Icecure Medical Ltd. - ICCM STOCK NEWS

IceCure Medical Ltd. (NASDAQ: ICCM) announced a public offering of 3,313,827 shares at $3.45 each, aiming to raise approximately $15 million. The offering includes pre-funded warrants to purchase 1,034,000 shares, priced at $3.449 each. Expected to close by December 13, 2021, the funds will support product development, business growth, and general corporate purposes. A.G.P./Alliance Global Partners is the book-running manager for the offering.

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.