American Society of Breast Surgeons

IceCure Medical Reports First Quarter 2023 Financial & Operational Results

Retrieved on: 
Montag, Mai 22, 2023

Builds Momentum as ProSense is Featured at Medical Conferences and Educational Courses

Key Points: 
  • Builds Momentum as ProSense is Featured at Medical Conferences and Educational Courses
    CAESAREA, Israel, May 22, 2023 /PRNewswire/-- IceCure Medical Ltd. (the "Company" or "IceCure") (Nasdaq: ICCM) (TASE: ICCM) developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today reported financial results as of and for the three months ended March 31, 2023 as well as operational and recent corporate developments.
  • We believe this momentum in the market is bolstered by a broader trend toward minimally invasive procedures," stated IceCure CEO Eyal Shamir.
  • Company's Ordinary Shares to Trade Exclusively on Nasdaq: IceCure announced its voluntary delisting from the Tel Aviv Stock Exchange ("TASE").
  • In the first quarter of 2023, sales increased in the U.S. and Europe relative to the same quarter last year.

Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for LUMISIGHT™ Optical Imaging Agent for Breast Cancer

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Montag, Mai 22, 2023

Lumicell, Inc ., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for the LUMISIGHT™ Optical Imaging Agent and accepted the Premarket Approval (PMA) application for the Lumicell™ Direct Visualization System (DVS).

Key Points: 
  • Lumicell, Inc ., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for the LUMISIGHT™ Optical Imaging Agent and accepted the Premarket Approval (PMA) application for the Lumicell™ Direct Visualization System (DVS).
  • The Lumicell DVS and LUMISIGHT are limited by Federal (or United States) law to investigational use only.
  • The Lumicell DVS is intended for use with the investigational optical imaging agent LUMISIGHT (pegulicianine) for fluorescence imaging of the lumpectomy cavity.
  • “Priority Review designation is further recognition of the potential of our system to significantly improve the effectiveness of breast cancer treatment.

Cryoablation Takes Center Stage at American Society of Breast Surgeons' 24th Annual Meeting

Retrieved on: 
Montag, Mai 1, 2023

A plan for a proposed ASBrS Cryoablation trial was presented at the very well-attended CME course titled "Cryotherapy: An Introductory Course for the Ultrasound-Experienced Surgeon" taught by cryoablation thought leaders who demonstrated using ProSense during the hands-on course.

Key Points: 
  • A plan for a proposed ASBrS Cryoablation trial was presented at the very well-attended CME course titled "Cryotherapy: An Introductory Course for the Ultrasound-Experienced Surgeon" taught by cryoablation thought leaders who demonstrated using ProSense during the hands-on course.
  • The cryotherapy trial plan presented during the course indicated inclusion criteria of women between the ages of 55 to 85.
  • IceCure welcomed a large number of breast surgeons at its exhibition booth where doctors gained knowledge and hands-on experience with ProSense.
  • "Our cryoablation system received the highest level of interest we've seen to date from the medical community.

NeoDynamics, Inc. Announces U.S. Availability of NEONAVIA, the First and Only Pulse Biopsy Technology, FDA-Cleared in Breast and Axillary Lymph Node Biopsies

Retrieved on: 
Donnerstag, April 27, 2023

MATAWAN, N.J., April 27, 2023 /PRNewswire/ -- NeoDynamics, Inc., a MedTech company pioneering innovative technologies to advance the diagnosis and care of breast cancer today announced the U.S. availability of NEONAVIA, the first and only biopsy system built on a patented pulse technology for controlled and precise needle insertion.

Key Points: 
  • - Commercial launch and introduction of NEONAVIA scheduled at 2 upcoming Conferences for Breast Surgeons and Breast Imaging Professionals.
  • - NEONAVIA PULSE Study abstract has been accepted for electronic presentation at the 2023 SBI Breast Imaging Symposium.
  • "We look forward to meeting with the thought leaders and multi-stakeholders at these important venues advancing breast care through early detection, diagnosis, and treatment.
  • NEONAVIA's PULSE study, has been accepted for electronic presentation at the 2023 SBI Breast Imaging Symposium.

IceCure Medical to Provide Educational Support in a First-of-its-Kind Cryotherapy Course at the American Society of Breast Surgeons' 24th Annual Meeting

Retrieved on: 
Montag, April 24, 2023

This marks the ASBrS's first cryoablation CME course offered at its annual meetings, and ProSense will be the cryoablation system to be used in this year's course for hands-on training.

Key Points: 
  • This marks the ASBrS's first cryoablation CME course offered at its annual meetings, and ProSense will be the cryoablation system to be used in this year's course for hands-on training.
  • The course, titled "Cryotherapy: An Introductory Course for the Ultrasound-Experienced Surgeon" is scheduled for Thursday, April 27 from 7:30 am – 11:30 am ET.
  • Recovery time is minimal and cosmetic outcomes are excellent with little loss of breast tissue and no scarring."
  • IceCure will be exhibiting and demonstrating ProSense at booth #816 and encourages physicians and other interested parties to visit the booth and/or contact [email protected] to schedule a meeting.

Koning Corporation to Attend Upcoming Society of Breast Imaging Symposium

Retrieved on: 
Donnerstag, April 20, 2023

WASHINGTON, April 20, 2023 /PRNewswire/ -- Koning Corporation, the leading developer and manufacturer of the innovative Koning Vera Breast CT, is proud to announce its participation in the upcoming Society of Breast Imaging Symposium to be held May 4-7 in Washington, DC.

