Volumina Medical Enters Human Trials with Single-Injection, High-Performance Polymer for Breast Reconstruction

The breast is a specialized soft tissue, and scaffold materials, as one of the three key elements of tissue engineering, play a particularly important role in breast tissue engineering.andIdeal scaffold materials shouldThisPossesses physical and biochemical properties similar to those of the target tissue, provides a suitable biochemical and physical microenvironment, and is capable of modulating the response of seed cells to specific tissue engineering requirements.

As an innovative biomaterials company, Volumina Medical focuses on the research and development of novel injectable polymeric biomaterials designed to reconstruct human soft tissues damaged by tumor resection, congenital deformities, natural aging, or trauma, thereby restoring the original appearance and function of the affected areas. Notably, Volumina’s products will be initially applied to breast reconstruction following mastectomy for breast cancer.

In stark contrast to traditional fillers that are fragile and rigid, the novel biomaterial developed by Volumina demonstrates superior performance: it can withstand significant external pressure without rupturing or deforming, thereby ensuring the stability of the scaffold’s shape and structure.This characteristic enables Volumina’s materials to provide durable support and guide soft tissue growth after implantation, delivering more reliable therapeutic outcomes for patients.

In 2017, Dr. Amélie Béduer, biologist Professor Thomas Braschler, and microsystems expert Professor Philippe Renaud co-founded Volumina Medical, which was incubated by the École Polytechnique Fédérale de Lausanne (EPFL).From 2000 to 2019, EPFL incubated 293 startups, 116 of which still maintain offices in the EPFL Innovation Park.

To attract more startups to the EPFL Innovation Park, the university established a dedicated office for intellectual property (IP) strategy and licensing within its organizational structure. This office not only facilitates research collaboration and exchanges with large corporations but also evaluates whether research outcomes from university teams are patentable, assists these teams in filing patent applications, and helps negotiate licensing agreements with large companies or startups. The revenue distribution model allocates 33% of technology licensing income to the inventor team, one-third to the respective laboratory, and the remaining one-third to the university.

The overall strategy for scientific research achievements is primarily based on licensing technologies to enterprises, while also encouraging research teams to incubate startup projects for direct market commercialization.

Each year, EPFL hosts its flagship event, “Investor Day,” bringing together investors and startup founders. The aim is to enhance the visibility of these companies and facilitate their meetings with network mentors. In 2023, thanks to the support of alumni, investor and corporate networks, as well as the EPFL Innovation Park, EPFL-born startups raised a total of CHF 470 million.

Volumina Medical is no exception. In 2023, Volumina Medical received CHF 2.5 million in funding to develop stents for the reconstructive and plastic surgery market, addressing the natural restoration of 3D soft tissues.

From the perspective of the founding team, Professor Philippe Renaud, the founder, not only serves as the head of the Microsystems Laboratory and the Microtechnology Center at EPFL but has also participated in incubating more than 16 successful startups. Meanwhile, Professor Thomas Braschler, as the head of the Microscopy Laboratory at the University of Geneva, possesses extensive expertise in neuroscience and biomaterials. In 2014, while Dr. Amélie Béduer was a postdoctoral researcher in Professor Philippe Renaud’s laboratory at EPFL, she and Professor Thomas Braschler jointly embarked on research into biomaterials for neural tissue engineering. They developed a compressible scaffold specifically designed for the minimally invasive transplantation of large, intact neural networks.

This millimeter-to-centimeter-scale injectable neural scaffold, based on macroporous cryogel materials and composed of alginate and carboxymethyl cellulose, not only enables sterile surgical processing but also ingeniously leverages natural laminin to promote nerve adhesion and neurite outgrowth. Its unique mechanical metamaterial properties allow the scaffold to be soft and injectable at the macroscopic level while protecting neuronal networks from damage at the microscopic level.

However, the research of Dr. Amélie Béduer and Professor Thomas Braschler did not stop there. By chance, through discussions with plastic surgeons, they learned about the unmet clinical need for soft tissue repair, particularly the challenge of large-volume soft tissue reconstruction following mastectomy for breast tumors.

