metaMe Health is committed to developing FDA-cleared Prescription Digital Therapeutics (PDT) for the treatment of gastrointestinal conditions.

IBS is a widespread and debilitating condition that arises partially from miscommunication between the brain and the gut. Treatments like Regulora aim to normalize brain-gut communication.

CHICAGO (PRWEB)
November 30, 2021

metaMe Health, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for Regulora®, the first FDA-authorized treatment of any kind specifically for abdominal pain associated with irritable bowel syndrome (IBS) in adults.

Treatment of abdominal pain associated with IBS is poised for a fundamental shift in clinical practice. The COVID-19 pandemic has prevented patients from engaging in many of the activities of daily living and has led to increases in pain and psychological distress due to IBS-related symptoms (1). This has created a growing unmet medical need for self-administered behavioral therapy options to treat IBS.    

Regulora provides behavioral therapy based on Gut-Directed Hypnotherapy (GDH) through a convenient smartphone app that can be used at home. GDH helps patients with their IBS symptoms by promoting healthier control of digestive tract function and delivering therapy designed to influence pain sensation (2). Until now, GDH has been provided only in-person by licensed therapists.

“The FDA’s clearance of Regulora, our first PDT, is a major achievement for the company,” said Tim Rudolphi, CEO of metaMe Health. “We are eager to expand access of this proven therapy to patients with all three subtypes of IBS.”

Regulora provides a valuable treatment option for IBS patients and their physicians. “Decades of studies show that GDH administered in person by therapists is effective in treating IBS symptoms. However, few therapists are trained in this highly specialized technique, so this option has not been available to most patients. Regulora now makes this treatment accessible to any adult with IBS through their regular doctor or GI specialist, and also makes it far more convenient because no therapist visits are needed,” said Dr. Olafur Palsson, Professor of Medicine in the Division of Gastroenterology and Hepatology at the University of North Carolina.

Irritable Bowel Syndrome is a chronic condition of the lower gastrointestinal tract that affects 10-15% of adults in the United States. IBS accounts for nearly 3.5 million physician visits in the U.S. annually and is one of the most common diagnosis made by gastroenterologists (3).

“IBS is a widespread and debilitating condition that arises partially from miscommunication between the brain and the gut. Stress and other external factors can contribute to normal gut signals being amplified and misinterpreted by the brain as abdominal pain. Treatments like Regulora aim to normalize brain-gut communication,” explained Dr. Neil Sengupta, Assistant Professor of Gastroenterology at the University of Chicago Pritzker School of Medicine.

About Regulora

Regulora is a digital therapeutic mobile app that is downloaded onto an Apple or Android mobile device. Regulora provides for seven 30-minute sessions of remote behavioral therapy based on Gut-Directed Hypnotherapy (GDH) that are administered over a period of 12 weeks. Prior to Regulora, GDH therapy would be provided only via a trained clinician in a medical clinic. With Regulora, video GDH treatment sessions are presented on your mobile device.

GDH provided in the clinic by trained therapists has been shown in numerous studies to help patients improve their IBS symptoms, including abdominal pain, constipation, diarrhea, and bloating. According to a 2020 systematic review of the scientific research, among the behavioral treatments for IBS, GDH has strong evidence of effectiveness and produces long-lasting beneficial effects (4).

Clinical Evidence Supporting Regulora

Regulora was evaluated in a multi-site, randomized, controlled, and blinded clinical trial of 362 evaluable subjects. Two of three analyses of the primary endpoint of abdominal pain achieved clinically significant separation from the control arm. Additionally, 68% of subjects assigned to Regulora reported overall satisfaction with the treatment and 87% would recommend Regulora to someone else with IBS. No serious adverse events were associated with Regulora. About 1% of study participants experienced non-serious adverse events including abdominal pain, constipation, fatigue, or headache. 87% of subjects assigned to Regulora were adherent to therapy.

Regulora Indications for Use

Regulora is a prescription-only digital therapeutic device intended to provide behavioral therapy through gut-directed hypnotherapy for adults 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Regulora is indicated as a 3-month treatment for patients with abdominal pain due to IBS and is intended to be used together with other IBS treatments.

About IBS

Irritable Bowel Syndrome is a chronic condition that affects 10-15% of adults in the United States. The central symptom is abdominal pain, which is accompanied by diarrhea (IBS-D), constipation (IBS-C), or mixed periods (IBS-M). IBS has a severe impact on quality of life; IBS sufferers say they would give 25% of their remaining life (an average of 15 years) to live symptom-free, according to a survey of nearly 2000 patients (5). Symptoms are mediated by a dysregulation of the sensory and motility signaling between the brain and the gut and exacerbated by cognitive, behavioral, affective, and physiologic factors. The annual cost of IBS treatment in the United States has been estimated to be between $1.7 billion and $10 billion in direct costs, with total indirect costs of $20 billion (6).

