BONES Study Completes Enrollment

Announced in March 2017 and enrolling its first patients in September of that same year, the Bioventus Observational Non-interventional EXOGEN Studies (BONES) clinical development program is providing Bioventus with the potential to expand the FDA label for EXOGEN in the US. We are due for an update on the progress of the study and there has been a lot of activity in the last couple of months.

BONES, you will remember,  is an innovative series of clinical studies to further validate the ability of the EXOGEN^® Ultrasound Bone Healing System to mitigate the risk of a fracture progressing to nonunion in the presence of known bone healing risk factors. BONES actually consists of three observational, non-interventional, direct-to-patient studies to collect real world data on the use of EXOGEN. The studies include bones representative of long and small bones of upper and lower extremities (fifth metatarsal, scaphoid and tibia) from US patients.

We spoke with Tawana Wester, Director of Clinical Development, who has been a part of BONES since its inception for this update.

“We previously completed the fifth metatarsal study, submitted it to FDA for review, and are currently responding to questions they have posed.  The scaphoid study completed late last year. We have locked the database in late December 2021 and took an interim look at top line results on December 28.  We are excited about the preliminary results and plan to submit this study to FDA for review later this year,” said Tawana. “In addition, we completed enrollment in the complex tibia fracture study on January 14 having enrolled 396 patients.”

The team learned they needed 90 or more accumulated EXOGEN treatments on patients with fifth metatarsal fractures to show clinical effectiveness. An interim look at the scaphoid fracture data has validated the results seen in the 5^th Met study and the expectation is the data review for patients with a tibia fracture will show similar positive results after 90 treatments.

“Statistical modeling for the scaphoid study is ongoing with plans to submit to FDA in the next few weeks. This will allow analysis of the data by comparing patients treated with EXOGEN to the control patients extracted from the MarketScan health claims database aligning their demographics and risk factor variables,” she added. “We expect the full analysis results to look even better when similar patients are compared against each other.  We will submit the scaphoid data to FDA for review in September.”

This process will repeat itself with the tibia data from EXOGEN patients in early 2023.

“In total we have enrolled about 3,500 patients across all three bones,” said Tawana. “It’s a huge amount of data. In addition to the data needed for label expansion, we hope to gain additional clinical publications from BONES.”

Depending on the speed of the reviewers at FDA, the BONES team believes approval for expanded indications in the fifth metatarsal and scaphoid could be granted in late 2023, with tibia indications to follow.

Tawana has leaned on many for help in getting the BONES program to this stage. Those that have helped steward BONES since 2017 include Alessandra Pavesio, Kim Kelly, Neill Pounder and Drew Sullivan.

“I’d like to also thank Sales, Marketing, and the EXOGEN Direct Order Management Team for their outstanding support in making patients aware of these studies,” said Tawana. “This was a true cross-departmental effort and accomplishment.”

As the milestones on the horizon in 2022 and 2023 are achieved, we will keep you updated.