The Catalyst of Change in the Spine Market: Centinel Spine® - Treating Patients through Anterior Column Reconstruction

In the present time, there are around 31 million Americans experiencing lower back pain. These problems often arise due to over stressing the spine or job related issues. These problems are commonly observed in athletes, active individuals, or those that work extended hours each day. Lower back pain may lead to disability and restrict a person from doing regular daily activities. According to experts, around 80% of the population will experience back pain at any given time in their life. Centinel Spine’s mission is to help patients that encounter these issues through its amazing product line and innovative technologies.

Centinel Spine began operations in 2008 through the merger-acquisition of two pioneering medical device companies—Raymedica, LLC and Surgicraft, LTD.

The Birth of Centinel Spine

Raymedica, LLC was founded in 1990 and was a recognized leader in nucleus replacement devices through the development of revolutionary products like the PDN^® and HydraFlex^®. Throughout its 18-year history, the company developed pioneering technologies and surgical approaches to the spine that helped thousands of patients restore function, reduce back pain, and avoid more invasive procedures. Raymedica was also the first company to develop a system for the Antero-Lateral Trans-Psoas Approach (ALPA)—implanting the PDN device via lateral access to the spine.

UK-based Surgicraft LTD started spine-focused operations eight years earlier in 1982 and launched the revolutionary titanium Hartshill Horseshoe product in 1988 —the first Stand-Alone/No Profile^® anterior lumbar interbody fusion device in the world. This first-of-its-kind device was the basis for future generations of the market-leading Integrated Interbody™ technology platform known today as STALIF^®.

STALIF technology has a 30-year clinical history, with over 65,000 devices implanted, and still remains the only stand-alone device demonstrating biomechanical equivalence to anterior plate and cage constructs in independent peer-reviewed publications.

The company’s leadership in anterior column reconstruction was further strengthened through its recent acquisition of the prodisc^® Total Disc Replacement technology platform—the most extensive cervical and lumbar motion-preserving reconstruction portfolio available today. The prodisc technology is the most studied and clinically-proven Total Disc Replacement system in the world, aligning with Centinel Spine’s focus on the proven clinical efficacy of its products. The prodisc design has been validated with over 125,000 device implantations and a reported reoperation rate of less than 1%.

With the addition of prodisc, Centinel Spine stands alone as the only company with comprehensive motion preserving and fusion solutions for both cervical and lumbar anterior column reconstruction.

A Brief Discussion on the Innovative Aspects of the Company with John Viscogliosi, Centinel Spine Chairman and CEO

What are the factors that make your brand most ‘innovative’ and why?

What makes our STALIF brand innovative is that it has a 30-year history of positive clinical results. It was originally designed with specific criteria to address a clinical unmet need from surgeons - an inner body cage with immediate and long-term fixation. We have made multiple generational improvements on the original design using advanced material technologies, but not venturing away from the core fundamental design principles of the technology. We were the first anterior inner body company and we created the market. There are many copies of our products on the market today, but we continue to innovate in materials utilized with our designs as well as expanding the indications for the implants. For example, our products can now be used in multi-level reconstruction and can be used with autograft or allograft tissue. Many of our competitors don’t have these regulatory approvals. This is what makes us unique and sets us apart.

What challenges did you face in your initial years?

A major challenge was shifting the mindset of the surgeons so that they could understand the benefits of our fusion and total disc replacement technologies. There was also the challenge convincing spine surgeons to adopt the anterior approach rather than a posterior approach. But all in all, we overcame these challenges and managed to make a mark within the spine community.

You must have received mixed responses from your customers, how has it helped you shape your company?

The response from our customers has been very favorable. The acquisition of the prodisc product line has been extremely uplifting for our company. Reviews from long-time patients with prodisc have been very positive, the technology has changed and improved their lives. We’ve had similar responses from patients who have our fusion products implanted in their bodies. Our STALIF technology was used on Tiger Woods to allow him to come back and play golf. Our prodisc technology has been implanted in more than 100,000 people around the world, and there are a number of spine surgeons who have not only aided high-performing athletes but have an implanted prodisc due to their own spine issues. Current professional golfers Rory Sabbatini and Brian Gay were both treated with prodisc C several years ago and were quickly able to return competitively to the PGA tour.

Do you have any new products that will be out soon?

We’re in the process of launching our newest implant technology platform called FLX™. This is a 3D-printed porous-titanium technology to be implemented with all of our current and future interbody devices. On the prodisc side of our business, we will be commencing a US clinical trial for several motion preserving products that have been sold outside the US for more than seven years. We’re bringing these versions to the US via a two-level clinical trial that we anticipate starting this year.

Where do you see yourself after a few years?

We’ll be introducing our expanded total disc replacement portfolio, expected to be the most comprehensive in the world. Further, we will continue to look at material enhancements and other improvements to our current anterior column portfolio to improve the options available to surgeons and patients.

The Backbone of the Company

John J. Viscogliosi, is the Chairman & Chief Executive Officer of Centinel Spine, the successor to Surgicraft Ltd. and Raymedica, LLC as of August 2008. Mr. Viscogliosi has >20 years of operations and turn-around experience in the orthopedic industry, which included being on the board of Small Bone Innovations, Inc., and applies such expertise within the active oversight of Centinel’s day-to-day operations.

Mr. Viscogliosi is a founding member and principal of Viscogliosi Bros, LLC. He previously co-founded Paradigm Spine, LLC, Small Bone Innovations, Inc., Knee Creations, LLC, Musculoskeletal Clinical Regulatory Advisers, LLC and Spine Solutions, Inc. Mr. Viscogliosi served on the Board of Directors of Small Bone Innovations, Inc. and was formerly on the Boards of Spine Solutions, Inc. and Knee Creations, LLC.

“We aim to become the worldwide leading company addressing spinal disease anteriorly with the widest breadth & depth of technology platforms. To provide clinically-proven products that help patients and allow individuals to continue to function at a high level.”