Kallisio ships SLS-printed oral stents for radiation patients within 72 hours of a scan

Kallisio, a medtech company from Baltimore, makes Stentra, a patient-specific oral stent printed in nylon by selective laser sintering for head and neck radiation therapy. The device ships within 72 hours of a valid intraoral scan, against up to two weeks for the traditional route. The CEO says the real constraint is clinical workflow, not print speed.

Context An oral stent is a mouthpiece that holds the tongue and jaw in the same position during each radiation session, so the dose lands where it was planned.

How the scan-to-device workflow runs

The oncology team sends a prescription with treatment parameters, including the direction in which the tongue should be displaced. Before the CT simulation, a dentist takes an optical scan, which needs about 10 to 15 minutes and often fits into an appointment already planned. Kallisio designs the stent and every design is approved before release. Myrava, formerly Ricoh 3D for Healthcare, handles production and quality control. The stent is printed by SLS in biocompatible nylon and carries FDA clearance and CE marking under the EU MDR.

Where the time is actually saved

The conventional route starts with impressions and plaster models, then wax or acrylic construction, a fitting visit and often adjustments. Each step depends on specialist availability and coordination between oncology, dentistry and the lab. According to the interview, MD Anderson measured about 48 hours of lab work for a conventional stent, less than Kallisio's 72 hours. The gain therefore comes from removing waits and handoffs within the two-week process, not from faster making.

Clinical evidence and reimbursement

The design stems from research by Dr. Eugene Koay at MD Anderson, protected by US Patent No. 11,730,561 and licensed to Kallisio. A study of 462 oropharyngeal cancer patients linked stent use to fewer long-term complications. Centres report no interrupted treatments due to the device, though this does not prove better outcomes. An internal model suggests 3 to 7 minutes saved per session, still under evaluation. Stentra is used at more than six US centres and is reimbursed under CPT code 77334. Talks are under way about Europe, Japan, Brazil and Australia.

What it means

The case shows that for patient-specific medical AM, the business case often rests on process design around the printer, not on print time. For European device makers and clinics, the relevant lessons are the regulatory groundwork (MDR marking, design controls), outsourced qualified production and reimbursement. Claims of clinical benefit remain preliminary, so buyers should treat the efficiency figures as modelled, not proven. In-hospital printing is described as a distant option, viable first for large systems.

Frequently asked questions

How fast does Kallisio deliver a Stentra stent?

The company ships the device within 72 hours of receiving a valid intraoral scan, compared with up to two weeks for the traditional process.

Is the SLS printing itself faster than traditional stent making?

Not necessarily. MD Anderson found about 48 hours of lab work for a conventional stent, so the digital gain comes from fewer waits and handoffs.

Is Stentra approved and reimbursed?

It has FDA clearance and CE marking under the EU MDR, and in the US it is reimbursed under CPT code 77334.