What is NICO?
NICO stands for Neurosurgical Intervention Company. It is also the name of the company’s first patient who underwent surgery using NICO’s first commercial device, the Myriad®.
NICO Corporation is an Indianapolis-based medical device company with medical devices — particularly the NICO BrainPath® — designed to provide atraumatic access to brain abnormalities.
What is the genesis of the company?
The founders of NICO previously worked together at Suros Surgical Systems—a medical device company that pioneered the Automated Tissue Excision and Collection (ATEC) breast biopsy system. This technology changed the standard of breast care for high-risk women when it was introduced in 2004, providing physicians with the ability to biopsy and completely resect abnormal breast tissue in the MRI suite and making it possible to diagnose the inaccuracies of open surgical biopsy which led to unnecessary mastectomies.
In 2007, the creators of this revolutionary technology entered the neurosurgery space and embarked on a mission to revolutionize neurosurgery by developing breakthrough technologies to improve the standard of care when it comes to accessing and addressing brain abnormalities.
What is the BrainPath Technology? How does it work?
The BrainPath provides atraumatic access to the brain abnormality by navigating through the delicate folds and fibers of the brain. The two-piece system consists of a clear plastic sheath around a smooth, cylindrical tool with a specially designed tip. The BrainPath enters the brain through an opening smaller than a dime, allowing the surgeon to then navigate through the brain’s natural folds and fiber tracts, carefully displacing brain tissue. Once at the location of the abnormality, the surgeon removes the cylinder from the sheath, leaving the sheath in place to create a portal or narrow corridor through which the surgeon operates.
How is the BrainPath different from existing minimally invasive brain surgery methods?
While existing minimally invasive approaches also use small openings, surgeons using the BrainPath are not required to cut through the brain’s white matter – tissue responsible for any number of cognitive and functional responses – to reach the target abnormality. The BrainPath eases through white matter by displacing tissues like a ship’s hull displaces water. When the surgeon removes the BrainPath tool, the brain tissue can return to its previous position.
What differentiates BrainPath from other technology used to conduct brain surgery?
The difference from a surgical standpoint is that surgeons using BrainPath enter the brain through the sulci, the natural folds of the brain, to displace the critical structures in the white matter to reach the abnormality, thereby reducing the potential for tissue damage. This sets BrainPath apart in the field of brain surgery. Techniques with other existing tools are “trans-gyral” and require surgeons to intentionally cut through the white matter.
There is no other technology on the market that allows this type of atraumatic access through the brain – moving brain surgery in a direction much like when knee surgery moved from open surgery to arthroscopic. Today, the trauma and lengthy recovery of open knee surgery is obsolete.
What do the results show?
The new integrated surgical approach that includes BrainPath is the focus of a growing number of professional neurosurgical organizations and national and international patient advocacy organizations. The approach is also gaining clinical credibility with increasing published evidence and data presentations, including:
- 85 peer-reviewed publications and abstracts
- 20 presentations at national and international neurosurgical conferences and annual meetings and with society and patient advocacy organization presentations, including the International Stroke Conference, American Brain Tumor Association (ABTA), National Brain Tumor Society (NBTS), Cancer Treatment Options and Management (CTOAM), Pediatric Brain Tumor Foundation (PBTF), Voices Against Brain Cancer (VABC), and Accelerate Brain Cancer Cure (ABC2)
Most recently, multi-center clinical results declared as “statistically significant” were granted a national podium presentation at the American Academy of Neurological Surgeons (AANS) and the International Stroke Conference (ISC). The pilot data was built around a standardized surgical approach that includes using BrainPath.
Each of these venues validates the clinical evidence of the approach and outcomes that have directly impacted the growing adoption of technologies used in the approach. Added interest and growing attendance has also been seen in training courses held throughout the year on the approach using BrainPath. Currently, more than 1,200 neurosurgeons have been trained using the BrainPath technology and more than 125 hospitals use the technology regularly and are designated BrainPath Centers.
What kind of impact will this make on the current methods of conducting brain surgery?
The BrainPath technology is a disruptive innovation in the field of neurosurgery. At a time when the entire health care model is transforming towards one of integrated, coordinated care, there is a desire to see the latest in technology, devices and approaches to many facets of medicine. This method will usher in a new era of brain access and tissue removal, especially subcortical access, and how we approach certain abnormalities.
Collected clinical data of BrainPath procedures demonstrates the possibility that BrainPath may be used in functional neurosurgery, trauma and anywhere access is a key challenge to treatment of brain abnormalities in what is a very complex surgical environment.
Which types of brain abnormalities will this method apply to?
The BrainPath is abnormality agnostic— it is all about access. The BrainPath technology does not apply itself by abnormality type, but rather where the abnormality is located. The device provides a pathway to deep locations within the brain.
