Global Medical Device Podcast powered by Greenlight Guru A Breakthrough Device that Aims to Prevent Osteoporosis
Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone health? Osteopenia and osteoporosis are very common problems that don’t have completely effective solutions, yet.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Yecies, CEO of Bone Health Technologies, about the product journey of OsteoBoost, a vibration belt that aims to prevent osteopenia and osteoporosis that has recently received the FDA’s Breakthrough Device Designation (BDD).
Learn what the BDD experience was like and how their team is currently navigating the FDA regulatory process and collecting the necessary clinical data with the hopes of soon placing OsteoBoost on the US market.
Some of the highlights of this episode include:
- More than 50 million Americans are suffering from osteopenia and low bone density. Half of all women will have a fracture from osteopenia and osteoporosis - that’s more than heart attack, stroke, and breast cancer combined.
- As people get older, especially women, shrinking is a real issue that is usually due to a fracture that causes pain as well as breathing and digestive problems.
- People with hip fractures have a 20-plus percent mortality rate. Hip fractures are difficult to recover from and a high percentage of people lose their independence.
- Currently, there are no approved treatments for osteopenia. Basically, your only options are to get enough Calcium and Vitamin D and do high-impact exercise. Give your bones enough stimulation to lessen the decline.
- There are medications for osteoporosis. However, the side effects, the way they work, and indications for use are for people with osteoporosis.
- When vs. If: Most people will eventually get osteopenia. Heredity is a factor that influences less dense and smaller bones. Lifestyle matters, such as excessive drinking and smoking or steroid use can have an impact on bone density.
- Also, if you are an astronaut or go into space, bone loss is accelerated. Evidence from NASA shows that using whole body vibration improves bone density.
- People must use such a device regularly, it is expensive, and it requires doing nothing for a period of time. Bone Health Technologies is developing OsteoBoost, a more practical and easy-to-use product that leverages whole body vibration.
Memorable quotes from Laura Yecies:
“Osteopenia is an incredibly common problem, and we have over 50 million Americans suffering from low bone density.”
“If you walk around a nursing home, people are there typically for one of two reasons - they have Alzheimer’s or they have a hip fracture.”
“Most people will eventually get it.”
“There’s a body of evidence from NASA about using whole body vibration essentially to improve bone density. Astronauts lose a lot of bone when they are in space. Their bone loss is accelerated.”
Links:
U.S. Food and Drug Administration (FDA)
FDA: Breakthrough Devices Program
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast