In a recent interview with PharmaShots, Laura Yecies, CEO of BoneHealth Technologies shared her views on OsteoBoost Vibration Belt that has been granted 'Breakthrough Device' designation by the US FDA

Shots:

• OsteoBoost receives the US FDA's BDD to reduce the risk of osteoporosis. It uses vibration technology that delivers mechanical stimulation to the hips & spine at a precise, individually calibrated frequency, encouraging the body to reduce bone resorption & potentially create new bone
• An initial study showed that just one 30min treatment with OsteoBoost reduced bone loss activity in all participants, showing a decrease of 14%, a reduction on par with bisphosphonate drugs
• The NIH funded a $2M to study for determining the positive effects of OsteoBoost in a larger study with a broader population. The study is currently enrolling patients & is scheduled to be completed in early 2022

Tuba: Can we discuss a little about Osteoporosis and how can a medical device be helpful (in the general overview)?

Laura: A healthy human body is constantly going through the cycle of creating new bone and resorbing old bone. When we are young, we create more bone than we resorb, and our bone density increases as a result. As we get older, this process reaches an equilibrium where we are making new bone and reabsorbing old bone at consistent rates. When we reach middle age the balance starts to swing towards making less bone than we resorb, especially if we aren't consistently doing high impact exercise that stimulates the body to make bone to withstand the impact. Osteoporosis, and its precursor, osteopenia, is a condition where the body is no longer making bone at the rate it used to, and the bones become more fragile and prone to fractures. As we age, the hips and spine are especially at risk for fractures. 

A medical device like OsteoBoost can be helpful to combat low bone mass (osteoporosis and osteopenia) because it simulates high impact exercise and essentially triggers the body to make more bone than it would have otherwise. This can tip the balance back to equilibrium so that someone with osteopenia (the first stage of significant bone loss) is no longer losing bone at a rate that will cause them to develop osteoporosis, preventing further bone loss and improving their chances of avoiding fractures.

Tuba: Can you tell us in detail about the mechanism of action for OsteoBoost, how it works?

Bone Health

Laura: The body responds to high impact exercise (a form of mechanical stimulation) by trying to strengthen itself to withstand future impact through the creation of new bone and reduction of bone resorption (the body's process of breaking down old bone). High impact exercise is a form of vibration, where the 'shockwaves' from the impact of your foot on the ground (e.g. running) sends vibrations through the skeleton, stimulating a response from the body to strengthen itself (i.e. the body thinks: I need to make more bone and resorb less bone to withstand future impact). OsteoBoost mimics the mechanical stimulation of high impact exercise by sending a gentle vibration through the hips and spine, signaling to the body that it needs to strengthen itself by resorbing less bone and making more new bone. The precise vibration strength and frequency is proprietary, but it has been shown in clinical studies to be safe, comfortable and effective.

Tuba: Do we discuss more on how vibration can be an effective treatment for osteoporosis patients? Share some research with our readers.

Laura: Vibration was first shown to be effective in reducing bone loss and encouraging bone growth through NASA-funded research. Astronauts tend to lose bone mass when they are in space because without gravity, their bodies see the less mechanical impact with movement. Thus, their bones are used less, so the body resorbs more bone and makes less. The first effective vibration treatments for preventing bone loss were vibration platforms that people stand on for 20-30 mins, These platforms send the vibration through the legs into the rest of the skeleton. While these products worked, the delivery of the vibration was inconvenient (having to stand in one place for 30 mins). OsteoBoost leveraged the NASA research and technology by developing a localized, targeted vibration treatment that stimulates the hips and spine (the areas most prone to debilitating fractures) with a gentle vibration. The OsteoBoost thus encourages the body to shift away from further bone loss towards equilibrium again (making bone and absorbing bone at approximately the same rate and therefore keeping bones stronger as we age). The key innovation of the OsteoBoost is packaging the vibration into a wearable belt that can be worn while doing normal daily activities, making it convenient and easy to incorporate into daily schedules.

Research:

Localized vibration belt:https://www.ors.org/Transactions/64/0725.pdf

Tuba: Discuss in detail about the significant advantages of this OsteoBoost.

Laura: OsteoBoost is very easy to use, comfortable, convenient, and has clinically proven effectiveness. There is no other product on the market with this combination of features. It's as simple and comfortable as wearing a belt. Simply wrap it around you, secure the Velcro, and press start. There is a built-in timer so it will automatically shut off after 30 mins (the recommended treatment time) and you can use it during your normal daily activities like going for a walk, getting ready in the morning, cooking, etc. The vibration is gentle and soothing, with many users reporting that it actually relaxes their lower back muscles. It is proven to reduce bone loss activity, with no side effects, and it is targeted at the parts of the body where a fracture is most devastating the hips and spine. Mortality and morbidity rates are high for hip fractures, and microfractures of the spine are what lead to the hunched-over posture that so many people associate with osteoporosis.

Tuba: Can you discuss the data of the initial study in all study participants?

Laura: All 17 post-menopausal women experienced a reduction in the amount of bone they were losing as measured by the biomarker NTX, a standard mechanism to measure bone loss. The average reduction in bone loss across all 17 subjects was 14% and that was after only ONE 30 minute treatment. This is similar to the reaction the body has after high impact exercise or osteoporosis drug treatments.

Tuba: Does Bone health Technologies have any subgroup analysis where any specific population is benefitting more from the device

Laura: We will have this data once the pivotal study is complete, but the initial study did not provide this level of granularity. We don't anticipate that there will be significant differences in patient sub-groups though, as we believe the mechanism of action will have a similar effect on anyone with osteopenia.

Tuba: Describe in your own words how this device is a game-changer in the care of bones health. 

Laura: There is currently no good option for people who are diagnosed with osteopenia. They are told to take calcium (which is marginally helpful), get more high impact exercise (studies have shown that walking is not enough), and they have sometimes prescribed a drug treatment (which can have side effects and is unpleasant for many to take so only 25% of people who are prescribed the drugs complete their treatment). Now with OsteoBoost they will have an easy and convenient way to prevent further bone loss, prevent the onset of osteoporosis, reduce their chance of a debilitating fracture, and all without side effects or the inconvenience or aches and pains associated with high impact exercise.

Tuba: When can we expect to launch of the OsteoBoost Vibration belt?

Laura: We expect OsteoBoost to be available midway through 2022.

Tuba: Is Bone health technologies planning to partner or license OsteoBoost. If yes? Then for what geographies?

Laura: No specific plans for partnering or licensing at this point, but we are active in the bone health community and future collaborations or partnerships are possible.

Tuba: Additionally, any highlights from the program and preparation process over the last few months. 

Laura: The FDA Breakthrough Device designation is further evidence that those who understand bone health and the challenges of treating osteopenia and osteoporosis believe in the potential for this product. The initial study data was so promising, and this is such a big problem to solve, that the National Institutes of Health provided $2 million in funding for us to pursue the pivotal study. Now FDA has also recognized the potential for this new treatment based on their own analysis, further validating our belief that this is a game-changing technology that can help millions of Americans and eventually people around the world to fight osteoporosis and prevent fractures.

Image Source: Jenny Craig Community

About Author:

Laura Yecies is an experienced CEO, Marketer, and Strategist with a proven ability to develop and market award-winning products, scale businesses as well as profitably exit. She currently is working with a select group of medical technology companies with breakthrough innovations to improve health outcomes.

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