A new pre-clinical study from CollPlant Biotechnologies and Stratasys seeks to create 200cc commercial-sized regenerative implants printed on a Stratasys Origin 3D printer. The study will test the implants' ability to promote natural breast tissue growth and completely degrade over time.
Since announcing the collaboration in April 2023, CollPlant and Stratasys have been developing a way to bioprint breast implants and scale-up the fabrication process. Initial results from the study are expected in the first half of 2025.
CollPlant's novel breast implants are designed to regenerate natural breast tissue without eliciting an immune response. The technology could provide a revolutionary alternative for reconstructive and aesthetic procedures, which represents a significant portion of the $3 billion breast implant market.
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Over the last 16 months, Stratasys adapted its Origin printer to print the regenerative implants, and CollPlant has successfully 3D-printed 200cc implants.
CollPlant is examining new tissue regeneration and organ manufacturing applications for the company's plant-based rhCollagen. According to the company, rhCollagen is identical to the type I collagen produced by the human body, making it an ideal building block for regenerative medicine. The company says the material has advantages over other tissue-derived collagens, such as improved biofunctionality, high homogeneity, and a reduced risk of immune response. The Origin 3D printer prints the implants using an rhCollagen-based bioink.
CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting tissues and organs, as well as medical aesthetics. CollPlant's products are based on its recombinant human collagen produced with a proprietary genetic engineering technology.
The global breast implant market is valued at $3 billion. Breast reconstruction and augmentation procedures are the second most common plastic surgery procedure performed worldwide, according to a 2021 ISAPS International Survey on Aesthetic/Cosmetic Procedures. The most common breast augmentation or reconstruction procedures use synthetic breast implantations made of silicone, an artificial substitution for natural regenerated tissue with a risk of complications.
Earlier this year, CollPlant announced data from previous pre-clinical studies that 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.
According to CollPlant, no adverse tissue reaction was present, confirming the safety profile of this novel implant in development.
Stratasys CEO Dr. Yoav Zeif said in a statement, "CollPlant's work is truly inspiring, and our collaboration exemplifies how Stratasys partners with customers to push the timeline and the boundaries of innovation."
"We are extremely happy about the progress we've made with our 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," said Yehiel Tal, CEO of CollPlant. "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."
3D printing technology has become increasingly critical in the medical market. Stratasys and Ricoh recently announced a clinical study to evaluate the use of 3D-printed models for orthopedic oncology. In June, the company launched the J5 Digital Anatomy 3D printer, which is specifically designed to make high-fidelity anatomical models.
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