, and will present NIS2+™ clinical performance results in three poster presentations at The Liver Meeting® 2022 hosted by the American Association for the Study of Liver Diseases (AASLD).

The first poster promotes NIS2+™ as an optimization of NIS4® technology for identifying at-risk NASH. This next-generation technology addresses unmet needs for identifying at-risk NASH patients using non-invasive tests (NIT) that are unaffected by critical patient characteristics. NIS2+™ demonstrated strong clinical performance in detecting at-risk NASH, while its composite scores were not impacted by the status of important subpopulations such as type 2 diabetes, age, and gender . While NIS4®was convincing, the distributions of the composite scores were significantly affected in certain subpopulations. In addition, the increased robustness and simplicity of the NIS2+™ technology (from a panel of 4 to 2 biomarkers) allows a broader and easier application in the clinical setting.

The second poster demonstrates that NIS2+™ is an effective screening tool for recruiting at-risk NASH patients into clinical trials, reducing liver biopsy failure rates and associated costs without inflating the number of patients to be screened .

Data from the third poster highlights NIS2+™ as a valuable prognostic tool for early detection of fibrosis progression in at-risk NASH patients with significant fibrosis (F2) to advanced fibrosis (F3) and cirrhosis (F4). ).

In November 2021, NIS4® the usefulness of the technology has been validated in a phase 1 study1 undertaken by the Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) initiative of the Foundation for the National Institutes of Health’s Biomarkers Consortium as demonstrating strong and unique performance in identifying at-risk NASH patients.2

Dr. Vlad Ratziu, Professor at Sorbonne University and Pitie-Salpetriere Hospital in Paris, France commented : “Rapid diagnosis of at-risk NASH patients is a critical unmet medical need, and so we welcome this next-generation diagnostic tool. NIS2+™ simplifies the analytical process with only two biomarkers, is more robust in terms of composite scores in critical subpopulations of interest, and can be widely implemented in clinical practice. I anticipate that in clinical practice, NIS2+™ will be a diagnostic test of choice to select NASH patients requiring pharmacotherapy, eliminating the need for a liver biopsy – a real progress for the management of patients. Moreover, there is a need for noinvasive tests for facilitate enrollment in NASH clinical trialsso that the number of liver biopsies, with their many challenges, can be reduced.

POSTER PRESENTATIONS

Poster number 1: #2484

Title: Derivation and validation of the NIS2+™ blood biomarker panel, an improvement of NIS4® Technology for identification of NASH at risk

Authors: Harrison SA, Ratziu V et al.

Poster number 2: #2503

Title: NIS2+™ Technology as a Screening Tool for Recruiting At-Risk NASH Patients into Clinical Trials

Authors: Ratziu V et al.

Poster number 3: #2522

Title: NIS2+™, an enhancement of NIS4® Technology for the early detection of fibrosis progression in patients with at-risk NASH proven by liver biopsy and F2

Authors: Ratziu V et al.

ON THE LIVER REUNION®

The meeting of the liver® organized by the AASLD is one of the most important hepatology congresses for the medical and scientific community. It brings together more than 10,000 scientists, gastroenterologists and hepatologists from all over the world. The meeting of the liver® 2022 will be held November 4-8, 2022 at the Walter E. Washington Convention Center in Washington DC.

ABOUT GENFIT

GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver disease characterized by significant unmet medical needs. GENFIT is a pioneer in the research and development of therapeutic and diagnostic solutions in liver disease, with a rich history and a strong scientific heritage spanning more than two decades. Thanks to its expertise in bringing high-potential early-stage actives to advanced development and pre-marketing stages, GENFIT now has a growing and diversified pipeline of innovative therapeutic and diagnostic solutions.