References

(1) Kamp et al. J Clin Gastroenterology. 2021; PMID:33780216.

(2) Palsson OS. Am J Clin Hypn. 2015; PMID: 26264539.

(3) International Foundation for Gastrointestinal Disorders (IFFGD) Facts About IBS (https://aboutibs.org/what-is-ibs/facts-about-ibs/statistics/).

(4) Black et al. Gut. 2020; PMID: 32276950.

(5) Gastrointestinal Society IBS Global Impact Report 2018 (https://badgut.org/wp-content/uploads/IBS-Global-Impact-Report.pdf).

(6) Hulisz, D., J Managed Care Pharm, 2004. PMID 15298528.

About metaMe Health, Inc.

metaMe Health is committed to developing FDA-cleared Prescription Digital Therapeutics (PDT) for the treatment of gastrointestinal conditions. Prescription Digital Therapeutics are software applications that deliver evidence-based therapeutic interventions to patients to prevent or treat a medical disorder or disease. They are used independently or in concert with medications or other therapies to optimize patient care and health outcomes. PDTs are developed under rigorous conditions complete with clinical trials, FDA clearance, and availability only through a physician’s prescription.

For additional information or investor inquiries, email info@metameconnect.com

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Sarasota Memorial Hospital – Venice Campus

“It’s been a long journey that required many years of thoughtful planning, but thanks to the incredible efforts of our staff, our partners, and the entire community, we can now celebrate this extraordinary hospital, which will save lives…” – Hospital Board Chairman Jim Meister

VENICE, Fla. (PRWEB)
November 30, 2021

Gilbane Building Company is pleased to announce the successful completion of its Sarasota Memorial Hospital-Venice campus project. Gilbane provided preconstruction and construction management at-risk services for the new, state-of-the-art building bringing 5-star care conveniently closer to area residents.

“Our team at Gilbane is proud to deliver the highest standards in hospital facilities,” said Heidi DeBenedetti, executive vice president of Gilbane Building Company. “Despite the strain of COVID-19 and its added consequences of supply chain interruptions, we stayed agile, flexible, and determined. The result is an exquisite new hospital built on time that will provide the utmost in quality patient care for the local community when it is needed the most.”

Located at the intersection of Laurel and Pinebrook roads near I-75 in Venice, Florida, Sarasota Memorial Hospital-Venice features 110 private patient rooms, with ten spacious labor, delivery, recovery, postpartum (LDRP) birthing suites. The 5-story, 365,000 square-foot facility also includes a 28-bed Emergency Care Center with a stroke hub and two resuscitation rooms; 8 surgical suites (including robotics and two surgical suites dedicated for OB patients); 22-bed Intensive Care Unit (with a negative-pressure ventilation system that can convert all or a portion of the critical care pods into pandemic units if needed); an interventional radiology suite; cardiac catheterization/electrophysiology labs; endoscopy/bronchoscopy procedural suites; full array of diagnostics and imaging services; a breast health center; a dedicated cardiac care unit with 24/7 telemetry monitoring, as well as specially equipped units and services for orthopedic, oncology, nephrology, neurology/neurosurgery, pulmonary, urology, general/vascular surgery and other medical/surgical patients.

The 65-acre campus also incorporates a 400-car parking deck, surface parking for approximately 1,050 vehicles, a 25,000 SF energy plant, and a 60,000 SF medical office building. The campus is designed to be flexible and expandable, and work is already underway on a third patient care tower that will add 68 private patient suites. The design will allow Sarasota Memorial to double the size of its Emergency Care Center and surgical suites and expand up to 400 private patient rooms without disrupting hospital operations in future phases.

“This is truly a momentous milestone in Sarasota Memorial’s 96-year history,” Hospital Board Chairman Jim Meister said at a recent ribbon-cutting ceremony. “It’s been a long journey that required many years of thoughtful planning, but thanks to the incredible efforts of our staff, our partners, and the entire community, we can now celebrate this extraordinary hospital, which will save lives and improve health and wellness throughout the region.”

About Gilbane Building Company

Gilbane provides a full slate of construction and facilities-related services for clients across various markets, from preconstruction planning and integrated consulting capabilities to comprehensive construction management, general contracting, design-build, and facility management services. Founded in 1870 and still a privately held, family-owned company, Gilbane has more than 45 office locations worldwide. For more information, visit http://www.gilbaneco.com.

