Adaptiiv Validates Formlabs 3D Printing Solutions to Offer FDA-Cleared, Patient-Specific Nova Surface Applicators for HDR Brachytherapy
HALIFAX, NS, November 2, 2023
Adaptiiv, a leader in delivering personalized radiation therapy medical devices, is collaborating with Formlabs, a leading manufacturer of 3D printers and printing materials, to offer on-demand production of Nova Surface Applicators for HDR brachytherapy. Adaptiiv On Demand is a regulatory cleared software platform as a service which allows clinical teams to customize, order and receive custom-made patient-specific radiation therapy (RT) accessories for cancer treatment.
Adaptiiv’s on demand service digitally manufactures and delivers 3D printed patient-specific medical devices for cancer treatment. 3D printed medical devices conform to patient anatomy, improving the accuracy of dose delivery while the integration of Adaptiiv software into clinical workflows provides improved efficiencies, such as reducing patient set up time both in CT simulation and on the treatment unit. The Adaptiiv On Demand platform can deliver best in class 3D printing technology and materials to customers around the United States who are treating cancer with radiation therapy.
The Adaptiiv On Demand solution has been validated with Formlabs Form 3B+ printers and Clear and BioMed Clear materials. Formlabs Form 3B+ printers are known for their high accuracy and reliability, and BioMed Clear resin is biocompatible, made in an FDA-registered, ISO 13485-certified facility, and is now validated in the FDA-cleared process.
“This partnership with Formlabs will ensure that cancer centers treating patients using HDR brachytherapy will have confidence that they can treat patients with best in class bio-medical materials and the highest quality 3D printing technology,” said Alex Dunphy, CEO of Adaptiiv. “Our Nova Surface Applicators are manufactured using Formlabs’ Form 3B+ printers and Clear materials which are ideal for producing high-quality applicators which are required to deliver precise cancer treatment.”
“We are proud to collaborate with Adaptiiv to enable on-demand production of Nova Surface Applicators,” said Guillaume Bailliard, President of Healthcare at Formlabs. “Formlabs printers are used by medical professionals around the world to produce custom-made medical devices, and we are committed to helping Adaptiiv make Nova Surface Applicators more accessible to patients.”
Nova Surface Applicators are used to deliver high-dose rate (HDR) brachytherapy to the surface of the skin. HDR brachytherapy is a form of radiation therapy that uses a sealed radioactive source to deliver radiation inside or next to an area requiring treatment. Nova Surface Applicators are custom-made for each patient, ensuring a precise and conformal fit.
Adaptiiv is a part of the Varian 3cosystem and is its first Gold Tier member. Through the involvement in the 3cosystem, Adaptiiv’s Nova Surface Applicators are now compatible with Varian’s BRAVOS system, an industry leading delivery system for HDR brachytherapy. This interoperability allows clinicians to design and order Nova Surface Applicators directly from the Adaptiiv software with confidence knowing it is compatible with BRAVOS .
Adaptiiv is a leader in the fabrication and delivery of personalized medical devices with a mission to democratize personalized solutions for radiation therapy cancer treatment. Adaptiiv On Demand* is an FDA 510(k) cleared service that allows clinical teams to customize and order 3D printed, patient-specific radiotherapy (RT) accessories. Adaptiiv’s products are used by clinicians around the world to treat a variety of head & neck, breast, skin, cervical, and other cancers.
Formlabs is expanding access to digital fabrication, so anyone can make anything. By combining clinically-validated 3D printing technology, in-house QA/RA expertise, accessible pricing, and a wide range of materials, the company enables healthcare professionals and medical device engineers to enhance surgery, radiology, orthotics and prosthetics, and device development. Formlabs has FDA-registered, ISO 13485 certified manufacturing facilities and a wide range of biocompatible, sterilizable materials made for both SLA and SLS print engines. Its solutions have been used in thousands of publications and are trusted by the world’s leading health systems and medical device manufacturers.