Its R&D is centered on three franchises: cholestatic diseases, Acute on Chronic Liver Failure (ACLF) and NASH diagnostics. In its cholestatic disease franchise, ELATIVE™, a global Phase 3 trial evaluating elafibranor3 in patients with primary biliary cholangitis (PBC) is on track after a successful Phase 2 clinical trial. The first data is expected to be announced in the second quarter of 2023. In 2021, GENFIT signed an exclusive license agreement with IPSEN to develop, manufacture and commercialize elafibranor in PBC and other indications.4 GENFIT is also developing GNS5611 in cholangiocarcinoma following the acquisition of exclusive rights in this indication from Genoscience Pharma in 20215. In ACLF, a Phase 1 clinical program with nitazoxanide was initiated in 2021, and GENFIT further expanded its ACLF pipeline in 2022 through the acquisition of Swiss clinical-stage company Versantis, with a Phase-ready program. 2 evaluating liposome technology and a small molecule preclinical study. As part of its diagnostic solutions franchise, the Company entered into an agreement with Labcorp in 2021 to commercialize NASHnext®powered by GENFIT NIS4 proprietary diagnostic technology®and recently developed NIS2+™, a scalable and optimized diagnostic tool to identify at-risk NASH.

GENFIT has facilities in Lille and Paris, France, and in Cambridge, MA, USA. GENFIT is listed on the Nasdaq Global Select Market and on compartment B of the regulated Euronext market in Paris (Nasdaq and Euronext: GNFT). In 2021, IPSEN became one of the first shareholders of GENFIT and holds 8% of the company’s capital. www.genfit.com

ABOUT NIS2+™

NIS2+™ is a blood diagnostic test specially designed to detect at-risk NASH in patients with metabolic risk factors based on an independent panel of 2 biomarkers. It has been developed and validated by GENFIT as a robust NIT on characteristics of interest such as type 2 diabetes, age and sex, allowing large-scale implementation in clinical practice.

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements regarding GENFIT, including those within the meaning of the Private Securities Litigation Reform Act of 1995, relating to the clinical performance of NIS2+™ and its suitability for use as a prognostic assessment of progressive fibrosis. The use of certain words, including “consider”, “contemplate”, “think”, “aim”, “expect”, “understand”, “should”, “aspire”, “estimate”, “believe “, “wish”, “may”, “could”, “allow”, “seek”, “encourage” or “trust” or (as applicable) the negative forms of these terms or any other variations of these terms or other similar terms their meaning is intended to identify forward-looking statements. Although the Company believes that its projections are based on reasonable expectations and assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially. of those expressed, implied or intended by the forward-looking statements. These risks and uncertainties include, among others, uncertainties inherent in research and development, including with respect to safety, biomarkers, the progress and results of its ongoing and planned clinical trials, the review and approval by regulatory authorities of its drugs and diagnostic candidates, the impact of the COVID-19 pandemic, fluctuations in exchange rates and the Company’s continued ability to raise capital to finance its development, as well as the risks and uncertainties discussed or identified in the public documents filed by the Company with the AMF, including those listed in Chapter 2 “Principal risks and uncertainties” of the Company’s 2021 Universal Registration Document filed with the AMF on April 29, 2022 under number D.22-0400, available on the Company’s website (www.genfit.com) and on the AMF’s website (www.amf-france.org) and the documents and pub reports lics filed with the United States Securities and Exchange Commission (“SEC”), including the Company’s 2021 Annual Report on Form 20-F filed with the SEC on April 29, 2022 and the 2022 Half-Year Business and Financial Report Furthermore, even if the results, performance, financial condition and liquidity of the Company, and the development of the industry in which it operates are consistent with these forward-looking statements, they may not be predictive of the results or developments. in future periods. These forward-looking statements speak only as of the date of the publication of this document. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACT

GENFIT | Investors

Tel: +33 3 2016 4000 | investors@genfit.com

PRESS RELATIONS | Media

Stéphanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com

1 https://fnih.org/sites/default/files/2021-11/CWS_NIMBLE_Abstract.pdf
2 https://ir.genfit.com/news-releases/news-release-details/genfit-fnih-nimble-study-demonstrates-nis4r-technologys-unique
3 Elafibranor and GNS561 are investigational compounds that have not been reviewed or approved by any regulatory authority
4 With the exception of China, Hong Kong, Taiwan and Macao where Terns Pharmaceuticals holds the exclusive license to develop and commercialize elafibranor
5 The agreement includes marketing and development in the United States, Canada and Europe, including the United Kingdom and Switzerland

