American Thyroid Association

Pulse Biosciences Reports Business Updates and Third Quarter 2023 Financial Results

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Monday, November 13, 2023
Health, Medical Devices, Surgery, Health Technology, General Health, Cardiology, Biotechnology, American Thyroid Association, Research, Annual general meeting, Bank statement, Completeness, FDA, Marketing, Initial, Atrial fibrillation, GAAP, Total, Table, Dermatology, Broadcasting, Medical device, Cryptocurrency

Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, today announced financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, today announced financial results for the third quarter ended September 30, 2023.
  • Initial group was treated percutaneously with initial parameters in June 2023 with evaluations at 30, 90, 180, and 360 days post treatment.
  • An additional group was started on November 7, 2023 with the goal of optimizing treatment parameters.
  • Cash used in the third quarter of 2023 was $8.7 million compared to $10.6 million in the same period in the prior year and $10.0 million used in the second quarter of 2023.

Baird Medical Attains FDA Clearance to Market Its Microwave Ablation System in the United States

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Tuesday, November 21, 2023
Woman, Food, Scar, Incidence, Needle, Patient, FDA, American Thyroid Association, MWA, Thyroid disease, Thyroid nodule, Neoplasm, Procedure, Physician, Breast, Medical imaging

FRISCO, Texas, Nov. 21, 2023 /PRNewswire/ -- Baird Medical Devices, Inc. ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, today announced that its subsidiary, Betters (Suzhou) Medical Co., Ltd, has received clearance from the U.S. Food and Drug Administration (the "FDA") under Section 510 (K) to begin marketing its portfolio of Microwave Ablation Systems and Disposable Microwave Ablation Needles as regulatory Class II devices in the United States.

Key Points: 
  • FRISCO, Texas, Nov. 21, 2023 /PRNewswire/ -- Baird Medical Devices, Inc. ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, today announced that its subsidiary, Betters (Suzhou) Medical Co., Ltd, has received clearance from the U.S. Food and Drug Administration (the "FDA") under Section 510 (K) to begin marketing its portfolio of Microwave Ablation Systems and Disposable Microwave Ablation Needles as regulatory Class II devices in the United States.
  • Ms. Haimei Wu, Founder and CEO of Baird Medical, commented, "Attaining FDA clearance represents a significant milestone in our geographical expansion.
  • This clearance grants us the ability to market our portfolio of MWA systems and disposable needles in the United States.
  • Based on our market research, we estimate that the U.S. presents a market opportunity of $1.6 billion for MWA systems alone.

Ascendis Presents TransCon™ PTH Data at the American Thyroid Association Annual Meeting

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Monday, October 2, 2023
American Thyroid Association, ATA, Urine, Week, Pathway, Clinical trial, Drug, Hypoparathyroidism, Calcium, PTH, Patient, Southern Transcon, Blood, European, HPES, Vitamin D, Poster, Health, Disease, Safety, CHMP, Pharmaceutical industry, Medical device

COPENHAGEN, Denmark, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) presented a poster with results of a sub-analysis of its Phase 3 PaTHway clinical trial data during the recent American Thyroid Association (ATA) annual meeting, showing that 81% of adults with chronic post-surgical hypoparathyroidism (n = 70) treated with TransCon PTH (palopegteriparatide) achieved independence from conventional calcium and active vitamin D therapy while maintaining normal serum calcium levels during the 26-week blinded portion of the trial, compared to 6% taking placebo. The results were comparable to those from the overall PaTHway Trial population (N = 82), which demonstrated consistency in improved outcomes with TransCon PTH treatment compared to conventional therapy across disease etiologies.

Key Points: 
  • TransCon PTH is an investigational prodrug with sustained release of active parathyroid hormone (PTH [1-34]) administered once daily.
  • TransCon PTH (palopegteriparatide) has received a positive CHMP opinion recommending approval in the European Union and is in development in the United States, and Japan for the treatment of adults with hypoparathyroidism.
  • A total of 84 patients were randomized 3:1 to treatment with TransCon PTH (n = 63) or placebo (n = 21), both co-administered with conventional therapy.
  • Of those, the 70 with post-surgical hypoparathyroidism (52 TransCon PTH, 18 placebo) were included in the sub-analysis population.

Lassen Therapeutics Presents Preclinical Data on LASN01, an Anti-IL-11 Receptor Antibody in Development for Treatment of Thyroid Eye Disease at the American Thyroid Association 2023 Annual Meeting

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Monday, October 2, 2023
Biotechnology, Other Health, Health, General Health, Pharmaceutical, Optical, Oncology, Other Science, Research, Science, Clinical Trials, American Thyroid Association, Therapy, ATA, Cancer, Cell proliferation, Hyaluronic acid, MBA, Doctor of Philosophy, Graves' ophthalmopathy, OF, Teprotumumab, Patient, Annual general meeting, IPF, Idiopathic pulmonary fibrosis, TED, Vaccine, Lassen

Lassen Therapeutics , a clinical stage biotechnology company developing first-in-class antibody therapeutics targeting interleukin-11 receptor (IL-11R; LASN01) as a potential treatment for fibro-inflammatory diseases including thyroid eye disease (TED) and idiopathic pulmonary fibrosis (IPF), and interleukin-18 binding protein (IL-18BP; LASN500), as a potential treatment for cancer, presented new preclinical data on LASN01, for treatment of TED, at the American Thyroid Association (ATA) Annual Meeting held in Washington DC, September 27 through October 1, 2023.

