Did you know that of the estimated 10 million Americans suffering from osteoporosis, approximately 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 more than three million osteoporotic fractures expected to occur annually by 2025, costing $25 billion in health care expenditures.
Thankfully, advances in vibration technology show promising results for improving bone strength without the use of medications that may have side effects. Bone Health Technologies has developed 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 non-pharmaceutical treatments exist for treatment. Adoption rates of pharmaceutical treatments for osteoporosis remain low.
In 2013, Dr. Shane Mangrum, a spine pain specialist and one of the founders of Bone Health Technologies, identified the need for a non-pharmacological approach to treating vertebral compression fractures in patients with osteoporosis. Born out of Theranova, 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 they developed the idea of using whole body vibration technology in the form of a belt called 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 $2 million grant for further testing and winning FDA Breakthrough Device designation.
The results of the pivotal trial, conducted by the University of Nebraska Medical Center (UNMC) and published in late 2022, showed that people with osteopenia can get pain relief and prevent fractures by wearing the belt three times a day for more than 30 minutes. one week.
Laura Yessis joined the company in September 2020. He completed a Series A round of funding and was appointed CEO in April 2023. Under his leadership, the company also applied for Breakthrough Device designation with the FDA, which was approved.
In 2021, the National Institute on Aging (NIA) of the National Institutes of Health (NIH) awarded a $2.7 million Commercialization Readiness Pilot grant to BHT 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 applied to the FDA for Class 2 prescription de novo approval. FDA’s de novo solicitation provides a marketing pathway to classify innovative medical devices with reasonable assurance of safety and effectiveness through general and specific controls. Nevertheless, without de novo it has no legally marketable predicate device.
“I’m hopeful that Medicare will reimburse it,” Yessis said. Fractures are expensive to repair. The company’s data has a very good correlation that OsteoBoost has a significant effect on bone density and strength. “We are a cost-saving device.”
There is a comprehensive solution to diabetes that includes treatment, education, nutrition, exercise, coaching and tracking. This all-in-one solution is Yesease’s approach to osteoporosis and osteopenia. “This is our goal,” he shouted.
Getting buy-in from the medical community, investors, and the public
There is a perception that osteoporosis only affects frail older women. “Due to low bone density, fractures are more common than heart attacks, strokes and breast cancer combined,” Yessis said. “We need to change our societal expectations.”
Women should remain as active and strong as possible in the last years of their lives. It’s not just about living longer; It’s about living this way where you don’t have pain from a vertebral fracture, so you can remain active and play with your grandchildren. “We need to change the mindset that this is a condition you have to accept,” Yessis.
There is much doubt that non-pharmacological treatments can work. Osteoporosis medications can be lifesaving, but many people don’t like the side effects, so less than 10% of patients receive standard care treatment after a fracture. Osteoboost can prevent fractures and loss of inches of height.
Getting your point across to the medical community at conferences and having a top-level scientific advisory board is important. Reaching out to women where they are, whether through social or traditional media, is also essential.
This period is a challenging funding environment. There is growing interest in financing women’s health. Still, “women’s health receives a small percentage of funding for medical devices and treatments,” Yessis said. “So I think we’ll overcome this, but it’s challenging.”
Women-led venture capital funds such as Portfolio, Golden Seeds, Estia and Good Growth Capital and women angel investors have played an important role in recognizing the need to invest in women’s health and activating further investments. These women provide the first money and drive momentum. “The first part of the hike is the hardest,” Yessis said.
How are you changing mindsets?