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GENFIT Announces Compelling Results for NIS2+™ Next-Generation Noninvasive Diagnostic Technology in NASH to be Showcased at AASLD Liver Meeting® https://mostobd.com/genfit-announces-compelling-results-for-nis2-next-generation-noninvasive-diagnostic-technology-in-nash-to-be-showcased-at-aasld-liver-meeting-3/ Tue, 25 Oct 2022 20:10:00 +0000 https://mostobd.com/genfit-announces-compelling-results-for-nis2-next-generation-noninvasive-diagnostic-technology-in-nash-to-be-showcased-at-aasld-liver-meeting-3/ [ad_1] NIS2+™ developed and validated inasmuch as optimization NIS4® technology for the detection of NASH patients at risk Data demonstrate robust and improved clinical performance of NIS2+™ allowing effective identification of at-risk NASHregardless of patient characteristics such as age, gender and type 2 diabetes NIS2+™’s analytical improvement To allows for bigr large-scale implementation in clinical […]]]>

[ad_1]

  • NIS2+™ developed and validated inasmuch as optimization NIS4® technology for the detection of NASH patients at risk

  • Data demonstrate robust and improved clinical performance of NIS2+™ allowing effective identification of at-risk NASHregardless of patient characteristics such as age, gender and type 2 diabetes

  • NIS2+™s analytical improvement To allows for bigr large-scale implementation in clinical practice and clinical trials

  • three posterss to be presented to the AASLD Meeting of the Liver®

Lille (France)), Cambridge (Massachusetts, USA), October 252022 – GENFIT (Nasdaq and Euronext: GNFT)a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver disease, today announced that it has developed NIS2+™, a next-generation technology for the diagnosis of non-alcoholic steatohepatitis (NASH) in risk, and will present NIS2+™ clinical performance results in three poster presentations at The Liver Meeting® 2022 hosted by the American Association for the Study of Liver Diseases (AASLD).

The first poster promotes NIS2+™ as an optimization of NIS4® technology for identifying at-risk NASH. This next-generation technology addresses unmet needs for identifying at-risk NASH patients using non-invasive tests (NIT) that are unaffected by critical patient characteristics. NIS2+™ demonstrated strong clinical performance in detecting at-risk NASH, while its composite scores were not impacted by the status of important subpopulations such as type 2 diabetes, age, and gender . While NIS4®was convincing, the distributions of the composite scores were significantly affected in certain subpopulations. In addition, the increased robustness and simplicity of the NIS2+™ technology (from a panel of 4 to 2 biomarkers) allows a broader and easier application in the clinical setting.

The second poster demonstrates that NIS2+™ is an effective screening tool for recruiting at-risk NASH patients into clinical trials, reducing liver biopsy failure rates and associated costs without inflating the number of patients to be screened .

Data from the third poster highlights NIS2+™ as a valuable prognostic tool for early detection of fibrosis progression in at-risk NASH patients with significant fibrosis (F2) to advanced fibrosis (F3) and cirrhosis (F4). ).

In November 2021, NIS4® the usefulness of the technology has been validated in a phase 1 study1 undertaken by the Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) initiative of the Foundation for the National Institutes of Health’s Biomarkers Consortium as demonstrating strong and unique performance in identifying at-risk NASH patients.2

Dr. Vlad Ratziu, Professor at Sorbonne University and Pitie-Salpetriere Hospital in Paris, France commented : “Rapid diagnosis of at-risk NASH patients is a critical unmet medical need, and so we welcome this next-generation diagnostic tool. NIS2+™ simplifies the analytical process with only two biomarkers, is more robust in terms of composite scores in critical subpopulations of interest, and can be widely implemented in clinical practice. I anticipate that in clinical practice, NIS2+™ will be a diagnostic test of choice to select NASH patients requiring pharmacotherapy, eliminating the need for a liver biopsy – a real progress for the management of patients. Moreover, there is a need for noinvasive tests for facilitate enrollment in NASH clinical trialsso that the number of liver biopsies, with their many challenges, can be reduced.