Consequently, Professor Thomas Braschler, Professor Philippe Renaud, and Dr. Amélie jointly decided to translate this scientific achievement into clinical applications, specifically for breast reconstruction. In 2017, they co-founded Volumina Medical.

In terms of its technological approach, Volumina Medical has charted a unique course by integrating the core principles of cell therapy, tissue engineering, and materials science to successfully develop Adipearl—a novel implantable polymeric biomaterial.

In terms of performance,Adipearl, with its unique sponge-like microgel suspension form, is not only soft and moldable but also highly porous, allowing it to be easily injected into the body through fine syringes and precisely construct scaffolds of desired shapes.Moreover, Adipearl boasts exceptional adaptability, flexibly changing its shape in response to natural body movements, thereby endowing reconstructed soft tissues with more natural, fluid contours and a realistic tactile feel.

Regarding the implantation method.With a single minimally invasive injection, the Adipearl biomaterial rapidly shapes in vivo to form a stable scaffold structure. This greatly simplifies the surgical procedure and reduces patient pain and inconvenience.“This scarless recovery approach not only minimizes the risk of complications but also significantly reduces treatment costs, offering patients a more economical and efficient restorative solution,” stated founder Professor Thomas Braschler publicly.

As a result, Volumina Medical has gained recognition from both the industry and investors. Currently, Volumina Medical has completed preclinical studies on its injectable implant materials and has successfully advanced to human clinical trials. The company’s first product—a single-use sterile syringe preloaded with Adipearl biomaterial—seamlessly integrates with existing surgical workflows and commonly used instruments, providing plastic surgeons with a powerful therapeutic tool.

In March 2024, Volumina Medical announced the completion of a $21 million Series A financing round. Reportedly, the proceeds from this financing will be primarily used to accelerate the commercialization of Adipearl—Volumina Medical plans to leverage these funds to further expand the scale of clinical studies to validate the safety and efficacy of Adipearl.。

In the field of biomaterials, cryogenic materials have become highly sought after in 3D cell culture due to their unique macroporous structure, high pore interconnectivity, large surface-to-volume ratio, and high mechanical stability. However, the technical challenges associated with synthesizing these materials at extremely low temperatures (e.g., -80°C) have remained a major bottleneck restricting their widespread application.

In 2021, Volumina Medical was pioneering an innovative 3D printing solution for functionalized cryogenic materials. This approach not only overcame the technical barriers associated with traditional cryogenic material synthesis but also enabled precise control over pore size, thereby opening new avenues for selective cell seeding.

It is understood that by adjusting the pore size of the printing cryoplotter, researchers at Volumina Medical were able to precisely control the location of cell seeding during the printing process, enabling 3D culture of cells within the printed scaffolds according to predefined patterns and positions.

“Through surface modification and the introduction of bioactive molecules, scaffolds can further mimic the in vivo microenvironment, promoting cell adhesion, proliferation, and differentiation.” A representative from Volumina Medical stated that this highly biomimetic culture environment helps researchers gain a deeper understanding of cell behavior and its interaction mechanisms with the surrounding environment.

With advances in 3D printing technology, 3D-printed prosthetic scaffolds are increasingly appearing in breast reconstruction research and even clinical applications. For example, Healshape’s bioprosthetic technology relies on an absorbable hydrogel that can be 3D-bioprinted into any freeform shape. After implantation, autologous fat transfer helps the patient’s own cells colonize the breast implant, promoting its development into natural breast tissue, while the hydrogel is gradually absorbed and replaced.

In China, the team led by Director Ling Rui at Xijing Hospital has employed 4D printing technology to implant biomaterials into patients. So-called 4D printing refers to products fabricated from smart materials using 3D printing technology, which can self-transform in a predetermined direction over time.

By modifying the structure and molecular weight of the materials, the filler can undergo deformation and degradation within a predetermined timeframe, thereby preventing the retention of foreign bodies in vivo. It is reported that the biodegradable material implants used in patients can deform and degrade within 1.5 to 2 years. During this period, autologous fibrous tissue gradually grows into the implant, ultimately replacing it completely and ensuring the maintenance of breast contour.