Hiatal Hernia

The company that focuses on remedies for gastrointestinal diseases announced on December 7 that the US Food and Drug Administration (FDA) has accepted for review its new drug application (NDA) for small molecule Voquenza as a daily treatment for adults. The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024. "Today marks an important step forward for Phathom Pharmaceuticals as we announce the FDA's acceptance for filing of our New Drug Application for Voquenza as a daily treatment of heartburn for patients with Non-Erosive GERD,” said Azmi Nabulsi, chief operating officer at Phathom. Non-erosive GERD treatment “Non-Erosive GERD represents a substantial segment of the US GERD population, affecting millions of individuals and impacting their quality of life. The supportive data in our regulatory application include the positive phase 3 results from the investigational PHALCON-NERD-301 trial, along with a safety profile consistent with prior studies. “We look forward to working closely with the FDA throughout the review process and if approved, expect to launch Voquenza for this new indication in the third quarter of 2024.” Non-Erosive GERD is the largest subcategory of GERD and is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions. Phathom says there are an estimated 38 million US adults living with Non-Erosive GERD, of these approximately 15 million are diagnosed and treated with a prescription medicine annually. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Episodic heartburn The company says symptoms impact the overall quality of life and can include episodic heartburn, especially at night, regurgitation, problems swallowing, and chest pain. Heartburn causes a burning feeling in the chest that is caused by stomach acid traveling up towards the throat – acid reflux. If this becomes regular it can be referred to as GERD. Other symptoms can include a unpleasant sour taste in the mouth, a cough or hiccups that keep returning, a hoarse voice, bad breath or bloating or feeling sick. The symptoms can often worsen when lying down or bending over. Research shows that although lots of people get heartburn from time to time, there are no obvious reasons why although some medicines such as anti-inflammatory painkillers, like ibuprofen, a hiatus hernia (when part of the stomach moves up into the chest, a stomach ulcer or bacterial infection in the stomach can be causes. Phase 3 study Phathom is also finalizing its plans to initiate an additional phase 3 study in 2024 evaluating Voquenza as an investigational as-needed treatment for episodic heartburn relief in adults with non-erosive GERD, a novel dosing treatment regimen for which proton pump inhibitors (PPIs) are not approved in the US. Voquenza (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated for the healing of all grades of erosive esophagitis (erosive GERD) and relief of heartburn associated with Erosive GERD in adults and for the maintenance of healing of all grades of erosive GERD and relief of heartburn associated with Erosive GERD in adults.

VMX 2024 to Feature World-Renowned Veterinary Presenters and the Latest in Disease Management and Diagnostics for Animals of All Kinds ORLANDO, Fla., Dec. 6, 2023 /PRNewswire/ -- Breakthrough drugs that can save the lives of thousands of diabetic cats, new approaches to help veterinarians and pet owners recognize and treat illnesses unique to French bulldogs, and how to better care for bearded dragons, America's most popular pet reptile, are just a sample of the more than 800 continuing education sessions that will be offered at the 41st annual Veterinary Meeting & Expo (VMX). Presented by the North American Veterinary Community (NAVC), VMX is the largest global veterinary conference and sets the direction each year for the $104 billion animal health industry. This forum for the latest advances and innovations in animal health will be held January 13 -17, 2024 in Orlando, Florida. Continue Reading VMX 2024 will look at new medications and how technology is transforming how we diagnose and treat animals. - Dr. Varble Post this Bearded dragons are the most popular reptile pets today "VMX is the world's most comprehensive veterinary conference. As the first veterinary conference of the year, it is where remarkable advances are announced and the newest lifesaving techniques are presented," said Dana Varble, DVM, CAE and NAVC Chief Veterinary Officer. "The global conference attracts the most distinguished veterinary leaders who will share and teach exciting breakthroughs taking place today across the industry. VMX 2024 will look at new medications, many designed specifically for animals, and how technology is transforming how we diagnose and treat animals. It's a very exciting and promising time to be in veterinary medicine." VMX 2024 will be led by world-renowned animal healthcare experts who are available for interviews. Look for more sessions and presenters who will be highlighted this month. See the VMX 2024 Full Program for session dates and times. Audrey Cook, DVM, professor of small animal internal medicine at Texas A&M University, Diplomate of both the American and European Colleges of Veterinary Internal Medicine and a recognized specialist in feline medicine through the American Board of Veterinary Practitioners. Breakthroughs in managing feline diabetes in America's most popular pet. From the veterinarian's perspective, feline diabetes is a very treatable disease – but for the pet owner, it's not so simple. According to Dr. Cook, one in 