Curated News
By: NewsRamp Editorial Staff
January 15, 2026
Sigyn's CardioDialysis Unlocks Efficient Clinical Pathway, Targets $700M+ Market
TLDR
- Sigyn Therapeutics' CardioDialysis offers a potential $700+ million revenue model by treating cardiovascular disease in dialysis patients, outperforming statins with 75-95% MACE reduction.
- Sigyn's CardioDialysis uses dialysis machines at 50,000 clinics worldwide, requiring FDA feasibility and efficacy studies in ESRD patients during regular dialysis sessions.
- CardioDialysis could extend lives of ESRD patients by reducing cardiovascular deaths, potentially adding $2.8 billion to dialysis industry revenues through improved patient outcomes.
- Sigyn explores Nasdaq mergers due to new $5 million MVLS rules while creating a private subsidiary to fund CardioDialysis with less shareholder dilution.
Impact - Why it Matters
This development represents a potential paradigm shift in cardiovascular disease treatment, particularly for high-risk dialysis patients who represent a vulnerable population with limited therapeutic options. Cardiovascular disease remains the leading global cause of mortality, and current treatments like statins only reduce adverse events by approximately 25%. CardioDialysis's approach—leveraging existing dialysis infrastructure at approximately 50,000 clinics worldwide—could democratize access to blood purification therapies that have shown 75-95% efficacy in clinical settings but have been restricted to specialized centers. For patients with end-stage renal disease, who face dramatically elevated cardiovascular risks and mortality rates, this technology could meaningfully extend life expectancy and quality of life. From an industry perspective, successful commercialization could disrupt the cardiovascular treatment landscape while creating substantial value for dialysis providers through new revenue streams. The company's strategic moves toward Nasdaq listing and private funding structures reflect broader trends in biotech financing, where innovative approaches to capital formation can determine which promising technologies reach patients.
Summary
Sigyn Therapeutics, a medical technology company developing dialysis-like therapies, has issued a comprehensive shareholder update outlining significant developments for its flagship CardioDialysis treatment and corporate strategy. The update, authored by CEO Jim Joyce, reveals that CardioDialysis—a first-in-industry medical device designed to treat cardiovascular disease—has unlocked a more efficient clinical pathway by allowing feasibility and pivotal efficacy studies to be conducted in dialysis clinics rather than intensive care units. This breakthrough addresses the leading cause of death worldwide, with CardioDialysis targeting a broader range of cardiovascular disease mechanisms than existing treatments like statins or lipoprotein apheresis, potentially reducing Major Adverse Cardiovascular Events (MACE) by 75-95% according to American Heart Association data. The company estimates that treating just 1% of the U.S. end-stage renal disease population could generate over $700 million in annual revenue, while extending patient lives by one month could boost dialysis industry revenues by approximately $2.8 billion.
The shareholder update also discloses three major corporate initiatives: clarifying the FDA clinical pathway for CardioDialysis commercialization, investigating Nasdaq merger opportunities, and implementing a strategy to fund clinical progression with reduced shareholder dilution. Sigyn has developed a feasibility study protocol in collaboration with a leading dialysis company, with an estimated cost of $1.25 million for a 12-15 subject study. Concurrently, the company is exploring merger opportunities with Nasdaq-listed companies at risk of falling below new minimum market value requirements, while also establishing a private subsidiary to raise capital at potentially more favorable valuations than its current OTCQB listing allows. These strategic moves aim to enhance market visibility, access restricted investment funds, and minimize shareholder dilution while advancing CardioDialysis through clinical trials.
Beyond cardiovascular disease, Sigyn's development pipeline includes oncology assets such as ImmunePrep™ for optimizing immunotherapeutic antibodies, ChemoPrep™ for enhanced chemotherapy delivery, and ChemoPure™ for reducing chemotherapy toxicity. The company emphasizes that CardioDialysis offers strategic value to the dialysis industry and could become an attractive acquisition target through its private subsidiary structure. Readers can learn more about these developments through the company's website at www.SigynTherapeutics.com, where additional resources including CEO notes and technical articles are available. The original release can be viewed on www.newmediawire.com, providing further context about Sigyn's therapeutic and corporate advancements in the blood purification space.
Source Statement
This curated news summary relied on content disributed by NewMediaWire. Read the original source here, Sigyn's CardioDialysis Unlocks Efficient Clinical Pathway, Targets $700M+ Market
