German medical startup BellaSeno has shared promising results from its Australian clinical trials leveraging resorbable breast implants.
These proposed studies assessed the use of biodegradable polycaprolactone (PCL) scaffolds as an alternative to traditional silicone implants for breast augmentation revisions and pectus excavatum correction.
Having begun in 2022, these trials involved 19 breast augmentation patients and 7 individuals with pectus excavatum, a congenital chest wall condition. All participants have now completed their one-year follow-ups, with findings showing no major complications linked to the scaffolds and no instances of scaffold removal.
“This is a very encouraging one-year clinical outcome,” said Mohit Chhaya, CEO of BellaSeno. “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.”
He further added that the strong clinical data set now provides a solid foundation to initiate a pivotal study of its resorbable breast scaffolds in the U.S. and Europe. What’s more, plans are underway to expand the use of these scaffolds to primary breast augmentation and lumpectomy procedures, with a final two-year follow-up scheduled for release next year.
3D printed resorbable breast implant. Image via BellaSeno.
BellaSeno’s 3D printed resorbable breast implants
Designed as interventional, single-arm clinical investigations, the studies focused on the safety and performance of BellaSeno’s resorbable implants. While post-surgery safety was the primary objective, patient outcomes, including quality of life and implant performance, were also evaluated.
According to the data, no serious issues such as infections, calcifications, or capsular contracture were reported, and all adverse events observed were within anticipated limits for revision surgeries.
After twelve months, patients described being pain-free and unaware of the scaffold’s presence. Additionally, the scaffolds demonstrated reliable volume replacement capabilities, with no replacements or removals required in either group.
Clinical investigators noted improved satisfaction among breast augmentation patients compared to their experiences with silicone implants. Feedback highlighted enhanced comfort and quality of life following the transition to BellaSeno’s biodegradable scaffolds.
Similar positive outcomes were observed in the pectus excavatum group, further underscoring the potential of this approach in addressing both reconstructive and cosmetic needs.
BellaSeno’s trials illustrate the viability of fully resorbable scaffolds in surgical procedures, offering a safe and effective solution for patients. With a focus on integrating natural tissue over time, this technology could pave the way for more sustainable and patient-friendly alternatives to traditional implants.
Manufacturing on Demand
Since 2015, BellaSeno has focused on developing an alternative to silicone breast implants. Over the next few years, the company secured ISO 13485 certification for its Senella breast scaffolds, and entered into a long-term agreement with German specialty chemicals company Evonik to utilize its bioresorbable polymer RESOMER in the production of these 3D printed scaffolds.
A sample of Evonik RESOMER material. Photo via Evonik
3D printed resorbable implants
Over the past few years, resorbable implant technologies are advancing to provide safer and more natural breast reconstruction options.
For instance, Lyon-based regenerative medicine startup Healshape raised $6.8 million in Series A funding to advance its bioprinted breast implants, designed for women recovering from mastectomies. Using a resorbable hydrogel scaffold and living patient cells, the implants reconstruct breast tissue and the nipple-areolar complex while reducing the risk of rejection.
Over time, the hydrogel is replaced by natural tissue, with full regeneration expected within six to nine months. Supported by Pulsalys SAS and over $1 million in French public funding since its 2020 launch, the medicine startup planned to begin clinical trials within two years of receiving the funding.
In an interview, Julien Payen, CEO and Co-founder of Lattice Medical, discussed the company’s breakthrough in natural breast reconstruction through its 100% resorbable Mattisse implantable device.
Designed for women recovering from mastectomies, the implant enables autologous reconstruction by regenerating vascularized tissue flaps harvested locally from the breast area, avoiding the need for silicone implants or complex microsurgery. This implant resorbs fully within 18 months, leaving patients with a natural breast, free of scars or long-term risks.
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Author: Ada Shaikhnag
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