FACS

TELA Bio Welcomes Acclaimed Surgeon as Vice President of Medical Affairs and Surgeon Strategy

Retrieved on: 
Monday, April 8, 2024
Surgeon, Plastic, Associate, Education, Matrix, National Cancer Institute, Bellevue Hospital, MD Anderson Cancer Center, NYU, University, General surgery, Surgical oncology, Health, FACS, Dentistry

MALVERN, Pa., April 08, 2024 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced Howard N. Langstein, MD, FACS, as Vice President of Medical Affairs and Surgeon Strategy.

Key Points: 
  • MALVERN, Pa., April 08, 2024 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced Howard N. Langstein, MD, FACS, as Vice President of Medical Affairs and Surgeon Strategy.
  • Dr. Langstein is the former Chief of Plastic and Reconstructive Surgery at the University of Rochester Medical Center, known for his extensive expertise, especially in microvascular reconstruction and innovative approaches to complex surgical problems.
  • “With more than 30 years of experience in plastic and reconstructive surgery, I understand the needs and challenges in this space,” said Dr. Langstein.
  • "We are thrilled to welcome Dr. Langstein to our team," said Paul Talmo, Chief Technology Officer of TELA Bio.

Ocugen Announces Positive Data and Safety Monitoring Board Review and Initiation of Enrollment in Medium Dose for OCU410—a Modifier Gene Therapy—in Phase 1/2 ArMaDa Study for Geographic Atrophy

Retrieved on: 
Friday, April 5, 2024
Retina, Disease, Inflammation, Patient, Data, Cohort, Șaeș, Life, Clinical trial, Armada, MPH, Injection, Safety, DSMB, FACS, Vaccine, Lipid metabolism, Geographic atrophy, Oxidative stress, Pharmaceutical industry

Three subjects with geographic atrophy (GA) were dosed in the Phase 1/2 clinical trial to date.

Key Points: 
  • Three subjects with geographic atrophy (GA) were dosed in the Phase 1/2 clinical trial to date.
  • An additional three subjects will be dosed with the medium dose (Cohort 2) and three patients with the high dose (Cohort 3) of OCU410 in the dose-escalation phase.
  • “The DSMB has recommended moving forward to medium dose for dosing subjects with GA,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410 clinical trial.
  • Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)].

Urology Care Foundation Announces 2024 Research Awards of Distinction

Retrieved on: 
Thursday, April 4, 2024
Western University, Research, American Urological Association, Xenobiotic, Translational research, Postdoctoral researcher, Prostate cancer, Environment, Lawson Health Research Institute, Immunology, Committee, Gut microbiota, University, Macrophage, Doctor of Philosophy, Role, Publication, Pediatrics, University of California, Pediatric urology, Division, FACS, Radiation therapy, Society, Michigan Medicine, Nursing

BALTIMORE, April 04, 2024 (GLOBE NEWSWIRE) -- The Urology Care Foundation, the world’s leading nonprofit urological health foundation and the official foundation of the American Urological Association, is pleased to announce the recipients of the 2024 Research Awards of Distinction.

Key Points: 
  • BALTIMORE, April 04, 2024 (GLOBE NEWSWIRE) -- The Urology Care Foundation, the world’s leading nonprofit urological health foundation and the official foundation of the American Urological Association, is pleased to announce the recipients of the 2024 Research Awards of Distinction.
  • "We are optimistic about the future of urologic research with the selection of the recipients of this year’s Urology Care Foundation Research Awards,” said Harris M. Nagler, MD, Urology Care Foundation President.
  • “We are thrilled with the Urology Care Foundation Research Awards of Distinction awardees this year,” said Steven Kaplan, MD, Chair of the AUA’s Research Council.
  • The awardees will be celebrated at the Urology Care Foundation Research Honors Program held at the AUA Annual Meeting in May 2024.

TearSolutions, Inc. Appoints Louis M Alpern, MD, MPH, FACS, FICS to its Board of Directors

Retrieved on: 
Wednesday, April 3, 2024
Principal, Harvard Medical School, Alpern, Public, Public health, FICS, Private practice, Telecanthus, Patient, DED, MPH, Therapy, FACS, Frustration, Ophthalmology, Pharmaceutical industry

“Dr.

