We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
IceCure Medical (ICCM) New Cryoablation System Gets FDA Nod
Read MoreHide Full Article
IceCure Medical Ltd (ICCM - Free Report) recently announced that it has 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 system, ProSense, including general minimally invasive cryoablation in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology and urology.
Significance of the Announcement
The FDA clearance is based on the safety and efficacy data of IceCure’s cryoablation platform. The platform offers a cutting-edge alternative to traditional surgical tumor removal by destroying tumors through freezing. The system uses liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung and liver.
Per IceCure Medical, the FDA approval for the XSense Cryoablation System marks a significant step in the medical technology landscape. Following the FDA clearance, IceCure is likely to solidify its position as a global leader in cryoablation solutions, providing multiple minimally invasive options that can potentially transform patient care across several illnesses like fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions and warts.
The XSense system, building on the success of the ProSense system, is set to address unmet medical needs with its versatility and effectiveness in treating various tissues and tumors. This development is anticipated to benefit patients by offering less invasive treatment options, physicians by expanding therapeutic tools, and healthcare payors by potentially reducing overall treatment costs.
More on the News
IceCure's cryoablation systems enhance value for patients and providers by accelerating recovery and reducing pain, surgical risks and complications. Their easy, transportable design and liquid nitrogen utilization enable ProSense and XSense collaboration to facilitate fast and convenient office-based procedures for breast tumors.
The company’s De Novo Classification Request for marketing clearance of the ProSense Cryoablation System for the treatment of patients with early-stage, low-risk breast cancer is under review with the FDA. An advisory panel is expected to be convened in the fourth quarter of 2024 to discuss the request, with a potential decision on FDA approval in early 2025.
Industry Prospects
Per a report by Global Market Insights, the global cryoablation market size was worth $691 million in 2022. It is anticipated to reach $1.6 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
In April, IceCure announced the submission of final data from the ICE3 study to the FDA to support its marketing authorization request for the use of 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. This outcome is comparable to a 97.7% recurrence-free rate from other breast cancer studies — the LUMINA study (evaluating breast-conserving surgery) and the 97.19% rate from the PRISMA meta-study (evaluating radiotherapy). ICE3 results align with real-world data from territories using ProSense. No significant device-related adverse events or complications were reported, with high satisfaction among patients and physicians.
Price Performance
Shares of IceCure Medical have declined 30.7% so far this year against the industry's 3.6% rise. The S&P 500 has witnessed a 15% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Other Key Picks
Currently, IceCure Medical 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 Ecolab Inc. (ECL - 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%.
DaVita’s shares have gained 43.4% compared with the industry’s 15.2% rise in the past 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 21.3% against the industry’s 20.4% decline in the past year.
Ecolab, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 14.3%. ECL’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 1.3%.
Ecolab’s shares have rallied 31.3% against the industry’s 12.9% decline in the past year
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
IceCure Medical (ICCM) New Cryoablation System Gets FDA Nod
IceCure Medical Ltd (ICCM - Free Report) recently announced that it has 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 system, ProSense, including general minimally invasive cryoablation in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology and urology.
Significance of the Announcement
The FDA clearance is based on the safety and efficacy data of IceCure’s cryoablation platform. The platform offers a cutting-edge alternative to traditional surgical tumor removal by destroying tumors through freezing. The system uses liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung and liver.
Per IceCure Medical, the FDA approval for the XSense Cryoablation System marks a significant step in the medical technology landscape. Following the FDA clearance, IceCure is likely to solidify its position as a global leader in cryoablation solutions, providing multiple minimally invasive options that can potentially transform patient care across several illnesses like fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions and warts.
The XSense system, building on the success of the ProSense system, is set to address unmet medical needs with its versatility and effectiveness in treating various tissues and tumors. This development is anticipated to benefit patients by offering less invasive treatment options, physicians by expanding therapeutic tools, and healthcare payors by potentially reducing overall treatment costs.
More on the News
IceCure's cryoablation systems enhance value for patients and providers by accelerating recovery and reducing pain, surgical risks and complications. Their easy, transportable design and liquid nitrogen utilization enable ProSense and XSense collaboration to facilitate fast and convenient office-based procedures for breast tumors.
The company’s De Novo Classification Request for marketing clearance of the ProSense Cryoablation System for the treatment of patients with early-stage, low-risk breast cancer is under review with the FDA. An advisory panel is expected to be convened in the fourth quarter of 2024 to discuss the request, with a potential decision on FDA approval in early 2025.
Industry Prospects
Per a report by Global Market Insights, the global cryoablation market size was worth $691 million in 2022. It is anticipated to reach $1.6 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
In April, IceCure announced the submission of final data from the ICE3 study to the FDA to support its marketing authorization request for the use of 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. This outcome is comparable to a 97.7% recurrence-free rate from other breast cancer studies — the LUMINA study (evaluating breast-conserving surgery) and the 97.19% rate from the PRISMA meta-study (evaluating radiotherapy). ICE3 results align with real-world data from territories using ProSense. No significant device-related adverse events or complications were reported, with high satisfaction among patients and physicians.
Price Performance
Shares of IceCure Medical have declined 30.7% so far this year against the industry's 3.6% rise. The S&P 500 has witnessed a 15% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Other Key Picks
Currently, IceCure Medical 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 Ecolab Inc. (ECL - 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 43.4% compared with the industry’s 15.2% rise in the past 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 21.3% against the industry’s 20.4% decline in the past year.
Ecolab, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 14.3%. ECL’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 1.3%.
Ecolab’s shares have rallied 31.3% against the industry’s 12.9% decline in the past year