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IceCure's (ICCM) ProSense Breast Cancer Study Meets Endpoint
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IceCure Medical Ltd. (ICCM - Free Report) recently announced the publication of data from an independent study evaluating its ProSense cryoablation system in the peer-reviewed journal — Cancers. Data from the study evaluating the system in patients with high-risk breast cancer in an outpatient setting demonstrated that liquid Nitrogen-based cryoablationis a safe local treatment for breast cancer with a low complication rate.
The system’s minimally invasive nature will allow it to be performed on an outpatient basis with excellent cosmetic results. The company’s ProSense cryoablation system is already approved for treating breast cancer in Europe. A regulatory application seeking approval of the system for early-stage breast cancer patients is under review with the FDA.
The ProSense Cryoablation System offers a minimally invasive treatment to destroy tumors by freezing them using liquid nitrogen. It effectively targets both benign and cancerous lesions in the breast, kidney, lung, and liver. The system enhances patient recovery by reducing pain, surgical risks and complications.
Significance of the Study
The independent study, conducted without any financial support from IceCure, evaluated liquid Nitrogen-based cryoablation with Prosense in out-patient settings with curative intention for non-metastatic patients, while patients with metastases were treated to achieve local tumor control.
Study data demonstrated the high efficacy and safety of IceCure's ProSense cryoablation system, with a 100% complete ablation rate and no observed complications.
In an outpatient setting, patients were treated with the ProSense Cryoablation System to achieve curative results for non-metastatic cases and local tumor control for metastatic cases. The study involved 45 patients with 56 tumors, aged between 31.3 and 86 years, including 11 with recurrent tumors and 21 with metastatic disease.
Patients underwent observations at three, six, nine, and 12 months and biannually after the first year. The study reported a 100% initial complete ablation rate with no complications in any of the 56 ablations. However, four cases experienced local tumor progression, resulting in a progression rate of 8.9%
The results highlight the system's effectiveness across a broad spectrum of breast cancer cases, from newly diagnosed early-stage to metastatic and recurrent diseases. This study supports the broader application of cryoablation as a minimally invasive, outpatient treatment with excellent cosmetic outcomes, potentially offering a viable alternative to traditional surgical tumor removal.
Industry Prospects
Per a report by Global Market Insights, the global cryoablation market size was worth $690 million in 2022. It is anticipated to reach $1.5 billion in 2032 at a CAGR of 8.5%
Continuous advancements in cryoablation devices will act as a significant factor in accelerating market penetration. Developing and launching advanced technology with inbuilt devices that offer better device performance, accuracy, and safety will boost the demand for cryoablation devices. Furthermore, several manufacturers are producing devices with superior cooling processes, enhanced imaging capabilities, and improved catheter designs for precise and efficient tissue targeting, which will propel market growth.
Recent Developments
This month,IceCure received marketing authorization from the FDA for its next-generation single-probe cryoablation system, XSense Cryoablation System with Cryoprobes. The XSense system, which is designed for general minimally invasive cryoablation, received FDA clearance for all the approved indications for IceCure’s other cryoablation systems.
In April, IceCure announced the submission of final data from the ICE3 study to the FDA to support its marketing authorization request for using ProSense in early-stage breast cancer.
The ICE3 study data demonstrated that 96.3% of early-stage breast cancer patients treated with ProSense cryoablation followed by hormone therapy were free from local recurrence at five years. ICE3 results align with real-world data from territories using ProSense.
Price Performance
Shares of IceCure have plunged 29.9% so far this year against the industry's 2.1% rise. The S&P 500 has witnessed a 17.6% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Other Key Picks
Currently, IceCure carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Universal Health Services (UHS - Free Report) and Dexcom (DXCM - Free Report) .
DaVita, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 13.6%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 29.4%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita’s shares have gained 34.2% compared with the industry’s 4.5% rise so far this year.
Universal Health Services, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 14.80%. UHS’s earnings surpassed estimates in each of the trailing four quarters, with the average being 8.12%.
Universal Health Services has gained 20.4% compared with the industry's 17.5% so far this year .
DexCom, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 22.9%. DXCM’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 34.10%.
DexCom’s shares have declined 9.4% against the industry's 3.5% increase so far this year.
