G

gemelli-biotech

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Gemelli Biotech Company Profile



Background



Overview

Founded in 2018, Gemelli Biotech is a specialty biotechnology company dedicated to enhancing health through precision diagnostics for gastrointestinal (GI) diseases. The company's mission is to leverage cutting-edge biological discoveries related to the microbiome to develop non-invasive diagnostic tools that enable clinicians to accurately detect scientifically validated biomarkers and effectively treat GI conditions, including Small Intestinal Bacterial Overgrowth (SIBO), Intestinal Methanogen Overgrowth (IMO), excess hydrogen sulfide, and post-infectious Irritable Bowel Syndrome (IBS).

Industry Significance

Gemelli Biotech plays a pivotal role in the biotechnology sector by addressing the substantial global burden of GI diseases. With IBS affecting approximately 800 million individuals worldwide and over 35 million Americans, the company's innovative diagnostic solutions offer significant advancements in patient care and healthcare efficiency.

Key Strategic Focus



Core Objectives

  • Precision Diagnostics: Develop and commercialize non-invasive diagnostic tests that provide actionable insights for GI diseases.


  • Microbiome Research: Utilize microbiome-related discoveries to inform diagnostic and therapeutic development.


Areas of Specialization

  • Gastrointestinal Diseases: Focus on conditions such as SIBO, IMO, excess hydrogen sulfide, and post-infectious IBS.


Key Technologies Utilized

  • trio-smart®: A clinical breath test measuring hydrogen, methane, and hydrogen sulfide levels to offer a comprehensive view of gut health.


  • ibs-smart®: A patented blood test diagnosing post-infectious IBS by detecting specific antibodies.


Primary Markets Targeted

  • Healthcare Providers: Gastroenterologists and primary care physicians seeking accurate diagnostic tools for GI conditions.


  • Patients: Individuals experiencing GI symptoms requiring precise diagnosis and treatment plans.


Financials and Funding



Funding History

  • Series A Financing: In June 2022, Gemelli Biotech completed a $19 million Series A funding round.


Investors

  • Lead Investor: Blue Ox Healthcare Partners, a private equity firm specializing in precision health and value-based care.


  • Other Investors: Cedars-Sinai, Carolina Angel Network, CerraCap Ventures, and several family offices.


Utilization of Capital

  • Commercialization: Accelerate the market introduction of trio-smart® and ibs-smart® diagnostic tests.


  • Expansion: Enhance sales and marketing efforts across the United States.


  • Infrastructure: Scale laboratory and manufacturing capacities and expand operational footprints in Raleigh and Los Angeles.


Pipeline Development



Key Products

  • trio-smart®: Launched in October 2020, this breath test measures hydrogen, methane, and hydrogen sulfide levels, providing a comprehensive assessment of gut health.


  • ibs-smart®: Introduced in October 2018, this blood test diagnoses post-infectious IBS by detecting anti-vinculin and anti-CdtB antibodies.


Development Stages

  • trio-smart®: Commercially available as a Laboratory Developed Test (LDT) conducted at a CLIA-certified lab.


  • ibs-smart®: Available for physician use in the United States through a kit-based system.


Target Conditions

  • trio-smart®: Aids in identifying SIBO, IMO, and excess hydrogen sulfide-related GI issues.


  • ibs-smart®: Diagnoses post-infectious IBS, distinguishing it from other GI disorders.


Anticipated Milestones

  • Market Expansion: Broaden the availability of diagnostic tests both domestically and internationally.


  • Product Development: Continue research and development to introduce new diagnostic tools for GI diseases.


Technological Platform and Innovation



Proprietary Technologies

  • trio-smart®: The only clinical breath test measuring hydrogen, methane, and hydrogen sulfide, offering a complete fermented gas profile of the microbiome.


  • ibs-smart®: A patented blood test detecting specific antibodies associated with post-infectious IBS, providing a non-invasive diagnostic option.


Scientific Methodologies

  • Breath Testing: Utilizes advanced gas measurement devices to accurately capture and analyze breath samples.


  • ELISA Blood Testing: Employs enzyme-linked immunosorbent assay techniques to detect specific antibodies in blood samples.


Leadership Team



Key Executives

  • Matt Mitcho: Co-founder and Chief Executive Officer.


  • Dr. Mark Pimentel: Co-founder and Chairman of the Scientific Advisory Board; Executive Director of the Medically Associated Science and Technology (MAST) program at Cedars-Sinai.


Scientific Advisory Board

  • Dr. William D. Chey: University of Michigan.


  • Dr. Brian E. Lacy: Mayo Clinic.


  • Dr. Anthony J. Lembo: Harvard University.


  • Dr. Satish Rao: Augusta University Medical Center.


  • Dr. Christopher Andrews: University of Calgary.


  • Dr. Max Schmulson: Universidad Nacional Autónoma de México.


Competitor Profile



Market Insights and Dynamics

  • Market Size: The global IBS diagnostics market is substantial, given the high prevalence of the condition.


  • Growth Potential: Advancements in diagnostic technologies and increasing awareness are driving market growth.


  • Industry Trends: There is a shift towards non-invasive, accurate diagnostic tools in GI healthcare.


Competitor Analysis

  • CynapseDx: Develops analytical technologies for detecting

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