An estimated 500,000 patients in the U.S. each year are diagnosed with brain abnormalities and have limited surgical options available to them. Worldwide, these numbers increase to 2 million. As of August 1, 2018, over 8,000 BrainPath procedures have been performed using atraumatic access to brain abnormalities and addressing some of the challenges encountered using traditional subcortical surgery methods.
What are the challenges of traditional white matter surgery?
One of the biggest challenges of traditional white matter surgery is access – how to reach brain lesions that are difficult to get to or located deep in the brain. In a clinical paper authored by MD Anderson, they identified the long-standing problem of traditional subcortical surgery: Subcortical Injury Is an Independent Predictor of Worsening Neurological Deficits Following Awake Craniotomy Procedures. This paper indicates a strong need for a solution in the marketplace.
Where is the BrainPath technology used?
The BrainPath technology is currently being used in more than 125 hospitals, with over 1,100 surgeons currently course trained. The technology is being used in large academic centers, medium-sized and small rural hospitals, indicating an across-the-board need for finding a solution to an unmet need. Among those institutions using BrainPath as a standardized surgical approach include:
|Aurora Neuroscience Innovation Institute||Milwaukee, WI||Midwest|
|Cleveland Clinic Foundation||Cleveland, OH||Midwest|
|Indiana University Health||Indianapolis, IN||Midwest|
|St. Louis University||St. Louis, MO||Midwest|
|Washington University||St. Louis, MO||Midwest|
|Brigham & Women’s Hospital||Boston, MA||North East|
|University of Pittsburgh||Pittsburgh, PA||North East|
|Duke University||Durham, NC||South|
|Emory Healthcare||Atlanta, GA||South|
|Houston Methodist Hospital||Houston, TX||South|
|Oklahoma University||Oklahoma City, OK||South|
|Sentara Norfolk General||Norfolk, VA||South|
|UAMS (Arkansas)||Little Rock, AR||South|
|University of North Carolina||Chapel Hill, NC||South|
|Abrazo Community Health Network||Phoenix, AZ||West|
|Cedars Sinai Medical Center||Los Angeles, CA||West|
|Oregon Health - Science University||Portland, OR||West|
|Sutter Eden Medical Center||Castro Valley, CA||West|
|UC Irvine Medical Center||Orange, CA||West|
How many surgeries have been performed?
Over 8,000 surgeries have been performed to date.
What body of physicians is supporting the BrainPath technology?
The Subcortical Surgery Group (SSG) is a group of neurosurgeons who formed a user group to support the awareness and advancement of this technique and other advanced technologies. The group, registered as a 501(c)(6), was formed to help doctors learn and become trained on the surgical approach, share experiences, and help patients find a surgeon in their area who is trained using the BrainPath integrated surgical approach.
The SSG is led by a Board and Executive Committee of 14 neurosurgeons. All are trained in using BrainPath and routinely perform BrainPath procedures. The SSG board is comprised of:
- Julian Bailes, MD, President & Chairman, SSG, Chairman, Department of Neurosurgery, NorthShore University HealthSystem, Surgical Director, NorthShore Neurological Institute
- Kaisorn Chaichana, MD, FACS, Associate Professor of Neurosurgery, Neuroscience, Oncology, & Otolaryngology, Mayo Clinic
- Sunit Das, MD, PhD, Scientist in the Keenan Research Centre for Biomedical Science, Associate Professor, Department of Surgery, University of Toronto
- J.D. Day, MD, Chairman, Department of Neurosurgery, University of Arkansas for Medical Sciences
- Gary Gallia, MD, PhD, Associate Professor of Neurosurgery & Oncology, Johns Hopkins University School of Medicine
- Mohamed Labib, MD, Neurosurgeon, Barrow Neurological Institute
- Zachary Litvack, MD, Neurosurgeon, Swedish Brain and Spine Specialists
- Gustavo Pradilla, MD, Assistant Professor of Neurosurgery, Emory University School of Medicine, Chief of Neurosurgery Service, Marcus Stroke & Neuroscience Center at Grady Health System
- Rohan Ramakrishna, MD, Neurosurgeon, Weill Cornell Brain and Spine Center
- Justin Singer, MD, Director of Vascular Neurosurgery Program, Spectrum Health
- Ronald Young II, MD, Neurosurgeon, Delray Medical Center
- Brad Zacharia, MD, Assistant Professor of Neurosurgery, Co-Director, Neuro Oncology Program, Director, Brain Tumor and Skull Base Surgery, Penn State Health
- Gabriel Zada, MD, Associate Clinical Professor of Neurosurgery. Keck Medicine of USC
- Lloyd Zucker, MD, FAANS, Chief of Neurosurgery, Delray Medical Center, CEO, Florida Neuroscience Institute, Partner, Brain & Spine Center South Florida
Are there similar technologies available right now?
No. Currently, there are no other technologies that provide atraumatic access to deep regions of the brain like BrainPath. Other procedures deemed “minimally invasive” either risk causing trauma to the white matter of the brain during the surgery or utilize tools that emit heat upon resection of the abnormality.