Recurrence

IceCure Medical Reports Full Year 2023 Financial Results: Global ProSense® and Disposables Sales Increase 26% as Company Continues Transition to Commercial Phase and Expects to Submit ICE3 Breast Cancer Study Data to FDA this Month for Marketing Clearance

Retrieved on: 
Wednesday, April 3, 2024
Momentum, Patient, History, Sale, IP, Endometriosis, Depreciation, USD, Marketing, Regulation, Research, Classification, Webcast, Freezing, Woman, Breast cancer, ICE3, Food, Case Western Reserve University, Neoplasm, Cancer, LN2, GAAP, FDA, Annual general meeting, Health, Conference call, Growth, The Twelve Months, Recurrence, Society, Patent, Physician, Kidney cancer

CAESAREA, Israel, April 3, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today reported sales as of and for the twelve months ended December 31, 2023 increased 26% compared to the twelve months ended December 31, 2022, as the Company continues to transition from a research and development and clinical phase company to a commercial phase company.

Key Points: 
  • Our U.S. commercial team is ready to launch marketing and distribution of ProSense® for breast cancer as we await the U.S. Food and Drug Administration's ("FDA") decision.
  • Should the FDA grant clearance, we believe this decision would further boost commercial demand in global markets where ProSense® already has approval for breast cancer."
  • "As we increased our commercial activities through medical conferences and added more distributors, we had a corresponding growth in 2023 revenues, system, and probe sales.
  • The FDA requested this data as part of IceCure's De Novo Classification Request for Marketing Authorization of ProSense® for the treatment of early-stage low-risk breast cancer.

UCLA and PreciseDx Announce New Collaboration to Advance AI-Enabled Predictions and Risk Mitigation for Triple-Negative Breast Cancer Recurrence

Retrieved on: 
Tuesday, April 2, 2024
HER2, Brain, Algorithm, Entrepreneurship, Immunotherapy, Disease, Risk, UCLA Health, Patient, Triple-negative breast cancer, Neoplasm, Research, MD, Medicine, Hospital, Breast cancer, Risk assessment, Pathology, Prognosis, Medical laboratory, Recurrence, TNBC, UCLA, Artificial intelligence, Health, Medical imaging

NEW YORK, April 2, 2024 /PRNewswire/ -- PreciseDx®, a leading innovator in oncology diagnostics leveraging Artificial Intelligence (AI) for revolutionary, morphology-driven disease analysis, today announced a sponsored research collaboration with UCLA's Department of Pathology and Laboratory Medicine in Los Angeles to evaluate PreciseBreast's™ ability to accurately assess risk of recurrence for patients with triple-negative breast cancer (TNBC). TNBC constitutes only 10-20% of all breast cancer cases, yet continues to demand significant clinical interest due to its limited response to conventional treatments, the association with younger women, BRCA1/2 mutations, ethnic/racial disparities, and its highly aggressive characteristics. 

Key Points: 
  • Our collaboration with PreciseDx has the potential to greatly improve our approach to predicting and managing recurrence in TNBC patients, ultimately leading to enhanced outcomes."
  • Integrating advanced AI algorithms and comprehensive clinical data, the collaborative study aims to confirm PreciseBreast as a highly effective and reliable digital breast cancer assay.
  • This new assay will potentially enhance the early detection of TNBC recurrence and support personalized treatment strategies tailored to individual patient needs.
  • The collaborative study between UCLA and PreciseDx represents a significant step forward in digital pathology and oncology breast cancer research.

Lipocine Announces Positive Week 52 Results from LPCN 1148 Phase 2 Study in Patients with Cirrhosis

Retrieved on: 
Thursday, March 28, 2024
OHE, Week, Cirrhosis, Patient, Mitt, NDA, MOA, File, Stage 2, SMI, Recurrence, FDA

SALT LAKE CITY, March 28, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company today announced positive topline results from a Phase 2 clinical study of LPCN 1148.

Key Points: 
  • SALT LAKE CITY, March 28, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company today announced positive topline results from a Phase 2 clinical study of LPCN 1148.
  • LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism of action (MOA).
  • This Phase 2 proof of concept study was a randomized placebo-controlled study in sarcopenic male patients with cirrhosis on the liver transplant waitlist.
  • During Stage 2, 8 participants who were on placebo in Stage 1 converted to LPCN 1148, and 11 participants who started the study on LPCN 1148 continued treatment with LPCN 1148.

