Stratasys Prints Regenerative Breast Implants for Preclinical Study

CollPlant Biotechnologies, a regenerative medicine firm focused on bioprinting of tissues and organs, has partnered with 3D-printing technology company Stratasys on a preclinical study involving breast implants. The 200-cc commercial-sized regenerative implants will be produced on Stratasys’ Origin 3D printer.

The collaboration is currently focused on the development of a bioprinting method for CollPlant’s breast implants, in addition to finding solutions to scale-up the fabrication process. The study is intended to test the ability of the implants to promote the growth of natural breast tissue and completely degrade over time.

Alternative to current breast implant procedures

CollPlant’s breast implants are designed to regenerate an individual’s natural breast tissue without eliciting an immune response. The technique could provide an alternative to reconstructive as well as aesthetic procedures, which represent a significant portion of the overall $3 billion addressable breast implant market, according to CollPlant.

“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 in a prepared statement. “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,” Zeif added.

Streamlined development and production process

CollPlant CEO Yehiel Tal said he was delighted with the progress made thus far in printing 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,” said Tal. His company’s rhCollagen-based regenerative implant has the potential to overcome the challenges of existing procedures that use silicone implants or autologous fat transfer, thereby significantly improving patient outcomes, he added.

The company's rhCollagen, or recombinant human type I collagen, is extracted from the leaves of genetically engineered tobacco plants. It is processed to achieve a highly purified material that can be used for the production of medical products, explains CollPlant on its website. rhCollagen is identical to the type I collagen produced by the human body, and has several advantages over tissue-derived collagens, including improved biofunctionality, homogeneity, and a reduced risk of immune response, says the company.

Since announcing the collaboration in April 2023, Stratasys has adapted the Origin printer to print the regenerative implants, which CollPlant successfully printed at the 200 cc size. CollPlant is expecting to have initial results from the study in the first half of 2025.

Studies show successful tissue regeneration

Earlier this year, CollPlant announced positive data from other preclinical studies currently underway that showed evidence of well-developed connective tissue containing blood vessels 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.