K2M Group Holdings Introduces Comprehensive Balance ACS Platform, Enters Development and Supply Agreements With 3D Systems

When last we wrote about global medical device company K2M Group Holdings, a leader in minimally invasive solutions for complex spinal issues, it had received FDA 510(k) clearances for its now successful titanium CASCADIA Interbody Systems, which feature Lamellar 3D Titanium Technology. That was less than a year ago, and the company is continuing to focus on achieving three-dimensional Total Body Balance. It recently introduced a new comprehensive platform, called Balance ACS (BACS), which helps drive high-quality outcomes for spine patients by applying 3D solutions “across the entire clinical care continuum.” BACS focuses on balancing the spine with a 360° approach of each anatomical vertebral segment: the axial, coronal, and sagittal planes. This is a key component in achieving successful surgical outcomes through Total Body Balance.

Since K2M got its start, the company has developed, designed, and commercialized some of the more complex techniques used by spine surgeons around the world to treat complicated spinal issues. This new BACS platform, when combined with K2M’s 3D printing techniques, technologies, and leadership in terms of spinal devices, will allow the company to continue competing on a global level with the rest of the spinal surgery market.

K2M Chief Medical Officer John P. Kostuik, MD, said, “Balancing the head over the pelvis and lower extremities is the foundation of spine surgery. The spine is a complex structure that provides both stability and three-dimensional motion. Each spine segment is an independent vertebrae that moves in the axial, coronal and sagittal planes. Movement of each segment is part of the complex integrated network of the comprehensive spine serving to provide balance for the entire body, which enhances energy preservation.”

As part of its new comprehensive spinal care platform, K2M launched the BACS System, which combines all of the necessary services, like preoperative planning and 3D anatomical modeling, so users can easily navigate all aspects of the intraoperative process. Predictive analytics will also be used, to help in the surgical decision making process, and to set up individual care solutions for spine patients. The BACS System is comprised of four major elements:

• Preauthorization: easy-to-follow insurance documentation tool, which helps lessen the likelihood of last minute case cancellations, and allows the surgeon to log in and record patient presentation at various stages prior to the surgery, for matters of insurance preapproval.
• Surgical Planner: advanced spinal image assessment and simulation software, so surgeons can measure and document skeletal parameters for both diagnosis and treatment and plan accordingly for surgery. It also provides simulated corrections, so the surgeon can simulate primary and alternative surgical options, compare pre-op and post-op images, and measure implants prior to the surgery to reduce time on the operating table.
• Anatomical Models: 3D printed patient-specific anatomical spinal models, used as a reference guide before and during difficult surgeries. The models are created using autoclavable materials, and are able to highlight existing spine hardware or tumors with color.
• Data Management: data collection and operative reporting system, used to track patient quality metrics achieved with spinal balance. This value-added service allows both K2M and the surgeon to collect patient data, in order to assess best practices in surgery and product efficacy. Patients can also login and record their symptoms.

K2M President and CEO Eric Major said, “Since our inception, K2M has been a leader in developing complex spine innovations, technologies and techniques to treat the most complicated spinal pathologies. However, we recognize that three-dimensional spinal balance, and ultimately Total Body Balance, cannot be achieved through surgical spine implants alone; it requires a holistic approach to enable healthcare providers to manage the entire patient experience throughout the continuum of care. As a leader in three-dimensional deformity correction and 3D printed spinal implants, we are uniquely positioned to take on this endeavor, and today, are excited to introduce our comprehensive platform for achieving Total Body Balance Balance ACS.”

K2M will be hosting symposiums and physican workshops on the BACS platform at leading spine conferences across the world; it looks like the next available ones will be held in early March, at the American Association of Neurological Surgeons / Congress of Neurological Surgeons Joint Section in Las Vegas. Prominent spine surgeons will present the clinical applications and latest research focused on the BACS platform. Another way for surgeons to educate themselves on the new platform is by visiting and working in the state-of-the-art BACS Lab, at K2M’s Virginia headquarters. The lab has six working stations and is used for product development and cadaveric research.

To continue enhancing its new BACS platform by advancing new capabilities, K2M has entered into a comprehensive development agreement with 3D Systems. The agreement includes an exclusive software solutions partnership, to continue the work K2M champions in balancing the spine across all three planes. The two companies have also set up a separate supply agreement, to support production of K2M’s CASCADIA Interbody Systems. In addition, K2M has acquired healthcare software platform e-Fellow, a service-based technology that helps surgeons and healthcare systems reduce surgery preauthorization denials by collecting real-time data and monitoring patient outcomes.

“Rapid innovation has been essential to K2M’s ability to drive organic growth at above-market rates and has fueled tremendous market share grown since the Company’s inception. With our Balance ACS platform, we recognized the opportunity to leverage our core competency of complex spine and minimally invasive offerings, as well as our leadership in comprehensive 3D printed solutions, to address the full spectrum of spinal care,” said Major. “We are excited to announce our expanded relationship with 3D Systems – a trusted partner through the development and manufacturing of our CASCADIA Interbody Systems featuring Lamellar 3D Titanium Technology – and look forward to incorporating 3D printed technology into future product development activities. These strategic initiatives, as well as contributions from our recent e-Fellow technology acquisition, reinforce our dedication to providing spine patients, surgeons and healthcare systems with the products, services and tools needed to achieve a complete patient experience and, ultimately, three-dimensional Total Body Balance.”

To learn more about the BACS Platform, check out K2M’s video:

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