About Sarasota Memorial Health Care System

Sarasota Memorial Health Care System is a regional referral center offering Southwest Florida’s greatest breadth and depth of care, with more than 1 million patient visits each year across its two hospital campuses, free-standing ER, and complete network of outpatient care centers. SMH-Venice is a 110-bed acute care hospital that opened in November 2021 to serve the growing south Sarasota County region. It offers a full array of medical and surgical care and seamless integration with the resources and expertise of the entire Sarasota Memorial Health Care System

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According to recent estimates, up to 74 percent of healthcare provider organizations use clinical decision support (CDS) technology.

CDS systems are great for helping physicians arrive at appropriate and timely clinical decisions regarding many aspects of patient care. However, in virtual or remote care settings, most if not all of these systems either don’t integrate at all or don’t do it well enough with other systems.

WALTHAM, Mass. (PRWEB)
November 30, 2021

The earliest clinical decision support systems date back to the 1960s, when pharmacists used automated technology to check patient allergies, research dosages, and check for drug-to-drug interactions.(1) Now, according to recent estimates, up to 74 percent of healthcare provider organizations use clinical decision support (CDS) technology.(2) These systems harness the power of artificial intelligence (AI) to help provide clinicians, staff members, patients, and others with person-specific health information. In New Jersey, a CDS system known as Clover Assistant is taking hold as an invaluable resource for physicians—the platform provides clinicians with patient-specific information that is relevant to the visit, as well as providing actionable insights to help improve long-term outcomes and guide preventative care.(3)

But there is still the problem of fragmentation. Stuart Long, CEO of InfoBionic, a leading digital cardiac health company, says, “CDS systems are great for helping physicians arrive at appropriate and timely clinical decisions regarding many aspects of patient care. However, in virtual or remote care settings, most if not all of these systems either don’t integrate at all or don’t do it well enough with other systems, and some are even difficult to incorporate into existing electronic health records systems. That can’t continue if we’re talking about providing the highest level of person-specific health care.”

Fragmentation of CDS systems in a virtual/remote care environment is a problem faced by healthcare entities across the nation. Beyond the problem of integration between CDS systems themselves, many also don’t easily incorporate into a healthcare entity’s existing electronic health records (EHR). Today, about 55 percent of healthcare provider organizations use multiple CDS systems for their current brick and mortar implementations.(2) Up to 48 percent of providers plan to continue to use multiple systems due to the challenges of standardizing CDS systems and EHRs.(2) Given the lack of full adoption for the hospital/health system side of the equation, widely implementing interoperable CDS systems in a virtual care environment is yet to be seen. As of today, no single platform seems to provide clinicians with all the information they need, regardless of patient status.

That’s not to say that CDS systems don’t have benefits. Such tools promote patient safety and better outcomes by providing:

• Computerized alerts and reminders to care providers and patients
• Clinical guidelines
• Condition-specific order sets
• Focused patient data reports and summaries
• Documentation templates
• Diagnostic support
• Contextually relevant reference information(4)

Virtual care introduces a variety of new challenges to using CDS systems. Users may not be comfortable using the technology, data integration may be interrupted if transmission signal strength declines, and users may rely too heavily on such systems to arrive at a diagnosis. It’s important to keep in mind that all CDS systems aren’t meant to replace the knowledge and expertise of formally trained physicians; instead, these technologies should only augment clinical experience to help clinicians arrive at the best diagnostic and treatment decisions possible.

CDS systems are also different from “telehealth”, or the provision of healthcare services using remote communication technologies. CDS technologies are composed of various AIs which use algorithms created from evidence-based practices and the most current research possible. As the technology continues to improve, AI will become even better at identifying relevant information in near real-time while filtering out irrelevant data that might incorrectly inform clinical decisions.

In the field of cardiology, AI is already improving patient outcomes. A recent study found that AI eliminated nearly two-thirds of false positives in remote monitoring for atrial fibrillation.(5) As remote patient monitoring technologies, such as InfoBionic’s MoMe® Kardia continue to evolve, they can be more easily integrated with AI systems to help create reliable platforms with accurate data collection. This, in turn, will help allow for greater consistency in patient treatment.

While different types of CDS systems may work best for different processes of care in various settings, the full integration of these systems, remote patient monitoring technologies, and electronic health records is key to providing care tailored to individual patients. Intercommunication will be essential for achieving the best patient care outcomes—but AI systems must advance to the point where they can manage multiple data sources and integrate that information into a single point of reference.

Long says, “We’re making progress toward our goal of complete integration, but we’re not there yet. It’s going to take time and dedication to figure out how we can incorporate all patient data points across all patient care platforms to provide one comprehensive resource to support clinician decisions.”

