Neuromodulation

LivaNova Reports Second-Quarter 2023 Results

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수요일, 7월 26, 2023
Research, Medical Devices, Neurology, Health Technology, Cardiology, Biotechnology, General Health, Health, Science, Other Science, Telephone, Growth, GAAP, Table, ACS, Neuromodulation, LivaNova, Yolo Bypass, Video game, Security (finance), Bank

On a U.S. GAAP basis, second quarter 2023 operating income was $17.4 million, as compared to $31.8 million for the second quarter of 2022.

Key Points: 
  • On a U.S. GAAP basis, second quarter 2023 operating income was $17.4 million, as compared to $31.8 million for the second quarter of 2022.
  • Adjusted operating income for the second quarter of 2023 was $49.5 million, as compared to $33.4 million for the second quarter of 2022.
  • Second-quarter 2023 adjusted diluted earnings per share was $0.78, as compared to $0.53 in the second quarter of 2022.
  • LivaNova now expects revenue for full-year 2023 to grow between 8% and 10% on a constant-currency basis.

Motif Neurotech Strengthens Leadership Team with Appointment of Steven Goetz as Chief Technology Officer

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월요일, 7월 24, 2023
Biotechnology, Health, Mental Health, Medical Devices, MSEE, Spinal cord stimulator, Depression, University, Rice University, Research, Multimedia, Brain, Rose–Hulman Institute of Technology, Medtronic, Publication, Computer engineering, BSEE, Engineering, Growth, R, TRD, Mental health, Electricity, Medical device, Motif, Neuromodulation

Motif Neurotech , a clinical-stage company developing minimally invasive bioelectronics for mental health, announces the appointment of Steven Goetz as Chief Technology Officer.

Key Points: 
  • Motif Neurotech , a clinical-stage company developing minimally invasive bioelectronics for mental health, announces the appointment of Steven Goetz as Chief Technology Officer.
  • “I’m so excited to add him to our team – Steve is my dream candidate for this role.
  • “Motif has developed an elegant new way to deliver neuromodulation therapy to the brain that avoids many of the barriers of more invasive approaches, and I’m excited to join the company at this time of growth to help translate this innovative technology to market,” said Steven Goetz, new Chief Technology Officer of Motif Neurotech.
  • He holds a BSEE from Rose-Hulman Institute of Technology and an MSEE from the University of Minnesota.

NeuroPace Announces CEO Transition

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수요일, 6월 28, 2023
Epilepsy, Carlson School of Management, IPO, University, Atrial fibrillation, RNS, COVID, Business administration, Patient, Electrophysiology, San Francesco delle Favete, Apiro, Growth, Cardiology, Master of Business Administration, St. Jude Medical, Arrhythmia, Management, Nursing, Neuromodulation

MOUNTAIN VIEW, Calif., June 28, 2023 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people living with epilepsy, today announced the appointment of Mr. Joel Becker as NeuroPace President & CEO and member of the Board of Directors effective July 10, 2023. Mr. Michael Favet will be stepping down as CEO and as a member of NeuroPace’s Board of Directors to pursue other opportunities. He has agreed to stay on as a consultant throughout the transition.

Key Points: 
  • Mr. Michael Favet will be stepping down as CEO and as a member of NeuroPace’s Board of Directors to pursue other opportunities.
  • He has agreed to stay on as a consultant throughout the transition.
  • “Joel brings a distinguished track record of successful commercial leadership and is highly qualified to lead NeuroPace as we move into our next phase of commercial expansion and corporate development,” said Frank Fischer, Chairman of the Board of Directors of NeuroPace.
  • “I am thrilled for the opportunity to join NeuroPace at this critical time in the Company’s history,” said Mr. Becker.

Rewiring the brain: More than $25 million to advance Sunnybrook's Harquail Centre for Neuromodulation

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목요일, 6월 22, 2023
Sunnybrook, Faculty, Deep brain stimulation, Psychiatry, Partnership, Depression, University, Tic disorder, Education, Internal medicine, Engineering, U of T, Research, DSM-IV codes, Hospital, Parkinson's disease, Patient, Post-traumatic stress disorder, University of Toronto Faculty of Applied Science and Engineering, University of Toronto Faculty of Medicine, Health, ALS, Family, Neurology, Alzheimer's disease, Sunnybrook Health Sciences Centre, Pharmaceutical industry, Medical imaging, Management, Medical device, Medicine, Maurice Harquail, Neuromodulation

The gift will also endow a new Harquail Chair in Neuromodulation to be held by the Harquail Centre's director.

