CollPlant and Stratasys Launch Pre-clinical Trial for Regenerative 3D-Printed Breast Implants

Stratasys (Nasdaq: SSYS) and CollPlant Biotechnologies (Nasdaq: CLGN) are working together on a new type of 3D printed breast implant that could be a game-changer for patients. These implants, made with a special bioink that encourages natural tissue to grow, are designed to completely dissolve over time. This means they could offer a safer, more natural option compared to traditional silicone implants, which have been linked to serious health problems.

The duo is launching a pre-clinical study to explore the potential of their 3D printed regenerative breast implants, aiming to disrupt a $3 billion breast implant market. What’s more, these implants could improve options for both cosmetic and reconstructive surgeries.

A team led by MIT researchers analyzed how varying the surface topography found on silicone breast implants influences the development of health complications. Image courtesy of Felice Frankel/MIT.

Traditional silicone implants, which are still the most commonly used in about 84% of breast augmentation procedures, have faced significant criticism from both patients and doctors over the years due to safety concerns. These implants have been linked to several serious health issues, including capsular contracture, where scar tissue forms around the implant, causing hardening, pain, and discomfort. Additionally, silicone implants can rupture, leading to leaks that cause inflammation and may require additional surgeries.

Furthermore, some patients have also reported symptoms like chronic fatigue, joint pain, and cognitive issues, often referred to as Breast Implant Illness (BII), which, though not officially recognized as a medical condition, has raised a lot of concern. Moreover, there is a rare but serious risk of Anaplastic Large Cell Lymphoma (BIA-ALCL), a type of immune system cancer linked specifically to textured silicone implants, which has led to recalls and increased scrutiny. These ongoing issues have led to debates about the safety of silicone implants and fueled interest in safer, more natural alternatives.

In response to these concerns, some alternatives have emerged. Saline implants, the main alternative to silicone, make up the remaining 16% of breast augmentation procedures. Other alternatives, like autologous fat transfer, where a patient’s fat is used, are growing in popularity but still represent a small percentage of overall procedures compared to silicone implants.

However, new developments in the field are also emerging, such as the work being done by ReConstruct, a spin-off from the Wyss Institute at Harvard University. ReConstruct is pioneering a new approach to breast reconstruction using bioprinted tissue made from a patient’s cells. This innovative method, which will soon start pre-clinical trials with large animals, offers a more natural and lasting alternative to traditional implants for breast cancer survivors, providing them with a safer and more effective solution.

Yet despite this progress and the growing concerns about silicone implants, experts note that the durability, feel, and widespread availability of silicone implants keep them the main choice in both cosmetic and reconstructive breast surgeries.

CollPlant and Stratasys hope to change that with their regenerative implants, designed to tackle these issues by offering a new solution that helps natural breast tissue grow while completely dissolving over time, removing the risks that come with long-term implants.

To achieve this, CollPlant is using rhCollagen (short for recombinant human collagen), a lab-made version of the natural collagen found in our bodies. This material helps the body grow its own tissue around the implant, making it highly compatible and reducing the risk of immune reactions.

The pre-clinical study, which will test 200cc-sized implants printed on a Stratasys Origin 3D printer, is an important step in making this innovation available to patients. Stratasys has even adapted its Origin printer specifically for this purpose, making sure it can produce high-resolution, commercial-sized implants with the necessary physical properties.

“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,” commented 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 printed breast implant made with CollPlant’s rhCollagen-based bioinks on a Stratasys’ Origin printer. Image courtesy of Business Wire.

Earlier this year, CollPlant announced additional positive results from previous pre-clinical trials, showing that the implants successfully develop healthy connective tissue with blood vessels inside them (what is known as neovascularization). According to the companies, tissue growth inside the implant was also observed, confirming that tissue regeneration is happening. The implant began to break down as expected, while its original structure remained intact. No harmful reactions were detected, confirming the safety of this new implant in development.

“This pre-clinical study marks a significant step forward in our effort to provide patients with care using regenerative medicine instead of traditional implants,” concluded Stratasys CEO Yoav Zeif. “Together, we are driven by a shared mission to challenge the status quo and find new ways to improve lives and advance healthcare.”

Stratasys CEO Yoav Zeif giving the AMS 2024 Keynote Speech. Image courtesy of Sarah Saunders/3DPrint.com.