FACS

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.

enGene Announces Hiring of Dr. Raj Pruthi as Senior Vice President, Urologic Oncology and Clinical Development

Retrieved on: 
Tuesday, April 9, 2024
NMIBC, BCG, American Urological Association, Master, Professor, Advisory Council, Patient, SVP, Thesis, University, Drug, Society, American College, LEGEND, Bladder cancer, Hofstra University, FACS, Stanford University, AUA, Prostate, Medicine, Pharmaceutical industry

In this role, Dr. Pruthi's responsibilities will include supporting the clinical development of EG-70 across the urologic space, including through engagement with the urological community.

Key Points: 
  • In this role, Dr. Pruthi's responsibilities will include supporting the clinical development of EG-70 across the urologic space, including through engagement with the urological community.
  • He joins enGene from Johnson & Johnson Innovative Medicine, where he was most recently the Global Medical Affairs Leader, Bladder Cancer and Senior Medical Director, Oncology (Global – Prostate and Bladder Cancer).
  • "We are thrilled to welcome Dr. Raj Pruthi to the enGene team.
  • In addition to his position at enGene, Dr. Pruthi maintains multiple prominent leadership roles within the urological community.

New Book Explores the Evolution of a Physician Leader

Retrieved on: 
Friday, April 5, 2024
Knowledge, Community, Altruism, FRCS, FACS, Physician, Collection, Management

WASHINGTON, April 5, 2024 /PRNewswire/ -- The American Association for Physician Leadership has published a new book by its president and CEO Peter Angood, MD, FRCS (C), FACS, MCCM, FAAPL(Hon), Inspiring Growth and Leadership in Medical Careers: Transform Healthcare as a Physician Leader.

Key Points: 
  • The book details a career journey for physicians who are moving toward becoming experienced leaders.
  • The sections of the book describe the phases of evolution into leadership: Beginnings, Knowledge of Healthcare Environment, Professionalism, Community and Relationship Management, Business Skills and Knowledge, Leadership, and Growth to Move Forward.
  • "Being a physician is an opportunity to emulate the traits of a leader in the community.
  • One does not need formal titled roles and a load of administrative responsibility to be recognized as a leader.

Humacyte Fourth Quarter and Year End 2023 Financial Results and Business Update

Retrieved on: 
Friday, March 22, 2024
Diagnosis, Research, U.S. FDA, Peripheral artery disease, Infection, Patent, Buddha's hand, Evaluation, PAD, Journal, Sale, University, Doctor of Philosophy, Efficacy, Priority review, Regenerative medicine, Clinical trial, Trial of the century, Vascular surgery, HAV, Hospital, Injury, Nationwide Children's Hospital, HUMA, FACS, Amputation, Food, FDA, Defense, BLA, PDUFA, Pharmaceutical industry

DURHAM, N.C., March 22, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2023 and highlighted recent corporate accomplishments in advancing the investigational Human Acellular Vessel (HAV) closer to planned U.S. market launch.

Key Points: 
  • There was no revenue for either the fourth quarter of 2023 or the fourth quarter of 2022, and there was no revenue for the year ended December 31, 2023.
  • Research and development expenses were $20.2 million for the fourth quarter of 2023, compared to $15.0 million for the fourth quarter of 2022, and were $76.6 million for the year ended December 31, 2023, compared to $63.3 million for the year ended December 31, 2022.
  • General and administrative expenses were $6.0 million for the fourth quarter of 2023, compared to $5.8 million for the fourth quarter of 2022, and were $23.5 million for the year ended December 31, 2023, compared to $22.9 million for the year ended December 31, 2022.
  • The 2023 increases in net loss resulted from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above.

Penn Highlands Healthcare Doctors Beyond the Borders

Retrieved on: 
Wednesday, March 20, 2024
MSUCOM, Famine, Forward surgical teams, Osteopathy, Hamas, The, Clinical professor, Patient, Trauma, Sports medicine, Medical director, Nursing, Research, Orthopedic surgery, Education, Samaritan's Purse, Woman, Water quality, General surgery, Emergency medicine, Injury, FACS, Altitude, EVP, Disease, Hospital, Poverty, Family, DOCARE, Universidad, Global Health, Firefighter, Physician, International health, Medicine

Penn Highlands Healthcare offers 849 physicians who provide a wide range of care and treatments at locations throughout 26 counties in Pennsylvania.

Key Points: 
  • Penn Highlands Healthcare offers 849 physicians who provide a wide range of care and treatments at locations throughout 26 counties in Pennsylvania.
  • Penn Highlands Healthcare physicians can be found in the health system’s eight hospitals as well as many community medical buildings, outpatient facilities, surgery centers and physician practices.
  • Some Penn Highlands Healthcare physicians do not allow county, state or continental borders to keep them from providing care where it is needed.
  • Dr. Sergent, who is an emergency medicine physician and the Central Region Medical Director of Emergency Medicine at Penn Highlands Healthcare, shares his skills and expertise beyond the U.S. borders in Central and South America.