BellaSeno GmbH

Favorable safety pro resorbable breast scaffolds in one-year follow-up No major scaffold-related complications or scaffold removals BellaSeno will initiate multicenter pivotal clinical trial with more than 100 patients Leipzig, Germany/ Brisbane, Australia, June 12, 2024 – BellaSeno GmbH, an ISO 13485-certified medtech company developing resorbable scaffolds using additive manufacturing technologies, today announced that 10 breast scaffold patients and 5 pectus patients have successfully passed one-year follow-up in BellaSeno´s Australian clinical trials. In the first-ever breast implant trial using PCL scaffolds and fat transfer, the interim analysis confirms a favorable safety pro the Company´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. Data review by the Independent Data Safety Monitoring Committee confirmed that all adverse events were within the expected range of complications for removal / replacement surgeries. In general, the Clinical Investigators observed a trend towards 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 and patients did not report awareness of the scaffold in situ after six to twelve months. Identical findings were made in the one-year follow up in pectus excavatum patients. Based on the positive data, BellaSeno plans to initiate a pivotal clinical trial to obtain regulatory approval of the breast scaffolds. “Following this favorable interim analysis, we are now well positioned to begin our pivotal clinical study to obtain full regulatory approval of our breast scaffolds in Europe and the U.S.,” said Mohit Chhaya, CEO of BellaSeno. “We are excited that our resorbable scaffolds do not only meet the desired safety criteria but have also shown an improvement of patients´ quality of life.” “All patients have had consistently favorable outcomes in the follow-up ranging from six months to two years. We’re excited by the progress and at the end of this year will publish the detailed one-year interim analysis for the scientific community," said Professor Owen Ung, Primary Investigator in the clinical trial. So far, 41 patients have been successfully operated and received BellaSeno´s hard or soft tissue scaffolds (5 bone scaffolds, 36 breast or pectus scaffolds). ### About BellaSeno BellaSeno GmbH was founded in 2015 and is headquartered on the BioCity campus in Leipzig, Germany, with a subsidiary in Brisbane, Australia. The Company is developing novel resorbable soft tissue and bone reconstruction implants made by additive manufacturing (3D-printing) under ISO 13485 certification. The Company has received substantial financial support from private investors as well as from the Saxony Development Bank (SAB), the European Fund for Regional Development (EFRE), Germany´s Federal Ministry of Education and Research (BMBF) and the Australian government. The Company has been co-funded from tax resources based on the budget adopted by the members of Saxony State Parliament. Contact BellaSeno BellaSeno GmbH Dr. Mohit Chhaya mohit.chhaya@bellaseno.com Tel.: +49 176 2283 9583 Media Inquiries akampion Dr. Ludger Wess / Ines-Regina Buth Managing Partners info@akampion.com Tel. +49 40 88 16 59 64 Tel. +49 30 23 63 27 68