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IceCure's (ICCM) ProSense Breast Cancer Study Meets Endpoint
IceCure Medical Ltd. (ICCM - Free Report) recently announced the publication of data from an independent study evaluating its ProSense cryoablation system in the peer-reviewed journal — Cancers. Data from the study evaluating the system in patients with high-risk breast cancer in an outpatient setting demonstrated that liquid Nitrogen-based cryoablationis a safe local treatment for breast cancer with a low complication rate.
The system’s minimally invasive nature will allow it to be performed on an outpatient basis with excellent cosmetic results. The company’s ProSense cryoablation system is already approved for treating breast cancer in Europe. A regulatory application seeking approval of the system for early-stage breast cancer patients is under review with the FDA.
The ProSense Cryoablation System offers a minimally invasive treatment to destroy tumors by freezing them using liquid nitrogen. It effectively targets both benign and cancerous lesions in the breast, kidney, lung, and liver. The system enhances patient recovery by reducing pain, surgical risks and complications.
Significance of the Study
The independent study, conducted without any financial support from IceCure, evaluated liquid Nitrogen-based cryoablation with Prosense in out-patient settings with curative intention for non-metastatic patients, while patients with metastases were treated to achieve local tumor control.
Study data demonstrated the high efficacy and safety of IceCure's ProSense cryoablation system, with a 100% complete ablation rate and no observed complications.
In an outpatient setting, patients were treated with the ProSense Cryoablation System to achieve curative results for non-metastatic cases and local tumor control for metastatic cases. The study involved 45 patients with 56 tumors, aged between 31.3 and 86 years, including 11 with recurrent tumors and 21 with metastatic disease.
Patients underwent observations at three, six, nine, and 12 months and biannually after the first year. The study reported a 100% initial complete ablation rate with no complications in any of the 56 ablations. However, four cases experienced local tumor progression, resulting in a progression rate of 8.9%
The results highlight the system's effectiveness across a broad spectrum of breast cancer cases, from newly diagnosed early-stage to metastatic and recurrent diseases. This study supports the broader application of cryoablation as a minimally invasive, outpatient treatment with excellent cosmetic outcomes, potentially offering a viable alternative to traditional surgical tumor removal.
Industry Prospects
Per a report by Global Market Insights, the global cryoablation market size was worth $690 million in 2022. It is anticipated to reach $1.5 billion in 2032 at a CAGR of 8.5%
Continuous advancements in cryoablation devices will act as a significant factor in accelerating market penetration. Developing and launching advanced technology with inbuilt devices that offer better device performance, accuracy, and safety will boost the demand for cryoablation devices. Furthermore, several manufacturers are producing devices with superior cooling processes, enhanced imaging capabilities, and improved catheter designs for precise and efficient tissue targeting, which will propel market growth.
Recent Developments
This month,IceCure received marketing authorization from the FDA for its next-generation single-probe cryoablation system, XSense Cryoablation System with Cryoprobes. The XSense system, which is designed for general minimally invasive cryoablation, received FDA clearance for all the approved indications for IceCure’s other cryoablation systems.
In April, IceCure announced the submission of final data from the ICE3 study to the FDA to support its marketing authorization request for using ProSense in early-stage breast cancer.
The ICE3 study data demonstrated that 96.3% of early-stage breast cancer patients treated with ProSense cryoablation followed by hormone therapy were free from local recurrence at five years. ICE3 results align with real-world data from territories using ProSense.
Price Performance
Shares of IceCure have plunged 29.9% so far this year against the industry's 2.1% rise. The S&P 500 has witnessed a 17.6% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Other Key Picks
Currently, IceCure carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Universal Health Services (UHS - Free Report) and Dexcom (DXCM - Free Report) .
DaVita, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 13.6%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 29.4%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita’s shares have gained 34.2% compared with the industry’s 4.5% rise so far this year.
Universal Health Services, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 14.80%. UHS’s earnings surpassed estimates in each of the trailing four quarters, with the average being 8.12%.
Universal Health Services has gained 20.4% compared with the industry's 17.5% so far this year .
DexCom, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 22.9%. DXCM’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 34.10%.
DexCom’s shares have declined 9.4% against the industry's 3.5% increase so far this year.