BellaSeno Completes Two Clinical Trials on 3D Printed Resorbable Breast Implants

German firm BellaSeno, which is focused on 3D-printed resorbable breast implants for both augmentation and lumpectomy, has completed two clinical trials for resorbable breast implants. These trials represent the first-ever use of polycaprolactone (PCL) scaffolds for implants designed to be fully resorbed and replaced with natural tissue.

The trials were conducted as sponsored, single-arm, open, mono-centric, interventional, prospective clinical investigation studies focused on primary endpoints, such as post-operative device safety, and secondary endpoints, including post-operative patient safety and device performance metrics, such as quality of life improvements and volume replacement.

A breast augmentation trial conducted in 2022 included 19 Australian patients, who recently participated in a follow-up study. Notably, none of these patients required scaffold removal or revision surgery. The company stated: “The one-year assessment confirms a very favorable safety profile of BellaSeno´s resorbable soft tissue implants. No major complications such as capsular contracture, calcifications, oil cysts, infections, tissue necrosis, or wound healing issues were observed. No scaffold removals or replacements were necessary, and no scaffold-related complications were observed in any patients six months post-surgery.”

Another trial involving seven patients with pectus excavatum, a condition characterized by a sunken breastbone, also reached the one-year follow-up milestone successfully.

“This is a very encouraging one-year clinical outcome. The data confirm that our resorbable scaffolds do not only meet the desired safety criteria but also show an improvement of patients´ quality of life. We now have a very strong clinical data set to initiate a pivotal study of our resorbable breast scaffolds in the U.S. and Europe. We will also expand the use of our scaffolds to primary breast augmentation and lumpectomy and also provide a final two-year follow-up next year,” said BellaSeno CEO Mohit Chhaya.

BellaSeno utilizes polycaprolactone (PCL) scaffolds, a well-established, highly safe material known for its exceptional properties, including tensile strength and elongation exceeding 1000%, along with its resorbable nature. The resorption timeline of PCL can also be partially programmed. With 3D printing, it is possible to create custom scaffolds that enhance patient symmetry or achieve tailored shapes. An Independent Data Safety Monitoring Committee reviewed the one-year follow-up data, concluding that all adverse events fell within the expected range for removal and replacement surgeries. Identical findings were observed in the one-year follow-ups for both the breast augmentation and pectus excavatum trials.

Among advancements in additive manufacturing, BellaSeno’s progress and the developments in 3D-printed PCL implants by others represent one of the areas I follow most closely. If efficacy and safety of PCL implants are thoroughly demonstrated, the sky is the limit. 3D printing can be used for oncology trauma, general trauma, nasal corrections, and various facial procedures. Any structural augmentation or preservation within the body could benefit from such scaffold-based approaches, as exemplified by BellaSeno, Lattice Medical, and 4D Biomaterials.

To me the next Align is going to be found in this area. If asked which company will dominate the additive space in the next decade, I couldn’t say for sure—but I’d wager on BellaSeno rather than an OEM.

BellaSeno is also solving a real need here. Breast augmentation is a big cultural thing and an oft requested procedure. The complications arising from them are impactful however. There are cancers associated with silicone breast implants but other complications abound. There are over 300,000 breast augmentations in the US per year. The risks therefore and the resulting potential market is enormous.

BellaSeno is addressing a significant and pressing need. Breast augmentation remains a prominent cultural practice and one of the most frequently requested procedures. However, complications associated with traditional methods are substantial. Silicone breast implants, for example, have been linked to certain cancers, alongside other prevalent complications. With over 300,000 breast augmentations performed annually in the U.S. alone, the associated risks underline the scale of the challenge—and the enormous market potential for safer solutions.

The company said that, ¨The Clinical Investigators reported higher patient satisfaction with breasts and quality of life associated with BellaSeno´s scaffolds compared to baseline (i.e. silicone implants). There was high acceptability; patients were pain-free and did not report awareness of the scaffold in situ after twelve months.¨

Taken together, this represents highly encouraging news for BellaSeno and the broader 3D printing industry. Since 2015, BellaSeno has been making consistent strides in developing 3D-printed PCL implants. Innovations of this kind demand significant time, patience, participants, and substantial financial investment. While success is not guaranteed—clinical trials are rigorous, expensive processes precisely because they aim to uncover potential complications and critical risks—BellaSeno is quietly marching towards being one of the most successful companies in additive. In fact, BellaSeno plans to launch a study of its resorbable breast scaffolds in the U.S. and Europe. The company also intends to expand applications of its scaffolds to primary breast augmentation and lumpectomy, while completing a two-year follow-up study next year.