Key Points: 
  • Lassen Therapeutics , a clinical stage biotechnology company developing first-in-class antibody therapeutics targeting interleukin-11 receptor (IL-11R; LASN01) as a potential treatment for fibro-inflammatory diseases including thyroid eye disease (TED) and idiopathic pulmonary fibrosis (IPF), and interleukin-18 binding protein (IL-18BP; LASN500), as a potential treatment for cancer, presented new preclinical data on LASN01, for treatment of TED, at the American Thyroid Association (ATA) Annual Meeting held in Washington DC, September 27 through October 1, 2023.
  • “We continue our work in demonstrating the potential benefit of LASN01 in orbital fibroblasts, the relevant cell type for thyroid eye disease,” said Maria Fardis, PhD, MBA, CEO at Lassen.
  • “In preclinical studies, LASN01 led to the suppression of cell proliferation and hyaluronan secretion from primary TED orbital fibroblasts, in addition to demonstrating anti-fibrotic activity.
  • The effects of LASN01 on HA release and OF proliferation were comparable to the approved anti-IGF-1R antibody, teprotumumab, indicating that LASN01 should be further investigated as a potential new therapeutic agent for the treatment of TED.

Sernova Presents Compelling New Data on the Cell Pouch System™ as a Promising Treatment for Post-Operative Hypothyroidism at the 2023 American Thyroid Association Annual Meeting

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Friday, September 29, 2023
Thyroid hormones, TSH, American Thyroid Association, Histology, Depression, FSE, ATA, FT4, Quality of life, PSH, Hypothyroidism, Weight gain, Thyroidectomy, Triiodothyronine, Patient, Cell, Annual general meeting, TSX, Poster, Memory, Fatigue, Thyroid, Medical imaging, Pharmaceutical industry

Thyroid stimulating hormone (TSH) levels had a significant peak immediately after thyroidectomy, with a gradual decline observed starting five weeks after the re-implantation of thyroid glands.

Key Points: 
  • Thyroid stimulating hormone (TSH) levels had a significant peak immediately after thyroidectomy, with a gradual decline observed starting five weeks after the re-implantation of thyroid glands.
  • Newly reported radio-isotope uptake imaging and histology assessments confirmed the presence of healthy and functional thyroid tissues within the Cell Pouch six months following re-implantation.
  • “With Sernova’s Cell Pouch System, we aim to improve quality of life with a treatment for post-operative hypothyroidism.
  • These new data replicate a human clinical scenario in which thyroid tissue is reimplanted into the patient, via the Cell Pouch, leading to the restoration of normal thyroid function.

New Analysis Highlights Importance of Adhering to Uninterrupted Full Course of Treatment with TEPEZZA® (teprotumumab-trbw) to Support Thyroid Eye Disease (TED) Patient Outcomes

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Friday, September 29, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Optical, Science, American Thyroid Association, ATA, Undisrupted, COVID-19, Medicine, QOL, Patient, CAS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, D.C, TED, Pharmaceutical industry

An analysis examined whether patients who experience a treatment disruption, defined as a >60-day gap between consecutive infusions, are more likely to need a second course of treatment.

Key Points: 
  • An analysis examined whether patients who experience a treatment disruption, defined as a >60-day gap between consecutive infusions, are more likely to need a second course of treatment.
  • Undisrupted patients (n=4,230) and disrupted patients (n=1,155) were observed for one year after the initial full course of treatment.
  • The analysis looked at baseline GO-QOL data for 171 moderate-to-severe TED patients prior to treatment in two clinical trials.
  • “The data presented this weekend help us further our mission of ensuring those in the Thyroid Eye Disease community receive appropriate care.”

New Data Presented at the 2023 ATA Annual Meeting Demonstrate that Veracyte’s Afirma-Based Testing Can Uncover Key Molecular Hallmarks of Thyroid Cancer

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Thursday, September 28, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Thyroid nodule, Database, American Thyroid Association, ATA, Classification, Cancer, BRAF, RNA, Washington University in St. Louis, FMT, Thyroid cancer, FNA, Aggression, Patient, ERK, GRID, Endocrinology, Immunohistochemistry, Diagnosis, NIS, UCLA, GSC, Malignancy, Thyroid, VI, Prostate cancer, Johns Hopkins School of Medicine, Medical imaging, Pharmaceutical industry, Medicine

(Nasdaq: VCYT) today announced that new data presented at the 2023 American Thyroid Association (ATA) Annual Meeting demonstrate the type of novel molecular insights for thyroid nodules and cancer that are enabled by analysis with the Afirma Genomic Sequencing Classifier (GSC).

