More than 100 million U.S. adults —about one in three—live with spine conditions, according to the National Spine Health Foundation. Chronic low back pain is among the leading reasons Americans seek medical care, and spinal deformities are widespread in older adults, affecting up to 68 percent.
Yet treatment outcomes —whether surgical or non-surgical — remain highly variable, and the costs of care continues to climb. U.S. treatment costs tallied $72.31 billion for low-back and neck pain in 2019, making it one of the top five healthcare expenditures,
Despite this massive public health burden, spine-related research receives only a fraction of the investment funneled into other large disease categories. In 2024, musculoskeletal startups — including those focused on the spine — raised just $868 million in venture funding, a fraction compared to the $7.3 billion for oncology drug development, according to HSBC’s 2024 Venture Healthcare Report.
The gap in clinical knowledge and investment has not only hampered progress in spine medicine. It also contributed to the opioid crisis, with chronic back pain being the leading non-cancer reason for prescribing opioids.
But change is on the horizon. Emerging technological, artificial intelligence, and a growing awareness of the huge unmet needs in spine health are fueling a new wave of innovation. Entrepreneurs and academic leaders alike are racing to address diagnostic blind spots, personalize treatment pathways, and generate the kind of data that could revolutionize patient care.
One innovator driving this transformation is Zoher Ghogawala, MD, Chairman of Neurosurgery at Lahey Hospital and Medical Center in Burlington MA, and Professor of Surgery at UMass Chan Medical School.
Gathering Clinical Evidence to Fill the Spinal Data Gap
An former president of the North American Spine Society, Ghogawala has dedicated his career to designing rigorous clinical trials to establish critical benchmarks in spine surgery, a field where diagnostic standards are still evolving.
Such trials are notoriously difficult to design and field because spine medicine lacks standardized definitions for many basic spine conditions, making benchmarking hard. Instability is the leading reason for spine surgery, for example, but surgeons do not have a gold standard reference definition for it or certain other indications. Longitudinal outcomes are extremely important in spine surgical populations but tracking patients over the 5 to 10 years to make sure procedures have long-term effects takes substantial resources.
In an exclusive interview with Cure, Ghogawala spoke recently about how innovative entrepreneurs can tackle some of the huge clinical gaps in spine surgery.
The Need to Improve Spinal Surgery Outcomes
Spine surgery has improved in many ways during the last two decades, Ghogawala noted, citing some important wins. Surgeons have become highly effective at identifying and decompressing pinched nerves and correcting spinal instability (excessive movement of vertebrae) via fusion.
More procedures have evolved to be minimally invasive, leading to less blood loss, shorter hospital stays, and faster recoveries for patients. These achievements are largely thanks to technological advances, notably improved pre- and intra-operative imaging enabling more accurate implant placement, thorough education of surgeons, and reimbursement changes that favor less invasive procedures.
However, clinical practice continues to rely on often-subjective assessments of patients’ pain and therapeutic options. Spine medicine also has insufficient insights and tools available to optimize decision making for treatment of chronic back pain. In contrast, precision medicine has revolutionized other large-population diseases like diabetes and cancer.
And, while surgeons have improved their understanding of the diagnosis of patients with certain common conditions like cervical myelopathy (a condition that compresses nerves in the neck) and lumber stenosis (narrowing of the spinal canal in the lower back), they continue to struggle with identifying the sources of lower back pain when a specific nerve is not compressed or when the misalignment of an area of the spine is poorly defined.
“We know that patients are suffering with severe back pain, and we do not have the best technology to identify the most appropriate non-surgical or surgical treatments for them because there’s no obvious single source of the pain,” Ghogawala said.
“We have a very common condition that affects hundreds of thousands of Americans each year, and we don’t have diagnostic specificity to know which patients are stable or unstable. It’s very much still an art.”
Spinal Opportunities for Entrepreneurs
Ghogawala sees a huge opportunity for innovators to address these challenges and improve care for patients.
He points to the opportunity for entrepreneurs who acquire large medical imaging data sets for spine conditions to leverage AI and machine-learning tools to recognize patterns that could lead the way to improved diagnostic and therapeutic decision-making products.
The resulting greater accuracy could improve identifying the most appropriate treatments for individual spine patients and the development of new MedTech approaches for therapeutic solutions. For example, AI and ML tools could accelerate the classification of spinal stability versus instability and their association with treatment algorithms and predictive models for risks patients might have from surgery.
To help advance such efforts, top surgeons are working to generate much-needed high-quality clinical evidence demonstrating the effectiveness of common procedures to the field of spine surgery. Ghogawala’s own study, known as SLIP II, demonstrates the painstaking work involved in this effort. SLIP II is a randomized, controlled, registry-based clinical trial involving roughly 662 patients.
The SLIP II researchers are trying to find ways to predict pre-operatively whether patients with a common spine disorder are likely to develop instability after surgery. Having that knowledge could impact medical decisions on how to treat these patients--with alternative surgical approaches having different outcomes and costs.
SLIP II investigators are developing a radiology-informed algorithm to identify the clinical features of patients that lead surgical experts to recommend one of two available options upfront: just a spinal decompression surgery alone or a decompression and a lumbar spinal fusion. The patients all have the common spine disorder lumbar stenosis combined with a condition called Grade 1 spondylolisthesis. The SLIP II results are now being analyzed, with an early readout expected in 2026.
In addition to clinical gains, information of the kind obtained from SLIP II, and comparative trials like it, could lead to tremendous financial savings across the continuum of care from surgery to rehabilitation. Such savings are likely to be attractive to many stakeholders under pressure to improve costs.
For example, lumbar spinal fusion alone accounted for $14.1 billion in 2018, making it among the hospital surgical procedures with the highest aggregate costs, and such fusions are projected to become more frequent as the population ages, he added.
Spinal Needs Ripe for Improvement: Motion Preservation, Imaging for Inflammation, Patient Education
Another spinal innovation opportunity lies in developing technology to preserve motion of muscle tissue. Such technologies are not as widely used in the US as they might be, and are more widely available in Europe, Ghogawala noted.
He has studied this problem in patients receiving surgery to alleviate cervical myelopathy (nerve compression in the neck region). Current devices for this indication have technical limitations, including consequences for the bone, or side effects like lingering neck pain, but he believes improvements in instrumentation could increase the efficiency and efficacy of the surgery, resolve such issues, and improve patient outcomes.
AI also could improve the imaging that currently provides information on the structure and biomechanics of the spine. Ghogawala said that some new imaging modalities can capture and quantify inflammation, a known contributor to nerve pain, and such technology could help improve diagnostic accuracy.
The need for imaging solutions that can help diagnosis the origin of multi-source pain remains unresolved, presenting another potential for innovation.
“There’s a tremendous opportunity [in spine] for academics and entrepreneurs to work hand-in-hand on acquiring data” and develop new tools and analytics, he said.