POSTER PRESENTATIONS

Poster number 1: #2484

Title: Derivation and validation of the NIS2+™ blood biomarker panel, an improvement of NIS4® Technology for identification of NASH at risk

Authors: Harrison SA, Ratziu V et al.

Poster number 2: #2503

Title: NIS2+™ Technology as a Screening Tool for Recruiting At-Risk NASH Patients into Clinical Trials

Authors: Ratziu V et al.

Poster number 3: #2522

Title: NIS2+™, an enhancement of NIS4® Technology for the early detection of fibrosis progression in patients with at-risk NASH proven by liver biopsy and F2

Authors: Ratziu V et al.

ON THE LIVER REUNION®

The meeting of the liver® organized by the AASLD is one of the most important hepatology congresses for the medical and scientific community. It brings together more than 10,000 scientists, gastroenterologists and hepatologists from all over the world. The meeting of the liver® 2022 will be held November 4-8, 2022 at the Walter E. Washington Convention Center in Washington DC.

ABOUT GENFIT

GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver disease characterized by significant unmet medical needs. GENFIT is a pioneer in the research and development of therapeutic and diagnostic solutions in liver disease, with a rich history and a strong scientific heritage spanning more than two decades. Thanks to its expertise in bringing high-potential early-stage actives to advanced development and pre-marketing stages, GENFIT now has a growing and diversified pipeline of innovative therapeutic and diagnostic solutions.

Its R&D is centered on three franchises: cholestatic diseases, Acute on Chronic Liver Failure (ACLF) and NASH diagnostics. In its cholestatic disease franchise, ELATIVE™, a global Phase 3 trial evaluating elafibranor3 in patients with primary biliary cholangitis (PBC) is on track after a successful Phase 2 clinical trial. The first data is expected to be announced in the second quarter of 2023. In 2021, GENFIT signed an exclusive license agreement with IPSEN to develop, manufacture and commercialize elafibranor in PBC and other indications.4 GENFIT is also developing GNS5611 in cholangiocarcinoma following the acquisition of exclusive rights in this indication from Genoscience Pharma in 20215. In ACLF, a Phase 1 clinical program with nitazoxanide was initiated in 2021, and GENFIT further expanded its ACLF pipeline in 2022 through the acquisition of Swiss clinical-stage company Versantis, with a Phase-ready program. 2 evaluating liposome technology and a small molecule preclinical study. As part of its diagnostic solutions franchise, the Company entered into an agreement with Labcorp in 2021 to commercialize NASHnext®powered by GENFIT NIS4 proprietary diagnostic technology®and recently developed NIS2+™, a scalable and optimized diagnostic tool to identify at-risk NASH.

GENFIT has facilities in Lille and Paris, France, and in Cambridge, MA, USA. GENFIT is listed on the Nasdaq Global Select Market and on compartment B of the regulated Euronext market in Paris (Nasdaq and Euronext: GNFT). In 2021, IPSEN became one of the first shareholders of GENFIT and holds 8% of the company’s capital. www.genfit.com

ABOUT NIS2+™

NIS2+™ is a blood diagnostic test specially designed to detect at-risk NASH in patients with metabolic risk factors based on an independent panel of 2 biomarkers. It has been developed and validated by GENFIT as a robust NIT on characteristics of interest such as type 2 diabetes, age and sex, allowing large-scale implementation in clinical practice.

