ProbioTech USA’s strategic goals are focused on bringing combined synergistic LBP and antioxidant microbiome biotherapeutics to the global prescription market.
Our patent-protected strategy channels fast-expanding research and real-life evidence on the benefits of microbes used in foods and dietary supplements into therapeutic prescription products administered by rectal, oral, or vaginal routes. We combine these health-promoting bacteria with powerful antioxidants that increase potency against infections and inflammation.
ProbioTech USA’s strategic goals are focused on bringing combined synergistic LBP and antioxidant microbiome biotherapeutics to the global prescription market.
Our patent-protected strategy channels fast-expanding research and real-life evidence on the benefits of microbes used in foods and dietary supplements into therapeutic prescription products administered by rectal, oral, or vaginal routes. We combine these health-promoting bacteria with powerful antioxidants that increase potency against infections and inflammation.
Our vision is treating and preventing a wide range of diseases by modulating the human microbiome.
ProbioTech USA, an IND-stage biopharmaceutical company based in Princeton, NJ, develops prescription oral, rectal, and vaginal therapeutics, combining proven bacterial strains with prebiotic antioxidants. Our patented dual-phase delivery technology ensures controlled release of active ingredients with established safety and efficacy for gastrointestinal, oncology, and women’s health conditions.
Our mission is advancing next-generation biotherapeutics for precision treatments.
The ProbioTech Approach
Proven biology meets Rx exclusivity
Well-understood bacterial strains + effective, safe antioxidant
Engineer them to work together (potency boost + targeted delivery)
Seeking funding to initiate clinical trials for FDA prescription approval and access to the Rx market
Science & Technology
Product pipeline
Our therapeutic targets are microbial dysbiosis and inflammatory changes caused by pelvic radiation therapy (radiation proctitis), chronic disease (ulcerative colitis), or infections (recurrent C.difficile infection, recurrent bacterial vaginosis). The patented dual-chamber technology can adapt to oral, rectal and vaginal products, for optimally localized therapy.
Transitioning to clinical phase
Opportunities for Expanded Clinical Footprint
Innovative, patent-protected, dual-phase technology delivering Live Biotherapeutics and Antioxidants to target sites.
ProbioTech USA has Innovation and Change ingrained in our DNA. Initiating global clinical trials to support the efficacy and safety of our active ingredients for many conditions in gastrointestinal, immune dysfunction, adjuvants for chemotherapy and can be modified for urogenital disorders. Custom active ingredients are sourced from leading international suppliers.
ORAL CAPSULE
BACTERIA IN CAPSULE WITHIN
ANTIOXIDANT OUTER CAPSULE
1. OUTER ORAL CAPSULE
Antioxidants are first released to enhance mucosa receptivity and for integrating and boosting growth of the live bacteria.
2. INNER CAPSULE
A blend of live bacteria, cultured from master cell banks, and freeze dried. Released after contents of outer compartment in both products.
Initial antioxidant release followed by the release of LBT enhances efficacy and maximizes therapeutic potential.
RECTAL SUPPOSITORY OR
VAGINAL INSERT
BACTERIA IN CAPSULE INSIDE
ANTIOXIDANT COMPARTMENT
3. OUTER COMPARTMENT
Contains the same antioxidants as outer oral capsule, formulated with fast-melting emollient for self-lubrication and mucosal health.
4. INNER CAPSULE
A blend of live bacteria, cultured from master cell banks, and freeze dried. Released after contents of outer compartment in both products.
Preclinical Research
Preclinical research at ProbioTech USA has demonstrated the synergistic effects of Live Biotherapeutic Products (LBPs) and antioxidants in three independent in vitro models of the human colon. Antioxidants boosted levels of beneficial bacteria, including lactobacilli and bifidobacteria, while increasing the production of key short-chain fatty acids: butyrate, acetate, and propionate. This led to improved diversity in the fecal microbiome, a key indicator of gut health. Additionally, our formulations effectively controlled C. difficile infections and suppressed toxin production, highlighting their potential in treating many serious gastrointestinal diseases.
ProbioTech USA’s technology improves gastrointestinal health
Bacterial Therapeutic efficacy amplified by Antioxidants
Our patented prescription-only products PT-106, PT-107, and PT-108 target microbiome imbalances in the gut and the urogenital tract, using insights from microbial ecology, immunology, and inflammation. Programs ready to enter the clinical phase of development are radiation proctitis, UC and rCDI. Microbiota composition and its function are major areas of interest.
Radiation proctitis is inflammation of the lower intestine that occurs as a result of acute rectal damage as a side-effect of pelvic radiation for treatment of cancer of the prostate, cervix, bladder, colon, ovaries, uterine endometrium, etc. Inflammation is triggered by radiation-induced cell damage, leading to acute edema and ulceration. Vascular damage, fibrosis, and tissue ischemia may result from the chronic inflammatory response to cell injury and abnormal healing. This ongoing damage results in symptoms like rectal bleeding, pain, and changes in bowel function. We are currently getting feedback from the Food and Drug Administration (FDA) on the clinical plan.