Key Points: 
  • WASHINGTON, April 20, 2023 /PRNewswire/ -- Koning Corporation, the leading developer and manufacturer of the innovative Koning Vera Breast CT, is proud to announce its participation in the upcoming Society of Breast Imaging Symposium to be held May 4-7 in Washington, DC.
  • Koning, the leading manufacturer of Koning Vera Breast CT, to participate in 2023 Society of Breast Imaging Symposium
    As a company dedicated to improving patient outcomes through innovative breast CT technology, Koning Corporation is excited to showcase its latest device at the conference.
  • "We are honored to participate in the Society of Breast Imaging Symposium and to share our Koning Vera Breast CT with prominent breast imaging professionals from around the world," says David Georges, President of Koning US.
  • The Society of Breast Imaging Symposium is one of the biggest annual events for healthcare professionals in the breast imaging industry.

Namida Lab Drives Expansion by Appointing Advisory Board and Announcing Organizational Changes

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Dienstag, Februar 28, 2023

Namida Lab , the world leader in tear-based cancer screening, announces the appointment of an advisory board composed of leaders from breast oncology and radiology, healthcare strategy, and consumer marketing fields.

Key Points: 
  • Namida Lab , the world leader in tear-based cancer screening, announces the appointment of an advisory board composed of leaders from breast oncology and radiology, healthcare strategy, and consumer marketing fields.
  • Clinical Advisory Board Member Dr. V. Suzanne Klimberg, MD, PhD, has over 30 years of experience in breast surgical oncology.
  • Additionally, Dr. Klimberg has won over 75 awards in teaching, research, and clinical care and is a Senior Director for the American Board of Surgery, the American Board of Plastic Surgery, and the American Board of Complex Surgical Oncology.
  • Advisory Board Member Marcus Osborne is the CEO of RightMove, a nationwide virtual musculoskeletal physical therapy provider.

TransMed7, LLC Announces First Clinical Cases of Concorde Soft Tissue Biopsy Devices for Commercial Launch

Retrieved on: 
Montag, Februar 6, 2023

These cases demonstrated Concorde’s combined forward and side coring action, which is unique to the Concorde family of advanced breast biopsy devices, and is designed to add a vital layer of precision, control, efficiency and confidence for biopsy procedure under advanced imaging modalities.

Key Points: 
  • These cases demonstrated Concorde’s combined forward and side coring action, which is unique to the Concorde family of advanced breast biopsy devices, and is designed to add a vital layer of precision, control, efficiency and confidence for biopsy procedure under advanced imaging modalities.
  • View the full release here: https://www.businesswire.com/news/home/20230206005223/en/
    Concorde US biopsy device shown with detachable VacuPac® for completely tetherless operation (Photo: Business Wire)
    Dr. Berry commented, “I was delighted to perform the first clinical cases using TransMed7’s new Concorde US ultrasound-guided soft tissue breast biopsy devices.
  • I finished these biopsy procedures in an average of less than 5 minutes, which represents significant cost savings as well.
  • The Concorde ST device is designed for stereotactic and 2D/3D tomosynthesis guidance breast biopsy procedures with full, built-in (console-replacing) capabilities.

IceCure's ProSense Presented in Hands-On Training Course at The American Society of Breast Surgeons Breast Follows Ultrasound Course

Retrieved on: 
Mittwoch, Januar 25, 2023

CAESAREA, Israel, Jan. 25, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing, today announced that on January 13-14, 2023, the Company participated in the American Society of Breast Surgeons ("ASBrS") Breast Fellows Ultrasound Course in Cincinnati, Ohio. The diagnostic and interventional breast ultrasound course was organized by ASBrS.

Key Points: 
  • (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing, today announced that on January 13-14, 2023, the Company participated in the American Society of Breast Surgeons ("ASBrS") Breast Fellows Ultrasound Course in Cincinnati, Ohio.
  • The diagnostic and interventional breast ultrasound course was organized by ASBrS.
  • Dr. Fine led a session of the course on cryoablation of breast tumors with ProSense and conducted a hands-on workshop and demonstration.
  • "ProSense was very well received by course participants who got hands-on training with our cryoablation system," stated Eyal Shamir, IceCure's Chief Executive Officer.

Medicare cuts harming seniors' access to surgical care set to take effect in less than two months

Retrieved on: 
Dienstag, November 1, 2022

WASHINGTON, Nov. 1, 2022 /PRNewswire/ -- The 2023 Medicare Physician Fee Schedule final rule released today by the Centers for Medicare & Medicaid Services (CMS) confirms the nearly 4.5 percent cut to surgeons and anesthesiologists, harming patient access to needed surgical care, the Surgical Care Coalition said today. 

Key Points: 
  • "Without Congressional action, vulnerable seniors' nationwide access to timely, high quality, and essential surgical care will be negatively impacted.
  • Combined with a 4% Medicare cut stemming from the Statutory Pay-As-You-Go Act, surgical care will face a nearly 8.5% Medicare cut on January 1, 2023.
  • Meanwhile, significant medical inflation, along with staffing and supply chain shortages, continues to harm surgical care teams across the country.
  • The Surgical Care Coalition advocates for access to quality surgical care for all Americans.