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements regarding GENFIT, including those within the meaning of the Private Securities Litigation Reform Act of 1995, relating to the clinical performance of NIS2+™ and its suitability for use as a prognostic assessment of progressive fibrosis. The use of certain words, including “consider”, “contemplate”, “think”, “aim”, “expect”, “understand”, “should”, “aspire”, “estimate”, “believe “, “wish”, “may”, “could”, “allow”, “seek”, “encourage” or “trust” or (as applicable) the negative forms of these terms or any other variations of these terms or other similar terms their meaning is intended to identify forward-looking statements. Although the Company believes that its projections are based on reasonable expectations and assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially. of those expressed, implied or intended by the forward-looking statements. These risks and uncertainties include, among others, uncertainties inherent in research and development, including with respect to safety, biomarkers, the progress and results of its ongoing and planned clinical trials, the review and approval by regulatory authorities of its drugs and diagnostic candidates, the impact of the COVID-19 pandemic, fluctuations in exchange rates and the Company’s continued ability to raise capital to finance its development, as well as the risks and uncertainties discussed or identified in the public documents filed by the Company with the AMF, including those listed in Chapter 2 “Principal risks and uncertainties” of the Company’s 2021 Universal Registration Document filed with the AMF on April 29, 2022 under number D.22-0400, available on the Company’s website (www.genfit.com) and on the AMF’s website (www.amf-france.org) and the documents and pub reports lics filed with the United States Securities and Exchange Commission (“SEC”), including the Company’s 2021 Annual Report on Form 20-F filed with the SEC on April 29, 2022 and the 2022 Half-Year Business and Financial Report Furthermore, even if the results, performance, financial condition and liquidity of the Company, and the development of the industry in which it operates are consistent with these forward-looking statements, they may not be predictive of the results or developments. in future periods. These forward-looking statements speak only as of the date of the publication of this document. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACT

GENFIT | Investors

Tel: +33 3 2016 4000 | investors@genfit.com

PRESS RELATIONS | Media

Stéphanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com

1 https://fnih.org/sites/default/files/2021-11/CWS_NIMBLE_Abstract.pdf
2 https://ir.genfit.com/news-releases/news-release-details/genfit-fnih-nimble-study-demonstrates-nis4r-technologys-unique
3 Elafibranor and GNS561 are investigational compounds that have not been reviewed or approved by any regulatory authority
4 With the exception of China, Hong Kong, Taiwan and Macao where Terns Pharmaceuticals holds the exclusive license to develop and commercialize elafibranor
5 The agreement includes marketing and development in the United States, Canada and Europe, including the United Kingdom and Switzerland

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Tesla’s self-diagnosis technology will soon be adopted on its cars in Korea https://mostobd.com/teslas-self-diagnosis-technology-will-soon-be-adopted-on-its-cars-in-korea/ Mon, 03 Oct 2022 08:18:01 +0000 https://mostobd.com/teslas-self-diagnosis-technology-will-soon-be-adopted-on-its-cars-in-korea/ [ad_1] As part of its commitment to developing the automotive industry, American electric vehicle manufacturer Tesla today revealed that it plans to develop its own vehicle diagnostic system for the first time and apply it to all Tesla models sold in South Korea from October next year. . Tesla’s self-diagnosis technology According to the electric […]]]>

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As part of its commitment to developing the automotive industry, American electric vehicle manufacturer Tesla today revealed that it plans to develop its own vehicle diagnostic system for the first time and apply it to all Tesla models sold in South Korea from October next year. .

Tesla’s self-diagnosis technology

According to the electric vehicle giant, instead of going through mandatory safety checks conducted by the local authority, it is raising concern among the public that Tesla may be hiding fatal technical issues on purpose.

With this development, Tesla will now adopt an in-house developed vehicle diagnostic system to avoid offering in-vehicle diagnostic data to KTSA.

The KTSA physically inspected Tesla vehicles. Accordingly, check things like the numbers on the dashboards and the integrity of the electrical wiring. A KTSA official said he would randomly choose a Tesla car to perform a spot inspection as long as Tesla refused to hand over the relevant data.

Additionally, Tesla is now delaying providing vehicle diagnostic data to regulators in China, Japan and Europe. Industry experts predict that Tesla will first install its self-diagnostic technology in Korea before expanding to other international markets.

Experts urge compromise work for safety inspections

Speaking about Tesla’s self-diagnostic capability, Kim Pil-soo, professor of automotive engineering at Daelim University, said it sounds innovative, but given the complicated safety inspections for electric vehicles in general in due to possible problems with the high-voltage battery, so urged Tesla to work out a compromise with the local authority.

In his words: “OBD data works as an important criterion for checking the condition of the vehicle, including whether the engine is exerting its power properly. For consumer safety, it is necessary for authorities to receive related data from Tesla. »

On the other hand, another industry insider urged the electric vehicle giant to find a fair and credible way to ensure vehicle safety instead of relying on its technology, citing “dieselgate 2015” from Volkswagen, in which the German automaker manipulated exhaust emissions to pass the test.

