Welcome to our dedicated page for IceCure Medical Ltd. Ordinary Shares news (Ticker: ICCM), a resource for investors and traders seeking the latest updates and insights on IceCure Medical Ltd. Ordinary Shares stock.
IceCure Medical Ltd. (Nasdaq: ICCM) is a commercial-stage medical device company specializing in advanced cryoablation systems and technologies. Leveraging liquid nitrogen (LN2), the company’s core offering, the ProSense® System, provides a minimally invasive alternative to surgical tumor removal by freezing tumors found in the breast, lungs, kidneys, bones, and other indications. Founded in Israel, IceCure is a pioneer in the medical field, developing solutions that offer safer, quicker, and more cost-effective treatments compared to traditional surgical interventions.
Recent Achievements:
- IceCure announced positive topline results from its ICE3 study, the largest controlled multicenter clinical trial for LN2-based cryoablation of low-risk, early-stage malignant breast tumors. Approximately 96.39% of patients were local recurrence-free after a 5-year follow-up, with no significant device-related adverse events reported.
- In April 2024, the company filed a 510(k) submission with the FDA for its next-generation single probe cryoablation system, the XSense™ System. This filing aims for clearance for all indications already approved for the ProSense® System, enhancing the system's potential to treat a range of conditions beyond breast tumors, including those in the kidney, liver, and neurology.
- Presented significant findings at the ASBrS 25th Annual Meeting, further demonstrating the efficacy of ProSense® in treating early-stage breast cancer. The presentation garnered strong interest and positive feedback from leading breast surgeons.
- Received regulatory approvals in Brazil, Canada, and China, expanding its global footprint. The company has also entered new distribution agreements in Portugal, India, and Brazil, facilitating the first breast cryoablation procedure in India.
Financial Performance:
For the twelve months ended December 31, 2023, IceCure reported a 26% increase in sales compared to the previous year, transitioning from a research and development phase to a commercial phase. The company’s revenues reached $3.2 million, with a significant portion driven by ProSense® system and disposable probe sales. Despite an overall net loss of $14.7 million, IceCure managed to reduce its operating expenses, enhancing its financial stability.
Partnerships and Pipeline:
IceCure is collaborating with several medical institutions and partners globally, focusing on expanding the clinical applications of ProSense®. Numerous third-party studies are underway to explore new indications such as endometriosis and kidney cancer, showcasing ProSense®’s versatility and potential for broader adoption.
As IceCure awaits the FDA’s decision on its De Novo Classification Request for Marketing Authorization, the company continues to innovate, aiming to establish ProSense® as the gold standard in cryoablation technology worldwide.
IceCure Medical (NASDAQ: ICCM) announced that interim data from its ICE3 Clinical Trial on cryoablation for small, low-risk breast cancer was presented by Dr. Kenneth Tomkovich at the RSNA meeting, which took place from November 29 to December 2, 2021. Dr. Tomkovich's presentation highlighted the growing acceptance of cryoablation as a treatment option. IceCure's CEO, Eyal Shamir, noted that this recognition supports the promising ICE3 data. The ProSense® System offers a minimally-invasive alternative to surgical tumor removal, focusing on effective treatment options for various cancers.
IceCure Medical Ltd (NASDAQ: ICCM) announced the appointment of Merav Nir Dotan as Vice President of Human Resources, enhancing its commitment to growth in human capital. With over 20 years of HR experience, Nir Dotan is set to support IceCure's global expansion of the ProSense® System, which provides a minimally invasive cancer treatment. The company aims to boost its R&D and clinical divisions as it seeks regulatory approvals in key markets, including the United States and China.
IceCure Medical Ltd. (NASDAQ: ICCM) reported an 11% revenue increase to approximately $2.75 million for the nine months ended September 30, 2021. However, the gross profit fell to $1.55 million, leading to a decreased gross margin of 56%. Operating expenses surged to approximately $8.15 million, resulting in a net loss of approximately $6.73 million or $0.25 per share, compared to a loss of $2.95 million in the prior year. Cash reserves improved to $15.4 million due to a $15 million private placement. Strategic developments include regulatory progress in the U.S. and China.