Key Points: 
  • (Nasdaq: VCYT) today announced that new data presented at the 2023 American Thyroid Association (ATA) Annual Meeting demonstrate the type of novel molecular insights for thyroid nodules and cancer that are enabled by analysis with the Afirma Genomic Sequencing Classifier (GSC).
  • Presented by clinical researchers in three posters, the findings are based on Afirma whole-transcriptome RNA sequencing data and reveal novel molecular profiles to advance research of thyroid nodules and cancer.
  • Their study was based on a retrospective analysis of nearly 48,000 thyroid nodules analyzed with the Afirma GSC, confirming that the classifier identified the expected immunophenotype for a specific type of thyroid cancer molecular alteration.
  • “We are excited to soon make this new tool available to the thyroid cancer research community,” said Dr. Klopper.

Pulse Biosciences’ First Study in a Surgical Application of Nanosecond Pulsed Field Ablation (nsPFA) Technology to be Featured in Two Poster Presentations at the American Thyroid Association Annual Meeting

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Wednesday, September 27, 2023
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“I am proud to have been a part of the first human surgical procedure study on benign thyroid nodules conducted with the nsPFA technology.

Key Points: 
  • “I am proud to have been a part of the first human surgical procedure study on benign thyroid nodules conducted with the nsPFA technology.
  • Advantages of nsPFA technology includes cellular tissue selectivity, sharp ablation zone margins, absence of thermally induced necrosis, and short treatment times.
  • This feasibility study suggests nsPFA may be a safe and effective method for treating benign thyroid tumors or nodules.
  • This feasibility study suggests nsPFA may be a safe and effective method for treating benign thyroid tumors or nodules.

Veracyte Announces Novel Afirma-Based Findings that Advance Molecular Understanding of Thyroid Cancer to Be Presented at the 2023 ATA Annual Meeting

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Thursday, September 21, 2023
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Veracyte, Inc. (Nasdaq: VCYT) today announced that three posters showcasing new data from the company’s Afirma Genomic Sequencing Classifier (GSC) will be presented at the 2023 American Thyroid Association (ATA) Annual Meeting being held in Washington, DC from September 27 to October 1.

Key Points: 
  • Veracyte, Inc. (Nasdaq: VCYT) today announced that three posters showcasing new data from the company’s Afirma Genomic Sequencing Classifier (GSC) will be presented at the 2023 American Thyroid Association (ATA) Annual Meeting being held in Washington, DC from September 27 to October 1.
  • Together, these abstracts offer novel insights into the molecular underpinnings of thyroid nodules and tumors based on whole-transcriptome RNA sequencing data from thyroid nodules analyzed with the Afirma GSC.
  • “The abstracts to be presented by our clinical research colleagues at the ATA meeting show that the Afirma GSC platform can be used to glean new insights about thyroid nodules and thyroid cancer preoperatively.
  • We believe that Afirma-based whole-transcriptome analysis will help drive cancer research and unlock findings that may ultimately be used in clinical care.”
    These abstracts will later be published as an online supplement to Thyroid, the official journal of the ATA.

Viridian Therapeutics Announces Presentations at Multiple Medical Meetings in September

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Thursday, September 7, 2023
Health, General Health, Research, Science, Pharmaceutical, Optical, Biotechnology, Abstract, American Thyroid Association, ATA, Graves' ophthalmopathy, DC, ETA, Annual general meeting, European Society of Clinical Microbiology and Infectious Diseases, Pharmacology, Therapy, TED, Pharmaceutical industry, Vaccine, Patient

Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced that multiple abstracts featuring clinical and preclinical data on the Company’s pipeline candidates for the treatment of thyroid eye disease (TED) will be presented at the following medical meetings:

Key Points: 
  • Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced that multiple abstracts featuring clinical and preclinical data on the Company’s pipeline candidates for the treatment of thyroid eye disease (TED) will be presented at the following medical meetings:
    The 45th Annual Meeting of the European Thyroid Association (ETA) to be held September 9-12, 2023, in Milan, Italy
    The 41st Annual Meeting of the European Society of Ophthalmic Plastic and Reconstructive Surgery (ESOPRS) to be held September 14-16, 2023, in Naples, Italy
    The Annual Meeting of the American Thyroid Association (ATA) to be held September 27-October 1, 2023, in Washington, DC
    Presentations at all three conferences will highlight clinical and pharmacologic data from studies of VRDN-001, a full antagonist antibody to the insulin-like growth factor-1 receptor (IGF-1R), in development for TED.
  • An additional presentation will feature pharmacokinetic data for VRDN-003, a next-generation, half-life extended antibody to IGF-1R for TED.
  • The Company will also present clinical pharmacodynamic responses to VRDN-001 in healthy volunteers and patients with active TED.
  • VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor: In Vitro Pharmacology and Phase 1/2 Results in Patients with Thyroid Eye Disease
    Preclinical Pharmacokinetics and Clinical Exposure Prediction for VRDN-003, a Next-Generation Half-life Extended Antibody to IGF-1R for Thyroid Eye Disease
    In Vitro Pharmacology and Phase 1/2 Results of VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor for Thyroid Eye Disease