Key Points: 
  • “Dr.
  • Alpern brings extensive real-world clinical experience treating patients with ocular surface disease, having prescribed or trialed virtually every dry eye treatment available,” said Anil Asrani, President and CEO of TearSolutions.
  • “Dr.
  • He received his Doctor of Medicine from Harvard Medical School and his Master of Public Health from the Harvard School of Public Health.

Silk Road Medical Strengthens TCAR Portfolio with Launch of ENROUTE Transcarotid Neuroprotection System PLUS

Retrieved on: 
Tuesday, April 2, 2024
Neuroprotection, Risk, Stroke, FSVS, NPS, Workflow, Stenosis, FACS, SILK, Blood, Physician, TCAR

SUNNYVALE, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the launch of its ENROUTE® Transcarotid Neuroprotection System PLUS (“NPS PLUS”), a key component of the TCAR® portfolio.

Key Points: 
  • SUNNYVALE, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the launch of its ENROUTE® Transcarotid Neuroprotection System PLUS (“NPS PLUS”), a key component of the TCAR® portfolio.
  • This next generation device builds upon the prior ENROUTE Transcarotid Neuroprotection System to deliver smoother arterial sheath insertion, greater flow precision, and a simplified prep experience for surgical teams, all while maintaining unparalleled neuroprotection during the TCAR procedure.
  • “With the launch of the NPS PLUS, we're thrilled to empower our TCAR-trained physicians with a solution that addresses their insights and feedback to further strengthen and streamline the TCAR procedure,” shared Chas McKhann, Chief Executive Officer of Silk Road Medical.
  • During TCAR, the surgical team inserts a tube-like sheath into the carotid artery and connects it to the ENROUTE Neuroprotection System, which temporarily reverses blood flow.

EyePoint Pharmaceuticals Expands Scientific Advisory Board with World-Renowned Retina Specialists

Retrieved on: 
Tuesday, April 2, 2024
Patient, MIB, ARI, Therapy, AAO, Research, Surgeon, Thomas Jefferson University, German Research Foundation, Chairperson, American Diabetes Association, Macular degeneration, SAB, FACS, Food, Cornell University, Empire, University, Castle Connolly Medical, Laborie (company), Publication, Emerita, AMD, FDA, Cochrane (organisation), Moorfields Eye Hospital, American Academy, Most, Consultant, Physician, Royal college, Diabetic retinopathy, Commander, Pharmaceutical industry

WATERTOWN, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced the appointment of leading global ophthalmologists to its Scientific Advisory Board (SAB), co-chaired by Carl Regillo M.D., FACS, Chief of the Retina Service at Wills Eye Hospital and Charles Wykoff, M.D., Ph.D., Director of Research of Retina Consultants of Texas. The SAB additions include Usha Chakravarthy, M.B.B.S., Ph.D.; Allen Ho, M.D. FACS FASRS, and Frank Holz, M.D., F.E.B.O., F.A.R.V.O. These three world-renowned retinal specialists will support advancement of the Company’s global clinical strategy ahead of the anticipated initiation of its Phase 3 pivotal trials in wet age-related macular degeneration (wet AMD) in the second half of this year. Additionally, the Company announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the trade name, DURAVYUTM (vorolanib intravitreal insert) for the Company’s lead product candidate, EYP-1901.

Key Points: 
  • “The SAB’s strategic counsel, global expertise, and scientific knowledge will be incredibly valuable during this critical time in EyePoint’s growth and expansion.
  • Dr. Chakravarthy has authored or co-authored over 400 publications, and she is invited to lecture in the UK and abroad.
  • FACS FASRS is Attending Surgeon, Director of Retina Research and Co-Director of the Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University.
  • He is a Board Member of the German Ophthalmological Society, and of the Club Jules Gonin and is past president of EURETINA.

Ocugen Announces Positive Data and Safety Monitoring Board Review and Initiation of Enrollment in Medium Dose for OCU410ST—a Modifier Gene Therapy—in GARDian Study for Stargardt Disease

Retrieved on: 
Monday, April 1, 2024
Stargardt disease, Gardian, Patient, Cohort, Șaeș, Clinical trial, MPH, Safety, DSMB, FACS, Vaccine, FDA, Pharmaceutical industry

Three patients with Stargardt disease were dosed in the Phase 1/2 clinical trial to date.

