CollPlant announced that it has successfully completed a large animal study for its recombinant human collagen (rhCollagen)-based 3D bioprinted regenerative breast implants, addressing the $2.5 billion global breast implant market. Supported by these promising results, the Company is planning to initiate a follow-up large animal study during 2023 using commercial-size implants to support subsequent human studies and future product commercialization. The objectives of the study were fully achieved, including the evaluation of the safety and efficacy of the bioprinted breast implants.

The histological analysis of the implants demonstrated progressive stages of tissue regeneration after three months, as indicated by the formation of maturing connective tissues and neovascular networks. The development of native tissue was synchronized with the degradation process of the implant, which was consistent with the desired outcome observed during the trial. There was also no indication of adverse reaction noted within the implants and the surrounding tissue.

The company's bioprinted regenerative implants aim to overcome the challenges of existing breast procedures using silicone implants or autologous fat transfer. According to the U.S. Food and Drug Administration, approximately 350,000 people have reported adverse events involving breast implants between 2009 and 2019. Reports range from autoimmune symptoms to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The company's regenerative breast implants are comprised of the Company's proprietary plant-derived rhCollagen, an ideal building block for regenerative medicine implants attributed to better bio-functionality, superior homogeneity, and improved safety. The printed implant is designed to degrade over time while promoting natural tissue regeneration and integration with host tissue. 3D bioprinting technology enables scalable production of highly precise and repeatable constructs which can be customized to the individual anatomy of patients.

In the product development process, the company uses modeling tools that enable an optimal design of the implant in terms of geometry, materials, physical properties, and biological environment. The modeling takes into consideration the internal anatomy of the breast tissue and the implant environment post-implantation. The implant testing is rigorous and includes static and dynamic loading in order to mimic breast tissue behavior under different conditions and comply with the most stringent safety requirements.

The implants are designed to withstand physiological loads and to provide what the company believes is a safer, more natural, and long-lasting alternative to current breast reconstruction and augmentation procedures.