New clinical trial site opened in Italy for pectus excavatum and planned in Germany for bone reconstruction Company aims to expand EU market authorization from custom-made to off-the-shelf products and and to pursue market approval in the USA Leipzig, Germany, January 31, 2024 – BellaSeno GmbH, an ISO 13485-certified medtech company developing resorbable scaffolds using additive manufacturing technologies, today announced that additional, investigator-initiated clinical trials of its novel regenerative scaffolds for bone reconstruction and chest-wall defects (pectus excavatum) will be conducted in Germany and Italy, respectively. In 2023, BellaSeno had received market authorization for its custom-made, resorbable bone and pectus excavatum scaffolds in Europe. The clinical pectus excavatum trial in Italy will enroll a total of 10 patients, with 4 individuals having undergone surgery already. While initial clinical use cases in Australia demonstrated promisingoutcomes last year, this is the first time that a fully resorbable sternal prosthesis is being used in Europe. For each patient, the prosthesis was individually designed and 3D printed using polycaprolactone - a proven medical material in use for decades, e.g., for resorbable suture material. There will be a 2-year patient follow-up to assess the outcome of the operation. Following the publication of first clinical data by BellaSeno, a total of four European university hospitals have announced their plans to set up independent, investigator-initiated clinical trials to investigate further into this promising technology. Among the first sites, the Clinic for Trauma and Reconstructive Surgery at the University Hospital Heidelberg under the lead of Professor Dr. med. Gerhard Schmidmaier plans to initiate its IIT in Q1/2024, aiming to include up to 20 patients with a follow-up time of 2 years. "We are excited that several leading European university hospitals have decided to evaluate our scaffolds in independent clinical trials. This will help us obtain further clinical evidence on our proprietary approach of treating both soft and hard tissue defects," said Dr. Mohit Chhaya, Chief Executive Officer of BellaSeno. "The addition of real-world data will be beneficial for our planned market approval for off-the-shelf breast and bone reconstruction products in the USA and EU." “We look forward to learning more about the scientific background of BellaSeno's groundbreaking technology, especially how such a scaffold is being vascularized while it secures the position of the autologous bone graft in a large size defect,” said Professor Dr. med. Gerhard Schmidmaier, the primary investigator of the IIT in Heidelberg. “The initial results are promising, and as a team, we are committed to supporting these trials comprehensively. This technology has the potential to deliver a step change in the field of regenerative medicine, and we are eager to demonstrate the benefits it brings to patients with complex reconstructive needs.” BellaSeno´s MDR-certified manufacturing platform is designed to meet the requirements of medical scaffolds ranging from soft tissue to bone and enables the production of both custom-made and off-the-shelf sterile medical implants. ### About BellaSeno BellaSeno GmbH was founded in 2015 and is headquartered on the BioCity campus in Leipzig, Germany, with a subsidiary in Brisbane, Australia. The Company is developing novel resorbable soft tissue and bone reconstruction implants made by additive manufacturing (3D-printing) under ISO 13485 certification. The Company has received substantial financial support from private investors as well as from the Saxony Development Bank (SAB), the European Fund for Regional Development (EFRE), Germany´s Federal Ministry of Education and Research (BMBF) and the Australian government. The Company has been co-funded from tax resources based on the budget adopted by the members of Saxony State Parliament. Contact BellaSeno BellaSeno GmbH Dr. Mohit Chhaya mohit.chhaya@bellaseno.com Tel.: +49 176 2283 9583 Media Inquiries akampion Dr. Ludger Wess / Ines-Regina Buth Managing Partners info@akampion.com Tel. +49 40 88 16 59 64 Tel. +49 30 23 63 27 68

BellaSeno, an ISO 13485-certified medtech company developing resorbable scaffolds using additive manufacturing technologies, has presented data on the design and manufacturing of customised, 3D-printed bone scaffolds at the recent German Congress of Orthopaedics and Traumatology (DKOU). BellaSeno presented an MDR-compliant (Medical Device Regulation) and ISO 13485 audited workflow for the design and manufacturing of 3D-printed, resorbable, custom-made polycaprolactone scaffolds for the treatment of segmental bone defects in conjunction with an autologous bone graft (RIA Reamer Irrigator Aspirator or cancellous bone). The presentation titled "Semi-automated workflow for the design and fabrication of 3D-printed patient-specific resorbable scaffolds for the treatment of large segmental bone defects while complying with MDR regulations" outlined the potential of BellaSeno's novel resorbable scaffolds for curing large segmental bone defects (> 5cm size). In these large injuries, biological reconstruction using the diamond concept is preferred. It provides for the application of osteogenic cells in conjunction with a scaffold. The scaffold is needed to hold the autologous bone graft in position for optimal vascularisation and bone healing. Scaffolds made by additive manufacturing from bioresorbable polymers represents a highly attractive opportunity to produce such patient-specific open-pore scaffolds. Following specialist indication, digital segmentation of the CT is performed with 3D reconstruction. The exact defect is defined and, following the treating surgeon’s direction, BellaSeno creates an anatomically oriented design to fill the defect. This is followed by adjustment of various parameters to customise the fit and mechanical performance of the scaffold. Depending on whether the scaffold is to be used in conjunction with plate or nailless osteosynthesis, additional features are integrated. Fused deposition modeling (FDM) will be used as a 3D printing technique as it offers clear biomechanical and economic advantages over other techniques (e.g., Selective Laser Sintering SLS). A prototype is sent to the practitioner for design freeze and is then biomechanically tested before manufacturing the scaffold under cleanroom conditions with subsequent post-processing and sterilisation. "This specific workflow allows a very time- and cost-effective manufacturing process for patient-specific scaffolds while complying with highest regulatory standards," said Dr. med. Tobias Grossner, chief medical officer of BellaSeno. "Depending on the desired properties of the scaffolds, the products can absorb static non-deformable axial forces of up to 4,000 N or shorten by up to 1cm under a load of up to 1,000N in a controlled manner without breaking. This results in a new generation of high-performance bone scaffolds which are well suited for the biological reconstruction of large bone defects." BellaSeno's ISO 13485 certified manufacturing platform is designed to meet the requirements of medical scaffolds ranging from soft tissue to bone and enables the production of both custom-made and off-the-shelf sterile medical implants.