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
IceCure Medical announced the FDA will convene a Medical Device Advisory Committee to review the De Novo Marketing Clearance Request for its ProSense® System, with a decision expected by early 2025. This review acknowledges the potential public health benefits of ProSense® as a minimally invasive treatment for early-stage breast cancer, affecting approximately 65,000 women annually in the U.S.
ProSense® offers cryoablation technology as an alternative to surgical tumor removal and is already approved in several countries. The Advisory Panel will meet in Q4 2024 to discuss the ICE3 study results, showing 96.3% of patients were free from local recurrence at a 5-year follow-up, with 100% patient and physician satisfaction.
IceCure's CEO, Eyal Shamir, emphasized the transparency and public involvement in the process, anticipating that increased awareness could support commercial efforts in the U.S. upon potential regulatory approval.
- FDA's Advisory Panel to review ProSense® highlights its public health importance.
- ProSense® offers a minimally invasive alternative to lumpectomy for early-stage breast cancer.
- ProSense® already approved in Europe, Brazil, India, and China.
- High 5-year follow-up success rate: 96.3% of patients free from local recurrence.
- 100% patient and physician satisfaction reported in ICE3 study.
- Potential increased awareness and commercial readiness in the U.S. upon approval.
- Regulatory decision not expected until early 2025, delaying potential market entry.
- Dependence on FDA approval for U.S. market, which holds significant revenue potential.
- Potential scrutiny and risk of negative feedback during the public Advisory Panel.
Insights
This development signifies a pivotal moment for IceCure Medical Ltd. as it seeks FDA clearance for its ProSense® system. From a financial perspective, the convening of an FDA Advisory Panel represents a critical step toward achieving market authorization in the U.S. This could potentially open a lucrative revenue stream, considering the U.S. market size for early-stage breast cancer treatment. An FDA approval would likely catalyze stock performance, lifting investor sentiment and enhancing market capitalization. However, investors should consider the inherent risk: the FDA panel's decision-making process can be unpredictable and a negative outcome could adversely affect IceCure's stock price. Analysts will be closely monitoring the FDA's announcement timeline and any interim developments.
The ProSense® cryoablation technology promises to revolutionize the treatment landscape for early-stage breast cancer. Current standard practices involve invasive surgical procedures like lumpectomies. ProSense® presents a less invasive alternative, potentially reducing recovery time and associated surgical risks. The ICE3 study's 96.3% effectiveness rate in preventing local recurrence and 100% patient satisfaction are compelling statistics, making it a viable treatment option from a clinical standpoint. However, the long-term efficacy and safety outcomes post-FDA approval will define its real-world clinical acceptance. Clinicians will evaluate these factors alongside patient quality of life improvements and procedural cost-effectiveness.
The impending FDA decision holds significant market implications. If approved, ProSense® could capture substantial market share in early-stage breast cancer treatments, currently dominated by traditional surgical methods. Its approval in Europe, Brazil, India and China sets a positive precedent, but the U.S. market is a different battleground with its own regulatory challenges. Market analysts will be keen on how IceCure's commercial strategies will unfold post-approval. Questions around insurance reimbursement rates, physician adoption rates and competitive positioning against other emerging technologies will be pivotal. The transparency of the FDA's Advisory Panel process also plays a role in shaping public and professional opinion, potentially influencing market dynamics.
- Demonstrates public health importance of assessing ProSense®'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
"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
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,
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.
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses 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.
ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared and approved to date including in the
Forward Looking Statements (Sullivan)
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses the upcoming Advisory Panel, the benefits of the Advisory Panel to all stakeholders, the impending submission of materials and data for and expected timeline and procedure of the Advisory Panel that is expected to take place in the last quarter of 2024, the belief that increased awareness of ProSense® as a result of the Advisory Panel will further the Company's commercial efforts upon potential regulatory approval, and that the decision on whether to approve ProSense® is expected by early 2025. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in
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