French regenerative medicine firm Healshape is preparing to raise $6.8 million through an ongoing seed-funding activity to scale and industrialize the production of 3D bioprinted breast implants for mammary reconstruction that use patients’ own cells. Headquartered in the city of Villeurbanne, in the Auvergne-Rhône-Alpes region of Lyon, this up-and-coming startup is currently at the preclinical stage and hopes to initiate clinical trials within the next two years on a sample of 15 patients.
This early-stage Series A financing round led by Pulsalys SAS, a Lyon-based technology transfer acceleration company, marks the second time that Healshape received funding, following a win at the i-Lab national innovation awards––a publicly financed competition to support startups in France.
Using technologies developed by the University of Lyon’s Institute for Molecular and Supramolecular Chemistry and Biochemistry (ICBMS) and LabSkin Creations, an advanced 3D skin model company, Healshape is generating 3D printed solutions for mammary reconstruction that are implantable, adapted to the morphology of each patient, and able to regenerate patient tissue using their own cells.
Set up in January 2020, Healshape developed a bioprosthesis using natural, resorbable hydrogel. This bioprinted implant is basically a 3D printed mold based on the patient’s anatomy. Because it is made from a patented biological ink made up of natural biomaterials, its composition is close to that of human tissue. So once the prosthesis is in place, the patient’s own cells from a fat transfer can colonize the implant, enabling the natural growth of the fatty tissue and the total absorption of the bioprosthesis. As a result, Healshape states that patients will be able to regain their physical integrity safely and permanently in a few months.
Once preclinical and clinical trials are finalized, this new bioprinting technique would offer over one million women who undergo a mastectomy every year the chance to adopt mammary reconstruction. Today, almost half of all women diagnosed with breast cancer have a surgical procedure to remove the breast. However, following this operation, only 14% of patients worldwide––and 20% in France––choose to undergo a mammary reconstruction, mainly due to the fear of being subjected to further surgery, postoperative pain, or even unsatisfactory aesthetic results. Yet Healshape claims it can offer a simple operation to help them.
“A woman will recover her own breast within six to nine months, with no trace of the bioprosthesis,” says Sophie Brac de la Perrière, co-founder and CEO of Healshape. “I hope this will help women accept their image and be happy with their bodies again.”
Creating the bioprosthesis itself is done using bioprinters designed and manufactured through a collaboration between LabSkin Creations and a group led by French National Centre for Scientific Research (CNRS) senior researcher Christophe Marquette, who is also the manager of 3d.FAB, an innovative technology platform (PTI) for 3D printing research and production. In technical terms, Healshape relies on know-how and a patented biological ink that allows reconstruction through bioprinting.
As Marquette describes, “initially, the technology was developed to print skin substitutes. However, for the Healshape project, it was necessary to adapt the process to printing volumes and ensure subsequent consolidation of the biological ink to make it compatible with implantation in the body.”
Healshape, along with its six co-founders, including Brac de la Perrière, Marquette, and the founders of LabSkin Creations, hold the exclusive license for the biological ink’s use in the medical field, which had to be adapted for compatibility with bodily implantation. So far, the startup is developing its process through two complementary paths: an industrial process and the preparation of in vivo preclinical trials.
As part of a growth strategy that aims to put bioprosthesis in surgeons’ hands in just a few years, 3d.FAB recently announced that a new BioAssemblyBot 500 printer had been installed at its tissue engineering laboratories to work on the biofabrication of living tissue and breast cancer reconstruction with Healshape. The latest addition will help the startup continue to advance regenerative medicine research and, specifically its first applications, bioprinted breast regeneration solutions.
The six-axis robotic arm BioAssemblyBot 500 bioprinter was designed and manufactured by Advanced Solutions Life Sciences, a Louisville, Kentucky manufacturer of robotic and vascular platforms for tissue engineering. It mainly provides a level of environmental control over the biofabrication process. Since it was explicitly designed for pharma and clinical applications, it is housed in a biosafety cabinet to ensure a sterile environment for life scientists to have more control over all parameters in their assays. It also incorporates a unique combination of technologies to enable clinic-grade manufacturing of human tissue models for new drug discovery and research and therapeutic tissues at the point of use.
Although there is still a long road ahead as Healshape transfers the technology from the lab to the patient, the biomedical application is becoming quite publicized due to its innovative process and has already tripled its workforce, going from only four employees in 2020 to 13 today. Once the new funding round is finalized, the startup can accelerate its bioprosthesis application and eventually make a difference in the lives of breast cancer survivors.
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