NASA-Based Vibration Treatment For Osteoporosis

Did you know that of the estimated 10 million Americans with osteoporosis, about eight million are women? That’s a whopping 80%! Women over 50 are especially at risk for this bone-weakening condition, along with osteopenia, which affects more than half of all postmenopausal white women and 35% of African-American women.

The numbers are staggering, with over three million osteoporotic fractures expected annually by 2025, costing $25 billion in healthcare expenditures.

Thankfully, advancements in vibration technology show promising results for improving bone strength without using medications that may have side effects. Bone Health Technologies has developed the OsteoBoost, a vibration belt designed to combat osteoporosis and osteopenia. OsteoBoost relies on 15 years of published research, including research from NASA.

FDA approval is expected in the coming months, making this a game-changing technology for women’s health.

Developing A Medtech Solution For Osteoporosis and Osteopenia

Despite 52 million people having osteopenia and their potential progression to osteoporosis, no approved nonpharmaceutical treatments exist for treatment. The adoption rate of pharmaceutical treatments for osteoporosis remains low.

In 2013, Dr. Shane Mangrum, a spine pain specialist and one of the founders of Bone Health Technologies, identified the need for non-pharmacological approaches to treat vertebral compression fractures in patients with osteoporosis. Born in TheraNova, the medtech incubator, Bone Health Technologies (BHT) has emerged as a potential game-changer for osteoporosis and its precursor, osteopenia. NASA’s work showed that mechanical stimulation of bones through vibration could improve bone density, so he developed the idea of utilizing whole-body vibration technology in a belt form named OsteoBoost.

The company received funding through a Small Business Innovation Research (SBIR) grant to conduct a proof-of-concept study. The results were encouraging, leading to a more significant grant of $2 million for a pivotal trial and winning an FDA Breakthrough Device Designation.

The results of the pivotal trial, conducted by the University of Nebraska Medical Center (UNMC) and published at the end of 2022, showed promise that people with osteopenia could relieve pain and prevent fractures by wearing the belt for 30 minutes, three-plus times a week.

Laura Yecies joined the company in September of 2020. She closed a Series A round of funding and was appointed CEO in April of 2023. Under her leadership, the company also applied for Breakthrough Device designation with the FDA, which was granted.

In 2021, the National Institute on Aging (NIA) of the National Institutes of Health (NIH) awarded BHT a $2.7 million Commercialization Readiness Pilot grant through the SBIR Program. This grant supports late-stage research and development and technical assistance programs focusing on age-related health innovations. In partnership with the San Francisco Veterans Affairs Health Care System, the University of California, San Francisco, and the Northern California Institute for Research and Education, BHT is conducting a one-year study to further demonstrate the effectiveness of its technology.

Bone Health Technologies has filed for Class 2 Prescription De Novo Approval with the FDA. The FDA’s De Novo request provides a marketing pathway to classify novel medical devices with reasonable assurance of safety and effectiveness through general and special controls. Still, it has no legally marketed predicate device without the De Novo.

“I’m hopeful that Medicare will reimburse it,” said Yecies. Healing fractures is expensive. The company has a very good correlation of data that OsteoBoost significantly impacts bone density and strength. “We are a cost-saving device.”

Diabetes has a comprehensive solution that includes treatment, education, nutrition, exercise, coaching, and tracking. This all-encompassing solution is Yecies’ vision for osteoporosis and osteopenia. “That’s what we aim to be,” she exclaimed.

Getting Buy-In From The Medical Community, Investors, And The Public

There is an attitude that osteoporosis only affects frail old ladies. “Fracturing from low bone density is more common than combined heart attack, stroke, and breast cancer,” said Yecies. “We need to change our societal expectations.”

Women must stay active and strong, as much as possible, through their later years. It’s not just about living longer; it’s living in a way where you don’t have pain from vertebral fractures, so you can be active and play with your grandchildren. “We need to change the mindset that this is a condition that you just have to accept,” Yecies.

There’s a lot of skepticism out there that a non-pharmacological treatment can work. Osteoporosis medications can be life-saving, but many people don’t like the side effects, so less than 10% of patients get standard care treatment after fracture. OsteoBoost can prevent fractures and the loss of inches of height.

Getting the word out to the medical community at conferences and having a top-tier Scientific Advisory Board is critical. Reaching women where they are, whether that is through social or traditional media, is also essential.

This period is a challenging funding environment. Interest in funding women’s health is growing. Still, “women’s health receives a tiny percentage of funding for medical devices and therapeutics,” said Yecies. “So I think we’ll overcome it, but it’s challenging.”

Women-led venture capital funds such as Portfolia, Golden Seeds, Astia, and Good Growth Capital, and women angel investors have played a critical role in understanding the need for investment in women’s health and energizing further investment. These women provide the first money and build momentum. “The first half of the raise is the hardest,” said Yecies.

How are you changing mindsets?