CareFirst BCBS Recognizes Nalu Neurostimulation System as Medically Necessary for Chronic Peripheral Pain, Expanding Access to 3.5 Million Covered Lives
This policy shift moves Nalu from its prior classification of 'Investigational/Experimental' to 'Medically Necessary' for eligible patients—opening access to more than 3.5 million additional covered lives in the Washington DC, Maryland and Northern Virginia area.
'CareFirst BCBS recognition of Nalu as a medically necessary therapy is a powerful validation of our technology, clinical evidence, and commitment to patient outcomes,' said Tom West, President and Chief Executive Officer of Nalu Medical. 'We've built a robust body of published clinical data demonstrating that Nalu PNS provides safe, effective, and durable relief for patients living with chronic, intractable pain. These strong clinical results are further supported by health economic data demonstrating that use of Nalu PNS results in significant cost savings. We're proud to see a leading payer like CareFirst acknowledge that value, and we look forward to engaging with other health plans to expand access to this life-changing therapy.'
Chronic peripheral nerve pain is often debilitating and unresponsive to conventional therapies, including long-term medication and surgery. The Nalu Neurostimulation System offers a minimally invasive, drug-free alternative that delivers precise electrical stimulation to targeted peripheral nerves, providing long-lasting relief while reducing the risks of opioid dependency and avoiding systemic side effects.
About the Nalu Neurostimulation System
The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG) 1 that is powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote control app. Despite its small size, the Nalu micro-IPG™ delivers treatment capabilities similar to larger IPGs as well as advantages associated with advanced waveforms, extensive programming options, robust software upgradability, and an expected service life of 18 years. The Nalu Neurostimulation System has been repeatedly recognized for its revolutionary technology, including being named as one of the world's top 100 new products by R&D Magazine in 2021 and ranking number 19 in the 2023 Deloitte Technology Fast 500. It is FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications. To learn more, visit www.nalumed.com.
About Nalu Medical, Inc.
Nalu is a Carlsbad, California-based medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain. The Nalu Neurostimulation System was designed to address major unmet needs in the treatment of chronic neuropathic pain and provide a differentiated value proposition for patients and physicians.
Indications for Use
Peripheral Nerve Stimulation — The Nalu PNS System is indicated for pain management in adults who have severe chronic intractable pain of peripheral nerve origin as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (≤ 30 days) to determine efficacy before recommendation for a permanent (long-term) device.
Spinal Cord Stimulation — The Nalu SCS System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (≤ 30 days) to determine efficacy before recommendation for a permanent (long-term) device.
Nalu and the Nalu logo are trademarks of Nalu Medical, Inc.
[1] Data on file, Nalu Medical, Inc. 2025.
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June 30, 2025 December 31, 2024 (Unaudited) CURRENT ASSETS Cash and cash equivalents $ 6,061,408 $ 7,511,079 Marketable securities 9,840,366 16,501,984 Prepaid expenses & other current assets 1,299,016 1,234,566 Total current assets 17,200,790 25,247,629 Property and equipment, net 39,524 47,440 Operating lease right-of-use assets 143,240 239,985 Other assets 36,738 36,738 TOTAL ASSETS $ 17,420,292 $ 25,571,792 CURRENT LIABILITIES Accounts payable and accrued expenses $ 4,752,848 $ 4,140,361 Operating lease liabilities, current 131,515 190,814 Total current liabilities 4,884,363 4,331,175 Operating lease liabilities, net of current portion 13,524 52,843 TOTAL LIABILITIES 4,897,887 4,384,018 COMMITMENTS AND CONTINGENCIES (NOTE 4) STOCKHOLDERS' EQUITY Preferred Stock (1,000,000 authorized at June 30, 2025 and December 31, 2024; $.0001 par value) (Zero shares issued and outstanding at June 30, 2025 and December 31, 2024) - - Common Stock (25,000,000 authorized at June 30, 2025 and December 31, 2024; $.0001 par value) (10,784,725 shares issued and outstanding at June 30, 2025 and December 31, 2024) 1,078 1,078 Additional paid-in capital 97,366,699 97,058,323 Accumulated other comprehensive income 48,043 153,990 Accumulated deficit (84,893,415 ) (76,025,617 ) Total stockholders' equity 12,522,405 21,187,774 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ $ 25,571,792 Expand About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 200 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of drug candidates that span multiple cancer indications, including both solid tumors and blood cancers and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0 - 2.5 million per program. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR ® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR ® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "model," "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that our research and the research of our collaborators may not be successful, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR ® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025. You may access our Annual Report on Form 10-K for the year ended December 31, 2024 under the investor SEC filings tab of our website at or on the SEC's website at Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. Lantern Pharma Disclosure Channels to Disseminate Information: Lantern Pharma's investors and others should note that we announce material information to the public about our company and its technologies, clinical developments, licensing matters and other matters through a variety of means, including Lantern Pharma's website, press releases, SEC filings, digital newsletters, and social media, in order to achieve broad, non-exclusionary distribution of information to the public. We encourage our investors and others to review the information we make public in the locations above as such information could be deemed to be material information. Please note that this list may be updated from time to time.
