Company: mBIOTA Labs, Santa Monica, CA
Nomination Submitted by: Matter Health
Company Description: mBIOTA Labs specializes in the development of medical foods for gastrointestinal (GI) dysfunction, including small intestinal bacterial overgrowth (SIBO) and other conditions. mBIOTA Labs is revolutionizing oral nutrition with their proprietary product, mBIOTA Elemental™ diet, a medical food designed to address the historic issues with elemental diets: poor taste and patient compliance.
Nomination Category: Company / Organization Categories
Nomination Sub Category: Innovation of the Year - Consumer Products Industries
 Nomination Title: mBIOTA Labs’ Revolutionary mBIOTA Elemental™
- Which will you submit for your nomination in this category, a video of up to five (5) minutes in length about the achievements of the nominated organization since January 1 2023, OR written answers to the questions for this category? (Choose one):
Written answers to the questions
- If you are submitting a video of up to five (5) minutes in length, provide the URL of the nominated video here, OR attach it to your entry via the "Add Attachments, Videos, or Links to This Entry" link above, through which you may also upload a copy of your video.
- If you are providing written answers for your submission, you must provide an answer to this first question: Briefly describe the nominated organization: its history and past performance (up to 200 words):
Total 198 words used.
After years of struggling with a debilitating GI disorder, Small Intestinal Bacterial Overgrowth (SIBO), Krystyna Houser, founder of mBIOTA Labs, was introduced to elemental diets, a form of medical nutrition proven effective for a multitude of GI issues. Unfortunately, the existing elemental diets offered were practically undrinkable, leading to extremely low patient compliance rates. To her doctor’s surprise, Krystyna completed the multi-week challenge, eradicating her SIBO and leaving her determined to find a better way. With concerning statistics such as 10-15% of the adult US population suffering from some combination of SIBO/IBS and low diagnoses rates, Krystyna assembled the top minds in gastroenterology, nutrition, and food science to create a product that revolutionized elemental diets.
mBIOTA Labs aimed to develop a “palatable” elemental diet while still remaining fully elemental. After spending three years developing its flagship formula, the company successfully completed clinical trials at Cedars Sinai in November 2023, launched mBIOTA Elemental™ online in 2024 and expanded to international shipping within six months. mBIOTA Elemental™ is the first and only elemental diet that has successfully developed a clinically-proven palatable formula. This medical-grade product is directly available to consumers and trusted by hundreds of referring healthcare specialists and dietitians.
- If you are providing written answers for your submission, you must provide an answer to this second question: Outline the organization's achievements since the beginning of 2023 that you wish to bring to the judges' attention (up to 250 words):
Total 247 words used.
mBIOTA Elemental™ was created to bring relief and hope to the millions of people suffering from gastrointestinal (GI) issues through the development of a clinically proven and truly palatable elemental diet. Despite decades of research proving the effectiveness of elemental diets at managing several conditions, they have been rarely used due to their historical poor taste and consequently poor diet completion rates. mBIOTA is changing the therapeutic landscape for consumer gut management by offering a revolutionary, clinically proven, direct-to-consumer medical food.
The first clinical trial using mBIOTA Elemental™ was completed at Cedars-Sinai Los Angeles in November 2023 and exceeded expectations with record-breaking results:
Launched to market in January 2024, the introduction of mBIOTA Labs’ truly palatable elemental diet offers consumers a viable and clinically reliable option to manage their GI disorders and feel much needed relief without struggling through less effective antibiotics and pharmaceuticals. Within their first year, mBIOTA shipped to every US state and 23 countries while amassing a dedicated subscriber base. This far-reaching attainability underscores their commitment to reducing barriers and providing an accessible health resource for effective dietary management of gastrointestinal dysfunction.
- If you are providing written answers for your submission, you must provide an answer to this third question: Explain why the achievements you have highlighted are unique or significant. If possible compare the achievements to the performance of other players in your industry and/or to the organization's past performance (up to 250 words):
Total 250 words used.
Across hundreds of clinical studies and 50+ years, doctors and scientists have demonstrated the clinical effectiveness of elemental diets for managing a range of gastrointestinal diseases. However, due to infamously sulfuric taste, elemental diets are rarely used and the medical food space has seen little to no innovation to solve this, until mBIOTA.
mBIOTA Labs has revolutionized elemental diets by developing a truly palatable flagship formula, significantly increasing patient compliance and unlocking new levels of potential for the medical applications of elemental diets – like reducing inflammation and visceral fat, and managing Celiac disease – now that a version is tolerable and trusted. mBIOTA Labs’ milestone of a 100% completion rate during their clinical trial is a remarkable feat – unheard of for elemental diets – and it’s no surprise that 100% of patients preferred the taste of mBIOTA Elemental™ over the leading competitor.
mBIOTA is a certified medical food available for sale directly to consumers. Over recent years, consumer interest in gut health has gained traction. Whether consumers want to overcome their debilitating GI conditions or understand the importance of a balanced microbiome, more individuals are taking charge of their gut health. This is especially relevant as alternative therapies are gaining interest amongst patients who are considering breaking away from traditional pharmaceuticals to find something more effective. Now with an accessible, science-backed product, even healthcare providers are exhibiting interest in prioritizing this nutrition-based solution as a primary option for GI management rather than a backup option after antibiotics fail.
- You have the option to answer this final question: Reference any attachments of supporting materials throughout this nomination and how they provide evidence of the claims you have made in this nomination (up to 250 words):
Total 245 words used.
- Clinical Evidence Supporting the Use of Elemental Diet for GI Disorders
- This page on mBIOTA’s website breaks down the initial results of mBIOTA Labs’ clinical trial assessing the efficacy of mBIOTA Elemental™ and the company’s abstract presentation of the study results at Digestive Disease Week in May 2024. This page provides an overview of the study results and further clinical evidence for the use of elemental diets for a span of GI disorders.
- mBIOTA Elemental Patient Stories and Customer Testimonials
- This website page highlights Manuela, an mBIOTA Elemental™ patient, and her journey with Intestinal Methanogen Overgrowth (IMO). This page features Manuela’s personal struggles in gut symptom management before discovering mBIOTA and her experience with mBIOTA Elemental™, from her prior hesitations to her ultimate symptom management relief. This page additionally features customer reviews and testimonials telling their own experiences and tips with completing the elemental diet.
- mBIOTA Elemental Information Sheet
- The mBIOTA Elemental™ information sheet provides details and key product features, such as ingredients, certifications, and insurance coverage information, along with an overview of its clinical trial completed in November 2023 and topline clinical data results. Additionally, patient testimonials echoing the achievements of this product are included, and a comparison chart of mBIOTA’s product characteristics versus those of its competitors is included.
- Elemental Diet and Gut Microbiome Clinical Trial
- This study record provides an overview of the mBIOTA Labs’ clinical trial, including a description of the trial, study ID number, study plan, participant criteria, and more.
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