Theralink® Technologies Receives Final Medicare Reimbursement Rate Determination and PTAN Enrollment

Rhea-AI Summary

Theralink Technologies (OTC: THER) has announced a significant advancement with the final determination of the Medicare reimbursement rate and completion of the Medicare enrollment process, including obtaining a Provider Transaction Access Number (PTAN). This milestone aims to broaden patient access to the Theralink Assay for advanced breast cancer, which analyzes individual patient biology for improved therapy selection. Initial studies show over 90% actionability and more than 75% clinical utility, indicating strong potential for clinical application.

Positive

• Final Medicare reimbursement rate determination received.
• Medicare enrollment completed, facilitating broader access to the Theralink Assay.
• Over 90% actionability and more than 75% clinical utility reported in initial studies.

Negative

• None.

Important Milestone Toward Enabling Increased Access and Insight for Patients With Advanced Breast Cancer Through Theralink's Precision Oncology Test

GOLDEN, Colo., Nov. 14, 2022 /PRNewswire/ -- Theralink Technologies (OTC: THER) ("Theralink" or the "Company"), a precision oncology company with a novel phosphoprotein-based assay for advanced breast cancer, today announced that the Company has received the final price determination for Medicare reimbursement, has completed the Medicare enrollment process and received its Provider Transaction Access Number (PTAN).

"Medicare enrollment for the Theralink Assay for Advanced Breast Cancer is an important milestone toward enabling broader access to our novel phosphoprotein assay for patients with advanced breast cancer," said Mick Ruxin, M.D., CEO of Theralink Technologies. "Theralink's Medicare PTAN enrollment and the finalization of our reimbursement rate is a major step in the Company's business growth trajectory. We look forward to the next step in the reimbursement process as it relates to coverage of our test by both Medicare and private payors."

It is estimated that approximately 269,000 women are living with and/or are newly diagnosed with advanced breast cancer in the United States. The Theralink Assay for all patients facing a journey of advanced breast cancer provides a new approach to testing that goes beyond genomic testing and analyzes each individual patient's biology for expressed proteins and phosphoproteins. This allows additional insight that can be provided to the medical oncologist and the patient's care team for potentially improved therapy selection.

Early results of a recent study showed over 90% Actionability and a greater than 75% Clinical Utility for Theralink's Lab Developed Test (LDT) for advanced breast cancer patients. Actionability is defined as providing physicians with test results that are actionable for patient treatment selection and Clinical Utility is defined as the percentage of times that the physician acts upon those test results to select the next course of treatment for the patient.

The Theralink Assay for Advanced Breast Cancer has been available to patients for the past 18 months with several oncologists and cancer programs making it part of their routine clinical practice. Theralink will continue to focus on its commercial deployment in academic/research facilities, large network health systems, and private practices in 2023. In addition, the Company plans to expand its testing indications into other solid tumor cancers in the near future.

About Theralink Technologies, Inc.
Theralink Technologies is a proteomics-based, precision medicine company with a CLIA-certified and CAP-accredited laboratory located in Golden, Colorado. Through its unique and patented phosphoprotein and protein biomarker platform and LDTs, Theralink's technology targets multiple areas of oncology and drug development. In addition to the Company's first assay for advanced breast cancer, Theralink is actively working on a second assay that is planned to be pan-tumor for solid tumors across multiple tumor types such as ovarian, endometrial, pancreatic, liver, head and neck, colorectal, lung, prostate, among others. Theralink provides precision oncology data through its powerful Theralink® Reverse Phase Protein Array assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both FDA-approved and investigational drug treatments. Theralink intends to help improve cancer outcomes for patients, help reveal therapeutic options for oncologists, and support biopharmaceutical drug development by using a beyond-genomics approach to molecular profiling that directly measures drug target levels and activity. For more information, please visit www.theralink.com.

Forward-Looking Statements
Certain statements contained in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, anything relating or referring to future financial results, patient enrollment and plans for future business development activities, and are thus prospective. Forward-looking statements are inherently subject to risks and uncertainties some of which cannot be predicted or quantified based on current expectations. Such risks and uncertainties include, without limitation, the risks and uncertainties set forth from time to time in reports filed by Theralink Technologies with the Securities and Exchange Commission. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business and although the company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct. Consequently, future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements contained herein. The company undertakes no obligation to publicly release statements made to reflect events or circumstances after the date hereof.

View original content:https://www.prnewswire.com/news-releases/theralink-technologies-receives-final-medicare-reimbursement-rate-determination-and-ptan-enrollment-301676353.html

SOURCE Theralink Technologies

FAQ

What is the significance of Theralink's Medicare reimbursement announcement?

Theralink's receipt of the final Medicare reimbursement rate and PTAN completion is a crucial milestone for expanding access to its assay for advanced breast cancer.

What are the actionability and clinical utility rates of the Theralink Assay?

Early results indicated over 90% actionability and more than 75% clinical utility for the Theralink Assay in treating advanced breast cancer patients.

When was the Medicare enrollment for Theralink completed?

Medicare enrollment for Theralink was completed prior to the announcement on November 14, 2022.

Which patients benefit from the Theralink Assay?

The Theralink Assay is designed for patients with advanced breast cancer, providing tailored insights for therapy selection.

What future plans does Theralink have for its testing?

Theralink plans to focus on commercial deployment in 2023 and expand testing indications into other solid tumor cancers.