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IceCure's ProSense® Destroyed 100% of Breast Cancer Tumors in Independent Study of Patients Who Chose Cryoablation Instead of Surgery

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IceCure Medical (Nasdaq: ICCM) announced results from an independent study on its ProSense® cryoablation technology for breast cancer treatment. The study, published in the British Journal of Radiology, showed:

- 100% complete ablation rate for Luminal A and B breast cancer tumors ≤ 25mm after 16 months median follow-up
- 95.6% of patients offered cryoablation accepted it
- Median patient age was 87 (range 60-96)
- No major complications were observed

The study concluded that cryoablation is a safe, effective alternative to surgery for early-stage breast cancer in non-surgical patients, well-tolerated as an outpatient procedure. IceCure CEO Eyal Shamir highlighted the potential increasing demand for ProSense® due to the aging population and higher breast cancer risk with age.

IceCure Medical (Nasdaq: ICCM) ha annunciato i risultati di uno studio indipendente sulla sua tecnologia di crioblazione ProSense® per il trattamento del cancro al seno. Lo studio, pubblicato nel British Journal of Radiology, ha mostrato:

- Tasso di ablazione completa del 100% per tumori al seno Luminal A e B ≤ 25mm dopo un follow-up mediano di 16 mesi
- Il 95,6% dei pazienti a cui è stata offerta la crioblazione l'ha accettata
- L'età mediana dei pazienti era di 87 anni (intervallo 60-96)
- Non sono state osservate complicazioni maggiori

Lo studio ha concluso che la crioblazione è un alternativa sicura ed efficace alla chirurgia per il cancro al seno in stadio iniziale in pazienti non chirurgici, ben tollerata come procedura ambulatoriale. Il CEO di IceCure, Eyal Shamir, ha evidenziato la crescente domanda potenziale per ProSense® a causa dell'invecchiamento della popolazione e del maggiore rischio di cancro al seno con l'età.

IceCure Medical (Nasdaq: ICCM) anunció los resultados de un estudio independiente sobre su tecnología de crioablación ProSense® para el tratamiento del cáncer de mama. El estudio, publicado en el British Journal of Radiology, mostró:

- Tasa de ablación completa del 100% para tumores de cáncer de mama Luminal A y B ≤ 25mm después de una mediana de 16 meses de seguimiento
- El 95,6% de los pacientes que se les ofreció la crioablación la aceptaron
- La edad mediana de los pacientes era de 87 años (rango 60-96)
- No se observaron complicaciones mayores

El estudio concluyó que la crioablación es una alternativa segura y efectiva a la cirugía para el cáncer de mama en etapas tempranas en pacientes no quirúrgicos, bien tolerada como procedimiento ambulatorio. El CEO de IceCure, Eyal Shamir, destacó la creciente demanda potencial de ProSense® debido al envejecimiento de la población y al mayor riesgo de cáncer de mama con la edad.

IceCure Medical (Nasdaq: ICCM)가 유방암 치료를 위한 ProSense® 냉동소작 기술에 대한 독립 연구 결과를 발표했습니다. British Journal of Radiology에 발표된 이 연구는 다음과 같은 결과를 보여주었습니다:

- 16개월의 중간 추적 관찰 후 Luminal A 및 B 유방암 종양 ≤ 25mm에 대한 100% 완전 소작률
- 크라이오블레이션을 제안받은 환자의 95.6%가 이를 수용
- 환자의 중간 연령은 87세(범위: 60-96)
- 주요 합병증은 관찰되지 않았습니다

연구는 냉동소작이 비수술 환자의 초기 발병 유방암에 대한 안전하고 효과적인 수술 대안이라고 결론지었습니다. IceCure의 CEO인 Eyal Shamir는 고령화 인구와 나이에 따른 유방암 위험 증가로 인해 ProSense®에 대한 수요가 증가할 가능성을 강조했습니다.