250 cats is diabetic, and one in 10 cats will be euthanized at the time of diagnosis. Studies suggest that less than two-thirds of cats diagnosed with this condition are still alive after three months. Dr. Cook predicts that thousands of cats will live longer and better lives, thanks to breakthroughs in treatment options for feline diabetes in the form of two newly FDA-approved drugs that replace insulin injections with a simple pill or liquid to manage blood sugar levels. "The mortality rate of feline diabetes is so high not because of the disease but because pet owners do not feel they can provide the care their cats need to live with diabetes," said Cook. "We're massively excited about the huge impact two new game-changing oral treatment options will have on our feline patients. We now have the option to simply give a pill or put some liquid medicine on the cat's food once a day. No more scary needles and regimented schedules. Even more important, with these drugs, there is essentially zero risk of cats experiencing clinical hypoglycemia!" Aida Vientós-Plotts, DVM, PhD, DACVIM (Small Animal Internal Medicine), assistant professor of small animal internal medicine, and the co-founder and co-director of The BREATHE Clinic at the University of Missouri. Frenchies Rule! Now What? – An Internist's Guide to Troubleshooting the Most Popular Breed in the U.S. Dr. Vientós-Plotts will conduct a session about common diseases affecting the most popular dog breed in the United States – French bulldogs, lovingly known as "Frenchies." Particularly, Dr. Vientós-Plotts will be highlighting a group of respiratory and gastrointestinal diseases often considered "normal" in these dogs. She will teach veterinarians what to look for and how to treat French bulldogs and other breeds so they can breathe better, swallow easier and improve their overall health and wellbeing. "Brachycephalic, or flat-nosed breeds like French bulldogs, face many health and respiratory issues due to their signature flat snouts and are susceptible to a variety of conditions, including pneumonia, digestive disorders and hiatal hernias, many of which are intimately interrelated," said Vientós-Plotts. "While behaviors like snoring, spitting up or regurgitating food may be typical in French bulldogs and other brachycephalics, they are not normal and may represent more serious conditions. Learning how to identify and address those conditions as early as possible may result in longer, happier and healthier lives." Stacey Leonatti Wilkinson, DVM, Diplomate ABVP (Reptile & Amphibian), adjunct assistant professor at North Carolina State University College of Veterinary Medicine and owner and head veterinarian at the Avian and Exotic Animal Hospital of Georgia. Myth Busters! Top 5 Common Myths From Bearded Dragon Keepers and How to Address Them. Dr. Leonatti Wilkinson will debunk the most common myths about the most popular reptile pets in the country from what they should eat (no, they should not be eating 50 crickets a day) to how to keep them hydrated and avoid "tail rot." Wilkinson will set the record straight about these popular reptiles and help other professionals relay the best information to the owners of these unique pets. "Bearded dragons are by far the most common reptile pets in captivity. We often see multiple in a day in our practice where we treat only exotic pets. Because of this, the care requirements and veterinary medicine for this species is constantly advancing," said Wilkinson. "When it comes to reptiles, it all depends on husbandry. The animal's health is directly related to proper lighting, temperatures, humidity, caging, diet, supplements, etc. It is not as simple as putting a premade diet in a bowl and taking them outside to use the bathroom. These things are important every day of that reptile's life, and they have to get them started right and be conscientious of everything they are doing for their pet all the time." Set to a veterinary-style World's Fair backdrop, this year's "Show of Shows" theme will offer attendees more than 1,000 hours of continuing education and feature exhibits on the latest in animal healthcare products and diagnostics from more than 600 companies and organizations from around the world in the award-winning VMX Expo Hall. The Expo Hall will also feature headlining entertainment, events and activities, including a carousel, a live miniature horse and carnival games. Credentialed media may attend VMX for free, in-person or virtually. To begin your registration process click here. About the NAVC The North American Veterinary Community (NAVC) is a nonprofit organization dedicated to supporting and advancing veterinary professionals worldwide. The world's leading provider of veterinary continuing education, NAVC delivers essential training, tools and resources for veterinary professionals to stay abreast of advances in animal medicine and provide the best medical care for animals everywhere. Through its commitment to innovation and excellence, the NAVC has developed a diverse portfolio of products and services, including educational events, headlined by VMX, the world's largest, most comprehensive continuing education conference and launchpad for new products and innovations within the veterinary industry; a robust digital platform for virtual learning and engagement; the veterinary industry's largest and award-winning portfolio of trade publications; and an advocacy arm which unites the veterinary community and pet lovers. The NAVC was founded in 1982 and is headquartered in Orlando, Florida. Since 2017, the NAVC has been recognized as one of the Top Workplaces by the Orlando Sentinel. To learn more about the NAVC's products and brands, visit . To see our schedule of upcoming events, visit . SOURCE North American Veterinary Community

