BioSurface Engineering Technologies (BioSET) has initiated a pilot clinical study of osteobiologic bone graft substitute Amplex to facilitate foot and ankle fusion surgery in Canada.
Amplex combines BioSET’s proprietary B2A growth factor mimetic with a ceramic scaffold/carrier.
Additionally, the Amplex osteobiologic device also is being investigated in lumbar spine fusion, enrolling 35 patients in pilot clinical studies in both the US and Canada.
The Amplex Foot and Ankle study is a randomized, prospective, multi-center, controlled clinical study which compares Amplex to the current standard of autograft taken from either the iliac crest of the hip or from the tibia.
The pilot study is designed to evaluate the safety and preliminary effectiveness of the osteobiologic construct and will enroll 24 subjects across three centers in Canada, out of which 6 subjects have completed their surgery.
BioSET president and CEO Tom Roueche said the promising early clinical results with Amplex device in lumbar fusion led to begin investigation in other surgical procedures where surgeons and patients seek an effective alternative to the painful harvesting of bone graft from a second surgical site.
"We thank our clinical investigators, their teams and most importantly, their patients for participating in our quest to provide robust and reliable scientific evidence in this very confounding field of bone grafts and bone regeneration," Roueche said.