BellaSeno GmbH, an ISO 13485-certified medtech company developing resorbable scaffolds using additive manufacturing technologies, announced the start of two clinical trials of its products in Australia, which are sponsored by its Australian subsidiary BellaSeno Pty. Already, recruiting has started in Brisbane, Australia.
The first trial is expected to enroll 10 patients with pectus excavatum, a common
congenital chest wall deformity in which the breastbone is sunken into the chest.
Principal investigator of this trial is Dr. Michael Wagels, Director of the Herston
Biofabrication Institute (HBI), Specialist Plastic and Reconstructive Surgeon at the
Princess Alexandra Hospital, Director of the Australian Centre for Complex Integrated
Surgical Solutions (ACCISS) and Senior Lecturer at the University of Queensland.
BellaSeno already published first-in-human data in 2021, demonstrating that its implant
was able to camouflage a pectus excavatum defect not reconstructable by conventional
The second trial aims to enroll 20 patients who either need breast implant revision or
surgery to correct congenital breast defects. Principal investigator of the second trial is
Prof. Owen Ung, Director of the Comprehensive Breast Cancer Institute (CBCI),
consultant breast surgeon at the Royal Brisbane and Women’s Hospital and Professor
of Surgery, University of Queensland, Australia.
In both trials, patients will receive porous polycaprolactone implants produced in
Bellaseno’s AI-driven additive manufacturing facilities by a no-touch approach.
Polycaprolactone has been used in healthcare for decades as absorbable suture
material. Once the implants are inserted in compressed form by minimal invasive
surgery, the structure unfolds and is subsequently grafted with the patient’s own fat
tissue obtained by liposuction. Within up to 5 years, the polycaprolactone scaffold is fully
absorbed and replaced by fat cells, leaving no permanent remnants of foreign material in
This scaffold-guided tissue reconstruction (SGTR) provides a promising
alternative to silicone or other permanent implants. The Company ́s novel implants are
designed to ultimately result in natural tissue. Primary outcome of the trials will be intra- and post-operative device safety; secondary endpoints are adverse event rate and frequency of complication. Secondary endpoints comprise, among others, change in (fat) volume and soft tissue retention as well as pain and quality of life.
“This trial is a very important step for us to demonstrate that our approach is not only
safe, but leads to substantial improvements in terms of long-term safety, health and
quality of life,” said Dr. med. Tobias Grossner, CMO of BellaSeno. “We very much hope
the trials once more confirm our scaffold-guided tissue reconstruction concept.”
“We are delighted to spearhead the administration of novel, fully absorbable implants
for soft tissue reconstruction applications. There is a clear need for a safe alternative to
contemporary alloplastic materials and operative techniques in pectus excavatum and
breast surgery. Having customizable implants that resorb, leaving behind the patient’s
own tissues, is a big step forward,” said Dr. Michael Wagels, Principal investigator of the
pectus excavatum trial.
“It is important to us that patients have access to healthier alternatives to permanent
implants. There is a strong demand for restoring fully natural breast tissue without
potentially risky remnants in the body. We believe that BellaSeno ́s solutions can play an
important role in addressing these needs,” added Prof. Owen Ung, Principal investigator
of the breast trial.
For more information, please visit www.bellaseno.com.