Pharma DECODED
Previous edition: 27 Mar 2024
Share article
Get the full version straight to your inbox.
Exclusive access to our best-in-class data & intelligence
Subscribe now
Implantica gears up for FDA approval of acid reflux device
Implantica has submitted the first module of the PMA application for RefluxStop, with subsequent modules planned for submission in the next six months.
Implantica has started the premarket approval process with the US Food and Drug Administration (FDA) for its gastroesophageal reflux disease (GERD) treatment, RefluxStop.
The Liechtenstein-based company is seeking approval for RefluxStop through the US FDA’s premarket approval application (PMA) modular review programme. The PMA modular review allows companies to complete sections, called modules, at different times and the final confirmation is granted once the applicant completes all sections of the PMA. The programme also allows for ongoing review and feedback from the FDA as the modules are submitted.
Implantica has submitted the first module and plans to submit the next two modules in three-month intervals later this year. Following the news, the company’s stock was up by over 8.7% in trading today.
The company has also conducted a human factors validation study as part of the PMA process. The study recruited 16 US-based surgeons with varying levels of surgical experience to carry out the RefluxStop procedure. The study aims to demonstrate that the device can be implanted by surgeons without serious use errors or problems. The data will be evaluated by an independent third party before submission to the FDA.
RefluxStop is an implantable, non-active, single-use device used in the laparoscopic treatment of GERD. The device is implanted near the left side of the oesophagus above the lower oesophageal sphincter and aims to correct oesophageal anatomy to form an anti-reflux barrier, thereby, stopping acid reflux. The device received a CE mark in 2018.
After one year of the device implantations, RefluxStop demonstrated an average 86% improvement in the GERD Health-Related Quality of Life (GERD-HRQL) total score of the participants recruited in the device trial (NCT02759094). At one year follow up, only one out of the 50 participants took regular daily PPIs due to improper (too low) placement of the device, thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in seven subjects.
GERD is a common gastrointestinal disorder and affects 10-20% of the population. The symptoms include acid regurgitation and heartburn. Common treatment for GERD is medications including antacids, which can lose efficacy if used for long durations.
Apart from GERD treatment, multiple companies have also developed diagnostic devices for the indication. Laborie Medical Technologies has developed a wireless pH-capsule reflux testing system, dubbed alpHaONE. Diversatek Healthcare’s MiVu system tests mucosal integrity for rapid diagnosis of GERD, eosinophilic oesophagitis (EoE) and Non-GERD. MiVu device can also be used monitor treatment response in patients with GERD and EoE.
Latest news
Regeneron hit with FDA rejection for blood cancer therapy
The agency said it required the confirmatory portion of odronextamab’s Phase III trial.
FDA approves Merck's WINREVAIR for pulmonary arterial hypertension
The latest approval is based on the results from the Phase III STELLAR study of WINREVAIR in adult PAH patients.
Astellas secures approval for gastric cancer antibody in Japan
The approval from Japan’s MHLW is based on positive results from two studies.
J&J's nipocalimab gains FDA fast track status for FNAIT risk reduction
Nipocalimab is the only therapy currently in clinical development for alloimmunised pregnant individuals with FNAIT risk.
Takeda's ADZYNMA gains Japanese approval for cTTP treatment
No acute TTP events were reported in patients under prophylactic treatment with ADZYNMA during the interim analysis.
Auxilius Pharma to launch Phase Ib anti-anginal trial after IND application
Auxilius Pharma has developed AUX-001 which is a once-daily version of nicorandil for patients with chronic stable angina pectoris.
Cleerly touts new data for AI cardiovascular software
The AI-QCT ISCHEMIA software uses AI to analyse atherosclerosis and blood vessel shapes from CCTA images.
In our previous edition
Pharma Decoded
Elahere secures full approval from FDA for types of ovarian cancer
26 Mar 2024
Pharma Decoded
FDA approves J&J's OPSYNVI for pulmonary arterial hypertension
25 Mar 2024
Pharma Decoded
EMA CHMP recommends Novo Nordisk's weekly insulin for diabetes
22 Mar 2024
Newsletters in other sectors
Aerospace, Defence & Security
Automotive
Banking & Payments
Construction
Medical Devices
Travel and Tourism
Search companies, themes, reports, as well as actionable data & insights spanning 22 global industries
Access more premium companies when you subscribe to Explorer