California Medical Device Company w/FDA Clearance 1238

Single Pass has announced their intent and desire to be fully acquired by a strategic partner with the ability to commercialize its unique and patented biopsy closure system. The company’s Kronos device has received both FDA Clearance and the CE Mark under EU MDR and is currently being marketed through a worldwide distribution network. The device efficiently seals biopsy channels, enhancing safety for high-risk patients and enabling the use of larger needles for more substantial tissue samples in fewer passes. Its usage may reduce procedure costs by eliminating the need for certain medications, hemostatic agents, and post-procedure observation. Effective channel sealing may also minimize hemorrhage, leading to improved patient outcomes. The device stands out as the only patented electro-cautery device designed to fit biopsy channels, ensuring innovation and effectiveness. NDA is required to secure comprehensive Confidential Information Memorandum (CIM) crafted by ProNova Partners. Detailed Information Facilities: Relocatable worldwide. Competition: In CIM, NDA required. Growth & Expansion: Significant growth opportunity. Financing: TBD if structure and terms are acceptable. Support & Training: As needed. Reason for Selling: The Owner wishes to capitalize on the significant IP and momentum gained by the company thus far.