| Monday | ||||
IceCure Medical has… IceCure Medical has received a Notice of Allowance from the USPTO for its patent application titled "Cryogen Pump". The patent will be in effect until February 2040 and was recently granted in the EU and allowed in Japan. IceCure's cryogenic pump is submersible in liquid nitrogen, works in a closed circuit, enables temperature control of the cryoprobe, improves the cooling rate during a procedure, and is designed to be used for multiple procedures or longer duration procedures without the need to refill liquid nitrogen. | ||||
| Over a week ago | ||||
IceCure Medical announced… IceCure Medical announced it has received a Notice of Allowance from the Japan Patent Office, or JPO, for IceCure's patent application titled "Cryogen Pump". The patent will be in effect until 2041. A patent for this invention has been issued in the European Union and is pending in other major markets, including the U.S. IceCure's novel cryogenic pump is submersible in liquid nitrogen, works in a closed circuit, improves the cooling rate during a procedure, and is designed to be used for multiple procedures or longer duration procedures without the need to refill liquid nitrogen. Moreover, this pump enables temperature control of the cryoprobe, as well as the use of a wider range of cryoprobes and catheters. | ||||
| Over a month ago | ||||
IceCure Medical… IceCure Medical "announced the pricing of its previously announced "best efforts" public offering of 8,787,880 shares of the Company's ordinary shares priced at-the-market under Nasdaq rules at a price to the public of $1.65 per share. The gross proceeds of the offering to the Company are expected to be approximately $14.5 million, before deducting placement agent fees, commissions, and other estimated offering expenses." | ||||
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IceCure Medical Ltd.… IceCure Medical Ltd. announced the commencement of a proposed public offering of its ordinary shares. The company intends to use the net proceeds from the offering to fund the development of its next generation single Probe and MultiSense systems, collecting clinical data and adding regulatory approvals in new territories and indications, business development, marketing and selling activities as well as for working capital and general corporate purposes. A.G.P./Alliance Global Partners is acting as lead placement agent for the offering on a best efforts basis. Brookline Capital Markets, a division of Arcadia Securities, is acting as a co-placement agent for the offering. | ||||
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IceCure Medical announced… IceCure Medical announced interim results from the ICESECRET study for the treatment of patients with small renal masses who cannot be offered kidney-preserving surgery. Data were presented on December 14, 2022 at the Urological Association Conference in Eilat, Israel. The presentation titled "Renal Mass Cryoablation - Interim Analysis ICESECRET Study" was delivered by Dr. Nasir Said of Bnai Zion Medical Center. According to the presentation, out of the 115 patients enrolled, 107 patients returned for follow-up with a mean duration of 22.8 months and a range 12-60 months. In a subgroup of patients with no previous history of kidney cancer on the same kidney and a lesion less than or equal to3 cm, an 89.5% recurrence-free rate was observed at a mean follow-up time of 22.2 months when the procedure protocol was followed. The recurrence-free rate was 85.1% for the 107 patients at a mean follow-up period of 16.5 months. 5 serious adverse events were reported, 4 of which were of mild severity and were treated conservatively and resolved within 1-5 days, with one severe complication of a new onset of ipsilateral hydronephrosis 7 months after the cryoablation procedure that led to nephrectomy. Cryoablation time and hospitalization time were relatively short, up to approximately 25 minutes and 2 days, respectively. The presentation concluded that, based on these interim results, cryoablation is safe and effective for treating renal masses under 5 cm. | ||||
| Over a quarter ago | ||||
Maxim analyst Anthony… Maxim analyst Anthony Vendetti initiated coverage of IceCure Medical with a Buy rating and $3 price target. The company's flagship ProSense System in the treatment of small benign and malignant tumors offers several advantages over surgical treatment alternatives including a lower cost, less pain, faster procedure times, minimal recovery time, lower infection risk, superior cosmetic results, and the ability to be performed outpatient, without the use of general anesthesia, the analyst tells investors in a research note. Vendetti further cites IceCure's focus on receiving FDA clearance for early-stage breast cancer indications, which he expects to significantly increase its total addressable market, adding that with $17.7M in cash and no debt, the company has sufficient capital to operate into Q3 of next year. | ||||
IceCure Medical announced… IceCure Medical announced it submitted a regulatory filing, a De Novo Classification Request, with the FDA for marketing authorization based on ICE3 clinical trial interim analysis of ProSense for the indication of early-stage low-risk breast cancer in patients who are at high risk to surgery, representing approximately 43,000 women in the U.S. annually. The specific indication filed is based on interim data and is in accordance with discussions IceCure has had with the FDA, which granted ProSense Breakthrough Device Designation, enabling closer communications regarding its regulatory filing. ICE3 is the largest controlled, multicenter clinical trial ever performed in the U.S. for liquid nitrogen-based cryoablation of small, low-risk, early-stage malignant breast tumors. To date, there have been six cases of ipsilateral breast tumor recurrence, or IBTR, out of 194 patients, or 3.09%. The survival-based estimate for the 5-year IBTR is 4.3% with a one-sided 95% confidence level, upper bound of 8.4% for the entire study population. Final ICE3 5-year follow-up data are expected in the first half of 2024, at which time IceCure plans to file with the FDA for a broader indication reflecting the entire study population-early-stage low-risk breast cancer for patients age 60 and over, representing approximately 65,000 women in the U.S. annually. | ||||