Cryoablation Highly Effective for Breast Cancer Patients with Large Tumors

Retrieved on: 
Saturday, March 23, 2024
Radiation, Breast cancer, Patient, Neoplasm, Research, Breast, Cancer, Society, Freezing, Woman, Cryoablation, Ice, Recurrence, Hypertension, Medical imaging

FAIRFAX, Va., March 23, 2024 /PRNewswire/ -- A minimally invasive technique that uses ice to freeze and destroy small, cancerous tumors has now been proven effective for breast cancer patients with large tumors, providing a new treatment path for those who are not candidates for surgery, according to new research to be presented at the Society of Interventional Radiology Annual Scientific Meeting in Salt Lake City.

Key Points: 
  • "For patients who have larger tumors but can't undergo surgery, this approach could be more effective than the current standard of care for patients who are not surgical candidates," said Yolanda Bryce, M.D., an interventional radiologist at Memorial Sloan Kettering Cancer Center.
  • Cryoablation is a minimally invasive treatment that uses imaging guidance such as ultrasound or a computed tomography (CT) scan to locate tumors.
  • If the tumors do grow, patients can be treated with cryoablation multiple times to control growth.
  • Patients with tumors larger than 1.4 cm were treated with multiple probes (one probe placement for each centimeter of disease).

PreciseDx Presents New Research on Their AI-Enabled Digital Test at 14th Annual European Breast Conference

Retrieved on: 
Friday, March 22, 2024
Conference, Allianz, Risk, Patient, Research, Doctor of Philosophy, MD, Breast cancer, Recurrence, Artificial intelligence

NEW YORK, March 22, 2024 /PRNewswire-PRWeb/ -- PreciseDx®, a leading innovator in oncology diagnostics leveraging Artificial Intelligence (AI) for revolutionary, morphology-driven disease analysis, today announced their attendance and participation at the 14th Annual European Breast Conference in Milan, Italy. PreciseDx Co-Founder and Chief Medical Officer, Michael J. Donovan, PhD, MD is presenting the findings from the PreciseBreast™ biopsy clinical validation study through a poster presentation.

Key Points: 
  • "This study marks a notable milestone in oncology prognosis, reflecting the continued advancement of breast cancer research and treatment.
  • "This study marks a notable milestone in oncology prognosis, reflecting the continued advancement of breast cancer research and treatment.
  • "We look forward to sharing the outcomes of our breast biopsy clinical validation study with a diverse group of international, multidisciplinary conference attendees at the European Breast Cancer Conference."
  • The full poster presentation details can be found here:
    Location: Allianz MiCo (Milan Convention Centre), Milan, Italy
    The European Breast Cancer Conference, the first conference of its kind, started in 1998.

Sycamore Services, Inc. Notification of Data Security Incident

Retrieved on: 
Tuesday, March 19, 2024
Name, Nature, Sycamore, Privacy, Recurrence, Identity theft, Letter, CST, Holiday, Acquisition, Fraud, Call centre, Confidentiality, Online shopping

DANVILLE, Ind., March 19, 2024 /PRNewswire/ -- On September 21, 2023, Sycamore Services, Inc. ("Sycamore") identified a cybersecurity issue.

Key Points: 
  • DANVILLE, Ind., March 19, 2024 /PRNewswire/ -- On September 21, 2023, Sycamore Services, Inc. ("Sycamore") identified a cybersecurity issue.
  • Upon becoming aware of this matter, Sycamore promptly initiated a comprehensive investigation and retained computer forensic specialists to determine the nature and scope of the incident.
  • While there was no evidence of any misuse of data, identity theft, or fraud caused by the incident, out of an abundance of caution, Sycamore worked diligently to identify all individuals who may have been impacted by the incident.
  • Sycamore mailed a notification letter offering identity theft protection and credit monitoring services at no cost to those individuals on March 1, 2024.

inHEART RECEIVES FDA CLEARANCE FOR ADVANCED AI-DRIVEN SOFTWARE MODULE THAT OPTIMIZES THE CREATION OF 3D MODELS OF THE HEART

Retrieved on: 
Tuesday, March 19, 2024
Automation, Patient, Hospital, 3D, AI, EAM, Heart, Recurrence, FDA, Physician, Medical device

CAMBRIDGE, Mass. and BORDEAUX, France, March 19, 2024 /PRNewswire/ -- inHEART, a privately-held medical device company delivering the world's most advanced, AI-driven digital twin of the heart, announced today that it has received FDA 510(k) clearance for its AI software module. The new AI module enables first-of-its-kind, fully automated segmentation of CT images in the creation of 3D cardiac models, allowing inHEART to deliver its solution to physicians with greater speed and efficiency. While this advancement has been commercially available to clinicians in the EU, with this clearance, inHEART will now deliver it to hospitals across the US.

