TensivePrivate▲ Positive
Regulationrelevance
Company nears CE mark approval for its bioresorbable scaffold, a key regulatory milestone.
Tensive has appointed serial entrepreneur Peter Crosby as Chairman of its Board of Directors as the company approaches pivotal clinical and regulatory milestones for its REGENERA™/SOFTAG™ bioresorbable breast reconstruction scaffold. Crosby brings more than 40 years of medical technology leadership, having served as chief executive of six medical device companies and guided numerous implantable devices through CE marking and U.S. FDA approval. He succeeds Bill Hunter, who chaired the board for the past two years. Tensive is in active discussions with regulators on CE mark approval, with first approval expected in early 2027, following positive pivotal-trial and first-in-human results for REGENERA™/SOFTAG™ after lumpectomy. The scaffold is designed to be inserted during lumpectomy, enabling the patient’s own healthy tissue to regrow and gradually absorb the implant, resulting in natural breast restoration.
Company nears CE mark approval for its bioresorbable scaffold, a key regulatory milestone.