FDA Grants Clearance for Groundbreaking Bone Measurement Device

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Dec 01, 2021, 17:07 ET

SANTA BARBARA, Calif., Dec. 1, 2021 /PRNewswire/ --

The Bone Score™ assessment is a fundamentally new approach to measuring bone.
Using groundbreaking technology, the assessment introduces established engineering principals to the field of bone health by enabling physicians to physically test bone tissue at a microscopic level.
Bone Score™, along with other diagnostic tests, helps physicians assemble a more comprehensive understanding of a patient's bone health.

Active Life Scientific, Inc. (ALSI) today announced it has received U.S. Food and Drug Administration De Novo clearance for its groundbreaking bone measurement device. The Bone Score™ assessment takes a fundamentally new approach to measuring bone and uses innovative technology to physically test bone tissue. It can be used, along with other diagnostic tests, to help physicians assemble a more comprehensive understanding of a patient's bone health. The recent U.S. clearance follows CE Mark in Europe (obtained in 2017) and marks an important step in expanding tools available to physicians who manage bone health.

"People are often shocked to learn that bone density is only one part of having strong healthy bones. In fact, most patients who suffer a fracture due to fragile bones do not have osteoporotic bone density," said Dr. Paul Hansma, a UC Santa Barbara Professor of Physics who invented the technology behind Bone Score™. "There's a difference between how much bone you have, or density, and how good your bone tissue is, or quality. Unfortunately, the clinical assessment of quality remains a 'black box'. The Bone Score™ test quantifies how bone tissue resists a physical challenge, on a safe, microscopic level, and provides previously unavailable data for physicians to consider when investigating the quality of a patient's bone."

A safe and radiation-free in-office assessment, Bone Score™, is differentiated from other radiological or imaging methods (X-ray, DEXA and CT) that measure bone mineral density and structure. It is a physical method, using a novel device (the OsteoProbe®), that is quantified as Bone Material Strength index (BMSi) or Bone Score™, and provides physicians with previously unavailable information that they can consider, along with other factors, when evaluating a patient's bone health.

"It's been decades since a new measurement method was introduced to the field of osteoporosis, as DEXA and ultrasound technologies have been widely used since the 1990s," said Dr. Peter Burks, the CEO of ALSI. "New clinical tools are desperately needed to understand the health of our bones. Many diseases have a library of measurement tools available, but bone health management remains mostly limited to radiation-based imaging technologies. Physical interaction with bone tissue unlocks a previously unavailable data stream for physicians to consider when evaluating their patients."

To learn more, or to find a clinic that offers the Bone Score™ test, visit www.bonescore.com.

About ALSI, Inc.: ALSI is a medical technology company that has developed a fundamentally new approach to measuring bone. They develop life science research and measurement tools to quantify physical properties of tissues without the need for an invasive biopsy. The company is headquartered in Santa Barbara, California.

Contact Information
Media Relations
[email protected] / 1-805-770-2600
www.bonescore.com / www.activelifescientific.com

SOURCE Active Life Scientific, Inc.