TechandBio
1 week ago
Now have superior data on higher risk breast cancer patients!
Professor Vogl commented, "Liquid Nitrogen-based cryoablation was found to be a safe local treatment for breast cancer, with a low complication rate—in fact, none were observed in the study. We experienced a very high complete ablation rate of 100%.
Treating higher risk breast cancer patients makes ICCM platform more dynamic plus treating Lung, Kidney and Bone cancer patients with cryoblast. Giving options for patients who don't want surgery or radiation treatment with these incredible data points and 100% patient and Dr satisfaction using ICCM technology IceCure will be valued closer to PLSE market cap which is a Billion dollars.[
Independent, third-party data published in highly influential peer-reviewed journal, Cancers, concluded cryoablation with ProSense® is a safe, local treatment for breast cancer with low complication rate, high complete ablation rate and satisfactory overall survival (OS), progression free survival (PFS) and local tumor control.
$ICCM
Paullee
1 week ago
even more good news
European Study Provides More Evidence Supporting IceCure’s ProSense® is Safe & Effective Cryoablation Treatment for Metastatic and Recurrent Breast Cancer
? Independent, third-party data published in highly influential peer-reviewed journal, Cancers, concluded cryoablation with ProSense® is a safe, local treatment for breast cancer with low complication rate, high complete ablation rate and satisfactory overall survival (OS), progression free survival (PFS) and local tumor control
? 8.9% recurrence rate in population of 45 patients who had previously received various therapies before cryoablation including surgery, radiation therapy, or chemotherapy with tumor sizes of up to 4 centimeters in diameter. Of those patients, 11 had recurrent tumors and 21 had metastatic disease
? The higher-risk population in this European study contrasts with the early-stage breast cancer patient subjects in the U.S. ICE3 study
CAESAREA, Israel, July 9, 2024 – IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” or the “Company”), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the publication of an independent study evaluating its flagship cryoablation system ProSense® titled: “CT-Guided Percutaneous Cryoablation of Breast Cancer: A Single-Center Experience” in Cancers, a leading peer-reviewed oncology journal. The study, led by Principal Investigator Professor Thomas J. Vogl, was conducted at the Institute of Radiology and Nuclear Medicine, University Hospital Frankfurt, at Goethe University, Germany.
Professor Vogl commented, “Liquid Nitrogen-based cryoablation was found to be a safe local treatment for breast cancer, with a low complication rate—in fact, none were observed in the study. We experienced a very high complete ablation rate of 100%. Overall survival, progression free survival and local tumor control were all good, especially given the very heterogenous patient population. The fact that this is a minimally invasive procedure that can be performed on an outpatient basis with excellent cosmetic results are clear advantages. We look forward to further evaluations of cryoablation especially in comparison to other treatment modalities for early, recurrent, and metastatic breast cancer.”
“While this study’s patient population is very different from our U.S. based ICE3 study and the target indication for which we have filed for regulatory approval in the U.S., the results of the study are highly valuable for ProSense® users in Europe where our system is approved for general breast cancer treatment. This higher risk patient population included patients with metastatic disease and tumors of up to 4 centimeters in diameter, as compared to our ICE3 study population with early-stage disease and tumors smaller than 2 centimeters in diameter, indicating a very different recurrence rate. Importantly, it further informs and supports the use cases of ProSense® across a broader range of breast cancer diagnoses, from newly diagnosed early-stage to metastatic and recurrent disease,” stated IceCure CEO Eyal Shamir. “We thank Dr. Vogl, his team, and University Hospital Frankfurt for their initiative in conducting this study and expanding the body of knowledge for the cryoablation of breast cancer.”
This independent study, which received no financial support from IceCure, retrospectively evaluated the efficacy and safety of liquid-nitrogen based CT-guided cryoablation with ProSense®. Patients were treated in out-patient settings with curative intention for non-metastatic patients, while patients with metastases were treated to achieve local tumor control. The patient population (n=45, with 56 tumors) with a mean age of 55.6 ± 12.5 years (range, 31.3–86.0 years) was very heterogeneous and different from IceCure’s ICE3 study population and included 11 patients with recurrent tumors and 21 patients with metastatic disease. Patients were observed at three, six, nine, and 12 months, respectively, and after the first year were followed up biannually. There were four cases of local tumor progression, representing a rate of 8.9%. There were no complications observed in any of the 56 ablations and initial complete ablation was achieved in 100% of cases.
Paullee
3 weeks ago
U.S. Food and Drug Administration Grants Regulatory Clearance to IceCure for Next-Gen XSense™ Cryoablation System with CryoProbes
CAESAREA, Israel, July 1, 2024 – IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” or the “Company”), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has received marketing authorization from the United States Food and Drug Administration (the “FDA”) for its next-generation single probe cryoablation system, the XSense™ Cryoablation System with CryoProbes.
