LN2

IceCure Medical Reports Final ICE3 Breast Cancer Cryoablation Trial Results of 100% Patient and Physician Satisfaction and 96.3% Recurrence Free Rate: Data Submitted to FDA Requesting Marketing Authorization to Treat Early-Stage Breast Cancer

Retrieved on: 
Monday, April 15, 2024
Luminal, Cryoablation, FDA, CMS, Kidney, Meta-analysis, LUMINA, Risk, Woman, Food, Economics, Freezing, Marketing, Recurrence, Breast, PRISMA, Patient, Liver, LN2, CPT, Society, Classification, Physician, Medicare, Neoplasm, Patient satisfaction, Clinical trial, Annual general meeting, ICE3, Breast cancer, Birth control

The ICE3 study was the largest controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors.

Key Points: 
  • The ICE3 study was the largest controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors.
  • ICE3 results are also in line with data from real-world use of ProSense® by third parties in territories where IceCure's cryoablation system is used to treat early-stage breast cancer.
  • Driven by favorable healthcare economics combined with patient satisfaction and demand, we expect rapid adoption pending FDA granting the DeNovo Classification Request for Marketing Approval."
  • Dr. Fine gave an oral presentation titled "Cryoablation Without Excision for Early-Stage Breast Cancer; ICE3 Trial 5 year follow up on Ipsilateral Breast Tumor 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.

IceCure Medical Reports Positive Topline Results From ICE3 Cryoablation Breast Cancer Study: Achievement of 96.39% Recurrence Free Rate Brings Company One Step Closer to Providing Women a Non-Surgical Alternative to Lumpectomy

Retrieved on: 
Tuesday, March 19, 2024
Classification, Patient, Neoplasm, LN2, Freezing, Marketing, Woman, Safety, ICE3, FDA, Food

In the ICE3 study, 96.39% of patients (187 out of 194 patients) were local recurrence-free with no significant device-related adverse events or complications reported.

Key Points: 
  • In the ICE3 study, 96.39% of patients (187 out of 194 patients) were local recurrence-free with no significant device-related adverse events or complications reported.
  • Based on the strength of the topline results, ProSense has the potential to be a safe and effective alternative to lumpectomy for early-stage breast cancer.
  • "We are very pleased with this topline outcome and believe these results demonstrate a highly favorable safety and efficacy profile that positions ProSense® as a desirable alternative to lumpectomy for early-stage breast cancer.
  • "On behalf of the entire IceCure team, I thank the patients, their families, the sites and the clinicians for taking part in this landmark study.

U.S. FDA Grants IceCure Medical's Appeal: Reopens De Novo Classification Request for Marketing Authorization of ProSense® for Early-Stage Breast Cancer

Retrieved on: 
Tuesday, January 30, 2024
Classification, Woman, Neoplasm, Patient, LUMINA, Breast cancer, Freezing, Luminal, Risk, Recurrence, De novo, Food, CFR, FDA, ICE3, Data, LN2, Pharmaceutical industry

CAESAREA, Israel, Jan. 30, 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 announced the U.S. Food and Drug Administration ("FDA") has responded affirmatively to the Company's request for supervisory review ("Appeal") under 21 CFR 10.75 regarding the FDA's prior denial of IceCure's De Novo Classification Request for treating patients with early-stage, low risk breast cancer.

Key Points: 
  • The FDA determined there is sufficient basis to reopen the De Novo file and requested IceCure to submit the full 5-year dataset from the Company's ICE3 trial.
  • The final ICE3 study patient is expected to complete her 5-year follow up examination by the end of February 2024.
  • Additionally, the FDA requested that IceCure submit an analysis of the ICE3 results compared with data from the LUMINA study.
  • A full peer-reviewed article on LUMINA results was published in August 2023, while FDA review of IceCure's De Novo request was underway.