IceCure Medical Ltd. (NASDAQ: ICCM) announced the publication of a peer-reviewed article in the Journal of Cancer Therapy, highlighting the use of its ProSense™ Cryoablation System for treating early-stage breast cancer in Japan. Conducted at St. Marianna University, the study involved eight women with invasive ductal carcinoma, demonstrating that cryoablation could eliminate small tumors without surgery under general anesthesia. The findings suggest that cryoablation presents a viable alternative to lumpectomy, offering safety and positive cosmetic outcomes, with procedures lasting around 40 minutes.
IceCure Medical (Nasdaq: ICCM) has announced an initial distribution agreement with Mobile SCANMED Systems to exclusively sell its ProSense™ Cryoablation System in Poland. This partnership is expected to pave the way for a long-term agreement within a year. The ProSense system, already CE-marked, provides a minimally invasive solution for cancer treatment, particularly for breast cancer, which saw 24,644 diagnoses in Poland in 2020. An initial purchase order of approximately $100,000 will follow the agreement, enhancing IceCure's presence in the EU market.
IceCure Medical Ltd. (NASDAQ: ICCM) has advanced its regulatory strategy in China by submitting an amendment for the registration certificate of its IceSense3® system to the National Medical Products Administration (NMPA). If approved by the end of 2022, this will enable the sale of IceSense3 Cryoprobes. The company anticipates launching commercial sales in early 2023, targeting the significant breast cancer market in China, which saw over 400,000 new cases in 2020. IceCure supports ongoing independent trials in Hong Kong and Shenzhen, with a new trial expected to commence in a leading Shanghai hospital.
IceCure Medical Ltd. (NASDAQ: ICCM) reported a 12% revenue increase to approximately $2.1 million for the six months ended June 30, 2021. Operating expenses rose significantly to about $4.9 million, leading to a net loss of approximately $3.8 million, or $0.16 per share. Key highlights include FDA Breakthrough Device Designation for the ProSense® system and positive interim results from the ICE3 clinical trial for cryoablation of breast cancer. The company also expanded its global distribution network, securing partnerships in Turkey, India, and Brazil.
IceCure Medical (NASDAQ: ICCM) announced the publication of a peer-reviewed article on the ICE3 Trial's interim results for cryoablation in low-risk, early-stage breast cancer. The study, published in the Annals of Surgical Oncology, found a low recurrence rate of just 2.06% (4 of 194 patients) at a mean follow-up of 34.83 months. CEO Eyal Shamir highlighted this milestone as a breakthrough in the adoption of their minimally invasive cryoablation technology. The procedure presents a promising alternative to surgery, with minimal risks and excellent cosmetic outcomes.
IceCure Medical (NASDAQ: ICCM) has signed an initial distribution agreement with Mutlu Medikim A.S. to exclusively sell its ProSense™ Cryoablation System in Turkey. The agreement aims to leverage Turkey's healthcare system, serving a population of over 80 million, to expand IceCure’s market presence. Mutlu Medikim A.S. plans to place an initial purchase order worth approximately $100,000, leading to expectations of a long-term agreement within a year. This partnership is part of IceCure's broader strategy to enhance distribution networks across multiple regions, including Europe and Asia.
IceCure Medical Ltd. (NASDAQ: ICCM) announced that its shares are now listed on the Nasdaq Capital Market, effective August 26, 2021. This milestone is expected to enhance the company's visibility and liquidity among U.S. and international investors. The Nasdaq listing follows a $15 million private placement in January 2021, aiming to expand IceCure's global reach in the minimally invasive cryoablation technology sector. The SEC has effectively approved the registration statement for shares related to this private placement.
FAQ
What is the current stock price of IceCure Medical Ltd. Ordinary Shares (ICCM)?
What is the market cap of IceCure Medical Ltd. Ordinary Shares (ICCM)?
What is IceCure Medical Ltd. known for?
What is the ProSense® System?
What recent achievements has IceCure Medical made?
How has IceCure Medical's financial performance been recently?
What are some key financial highlights for IceCure Medical?
What partnerships does IceCure Medical have?
What is the significance of the ICE3 study?
What are IceCure Medical's future plans?
What new products is IceCure Medical developing?
How is IceCure Medical expanding its global reach?