“This latest FDA regulatory clearance further validates the safety and efficacy of our platform cryoablation technology,” commented Eyal Shamir, IceCure’s Chief Executive Officer. “The next-generation XSense™ system is cleared for the same indications as our flagship ProSense® system and we believe it has future potential to address other indications in the U.S. for significant indications with unmet needs. Through our innovation, IceCure is a global leader in liquid nitrogen-based cryoablation systems that offer a new minimally invasive treatment with benefits for patients, doctors and payors alike.”
XSense™ and its cryoprobes are cleared for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology and urology. The system is designed to destroy tissue by the application of extreme cold temperatures, including fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions and warts.
About IceCure’s Cryoablation Systems
IceCure’s platform technology, including the ProSense® Cryoablation System and XSense™ Cryoablation System and CryoProbes, provides a minimally invasive treatment option to destroy tumors by freezing them. The systems uniquely harness the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
IceCure’s cryoablation systems enhance patient and provider value by accelerating recovery, reducing pain, surgical risks and complications. With easy, transportable design and liquid nitrogen utilization, ProSense® and XSense™ open the door to fast and convenient office-based procedure for breast tumors.
Paullee
1 month ago
Guess Mr Market wasn't happy with the timing
FDA to Convene Advisory Panel for Review of IceCure’s De Novo Marketing Clearance Request for ProSense®, Decision Expected Early 2025; Aligns with Commercial Readiness Plan
? Demonstrates public health importance of assessing ProSense®â€™s potential to offer optimal treatment that benefits women with early-stage breast cancer
? Patients, patient advocacy groups, doctors, and the general public will be welcome to participate and comment in the open public hearing
? IceCure welcomes a transparent public forum to share ICE3 study results and show how ProSense® cryoablation could potentially offer a minimally invasive alternative treatment to women diagnosed with early-stage breast cancer estimated at 65,000 in the U.S. annually
? ProSense® is already approved for the treatment of early-stage breast cancer in numerous European countries, as well as Brazil, India, and China
CAESAREA, Israel, June 4, 2024 – IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” 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”) will convene a Medical Device Advisory Committee for a panel meeting (the “Advisory Panel”) to obtain independent expert advice on scientific, technical, and policy matters related to ProSense® to help the FDA make a sound decision.
“We believe the opportunity to have a public, transparent, and open forum about this important women’s health issue, led by outside, independent experts including physicians and researchers, will be highly beneficial to all stakeholders,” stated IceCure’s CEO, Eyal Shamir. “We applaud the FDA’s decision to convene the Advisory Panel and for acknowledging the public health importance of being able to offer a minimally invasive alternative to lumpectomy. The ICE3 data for ProSense®, which has been consistently positive throughout IceCure’s ICE3 study, will be shared with the Advisory Panel, highlighting its clinical and economic benefits and why women who have undergone a ProSense® cryoablation procedure have reported a 100% satisfaction rate. As we continue to engage with the FDA leading up to the Advisory Panel, we believe increased awareness of ProSense® as a result of the Advisory Panel may enable our U.S. commercial team to further support our commercial efforts upon potential regulatory approval in the U.S.”
The Advisory Panel is expected to convene in the fourth quarter of 2024, with an FDA decision on whether to approve ProSense® expected by early 2025. The FDA is expected to provide the exact date for the Advisory Panel in the coming weeks, which the Company will also make known to its shareholders. The FDA generally makes Advisory Panel meeting materials and the live webcast link available to the public no later than two business days before any meeting. The Advisory Panel will review the vast body of data available on ProSense® as a treatment for early-stage breast cancer, including results from the ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen-based cryoablation of early-stage malignant breast tumors. Per the analysis, at the 5-year follow-up evaluation, 96.3% of the subgroup of patients treated with ProSense® cryoablation, followed by hormone therapy, were estimated to be free from local recurrence. 100% patient and physician satisfaction was reported.
As part of its De Novo Classification Request for Marketing Authorization, IceCure submitted data, including its final ICE3 study results, to the FDA, as part of its request for clearance for ProSense® for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy.
Paullee
3 months ago
As Early-Onset Breast Cancer Cases Soar in North America and EU, Biotech Ramps Up Response
10:30 am ET April 30, 2024 (PR Newswire) Print
USA News Group Commentary
USA News Group - An alarming rise in early-onset cancers has medical experts very concerned, as cancer cases in younger people are rising sharply. In particular, a surge in cases of breast cancer is being witnessed in Canada, the USA, and the EU, with extra concern to patients thought to be in remission contracting breast cancer a second time, according to a new study from the University of Cambridge. However, there's still optimism towards new treatments, and significant growth of 9.3% CAGR in the metastatic HR+/HER2- breast cancer market through 2032 has treatment developers working harder to make gains for patients. Among the biotech companies currently making strides are Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), IceCure Medical Ltd (NASDAQ: ICCM), Atossa Therapeutics, Inc. (NASDAQ: ATOS), Arvinas, Inc. (NASDAQ: ARVN),and Pfizer Inc. (NYSE: PFE) (NEO: PFE).
