“Measure what is measurable, and make measurable what is not so.” – Galileo Galilei
Our skeleton is one of the most important organs in the human body. Our bone integrity plays a critical role in our overall wellbeing. The integrity of our bones can greatly affect the physical health of people as they age. Despite playing a critical role in our health, collecting data about the current state and quality of an individual’s bones has not always been a simple task. This was the case until Active Life Scientific entered the market. The medical device company developed a modern and accurate technology that assesses bone health. Their goal is to help physicians and patients maintain a healthier and active lifestyle.
Active Life Scientific was founded in 2007 by UC Santa Barbara (UCSB) physics undergraduate student Alexander Proctor with the help of fundamental research conducted by Professor Paul Hansma, PhD. from the Department of Physics. Dr. Hansma invented the Reference Point Indentation (RPI) method for clinically measuring tissue material properties, which inspired Proctor to apply for a research assistant position in the professor’s lab. There, Proctor produced the first prototypes for this technology and entered the idea into UCSB’s New Venture Competition, ultimately winning two of the top awards. Proctor started the company after graduating college.
The Santa Barbara based company used RPI technology to develop OsteoProbe®, a portable handheld microindenter that measures bone material quality. OsteoProbe® uses a single-use, acupuncture-like tip that makes a microscopic subcutaneous measurement, and directly quantifies bone health by safely and gently touching the bone. Measuring bone material quality has never been possible before and cannot be done by currently available indirect methods. The current standard of care is an x-ray scan called the DEXA. It measures bone mineral density or BMD. DEXA is excellent at identifying patients with low bone mass; in other words, patients who do not have enough mineralized calcium in their skeleton. However, the bone density scan, or DEXA, misses over 50% of the patients who fracture. Changes in BMD can take over a year to show any changes as a result of disease or treatment. Another key element to bone health besides how much bone is present is the quality of the one material itself. Just like better quality or stronger building materials for your home, good bone material is critical for a healthy skeleton. Bone material quality has never been measurable in a clinic. OsteoProbe® is the first medical device to directly quantify bone material quality.
Rather than using intrusive methods like incisions or biopsies to quantify bone material quality, the OsteoProbe® allows for a quick and easy five-minute procedure with immediate results. The output from the device is a Bone Score™ ranging from 40 to 100 (softer bones have lower scores). This is a fundamentally new approach for measuring bone integrity. The OsteoProbe® is currently an approved medical device in Europe and has led to research that is changing the medical industry and helping people around the world live a longer and more active life.
In November 2017, Active Life Scientific was established as an ISO 13485 medical device manufacturer and obtained the European regulatory approval CE Mark. In 2018, the company submitted an application to the Food and Drug Administration to obtain approval of OsteoProbe’s® clinical use in the United States. The Company also applied for and received a reimbursement code (CPT III) from the American Medical Association for the procedure. OsteoProbe® is well on the way to aiding patients and physicians worldwide better understand bone health. Top medical researchers, scientists and physicians all around the world are conducting ongoing studies to discover new ways of using OsteoProbe® and how to improve bone material quality.