Randomized controlled trial

EDAP Reports Fourth Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Wednesday, March 27, 2024
AAGL, Patient, TMS, Investment, Endometriosis, Therapy, USD, Marketing, Congress, Urology, Teaching hospital, INPI, Food, Prostate cancer, EAU, Cancer, Hospital, Intellectual property, AUA, FDA, Diagnosis, DIE, Growth, EDAP, Operating cost, EDT, Randomized controlled trial

Total revenue in the HIFU business for the fourth quarter of 2023 was EUR 7.5 million (USD 8.1 million), as compared to EUR 5.4 million (USD 5.5 million) for the fourth quarter of 2022.

Key Points: 
  • Total revenue in the HIFU business for the fourth quarter of 2023 was EUR 7.5 million (USD 8.1 million), as compared to EUR 5.4 million (USD 5.5 million) for the fourth quarter of 2022.
  • The increase was driven by 10 Focal One systems sold in the fourth quarter of 2023 versus 7 systems sold in the fourth quarter of 2022.
  • Total revenue in the Distribution business for the fourth quarter of 2023 was EUR 9.9 million (USD 10.7 million), as compared to EUR 6.7 million (USD 7.0 million) for the fourth quarter of 2022.
  • Operating loss for the fourth quarter of 2023 was EUR 3.5 million (USD 3.8 million), compared to an operating loss of EUR 1.6 million (USD 1.6 million) in the fourth quarter of 2022.

GammaTile® Marks Milestone: 100th Patient Enrolled in Groundbreaking ROADS Phase 3 Clinical Trial for Newly Diagnosed Metastatic Brain Tumors

Retrieved on: 
Tuesday, April 9, 2024
RCT, Radiation, Brain, Completion, Progression-free survival, Risk, Patient, Lung, SRT, Neoplasm, Research, Indiana University, Breast, Doctor of Philosophy, MD, Quality of life, Trial of the century, Clinical trial, Melanoma, Recurrence, FDA, Craniotomy, Randomized controlled trial, Medical imaging

TEMPE, Ariz., April 9, 2024 /PRNewswire/ -- GT Medical Technologies, Inc. (GT MedTech), a medical device company with the mission of improving the lives of patients with brain tumors, today announced it has enrolled the 100th patient in its ROADS clinical study. ROADS, or Radiation One and Done Study, is the randomized control trial (RCT) designed to compare FDA-cleared GammaTile with stereotactic radiotherapy (SRT).

Key Points: 
  • ROADS, or Radiation One and Done Study, is the randomized control trial (RCT) designed to compare FDA-cleared GammaTile with stereotactic radiotherapy (SRT).
  • Patients enrolled in the ROADS clinical trial are randomized into two treatment groups following craniotomy with brain metastasis tumor removal: GammaTile implant at the time of surgery versus post-operative SRT.
  • Enrollment in the Phase 3 trial has now surpassed half of the 180 planned patients.
  • Our dedication to the ROADS trial is fueled by our mission to furnish the highest caliber of clinical evidence through randomized trial research.

Inari Medical Announces Interim Two-Year Results from the ClotTriever CLOUT Registry

Retrieved on: 
Tuesday, March 12, 2024
Deep vein thrombosis, Pulmonary embolism, VTE, Incidence, Sequela, CAVA, Patient, Post-thrombotic syndrome, Research, PTS, DVT, Randomized controlled trial, Safety, FACS, American Venous Forum, Data, Pharmaceutical industry

IRVINE, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous and other diseases, announced positive two-year interim results from the CLOUT registry.

Key Points: 
  • IRVINE, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous and other diseases, announced positive two-year interim results from the CLOUT registry.
  • The interim results are the largest prospective, multi-center two-year dataset in deep vein thrombosis (DVT) since the ATTRACT trial and confirm the excellent safety, effectiveness, and long-term outcomes of the ClotTriever system in real-world DVT patients.
  • Patients had low incidence of independently adjudicated safety events related to rethrombosis, with only 5.0% and 8.4% at 30-days and 6 months, respectively.
  • We remain committed to establishing the ClotTriever and FlowTriever systems as standard of care for deep vein thrombosis and pulmonary embolism (PE) patients.”

