Podcast: BelloSeno Trials Next Generation Breast Implant Technology

04 May 2023

BellaSeno is a clinical-stage medical device company developing a next generation fully resorbable breast implant for soft tissue reconstruction following reconstructive surgery or congenital defects. Formed in Queensland, Australia in 2015, the company expanded its operations to Liepzig in Germany – but the journey for this German-Australian company started years earlier.

In 2011, research led by biomedical engineer Dr Mohit Chayya began at the Queensland University of Technology in collaboration with the Technical University of Munich in Germany using bench testing and preclinical studies. The team saw promising outcomes and a need to find alternatives to silicone implants by using a resorbable implant with a regenerative scaffold to help patients.

CEO and Co-Founder, Dr Mohit Chayya, who is now based in Germany, explained that collaborating with surgeons from the beginning was especially important.

“(We needed to) … talk to the end users of the product, which in our case was the surgeons as early and as often as possible. There's no way that an engineer like myself would ever know the realities of the operating theatre or the patient’s needs.”

Traditional breast implants available in the market are made of silicone or saline and are available in a limited number of shapes and sizes. They can be prone to rupture, leakage, and capsular contracture, a condition where the body's immune system reacts to the implant by forming scar tissue around it.

On the other hand, BellaSeno's 3D-printed breast implants are made of a special bioresorbable polymer that gradually dissolves over time (two years), leaving behind a stable platform for the patient's natural injected fat tissue to mature, adapt to its environment and stabilize. This aims to alleviate the complications and risks found in current breast reconstruction approaches.

In 2021, Bellaseno began one of two clinical trials for its breast scaffold implantation in Brisbane under the supervision of principle investigator, Professor Owen Ung, Director of the Comprehensive Breast Cancer Institute (CBCI) and consultant breast surgeon at the Royal Brisbane and Women’s Hospital. The trial is for up to 20 adult patients enrolled at the Royal Brisbane and Women’s Hospital. Professor Ung explained that the patients will be followed up for two years after their implant surgery with regular interviews and imaging reviews. So far, the results are promising.

“The first woman to receive a 3D printed Scaffold was in June 2022, so she's now had more than six months of follow up. We've got several patients coming up for their six-month reviews… All of them are doing very well. There's been no adverse serious reactions, no complications. They've all been well tolerated and, so far as we can tell, the scaffolds are doing exactly what they're designed to do, but it is early days,” Professor Ung said.

The next step is bringing this technology to market but, the trial size will need to be expanded to provide the company with the safety data set required. BellaSeno aims to enrol more clinical centres in Australia and Europe later this year to build on what it has already established.

“The right clinical investigator team is key for us. Starting with Professor Ung and moving into the next trial and then expanding on that, we think is the best way for this technology to come into the market,” Dr Chayya said.

BellaSeno with Brisbane’s Herston Biofabrication Institute is using additive manufacturing technologies (3D-printing) under ISO 13485 certification to manufacture the 3D printed scaffolds for the Australian clinical trial, building on a long-standing relationship.

In 2021, BellaSeno was recognised with a prestigious German Innovation Award from the German Design Council for its leading-edge Senella® soft tissue technology. The company has received financial support from investors including German Government, European Fund for Regional Development and Australian Global Innovation Linkages Program.

To find out more about BellaSeno’s ground-breaking technology, tune into the MTPConnect podcast hosted by MTPConnect’s Caroline Duell and Andrew Bowskill - episode 151.