SAN DIEGO, CA - March 13, 2026 (NEWMEDIAWIRE) - Sigyn Therapeutics, Inc. (“Sigyn” or the “Company”) (OTCQB: SIGY), a developer of dialysis-like therapies to address cardiovascular disease and cancer, today released the following shareholder update authored by Chief Executive Officer, Jim Joyce.
Dear Shareholders and Interested Parties,
Prior to our formation of Sigyn Therapeutics, I was the founder of Aethlon Medical and oversaw the development of the Aethlon HemopurifierTM from concept to becoming the first therapy to receive multiple FDA “Breakthrough Device” designations and first medical device cleared by FDA to treat a pandemic virus. TIME magazine named the HemopurifierTM a “Top 25 Invention” and a “Top Eleven Medical Breakthrough.” During my tenure, Aethlon became Nasdaq-listed and had a peak-market value of approximately $200 million.
At Sigyn Therapeutics, we have developed CardioDialysisTM to address relevant therapeutic targets underlying a wide range of life-threatening disease conditions. These include clinically significant drivers of cardiovascular disease (leading cause of death worldwide), as well as relevant pathogenic and inflammatory molecules that fuel sepsis, the leading cause of in-hospital mortality. Based on invitro study results, CardioDialysisTM also offers a potential therapeutic solution to address traumatic brain injury (TBI) and other disorders whose recovery would benefit from a reduction of systemic inflammation. Our TBI indication has recently emerged to become asset whose value we hope to leverage through a strategic transaction.
Our opportunity to treat cardiovascular disease is straightforward, yet among the most significant opportunities in healthcare. Lipoprotein apheresis devices that reduce the presence of cholesterol-transporting lipoproteins in the bloodstream reduce heart attacks, strokes and other major adverse cardiovascular events (MACE) to a far greater extent than cardiovascular disease drugs. However, the availability of lipoprotein apheresis is limited to fewer than 60 specialized apheresis centers in the United States. Whereas CardioDialysisTM targets cholesterol-transporting lipoproteins plus inflammatory molecules and is designed for use on dialysis machines already located at more than 7,500 dialysis clinics in the United States alone.
At present, there is no approved therapy to address sepsis. The leading treatment candidate is the PMX hemoadsorption device, which removes endotoxin from the bloodstream. The PMX device has been advanced through groundbreaking clinical studies conducted by industry colleagues at Spectral Medical, a Toronto Stock Exchange company whose market value is approximately $300 million. Should the PMX device receive FDA market clearance, it may become notable that CardioDialysis has been validated to reduce the presence of sepsis inducing bacterial toxins (including endotoxin) and a broad-spectrum of inflammatory mediators from human blood plasma. In the meantime, I encourage you to follow Spectral Medical.
While I am proud of our advancements at Sigyn Therapeutics, it was not our intent be an OTC traded company at this point in our endeavors. In my previous company, we became public through a merger with an established OTC company and subsequently were able to conduct a successful uplist to Nasdaq financing.
At Sigyn Therapeutics, we also became public through a merger with an established OTC company yet failed to execute on an uplist to Nasdaq financing. The financing was a firm commitment offering led by a FINRA member broker-dealer and was supported by the same lead investor and advisory team that got us across the goal at my previous company. However, it was not anticipated that Nasdaq would request to review and approve our investors prior to obtaining an effective registration statement from SEC. For those not familiar with the process, this was a real catch-22 as investors are not supposed to be solicited prior to a registration statement being deemed effective by SEC. Inversely, SEC wanted to know if we had contingent listing approval from Nasdaq prior to deeming our registration statement effective. Recognizing the futility of our efforts, we eventually withdraw the registration statement underlying our uplist to Nasdaq financing.
While share price and exchange does not impact the ability of our therapies to address life-threatening disease conditions, it has clearly impacted our ability capitalize our endeavors without harming shareholder value. I encourage you to review my January 15th shareholder update which highlights our strategies to navigate forward with reduced shareholder dilution. Included among these is the sale of certain assets and a potential merger with a Nasdaq listed company at risk of not meeting the forthcoming $5 million minimum market value of listed securities (MVLS) requirement that will soon be necessary for continued listing on Nasdaq.
In closing, I thank you for taking the time to read my update. For those who have inquired, we have 2,330,042 shares outstanding as of March 11, 2026. If you have questions or comments, I can be reached at jj@sigyntherapeutics.com.
Sincerely, Jim
About Sigyn Therapeutics™
Sigyn Therapeutics is developing dialysis-like therapies to address cardiovascular disease and cancer. The Company’s therapeutic candidates are designed to improve and extend the quality of patient lives, and their successful clinical advancement offers to provide strategic value to the dialysis and biopharmaceutical industry.
Sigyn CardioDialysis™ is a first-in-industry medical device to treat cardiovascular disease, the leading cause of death globally. CardioDialysis™ aims to reduce the circulating presence of inflammatory molecules that fuel cardiovascular disease progression while simultaneously lowing levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE). Based on its broad-spectrum mechanism, CardioDialysis™ offers to reduce the incidence of MACE by overcoming the inherent limitations of single-target drugs.
The Company’s development pipeline is comprised of ImmunePrep™ to optimize the delivery of immunotherapeutic antibodies to treat cancer; ChemoPrep™ to enhance the targeted delivery of chemotherapy; and ChemoPure™ to reduce the toxicity of chemotherapy.
To learn more about Sigyn Therapeutics, visit: www.SigynTherapeutics.com
CONTACT:
Sigyn Therapeutics, Inc.
Jim Joyce
Inventor CEO
Email: jj@SigynTherapeutics.com
Cautionary Note Regarding Forward-Looking Statements
This information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties. All statements contained in this summary are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties, and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Sigyn's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences may include, without limitation, the Company's ability to clinically advance Sigyn Therapy in human studies required for market clearance, the Company's ability to manufacture Sigyn Therapy, the Company's ability to raise capital resources, and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this report speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.
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