The Business of Biofabrication

The procedure takes 3D bioprinting beyond chronic wound care and into reconstructive surgery—while offering a glimpse of what point-of-care biofabrication could look like in practice.

A 3D bioprinter originally introduced for wound care has now been used to create what Kaleida Health says is the world’s first 3D-printed fat graft to the breast.

The procedure was performed by Raymond O. Schultz, MD, FACS, a plastic surgeon at Buffalo General Medical Center, using the APLICOR 3D platform distributed in the United States by Tides Medical.

The patient, a 56-year-old woman who had previously undergone a mastectomy for breast cancer, was left with a visible depression following reconstruction. Previous attempts to correct the defect using conventional fat grafting had been unsuccessful, in part because scar tissue made it difficult for the transferred fat to survive.

Schultz released the scar tissue and instead created a patient-specific graft using the patient’s own adipose tissue. The graft was printed at the point of care and placed directly into the breast defect.

According to Kaleida Health, early follow-up showed that the transferred fat remained viable and the breast contour improved significantly. The team has subsequently begun using the approach for other reconstructive cases, including correcting defects following lumpectomy and refining the shape of previously reconstructed breasts.

From wound care to reconstructive surgery

The significance of the procedure extends beyond a single breast reconstruction case.

APLICOR 3D has primarily been commercialized by Tides Medical as a point-of-care system for treating complex wounds.

The workflow begins by capturing the geometry of the tissue defect. Tides’ platform uses an imaging system to measure the area and depth requiring treatment and converts that information into a file that can be used by the printer.

Adipose tissue is then harvested from the patient and processed into material suitable for printing. The APLICOR 3D system prints that material into a graft matching the patient’s defect, which can then be placed by the surgeon.

Tides says the complete workflow—from tissue harvesting through graft application—can be performed in roughly an hour. The company has previously highlighted applications including diabetic foot ulcers, venous ulcers, pressure injuries, burns, trauma wounds and wounds following Mohs surgery.

Breast reconstruction is a noticeably different application.

Instead of using the printed tissue to cover an open wound, the Buffalo team used the technology to reconstruct missing soft-tissue volume.

That turns APLICOR from primarily a wound-regeneration platform into something potentially broader: a point-of-care soft-tissue fabrication system.

Why print the fat at all?

Autologous fat transfer is already common in reconstructive and plastic surgery.

Typically, adipose tissue is harvested through liposuction, processed and reinjected into the area being reconstructed. The technique can work well, but graft survival can be unpredictable.

This becomes particularly difficult in tissue that has undergone previous operations, significant scarring or radiation therapy. The injected fat must establish sufficient blood supply in its new environment, and some portion of the graft can be reabsorbed over time.

The premise behind the APLICOR approach is different.

Rather than injecting free fat into the defect, the surgeon can fabricate a defined structure tailored to the geometry of the tissue that needs to be replaced.

The Buffalo case provides an early example of where that difference could matter. Conventional fat grafting had already failed. Printing the patient’s adipose material into a defined graft gave the surgeon another way to approach the defect.

Whether this ultimately produces better long-term volume retention than conventional fat transfer remains to be demonstrated.

But clinically, it creates an interesting new tool.

Biofabrication moves into the operating room

The procedure is also notable for where the manufacturing happens.

Much of regenerative medicine has been built around centralized production.

Cells are expanded or tissues manufactured in specialized facilities, subjected to quality control, packaged, shipped and eventually delivered to the patient.

APLICOR represents a fundamentally different model.

The patient supplies the raw material.

The hospital becomes the manufacturing site.

And the surgeon becomes part of the biofabrication workflow.

ROKIT Healthcare developed the APLICOR technology, while Tides Medical distributes and supports the platform in the United States. Tides describes the system as enabling surgical teams to manufacture patient-specific grafts directly from autologous adipose tissue.

That model could prove particularly attractive for tissue applications where using a patient’s own material is feasible.

It eliminates the need to manufacture a standardized implant remotely and then adapt it to the patient. Instead, the implant can be manufactured around the patient who is already in the operating room.

Scan the defect. Harvest the tissue. Process it. Print the graft. Implant it.

That is point-of-care biofabrication in a remarkably literal sense.

One platform, multiple procedures

The other interesting element is how the breast application emerged.

The same basic system being used to fabricate grafts for chronic wounds could be applied to an entirely different clinical problem without fundamentally reinventing the hardware.

That is one of the potential advantages of biofabrication platforms over fixed implants.

A conventional medical implant is generally manufactured in a defined range of sizes and designed for a particular procedure.

A printer is different.

Change the geometry, the tissue input and the surgical workflow, and the same manufacturing platform may become relevant to another indication.

Breast reconstruction may only be one example.

Soft-tissue defects occur throughout reconstructive surgery following cancer resections, traumatic injuries, congenital abnormalities and previous operations. If surgeons can reliably fabricate autologous grafts in customized shapes and volumes, the opportunity could eventually extend well beyond wound care.

That remains a hypothesis rather than a demonstrated market.

But the Buffalo procedure provides an unusually tangible example of how indication expansion can occur once biofabrication technology is placed directly into surgeons’ hands.

What comes next

The most important question now is durability.

A successful early surgical result does not yet demonstrate that a printed adipose graft performs better than conventional fat grafting.

Long-term follow-up will need to show how much of the implanted tissue survives, whether the reconstructed volume is maintained and whether complications differ from existing techniques.

Reproducibility will matter too.

One procedure performed successfully by an experienced surgeon can establish feasibility. A scalable medical technology ultimately needs similar outcomes across multiple surgeons, hospitals and patient populations.

But the significance of the case should not be understated.

For years, much of the conversation around bioprinting has centered on what might eventually be manufactured: organs, vascularized tissues and increasingly complex living structures.

The Tides APLICOR case represents something more immediate.

A patient’s own tissue was processed, digitally shaped and 3D printed into a customized graft at the point of care, then implanted during reconstructive surgery.

It is not a printed organ.

But it may be a much clearer picture of how clinical biofabrication begins.

The factory is moving into the operating room.

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Sources: Kaleida Health; Tides Medical; ROKIT Healthcare/ROKIT America regulatory filings.