Regulatory and Clinical Progress
- ICE3 Clinical Trial: Positive interim results were presented at major medical conferences, demonstrating the efficacy and safety of the ProSense® system for minimally invasive cryoablation of small breast cancer tumors.
- Regulatory Achievements: Granted Breakthrough Device Designation by the FDA for the ProSense® system, submitted a pre-submission package to the FDA for early-stage breast cancer treatment, and submitted an amendment to China's NMPA for the IceSense3® system.
Commercial Expansion
- Global Distribution: Expanded distribution networks in Turkey, India, Brazil, Thailand, Japan, Singapore, and Poland.
- Financial Milestones: Completed a $15 million private placement and a $17 million follow-on offering, with shares commencing trading on the Nasdaq Capital Market.
Future Objectives
- 2022 Focus: Aiming for regulatory clearance in the United States, China, and Japan, and continuing the development of next-generation single and multi-probe systems for treating larger or multiple tumors.
- Strategic Partnerships: Cooperating with Terumo Corporation to advance the regulatory process in Japan.
Acknowledgments
- Team and Shareholders: Expressed gratitude for the team's efforts and shareholders' support, emphasizing the company's commitment to advancing cryoablation technology for tumor therapy.
IceCure Medical continues to focus on becoming the new gold-standard for cryoablation tumor therapy, leveraging its minimally-invasive technology to offer safe and effective alternatives to surgical tumor removal.
