IceCure Medical Submits Regulatory Filing in Vietnam for Approval of ProSense

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Summation

  • ICCM) (“IceCure” or the “Company”), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has submitted a regulatory filing with the Department of Medical Equipment and Construction (“DMEC”) of Vietnam’s Ministry of Health for the ProSense System and accessories.
  • “Asia is a significant market for ProSense and Vietnam is one of the fastest growing healthcare markets in the region.
  • Liver, lung, and breast cancer were the three most prevalent cancers in Vietnam in 2020 according to the World Health Organization.

IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” or the “Company”), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has submitted a regulatory filing with the Department of Medical Equipment and Construction (“DMEC”) of Vietnam’s Ministry of Health for the ProSense System and accessories.

IceCure Medical Submits Regulatory Filing in Vietnam for Approval of ProSense
ProSense™

The application covers indications including benign and malignant breast tumors, benign and malignant lung tumors, benign and malignant liver tumors, kidney cancer, ablation of cancerous or malignant tissue, musculoskeletal tumors, and other indications.

Vietnam’s medical device market was valued at $1.4 billion in 2019 and was projected to grow 10% annually through 2024, according to the U.S. Department of Commerce, with overall healthcare expenditures in the country totaling $17 billion. Liver, lung, and breast cancer were the three most prevalent cancers in Vietnam in 2020 according to the World Health Organization.

“Asia is a significant market for ProSense and Vietnam is one of the fastest growing healthcare markets in the region. Having started the regulatory process in Vietnam, we anticipate high interest from potential distributors in the country,” stated IceCure CEO, Eyal Shamir. “This comes on the heels of our recent successes in the region with Shanghai Medtronic Zhikang Medical Devices Co. Ltd. in China and Terumo in Japan, Singapore, and Thailand.”