Absorbable soft tissue reconstruction scaffold is being ready to transform reconstructive surgery and make a meaningful difference in the lives of patients.
FREMONT, CA: BellaSeno GmbH, an ISO 13485-certified medtech company, developing absorbable scaffolds using additive manufacturing technologies reveals the news about the initiation of a first-in-human trial of its novel, absorbable soft tissue reconstruction scaffold (Senella). A patient with Pectus Excavatum congenital defect has undergone surgery at Princess Alexandra Hospital in Brisbane, Australia, earlier this month. The procedure was performed by Dr. Michael Wagels, Principal Investigator of the trial and Plastic and Reconstructive Surgeon at Princess Alexandra Hospital.
The primary endpoint of the trial will be the assessment of post-operative adverse device effects (ADE) 12 and 24 months after pectus scaffold implantation. Secondary endpoints cover safety criteria such as adverse events, frequency of complication (short term and long term), number of revision surgeries due to ADEs, and pain.
The advantage of using an absorbable scaffold is the simplicity compared to other orthopedic techniques which use silicone or metal implants. The surgery is developed as a minimally invasive procedure where no bones are touched, and the recovery is expected to be less painful than other treatment approaches. Moreover, Senella scaffolds are tailored to be fully absorbed by the recipient’s body within two years after surgery, leaving no harmful or risky substances.
Moreover, BellaSeno also announces that a key patent covering design and porosity features of its Senella platform has been granted in the U.S. The Company has exclusively licensed the patent from Technical University Munich, Germany. The company’s first-in-human study with Senella helps build the foundation for expanding clinical trials to European sites and additional breast reconstruction indications later this year. In addition, the company is delighted to further strengthen its global patent portfolio.