Adaptiiv, a Halifax-based medical technology company, has received 510(k) clearance from the U.S. Food and Drug Administration to sell its 3D Bolus Software in the United States.

Formerly known as 3DBolus, Adaptiiv has developed software that works with 3D printers to produce a personalized bolus – a plastic fitting used in radiation therapy.

The company has launched three different products, booked sales in at least six countries, and as of April raised almost $3 million in equity funding. It has also struck a global distribution agreement with Iowa-based CIVCO Radiotherapy, which will give it sales representatives in key markets.

Now it has received the key FDA approval to sell its main product in the U.S.

“This 510(k) clearance uniquely positions Adaptiiv to fuel the growth of personalized medicine through elegantly simple, intuitive technology,” said Adaptiiv CEO Peter Hickey in a statement. “Our technology platform is the first of its kind and allows users to easily design patient-specific devices that can be 3D printed and used during radiation treatment.”

Coupled with the CIVCO Radiotherapy deal, Adaptiiv said it continues to make significant strides in the battle against cancer and transforming novel and experimental ideas into real world applications.

Adaptiiv, CIVCO Ink Distribution Deal

What Adaptiiv does is revolutionize the use of a bolus in radiation therapy. A bolus is a piece of plastic placed over the cancerous area, assuming the tumours are close to or in the skin. The radiation hits the bolus, builds up and then is transferred into the tumour.

There can be no air pockets between the bolus and the skin, which complicates matters given that every body is unique. Hospitals using the Adaptiiv product buy a system that includes 3D printers with special filaments, so boluses customized to each patient can be printed within seconds. They can be reused as the patient receives repeated radiation dosages. Or, if the patient’s body shape changes over the course of multiple treatments, the medical staff can print off another bolus quickly.

The company has received its CE Mark certification, meaning it can sell into several countries including members of the European Union. It already has clients in the U.K., Ireland, Israel, Australia and Canada.