VADUZ, Liechtenstein, Nov. 22, 2023 /PRNewswire/ -- RefluxStop™ - Beginning of a New Era of Acid Reflux Treatment Significant events in the third quarter of 2023 A big milestone was achieved in the U.K. with our first NHS RefluxStop™ implants performed at St. Mary's Hospital, London, part of the Imperial Healthcare NHS Trust, recognized as one of the most rigorous single payer healthcare systems in the world. The Interventional Procedures Advisory Committee (IPAC) has now started its review of the safety and efficacy of RefluxStop™. IPAC is part of the U.K.'s National Institute for Health and Care Excellence (NICE), which advises the U.K.'s healthcare body NHS on new health technologies. The IPAC review process is a key step for NHS hospitals to adopt our technology with strong international influence. A major peer-reviewed article, 'Laparoscopic Large Hiatal Hernia Repair with RefluxStop: Outcomes of 6 Months Follow-up in 30 Patients' was accepted in the reputed journal, Journal Surgical Laparoscopy Endoscopy & Percutaneous Techniques (SLEPT), emphasizing the benefit of RefluxStop™ in large hernia patients, a market representing a large unmet need. RefluxStop™ made a substantial impact at this year's American Foregut Society (AFS) congress in Dallas, Texas, supporting our U.S. pre-launch market development. One highlight included a surgical panel discussion on RefluxStop™ attended by more than 100 congress participants. Significant events after the end of the period The pre-launch of RefluxStop™ in the U.S. is starting with training in Europe by our KOLs for surgeons from more than 10 key U.S. centers. The surgeons will take part in a Cadaver training and Usability study in the U.S. during targeted February 2024, the data of which will be used in our PMA (pre-market approval) application, as requested by FDA (Food & Drug Administration) in the U.S. The 2nd Annual RefluxStop™ Users Meeting was conducted with more than 50 participants including current and potential RefluxStop™ surgeons and gastrointestinal doctors from the U.S., Canada, UK and across Europe. Top surgeons from around the world gathered for dialogue and learning on the RefluxStop™ procedure. RefluxStop™ has been successfully operated in 600 patients in Europe. RefluxStop™ superior cost-effectiveness research has received top recognition at ISPOR, the world's leading European health-economics conference. Economic analyses for four additional countries have found RefluxStop™ to be more cost-effective than the competition, fundoplication, magnetic sphincter augmentation and PPI-based medical therapy. The Annual European Foregut Society (EFS) congress included the symposium, 'Reconstruction of the Anti-Reflux Barrier (ARB) with RefluxStop™- an innovative approach.' This very successful symposium made a large impact and was moderated by Univ.-Prof. Dr. Schoppmann from AKH Vienna, who was joined by seven other leading GERD surgeons and gastro-intestinal experts from Germany, the U.K., Switzerland, the U.S. and Italy. Financial summary third quarter 2023 Net sales increased 25% to TEUR 244 (195). Adjusted gross margin amounted to 94% (94%). Operating loss (EBIT) increased to TEUR 5,752 (4,581). Loss after tax amounted to TEUR 5,699 (5,868). Basic and diluted loss per Class A share amounted to EUR 0.08 (0.08). Cash and short-term investments as at the end of the period amounted to MEUR 93.8. First nine months Net sales increased 50% to TEUR 900 (600). Adjusted gross margin amounted to 94% (96%). Operating loss (EBIT) increased to TEUR 14,898 (13,339). Loss after tax amounted to TEUR 15,768 (16,614). Basic and diluted loss per Class A share amounted to EUR 0.22 (0.23). Telephone conference Implantica will hold a teleconference on 22 November 2023 at 15:00 (CET) with Peter Forsell (CEO), Andreas Öhrnberg (CFO), and Nicole Pehrsson (Chief Corporate Affairs Officer). Please see the dial-in details below to join the conference: Webcast Dial-in Dial-in numbers to the teleconference will be received by registering on the link below. After registration, you will be provided phone numbers and a conference ID to access the conference For further information, please contact: Nicole Pehrsson, Chief Corporate Affairs Officer Telephone (CH): +41 (0)79 335 09 49 [email protected] Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm. The company's Certified Adviser is FNCA Sweden AB, [email protected] This information is information that Implantica AG is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 2023-11-22 08:00 CET. About Implantica Implantica is a medtech group dedicated to bringing advanced technology into the body. Implantica's lead product, RefluxStop™, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also focuses on eHealth inside the body and has developed a broad, patent protected, product pipeline based partly on two platform technologies: an eHealth platform designed to monitor a broad range of health parameters, control treatment from inside the body and communicate to the caregiver on distance and a wireless energising platform designed to power remote controlled implants wirelessly through intact skin. Implantica is listed on Nasdaq First North Premier Growth Market (ticker: IMP A SDB). 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