Key Points: 
  • Three patients with Stargardt disease were dosed in the Phase 1/2 clinical trial to date.
  • An additional three patients will be dosed with the medium dose (Cohort 2) and three patients with the high dose (Cohort 3) of OCU410ST in the dose-escalation phase.
  • “The DSMB has recommended moving forward to medium dose for dosing subjects with Stargardt disease,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410ST clinical trial.
  • Phase 1 is a multicenter, open-label, dose ranging study consisting of three dose levels [low dose (3.75×1010 vg/mL), medium dose (7.5×1010 vg/mL), and high dose (2.25×1011 vg/mL)].

Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Operating and Financial Results

Retrieved on: 
Thursday, March 28, 2024
Research, JDRF, Kidney disease, Massachusetts General Hospital, Risk, Immunosuppression, Patient, Kidney transplantation, OLE, University, Tacrolimus, Glomerular filtration rate, Net, Investment, Society, Hospital, EGFR, Kidney, Safety, Pharmacokinetics, FACS, Annual general meeting, Pharmaceutical industry

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2023 operating and financial results and reviewed recent business highlights.

Key Points: 
  • In addition to our clinical development progress, tegoprubart was used for immunosuppression in historical kidney and heart pig-to-human xenotransplant procedures.
  • The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man with end-stage kidney disease.
  • Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting held in Philadelphia, PA in November 2023.
  • General and administrative expenses were $12.7 million for the year ended December 31, 2023, compared to $12.7 million for the year ended December 31, 2022.

AffyImmune Therapeutics Announces Clinical and Regulatory Advisory Board to Support Development of AIC100 in Solid Tumors

Retrieved on: 
Monday, April 8, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Other Health, Clinical research, Harvard Medical School, Melanoma Research, Translational research, Surgery, Clinical, Associate, George Washington University, Patient, Regulatory affairs, University, Cancer, Doctor of Philosophy, Melanoma, Brown University, Translation, Treatment, Therapy, Drug development, Safety, FACS, University of Southern California, Biomedical Research, Pathology, Research fellow, School, Pharmaceutical industry

The CRAB will provide strategic counsel and expertise as AffyImmune advances its affinity-tuned CAR T therapeutics in clinical development.

Key Points: 
  • The CRAB will provide strategic counsel and expertise as AffyImmune advances its affinity-tuned CAR T therapeutics in clinical development.
  • “This group of distinguished scientists and advisors bring to AffyImmune invaluable CAR T drug development experience from research to commercialization,” said Sonal Gupta, MD, PhD, AffyImmune SVP and Head of Clinical Development.
  • ‘’I am honored to join Affylmmune’s Clinical and Regulatory Advisory Board and look forward to working with the other members to advance the development of novel treatments,” said Carmelo Nucera, MD, PhD.
  • Jorge J. Nieva, MD , Associate Professor of Clinical Medicine, Keck School of Medicine, University of Southern California and Section Head, Solid Tumors, USC/Norris Cancer Center.

Spirair Receives FDA Clearance for SeptAlign, the First and Only Minimally Invasive Therapy for Mechanical Correction of Nasal Septal Deviation

Retrieved on: 
Monday, April 8, 2024
General Health, FDA, Surgery, Medical Devices, Health, NSD, Patient, NSR, St Luke's, NAO, ASC, Cartilage, Nose, FACS, Septum, University Health Network, Otorhinolaryngology, Physician, Luke the Evangelist, Food, IRB

This comes on the heels of FDA clearance of the SeptAlign bioabsorbable Implant in August 2023 and represents the final step in completing the FDA clearance process for the SeptAlign System.

Key Points: 
  • This comes on the heels of FDA clearance of the SeptAlign bioabsorbable Implant in August 2023 and represents the final step in completing the FDA clearance process for the SeptAlign System.
  • "Septal deviation is one of the primary contributors to nasal airway obstruction.
  • Physicians can't move septal cartilage with medicines so mechanical correction through surgery has been the best choice for many patients.
  • Following the clearance of the SeptAlign system, Spirair plans to begin a Series B fundraising round and start commercialization.