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Thorne HealthTech’s OneDraw™ Blood Collection Device Receives PMDA Certification in Japan
NEW YORK (August 23, 2022) – Thorne HealthTech, Inc. (“Thorne HealthTech” or “Thorne”) (NASDAQ: THRN), a leader in developing innovative solutions for a personalized approach to health and wellness and majority owner of Drawbridge Health announced today that its OneDraw™ Blood Collection Device has been certified in Japan as a medical device, having been cleared by the Pharmaceutical and Medical Devices Agency (PMDA).
“This is a major victory for the OneDraw device because the PMDA has notoriously stringent qualifications to clear a device,” said Paul Jacobson, CEO of Thorne HealthTech. “The device’s clearance paves the way forward to providing high-quality testing and on-demand care while greatly improving the user’s overall experience. We appreciate the help from our partners in Japan because we believe this will create many additional opportunities to expand our relationships globally, while we continue to move forward on a similar regulatory pathway in the United States.”
OneDraw is a small, lightweight device that incorporates two miniature lancets to make an incision in the skin and then a built-in vacuum draws blood to the skin’s surface. The blood is deposited onto a dried stabilization matrix within a removable cartridge. The convenient, contamination-free cartridge is then inserted into a transport sleeve that encloses and protects the sample during shipping to a clinical laboratory. This automated system enables a standardized blood sample collection with minimal instruction, and samples can be stored at room temperature for up to 28 days through proprietary cold-chain-free storage technology. OneDraw uniquely facilitates remote sample collection anytime and anywhere in a convenient, comfortable way.
“PMDA certification further reinforces the fact that OneDraw is putting health in the hands of the individual and is reshaping how we think about health-care accessibility,” said Jerome Scelza, Co-CEO of Drawbridge Health. “The OneDraw technology will transform the way patients access their health information. We intend to bring this technology to the Japanese market, where we believe near pain-free blood collection will have a tremendously positive impact on health outcomes by enabling individuals to have greater control over their health.”
In addition to the recent PMDA approval, OneDraw is already approved by the FDA as a Class II medical device, and it has a European Conformity mark for supervised use by health-care professionals to collect blood samples to measure HbA1c for monitoring the long-term control of blood sugar (glucose) in diabetic individuals.
Thorne HealthTech is currently analyzing additional OneDraw applications and anticipates the device will contribute to its long-term core focus on healthy aging, longevity, and precision wellness.
About Thorne HealthTech:
Thorne HealthTech is a leader in developing innovative solutions for delivering personalized approaches to health and wellness. As a science-driven wellness company that empowers individuals with the support, education, and solutions they need to achieve healthy aging – living healthier longer – Thorne utilizes testing and data to create improved product efficacy and to deliver personalized solutions to consumers, health professionals, and corporations. Predicated on the power of the individual, Thorne leverages artificial intelligence models to provide insights and personalized data, products, and services that help individuals take a proactive and actionable approach to improve and maintain their health over a lifetime. Thorne is the only supplement manufacturer that collaborates with Mayo Clinic on health and wellness research and content, and is trusted by more than five million customers, 46,000+ health-care professionals, thousands of professional athletes, and more than 100 professional sports teams and U.S. National Teams. For more information, visit Thorne.com.
About Drawbridge Health
Drawbridge Health is a healthcare technology company focused on reinventing the blood draw experience, enabling comfortable convenient blood sample collection anytime and anywhere. By integrating engineering, chemistries and modular design, Drawbridge Health has developed a people-friendly system for collecting and stabilizing blood samples, opening new doors to enable access to important health information. For more information, please visit www.drawbridgehealth.com.
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