Patient interactions with the healthcare system often involve interactions with equipment and devices – from syringes and bandages, blood pressure monitors, and pregnancy testing kits, to surgical instruments, pacemakers.
The medical technology (medtech) industry designs and manufactures a wide range of products to diagnose, monitor, and treat patients and is instrumental in helping healthcare organizations achieve better patient outcomes, lower healthcare costs, improved efficiency, and implement new ways of engaging and empowering patients.
Implantica is at the forefront of designing smart medical implants for the betterment of mankind and improvement of quality of life. Implantica is a medtech group dedicated to bringing innovative advances in technology into the body. Implantica’s pipeline includes medical implants previously seen as unachievable that seek to alleviate unmet medical needs.
In conversation with Dr. Peter Forsell, CEO, and Founder of Implantica AG
Q. What gap in the market does the company fill and talk a little about the company’s product pipeline?
The gap between available medical implant products and patient needs is often significant. Technology has developed at high speed outside the body; however, these advancements have not reached inside the body. Implantica has therefore developed two platform technologies, one wireless energizing and one eHealth platform to be able to build smart medical implants that could further improve healthcare.
Based on these platform technologies Implantica went through treatment field, after treatment field, looking at all the existing solutions to see how we could improve healthcare simultaneously filing nearly 2000 patent cases. After performing market analysis, product analysis, patent analysis, and prototyping, we selected more than 40 products out of our 300 inventions, which builds our unique product pipeline.
Q. How is Implantica leading an innovative surge on the eHealth front?
Most of our products and patents are based on these two key platform technologies mentioned above. The wireless energizing platform can charge the battery of an implanted device directly through intact skin, and the eHealth platform with a remote-controlled action, measures treatment results and various parameters from inside the body and then communicates them to the caregiver.
The intent is that the healthcare provider should be able to monitor the patient’s treatment results and adjust the treatment as needed from distance.
Q. What Medtech solutions does Implantica offer now that are helping patients?
There are many treatment areas where we can improve outcomes without the need for energized implants and where a passive device can successfully address the unmet need. A great example is RefluxStop, currently commercially available. It is a passive implant designed to restore the natural physiological anatomy of the body and treat acid reflux. One billion people are affected every week by acid reflux and around 400m of those suffer from it daily. Symptoms often involve pain, negatively impacting their quality of life.
Gastroesophageal reflux disease (GERD) occurs when stomach contents flow back into the esophagus. A specialized ring of muscle at the bottom of the esophagus called the lower esophageal sphincter (LES) stays closed to prevent backflow into the esophagus in between meals. The esophageal sphincter functions properly when it is in its natural position below the diaphragm, however, when the esophageal sphincter is moved upwards too close to, or even above the diaphragm, the normal function is often prevented, allowing acid contents from the stomach to push up into the esophagus. RefluxStop restores and maintains the sphincter in its original correct position without encircling and putting pressure on the food passageway.
Q. How is Implantica’s RefluxStop creating a potential paradigm shift in acid reflux treatment?
RefluxStop is the first implantable medical device that truly restores and maintains the normal physiology of the body without encircling the food passageway. This very unique, innovative mechanism of action is based upon the understanding that the esophageal sphincter’s natural position is compromised in those suffering from acid reflux. Due to the pressure variations created when breathing, the LES sphincter does not function correctly when misplaced too close to or above the diaphragm.
The RefluxStop procedure focuses on correcting this malfunction. It is a minimally invasive procedure performed laparoscopically. During the RefluxStop procedure, any hiatal hernia that may be present is repaired. The lower part of the esophagus that contains the sphincter is returned to its natural position below the diaphragm, while the upper part of the stomach, called the fundus, is attached to the esophagus. The RefluxStop is placed on the outer stomach fundus wall to prevent the esophageal sphincter from gliding back up towards or into the chest and to support its natural anatomy and position.
Correcting and maintaining the natural physiological anatomy in turn resolves acid reflux. Because of RefluxStop’s unique mechanism of action, restoring the natural physiology of the body without putting pressure on the food passageway, it also helps to avoid the typical unpleasant side effects experienced after other anti-reflux surgical procedures.
Q. Would you like us to highlight something important happening in your company that we may have missed asking?
FDA, the agency in the USA that approves medical implants, normally requires a specific US clinical trial, however, in our case the FDA has allowed us to submit a PMA submission for approval to sell in the US based on our European trial. This is a unique decision and emphasizes the superior 3-year results of RefluxStop with 98% satisfied patients at year 3.
Increasing patients’ Quality of life with the help of dedicated medtech devices
Dr. Peter Forsell is the CEO and Founder of Implantica AG. Dr. Forsell was the Executive Chairman of Obtech Medical AG, the team’s previous successful medical technology business which commercialized the SAGB, an adjustable gastric band to treat obesity that Dr. Forsell developed.
He is the inventor and originator of most of Implantica’s products and has a large patent portfolio of >1,000 patent cases. Dr. Forsell is a surgery specialist, and he obtained his medical degree at the Karolinska Institute in Stockholm, Sweden. He has also studied basic law, tax, and finance.