Smart Health Diagnostics Company (SmartHealth Dx)
Revolutionizing Precision Diagnostics in Pathology with the Power of Digital Fluorescent Imaging

Tissue sampling is a critical step in detecting and diagnosing disease. Unfortunately, the existing procedure for analyzing tissue samples is time-consuming and often challenging. After a tissue sample is surgically removed, the typical protocol requires staining and freezing of the tissue sample for slide preparation. During the quick freeze process, ice crystals may form on the tissue causing potential artifacts, making diagnosis challenging. Moreover, the chemicals used in tissue preparation procedures are toxic, compromising the integrity of the tissue and rendering it useless for additional studies. In addition, these toxic chemicals pose a health risk to laboratory personnel.

SmartHealth Dx is poised to revolutionize this scenario, equipped with diagnostic technologies capable of addressing and augmenting clinical needs in most current pathology procedures and other high-risk diseases. SmartHealth Dx is a specialty diagnostics technology provider specializing in developing, manufacturing, and distributing unique medical diagnostic tests that combine cutting-edge science, technology, and proprietary analytics.

At the forefront of SmartHealth Dx's innovative solutions is its unique diagnostic imaging tool, SmartPath Dx, a rapid onsite evaluation (ROSE) ultraviolet pathology instrument that many believe will dramatically improve diagnostic microscopy.

"SmartPath Dx is changing how pathology tissue sample images are prepared, processed, and viewed for diagnosing diseases in just minutes. High-quality images are generated using non-destructive techniques leaving the tissue samples intact for further diagnostic investigation," says Mitch Levine, CEO and Chairman of the Board, SmartHealth Dx.

The SmartPath Dx imaging device has an intuitive and user-friendly interface designed for pathologists and medical professionals. The device emits low-power UV light to capture high-resolution images of tissue samples. The 2D and 3D images of the tissue samples are quickly processed and displayed on a pathology-viewing monitor up to three hundred microns to provide better clarity and visibility in real-time.

This simplified procedure replaces the tedious process of using multiple glass slides for the same specimen to obtain an equivalent volume of images and diagnostic information. In just minutes, pathologists and clinicians can access highly detailed images that inform the presence of tissue disease and other characteristics needed for an accurate diagnosis.

"SmartPath Dx provides pathologists and healthcare professionals the ability to make accurate diagnoses and discoveries within minutes, reducing time, labor, and equipment costs," says Levine.

SmartHealth Dx is not just about imaging technology; it is also about the data generated. Our AI-capable technology creates significantly more data dimensionality for those interested in applying various AI capabilities to research or pathologist-assisting tools in the future. SmartHealth Dx plans to expand the business model to include opportunities for data transport, storage, and data integration services.

Our technology has been termed the greatest innovation in pathology instrumentation in the last 100 years, as it is capable of speeding up the process from sample collection to diagnosis for patients undergoing biopsy or surgical procedures

In the pre-FDA clearance phase, SmartHealth Dx's technology has gained significant traction among many healthcare segments, including pathology, veterinarian medicine, hospitals, clinics, and research institutions alike. Recent feedback from our Key Opinion Leaders has called SmartPath Dx "massively disruptive." The company is set to conduct clinical trials this summer and submit its findings to the FDA for clearance.

"Our technology has been termed the greatest innovation in pathology instrumentation in the last 100 years, as it is capable of speeding up the process from sample collection to diagnosis for patients undergoing biopsy or surgical procedures," says Levine.

SmartPath Dx’s proprietary workflow allows accessibility to underserved markets anywhere in the world where current histology laboratories are not present nor have the staff to process pathology samples. The processed DICOM images can be sent to any pathologist worldwide for diagnostic evaluation.

SmartPath Dx provides a complete set of ancillary consumables, such as proprietary specimen cassettes, reagents, and water-based stains. These components are vital for accurate and high-quality sample analysis.
In addition to SmartPath Dx, SmartHealth Dx's platform portfolio includes an oncology diagnostics program with Mayo Clinic, including SmartKidney Dx, a kidney diagnostic test; SmartVascular Dx, for the commercial stage for diagnosing endothelial damage, which can lead to heart attacks, stroke, and other life-threatening or debilitating disease states; SmartScience Dx, biobank and sample-reporting data repository.

These strategic platforms, coupled with our innovative technology, make SmartHealth Dx a true disruptor in the healthcare space. As the company continues developing its products and services, it aims to significantly improve the patient’s path of care.

In Summary, Levine says, "SmartPath Dx has the potential to revolutionize the Diagnostic-to-Treatment Cycle in pathology. With its rapid, slide-free pathology instrument, vast amounts of data and dimensionality can be generated, opening the door for new research and assisting healthcare professionals. Additionally, the company’s focus on data transport, storage, and integration services expands its business model to new opportunities making it a dynamic and exciting player in the healthcare industry."