Orthovita presses on with US kyphoplasty trial:
This article was originally published in Clinica
Executive Summary
Orthovita has completed the patient-enrolment phase of its second US pilot study evaluating its Cortoss biomaterial as a treatment for vertebral compression fractures of the spine. The 20-patient, four-centre study is assessing use of the synthetic cortical bone void filler during kyphoplasty. With kyphoplasty, an inflatable bone tamp is used to restore vertebral height and create a void into which the biomaterial can be injected percutaneously to stabilise the fracture and restore load-bearing capability. Another US trial testing Cortoss in spinal fractures is also underway, notes the Malvern, Pennysylvania firm. It is testing use of the biomaterial during vertebroplasty, whereby Cortoss is injected directly into the vertebral body. Cortoss is already approved in Europe for treating vertebral compression fractures.
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.