IceCure Medical Ltd.
ICCM evidence brief
What we can confirm
What it means
What to watch
Prepared research question
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Traceable citations · Unknowns marked
BioSniper AI · ICCM
IceCure Medical Ltd. is a commercial-stage medical device company developing cryoablation systems for tumor treatment, with its ProSense system recently receiving FDA De Novo authorization for early-stage breast cancer.
Key risk: Cash runway insufficient
BioSniper Score
Based on 2 of 6 signals
Limited data coverage
Financial data as of Dec 31, 2025.
IceCure Medical Ltd. is a commercial-stage medical device company developing cryoablation systems for tumor treatment, with its ProSense system recently receiving FDA De Novo authorization for early-stage breast cancer.
- IceCure is a commercial-stage medical device company focused on cryoablation systems using liquid nitrogen for tumor treatment [sec · filed 2026-03-17].
- In October 2025, the FDA granted De Novo authorization for the ProSense system for early-stage, biologically low-risk breast cancer [sec · filed 2026-03-17].
- As of December 31, 2025, cash and equivalents were $8.9 million, with an accumulated deficit of $120.4 million [sec · filed 2026-03-17].
- As of March 13, 2026, cash, cash equivalents, and short-term deposits were approximately $4.7 million, and the company states its current cash is not sufficient to fund operations for at least the next 12 months [sec · filed 2026-03-17].
- The company has incurred significant operating losses and minimal product sales to date, with total revenue of $3.4 million and a net loss of $15.1 million for the year ended December 31, 2025 [latest reported financials (authoritative, structured)].
What works
- The FDA granted De Novo authorization for the ProSense system in October 2025 for early-stage breast cancer, opening a U.S. market opportunity [sec · filed 2026-03-17].
- The company has a clear growth strategy including obtaining additional regulatory approvals, generating clinical data, and pursuing reimbursement pathways such as CPT III codes and Transitional Pass-Through Payment [sec · filed 2026-03-17].
- IceCure has no debt, with total debt of $0.0 million as of December 31, 2025 [latest reported financials (authoritative, structured)].
What to weigh
- As of March 13, 2026, cash and equivalents were only $4.7 million, and the company states it cannot fund operations for at least the next 12 months, indicating a need for substantial additional funding [sec · filed 2026-03-17].
- Accumulated deficit reached $120.4 million as of December 31, 2025, reflecting years of operating losses and minimal revenue [sec · filed 2026-03-17].
- The company faces intense competition from larger, better-funded competitors with dominant market positions and greater resources [sec · filed 2026-03-17].
- Clinical trials and regulatory processes may encounter delays, suspensions, or terminations, which could hinder product development and commercialization [sec · filed 2026-03-17].
From the filings
Quoted directly from source documents.
FDA De Novo authorization for ProSense in breast cancer
“In October 2025, the FDA granted De Novo authorization for the use of our ProSense system for the treatment of early-stage, biologically low-ri”
SEC filings · March 17, 2026
Cash position insufficient for 12 months
“The Company's current cash and cash equivalents position is not sufficient to fund its planned operations for at least the next 12 months beyond the filing date of this Annual Report.”
SEC filings · March 17, 2026
Accumulated deficit of $120.4 million
“as of December 31, 2025 and 2024, our accumulated deficit was $120.4 million and $105.4 million, respectively.”
SEC filings · March 17, 2026
Cash and equivalents as of March 13, 2026
“As of March 13, 2026, the Company's cash, cash equivalents, and short-term deposits were approximately $4.7 million.”
SEC filings · March 17, 2026
Risks & what to watch (4)›
Key risks
- Cash runway insufficient — Cash of $4.7M as of March 13, 2026 is not enough to fund operations for 12 months; needs additional funding [sec · filed 2026-03-17].
- Accumulated losses — Accumulated deficit of $120.4M as of Dec 31, 2025, with minimal revenue and ongoing net losses [sec · filed 2026-03-17].
- Clinical and regulatory delays — Trials may be delayed, suspended, or terminated due to enrollment issues or safety concerns [sec · filed 2026-03-17].
- Intense competition — Larger, better-funded competitors with dominant market positions may limit market share [sec · filed 2026-03-17].
What to watch
- Ability to raise additional funding given cash runway concerns [sec · filed 2026-03-17].
- Commercial uptake and reimbursement progress for ProSense in the U.S. following FDA De Novo authorization [sec · filed 2026-03-17].
- Regulatory approvals for ProSense and other systems in additional countries and indications [sec · filed 2026-03-17].
- Clinical trial results and any updates on the XSense and MSense systems [sec · filed 2026-03-17].
Sources: SEC filings · Generated August 27, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 2 of 6 signals · derived from public data
No clinical pipeline tracked — this score reflects financial & catalyst signals only.
2.1 months
D/E 0.53 · 0% dilution
No tracked pipeline phase
No tracked pipeline candidates
No upcoming catalysts tracked
No insider transactions in the last 180 days
Runway
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
12
Total value held
$853K
| Holder | Shares | Value |
|---|---|---|
| armistice capital, llc | 2,712,000 | $816K |
| geode capital management, llc | 40,453 | $12K |
| hudson bay capital management lp | 30,000 | $9K |
| morgan stanley | 17,000 | $5K |
| foundations investment advisors, llc | 15,000 | $5K |
| wellington shields capital management, llc | 15,000 | $5K |
| jpmorgan chase & co | 5,950 | $2K |
| bartlett & co. wealth management llc | 250 | $73 |
| hrt financial lp | 47,596 | $14 |
| sbi securities co., ltd. | 9 | $3 |
Showing top 10 of 12 institutional holders of IceCure Medical Ltd.. Open the full 13F history after sign-in.
Short Interest
as of May 12, 2026- % of float
- 2.3%
- Days to cover
- 1.6
- Shares short
- 1,095,029
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
ICCM short interestFrequently asked questions
What is the AI investment thesis for IceCure Medical Ltd.?
IceCure Medical Ltd. is a commercial-stage medical device company developing cryoablation systems for tumor treatment, with its ProSense system recently receiving FDA De Novo authorization for early-stage breast cancer.
Who is the CEO of IceCure Medical Ltd.?
Mr. Eyal Shamir is the chief executive officer of IceCure Medical Ltd. (ICCM).
Where is IceCure Medical Ltd. headquartered?
IceCure Medical Ltd. (ICCM) is headquartered in Caesarea, Israel.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.