About InfoBionic:

InfoBionic is a digital health company transforming the efficiency and economics of ambulatory remote patient monitoring processes by optimizing clinical and real-world utility for the users that need it most – physicians and their patients. The Massachusetts-based team of seasoned entrepreneurs have had successful careers in healthcare, IT, medical devices and mobile technology, and bring specific expertise in remote monitoring and cardiology. They have seen first-hand the complexities of traditional cardiac arrhythmia detection and monitoring processes and designed the transformative MoMe® Kardia platform to remove the roadblocks hindering faster, more effective diagnosis and decision-making. Frost & Sullivan bestowed the 2019 North American Remote Cardiac Monitoring Technology Leadership Award upon InfoBionic.

Sources

1. Wasylewicz. “Clinical Decision Support Systems.” Fundamentals of Clinical Data Science [Internet]., U.S. National Library of Medicine, 22 Dec. 2018, ncbi.nlm.nih.gov/books/NBK543516/#:~:

2. Siwicki, Bill. “New Study Identifies Top 11 Clinical Decision Support Vendors.” Healthcare IT News, 10 Oct. 2018, healthcareitnews.com/news/new-study-identifies-top-11-clinical-decision-support-vendors.

3. Clover Assistant, cloverassistant.com/.

4. “Clinical Decision Support.” HealthIT.gov, 10 Apr. 2018, healthit.gov/topic/safety/clinical-decision-support.

5. Hmpgloballearningnetwork.com, hmpgloballearningnetwork.com/site/EpLab/new-study-published-validates-cardiologs-ai-eliminates-nearly-two-thirds-false-positives-remote-monitoring-atrial-fibrillation.

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Many of us here at Makers are parents and siblings, and most of us can only imagine what it is like to be facing a challenge as difficult as childhood illness. We are just happy to help as much as we can.

HAUPPAUGE, N.Y. (PRWEB)
November 30, 2021

Marking its fourth donation to Friends of Karen over the past few years, Makers Nutrition is filling the holiday wish lists of five children assisted by the non-profit for their 2021 holiday Adopt-a-Family season.

Gift cards are undoubtedly high in demand by people of all ages, but children especially. It’s freedom to choose whichever toy or article of clothing they would like. Makers Nutrition is providing $100 gift cards of a specific child’s choosing to each of the five children. These gift cards will help children with life-threatening illnesses and their siblings make this holiday season one to remember.

“Friends of Karen is an absolute pleasure to work with and our team could not be happier be donating once again to a charity that truly understands the importance of family,” said Vice President of Sales Patrick Gillespie. “Many of us here at Makers are parents and siblings, and most of us can only imagine what it is like to be facing a challenge as difficult as childhood illness. We are just happy to help as much as we can.”

About Makers Nutrition

A two-time Inc. 5000 honoree, Makers Nutrition, is a groundbreaking provider for dietary supplement companies worldwide. Specializing in capsules, tablets, powders, softgels and gummies, Makers Nutrition provides a full-service option for all contract manufacturing, graphic design, packaging, and fulfillment service needs. Click here to learn more.

About Friends of Karen

Friends of Karen is a non-profit organization that provides emotional, financial, and advocacy support for children with a life-threatening illness and their families in order to keep them stable, functioning, and able to cope. For families living in the New York tri-state region, Friends of Karen gives them more time for what’s most important: each other. The organization helps hundreds of ill children and their families every month, at no cost to them. Friends of Karen has received top ratings from Charity Navigator, an independent organization that evaluates the financial efficiency and responsibility of thousands of U.S. charities. Friends of Karen also meets the 20 Standards of Charity Accountability of the BBB of Metropolitan New York. Donate here.

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We’ve always focused our philanthropy efforts towards giving to children, veterans, and seniors with limited access to dental care. This year we partnered with a charity that supports female empowerment and underprivileged youth, said Livionex Vice President Hirsh Goswamy.

SAN FRANCISCO (PRWEB)
November 30, 2021

Today, Livionex, maker of the popular dental gel LivFresh, which removes plaque 250% better than traditional toothpaste, announces its participation in #GivingTuesday on November 30th, a global day of giving that harnesses the collective power of individuals, communities, and organizations to celebrate generosity worldwide. To celebrate, Livionex, announces its biggest donation to date by joining with the non-profit, Project Glimmer, to gift 3000 of its new LivFresh Teeth Whitening Kits to adolescent girls across the country. The kits, a retail value worth $450,000 will go to girls in Project Glimmer’s vast network of foster care, homeless shelters, crisis care, and youth services centers across Alabama, California, Florida, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, and Tennessee. Additionally, Project Glimmer will distribute some of the kits at their Foster Care holiday “shopping” event” on December 4th.    

