NeuroMetrix Announces Publication of Study Demonstrating that DPNCheck Accurately Diagnoses Diabetic Peripheral Neuropathy

Rhea-AI Summary

NeuroMetrix, Inc. (NURO) announces a study showcasing DPNCheck's efficacy in detecting diabetic peripheral neuropathy. The study reveals high diagnostic performance using DPNCheck combined with CVR-R, with an area under the receiver operating curve of 0.88. The findings support the simplicity, ubiquity, reproducibility, and reliability of DPN diagnosis using DPNCheck.

Insights

Medical Research Analyst

The study highlighted in the press release showcases the diagnostic capabilities of NeuroMetrix's DPNCheck in detecting diabetic peripheral neuropathy (DPN), which is a significant complication of diabetes. The findings suggest a potential shift in the diagnostic paradigm for DPN, from the traditional monofilament testing to a more accurate method. This could have implications for the adoption rate of DPNCheck in clinical settings, as healthcare providers seek reliable and reproducible diagnostic tools.

From a medical research perspective, the high area under the receiver operating curve (AUC) of 0.88 indicates strong diagnostic performance. In clinical terms, a high AUC reflects a test's ability to correctly identify patients with the condition (true positive rate) while minimizing false positives. The integration of patient age and autonomic function, as quantified by the coefficient of variation of R-R intervals (CVR-R), into the predictive formula is a notable advancement, potentially increasing the clinical utility of the test.

Healthcare Industry Analyst

For investors and stakeholders in the healthcare sector, the adoption of DPNCheck could have financial implications for NeuroMetrix, Inc. Increased diagnostic accuracy and reliability can lead to higher demand for DPNCheck, potentially expanding its market share. The reference to over 10 independent studies evaluating the accuracy of DPNCheck in over 1500 patients provides a robust evidence base that could strengthen the company's marketing efforts and appeal to clinicians.

Additionally, the critique of the conventional 5.07/10 g monofilament test for its low accuracy and reliability, as mentioned by the CEO, positions DPNCheck as a superior alternative, which could disrupt the current standard of care. The transition to more accurate diagnostic tools like DPNCheck could lead to earlier detection and management of DPN, potentially reducing long-term healthcare costs associated with complications of undiagnosed or poorly managed DPN.

Financial Analyst

The publication of this study could be seen as a positive development for NeuroMetrix's financial health, given the potential for increased sales of DPNCheck. The market for diabetes management and diagnostic tools is substantial, with the global prevalence of diabetes continuing to rise. An effective diagnostic tool that can be widely adopted in clinical practice represents a significant revenue opportunity for NeuroMetrix.

However, it is essential to monitor the company's ability to scale production, manage costs and navigate the regulatory landscape, which can affect the speed and extent of market penetration. Furthermore, the long-term financial impact will depend on the healthcare industry's acceptance of the product, competitive responses and potential insurance coverage changes that may influence the product's profitability.

WOBURN, Mass., March 14, 2024 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) noted the recent publication of a large study demonstrating that DPNCheck^® combined with standard EKG or DPNCheck alone accurately detects diabetic peripheral neuropathy (DPN).

Hayashi and colleagues evaluated 167 patients with Type 1 or Type 2 diabetes. The reference standard for DPN was a gold standard nerve conduction study. The authors developed a predictive formula based on DPNCheck measurements, patient age and the coefficient of variation of R-R intervals (CV_R-R), which quantifies autonomic function and is a standard output of EKG machines. DPNCheck combined with CV_R-R had high diagnostic performance with an area under the receiver operating curve of 0.88. Similar performance was reported when using just DPNCheck to diagnose DPN. The authors concluded "The use of DPNCheck and electrocardiogram would make the diagnosis of DPN simple, ubiquitous, and with high reproducibility and reliability."

"This novel study by Professor Kamiya and his colleagues at the Aichi Medical University School of Medicine continues to build the large body of scientific evidence supporting the use of DPNCheck to diagnose DPN. The diagnostic accuracy of DPNCheck has now been reported in more than 10 independent published studies that evaluated over 1500 people with diabetes," said Shai N. Gozani, M.D., Ph.D., CEO of NeuroMetrix. "The consistently high accuracy of DPNCheck stands in stark contrast to monofilament testing, which has been the standard approach to DPN screening despite its low accuracy and reliability. A recent large, multi-center study by Dunker and colleagues concluded "We do not recommend the use of the 5.07/10 g monofilament in the evaluation of patients with diabetes referred to polyneuropathy assessments."

About Diabetic Peripheral Neuropathy

Diabetic peripheral neuropathy (DPN) is the most common long-term complication of diabetes, affecting half of people with diabetes. The clinical and economic burden of DPN stems from its central role in the development of foot ulcers that can lead to lower extremity amputation. DPN also causes debilitating chronic nerve pain and altered proprioception that increases the risk of falling, particularly in the elderly. Overall, DPN is associated with a substantial reduction in quality of life and decreased activities of daily living.

About DPNCheck

DPNCheck is an automated, fast, accurate, and quantitative sural nerve conduction test used to evaluate peripheral neuropathies. It is designed to be used by clinicians at the point-of-care to detect peripheral neuropathies at an early stage when intervention is likely to be most effective, to stage the severity of nerve deterioration and to monitor disease progression and treatment benefits. For more information, visit dpncheck.com.

About NeuroMetrix

NeuroMetrix is a commercial stage healthcare company that develops and commercializes neurotechnology devices to address unmet needs in the chronic pain and diabetes markets. The Company's products are wearable or hand-held medical devices enabled by proprietary consumables and software solutions that include mobile apps, enterprise software and cloud-based systems. The Company has two commercial brands. Quell^® is a wearable neuromodulation platform. DPNCheck^® is a point-of-care screening test for peripheral neuropathy. For more information, visit www.neurometrix.com.

Source: NeuroMetrix, Inc.

Thomas T. Higgins
SVP and Chief Financial Officer
neurometrix.ir@neurometrix.com

FAQ

What does the recent study on DPNCheck by NeuroMetrix reveal?

The study demonstrates that DPNCheck, combined with CVR-R, accurately detects diabetic peripheral neuropathy with high diagnostic performance.

Who conducted the study evaluating DPNCheck's efficacy?

The study was conducted by Hayashi and colleagues, evaluating 167 patients with Type 1 or Type 2 diabetes.

What was the reference standard for diagnosing DPN in the study?

The reference standard for DPN diagnosis in the study was a gold standard nerve conduction study.

What was the conclusion drawn by the authors of the study regarding DPNCheck's diagnostic accuracy?

The authors concluded that the use of DPNCheck and electrocardiogram would simplify DPN diagnosis and offer high reproducibility and reliability.

How many independent published studies have evaluated the diagnostic accuracy of DPNCheck?

Over 10 independent published studies, evaluating more than 1500 people with diabetes, have reported on the diagnostic accuracy of DPNCheck.