MaaT Pharma Announces 2023 Annual Results and Provides a Business Overview

Retrieved on: 
Thursday, March 28, 2024
Biotechnology, Pharmaceutical, Finance, Oncology, Health, FDA, Professional Services, Clinical Trials, AP-HP, Bone marrow, Survival, Immunotherapy, Patient, Innovation, IND, Ipilimumab, European Medicines Agency, Therapy, Artificial intelligence, Charcot disease, ASH, EMA, Head, MET, Investigational New Drug, Nivolumab, Safety, SITC, Microbiome, Food, ODD, Development, Acceleration, Maat, ARES, Cancer, AACR, DSMB, Haematopoietic system, Annual general meeting, OS, EUR, Physician, CIMON, CGMP, EAP, EBMT, ICI, Society, Randomized controlled trial, Symantec Endpoint Protection, Pharmaceutical industry

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today reported the full-year 2023 annual results and provided a business overview.

Key Points: 
  • MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today reported the full-year 2023 annual results and provided a business overview.
  • In December 2023 , the Company presented positive results from the Early Access Program (EAP) in Europe involving 111 patients with aGvHD treated with MaaT013, at the 2023 American Society of Hematology (ASH) Annual Meeting.
  • In April 2023 , data from the Phase 1b study (CIMON) with MaaT033, previously communicated during the 64th annual ASH meeting, were also presented at the EBMT 2023 conference.
  • During 2023 and Q1 2024, MaaT Pharma reinforced its board of directors, executive team, and key functions:
    Karim Dabbagh as Chairman and Nadia Kamal as Director, both independent.

LivaNova Announces a Positive Predictive Outcome of Trial Success in its OSPREY Clinical Study for Moderate to Severe Obstructive Sleep Apnea

Retrieved on: 
Wednesday, March 20, 2024
Research, Mental Health, Medical Devices, FDA, Clinical Trials, Cardiology, Biotechnology, Pharmaceutical, Health, Science, Principal, OSA, LivaNova, Obstructive sleep apnea, Somnolence, PLC, Patient, AHI, University, Trial of the century, LIVN, University of California, Randomized controlled trial, Safety, Probability, Food, Medical imaging

LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced its OSPREY clinical study, Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation , has achieved a positive predictive outcome and will conclude enrollment earlier than anticipated.

Key Points: 
  • LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced its OSPREY clinical study, Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation , has achieved a positive predictive outcome and will conclude enrollment earlier than anticipated.
  • This means there is a greater than 97.5% probability that the OSPREY trial will successfully meet its primary endpoint.
  • LivaNova notified the U.S. Food and Drug Administration (FDA) and its partner trial sites of this significant milestone for the OSPREY study.
  • “We are pleased to have achieved this positive milestone for the OSPREY study,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova.

Linnaeus Therapeutics Announces Issuance of Composition of Matter Patent for LNS8801 by the European Patent Office

Retrieved on: 
Tuesday, April 2, 2024
Salt, Progression-free survival, Patient, EPO, MD, Pembrolizumab, Human, Therapy, European Patent Convention, Safety, Pharmacokinetics, Randomized controlled trial, Patent, EP, Animal, SRR, Pharmaceutical industry

HADDONFIELD N.J., April 2, 2024 /PRNewswire/ -- Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, today announced that on March 6, 2024, the European Patent Office (EPO) issued EP patent 3,823,617 ('617 patent) covering the pharmaceutical composition of matter for the company's lead compound, LNS8801.

Key Points: 
  • European Patent 3,823,617 Issued on March 6, 2024
    HADDONFIELD N.J., April 2, 2024 /PRNewswire/ -- Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, today announced that on March 6, 2024, the European Patent Office (EPO) issued EP patent 3,823,617 ('617 patent) covering the pharmaceutical composition of matter for the company's lead compound, LNS8801.
  • "We are extremely pleased that the EPO has issued this composition of matter patent," commented Patrick Mooney, MD, CEO of Linnaeus.
  • As we continue to collect very promising data from our clinical trials with LNS8001, we will continue to prosecute the claims in this patent worldwide."
  • The study will enroll 135 patients who will be selected based on a predictive biomarker and then randomized to receive LNS8801 alone, LNS8801 and pembrolizumab, or physician's choice therapy.

Positive Action, Inc. Launches Pasela Digital Interactive Platform for Social and Emotional Learning

Retrieved on: 
Wednesday, March 27, 2024
Software as a service, PAI, Genome, Education, School, Climate, Differentiated instruction, Public policy, Policy, Bullying, Absenteeism, Student, Positive, Content, Randomized controlled trial, Positive Action campaign, Management

TWIN FALLS, Idaho, March 27, 2024 /PRNewswire/ -- Positive Action, Inc. ("PAI"), a leading education and technology company for evidence-based social and emotional learning (SEL) programs, announced today that it has launched Pasela™, a software as a service (SaaS) platform that enables digital implementation of the Positive Action® Program.

