Medical Device Daily Senior Staff Writer

In every industry there are those who work in the spotlight and those who work behind the scenes. In the film industry for example, the opening credits are reserved for starring cast members, directors and producers, and studio names. Everybody else gets their name in nano-sized type for a couple of seconds at the end of the movie even though they may have played critical roles in the overall production process.

The medical device industry is no exception. DSM Biomedical (Berkeley, California) is a prime example of a company working behind the scenes but playing a critical role in the success of many devices, particularly in but not limited to the spine space. DSM provides materials aimed at enabling the replacement, repair, enhancement and ultimately the regeneration of tissue and organ function that are found on many different types of medical devices.

Most recently, the company entered into a license and supply agreement with orthopedic device maker Interventional Spine (Irvine, California). The agreement grants Interventional Spine the use of Bionate PCU, a DSM polymer, in its Percutaneous Dynamic Stabilization (PDS) system.

The PDS system is the first percutaneous bilateral facet-augmentation system for treating degenerative disc disease and lumbar spinal stenosis, the company noted. The Interventional Spine PDS system implant is delivered percutaneously through the skin, making the over-the-wire procedure minimally invasive for the patient. The tough, load bearing qualities of Bionate PCU help secure the implant in place as it flexes with the natural movement of the spine, DSM added. Terms of the agreement were not disclosed, but contain a mix of royalties on devices sold and annual fees.

Interventional Spine's PDS system has received CE mark approval and is commercially available outside the U.S.

"We at Interventional Spine Inc. are very pleased to partner with DSM Biomedical for one of the key components of our PDS system," said Walter Cuevas, Interventional Spine CEO. "The combination of DSM's superior materials technology and Interventional Spine's unique approach to treat degenerative disc disease and lumbar spinal stenosis, underscore our efforts to help patients with debilitating low back pain live normal and pain free lives."

Rob Evans, global business director of biomaterials at DSM, told Medical Device Daily that what makes Bionate unique is that it is a patented polymer that was improved by DSM and has been used in the spine industry for more than 15 years by medical device companies. "Customers that approach us are really looking for materials that are proven," Evans said. "They don't want to go through the process of getting a new material that's not proven," which might make getting the device through the regulatory process more difficult.

Evans also noted that the Bionate PCU is a much higher strength material than other materials such as silicon. "The advantages of the polymer that we offer is it offers biostability making it acceptable for chronic implantation," he said.

"DSM continues to forge ahead along a successful track in building new relationships with medical device manufacturers who want to improve clinical outcomes for patients," said Evans. "Interventional Spine's novel product portfolio provides benefit-driven fixation options for both normal and osteoporotic bone."

These are biostable elastomers that are used in a number of application areas, with the most clinical history in the spine area, Evans said.

He noted that one of the key selling points for using DSM's materials is the data it has in its master files and the amount of additional testing that's been done which regulatory bodies will look at when it comes time to consider the device for marketing approval.

"Typically we feel [the reason customers chose DSM] comes down to the fact that they can trust our materials," Evans told MDD.

But a changing regulatory environment in the U.S. could present challenges for next-generation and new materials the company plans to offer in the future. "When we sign a license agreement with a customer . . . we have found in the past several years that the types of questions we are getting back from our customers and through the FDA are much more extensive and it's clear that the FDA is exerting a greater degree of diligence [regarding the biomaterials used]."

On the other hand, while the questions are tougher Evans said this also confirms that the master file data DSM has on its currently offered materials is pretty solid.

Amanda Pedersen, 309-351-7774;

amanda.pedersen@ahcmedia.com

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