Last year, Baltimore-based medical device company Kallisio received FDA 510(k) clearance for its 3D printed patient-specific Stentra device. Oral stents like this are critically important in protecting a patient’s healthy tissue during radiation treatments for head and neck cancers (HNC). Now, the company has announced a strategic partnership with RICOH 3D for Healthcare to make and distribute Stentra to improve radiation oncology care.
“Partnering with RICOH 3D for Healthcare is a natural fit for our mission to transform cancer care. Ricoh’s expertise in advanced manufacturing and their robust distribution network, including point-of-care production capabilities and clinical applications team, make them an ideal partner,” said Kallisio CEO Rajan Patel. “Together, we can ensure that Stentra™ reaches radiation oncology teams efficiently, enhancing treatment precision and patient outcomes on a broad scale.”
Based on cancer statistics in the U.S. this year, incidents of HNC were estimated to reach over 58,000 cases, according to a 3DHEALS blog post. A combination of surgery, chemotherapy, and radiotherapy is typically used for cancer management and treatment, but radiation-induced oral mucositis (RIOM) is common. This is when the oral tissue is damaged by radiation, and can cause pain, dry mouth, difficulty speaking and eating, ulcers, and more.
Custom stents are designed to secure patients in specific positions and reduce their movements. This is done in order to more accurately target radiation towards tumors and thus improve its effectiveness, plus lower the risk of damaging healthy tissue. But the 3D printed Stentra does even more than your typical oral stent. Kallisio’s mission is to use advanced technology to improve treatment options, help oncologists deliver effective treatment, and keep patients safe from healthy tissue harm and other radiation side effects. So Stentra was also designed to help manage harmful radiation toxicity, as well as better target tumors.
Kallisio’s Stentra was developed using technology that was exclusively licensed by an existing patent by researchers at the MD Anderson Cancer Center. The 3D printed stent is able to very precisely displace and immobilize the sensitive areas during radiation treatments, for more effective delivery. Not only does this improve treatment outcomes, but it also helps to decrease side effects to the patient.
Ricoh 3D for Healthcare, which integrates with IBM iConnect Access from IBM Watson Health, excels at manufacturing patient-specific medical devices. Recently, it joined Kallisio at the ASTRO 2024 Annual Meeting in Washington, D.C. to showcase and demonstrate Stentra. Per their collaboration, Ricoh 3D for Healthcare will turn to its network of FDA-registered 3D printing facilities to manufacture the 3D printed oral stent.
“Our collaboration with Kallisio highlights our shared commitment to advancing cancer care by addressing critical needs in toxicity management. Stentra™ not only protects the tongue and other healthy tissues from exposure to radiation but also enhances the precision of radiation therapy, thereby reducing side effects and improving patient quality of life,” said Gary Turner, Managing Director, RICOH 3D for Healthcare.
Beginning this month, radiation oncologists across the U.S. will be able to quickly and efficiently order Kallisio’s Stentra through Ricoh 3D for Healthcare’s Clinical Applications Specialists.
Images courtesy of Kallisio
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