DiFusion, Genesis Medical Plastics Establish Licensing Agreement

DiFusion Inc. has negotiated a licensing agreement with Genesis Medical Plastics to market and sell its ZFUZE Immunomodulatory polymer and stock shapes in Asia and the European Union. ZFUZE is an ASTM F2026-compliant material suitable for long-term human implantation.

The strategic partnership involves a mix of upfront financial participation and a long-term revenue-sharing agreement between the companies, though neither party shared details of the arrangement. DiFusion concurrently announced the start of a Series C investment round to finance the U.S. commercialization of its ZFUZE spinal fusion cages and R&D expansion for ZFUZE applications in the cardiology, sports medicine, and dental markets.

Recent post market studies have shown ZFUZE superiority for spinal fusions demonstrating a 93.4% fusion rate at seven months, while comparative peer-reviewed studies post an average 68% fusion rate at 12 months. “ZFUZE has consistently shown faster and higher fusion rates in multiple third-party studies because ZFUZE avoids the foreign body response, which allows for faster healing due to lack of chronic inflammation,” DiFusion CEO Derrick Johns stated. “We are pleased to be partnered with Genesis Medical Plastics, which will expand our sales for ZFUZE outside the U.S. while simultaneously making our supply chain more efficient.”

Genesis initially will offer ZFUSE polymer and a range of ZFUZE machinable shapes and expand the product line to other forms as new requirements and applications are identified.

“We have been the machinable shapes provider for DiFusion’s ZFUSE through many years of studies, trials, and approvals,” Genesis President Steven Quance said. “We have long recognized that ZFUZE is a game-changing material technology in implantable polymers, and we are excited to be working closely with DiFusion to bring their products to our international customers. It’s an ideal match-up, as ZFUZE fits precisely within Genesis’ mission to advance technology in implantable medical devices and improve patient outcomes.”

By definition, all biomaterials are foreign bodies. Historically, their design has largely been based upon mechanical and physical properties, and inertness was a desirable characteristic. But as the adaptability of immune cells and the role that biomaterials play on immune-mediated tissue responses becomes better understood, there is a shift towards designing materials that can proactively modulate the immune system.

Located in Austin Texas, DiFusion was founded in 2016. It has engineered and brought to market patented immunomodulatory, tissue regenerating and antimicrobial polymers.

Genesis is an ISO 13485:2016 certified company and a U.S. Food and Drug Administration-registered medical device manufacturer based in Cypress, Texas. Capabilities include shapes, film, and thin sheet extrusion, precision CNC machining, and injection molding. Its machinable shapes include Genesis PEEK extruded from implantable PEEK resin, ZFUSE immunomodulatory implantable biomaterial, Eviva PSU extruded from Syensqo’s implantable Eviva polysulfone resin, and shapes extruded from most other major medical polymers. Its production team has decades of processing experience in medical-grade polymers from polypropylene through PEEK.