The OBD system

An automobile’s computer system, known as OBD, performs self-diagnosis and reports on emissions, engine, brakes, and safety features. The KTSA receives and stores relevant data so that officials can use it during routine inspections. Since 2009, an OBD system has been standard equipment on all locally produced and imported electric vehicles.

Only Tesla, one of Korea’s 26 automakers, has resisted implementing OBD since 2018, citing concerns about security flaws in self-driving software.

Tesla’s sales so far

In 2021, Tesla sold a total of 17,828 automobiles in Korea, up about 50% from the previous year. Tesla ranks fourth among foreign automakers in terms of electric car sales in the country, after Mercedes-Benz (76,284), BMW (65,682) and Audi (25,626). Likewise, the company’s Model 3 was the third best-selling electric vehicle in the first half of this year.

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Tesla’s self-diagnosis technology will soon be adopted on its cars in Korea https://mostobd.com/teslas-self-diagnosis-technology-will-soon-be-adopted-on-its-cars-in-korea-2/ Mon, 03 Oct 2022 07:00:00 +0000 https://mostobd.com/teslas-self-diagnosis-technology-will-soon-be-adopted-on-its-cars-in-korea-2/ [ad_1] As part of its commitment to developing the automotive industry, the American electric vehicle manufacturer Tesla revealed today that it plans to develop its own vehicle diagnostic system for the first time and apply it to all Tesla models sold in South Korea from October next year. Tesla’s self-diagnostic technology According to the electric […]]]>

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As part of its commitment to developing the automotive industry, the American electric vehicle manufacturer Tesla revealed today that it plans to develop its own vehicle diagnostic system for the first time and apply it to all Tesla models sold in South Korea from October next year.

Tesla’s self-diagnostic technology

According to the electric vehicle giant, instead of going through mandatory safety checks conducted by the local authority, it is raising concern among the public that Tesla may be hiding fatal technical issues on purpose.

With this development, Tesla will now adopt an in-house developed vehicle diagnostic system to avoid offering in-vehicle diagnostic data to KTSA.

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The KTSA physically inspected Tesla vehicles. Accordingly, check things like the numbers on the dashboards and the integrity of the electrical wiring. A KTSA official said he would randomly choose a Tesla car to perform a spot inspection as long as Tesla refused to hand over the relevant data.

Additionally, Tesla is now delaying providing vehicle diagnostic data to regulators in China, Japan and Europe. Industry experts predict that Tesla will first install its self-diagnostic technology in Korea before expanding to other international markets.

Experts urge compromise work for safety inspections

Speaking about Tesla’s self-diagnostic capability, Kim Pil-soo, professor of automotive engineering at Daelim University, said it sounds innovative, but given the complicated safety inspections for electric vehicles in general in due to possible problems with the high-voltage battery, so urged Tesla to work out a compromise with the local authority.

In his words: “OBD data works as an important criterion for checking the condition of the vehicle, including whether the engine is exerting its power properly. For consumer safety, it is necessary for authorities to receive related data from Tesla. »

On the other hand, another industry insider urged the electric vehicle giant to find a fair and credible way to ensure vehicle safety instead of relying on its technology, citing “dieselgate 2015” from Volkswagen, in which the German automaker manipulated exhaust emissions to pass the test.

The OBD system

An automobile’s computer system, known as OBD, performs self-diagnosis and reports on emissions, engine, brakes, and safety features. The KTSA receives and stores relevant data so that officials can use it during routine inspections. Since 2009, an OBD system has been standard equipment on all locally manufactured and imported products. electric vehicles.

Only Tesla, one of Korea’s 26 automakers, has resisted implementing OBD since 2018, citing concerns about security flaws in self-driving software.

Tesla’s sales so far

In 2021, Tesla sold a total of 17,828 automobiles in Korea, up about 50% from the previous year. Tesla ranks fourth among foreign automakers in terms of electric car sales in the country, after Mercedes-Benz (76,284), BMW (65,682) and Audi (25,626). Likewise, the company’s Model 3 was the third best-selling electric vehicle in the first half of this year.

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