Key Points: 
  • TWIN FALLS, Idaho, March 27, 2024 /PRNewswire/ -- Positive Action, Inc. ("PAI"), a leading education and technology company for evidence-based social and emotional learning (SEL) programs, announced today that it has launched Pasela™, a software as a service (SaaS) platform that enables digital implementation of the Positive Action® Program.
  • "Positive Action remains one of the most effective educational programs available, and Pasela vastly improves the scalability of our products."
  • The Positive Action Program offers more than 2,000 lessons that have been scientifically validated through multiple randomized controlled trials.
  • In addition, the platform includes a suite of fully interactive features that streamline and simplify the implementation process.

CHOP Researchers Find Branched Chain Amino Acid Supplementation May Aid in Concussion Recovery

Retrieved on: 
Tuesday, March 19, 2024
Online, Research, Mind, Stroke, Concussion, Assistant, CHOP, Critical Care Medicine (journal), Patient, DSM-IV codes, Journal, Anesthesiology, Leucine, Dana Foundation, Health, University, Doctor of Philosophy, MD, Human, Valine, Critical care, Adolescence, Isoleucine, Veteran, Clinical trial, BCAA, Pediatrics, Traumatic brain injury, National Institutes of Health, Hospital, Head injury, Randomized controlled trial, Safety, Ageing, HIT, Bangladesh Technical Education Board, Medicine, Children's Hospital of Philadelphia, MSCE, Dietary supplement

PHILADELPHIA, March 19, 2024 /PRNewswire/ -- In the first clinical trial of a targeted pharmacologic therapeutic for mild traumatic brain injury in pediatric patients, scientists from the Minds Matter Concussion Frontier Program at Children's Hospital of Philadelphia (CHOP) have found preliminary evidence that adolescents and young adults with concussion who take a specific formulation of branched chain amino acid (BCAA) supplements after injury experience faster symptom reduction and return to physical activity. The findings were published online by the Journal of Neurotrauma.

Key Points: 
  • The mainstay of treatment remains symptom management with temporary modification of cognitive and physical activity and over the counter medication.
  • Although active rehabilitation strategies have shown promise for improving recovery time, including aerobic, vestibular, and vision interventions, these can be time and labor intensive.
  • To date, no targeted pharmacologic intervention to improve clinical outcomes in concussion has been evaluated in humans.
  • However, prior to this study, no human studies involving adolescents and young adults have assessed the potential benefits of this formulation of BCAAs as a specific treatment to aid in concussion recovery.

INHALE-3 Study’s Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps

Retrieved on: 
Monday, March 11, 2024
Diabetes, Senior, Randomized controlled trial, Inhalable insulin, RAA, Teaching, Hyperglycemia, MannKind Corporation, AUC, A1C, Standard of care, Conference, ATTD, Safety, University, MDI, Patient, Insulin, Automation, Clinical trial, T1D, Pharmaceutical industry

INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.

Key Points: 
  • INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.
  • “In this large, randomized trial utilizing more appropriate dose conversion, we are excited to see meal challenge results support the safety and efficacy of inhaled insulin from the start.”
    INHALE-3 is a 17-week randomized controlled trial with a 13-week extension.
  • Subjects utilizing inhaled insulin received a higher initial conversion dose than in the current label.
  • For the meal challenge, the inhaled insulin group took an inhaled insulin dose immediately prior to a standardized meal (a 240 calorie nutritional shake) whereas those using usual care used RAA 5-15 minutes prior to the meal.

Sight Sciences Reports Fourth Quarter and Full Year 2023 Financial Results and Initiates Full Year 2024 Financial Guidance

Retrieved on: 
Thursday, March 7, 2024
ASPS, IOP, Research, Randomized controlled trial, OMNI, Growth, Ophthalmology, Telecanthus, Nature, Intraocular pressure, Safety, GAAP, Medicare, Patient, News, Webcast, Clinical trial, Uncertainty, Security (finance), LCD, Environment, Depreciation, Pharmaceutical industry

Reduced cash used to $6.4 million in the fourth quarter of 2023 compared to $10.0 million used in the third quarter of 2023, a decrease of 36%, and $14.8 million used in the fourth quarter of 2022, a decrease of 57%.

Key Points: 
  • Reduced cash used to $6.4 million in the fourth quarter of 2023 compared to $10.0 million used in the third quarter of 2023, a decrease of 36%, and $14.8 million used in the fourth quarter of 2022, a decrease of 57%.
  • Gross profit for the fourth quarter of 2023 was $16.0 million compared to $16.9 million in the same period in the prior year.
  • Gross margin for the fourth quarter of 2023 was 85%, compared to 82% in the same period in the prior year.
  • Sight Sciences' management team will host a conference call today, March 7, 2024, beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.