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Designing for the FDA

How we reduced Exogen’s risk during FDA review with a clear vision for testing and reporting

Bioventus’ first-generation device, EXOGEN, was a remarkable breakthrough. It gave patients a simple, painless way to stimulate bone healing, at home, in only 20 minutes per day.

But bone healing takes time—up to six months—and patients were losing motivation. Only half of patients were staying on track through the end, making EXOGEN less effective for patients, less powerful for physicians, and a less compelling candidate for reimbursement to insurance companies.

Bioventus’ first-generation device, EXOGEN, was a remarkable breakthrough. It gave patients a simple, painless way to stimulate bone healing, at home, in only 20 minutes per day.

But bone healing takes time—up to six months—and patients were losing motivation. Only half of patients were staying on track through the end, making EXOGEN less effective for patients, less powerful for physicians, and a less compelling candidate for reimbursement to insurance companies.

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An optional caption

Bioventus’ first-generation device, EXOGEN, was a remarkable breakthrough. It gave patients a simple, painless way to stimulate bone healing, at home, in only 20 minutes per day.

But bone healing takes time—up to six months—and patients were losing motivation. Only half of patients were staying on track through the end, making EXOGEN less effective for patients, less powerful for physicians, and a less compelling candidate for reimbursement to insurance companies.

06 Article Wilson Side Bottom One @2X
06 Article Wilson Side Pic Three @2X
Two images with a caption

Bioventus’ first-generation device, EXOGEN, was a remarkable breakthrough. It gave patients a simple, painless way to stimulate bone healing, at home, in only 20 minutes per day.

But bone healing takes time—up to six months—and patients were losing motivation. Only half of patients were staying on track through the end, making EXOGEN less effective for patients, less powerful for physicians, and a less compelling candidate for reimbursement to insurance companies.

A Video Caption

Bioventus’ first-generation device, EXOGEN, was a remarkable breakthrough. It gave patients a simple, painless way to stimulate bone healing, at home, in only 20 minutes per day.

But bone healing takes time—up to six months—and patients were losing motivation. Only half of patients were staying on track through the end, making EXOGEN less effective for patients, less powerful for physicians, and a less compelling candidate for reimbursement to insurance companies.