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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.
On August 9, 2021, IceCure Medical announced an 8-for-1 reverse stock split effective August 8, 2021, in preparation for its planned uplisting to the Nasdaq Capital Market. The reverse split reduces the number of outstanding shares from approximately 254.57 million to 31.82 million, while the number of authorized shares decreases from 20 billion to 2.5 billion. This action aims to meet Nasdaq's stock price requirements, although there is no assurance that the application will be approved. Shareholders previously approved the reverse split on July 27, 2021.
IceCure Medical has announced a distribution agreement with KTRFIOS IMPORTACAO E EXPORTACAO LTDA to market its ProSense™ Cryoablation System in Brazil. This exclusive deal is set for five years, with projected sales of at least $6.6 million. ProSense™ aims to address Brazil's significant cancer burden, with over 500,000 new cancer cases annually. IceCure previously secured similar agreements in various regions, indicating the growing validation of its cryotherapy technology. The company anticipates regulatory approval within 18 months.
IceCure Medical announced positive interim results from its ICE3 clinical trial for the ProSense® cryoablation system, aimed at treating low-risk early-stage breast cancer. At a mean follow-up of 34.83 months, only 2.06% of 194 patients experienced cancer recurrence. The trial, the largest of its kind in the U.S. for this treatment, shows a local failure-free probability of 99.22%. The non-invasive procedure has garnered high satisfaction rates from patients and physicians alike, with no significant device-related adverse events reported. IceCure aims to expedite commercialization of ProSense® with FDA support.
IceCure Medical, a developer of cryoablation technology, will present updated clinical data from its ICE3 trial for ProSense® at the American Society of Breast Surgeons Annual Meeting from April 29–May 2, 2021. The ICE3 trial, the largest of its kind, included 206 patients across 19 U.S. medical centers and reported a recurrence-free rate exceeding 98%. Dr. Richard Fine will present the findings on April 30, 2021, at 1:30 pm EDT. This presentation highlights IceCure's innovative, minimally invasive treatment approach for early-stage breast cancer.
IceCure Medical, based in Israel, has received Breakthrough Device Designation from the FDA for its ProSense® cryoablation system, aimed at treating T1 invasive breast cancer. This recognition allows for accelerated review and collaboration with the FDA towards commercialization. ProSense® has shown promise in clinical studies and previously received FDA approval for treating various tumor types. Upcoming interim results from the ICE3 trial on breast cancer will be presented at the American Society of Breast Surgeons Annual Meeting on April 30. The potential for Medicare coverage under the MCIT program is also noted.