Key Points: 
  • and BORDEAUX, France, March 19, 2024 /PRNewswire/ -- inHEART, a privately-held medical device company delivering the world's most advanced, AI-driven digital twin of the heart, announced today that it has received FDA 510(k) clearance for its AI software module.
  • The new AI module enables first-of-its-kind, fully automated segmentation of CT images in the creation of 3D cardiac models, allowing inHEART to deliver its solution to physicians with greater speed and efficiency.
  • inHEART receives FDA 510(k) clearance for AI software module to deliver its solution with greater speed and efficiency.
  • With the addition of this new module, inHEART is now able to deliver its solution to physicians with the efficiency of AI.

Breakthrough in Treatment of Cervical High-Grade Squamous Intraepithelial Lesion: Release of Positive Results from Multicenter Phase III Global Clinical Study

Retrieved on: 
Tuesday, March 19, 2024
Medicine, Cervical cancer, Patient, Cancer, HPV16, School, Congress, Gynaecology, Risk, Peking Union Medical College, Woman, LEEP, Safety, Gynecologic Oncology (journal), Pathology, Recurrence, Squamous intraepithelial lesion, Acceleration, Research, Șaeș, SGO, Death, National Cancer Center, Vaccination, Molina Healthcare, Annual general meeting, Health, Obstetrics, Hysterectomy, HSIL, Public health, Infection, Incidence, LSIL, HPV, Bleeding, Physician, Birth control

This study is a prospective, randomized, double-blinded, placebo-controlled multicenter Phase III global clinical study designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL.

Key Points: 
  • This study is a prospective, randomized, double-blinded, placebo-controlled multicenter Phase III global clinical study designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL.
  • Primary endpoint of the study is the proportion of responders at 6 months after the initial treatment.
  • The study is led by Dr. Jinghe Lang, an academician at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences.
  • Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said, "We are extremely proud of the results from the international multicenter Phase III clinical study of APL-1702.

Labcorp Presents New Research Demonstrating Clinical Impact of Precision Diagnostics in Guiding Biomarker-targeted Therapies for Patients with Epithelial Ovarian Cancer

Retrieved on: 
Saturday, March 16, 2024
Diagnosis, Ovarian cancer, MIRV, Mutation, Health, BRCA, Science, Disease, Partnership, Patient, Education, Glomus tumor, Roche, Biomarker, Neoplasm, Research, Cancer, EOC, Recombinant DNA, Woman, HRP, PARP, TTD, Fibroadenoma, HRD, Mirvetuximab soravtansine, BRCA2, Recurrence, LH, BRCA1, ADP, Pharmaceutical industry

BURLINGTON, N.C., March 16, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today presented the results from two studies at the 2024 SGO Annual Meeting on Women's Cancer. The studies demonstrate the value of biomarker testing in closing testing gaps and guiding targeted therapies for patients with epithelial ovarian cancer (EOC).

Key Points: 
  • The studies demonstrate the value of biomarker testing in closing testing gaps and guiding targeted therapies for patients with epithelial ovarian cancer (EOC).
  • Labcorp researchers conducted two studies to generate further evidence of the value of comprehensive genomic profiling to drive guideline-compliant testing that enables increased patient access to targeted therapies for improved outcomes.
  • When combined, the results of BRCA and HRD testing can determine which patients are most likely to benefit from treatment with poly-ADP ribose polymerase (PARP) inhibitors.
  • "This research emphasizes the power of comprehensive biomarker testing in advancing the treatment of ovarian cancer.

Canadian Solar Reports Fourth Quarter and Full Year 2023 Results

Retrieved on: 
Thursday, March 14, 2024
Solar, ASPS, Growth, CFO, Partnership, Topcon, FIT, Nominal power (photovoltaic), BlackRock, Depreciation, Senior, GWP, Investment, Kilowatt-hour, Safety, Recurrence, PPA, Engineering, Total, EPC, Professional, Renewable energy

GUELPH, ON, March 14, 2024 /PRNewswire/ -- Canadian Solar Inc. ("Canadian Solar" or the "Company") (NASDAQ: CSIQ) today announced financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • GUELPH, ON, March 14, 2024 /PRNewswire/ -- Canadian Solar Inc. ("Canadian Solar" or the "Company") (NASDAQ: CSIQ) today announced financial results for the fourth quarter and full year ended December 31, 2023.
  • Total operating expenses in the fourth quarter of 2023 were $213 million, compared to $225 million in the third quarter of 2023 and $213 million in the fourth quarter of 2022.
  • Depreciation and amortization charges in the fourth quarter of 2023 were $89 million, compared to $76 million in the third quarter of 2023 and $50 million in the fourth quarter of 2022.
  • Net interest expense in the fourth quarter of 2023 was $18 million, compared to $11 million in the third quarter of 2023 and $11 million in the fourth quarter of 2022.