FDA Clears OsteoProbe® (K250216): First-Ever Device Indication for Measuring Bone Material Strength

SANTA BARBARA, Calif., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Active Life Scientific, Inc. (ALSI), a leader in innovative medical devices for bone quality, today announced that the U.S. Food and Drug Administration (FDA) has granted a new 510(k) clearance (K250216) for OsteoProbe®, marking a historic milestone as the first device with an indication to measure the Bone Material Strength index (BMSi). This novel metric, called BoneScore® commercially, offers a direct, minimally-invasive assessment of bone tissue quality, significantly correlating with whole bone strength at critical fracture sites—the hip, wrist, and spine—as well as traditional mechanical properties such as fracture toughness.

Osteoporosis and related fragility fractures affect more than 10 million Americans, with indirect costs exceeding $19 billion annually. Current diagnostic tools, like dual-energy X-ray absorptiometry (DXA), primarily measure bone mineral density (BMD), which explains only about 70% of bone strength variability. OsteoProbe® addresses this gap by using reference point microindentation (RPI) technology—a quick, office-based procedure performed on the mid-tibia—to quantify BMSi, revealing intrinsic bone material properties that BMD scans miss.

"This clearance represents a paradigm shift in how we evaluate and manage bone health," said Alexander Proctor, Founder of Active Life Scientific. "For the first time, clinicians can measure bone strength in a simple, point-of-care setting, providing actionable data that correlates strongly with bone strength at the hip, wrist, and spine. By integrating OsteoProbe® into routine assessments, we hope to identify at-risk patients earlier, personalize treatment plans, and ultimately reduce the devastating impact of fractures."

The clearance was based on an NIH funded Phase II Small Business Innovation & Research grant (R44AG071034) that demonstrated that BMSi measurements from OsteoProbe® exhibit strong correlations with ex vivo whole bone strength testing across multiple skeletal sites, including hip and spine models, and aligns closely with established metrics like fracture toughness and post-yield deformation. The device is indicated for use in adults to assess bone material strength as an adjunct to other diagnostic tools, enabling physicians to make more informed decisions.

"Traditional bone density tests are invaluable, but they don't tell the whole story,” noted Mr. Proctor. "Measuring intrinsic tissue strength offers a game-changing complement to DXA, particularly for patients with normal or osteopenic BMD. Our goal is to transform care from reactive to proactive."

With this expanded indication, OsteoProbe® builds on ALSI's foundational De Novo classification (DEN210013), which established it as the first FDA-cleared microindentation device for bone tissue assessment. The handheld system is designed for ease of use in outpatient settings, requiring minimal training and delivering results in under five minutes.

About Active Life Scientific, Inc. Active Life Scientific, Inc. (ALSI) is a privately held medical device company dedicated to advancing bone health through innovative technologies. ALSI's OsteoProbe® platform empowers clinicians to go beyond bone density, delivering precise measurements of bone material strength to improve patient outcomes and reduce fracture-related healthcare burdens. For more information, visit www.bonescore.com.

Media Contact: Alexander Proctor, Founder & CEO

Phone: (805) 770-2600

Email: info@activelifescientific.com

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