Key Points: 
  • The gift will also endow a new Harquail Chair in Neuromodulation to be held by the Harquail Centre's director.
  • "The Harquail family's generous foundational support established the Harquail Centre as a global leader in brain therapy," said Dr. Nir Lipsman, director of the Harquail Centre for Neuromodulation and associate professor of surgery at U of T, who will be the inaugural Harquail Chair in Neuromodulation.
  • In addition to the Harquail family's investment, Sunnybrook Foundation and U of T have committed $3 million and $1 million respectively in matching funds to the Harquail Centre for Neuromodulation.
  • Deeply interdisciplinary in its approach, the Harquail Centre supports a critical mass of experts in surgery, internal medicine, psychiatry, neurology and other fields.

DiaMedica Therapeutics Announces Appointment of Dr. Richard Kuntz to the Board of Directors

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화요일, 5월 30, 2023
FDA, Health, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Chief scientific officer, Collateral circulation, DMAC, University, Senior, Internal medicine, Patient-Centered Outcomes Research Institute, Harvard T.H. Chan School of Public Health, Stroke, TPA, Harvard University, Associate, Bangladesh Technical Education Board, Harvard Medical School, NYSE, Master of Science, Public health, Miami University, Publication, National academy, Beth Israel Hospital, Patient, Division, Neuromodulation, PCORI, Executive Committee, Case Western Reserve University School of Medicine, S-1 Executive Committee, Biostatistics, HEAL, Neurology, NIH, Interventional cardiology, Pharmaceutical industry, Nursing, Science, Medtronic, Brigham, Parkland Memorial Hospital, Medicine

DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on acute ischemic stroke and other vascular diseases, today announced the appointment of Dr. Richard Kuntz to its Board of Directors effective May 30, 2023.

Key Points: 
  • DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on acute ischemic stroke and other vascular diseases, today announced the appointment of Dr. Richard Kuntz to its Board of Directors effective May 30, 2023.
  • Dr. Richard Kuntz recently retired from Medtronic plc (NYSE:MDT) where he was the Chief Medical Officer & Scientific Officer and a member of the Executive Committee.
  • Prior to that, he served as Senior Vice President and President, Neuromodulation of Medtronic from October 2005 to August 2009.
  • Before joining Medtronic, he was the founder and Chief Scientific Officer of the Harvard Clinical Research Institute in Boston.

QuantalX Receives FDA Breakthrough Designation for Diagnosis of Normal Pressure Hydrocephalus and Prediction of Treatment Response

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화요일, 5월 30, 2023
CT, Vascular dementia, Prevalence, Shunt (electrical), DSM-IV codes, Stroke, Quality of life, Alzheimer's disease, Delphi, Cerebrospinal fluid, Dementia, KFAR, MRI, Science, Medtronic, Walking, VPS, Parkinson's disease, Patient, Risk, Physician, Diagnosis, Entrepreneurship, CSF, FDA, Health, NPH, Pharmaceutical industry, Medical imaging, Neuromodulation

KFAR SABA, Israel, May 30, 2023 /PRNewswire/ -- QuantalX, the developer of Delphi-MD, a novel point-of-care neurodiagnostic device, has announced that they have received the prestigious FDA breakthrough designation medical device status for another clinical application, Normal Pressure Hydrocephalus (NPH). The FDA recognized the innovative value of the device in diagnosing NPH patients and predicting the response to the recommended treatment for NPH, ventriculoperitoneal shunting (VPS) surgery.

Key Points: 
  • The FDA grants the Delphi-MD device breakthrough designation technology status for the diagnosis of Normal Pressure Hydrocephalus (NPH) patients and prediction of response to highly effective, ventriculoperitoneal shunting surgery (VPS) treatment.
  • KFAR SABA, Israel, May 30, 2023 /PRNewswire/ -- QuantalX, the developer of Delphi-MD, a novel point-of-care neurodiagnostic device, has announced that they have received the prestigious FDA breakthrough designation medical device status for another clinical application, Normal Pressure Hydrocephalus (NPH).
  • The FDA recognized the innovative value of the device in diagnosing NPH patients and predicting the response to the recommended treatment for NPH, ventriculoperitoneal shunting (VPS) surgery.
  • This marks the second time that the Delphi-MD device has been granted a breakthrough designated medical device by the FDA.

Sinaptica Appoints Ken Mariash as Chief Executive Officer

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수요일, 5월 24, 2023
Mental Health, Medical Devices, FDA, Seniors, Clinical Trials, Biotechnology, Health, Consumer, General Health, University of Oxford, Therapy, CSL Behring, Marketing, Baxter, Pathology, Business, Business economics, CRA International, EBT, Multimedia, Strategic planning, Economics, Amyloid, HIV disease progression rates, Patient, Oxford University Press, Neuromodulation, Investment, Associate, Brown University, System, Overactive bladder, R, AD, Medtech, Memory, BD, Pharmaceutical industry, Takeda, Boston Scientific, Biochemistry, Brain

Sinaptica Therapeutics, Inc ., a clinical-stage company leading the development of a new class of personalized neuromodulation therapeutics to treat Alzheimer’s and neurodegenerative diseases, announces the appointment of Ken Mariash Jr. as Chief Executive Officer.

