Currently the global breast implant market is estimated to be $3 billion, while breast reconstruction and augmentation procedures represent the second most common plastic surgery procedure performed worldwide. The most common breast augmentation or reconstruction procedures utilize synthetic breast implantations made of silicone, an artificial substitution for natural regenerated tissue with a risk of complications.
In a significant step in the advancement of regenerative medicine, CollPlant Biotechnologies, a pioneering regenerative and aesthetics medicine company, and Stratasys Ltd., a leader in polymer 3D printing solutions, announced the commencement of a pre-clinical study with 200cc commercial-sized regenerative implants printed on a Stratasys Origin 3D printer.
Related: The Implant-Free Breast Augmentation is a Modern Alternative to Traditional Plastic Surgery
CollPlant x Stratasys Collaboration: Regenerative Breast Implants
CollPlant's novel breast implants have been designed to regenerate an individual's natural breast tissue without eliciting an immune response, and could provide a revolutionary alternative for both reconstructive and aesthetic procedures, which represents a significant portion of the overall $3 billion addressable breast implant market.
Since announcing their collaboration in April of 2023, Stratasys has adapted the Origin printer to print the regenerative implants, and CollPlant successfully managed to 3D-print them at 200ccs, per CollPlant. The collaboration, focused on the development of a bioprinting solution for CollPlant's breast implants, in addition to finding solutions to scale-up the implant's fabrication process, has proven to be a successful on thus far, particularly in light of this recent announcement.
Pre-Clinical Study: 3D Printed 200cc Commercial-Sized Regenerative Implants
The pre-clinical study is intended to test the ability of the implants to promote the growth of natural breast tissue and completely degrade over time. CollPlant is expecting to have initial results from the study in the first half of 2025.
"This pre-clinical study marks a significant step forward in our effort to provide patients with care using regenerative medicine instead of traditional implants," said Stratasys CEO Dr. Yoav Zeif. "CollPlant's work is truly inspiring, and our collaboration exemplifies how Stratasys partners with customers to push the timeline and the boundaries of innovation. Together, we are driven by a shared mission to challenge the status quo and find new ways to improve lives and advance healthcare."
Earlier this year, CollPlant announced additional positive data from its previous pre-clinical studies that are currently underway, which showed evidence of well-developed connective tissue containing blood vessels(i.e., neovascularization) within the implant. Progressing tissue ingrowth inside the implant was also observed confirming tissue regeneration. An initial biodegradation process was noticed, while the original structure of the 3D breast implant was preserved. No adverse tissue reaction was present, confirming the safety profile of this novel implant in development, per CollPlant.
Yehiel Tal, CEO of CollPlant, commented, "We are extremely happy about the progress we've made withour breast implants program, and with Stratasys' successful achievement to develop a printer that enables us to print a commercial-size implant with high resolution and optimal physical properties. The combined pioneering technologies of both companies is expected to streamline the development and production process so that we have the most efficient means to produce our regenerative breast implants. We believe that our rhCollagen-based regenerative implant has the potential to overcome the challenges of existing breast procedures that use silicone implants or autologous fat transfer, thereby significantly improving patient outcomes."
References:
1. ISAPS International Survey on Aesthetic/Cosmetic Procedures, 2021
