Osteoboost Launches First FDA-Cleared Prescription Wearable Nationwide to Combat Low Bone Density

What You Should Know: 

– Osteoboost Health announced the nationwide availability of Osteoboost, a groundbreaking prescription medical device. Osteoboost aims to provide hope for millions diagnosed with low bone density, helping to reduce the risk of fractures that can severely impact mobility and independence.

– As the first and only FDA-cleared device of its kind for low bone density, Osteoboost introduces a novel, protective, and preventative approach to bone health, offering a new option for tens of millions of individuals currently without effective interventions.

– The launch comes as societal views on aging are evolving. The traditional idea of “aging gracefully” is increasingly being replaced by a vision of longevity centered on maintaining strength and an active lifestyle, with bone health recognized as a pivotal component. 

Wearable Device for Bone Health

Osteoboost is a novel wearable device that seamlessly integrates next-generation consumer health technology with rigorously tested medical innovation. Designed for convenient at-home use, the clinically proven device delivers targeted, precisely calibrated vibration therapy directly to the spine and hips—areas particularly susceptible to osteoporotic fractures.

More than just a user-friendly wearable, Osteoboost is an FDA-cleared medical device. It received Breakthrough Device designation from the FDA and was approved through the De Novo pathway. Its patented vibration technology was validated in a gold-standard randomized controlled trial, demonstrating its ability to significantly slow the loss of vertebral bone density and strength.

Addressing the Silent Threat of Osteopenia

While osteoporosis typically garners more attention, over half of all fragility fractures occur during osteopenia, its precursor stage. In the United States, a staggering 54% of postmenopausal women are affected by osteopenia. Historically, treatment options have largely focused on medications prescribed primarily in the osteoporosis stage, often only after a fracture has occurred. Osteoboost aims to fill this critical treatment gap.

Leading the charge at Osteoboost is CEO Laura Yecies, a seasoned entrepreneur with over three decades of experience building and scaling companies, including a prior startup sold to Apple.

“The longevity conversation is everywhere, but people rarely mention bone health even though it is fundamental to aging with confidence,” said Yecies. “Osteoboost empowers people to lead longer, stronger, and more active lives. And while the belt is sophisticated medical technology rigorously tested and validated for efficacy, the treatment is so easy – 30 minutes a day of gentle vibration therapy that can be done while walking, cooking, or other daily activities.”

Clinically Proven Efficacy in Slowing Bone Loss

The efficacy of Osteoboost was demonstrated in a gold-standard, double-blinded, placebo-controlled clinical trial conducted at the University of Nebraska Medical Center. The study focused on postmenopausal women with osteopenia who used the device at least three times per week. The results were significant:

• 85% reduction in the loss of bone density in the spine
• 83% reduction in the loss of bone strength in the spine
• 55% reduction in the loss of bone density in the hip

The trial also reported no serious adverse events from the device and noted over 80% patient compliance, highlighting its safety and ease of use.

Expanding Accessibility and Strategic Growth

To make Osteoboost more accessible, the company has partnered with Beluga Health to offer online prescription consultations. This gives patients the flexibility to obtain a prescription either through their personal physician or conveniently from home via the online service, streamlining access to this new treatment.

Osteoboost Health also announced new strategic investments from AARP, Harvard Business School Angels, and She’s Independent, along with a follow-on investment from Esplanade Healthtech Ventures. These investments will support the nationwide rollout and further development.

Further strengthening its position, the company recently secured its sixth U.S. patent for its vibration technology. Last July, Osteoboost Health strategically acquired Wellen, an online exercise and fall prevention platform tailored for women with low bone density, indicating a commitment to a comprehensive approach to bone health and active aging.

Cost/Availability

Osteoboost is currently available for a special launch price of $995 for self-pay. The company is currently working to secure coverage from major insurers and Medicare, Osteoboost is eligible for payment from your FSA or HSA account.