World Courier to Expand Storage Capacity and Cold Chain Capabilities With Three New Transport Stations in the United States

Retrieved on: 
Tuesday, December 19, 2023
Pharmaceutical, Medical Supplies, Health, Consulting, Health Technology, Professional Services, Logistics, Supply Chain Management, Transport, LN2, Region, Temperature, Humidity, AmerisourceBergen, Investment, Patient

The transport stations — which will be located in Denver, Indianapolis and San Diego — will expand World Courier’s capacity to store, handle and transport complex specialty pharmaceutical products, including those that require cryogenic storage.

Key Points: 
  • The transport stations — which will be located in Denver, Indianapolis and San Diego — will expand World Courier’s capacity to store, handle and transport complex specialty pharmaceutical products, including those that require cryogenic storage.
  • The facility in Indianapolis will be equipped with liquid nitrogen (LN2) tanks and charging capabilities, bolstering World Courier’s global network of charging centers and stations .
  • The new facilities in the United States and phased rollout of Container Freight Stations are the latest in an ongoing series of investments World Courier has undertaken to enhance and expand its capabilities globally.
  • In addition to the facility investments in the United States, World Courier will expand its presence in Denmark and Germany and increase its cold chain and cryogenic storage capabilities globally.

IceCure Medical to Join Hands-On Cryoablation Session with ProSense and Host Symposium Led by Renowned Doctors at the CIRCE 2023 Annual Congress

Retrieved on: 
Friday, September 8, 2023
ENT, Endometriosis, CE, Abstract, IR, Plantar fibromatosis, Travel, Ablation, Cryoablation, Q&A, Neoplasm, Woman, Breast, CIRSE, Doctor of Philosophy, Lung, Congress, CHU, Traction, Freezing, Circulatory system, Cardiovascular and Interventional Radiological Society of Europe, Kidney, Liver, Malignancy, LN2, Medical imaging, Management, MD

IceCure will exhibit ProSense and provide hands-on demonstrations at booth #D56.

Key Points: 
  • IceCure will exhibit ProSense and provide hands-on demonstrations at booth #D56.
  • IceCure will be participating in the Tumor Ablation Hands-On Device Training with the ProSense cryoablation system.
  • This is a great opportunity for attendees to gain hands-on knowledge of IceCure's cryoablation device and to see the system's advantages.
  • Thanks to this grant, ten aspiring women interventional radiologists' abstracts were accepted and will receive sponsored congress registration, travel, and accommodation.

BioLife Solutions Launches the IntelliRate™ i67C Liquid Nitrogen (LN2) Controlled-Rate Freezer

Retrieved on: 
Tuesday, June 6, 2023
CRF, Availability, CGT, Gene, CFR, Cane, Freezing, Cell, Title 21 CFR Part 11, BLFS, Takeda Pharmaceutical Company, LN2, Fine chemical

BOTHELL, Wash., June 6, 2023 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of class-defining bioproduction products and services for the cell and gene therapy (CGT) and broader biopharma markets, today announced the launch of a new, large-capacity controlled-rate freezer (CRF) to expand its CRF product line, which now stands at three different form factors. Branded as the IntelliRate i67C, this tabletop freezer fulfills a crucial customer need for higher volume production of cell therapies.

Key Points: 
  • Branded as the IntelliRate i67C, this tabletop freezer fulfills a crucial customer need for higher volume production of cell therapies.
  • We designed the IntelliRate i67C to increase single-batch, LN2 CRF capacity from mid- and late-stage clinical research to initial commercial manufacturing volumes.
  • Berard continued, "BioLife already has the largest selection of controlled-rate freezer sizes and features.
  • To learn more about the IntelliRate i67C and BioLife's complete line of freezers, please visit us here or contact our sales or customer care team at [email protected] .

