SurgiBox Achieves CE Mark for SurgiField System Devices to Improve Access to Safe Surgery at the Point of Need

The CE Mark under the European Union's Medical Device Regulation (MDR 2017/745) standards certifies compliance with stringent health, safety, and environmental protection standards required for medical devices in the European Union. SurgiBox received CE Mark approval today for the SurgiBubble^™, the sterile device component of its SurgiField^™ System, an ultraportable technology platform integrating intraprocedural environmental control and personal protective equipment. Combined with the previously approved electronic filtration system, the complete SurgiField System is now ready for market deployment.

This milestone, spearheaded by SurgiBox co-founder Sashidhar Jonnalagedda and CTO Atif Rakin, marks the successful certification of conformity with the EU's Medical Device Regulation (MDR 2017/745) and ISO 13485:2016 standards - paving the way for commercial distribution across Europe and other key international markets.

The SurgiField System is a first-of-its-kind, ultraportable surgical environment that protects both patients and surgical teams from cross-contamination with bodily fluids. Medical professionals apply the disposable SurgiBubble to the patient's surgical site using standard draping techniques. They then activate operating room-quality HEPA airflow through the battery-powered Smart Control Module and pop-up frame. Surgeons insert their arms through integrated sleeve ports - similar to putting on surgical gowns - and proceed with the procedure as normal. The CE Mark approval is supported by comprehensive testing, including preclinical laboratory studies and usability data. These studies consistently demonstrated that the SurgiBubble protects the surgical site from the outside environment. Additionally, the SurgiField System seamlessly integrates into surgical workflows across diverse environments, from field conditions to established medical facilities.

Timely access to safe, clean surgery is a massive challenge globally across the spectrum of healthcare resources, with an estimated 5 billion people chronically lacking consistent access to safe surgery, resulting in 18 million preventable deaths annually. Even in high-resource settings with quality surgical facilities, ballooning costs, logistical challenges, and rising wait times have pushed surgeons and health systems to look toward alternative settings like hospital bedside, ambulatory surgery centers, birth centers, and clinic offices.

"This MDR CE certification marks a major inflection point for SurgiBox," said Dr. Mike Teodorescu, CEO of SurgiBox. "It reflects years of hard work and dedication to rigorous design, testing, and regulatory compliance, in collaboration with leading clinicians around the world who make up the 'SurgiClub.' With the new MDR CE Mark approval, we're finally ready to answer clinicians' requests to bring the SurgiField System to their patients."

"Ambit Health Ventures is immensely proud of SurgiBox's team and the invaluable support from its partners," said Dr. Sam Goldberger, a retired oculoplastic surgeon who is now a Board Director at SurgiBox and Managing Partner of Ambit Health Ventures."This CE Mark is a significant milestone, validating our long-term commitment to making safe surgery accessible to all, especially those facing crises. Furthermore, SurgiBox technology promises to expand access to safe surgery in areas with limited operating room infrastructure. Looking ahead, SurgiBox offers the potential to reduce healthcare costs significantly. The technology enables safe surgery to be performed in any setting, even non-sterile ones, within hospitals and private practices - procedures that would otherwise require a traditional expensive operating room. This CE Mark allows us to scale our global impact significantly."

SurgiBox is now actively fulfilling global sales orders and ramping up operational readiness to support a rapidly growing sales pipeline. The company is bolstering its supply chain and expanding its network of distributors to ensure smooth delivery and outstanding customer satisfaction.

Backed by new strategic partnerships, SurgiBox is accelerating market penetration and expanding its global footprint. The company has simultaneously launched a fundraising campaign to ensure the resources and capital needed to meet rising demand - offering investors the opportunity to support and share in its next phase of growth.

About SurgiBox: Headquartered in Cambridge, MA, USA, SurgiBox Inc. is a medical technology company committed to bringing safe surgery to patients, anytime, anywhere.

For further information, please see: www.surgibox.com.

SOURCE SurgiBox Inc