“We’ve always focused our philanthropy efforts towards giving to children, veterans, and seniors with limited access to dental care. Our team wanted to share this year’s success by partnering with a charity that supports female empowerment and underprivileged youth, who are often forgotten during the holiday season. We know that self-confidence is critical in shaping a teenager’s life. We felt that partnering with Project Glimmer to provide adolescent girls with a means to brighten their smile would be a wonderful way to improve their self-esteem,” said Livionex Vice President Hirsh Goswamy. “Confidence is cultivated, and when nurtured, it can positively impact one’s future. We want to let these girls know that they are cared for and that they have a community focused on helping them excel both personally and professionally,” added Goswamy.

Despite the pandemic, Project Glimmer has been successful in expanding the non-profit’s reach and boosting self-confidence in adolescent girls. The organization’s partnership with Livionex builds on what has already been an impactful year, as shown by the success of its most recent annual gala which raised half a million dollars for girls in need.

“Project Glimmer is excited to partner with LivFresh this year for GivingTuesday, generously donating 3,000 teeth whitening kits for our current holiday gifting program. The therapeutic dental brand develops novel therapies that affect billions of people worldwide and uses proprietary technology that repels bacteria from the tooth surface and modulates metal ions that cause oxidative stress and inflammation to treat and prevent age-related diseases. These gifts will help young women, not only with dental health, but also increase personal confidence,” said Project Glimmer Deputy Director Jenni Bingham.

Founded by Sonja Hoel Perkins, Project Glimmer has grown from a single holiday gift drive for forgotten teenage girls to a nationwide platform of programs that inspires a girl’s ambition, connects her with a network of peers and mentors, and supplements some of her most basic personal needs.

The girls in the Project Glimmer network will each receive a LivFresh Teeth Whitening System that blends science and luxury to get even the most sensitive teeth up to 8 shades whiter in as little as 10 minutes a day. The proprietary formula is unique because it blends a mixture of carbamide and hydrogen peroxide— with potassium nitrate, the same desensitizing ingredient found in Sensodyne toothpaste. In internal tests, LivFresh’s formula produced stronger whitening results than when each ingredient was used individually.

The LivFresh Whitening System includes a blue light emitting mouthpiece that connects to a mobile device and four whitening gels; three silver pens for general use and one gold pen, that contains a higher concentration of whitening for special occasions. The elegantly packaged kit contains up to 21 treatments and the whitening serums are gluten-free, vegan, sugar-free, SLS and triclosan free. All the products are cruelty-free and don’t contain salicylates and parabens.

About Livionex

Livionex was founded in 2009 by Stanford and UC Berkeley alums with the goal of enhancing the quality and longevity of human life. Headquartered in Los Gatos, CA, Livionex develops novel therapies for a variety of age-related diseases affecting billions of people worldwide. The Company’s first product to market, LivFresh Dental Gel, is based on its proprietary technology that modulates metal ions that cause oxidative stress and disease. Supported by thousands of dentists, including the former President of the American Dental Association, LivFresh is clinically proven to remove plaque 250% better than traditional toothpaste and is seeking to become the world’s first treatment for gum disease. A recent double-blind study in the Journal of Periodontology, showed those who brushed with LivFresh saw 2.5 times less gum inflammation and 1.9 times less gum bleeding as compared to the control group. LivFresh’s Dental Gel was also recently approved as the world’s first CE Marked toothpaste product in Europe for the treatment and prevention of periodontitis and gingivitis. Besides introducing products in the oral health industry, the Company is introducing a new category of treatment for various disorders and diseases associated with metallo lipid protein aggregates, inflammation, and/or bacterial biofilms across ophthalmology, dermatology and oral care. The LivFresh line of products is available on-line at GetLIVFRESH.com and in dental offices across the country.

About Project Glimmer

Project Glimmer is a national non-profit on a mission to build self-confidence in adolescent girls. Project Glimmer has grown from a single holiday gift drive for forgotten teenage girls to a nationwide platform of programs that inspires a girl’s ambition, connects her with a network of peers and mentors, and supplements some of her most basic personal needs. The organization has served over 700,000 teenage girls and women, 86% of whom are young women of color. Project Glimmer works in all 50 states through partnerships with 1,000+ organizations including foster care, homeless, crisis care, and youth services. Through their programs including Gifts + Goods, Day of Empowerment, Empower Hour, and Career Coaching, they are dedicated to helping end gender and racial inequality. More can be found at http://www.projectglimmer.org

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