Sigyn Therapeutics Releases Shareholder Letter to Introduce CardioDialysis(TM)
- CardioDialysis(TM) is a precedent-based medical device to treat cardiovascular disease, the leading cause of death globally
- The broad-spectrum mechanism of CardioDialysis(TM) offers to overcome inherent limitations of single-target pharmaceutical drugs to treat cardiovascular disease
- CardioDialysis(TM) is deployed for use on dialysis machines located within more than 7,500 dialysis clinics in the United States
- FDA human studies will initially enroll kidney dialysis patients, whose cardiovascular disease mortality rate is 67% according to the U.S. Renal Data System
- The successful advancement of CardioDialysis(TM) offers to transform dialysis clinics into Renal and CardioDialysis(TM) treatment centers
SAN DIEGO, CALIFORNIA - November 6, 2025 (NEWMEDIAWIRE) - Sigyn Therapeutics, Inc. (“Sigyn” or the “Company”) (OTCQB: SIGY), a developer of dialysis-like therapies to address cardiovascular disease and cancer, today issued a Letter to Shareholders from its CEO-Inventor, Jim Joyce.
Dear Shareholders,
We recently filed a trademark application with the United States Patent and Trademark Office to protect the name CardioDialysis(TM). This action reflects our evidence-based intent to prioritize the previous therapeutic focus of Sigyn Therapy(TM) toward cardiovascular disease.
Beyond providing a pathway into a significantly larger market opportunity, we plan to leverage an FDA-approved precedent that demonstrates the remarkable ability of blood purification to reduce Major Adverse Cardiovascular Disease Events (MACE). As compared to our previously proposed treatment indications, it will also be less burdensome to enroll cardiovascular disease subjects into pivotal efficacy studies required for FDA market approval. Furthermore, we consider our potential value to the dialysis industry as a majority of their patients will die from cardiovascular disease.
About CardioDialysis(TM)
We are advancing CardioDialysis(TM) to treat cardiovascular disease, the leading cause of death globally. CardioDialysis(TM) aims to reduce the circulating presence of inflammatory molecules that fuel cardiovascular disease progression while simultaneously lowering 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(TM) offers to reduce the incidence of MACE by overcoming the inherent limitations of single-target drugs. The annual market for MACE-reducing therapies is reported to exceed $100 billion.
Our Initial Clinical and Commercialization Focus to Treat ESRD Dialysis Patients
Our initial clinical and commercialization focus of CardioDialysis(TM) is directed toward the treatment of cardiovascular disease in end-stage renal disease (ESRD) patients. According to the U.S. Renal Data System (USRDS), cardiovascular disease is attributed to 67% of ESRD patient deaths and its incidence is 20 times higher in dialysis patients as compared to the general population. Whereas the USRDS reports that infections, including sepsis account for 10.1% of ESRD patient deaths. As disclosed in SEC filings, our previous treatment indications include sepsis, drug-resistant bacterial infections and life-threatening viral infections, which are included in the 10.1% calculation.
Beyond high mortality rates, cardiovascular disease is a well-defined, yet substantial market opportunity, given an estimated 550,000 ESRD patients receive ~85 million dialysis treatments in the U.S. each year. To optimize market penetration within the dialysis industry, CardioDialysis(TM) can be conveniently integrated with regularly scheduled dialysis treatments.
A Medical Device Precedent to Treat Cardiovascular Disease
CardioDialysis(TM) targets multiple key therapeutic pathways, including cholesterol-transporting lipoproteins that play a central role in the development and progression of cardiovascular disease.
Lipoprotein Apheresis (LA) is an FDA-approved precedent that demonstrates a medical device can significantly reduce Major Adverse Cardiovascular Events (MACE) by lowering levels of lipoprotein(a) and low-density lipoprotein cholesterol (LDL-C) in the bloodstream. In a recent review article published by the American Heart Association, Lipoprotein Apheresis was reported to lower the incidence of MACE by 59% to 95% across 11 studies encompassing 1,387 treated patients. In contrast, pharmaceutical statins (Lipitor, Crestor, and Zocor) to reduce LDL-C levels are reported to reduce MACE by 20% to 45%.
However, the clinical adoption of Lipoprotein Apheresis has remained constrained by a limited delivery infrastructure, with fewer than 60 specialized apheresis centers able to provide access to the therapy in the United States.
Leveraging the Global Infrastructure of Dialysis Machines
CardioDialysis(TM) is not constrained by delivery infrastructure as it can be deployed on dialysis machines already located in hospitals and clinics around the world. An estimated 150,000 dialysis machines are located in more than 7,500 kidney dialysis clinics in the United States alone. By leveraging this infrastructure, we envision a possibility to transform current kidney dialysis clinics into Renal and CardioDialysis(TM) treatment centers.
Potential Value of CardioDialysis(TM) to the Dialysis Industry
If successfully advanced, CardioDialysis(TM) will improve and extend the quality of life of ESRD patients who rely on dialysis for survival. Beyond introducing a new revenue source to the dialysis industry, CardioDialysis(TM) offers a pathway to treat cardiovascular disease in the general population, which is the current commercialization focus of Lipoprotein Apheresis.