Mild to moderate Ulcerative colitis (UC), a chronic lifelong condition caused by chronic mucosal inflammation. UC starts in the rectum and generally extends through part of, or the entire, colon. The most common symptoms of UC include diarrhea, rectal bleeding, nausea and vomiting, and abdominal pain or tenderness. The treatment goal for UC is to control symptoms to the best extent possible so that patients of all ages can lead normal lives. The clinical plan has been cleared by FDA.
Clostridioides difficile, also known as C. difficile or C. diff., can cause severe and potentially life-threatening infections. Symptoms can range from mild diarrhea to life-threatening inflammation, sepsis, organ failure or death. Antibiotic usage increases the risk of C. diff infection, especially in hospitalized and elderly patients. C. diff is estimated to cause almost half a million infections in the United States each year, and about 1 in 6 patients get repeat infections in 2-8 weeks. For preventing recurrent C. difficile infections, we have filed an Investigational New Drug Application (IND) and submitted an application for Orphan Drug Designation.
Our women’s health regimen was created to rebalance the microbiome.
The vaginal microbiome is a complex and dynamic ecosystem. Dysbiosis is a disruption or imbalance of the vaginal microbial ecosystem with a loss of protective Lactobacilli.
Vaginal dysbioses are associated with Bacterial Vaginosis (BV) and recurrent Urinary Tract Infections (rUTI). Bacterial vaginosis (BV) results in characteristic symptoms and unpleasant odor, and may lead to infertility and risk of preterm birth. Antibiotics used to treat BV and UTI act by inhibiting or killing the bacteria, but they prolong and accentuate dysbioses and do not restore protective Lactobacilli. Our dual-phase technology combining live bacteria and antioxidants is designed to restore a healthy microbiome and prevent BV recurrence.
ProbioTech USA’s technology improves vaginal health
About Us
ProbioTech USA was founded in 2015 by inventor and entrepreneur Deborah L. Lynch. Prior to starting the company, Deborah started researching the importance of the microbiome in the gastrointestinal tract and found that there was no product on the market that effectively targeted gut health from all angles. Since that moment of discovery, Deborah has been on a mission focusing for over 10 years, developing patents, supply chains and products that start with targeting the microbiome.
Today, ProbioTech USA has demonstrated synergy in vitro with their breakthrough technology generating a healthy microbiome and improving gut and vaginal health, and immune health by using a combination of antioxidants and Live Biotherapeutic Products (LBP) and ensuring delivery to the site of action through a patented dual-phase novel delivery method.
Together with their team of experienced professionals, global medical experts and academic collaborators including Mayo Clinic and Baylor College of Medicine, ProbioTech USA has been successfully developing its products capable of truly making a positive impact on human health: We continue to develop our innovative prescription-only pipeline and initiating clinical trials.
Patents
ProbioTech USA is the only company developing innovative combinations of antioxidants and Live Therapeutic Bacteria formulated in oral, rectal and vaginal dual delivery systems. Patents have been granted in the United States, Europe, and Australia, and we have several pending PCT patent applications.
- US patent 10,314,868 B2 and 11,523,989
- US patent 11,523,989
- US patent 12,558,315
- European patent EP 3810088 (validated in ES, FR, GB, IT and DE).”
- Australian patent AU 2016353091
Please get in touch to request a comprehensive list of all associated patents and trademarks.
Our Team
We believe that ProbioTech USA is at the forefront of innovation in the field of bacteria-based therapies. With developing products aimed at prevention and treatment, we have an opportunity to lead and change the field forever.
With years of research and practical experience, the ProbioTech USA team is dedicated to creating innovative solutions that can transform healthcare strategies to improve the treatment and prevention of infections and inflammatory disorders.
We are committed to developing safe and effective Live Biotherapeutics enhanced by antioxidants and driven by a desire to improve the health of patients by leveraging the power of the microbiome. We work collaboratively with medical experts and basic researchers to develop and test our products, ensuring that they meet the highest standards of safety and efficacy.
