Introduction: According to the World Health Organization, more than 2 million women worldwide are diagnosed with breast cancer every year. It is the most prevalent cancer in women in the world, killing nearly 700,000 people each year.
About 40 percent of people diagnosed with the disease end up having to undergo mastectomy, which involves partial or complete removal of the affected breast tissue. However, with modern treatments, the survival rate is over 90%, which means that more and more women are seeking breast reconstruction treatments to replace lost tissue.
△Bioprinted breast implants contain patient cells to improve transplant success, image via Healshape
French Healshape receives $6.8 million in Series A financing
On January 23, 2022, Antarctic Bear learned that Healshape, a French regenerative medicine startup, has raised $6.8 million (about 43 million yuan) in Series A financing to develop 3D bioprinted breast implants using living patient cells.
The company, backed by technology transfer accelerator Pulsalys SAS, has received more than $1 million in pro bono funds and subsidies from France since its launch in January 2020.
Healshape's mission is to provide specific 3D bioprinted breast prostheses for breast cancer patients undergoing mastectomy. These implants can be printed in virtually any shape and size and can help rebuild breasts and nipples without the risk of implant rejection.
Sophie Brac de la Perrière, CEO of Healshape, said: "Female patients will have their breasts restored within 6 to 9 months, with no trace of a bioprosthesis. This will help patients accept their own image and recreate their own body. Satisfied."
△Healshape scientists 3D bioprinted custom breast implants, photo from Healshape
Previously, breast reconstruction surgery typically used artificial implants, or soft tissue matrices from other humans and animals. Implants from these sources are always at risk of an immune reaction that can delay the healing process.
Healshape's tissue engineering approach addresses these issues by combining 3D bioprinting technology with live cell cultures taken from the patient's own body.
Bioprinted absorbable breast implants
Healshape's bioprosthetic technology relies on an absorbable hydrogel that can be 3D bioprinted into any freeform shape. Once implanted in the human body, fat transfer from the patient's own body cells facilitates the colonization of the breast implant and allows it to develop into natural breast tissue, while all of this hydrogel is gradually absorbed and replaced.
Healshape's technology is the result of a bioprinting study in collaboration with a research group led by Christophe Marquette, a senior researcher at the Institute for Molecular and Supramolecular Research at the French National Centre for Scientific Research (ICBMS). Marquette also leads the 3d.FAB platform and founded the tissue engineering company LabSkin Creations. Healshape's bioink technology is currently patent protected.
Marquette added: "Originally, the technology was developed for printing skin substitutes. For the Healshape project, it was necessary to adapt the process to print volumes and ensure subsequent consolidation of the bioink to make it compatible for implantation in vivo" .
Healshape's 3D bioprinting technology is currently in the preclinical stage, with clinical trials expected to begin within the next two years.
Research progress of global 3D printing breast prosthesis
In 2016, Zhang Xue (pseudonym), who suffered from breast cancer, was treated at Xijing Hospital. At that time, the size of the tumor exceeded 6 cm, and despite neoadjuvant chemotherapy, only a total mastectomy was performed. Experts decided to perform breast reconstruction surgery with computer-aided 4D printing of biodegradable material fillers.
Before surgery, a thin-layer breast MRI scan was performed by the team from the Department of Radiology, Xijing Hospital. The surgical team accurately collected tumor and breast image information through MRI, and performed 3D reconstruction and simulated resection on the computer. On this basis, the size of the filler is precisely designed according to the simulated tissue defect, and the defect site is 3D printed one-to-one.
△ 4D printed biodegradable material filler
On the day of the operation, director Ling Rui and associate professor Zhang Juliang of the Department of Breast Vascular Surgery of Xijing Hospital performed extensive excision of left breast cancer and axillary lymph node dissection based on the results of computer simulation. Pre-engineered 4D-printed biodegradable material filler for successful breast reconstruction. The patient recovered well after the operation and was discharged on the third day. The patient also received radiotherapy routinely after the operation. After several re-examinations, the implants were gradually shaped, and had good tissue compatibility, and autologous fibrovascular tissue began to grow.
In 2018, two University of Plymouth students Rosie Brave and Sam Jackman designed a 3D-printed pink fake breast that will change the lives of breast cancer survivors.
Brave was inspired by Jackman's mother, who had had surgery and had traditional breast implants installed, but was confused by the "sweaty" and "uncomfortable" breast implants.
So Brave and Jackman set out to completely rethink breast implant design and come up with designs that would bring joy to the wearer. The 3D printed models they create are colorful, light and breathable, and designed with those who have experienced the trauma of breast cancer and mastectomy.
In 2019, New Zealand-based medical start-up myReflection used 3D scans and 3D printed molds to develop personalized breast implants for cancer patients after mastectomy.
The prosthesis uses 3D scanning technology to determine the external dimensions, and is designed with an inner core and an ISO-certified silicone material on the outside.
△Customized breast prosthesis made with 3D printing mold, picture from myReflection
In 2021, South Korea-based biotech startup Plcoskin announced that it would lead an international joint research project focused on developing a new type of 3D printed breast implants. Together with Yonsei University and LipoCoat, a Netherlands-based medical device coating company, Plcoskin will receive about 2 billion won ($1.7 million) in funding over the next three years.
In 2021, 3D printer manufacturer 3D Systems recently announced a co-development agreement with regenerative medicine company CollPlant to develop 3D bioprinted soft tissue structures for breast reconstruction treatments. Soft tissue structures will be used to provide support to the lower part of the breast and increase the overall coverage of the implant. Like Healshape, the ultimate goal is to improve the success of breast reconstruction surgery for cancer survivors.
