MVITRO's ORTIV Receives FDA Clearance for Needle-Free Blood Sampling
Key Insights
MVITRO (search)'s ORTIV (search), a laser-based device for painless blood sampling and glucose monitoring, has secured FDA 510(k) clearance, marking a significant advancement in diabetes (search) management.
ORTIV (search) utilizes micro-lasers to minimize skin damage and eliminate infection risks, offering real-time glucose readings via a dedicated app, addressing the stress of traditional blood sampling.
Following FDA approval, MVITRO (search) has seen increased interest from global pharmaceutical and medical device companies, including a contract with U.S.-based Applied Science Inc.
MVITRO (search), a Korean laser-based home healthcare devices maker, announced that its first device, ORTIV (search), has received 510(k) clearance from the U.S. FDA. This innovative device offers a needle-free solution for blood sampling and glucose monitoring, potentially revolutionizing diabetes (search) management.
ORTIV (search) employs micro-lasers to painlessly draw blood and measure blood glucose levels, eliminating the need for disposable needles. The glucose readings are instantly transmitted to MVITRO (search)’s dedicated app for real-time monitoring. According to MVITRO, the device significantly reduces pain, making blood sampling nearly painless. The high-temperature laser technology minimizes skin damage and eliminates infection risks.
Industry Interest and Collaborations
Following FDA approval, MVITRO (search) has experienced a surge in inquiries from global pharmaceutical and medical device companies regarding ORTIV (search)’s potential in the North American market. Applied Science Inc. (ASI), a U.S.-based medical equipment supplier, signed a contract with MVITRO prior to the FDA approval. Additionally, Vitalant, a major blood donation organization in the U.S., is collaborating with MVITRO to co-develop a painless, laser-based hemoglobin measurement device.
While many companies and hospitals have expressed interest, details remain confidential due to ongoing contracts. MVITRO (search) aims for a B2C model but is currently focusing on interest from medical device companies, pharmaceutical companies, and hospitals. A major Korean pharmaceutical company, which remains undisclosed, is preparing to exclusively distribute ORTIV (search). MVITRO is also exploring export opportunities in Europe, China, and Southeast Asia.
Expansion and Future Developments
MVITRO (search) anticipates gaining sales approval for ORTIV (search) in Korea by the first half of next year and in Europe by the second half. The company is also developing a painless laser blood sampling device for diagnosing various diseases, commissioned by Japan’s Toyobo (search), a manufacturer of enzymes, antibodies, and antigens for diagnostic applications.
Addressing Diabetes Prevalence
According to the Korea Disease Control and Prevention Agency (KDCA), 16.3% of Korean adults over 30 had diabetes (search) in 2021, affecting approximately 6 million people. Including prediabetics, around 63% of adults—or 23 million people—require management. Globally, approximately 1 billion people have diabetes, with an estimated 2.5 billion, including prediabetic individuals, needing care.
CEO's Perspective
MVITRO (search) CEO Lee Young-woo stated, “We spent seven years developing this technology due to the challenges of reducing pain during blood sampling. We understand how stressful blood sampling is for diabetes (search) patients and wanted to make it nearly pain-free with ORTIV (search), which we believe is a groundbreaking solution.” Lee emphasized that ORTIV offers an innovative alternative to the painful blood sampling methods used by type 1 and severe diabetes patients who rely on continuous glucose monitoring (CGM) devices.