Alcami Builds cGMP Biostorage Facility in North Carolina

Retrieved on: 
Thursday, December 1, 2022
CGMP, Multimedia, Tissue, Temperature, Masis, Armenia, Environmental monitoring, ICH, LN2, Laboratory, Microbiology, CDMO, Vaccine, RTP, Warehouse, Fine chemical

RALEIGH, N.C., Dec. 1, 2022 /PRNewswire/ -- Alcami, a leading contract development and manufacturing organization (CDMO), today announced that the build-out is underway of a new 65,000-square-foot cGMP biostorage facility.

Key Points: 
  • RALEIGH, N.C., Dec. 1, 2022 /PRNewswire/ --Alcami, a leading contract development and manufacturing organization (CDMO), today announced that the build-out is underway of a new 65,000-square-foot cGMP biostorage facility.
  • Located near the RTP corridor in North Carolina, this new facility will leverage Alcami's Masy division's industry-leading biostorage systems and processes and feature high levels of redundancy to ensure the protection of customer-owned materials.
  • The new North Carolina warehouse will provide a reliable, secure biostorage facility to support various cGMP storage needs in the RTP region.
  • Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle.

IceCure Files De Novo Classification Request with the FDA for Marketing Authorization of ProSense® with Breakthrough Indication: Early-Stage Low-Risk Breast Cancer Patients at High Risk to Surgery

Retrieved on: 
Wednesday, October 19, 2022
Freezing, The Queen's Award for Enterprise: Innovation (Technology) (2003), ICE3, Risk, SEC, Technology, Population, Luminous Engine, Woman, MCIT, Annual report, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NASDAQ, Neoplasm, Patient, CE marking, Patient satisfaction, CMS, Hospital, CPT, Science and technology in Asia, Luminal, TASE, Data, Nasdaq, Kidney, Private Securities Litigation Reform Act, De novo, Food, Company, U.S. Securities and Exchange Commission, LN2, Breast cancer, Disease, Securities & Exchange Commission of Pakistan, Breast, Genta (company), Cryoablation, Clinical trial, FDA, Columbia University Irving Medical Center, Health insurance, Pharmaceutical industry, Medical imaging, Dietary supplement

To date, there have been six cases of ipsilateral breast tumor recurrence ("IBTR") out of 194 patients, or 3.09%.

Key Points: 
  • To date, there have been six cases of ipsilateral breast tumor recurrence ("IBTR") out of 194 patients, or 3.09%.
  • The total group of Luminal A breast cancer for women in all ages, is estimated at 144,000 cases annually in the U.S.
  • Approximately 66% of the ICE3 patients were determined to be at high risk to surgery due to factors including age and co-morbidities.
  • Data suggests the use of ProSense cryoablation in breast procedures eliminates the risk of re-excision (a second surgery).

CSafe and BioLife Solutions, Inc. announce partnership to expand supply chain solutions for the cell and gene therapy market

Retrieved on: 
Tuesday, October 11, 2022
Solution, Partnership, NASDAQ, Baxter International, Patient, CGMP, Master minimum equipment list, LN2, COVID-19, BLFS, CGT, History, Pharmaceutical industry

MONROE, Ohio and BOTHELL, Wash., Oct. 11, 2022 /PRNewswire/ -- CSafe, one of the largest active and passive temperature-controlled shipping solutions providers for pharmaceuticals, and BioLife Solutions, Inc. (NASDAQ: BLFS), a leading supplier of class-defining bioproduction tools and services for the cell and gene therapy ("CGT") and broader biopharma markets, announced today a new partnership to provide a combined global service network to support CGT products, with a focus on enhanced reliability, security and quality.

Key Points: 
  • CSafe joins BioLife's global partner network of cold chain solution providers serving the CGT market.
  • BioLife expects to support 10,000-12,000 evo shipments of CGT starting materials and manufactured doses over the next 12 months.
  • The new partnership will provide expanded supply chain options for any CGT product, at any stage of development, from early clinical-phase trials to global commercial scale.
  • "CSafe is honored to partner with the team at BioLife Solutions, whose range of CGT bioproduction tools and services is peerless in the market.