Spinal fusions are one of the fastest growing types of orthopedic surgeries performed today. Between 1998 and 2008, the annual number of spinal fusions has increased 2.4-fold. The rising demand for such procedures has pushed companies to develop high-value materials for these surgeries. A major concern for fusions is failure rate: according to a 2009 study in Applied Radiology, over 10% of surgeries with instrumentation report unsuccessful fusion due to hardware fracture or dislodging. Thus durability of fusion material is a significant concern.
Enter Amedica, a company based in Salt Lake City, Utah that received FDA clearance in 2009 for the first load-bearing ceramic spinal device. Amedica focuses on using Silicon Nitride for its spinal implants. You may know of Silicon Nitride because it has been used in such applications as automobile engines, metal cutting tools, and even in the main thrusters of the NASA Space Shuttle! Yes – the same Silicon Nitride used for rocket engines is now being implanted in patients.
Amedica has shown that Silicon Nitride has enhanced osteogenic response, anti-infective properties, and imaging compliance compared to other materials. It has expanded its use of the material to multiple spinal procedures and conditions.
We had a chance to speak with Amedica President and CEO Eric Olson about the material and its applications:
Ravi Parikh, Medgadget: Could you give us a bit of your background? What inspired you to get into the spinal and orthopedic arenas?
Eric Olson, Amedica: I’ve always been interested in the field of medicine. Working with medical device companies—specifically spinal and orthopedic companies—has allowed me a number of opportunities to impact patient care. It is an incredibly gratifying field. Prior to joining Amedica, I was the Executive Vice President of Sales & Marketing for Axial Biotech, Inc. where I was responsible for bringing the first orthopedic molecular diagnostic test to market. I also previously held the position of Vice President of Sales & Marketing for Facet Solutions, Inc. a spinal implant company that focused on lumbar spinal stenosis and facet degeneration, a motion preservation alternative to fusion. Earlier in my career, I held senior Business Development, and Sales and Marketing positions with several companies including Medtronic Neurological and Smith & Nephew.
Medgadget: Tell us a little about Amedica and the spinal fusion technology you employ.
Olson: Amedica is focused on the development of technologies that improve patient outcomes and lower costs in spine and orthopedic surgery. Our proprietary biomaterial, Silicon Nitride (Si3N4) demonstrates superior new bone formation and resistance to bacterial infection compared to other products used for spinal fusion such as poly-ether-ether-ketone (PEEK) and titanium (Ti). Si3N4 also provides unparalleled mechanical support, and significantly improved imaging compatibility.
Medgadget: We’ve heard that Silicon Nitride (Si3N4) has been used in several environments, even in space! How did the idea come about to bring this material to healthcare?
Olson: Si3N4 has a long history and proven track record of use in many demanding industrial applications. Beginning in the late 1940s, the compound was used as a refractory for industrial furnaces and in the 1970s through 1990s, it was introduced across multiple industries, ultimately providing key components in electronics, turbo machinery, cutting tools, high speed bearings, and even orbital satellites.
The idea to use Silicon Nitride as a medical device was conceived by a Utah scientist who approached a few local orthopedic surgeons with a prototype femoral head. That initial approach resulted in what is now known as Amedica Corporation. We are now the only company with the scientific know-how to produce medical grade Si3N4. This patented platform technology is currently being used in the spine and soon in reconstructive joint applications.
Medgadget: Are there any applications beyond spinal fusions? What procedures are you hoping to expand to next?
Olson: We are looking to expand Si3N4beyond spinal fusion for different types of surgical implant devices such as hip and knee replacements, dental implants and suture anchors.
We are also focused on further developing our Valeo Interbody Fusion Devices; we received 510(k) clearance for a second generation design in September 2012 and are pursuing clearance of an interbody fusion device featuring Cancellous Structure Ceramic (CSC) core. CSC closely mimics the pore size of cancellous bone, and is an ideal osteoconductive matrix that should allow bone to grow though the material.
Medgadget: What advantages does your technology offer compared to current spinal and arthroplasty materials?
Olson: Amedica’s Silicon Nitride technology has four key advantages compared to traditional implants typically comprised of PEEK and Ti, including:
· Antimicrobial: Treating implant-related infections is costly and generally requires repeat surgery that could result in extended disability and suffering. Si3N4’s hydrophilic surface properties inhibit bacteria growth, potentially reducing the risk of infection.
· New Bone Growth: The hydrophilic properties of Si3N4help promote bone on-growth and osteogenerative proteins.
· Reliability: 100 times stiffer than cancellous bone and 60 times stiffer than PEEK and Femoral Ring Allograft, Si3N4 offers increased durability.
· Enhanced Imaging: Si3N4 is partially radiolucent with clearly visible boundaries. Additionally it does not produce MRI or CT imaging artifacts. This is a major advantage for intraoperative implant placement and post-op assessment.
Medgadget: Where are your products now in development and trials? How close are clinicians to getting this into their hands?
Olson: Valeo Interbody Fusion Devices are currently on the market and nearly 10,000 implants have been implanted. Additionally, the company will be marketing a second generation family of cervical and lumbar interbody fusion devices later this year. The second generation offers design enhancements including a threaded insertion feature, additional footprints, and elements that will allow surgeons to perform minimally invasive and lumbar lateral interbody fusion approaches.
Amedica is also discussing possible joint ventures, distribution agreements and co-development deals with other leaders in the spine and orthopedic reconstructive space.
Medgadget: Could you tell us about the material’s compatibility with imaging?
Olson: Si3N4 implants are semi-radiolucent with clearly visible boundaries. They produce no distortion under MRI and no scattering under CT which enables an exact view of the implant for precise intraoperative placement and postoperative fusion assessment.
Medgadget: Do you have any additional thoughts or insights that we did not touch on?
Olson: Si3N4 is a disruptive technology at the helm of shifting the standard of care for interbody fusion devices. Recent in-vitro and in-vivo studies, have demonstrated that Si3N4 is osteopromotive and anti-infective, reducing the risk for infection and increasing the potential for improved fusion rates.
We thank Eric for taking time to talk to us. We look forward to hearing more about Amedica’s future applications with this remarkable material.
Check out a video of Amedica’s proprietary Silicon Nitride technology: