PMID

BioRestorative Therapies Partners with Galen Patient Recruitment to Accelerate Completion of Enrollment in Phase 2 Trial of BRTX-100 in Chronic Lumbar Disc Disease

Retrieved on: 
Monday, April 8, 2024
Online, Systematic review, PMID, Partnership, Clinical trial, Meta-analysis, Safety, Pharmaceutical industry

MELVILLE, N.Y., April 08, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced a collaboration with Galen Patient Recruitment, Inc. (“Galen”) which, combined with the recent expansion of clinical trial capacity from approximately 10 to 30 participants per month, is expected to help accelerate the completion of patient enrollment in the ongoing Phase 2 study of BioRestorative’s lead clinical candidate, BRTX-100, in chronic lumbar disc disease (“cLDD”).

Key Points: 
  • BRTX-100 is a novel cell-based therapeutic engineered to target areas of the body that have little blood flow.
  • The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study.
  • A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States.
  • Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo.

OneOme Introduces RightMed Oncology: Empowering Clinicians to Personalize Treatment and Reduce Toxicity Risk with Pharmacogenomics

Retrieved on: 
Tuesday, April 2, 2024
FDA, Other Health, Practice Management, Pharmaceutical, Surgery, Managed Care, Oncology, Mental Health, Hospitals, Genetics, Clinical Trials, Biotechnology, Science, Other Science, Research, Health, Toxicity, DPYD, Irinotecan, Clinical professor, PMID, UGT1A1, Risk, Mayo Clinic, Mental health, Wastewater treatment, Cancer, Doctor of Philosophy, MD, Medicine, E pluribus unum, Safety, Patient safety, Pain management, DPD, Colorectal cancer, Vomiting, Clinical Pharmacogenetics Implementation Consortium, Pharmaceutical industry

The RightMed oncology portfolio empowers innovative health systems, oncology practices and prescribers to be as focused or comprehensive as their program requires.

Key Points: 
  • The RightMed oncology portfolio empowers innovative health systems, oncology practices and prescribers to be as focused or comprehensive as their program requires.
  • Using PGx can inform usage and dosage decisions for a wide range of chemotherapy and supportive care medications.
  • For more information about RightMed Oncology, please visit OneOmeInstitute.com/Oncology or reach out directly to discuss a PGx program for your health system.
  • OneOme aims to improve patient safety, reduce overall cost of care, and improve patients' health outcomes.

Spirair, Developer of the First and Only Minimally Invasive Therapy for Mechanical Correction of Nasal Septal Deviation, Announces Appointment of Benjamin Bishop as Chief Executive Officer

Retrieved on: 
Tuesday, March 12, 2024
Surgery, Medical Devices, Health, Health Technology, Medical Supplies, NSD, Clinical Otolaryngology, PMID, Patient, Acquisition, NSR, Stanford University, NAO, Otorhinolaryngology, ENT, Therapy, Septum, Marketing, IRB, Pharmaceutical industry

Spirair™, an early-stage company pioneering minimally invasive solutions that help ENTs advance care for their patients, today announced the appointment of Benjamin Bishop as its chief executive officer.

Key Points: 
  • Spirair™, an early-stage company pioneering minimally invasive solutions that help ENTs advance care for their patients, today announced the appointment of Benjamin Bishop as its chief executive officer.
  • The company is developing a novel therapy for symptomatic nasal septal deviation (NSD) that supports and straightens minor deviations in the septum with a bioabsorbable implant.
  • Treatment options for symptomatic NSD have been limited to either over-the-counter medications to alleviate symptoms or invasive surgical techniques to address the structural issues that cause these symptoms.
  • were co-fellows in the program and identified an opportunity in the ENT space when they discovered the unmet need for a minimally invasive nasal septal deviation correction therapy to help address nasal airway obstruction.

Implantica submits U.S. FDA Premarket Approval (PMA) application for RefluxStop® (first module)

Retrieved on: 
Wednesday, March 27, 2024
Cancer, PPI, CE, PMID, Patient, Internet, PMA, Literature, File, Gastroesophageal reflux disease, FDA, Certification, Pharmaceutical industry

The U.S. FDA has agreed to a modular submission process for the RefluxStop PMA application.

