A “game-changing” nanosynthetic putty used for healing after bone graft procedures has received approval from the US Food and Drug Administration (FDA).

The Osteo3 ZP Putty, developed by UK medical device firm Sirakoss, has been given 510(k) clearance by the FDA, and can now be commercialised in the US.

By promoting rapid and complete bone regeneration, the product is designed to provide an easy-to-use solution for surgeons to fill in gaps during spine and trauma-related bone grafts.

Sirakoss director Tom Buckland believes that breaking into the world’s largest bone grafting market in America is an “essential step” in positioning the company for future growth.

US FDA clearance is obviously a major achievement for Sirakoss, enabling us to implement the commercial strategy for this game-changing product,” he added.

“Osteo3 ZP Putty brings patented, best-in-class handling properties to enhance Sirakoss’ exceptional nanosynthetic bone regeneration potential, giving surgeons a one-two punch of repair confidence and intraoperative ease-of-use for spine and trauma bone grafting applications.

“It doesn’t seek to change the fundamental way that bone grafting is performed, but to provide a solution for surgeons that does not currently exist: a best-in-class bone regeneration material that heals the patient without introducing other risks or excessive cost.

“We believe Osteo3 ZP Putty will become the standard of care in bone grafting. In support of this, Sirakoss plans to expand and build its clinical experience with Osteo3 ZP Putty by running larger clinical studies.”


Sirakoss’ putty for post-bone graft healing

Having been spun out of the University of Aberdeen in 2011, Scotland-based company Sirakoss develops nanosynthetic substitutes to promote regeneration and healing following bone grafting procedures.

These procedures involve fusing bones together in order to fix congenital or degenerative conditions — for example, in correcting curvature of the spine, or in instances where the bone has failed to heal following a traumatic injury.

The Osteo3 ZP Putty, which is an entirely synthetic, nanoporous bone graft substitute, is designed to catalyse rapid and complete bone regeneration following these procedures.

It can be used straight from the pack by surgeons, making it easy to handle during procedures in the operating room environment, according to Sirakoss.

Sirakoss’ Osteo3 technology has now received a CE mark for use across Europe, and FDA approval for use in the US (Credit: Sirakoss)

This also means patients need to spend less time under anaesthetic, which has the knock-on effect of making these procedures more cost-effective for healthcare providers because less time is spent in the operating theatre.

Following these procedures, Osteo3 ZP Putty allows clear imaging of post-operative repair as well, and is readily resorbed once it has been integrated with the patient’s bone tissue.

Buckland said: “Osteo3 ZP Putty was developed based on our advanced and proprietary understanding of calcium phosphate chemical composition, and scaffold structure.

“It catalyses rapid and complete bone regeneration. This means that the interaction with host bone biology is unique, and it does not require donor tissue or supraphysiologically large concentrations of growth factors.

“Our studies demonstrate that Osteo3 ZP Putty is more effective and extensive at bone repair than other bone graft substitutes currently available to surgeons, as well as being easy to handle during the surgical procedure.”


Importance of US approval

Sirakoss secured a CE mark for its Osteo3 bone graft substitute in February 2019 — a development that Buckland described as a “tremendously important step” in validating the company’s technology.

And now, having secured FDA clearance, it will be able to address the bone grafting market in the US, and its need for a product with excellent handling characteristics, according to Buckland.

“Many consider the US market to be overcrowded with bone graft substitutes,” he added.

“However, the vast majority of these are second- or third-generation products that surgeons are not confident will deliver reliable fusion results.

“They are often used only as bulking agents alongside what surgeons perceive as more potent materials — but, these carry their own risks, such as disease transmission, cost and potential for severe adverse events.

“The US market in particular increasingly needs an efficacious, reliable, low-risk bone graft that can be delivered for a reasonable cost. Sirakoss’ Osteo3 ZP Putty is a true fourth-generation bone graft that can provide all of these attributes.”