IceCure Medical (Nasdaq: ICCM) a annoncé les résultats d'une étude indépendante sur sa technologie de cryoablation ProSense® pour le traitement du cancer du sein. L'étude, publiée dans le British Journal of Radiology, a montré :

- Taux d'ablation complet de 100 % pour les tumeurs de cancer du sein Luminal A et B ≤ 25 mm après un suivi médian de 16 mois
- 95,6 % des patients à qui la cryoablation a été proposée l'ont acceptée
- L'âge médian des patients était de 87 ans (plage 60-96)
- Aucune complication majeure n'a été observée

L'étude a conclu que la cryoablation est une alternative sûre et efficace à la chirurgie pour le cancer du sein à un stade précoce chez les patients non chirurgicaux, bien tolérée comme procédure ambulatoire. Le PDG d'IceCure, Eyal Shamir, a souligné la demande croissante potentielle pour ProSense® en raison du vieillissement de la population et du risque accru de cancer du sein avec l'âge.

IceCure Medical (Nasdaq: ICCM) gab die Ergebnisse einer unabhängigen Studie zu seiner ProSense® Kryoablationstechnologie zur Behandlung von Brustkrebs bekannt. Die im British Journal of Radiology veröffentlichte Studie zeigte:

- 100%ige vollständige Ablationsrate für Luminal A und B Brustkrebs-Tumoren ≤ 25 mm nach einer medianen Nachbeobachtungszeit von 16 Monaten
- 95,6% der Patienten, denen Kryoablation angeboten wurde, haben sie angenommen
- Das durchschnittliche Alter der Patienten betrug 87 Jahre (Bereich 60-96)
- Es wurden keine größeren Komplikationen beobachtet

Die Studie kam zu dem Schluss, dass Kryoablation eine sichere und effektive Alternative zur Chirurgie für Brustkrebs im Frühstadium bei nicht-chirurgischen Patienten ist und gut als ambulantes Verfahren toleriert wird. Der CEO von IceCure, Eyal Shamir, hob die potenziell wachsende Nachfrage nach ProSense® aufgrund der alternden Bevölkerung und des höheren Brustkrebsrisikos mit zunehmendem Alter hervor.

Positive
  • 100% complete ablation rate for breast cancer tumors ≤ 25mm after 16 months follow-up
  • 95.6% acceptance rate among patients offered cryoablation
  • No major complications observed in the study
  • Potential for increasing demand due to aging population and higher breast cancer risk with age
Negative
  • None.

This study presents compelling evidence for the efficacy of IceCure's ProSense® cryoablation system in treating early-stage breast cancer. The 100% complete ablation rate for tumors ≤25mm is particularly noteworthy, suggesting a potential paradigm shift in breast cancer treatment for specific patient groups.

Key points to consider:

  • High patient acceptance rate (95.6%) indicates strong preference for non-surgical options
  • Median patient age of 87 highlights the system's potential for elderly patients who may not be suitable for surgery
  • No major complications reported, underscoring the safety profile of the procedure

While promising, it's important to note the relatively small sample size and short follow-up period. Long-term studies will be important to establish cryoablation as a standard alternative to surgery in early-stage breast cancer treatment.

The results of this study are intriguing from an oncological perspective. The 100% complete ablation rate for Luminal A and B breast cancers ≤25mm is impressive and could potentially change treatment protocols for certain patient populations, particularly elderly or surgery-averse individuals.

However, we must consider several factors:

  • Long-term recurrence rates and overall survival data are still needed
  • The study's focus on non-surgical patients may not be representative of the broader breast cancer population
  • The potential impact on adjuvant therapy decisions needs further investigation

While cryoablation shows promise as a less invasive alternative, it's important to conduct larger, randomized trials comparing it directly to standard surgical approaches before broadly implementing this technique.

