Summary: CollPlant Biotechnologies successfully 3D printed 200 cc commercial-size breast implants using rhCollagen bioinks, with positive interim preclinical data showing promising tissue regeneration and no adverse reactions, suggesting a potential alternative for aesthetic and reconstructive procedures.

Key Takeaways

  • Bio-printing technology now enables fabrication of 200cc implant size and above to address future commercial demand.
  • Interim pre-clinical data shows tissue growth including regeneration of maturing connective tissue as well as neovascularization, synchronized with progressive implant degradation.
  • No adverse tissue reaction was observed.
  • Large-animal studies with commercial-size implants are currently underway with results expected in the fourth quarter of 2024 and the first quarter of 2025.

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CollPlant Biotechnologies has successfully 3D printed 200 cc commercial-size breast implants using its proprietary rhCollagen bioinks. Additionally, interim preclinical data from ongoing large-animal studies show positive results for their regenerative breast implants.

Regenerative Breast Implant Advancements

“Through the development of regenerative breast implants, CollPlant is establishing the technological building blocks that are essential for tissue and organ manufacturing,” says Yehiel Tal, CollPlant’s CEO. “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 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.

3D-Bioprinted Implants May Reduce Complications

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, or 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 an alternative for aesthetic and reconstructive procedures, including postmastectomy for cancer patients.

New Hope for Breast Reconstruction

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

In December 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.