The implants, which will be the first of their kind, have been treated using Promimic’s HAnano Surface® technology, renderring a bioactive exterior of the implant that improves the integration process and stimulates new bone formation and bone on-growth to the implant

FDA device

The US FDA’s Center for Drug Evaluation and Research. (Credit: The U.S. Food and Drug Administration)

Karolinska Development (Nasdaq Stockholm: KDEV) announces that the portfolio company Promimic’s customer and business partner INNOVASIS Inc. has received 501(k) FDA clearance of a series of 3D printed implants used in spinal fusion surgery.

The implants, which will be the first of their kind, have been treated using Promimic’s HAnano Surface® technology, renderring a bioactive exterior of the implant that improves the integration process and stimulates new bone formation and bone on-growth to the implant.

Promimic’s partner Innovasis Inc. is a US based medtech company engaged in research, development and marketing of spinal implant devices and related products. The companies’ collaboration extend to the co-development of the 3D printed products which are treated with Promimic’s patented HAnano technology. Following a clearance from the US Food and Drug Administration (FDA), the products will now be the first of their kind to reach the US market.

HAnano Surface® is a bioactive nano treatment of implant device surfaces leading to increased molecular anchoring of medical implants into previously existing bone tissue. In effect, these properties lead to a shortened healing time.

Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients’ lives while providing an attractive return on investment to shareholders.

Source: Company Press Release