Steve DiGioia

FDA Clears Breakthrough Non-Drug Device for Low Bone Density Treatment

fda-clears-breakthrough-non-drug-device-for-low-bone-density-treatment

A new belt has been approved by the FDA that delivers targeted shocks to the spine and hips. This groundbreaking medical device is the first of its kind to effectively address low bone density, a significant risk factor for osteoporosis. 

A new device has been developed that offers women who have gone through menopause the opportunity to take vitamin and mineral supplements, based on promising results from clinical studies.

Women who have gone through menopause have a higher risk of experiencing bone fractures due to the absence of estrogen. 

When estrogen levels decrease, it can lead to osteopenia, a condition characterized by low bone density. 

Estrogen plays a crucial role in maintaining bone density. A significant percentage of individuals globally are affected by osteopenia, a condition that has the potential to progress into osteoporosis.

Osteoboost is a cutting-edge wearable device developed by Bone Health Technologies (BHT) that utilizes gentle shocks to stimulate bone growth in the lower back and hips. 

The device has recently received FDA clearance for the treatment of osteopenia. This is the first non-drug prescription medical gadget to receive such approval.

On January 18, when the FDA announced its news, Laura Yecies, CEO of BHT, expressed her excitement, stating, “This groundbreaking decision marks a significant milestone in the treatment of this prevalent and severe condition.” 

“Osteoboost offers a fresh treatment alternative that aligns with the body’s innate ability to stimulate bone growth. 

It does not cause any significant side effects. Women’s health has been neglected for far too long. 

This development represents a significant advancement for older women who have been lacking access to effective treatment options and are seeking solutions to maintain optimal bone health.

Whole-body vibration therapy (WBVT) is a form of technology developed by NASA to address the issue of bone density loss in pilots working in zero gravity environments. 

This is achieved by simulating the mechanical stress experienced by bones during high-impact exercise. 

Research has indicated that WBVT has a positive impact on bone growth and may be effective in preventing bone loss in older women, particularly in the hips and lower back. 

WBVT is typically delivered through a standalone rotating platform. Instead, Osteoboost delivers gentle shocks to the hips and lower back, targeting the areas most prone to osteoporotic fractures.

FDA Approves Osteoboost: Promising Bone Density Treatment

fda-clears-breakthrough-non-drug-device-for-low-bone-density-treatment
A new belt has been approved by the FDA that delivers targeted shocks to the spine and hips.

The FDA granted approval after reviewing the findings of a clinical study assessing the effectiveness of Osteoboost. 

The findings were published in the Journal of the Endocrine Society. A randomized controlled study included 126 women over 50 who had low bone density and had undergone menopause. 

The Osteoboost treatment was administered five times a week for a year, using either the active setting or a fake setting.

In the fictional scenario, the device emitted a noise but failed to deliver an electric shock. There were significant variations in the percentage change in vertebral bone strength among individuals in the 50–60-year-old age group. 

The group that received the sham treatment experienced a significant decrease of 3.4% in their vertebral bone strength, whereas the group that received the active treatment only experienced a minimal decrease of 0.5%. Individuals who consistently adhered to the Osteoboost treatment regimen three times a week experienced a reduction of 2.84% in their bone strength, whereas the exercise group only saw a decrease of 0.48%.

It is worth noting that the group in question experienced a significant decrease in bone strength, five times greater than expected. 

The Osteoboost treatment effectively maintained the bone density of the first lumbar vertebra (L1). 

The active group experienced a decrease of 0.29% in bone mineral density (BMD), while the sham group had a much larger decrease of 1.97%, which is 6.8 times greater than the active group.

“The decline in estrogen and subsequent rapid loss of bone mass in women poses a significant threat to their overall health and ability to maintain an active lifestyle,” stated Laura Bilek, the primary researcher of the study. 

Modifications in lifestyle, such as engaging in physical activity and adopting a healthy eating regimen, have a positive impact on bone health, albeit a modest one. 

It appears that Osteoboost may have the potential to slow down the decline of bone mass and strength, potentially addressing gaps in current treatment options.

When BHT requested FDA approval for Osteoboost prior to its designation as a Breakthrough Device, they utilized the De Novo classification process, which allows for the categorization and marketing of new medical devices. 

With its approval, a whole new range of treatments for low bone density that do not rely on medication are now available. 

Osteoboost is crucial because it is the pioneering medical gadget that has been developed and approved for the treatment of osteopenia.

Currently, the primary method of addressing osteopenia involves the use of calcium and vitamin D supplements.

According to David Karpf, an Adjunct Clinical Professor of Endocrinology, Gerontology, and Metabolism at Stanford University School of Medicine, there is a lack of innovative approaches in the field of bone health. 

There haven’t been any recent developments in clinical trials for osteoporosis, and unfortunately, there are no new options available for women with osteopenia. 

Due to the aging population, it is crucial to find innovative methods to combat the decline in bone mass and strength that women experience during or after menopause.

 

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