About

Breathe Biologics, Inc. is a regenerative medicine company focused on developing patented multi-potent mesenchymal umbilical cord tissue stem cell therapies to treat chronic lung diseases, specifically, Acute Respiratory Distress Syndrome (ARDS), Chronic Obstructive Pulmonary Disease (COPD) and over 40 respiratory diseases. Breathe Biologics was created to commercialize a specific umbilical cord tissue stem cell technology aimed at repairing lung damage rather than just managing symptoms. Breathe Biologics' primary asset is a patented type of stem cell known as JadiCell™. JadiCells are supercharged, nanog free, allogeneic umbilical cord tissue mesenchymal stem cells. JadiCells™ are unlike older stem cell methods, JadiCells are "universal donor" cells, meaning they don't require a genetic match for the patient.  Unlike standard treatments that use inhaled steroids to reduce inflammation, JadiCells are designed to be regenerative. They possess anti-inflammatory and neuroprotective properties that may help repair the alveoli (tiny air sacs in the lungs) that are destroyed by COPD.  The therapy has been granted a Phase 3 Investigational New Drug (IND) number by the FDA ($28508$) for clinical trials.  Breathe Biologics is conducting Phase III trials for JadiCell in treating Acute Respiratory Distress Syndrome (ARDS). JadiCells are considered safe primarily because they belong to a class of cells that are "immunoprivileged," meaning they can be transplanted into almost anyone without the body’s immune system attacking them.  In clinical trials for severe conditions like ARDS (lung failure), they have shown a "favorable safety profile" with no serious adverse events attributed to the cells themselves. "Immune Privilege" (Low Rejection Risk)  Traditional organ or bone marrow transplants require a near-perfect genetic match between donor and recipient to prevent rejection. JadiCells (which are umbilical cord-derived tissue mesenchymal stem cells) bypass this because: JadiCells Lack of HLA-DR: They do not express "Major Histocompatibility Complex II" (MHC-II) on their surface. These are the "ID badges" that the immune system looks for to identify foreign invaders.  Jadi-Cells' Cloaking Mechanism: Because they lack these markers, the recipient's T-cells essentially don't "see" them as foreign, allowing them to exist in the body long enough to do their work without being rejected.

Immunomodulation vs. Immunosuppression:
Most drugs for inflammation (like steroids) shut down the entire immune system, leaving you vulnerable to infections. JadiCells work differently: They act as "smart controllers." When they sense a "cytokine storm" (massive over-inflammation), they release anti-inflammatory molecules to calm the storm. They have been shown to increase T-regulatory cells and Interleukin-35, which are the body’s natural "peacekeepers," promoting healing rather than just killing off immune cells.

Ethical and Biological Purity:
Because JadiCells are harvested from umbilical cords (post-birth, with consent), they offer several safety advantages over other stem cell sources: Youthful Potency: They are much younger and more "robust" than stem cells taken from an adult’s bone marrow or fat, which may have accumulated genetic mutations or environmental damage over decades.

Non-Tumorigenic: Clinical data so far indicates that these cells do not form tumors (teratomas), a common safety concern with other types of "pluripotent" stem cells.

The safety of JadiCells is often highlighted by their lack of Nanog and oncogenes, which addresses the primary safety hurdle in regenerative medicine: the risk of cancer or tumor formation. While all stem cells have healing potential, "pluripotent" stem cells (like embryonic or iPS cells) carry a higher risk of forming teratomas (tumors containing multiple tissue types) because they are designed to grow and differentiate indefinitely. JadiCells are engineered and selected specifically to avoid these risks.

The Absence of Nanog
Nanog is a transcription factor that is essential for maintaining "pluripotency"—the ability of a cell to become any cell type in the body. While this sounds good for healing, it is a double-edged sword:

Controlled Growth: By naturally lacking Nanog, JadiCells are considered "multipotent" rather than pluripotent. They can heal and modulate the immune system, but they lack the "unlimited" growth signal that could lead to unwanted tumor formation.

Safety Marker: The absence of Nanog is used as a quality control biomarker to prove that the JadiCell population is stable and will not revert to a more dangerous, "primitive" state once injected. Lack of Oncogenes & Genetic Stability
Oncogenes are genes that, when mutated or expressed at high levels, can turn a healthy cell into a tumor cell.