The Business of Biofabrication

The FDA’s recent De Novo authorization of COAPTIUM Connect removes a long‑standing barrier for photopolymer 3‑D‑printed implants. Developed by Paris‑ and Cambridge‑based TISSIUM and produced on a bespoke printing line co‑engineered with 3D Systems, the fully bioabsorbable sleeve offers an atraumatic, suture‑free method for coupling severed peripheral nerves. U.S. commercial launch began on 23 July 2025, marking the first time a vat‑photopolymerised device has reached the operating room.

A programmable polymer tailored for soft‑tissue mechanics

At the heart of COAPTIUM Connect is a light‑curable poly(glycerol‑sebacate‑acrylate) resin. By modulating crosslink density and backbone length, chemists can “dial‑in” elasticity, degradation rate and surface energy so the printed sleeve mirrors the compliance of native epineurium while fully resorbing over the nerve‑healing window. A companion formulation called TISSIUM Light is applied intra‑operatively and activated with visible blue light to seal the sleeve to the nerve ends in seconds, replacing painstaking microsuturing.

High‑resolution vat photopolymerisation delivers the geometry

3D Systems provided what’s believed to be a medical‑grade variant of its Figure 4 architecture, adapted for clean‑room resin handling and ISO 13485 production. Sub‑50 µm voxel resolution enables thin, flexible struts that prevent kinking yet protect the coaptation site an architecture nearly impossible with filament or powder‑bed methods. The same platform can be re‑tuned for other soft‑tissue devices by swapping build parameters and resin batches.

Which printer is behind it?

Neither company names the platform, but regulatory filings and 3D Systems’ own statements point to a medical‑grade variant of the Figure 4 vat‑photopolymerisation architecture:

• 3D Systems has publicly described repurposing its Figure 4 high‑speed light engine for regenerative‑medicine bioprinting, citing the need for high‑resolution elastomeric 3‑D‑printed medical implants.
• Figure 4 already supports open‑air, UV‑cured elastomers; the TISSIUM collaboration likely swaps in a wavelength‑matched, clean‑room light engine and a sterile resin‑delivery loop, then locks the material set for GMP production.
• Layer thicknesses reported for COAPTIUM prototypes (<50 µm) align with Figure 4’s native voxel size, reinforcing the link.

Until an FDA device summary is published, the exact model number will remain proprietary but all evidence suggests a custom Figure 4 “biomedical” chassis coupled to TISSIUM’s resin cartridge and post‑cure recipe.

Regulatory firsts for photopolymer SLA

Until now, FDA‑cleared polymer implants used powder‑bed or filament extrusion. COAPTIUM Connect proves that a photo‑cured, degradable resin can satisfy biocompatibility and residual‑monomer limits, expanding the additive‑manufacturing toolbox for implant developers. The De Novo classification also streamlines future submissions that leverage the same material family and manufacturing process.

Was SLA photopolymerisation ever approved for implants before?

No. Earlier polymer implants that cleared FDA review OPM’s PEKK cranial plate or PEEK spinal cage —used laser sintering or fused‑filament processes, not photo‑curing resins. COAPTIUM Connect therefore represents the first time the agency has accepted a light‑cured, vat‑polymerised material as a permanent (albeit bioresorbable) implant, a milestone noted by ACS C&EN and others.

Thoughts on Key factors that made approval possible:

• Ultra‑low residual monomer after post‑processing and sterilisation
• Self‑sealing elastomeric network that avoids particle shedding
• Complete in‑vivo resorption within the nerve‑healing window, reducing long‑term toxicity risk

Given the early clinical success of COAPTIUM Connect and the platform’s modularity, both companies anticipate accelerating the rollout of additional degradable photopolymer implants over the next five years, subject to regulatory clearances and manufacturing scale‑up.

Take‑home for biofabricators

• Photopolymer SLA is now a viable regulatory path provided the chemistry is bioabsorbable and post‑cure leachables are tightly controlled.
• Owning the material IP matters: TISSIUM’s programmable‑polymer platform gives it leverage far beyond a single device.
• High‑speed vat photopolymerisation unlocks micro‑architectures (thin walls, lattice reinforcement) that match soft‑tissue mechanics better than fused‑filament or laser‑sintered PEEK.

COAPTIUM Connect is more than a nerve‑coupling sleeve; it’s a proof‑of‑concept that SLA bioprinting has crossed the implantation threshold, setting a precedent that could accelerate the entire biofabrication field.

About TISSIUM

TISSIUM is a MedTech company pioneering biomorphic programmable polymers for tissue reconstruction. Founded in 2013, the firm combines proprietary chemistry, custom light‑delivery systems and additive manufacturing to create minimally invasive, bioabsorbable solutions for nerve, cardiovascular and soft‑tissue repair. TISSIUM operates R&D and GMP resin‑production facilities in Paris and Roncq, France, with a commercial office in Cambridge, Massachusetts.

About 3D Systems

3D Systems (NYSE: DDD) invented stereolithography in 1983 and today delivers end‑to‑end additive‑manufacturing solutions spanning industrial, dental and medical markets. Its healthcare division has supported more than 150,000 patient‑specific surgical planning cases and produced over two million implants and instruments from FDA‑registered, ISO 13485‑certified facilities in Colorado and Belgium. The company’s regenerative‑medicine group collaborates with partners to develop bioprinting platforms for tissues and organs, extending additive manufacturing’s impact from the lab bench to the bedside.

This article includes forward-looking statements that reflect current expectations and involve risks and uncertainties; actual outcomes may differ materially.