Key Points: 
  • Sinaptica Therapeutics, Inc ., a clinical-stage company leading the development of a new class of personalized neuromodulation therapeutics to treat Alzheimer’s and neurodegenerative diseases, announces the appointment of Ken Mariash Jr. as Chief Executive Officer.
  • As Chief Executive Officer, Mariash joins the company to accelerate clinical product development of the company’s SinaptiStim™ System, a closed-loop neuromodulation therapy that utilizes a novel approach to treating AD by enhancing neuroplasticity via neurostimulation of key brain networks involved in memory.
  • “As Sinaptica prepares for a pivotal clinical trial of our closed-loop neuromodulation therapy, Ken is the ideal choice to lead the company through this important stage,” said Rich Macary, President of Sinaptica Therapeutics.
  • Prior to EBT, Mariash was Director, Strategy and New Markets for the nearly $1B Neuromodulation division of Boston Scientific.

Magnus Medical Shares New Study Results That Find Treatment With SAINT for Severe Depression Changes Abnormal Brain Signals

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월요일, 5월 15, 2023
Mental Health, Medical Devices, Neurology, Clinical Trials, Health Technology, Biotechnology, Health, Pharmaceutical, General Health, ACC, Medicine, National academy, Depression, Clinical trial, Brain, Biomarker, Magnetic resonance, DSM-IV codes, Washington University in St. Louis, MRI, Mevalonate pathway, Magnetic resonance imaging, MDD, Patient, Neuromodulation, Stanford University School of Medicine, Behavioural sciences, Psychiatry, Diagnosis, FDA, SAINT, Medical imaging

Findings also reveal a new biomarker that may be helpful in the diagnosis and treatment of major depressive disorder (MDD).

Key Points: 
  • Findings also reveal a new biomarker that may be helpful in the diagnosis and treatment of major depressive disorder (MDD).
  • Researchers conducted the first investigation of the relationship between resting-state fMRI brain activity, major depression, and treatment response to the FDA-cleared SAINT Neuromodulation therapy.
  • Findings show that treatment with SAINT for major depression produces changes in brain signaling by reversing the direction of abnormal brain signals in the bilateral anterior cingulate cortex (ACC)—the region that manages fundamental emotions, which predicts improvement in depression symptoms.
  • The results also indicate that the higher quantity of abnormal signaling in the ACC is related to the severity of major depression.

LivaNova Reports First-Quarter 2023 Results

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수요일, 5월 3, 2023
Research, Medical Devices, Neurology, Health Technology, Cardiology, Biotechnology, General Health, Health, Science, Other Science, Telephone, COVID, Extracorporeal membrane oxygenation, ECMO, Growth, Table, Patient, ACS, Neuromodulation, LivaNova, Yolo Bypass, Bank, Video game, Security (finance)

Adjusted operating income for the first quarter of 2023 was $26.8 million, as compared to $28.4 million for the first quarter of 2022.

Key Points: 
  • Adjusted operating income for the first quarter of 2023 was $26.8 million, as compared to $28.4 million for the first quarter of 2022.
  • First-quarter 2023 adjusted diluted earnings per share was $0.43, as compared to $0.48 in the first quarter of 2022.
  • LivaNova now expects revenue for full-year 2023 to grow between 4 and 6 percent on a constant-currency basis.
  • Adjusted diluted earnings per share for 2023 are now expected to be in the range of $2.50 to $2.70, assuming a fully diluted share count of 54 million for full-year 2023.

Cleerly Expands Executive Team With Appointment of New Chief Financial Officer and Executive Vice President of Regulatory Affairs Positions

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월요일, 5월 1, 2023
Health, FDA, Technology, Health Technology, Artificial Intelligence, Cardiology, Biotechnology, Heart, IQVIA, Duke University, University, Fuqua School, Senior, Life, Audit, Java transaction service, FACC, Business, MBA, Triple accreditation, Exact sciences, Quality, PwC, University of Wisconsin–Madison School of Education, Neuromodulation, CFO, Regulatory affairs, Assurance, FESC, Management, Medtronic, MD

Cleerly , the company creating a new standard of care for heart disease, announced today it has appointed Krissy Wright as Chief Financial Officer (CFO) and Sandra Statz as Executive Vice President of Regulatory Affairs.

Key Points: 
  • Cleerly , the company creating a new standard of care for heart disease, announced today it has appointed Krissy Wright as Chief Financial Officer (CFO) and Sandra Statz as Executive Vice President of Regulatory Affairs.
  • Statz will oversee global regulatory strategy and submissions in compliance with applicable regulatory requirements and in alignment with Cleerly’s goals.
  • Before joining Cleerly, she served as Senior Vice President, Clinical & Regulatory Affairs at Exact Sciences Corporation.
  • She also served as Vice President, Clinical, Quality & Regulatory at Exact Sciences, as well as Sr. Director, Clinical Affairs.