Mermaid Medical A/S

The FDA has determined the device is substantially equivalent to predicate devices regarding its safety and effectiveness The Single Pass Kronos device. (Credit: PR Newswire/ Single Pass, Inc.) Single Pass, Inc. is proud to announce that its Class II Kronos biopsy closure device has received clearance from the U.S. Food and Drug Administration (FDA). The FDA has determined the device is substantially equivalent to predicate devices regarding its safety and effectiveness. Under the leadership of Bill Colone and its Board of Directors, the Single Pass team collaborated with their contract manufacturing partner, M4D, based in Lake Forest, CA to bring the Kronos device to market. The company previously achieved the CE Mark under the EU MDR regulations, as now the Kronos device is now commercially available globally. “We are thrilled to have received FDA clearance for our Kronos biopsy closure device,” said Bill Colone, Co-founder, and CEO of Single Pass. “The Kronos device represents a significant advancement, offering healthcare professionals a reliable and efficient solution for post biopsy bleeding and improved patient care.” Mermaid Medical, the US distribution partner, is prepared to initiate sales in the US, ensuring immediate national access to this groundbreaking technology. This strategic partnership will facilitate widespread coverage for this innovative and unique technology ultimately benefiting patients and healthcare providers across the country. Source: Company Press Release

LAKE FOREST, Calif., April 29, 2024 /PRNewswire/ -- Single Pass, Inc. is proud to announce that its Class II Kronos biopsy closure device has received clearance from the U.S. Food and Drug Administration (FDA). The FDA has determined the device is substantially equivalent to predicate devices regarding its safety and effectiveness. Continue Reading The Single Pass Kronos device being used for a kidney biopsy procedure in Rome, Italy. The Single Pass Kronos device Under the leadership of Bill Colone and its Board of Directors, the Single Pass team collaborated with their contract manufacturing partner, M4D, based in Lake Forest, CA to bring the Kronos device to market. The company previously achieved the CE Mark under the EU MDR regulations, as now the Kronos device is now commercially available globally. "We are thrilled to have received FDA clearance for our Kronos biopsy closure device," said Bill Colone, Co-founder, and CEO of Single Pass. "The Kronos device represents a significant advancement, offering healthcare professionals a reliable and efficient solution for post biopsy bleeding and improved patient care." Mermaid Medical, the US distribution partner, is prepared to initiate sales in the US, ensuring immediate national access to this groundbreaking technology. This strategic partnership will facilitate widespread coverage for this innovative and unique technology ultimately benefiting patients and healthcare providers across the country. For more information about Single Pass and its innovative medical devices, please visit . About Single Pass: Single Pass is a medical device company dedicated to developing an innovative solution to post biopsy bleeding, enhance patient care, and improve clinical outcomes. With a focus on precision and reliability, Single Pass strives to revolutionize the healthcare landscape through cutting-edge technology by safely cauterizing deep tissue through a guide needle, promising swift, easy, and safe biopsy procedures. For media inquiries, please contact: Bill Colone CEO Single Pass +1-602-618-3377 [email protected] SOURCE Single Pass, Inc.

Under the agreement, Mermaid Medical Group will act as the sole distributor of Single Pass's biopsy closure device in the US using its broad network and expertise in the medical technology sector An image of Single Pass biopsy closure device. (Credit: PR Newswire/ Single Pass, Inc.) Single Pass has signed an exclusive distribution agreement with Mermaid Medical Group to distribute the former’s biopsy closure device to healthcare professionals in the US market. The Single Pass biopsy closure device is an advanced device intended to improve the results of biopsy closure procedures and patient care. The device is said to offer a safe and effective way to close biopsy sites, lower the risk of complications, and speed up patient recovery using its latest technology and user-friendly design. Under the distribution deal, Mermaid Medical Group will act as the sole distributor of the biopsy closure device in the US. Mermaid Medical Group, a medical technology company, will use its broad network and expertise in the medical technology sector to distribute the products. The firm will make widespread availability of the biopsy closure device and ensure efficient delivery of this device to healthcare facilities across the US. Single Pass CEO Bill Colone said: “We are thrilled to partner with Mermaid Medical Group for the exclusive distribution of our biopsy closure device in the United States. “Mermaid Medical Group’s reputation for excellence and their commitment to advancing patient care aligns perfectly with our mission. Together, we aim to revolutionise biopsy closure procedures and improve patient outcomes.” Single Pass said the collaboration between both firms represents a noteworthy achievement in the field of biopsy closure technology. The integration of Single Pass’s device with Mermaid Medical Group’s broad distribution network is expected to provide US healthcare practitioners with an enhanced biopsy closure technique solution. Mermaid Medical Group general manager Marcus Nielsen said: “We are excited to collaborate with Single Pass and introduce their groundbreaking biopsy closure device to the US market. “This partnership reflects our dedication to providing healthcare professionals with innovative solutions that enhance patient care. “We look forward to working closely with Single Pass to make this device widely accessible to medical facilities across the country.”