Extending ESRD patient lives and reducing their hospitalizations also provides quantifiable value to the dialysis industry. When ESRD patients are hospitalized, dialysis companies lose revenues as in-clinic dialysis treatments are suddenly administered at out-of-network hospitals. Based on average dialysis revenues of $400 per treatment, the U.S. dialysis industry could recoup up to $654 million in lost revenues for each week of reduced ESRD patient hospitalizations. The U.S. dialysis industry could also increase top-line revenues by ~$2.8 billion for each month of extending ESRD patient lives. What if ESRD patient lives could be extended by a year or more?
Addressing the Unique Cardiovascular Disease Challenges of Dialysis Patients
ESRD patients face unique cardiovascular disease challenges that are not addressed with drug therapies. Once they become dialysis dependent, the median length of ESRD patient survival is typically 3-5 years. Unlike the general population, clinical studies reveal that ESRD patients receive limited, if any clinical benefit from LDL-C reducing statins, the leading class of drugs to treat cardiovascular disease. Additionally, circulating levels of cholesterol-transporting lipoprotein(a) are reported to be two to four times higher in ESRD dialysis patients.
Compounding these treatment challenges is an unfortunate reality. Dialysis treatments induce inflammatory responses that further contribute to cardiovascular disease progression. More specifically, circulating levels of endotoxin and inflammatory cytokines are often elevated in response to dialysis treatment.
At present, there are no market-cleared pharmaceutical products to address Lipoprotein(a), endotoxemia, or the broad-spectrum of inflammatory cytokines observed to be elevated in dialysis patients.
In response, CardioDialysis(TM) provides a strategy to reduce circulating LDL-C and Lipoprotein(a) levels, which is clinically proven to reduce major adverse cardiovascular events (MACE). Simultaneously, CardioDialysis(TM) offers to control dialysis-induced spikes of endotoxin and inflammatory cytokines that contribute to cardiovascular disease progression.
The Rationale to Enroll ESRD Patients into Dialysis Clinic Studies
At the outset of this letter, I indicated it to be less burdensome to enroll cardiovascular disease subjects into pivotal efficacy studies required for FDA market approval. From a clinical execution standpoint, I believe this factor to be the most unappreciated rational to advance CardioDialysis(TM) to treat cardiovascular disease.
In this regard, we have an opportunity to conduct both feasibility (safety) and pivotal efficacy studies of CardioDialysis(TM) in dialysis clinics, whereas pivotal studies of our previously proposed indications to treat sepsis, drug-resistant bacterial infections and life-threatening viruses would require patients to be enrolled in a hospital intensive care unit (ICU) setting. Historically, the enrollment of ICU patients into clinical studies has been a daunting challenge for a multitude of reasons.
As an example, the first four therapies to receive FDA Emergency-Use Authorization to treat COVID-19 were blood purification devices. This provided an unprecedented opportunity to collect clinical data in an ICU setting. Yet, sufficient evidence to support formal FDA approval was never obtained for any of these devices. Furthermore, as it relates to our previously proposed treatment indications, I am aware of just one example where an industry colleague completed enrollment of clinical efficacy studies. In this case, it was a blood purification device to treat endotoxin-induced septic shock for which clinical efficacy studies stretched out for more than a decade.
In regard to the efficiency to enroll and treat clinical study subjects, consider that ESRD patients already have blood access and CardioDialysis(TM) can be administered during regularly scheduled dialysis sessions at their dialysis clinic. Based on prevalence, a significant percentage of ESRD patients are likely to meet our clinical study inclusion/exclusion criteria. Furthermore, the staff at dialysis clinics have extensive experience in administering extracorporeal blood purification therapies and are able to identify candidate enrollment subjects among the ESRD patients they already know and treat on a regular basis. Although ESRD patients may be health compromised, their condition is considerably more stable as compared to ICU admitted subjects. Thus, reducing the potential for unexplained in-study adverse events that might be attributed to our therapy.
Forthcoming FDA Regulatory Steps to Advance CardioDialysis(TM)
We previously collaborated with the clinical research division of a leading dialysis company to design a clinical feasibility study protocol to demonstrate safety of our technology in 12-15 ESRD subjects at three dialysis clinic site locations. We then incorporated this protocol into an Investigational Device Exemption (IDE) that we drafted for FDA submission. While these actions may sound promising, our clinical plan has remained incomplete as we did not fulfill FDA’s regulatory requirement to clearly define the disease condition we intend to treat in our IDE submission.
In this regard, I am pleased to confirm that our IDE submission is being edited to clearly define our intent to treat cardiovascular disease.
Sincerely,
Jim
About Sigyn Therapeutics(TM)
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(TM) is a first-in-industry medical device to treat cardiovascular disease, the leading cause of death globally. CardioDialysis(TM) 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(TM) to optimize the delivery of immunotherapeutic antibodies to treat cancer; ChemoPrep(TM) 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
CEO, Inventor
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.
