TORONTO, Sept. 11, 2024 /CNW/ - NetraMark Holdings Inc. (the "Company" or "NetraMark") (CSE: AIAI) (OTCQB: AINMF) (Frankfurt: 8TV) a generative AI software leader in clinical trial analytics, is pleased to announce the expansion of its product base to now include a suite of five innovative offerings designed to enhance clinical trial outcomes, support product differentiation, and optimize market access strategies.

"In response to ongoing client requests, we are announcing the expansion of our product offerings to greatly expand the solutions we offer the market. This increases our addressable market and our capabilities to push the boundaries of what's possible in clinical trials with advanced machine learning techniques," said George Achilleos, CEO of NetraMark. "These new offerings reflect our commitment to innovation and our mission to transform how clinical trials are conducted, from protocol enrichment through to market launch. It's important to note that these offerings build on the Company's base NetraAI platform, which provides unique capabilities to analyze a sponsor's own clinical trial data and provide core insights for protocol enrichment.

The newly introduced product suite now includes the following key offerings:

1. Core base product - Protocol Enrichment: NetraMark can identify specific personas and associated variables that influence both placebo, drug response, and adverse events.

Clinical trial impact - This NetraMark offering better informs a sponsor's decision-making capabilities by supporting study population enrichment decisions, in subsequent protocols.  The goal being to improve the possibility of a positive outcome in the sponsor's next development phase.

2. Covariate Analysis: NetraMark can perform an in-depth covariate analysis by examining  variables that are not the primary focus of the study but may influence the study outcome.

Clinical trial impact - By using the covariate-determined personas and associated variables discovered by NetraMark's technology, additional treatment-responsive subpopulations may be identified, enhancing the ability to demonstrate drug efficacy.  This has several benefits including better control over variables that might otherwise skew or obscure treatment response.  The improvements in targeting likely responsive patients is expected to increase the precision of the estimated treatment effect and correction of imbalances in covariates between the treatment and control groups included in a study.  Collectively, these adjustments to the study analysis are intended to ensure the results are reflective of the true effect of the treatment.

3. Target Product Profile (TPP) Enhancement/Change: NetraMark can help inform the TPP.  The TPP is a strategic planning tool used in the pharmaceutical and biotechnology industries to outline the desired characteristics of a drug that is under development. The TPP serves as a guide throughout the drug development process, helping to ensure that the product meets the necessary clinical requirements for the product under development so as to successfully address  the needs of patients, clinicians, regulatory authorities and healthcare providers. 

The clinical trial benefit - Whether refining an existing TPP or pivoting towards a new indication using a different or altered endpoint, NetraMark can support the definition and alignment of the product's attributes with the market and regulatory strategy. 

4. Rapid Market Access: Rapid market uptake is critical to commercial success. The overall business goal is in ensuring that a new drug can reach the intended market after it has been developed and approved. This involves ensuring that the product is available, accessible, and reimbursable by healthcare systems, payers, and insurers.  NetraMark can aid in the development of the market access strategy by helping to identify a product's potential strengths within the context of the current market.

Clinical trial implications - NetraMark's enriched treatment responder/non-responder personas support product differentiation by identifying characteristics of ideal persons for inclusion in clinical trials and, ultimately, for treatment.  Successful hypothesis-testing of these personas will support a publication strategy and development of a marketing toolkit that can be used to better define a product's competitive edge and support marketing success.

5. Precision Medicine: NetraMark technology can be used to identify variables that influence the understanding of how the drug works.  This approach can help better tailor treatment prescription to individual patient characteristics, needs, and preferences.

The clinical trial impact - Using NetaMark's personas and associated variables, a sponsor can identify an increased effect size associated with important points of differentiation to better support investigators in their selection of likely treatment-responsive patients into the trial and potentially decreasing the number of patients necessary for overall enrollment.

NetraMark's expanded offerings are now available to all clients, providing insights to drive success across the entire drug development lifecycle and demonstrate support for the Company's corporate objectives.

"With this expanded suite, the Company is positioned to provide our customers with cutting-edge solutions that drive efficiency, productivity, and growth," said Josh Spiegel, President of NetraMark. "These new offerings have been built based on the Company's direct discussions with Sponsors and channel partners and mirror the Company's specific inbound demand while leveraging our advanced technology platform."

About NetraAI

In contrast to other AI-based methods, NetraAI is uniquely engineered to include focus mechanisms that separate small datasets into explainable and unexplainable subsets. Unexplainable subsets are collections of patients that can lead to suboptimal overfit models and inaccurate insights due to poor correlations with the variables involved. The NetraAI uses the explainable subsets to derive insights and hypotheses (including factors that influence treatment and placebo responses, as well as adverse events) providing the potential to increase the chances of a clinical trial success.  Many other AI methods lack these focus mechanisms and assign every patient to a class, often leading to "overfitting" which drowns out critical information that could have been used to improve a trial's chance of success.

About NetraMark

NetraMark is a company focused on being a leader in the development of Generative Artificial Intelligence (Gen AI)/Machine Learning (ML) solutions targeted at the Pharmaceutical industry. Its product offering uses a novel topology-based algorithm that has the ability to parse patient data sets into subsets of people that are strongly related according to several variables simultaneously. This allows NetraMark to use a variety of ML methods, depending on the character and size of the data, to transform the data into powerfully intelligent data that activates traditional AI/ML methods. The result is that NetraMark can work with much smaller datasets and accurately segment diseases into different types, as well as accurately classify patients for sensitivity to drugs and/or efficacy of treatment.

For further details on the Company please see the Company's publicly available documents filed on the System for Electronic Document Analysis and Retrieval+ (SEDAR+).

Forward-Looking Statements

This press release contains "forward-looking information" within the meaning of applicable Canadian securities legislation including statements regarding the objectives of the Company and its technology, their addressable market, the capabilities of the technology to enhance clinical trials, product design, market access and tailor treatment prescription to individual patient characteristics, needs, and preferences , and the potential value of our technology to pharmaceutical and biotechnology companies to drive efficiency, productivity, and growth which are based upon NetraMark's current internal expectations, estimates, projections, assumptions and beliefs, and views of future events. Forward-looking information can be identified by the use of forward-looking terminology such as "expect", "likely", "may", "will", "should", "intend", "anticipate", "potential", "proposed", "estimate" and other similar words, including negative and grammatical variations thereof, or statements that certain events or conditions "may", "would" or "will" happen, or by discussions of strategy. Forward-looking information includes estimates, plans, expectations, opinions, forecasts, projections, targets, guidance, or other statements that are not statements of fact. The forward-looking statements are expectations only and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results of the Company or industry results to differ materially from future results, performance or achievements. Any forward-looking information speaks only as of the date on which it is made, and, except as required by law, NetraMark does not undertake any obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise. New factors emerge from time to time, and it is not possible for NetraMark to predict all such factors.

When considering these forward-looking statements, readers should keep in mind the risk factors and other cautionary statements as set out in the materials we file with applicable Canadian securities regulatory authorities on SEDAR+ at www.sedarplus.ca including our Management's Discussion and Analysis for the year ended September 30, 2023. These risk factors and other factors could cause actual events or results to differ materially from those described in any forward-looking information.

The CSE does not accept responsibility for the adequacy or accuracy of this release.