Key Points: 
  • The U.S. FDA has agreed to a modular submission process for the RefluxStop PMA application.
  • This process provides for ongoing review and feedback from the FDA as the modules are submitted.
  • The second and third (final) modules are anticipated to be submitted to the FDA in three-month intervals later this year.
  • Dr. Peter Forsell, CEO of Implantica, says, "This FDA filing is a key fundamental milestone for RefluxStop®3 and puts us in motion for the U.S. launch preparation ahead of the pending FDA approval.

Implantica completes Human Factors Validation Study for RefluxStop™ as part of the US FDA Premarket Approval Process

Retrieved on: 
Tuesday, March 26, 2024
Cancer, PPI, PMID, Gastroesophageal reflux disease, Patient, Internet, Foregut, GERD, Northwestern University, Surgeon, Certification, PMA, Literature, Human factors and ergonomics, FDA, Pharmaceutical industry

), a medtech company at the forefront of bringing advanced technology into the body, announces completion of the Human Factors Validation Study with 16 US surgeons as part of the US FDA Premarket Approval (PMA) process for RefluxStop™.

Key Points: 
  • ), a medtech company at the forefront of bringing advanced technology into the body, announces completion of the Human Factors Validation Study with 16 US surgeons as part of the US FDA Premarket Approval (PMA) process for RefluxStop™.
  • In March, 16 foregut surgeons in the United States (U.S.) participated in a Human Factors Validation Study of the RefluxStop™ procedure at Northwestern University's Simulation Lab in Chicago.
  • In the next step of the study, an independent third party is evaluating the data collected during testing in Chicago.
  • Dr. Peter Forsell, CEO of Implantica, says, "We're very grateful to the independent US surgeons and healthcare professionals who participated in the Human Factors Validation study, a key milestone for the FDA approval process.

Summit Venture Studio Licenses Medication Administration Protection System to Enhance Medication Safety

Retrieved on: 
Tuesday, March 19, 2024
Medicine, PMID, Risk, EMR, Patient, Internet, Pharming, Research, Artificial intelligence, Software, Death, HMH, Medical error, Patient safety, Machine learning, LEHI, MAPS, Health, Approximation error, BMJ, Nursing

LEHI, Utah, March 19, 2024 /PRNewswire-PRWeb/ -- Summit Venture Studio is excited to announce its license and commercialization of the clinical surveillance tool MAPS (Medication Administration Protection System). MAPS is a pioneering software, designed by Houston Methodist, that enhances medication safety in the health care setting.

Key Points: 
  • Summit Venture Studio is excited to announce its license and commercialization of the clinical surveillance tool MAPS (Medication Administration Protection System).
  • MAPS is a pioneering software, designed by Houston Methodist, that enhances medication safety in the health care setting.
  • LEHI, Utah, March 19, 2024 /PRNewswire-PRWeb/ -- Summit Venture Studio is excited to announce its license and commercialization of the clinical surveillance tool MAPS (Medication Administration Protection System).
  • MAPS is a pioneering software, designed by Houston Methodist, that enhances medication safety in the health care setting.

Fujifilm Receives 510(k) Clearance for SCALE EYE®, a Novel Endoscopic Imaging Technology for Measuring Colonic Lesions

Retrieved on: 
Monday, February 26, 2024
Polyp (medicine), Colonoscopy, FDA, Polyp, EYE, Risk, Fujifilm, Colorectal polyp, PMID, Malignancy, Instrument, Subjectivity, NYU Langone Health, SCALE, Neoplasm, Hepatology

LEXINGTON, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Healthcare Americas Corporation, a leading provider of endoscopic imaging and endosurgical solutions, has been granted FDA 510(k) clearance for SCALE EYE, a new endoscopic imaging technology and part of its expanding ELUXEO Endoscopic Imaging System.