Following a Fast Track Designation by the FDA in late 2022 for Oncolytics Biotech Inc.'s (NASDAQ: ONCY) (TSX: ONC) drug candidate, pelareorep, for pancreatic cancer treatment, the company is now gaining traction towards another pivotal FDA engagement, this time focusing on breast cancer. Recently, Oncolytics announced that they had submitted a Type C meeting request to the FDA to discuss a forthcoming trial for pelareorep aimed at treating HR+/HER2- metastatic breast cancer (mBC) patients.
"A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics. "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer. Our position is strengthened by encouraging data from two randomized studies (BRACELET-1 and IND-213) and the AWARE-1 study, paving the way for the next phase of pelareorep's development and registration."
Dr. Coffey has shared that Oncolytics' continuous interactions with clinical collaborators and partners have been instrumental in crafting a detailed and persuasive briefing document. The company looks forward to meeting with the FDA in Q2 2024 to finalize the trial design and goals for using pelareorep in treating metastatic breast cancer. This meeting is crucial for advancing this promising therapy toward patient use. With expected survival data from its BRACELET-1 study and constructive dialogues with the FDA, Oncolytics is optimistic that 2024 will be a landmark year for the company and its stakeholders.
"The data from the randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in HR+/HER2- metastatic breast cancer patients, with a nearly tripled confirmed response rate, a 50% improvement in median progression-free survival, and a hazard ratio of 0.29 compared to the paclitaxel alone control," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Importantly, these data support the statistically significant near doubling of median overall survival in another randomized phase 2 study, IND-213, which also evaluated pelareorep and paclitaxel in HR+/HER2- metastatic breast cancer patients."
Also seeking the FDA's attention, Israel-based IceCure Medical Ltd (NASDAQ: ICCM) recently reported its final ICE3 breast cancer cryoablation trial results with 100% patient and physician satisfaction and 96.3% recurrence-free rate for its ProSense(R) System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal.
With this new data in hand, IceCure has submitted final data to the FDA, requesting marketing authorization for ProSense(R) for the indication of treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. ProSense(R) has already received FDA Breakthrough Designation and is cleared for use in the US for several other indications, including treating benign tumors of the breast, and tumors in the kidney and liver.
"We believe ICE3 is a ground-breaking study and are excited to report that the efficacy data of our minimally invasive ProSense(R) cryoablation procedure show similar outcomes in recurrence compared to more invasive breast surgery, the current standard of care for early-stage breast cancer," said Eyal Shamir, CEO of IceCure. "Initial reimbursement codes are already in place and our U.S. marketing and commercial team is ready, as we await the FDA's response. 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."
A new clinical trial was announced by Atossa Therapeutics, Inc. (NASDAQ: ATOS)to evaluate the company's proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO(R)), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, in women with ER+/HER2- breast cancer. Set to enroll approximately 20 newly diagnosed women, the new study arm will have participants receiving 40mg (Z)-endoxifen once daily in combination with 150mg abemaciclib twice daily for a total of 24 weeks prior to surgery.
"Endocrine therapy in combination with CDK 4/6 inhibition is a widely used treatment for patients with advanced-stage ER+ breast cancer and as an adjuvant therapy for node positive, hormone positive early-stage disease, found at the time of surgical resection," said Dr. Laura Esserman, director of the University of California San Francisco Breast Care Center and founder of Quantum Leap Healthcare Collaborative. "Women with high clinical stage but less proliferative tumors (molecularly low risk or those with late recurrence risk) are challenging to treat. Late recurrence is high regardless of either endocrine or chemotherapy. Thus, we are looking for new combined treatments, which can be used in the pre-surgery (neoadjuvant) setting. We look forward to learning more about the potential of (Z)-endoxifen in combination with abemaciclib in the neoadjuvant setting in the I-SPY TRIAL."
Vepdegestrant (ARV-471) is another treatment that recently received FDA Fast Track Designation, which is a novel oral PROteolysis Targeting Chimera (PROTAC(R)) ER degrader that is being jointly developed by Arvinas, Inc. (NASDAQ: ARVN),and Pfizer Inc. (NYSE: PFE) (NEO: PFE). The ongoing Phase 3 VERITAC-2 clinical trial is evaluating vepdegestrant or fulvestrant in patients with locally advanced or metastatic ER+/HER2- breast cancer who have been previously treated with an endocrine-based therapy.
"The receipt of Fast Track designation reinforces the potential of vepdegestrant to provide an important new therapeutic option for people with ER+/HER2- breast cancer whose disease has progressed," said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. "We are proud to continue our legacy of developing innovative treatment options for people impacted by metastatic breast cancer and look forward to working with the FDA as we advance our development program for vepdegestrant."
Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
Paullee
7 months ago
“Study Using IceCure’s ProSense® Finds: “Cryoablation Allows the Ultimate De-escalation of Surgical Therapy for Select Breast Cancer Patients.”
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
IceCure Medical Ltd.
Date: December 13, 2023 By: /s/ Eyal Shamir
Name: Eyal Shamir
Title: Chief Executive Officer
2
Exhibit 99.1
Study Using IceCure’s ProSense® Finds: “Cryoablation Allows the Ultimate
De-escalation of Surgical Therapy for Select Breast Cancer Patients”
? Independent study published in Annals of Surgical Oncology concludes cryoablation is an oncologically safe and feasible minimally invasive procedure option in lieu of surgery for patients with early-stage, low-risk breast cancer
? Study’s authors suggest the widespread use of screening mammography allows for earlier detection - and therefore increased customization of treatment, less aggressive management, reduced treatment burden, improved quality of life - and examines cryoablation as the “next step in the surgical de-escalation of breast cancer”
? Study suggests that cryoablation provides a significantly superior alternative when it comes to financial implications, as compared to surgical resection
CAESAREA, Israel, December 13, 2023 – IceCure Medical Ltd. (Nasdaq: ICCM), 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 publication of a study titled “Cryoablation Allows the Ultimate De-escalation of Surgical Therapy for Select Breast Cancer Patients” in the peer-reviewed journal Annals of Surgical Oncology.
The independent study, in which ProSense® was one of two cryoablation systems analyzed, was overseen and conducted at the Breast Center of Excellence and the Department of Surgery, School of Medicine at Texas Tech University Health Sciences Center by Sonia Y. Khan MD, Jaclyn Cole MD, Zaina Habrawi MD, Michael W. Melkus PhD, and Rakhshanda Layeequr Rahman MD.
A total of 32 early-stage breast cancer patients with a median age of 70 (range of 50-91) were treated with cryoablation. Six of the 32 patients (18.5%) received adjuvant radiation, and 31 of 32 patients (97%) received adjuvant endocrine therapy. The mean follow-up was 15 months, with 20 patients (62.5%) completing two years, and 12 patients (37.5%) completing more than three years.
All patients were disease-free at the last follow-up visit, and no major complications from the procedure were reported. One patient had regional disease at 18 months. She did not have sentinel node biopsy and did not take endocrine therapy. She had delayed axillary dissection, started endocrine therapy, and remains disease-free after 5 years of follow-up evaluation. One patient died one year after cryoablation due to unrelated causes. The patient population in this study is similar to the population in IceCure’s ongoing ICE3 study, the largest controlled multi-center clinical trial ever performed in the U.S. for liquid nitrogen-based cryoablation of small, low-risk, early-stage malignant breast tumors as an alternative to surgery.
Highlights from the article include:
? Regarding cost of care, the article states: “Clinical trials have determined not only that cryoablation is just as effective as surgical resection for early-stage, low-risk tumors, but that cryoablation also provides a superior alternative when it comes to financial implications.”
? Citing ICE3 as a leading study that makes the case for surgical de-escalation, the article states: “The ablative therapies were first entertained as options for women who might not be good surgical candidates or refuse surgery. However, two large multi-institutional studies on cryoablation (Simmons et al. (ACOSOG Z-1072), and Fine et al. (ICE3) have led the way to the use of ablation as a means for further surgical de-escalation for small early-stage, low-risk breast cancers.”
“Cryoablation is an excellent option for select patients to avoid general anesthesia, and enjoy a potential cure without surgery through an outpatient procedure with minimal disruption of life.” Stated study co-author, Dr. Rakhshanda Layeequr Rahman
“This independent study is quite compelling in that it goes beyond providing data. It presents the case that due to widespread screening with mammography, early-stage tumors can be treated with new, safe, and effective treatments that minimize the impact on patients and the healthcare system in general,” stated IceCure’s Chief Executive Officer, Eyal Shamir. “We are grateful, as always, to the growing number of medical professionals who are using ProSense® to improve patient outcomes and going above and beyond to publish their results for the advancement of innovative new treatments that improve care.”
About ProSense®
ProSense® cryoablation is a minimally invasive, non-surgical, outpatient 40-minute treatment option that destroys tumors by freezing them. The procedure only requires a local 1% lidocaine injection (similar to its use by dentists when performing certain dental procedures) enabling the patient to remain alert during the procedure and then walk out of the doctor’s office to resume their day. ProSense® has been investigated and proven effective in various clinical applications, including breast tumors, kidney cancer, lung cancer, and in palliative care. Independent and company-sponsored clinical studies of ProSense® have shown strong results, with high rates of tumor destruction, and patient and physician satisfaction.
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