Leadership
As the Founder and President of ProbioTech USA we continue to achieve significant milestones in our journey, marked by a sense of accomplishment and gratitude. It has taken considerable time and effort to reach this point, and we are inspired by our discoveries and the promising future ahead. Though our work is ever-evolving, we are just beginning this exciting chapter
The transformation of our vision into a meticulously crafted scientific thesis has exceeded even my highest expectations. The collective narrative emerging from our diverse perspectives converging into a singular focus is truly exhilarating. Our diligence and commitment reassure me that we are on the right path, poised for impactful discoveries in the field of microbiome science
Our ongoing achievements are a testament to years of dedication and collaborative effort. Starting as a small core team operating with virtual efficiency, we have grown into a consortium of world-class consultants and medical advisors. The collective narrative emerging from our diverse perspectives converging into a singular focus is truly exhilarating. I am profoundly grateful for the privilege of working alongside such passionate and expert individuals, witnessing their contributions and interactions as they help lead ProbioTech USA to deliver our prescription product pipeline
Deborah
As the Founder and President of ProbioTech USA we continue to achieve significant milestones in our journey, marked by a sense of accomplishment and gratitude. It has taken considerable time and effort to reach this point, and we are inspired by our discoveries and the promising future ahead. Though our work is ever-evolving, we are just beginning this exciting chapter
The transformation of our vision into a meticulously crafted scientific thesis has exceeded even my highest expectations. The collective narrative emerging from our diverse perspectives converging into a singular focus is truly exhilarating. Our diligence and commitment reassure me that we are on the right path, poised for impactful discoveries in the field of microbiome science
Our ongoing achievements are a testament to years of dedication and collaborative effort. Starting as a small core team operating with virtual efficiency, we have grown into a consortium of world-class consultants and medical advisors. The collective narrative emerging from our diverse perspectives converging into a singular focus is truly exhilarating. I am profoundly grateful for the privilege of working alongside such passionate and expert individuals, witnessing their contributions and interactions as they help lead ProbioTech USA to deliver our prescription product pipeline
Deborah
Advisors
Justin Crotty, JD, PHD
IP Consultant Partner, Saul Ewing
Andrew Bosco
CMC-Reg Consultant Dunn Regulatory Associates
Alastair Southwell
Corp Dev Consultant Alacrita Consulting
Luc Poppe
BD ConsultantSentosa Partners
Strategic Advisors
Joanne Brown
William Lynch
Opinion Makers
Thought leadership in Microbiome medicine and innovation exploring breakthroughs, challenges, and the road ahead in Microbiome Rx.
Bacterial Vaginosis – From Disregarded Nuisance to Diagnostic Relevance and Definitive Treatment
Jane Schwebke, MD
09/09/2025
Bacterial vaginosis (BV), once dismissed as a minor concern, is now recognized as a significant disruption of the vaginal microbiome with serious consequences, including infertility, pregnancy complications, and increased risk of sexually transmitted infections. Standard antibiotics often fail to prevent recurrence, highlighting the urgent need for better therapies. ProbioTech USA is exploring innovative approaches combining probiotics, antioxidants, and fatty acids to restore balance and prevent recurrent BV.
C. difficile and Ulcerative Colitis: Microbiome Insights and Emerging Therapies
Paul Feuerstadt, MD, FACG, AGAF
08/06/2025
C. difficile and ulcerative colitis share key links through microbiome disruption, increasing infection risk and recurrence. Learn how ProbioTech’s dual-phase delivery system may offer a targeted, microbiome-restoring approach alongside standard treatments to improve outcomes for patients with both conditions.
The Changing Landscape of C. difficile Infection: New Risks, Recurrence, and a Prescription-Based Path Forward
Brinda Wiita, PHD, MBA
07/25/2025
Clostridioides difficile (commonly known as C. difficile or C. diff) is a leading cause of antibiotic-associated diarrhea and colitis in the United States. Once largely confined to hospitals and long-term care facilities, C. difficile infection (CDI) has evolved into a broader public health challenge, impacting younger, healthier individuals in community settings. A Shifting Epidemiology: Who’s
Prescription Microbiome Therapy: A Novel Approach to Combating Inflammation
Brinda Wiita, PHD, MBA
07/09/2025
Chronic inflammation plays a central role in the development and progression of many diseases including inflammatory bowel disease (IBD), cardiovascular conditions, arthritis, and metabolic disorders. While inflammation is a necessary immune response, prolonged or dysregulated inflammation can compromise tissue repair, immune function, and overall health. Emerging research highlights the gut microbiome as a critical modulator
Ulcerative Colitis: A Chronic Inflammatory Condition in Need of New Solutions
Brinda Wiita, PHD, MBA
06/25/2025
Ulcerative colitis is a chronic inflammatory bowel disease with no known cure. ProbioTech USA is developing microbiome-based therapeutics to complement standard treatments like mesalamine, aiming to reduce flare-ups, improve remission, and enhance quality of life through a novel, synergistic mechanism targeting gut health at the source.
Navigating the FDA Regulatory Landscape for Probiotics and Live Biotherapeutic Products (LBPs)
Emilia Lonardo, MT (ASCP), PHD
06/12/2025
Probiotics are regulated differently based on their intended use, as food, supplements, or prescription Live Biotherapeutic Products (LBPs). This article explores how the FDA defines each category, the path to approval for microbiome-based therapeutics, and how companies like ProbioTech USA navigate these complex regulatory frameworks to deliver innovative treatments.
