• Sigyn Therapeutics is developing four medical device candidates – Sigyn Therapy(TM), ChemoPrep(TM), ChemoPure(TM), and ImmunePrep(TM) – designed to overcome current therapeutic limitations in healthcare
• Sigyn Therapy(TM), the company’s lead product candidate, is a single-use disposable device to treat life-threatening inflammatory conditions that are beyond the reach of drugs
• ChemoPrep(TM) is designed to optimize the tumor-site delivery of chemotherapy, while ChemoPure(TM) intends to reduce the toxicity of chemotherapy by sweeping off-target chemotherapy out of the bloodstream
• ImmunePrep(TM) is designed to reduce the presence of circulating drug decoys that interfere with the delivery of immunotherapeutic antibodies to treat cancer

Medical technology company Sigyn Therapeutics (OTCQB: SIGY) is developing blood purification technologies to treat life-threatening conditions that are not addressed with current market-cleared drug agents as well as an expansive pipeline of technologies to optimize the benefit of cancer therapies. The company has a proven team of professionals with multiple first-in-industry achievements.

The company’s lead product candidate, Sigyn Therapy(TM), is a single-use disposable device that is deployable on the global infrastructure of hemodialysis and continuous renal replacement therapy (“CRRT”) machines already installed in hospitals and clinics. The device incorporates a formulation of adsorbent components to optimize the broad-spectrum reduction of viral pathogens, bacterial toxins, and inflammatory mediators from the bloodstream. The device is designed to treat life-threatening conditions that are not addressed with drug therapies.  In this regard, candidate treatment indications include drug resistant viral and bacterial infections, endotoxemia, and sepsis, which is the leading cause of hospital deaths.

The Company is preparing to file an Investigational Device Exemption (“IDE”) with the U.S. Food and Drug Administration (“FDA”) related to a human feasibility study of Sigyn Therapy in dialysis dependent end-stage renal disease (“ESRD”) patients with endotoxemia and concurrent inflammation, which are currently untreatable conditions that contribute to increased mortality in ESRD patients.

The company is also deploying novel strategies to enhance the performance of cancer therapies.  In this regard, ChemoPrep(TM), is designed to optimize the delivery of chemotherapy, the most commonly administered cancer drug, while ImmunePrep(TM) is designed to enhance the benefit of immunotherapeutic antibodies, which account for 9 of the top 15 selling cancer drugs. These technologies, the company says, extract circulating factors that obstruct these drug agents from reaching their intended therapeutic targets.

Studies have shown that tumor-released exosomes contribute to cancer progression (https://ibn.fm/TSleY) and reduce patient responses to chemotherapy as exosomes can sequester the delivery of chemotherapy to intended cancer cell targets (https://ibn.fm/gBuG7). As a result, only about 0.05% to 3.5% of the chemotherapy dose is delivered to the target tumor site, according to Sigyn Therapeutics (https://ibn.fm/ZNk6T), a figure the company is out to improve.

ChemoPrep(TM) is designed to be administered prior to chemotherapy infusion. The therapeutic candidate works by sweeping cancer-related exosomes out of the bloodstream, a mechanism of action that the company believes will improve chemotherapy delivery. Relatedly, Sigyn has recognized that if a vast majority of chemotherapy is missing its target, then patients are at risk of toxicities and unwanted side effects. To address this issue, the company is developing ChemoPure(TM) to be a post-treatment solution that sweeps off-target chemotherapy out of the bloodstream to further reduce toxicity.

Beyond chemotherapy, Sigyn is targeting the antibody-based immunotherapy market with its ImmunePrep(TM) platform. While monoclonal antibodies (“mAbs”) have revolutionized the treatment of incurable diseases, including cancer, their treatment benefit has been suboptimal, with researchers observing that only a tiny percentage of infused antibodies ever reach their intended therapeutic target. The cause: circulating mAb decoys express the same surface protein that mAbs are designed to lock onto on the surface of the target. This means the mAbs will often end up attaching to the decoys rather than their targets.

The ImmunePrep(TM) is an adjunct device designed for deployment on blood processing systems that can be located in facilities that infuse immunotherapeutic antibodies to treat cancer and other conditions. The device uses a reverse-decoy mechanism: it allows for a mAb to be the active component in the device. This allows the antibody to both attach to circulating decoys that would block the delivery of the same antibody, thus eliminating them, and optimize the availability of the antibody to interact with their intended therapeutic target. “The infusion of mAb therapy is intended to occur immediately after an ImmunePrep(TM) device has depleted mAb decoys from the bloodstream,” Sigyn states on its website (https://ibn.fm/cBi8h).

Sigyn Therapeutics believes that if ImmunoPrep(TM) is demonstrated to be clinically effective, the technology would overcome a therapeutic limitation in healthcare and likely provide a competitive advantage to biopharmaceutical organizations that develop therapeutic antibodies.

“We don’t make the drugs; we make the drugs perform better,” said James A. Joyce, Sigyn Therapeutics’ Co-Founder, Chairman, and CEO, in his concluding remarks during last year’s Emerging Growth Conference.

For more information, visit the company’s website at www.SigynTherapeutics.com.

NOTE TO INVESTORS: The latest news and updates relating to SIGY are available in the company’s newsroom at https://ibn.fm/SIGY

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