Opportunities

We are a private medical device company focused on leveraging our proprietary Partial Wave Spectroscopy (PWS) NanocytologyTM platform for the early detection and treatment of cancer through a cellular understanding of individual cells at the nanoscale. Our team is creating and advancing the field of nanocytology, which is the study of cells at the nanoscale.

A better understanding of the earliest changes in cellular structure will help cytologists, cytopathologists, physicians and researchers increase their impact and influence in cancer diagnostics and treatments.

Our current technologies fall into three distinct yet complementary opportunities that will increase the depth and quality of clinically relevant information:

 

Sample Prep

Our novel sample preparation systems enhance the evaluation of cells by creating an improved cell monolayer, enabling a range of downstream applications. They deliver efficiency improvements in a small, customer-friendly footprint, enabling automation that advance current microscale evaluations for use in multiple applications for both academic and commercial organizations.

Our systems will offer significant, automated improvements to the high-pressure environment of the biopsy/operating suite. With the growth of fine needle biopsies and the ability of Rapid On-Site Evaluation (ROSE) procedures to reduce the need to re-biopsy patients, this is a growth market (approximately $60M per year) with significant unmet needs.

Other promising opportunities include the gynecology, non-gynecology and research markets, which total close to $700 million/year in annual revenue.

Our sample preparation systems require Class 1 registration with the FDA for our initial target markets. We will assemble the systems in our ISO 13485-certified facility and/or contract with an approved manufacturer of medical equipment. 

PWS NANOCYTOLOGY™ - Fixed



A Two-Tiered Approach to Early DetectionWe are focused on leveraging our PWS Nanocytology™ – Fixed Cell technology to develop low-cost screening tests that improve the early detection of cancer.

We have validated the technology and its potential to detect cancer in more than 1,500 patients in seven different cancers (lung, colorectal, prostate, pancreas, ovarian, thyroid and esophageal).

Results have been comparable to current gold-standard screening technologies and we are preparing to initiate our pivotal clinical studies for the lung test in Q1 2018. 

Market research indicates that low-cost, minimally invasive, highly accurate and easy-to-use screening tests, such as ours, enable physicians to identify patients most likely to benefit from more invasive, second-tier tests, such as Low-Dose Computed Tomography (LDCT) for lung cancer and colonoscopy for colorectal cancer.

An example of the impact of first-tier screening is the Pap smear; its widespread use has resulted in a 90 percent improvement in the survival rate for women with cervical cancer.

Cell samples for our tests will be collected using a simple brushing technique during routine physical exams in primary care physicians’ (PCPs) offices. Test results will enable PCPs to identify which high-risk patients warrant second-tier testing, and which can forego the costs and potential complications of more invasive cancer screening. We anticipate high adoption rates of our tests in this multibillion-dollar market.

 

Initial Market Opportunities
Lung Test: Approximately 12 million Americans are at high risk for lung cancer (ages 55-80 with a history of smoking). Millions more have hereditary concerns and/or have been exposed to potentially carcinogenic environmental conditions. We estimate the  total domestic market size at approximately $2 billion/year. International markets with high smoking and environmental risks also provide significant revenue opportunities.

Colorectal Test: Approximately 80 million Americans are at risk for colorectal cancer (ages 50 – 75). Only 50% of those at high risk are currently being tested and a vast majority of those tests confirm that a patient does not have polyps/advanced adenomas. The potential for a low-cost, minimally invasive, highly accurate and easy-to-use test, such as ours, has significant potential in the current $12 billion/year market. Our test is designed to identify patients at high risk for developing colorectal cancer, reserving invasive colonoscopies for patients most likely to benefit from the procedure.

PWS NANOCYTOLOGY™ - Live

With an understanding that nanoscale structural changes are the first indication of cellular changes, we developed the proprietary PWS Nanocytology™ – Live Cell system to measure and visualize changes in live cells. Recent studies have demonstrated that profound nanoscale changes are observable in live cells when introduced to low concentrations of common therapeutic drugs. This technology could lead to improved selection and dosing of chemotherapeutic agents, as well as aid in the development of newly improved and effective therapies for early stages of cancer.
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