Key Points: 
  • LEXINGTON, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Healthcare Americas Corporation, a leading provider of endoscopic imaging and endosurgical solutions, has been granted FDA 510(k) clearance for SCALE EYE, a new endoscopic imaging technology and part of its expanding ELUXEO Endoscopic Imaging System.
  • Measurement time was 2.8 seconds using SCALE EYE, compared to 8 seconds when measuring with forceps.
  • Comparing size measurement of colorectal polyps using a novel virtual scale endoscope, endoscopic ruler or forceps: A preclinical randomized trial.
  • Introduction and preliminary evaluation of novel endoscope with pinpoint laser technology for adequate size estimation of colon lesions.

Immix Biopharma 12 Month Review Progress Update

Retrieved on: 
Wednesday, February 21, 2024
Boston University, Research, Autoimmune disease, Toxicity, Doctor of Philosophy, Boston Medical Center, PMID, Health, Multiple myeloma, Patient, Poster, Blood, Investigational New Drug, Presentation, Bank, Johnson & Johnson, GMP, BCMA, Amyloidosis, BioMarin Pharmaceutical, Autoimmunity, MBBS, Pfizer, ASH, European, IMS, Conference, ODD, Haematologica, IND, Public, Gene, MD, FDA, Food, U.S. FDA, Cell, ALA, Letter, Society, Publication, BMC, Pharmaceutical industry

LOS ANGELES, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced its 12-month progress update including shareholder letter.

Key Points: 
  • LOS ANGELES, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced its 12-month progress update including shareholder letter.
  • “The past 12 months have seen landmark achievements for Immix Biopharma, cementing our position as a leading cell therapy company in autoimmune disease.
  • NXC-201 is the first and only ‘Single-Day CRS‘ CAR-T, a critical advancement for autoimmune diseases like AL Amyloidosis,” said Ilya Rachman, MD PhD CEO Immix Biopharma.
  • As we reflect on the last 12 months of progress, we wish to connect with you offering an update on Immix Biopharma.

Perimeter Medical Imaging AI Announces Publication of Peer-Reviewed Research Examining the High Rates of Re-Operations Following Breast-Conserving Surgeries and the Associated Increased Healthcare Costs

Retrieved on: 
Tuesday, February 20, 2024
Woman, Perimeter, BCS, University, OTC, Surgeon, PINK, Surgical oncology, Risk, MD Anderson Cancer Center, Attention, PMID, Medicare, Mastectomy, Conversion, Patient, Research

The results of our study demonstrate that high reoperation rates after breast-conserving surgery persist and are correlated with elevated risks and adverse outcomes for patients.

Key Points: 
  • The results of our study demonstrate that high reoperation rates after breast-conserving surgery persist and are correlated with elevated risks and adverse outcomes for patients.
  • I believe that these data underscore the need for new approaches to address high reoperation rates, including better methods of margin assessment for surgeons."
  • Funding to support this research was provided, in part, by Perimeter Medical Imaging AI, Inc.
    1 Kim Y, Ganduglia-Cazaban C, Tamirisa N, Lucci A, Krause TM.
  • Contemporary Analysis of Reexcision and Conversion to Mastectomy Rates and Associated Healthcare Costs for Women Undergoing Breast-Conserving Surgery.

Oncolytics Biotech® Initiates Enrollment Expansion of GOBLET Anal Cancer Cohort

Retrieved on: 
Wednesday, February 14, 2024
Anal, International, SAN, Breast cancer, Cetuximab, SCCA, TSX, AIO, Hope, E pluribus unum, Conference, PR, Symantec Endpoint Protection, Carcinoma, Lancet, PMID, SCAC, Anal canal, Patient, Optimism, Clinical trial, Poster, Anal cancer, Pancreatic cancer, ONC, Pharmaceutical industry

SAN DIEGO and CALGARY, Alberta, Feb. 14, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the expansion of enrollment for the anal cancer cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq®) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The study was expanded based on positive data from Stage 1 of the study, presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) in November 2023 (link to the PR, link to the poster).

Key Points: 
  • "These exciting clinical data, which exceed the Simon two-stage success criteria, provide strong support to expand the evaluation of pelareorep in patients with advanced anal cancer.
  • "We begin the Stage 2 expansion with substantial optimism for patients and the potential of pelareorep, especially considering the initial efficacy signal observed for pelareorep-based therapy in pancreatic cancer.
  • There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment.
  • Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study.