This study presents significant market implications for IceCure Medical and the broader oncology treatment landscape. Key points to consider:

  • High patient acceptance rate (95.6%) suggests strong market potential, especially among elderly patients
  • Outpatient procedure nature could drive healthcare cost reductions and improve patient experience
  • Aging global population and increasing breast cancer incidence in older adults may expand the target market

However, market penetration will depend on:

  • Regulatory approvals in various regions
  • Adoption by healthcare providers and inclusion in treatment guidelines
  • Reimbursement policies from insurance companies and healthcare systems

While the study results are promising, IceCure will need to navigate these challenges to fully capitalize on the market opportunity presented by ProSense®.

  • After a median follow-up of 16 months, the complete ablation rate in Luminal A and B breast cancer tumors ≤ 25mm was 100%
  • Study concluded that most non-surgical patients with early-stage breast cancer accepted cryoablation when the treatment was offered and that cryoablation is a safe, effective alternative to surgery and well-tolerated as an out-patient procedure 

CAESAREA, Israel, Aug. 14, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the publication of an independent study titled "Acceptance and results of cryoablation for the treatment of early breast cancer in non-surgical patients" in the British Journal of Radiology, a publication of the British Institute of Radiology. The single-site study, led by Lucia L. Garna Lopez, PhD, was conducted by researchers in the radiology, oncology, and surgery departments at Hospital Lucus Augusti in Lugo, Spain.

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The aim of the study was to evaluate the acceptance of percutaneous cryoablation treatment by patients with early-stage breast cancer who choose not to have surgery. Of the 45 patients offered cryoablation with ProSense®, 43 patients, or 95.6% accepted. 36 of these, representing 39 malignant tumors (median size 24mm), proceeded to undergo cryoablation.

"This study is a good case in point that when women who elect not to have surgery, or are not eligible for surgery, are given the option, they overwhelmingly choose cryoablation to treat their breast cancer," stated IceCure CEO Eyal Shamir. "In addition to providing excellent data on the safety and efficacy of ProSense® in patients who chose not undergo surgery, the study's authors also point to the correlation between a larger aging population, increased risk of breast cancer with age, and the fact that most patients who elect not to have surgery or are not eligible are elderly patients. These factors, we believe, point to increasing demand for ProSense® when it is presented as an option."

The median age of patients treated with cryoablation was 87, with a range of 60-96. After a median follow-up of 16 months, the complete ablation rate in luminal breast cancer with tumors ≤ 25mm was 100%. No major complications were seen.

The study investigators concluded that most non-surgical patients with early-stage breast cancer accepted cryoablation when the treatment was offered and that cryoablation is safe, effective, and well-tolerated as an outpatient procedure. The published article went on to state that outcomes suggest cryoablation could be an alternative to surgery for the management of breast cancer in this group of patients and pointed to financial, physical, and cosmetic benefits.

About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.

ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.

About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe and China.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses the belief that the correlation between an aging population, increased risk of breast cancer with age, and the fact that most patients who elect not to have surgery or are not eligible are elderly patients point to increasing demand for ProSense® when it is presented as an option. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC on April 3, 2024, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law

IR Contact:
Email: investors@icecure-medical.com 

Michael Polyviou
Phone: 732-232-6914

Todd Kehrli
Phone: 310-625-4462

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SOURCE IceCure Medical

FAQ

What was the complete ablation rate for breast cancer tumors in the IceCure ProSense® study?

The study showed a 100% complete ablation rate for Luminal A and B breast cancer tumors ≤ 25mm after a median follow-up of 16 months.

What percentage of patients accepted cryoablation treatment with ProSense® in the study?

95.6% of patients (43 out of 45) offered cryoablation with ProSense® accepted the treatment.

Were there any major complications reported in the IceCure ProSense® cryoablation study?

No major complications were observed in the study using IceCure's ProSense® cryoablation technology for breast cancer treatment.

What was the median age of patients treated with ProSense® cryoablation in the study?

The median age of patients treated with ProSense® cryoablation was 87, with a range of 60-96 years old.

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