CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived recombinant human collagen (rhCollagen) for tissue regeneration and organ manufacturing, today announced that it has successfully printed for the first-time breast implants of 200 cc, which are commercial size. These implants were printed using CollPlant’s proprietary rhCollagen bioinks. In addition, CollPlant announced additional, positive, interim preclinical data from ongoing large-animal studies, evaluating its regenerative breast implants. Currently there are no other commercial products that allow regeneration of soft tissues such as the breast.

“Through the development of regenerative breast implants, CollPlant is establishing the technological building blocks that are essential for tissue and organ manufacturing. We believe this will position CollPlant as a market leader in the field of regenerative medicine, in accordance with the Company’s vision statement,” said Yehiel Tal, CollPlant’s Chief Executive Officer. “During the last year we have upgraded our bioprinting process and capabilities to fabricate 200CC-size implants, which will be included in future studies. The data we see from the animal studies, such as tissue regeneration, are very encouraging and we are looking forward to reporting results from additional ongoing animal studies in the fourth quarter of this year and in the first quarter of 2025.”

Additional positive data from CollPlant’s pre-clinical studies that are currently underway show evidence of well-developed connective tissue containing blood vessels (i.e., neovascularization) within the implant. Progressing tissue ingrowth within the implant was also observed confirming tissue regeneration. An initial biodegradation process was observed, while preserving the original structure of the 3D breast implant. No adverse tissue reaction was observed, confirming the safety profile of this novel implant in development. 

The most common breast augmentation or reconstruction procedures today are based on synthetic silicone breast implantations, an artificial substitution for natural regenerated tissue with risks of complications.

In the U.S. alone, hundreds of thousands of people per year experience adverse events that range from autoimmune symptoms to the very serious breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). CollPlant’s rhCollagen-based, 3D-bioprinted breast implants that are comprised of CollPlant’s proprietary plant-derived rhCollagen and other biomaterials, are expected to regenerate breast tissue without eliciting immune response, and therefore may provide a revolutionary alternative for aesthetic and reconstructive procedures, including postmastectomy for cancer patients.

In addition, CollPlant’s regenerative breast implants have the potential to provide a novel solution for women in the need for breast reconstruction and augmentation, the need of which is sizeable, as it is the second most common plastic surgery procedure that is performed worldwide today. 

In December of 2023, CollPlant initiated an additional large-animal study to evaluate commercial-size versions of the 3D-bioprinted, regenerative breast implants. This study will be used to obtain data to support subsequent human studies and future product commercialization. CollPlant expects to report topline data from this study, and an additional ongoing study, in the fourth quarter of this year and first quarter of next year.