Implantica: Dr. Peter Forsell, the company’s founder, CEO, and recognized specialized surgeon, believes that healthcare could be significantly improved, which is why he founded Implantica in 2015. “The gap between available medical implant products and patient needs is often significant,” he said in his own words. Outside of the body, technology has advanced quickly; however, these advancements have not reached inside the body.
Driven by a desire to fill this gap, combined with selling his very successful adjustable gastric band business to Johnson and Johnson for nearly USD 200M, Dr. Forsell reinvested the money and established Implantica. The bold ambition of Implantica is to introduce cutting-edge technology into the body with the potential to revolutionize healthcare for millions of patients worldwide. “I have always been curious to learn how to solve the challenging issues I have seen in the lives of my patients. This was the foundation of my vision when I founded Implantica, to leverage technology to enhance healthcare and improve patient outcomes with implantable solutions,” says Dr. Forsell.
Associated Market Trends
Market trends in association with the commercially accessible product RefluxStopTM are truly favorable. *RefluxStopTM has the potential to create a paradigm shift in the treatment of acid reflux, a disease that affects more than one billion people globally. It treats acid reflux by restoring and maintaining the natural physiologic anatomy. The outcomes of RefluxStopTM speak for themselves. In contrast to current surgical techniques, Implantica treats dangerously low pH brought on by acid reflux without inducing complications like swallowing difficulties. RefluxStopTM treats the cause of acid reflux as opposed to simply relieving its symptoms as with medical treatment. The team at Implant is confident that their innovative method of treating acid reflux has the opportunity to help millions of patients around the world who deserve access to a solution that effectively addresses the underlying cause of acid reflux and restores quality of life.
Implantica XaaS
Implantica’s future product pipeline program includes smart medical implants with sophisticated treatment options that could fill a big gap in present treatments and patient requirements.
Implant developed two platform technologies to address these unmet needs: a wireless energizing platform to charge the implant directly in the wireless field or through intact skin and an eHealth platform designed to collect data on treatment progress and allow the healthcare provider to control and change treatment remotely. The eHealth platform measures various parameters from inside the body that are sent to the caregiver to establish the treatment status. The healthcare provider can view and analyze the patient’s treatment results and will be able to adjust or change the treatment from a distance as needed.
Implantica’s eHealth platform is designed to provide many more technologically advanced therapeutic solutions to address unmet patient requirements, improve patient quality of life, and save costs for society. After years of market and product research and prototyping, the team chose 40 products from 300+ inventions in diverse treatment disciplines to improve treatment and outcomes. Most of these are based on their platform technologies that will revolutionize how care is delivered in the future. Implantica’s eHealth technology is unique. They have recently filed a 25,000-page eHealth patent covering their eHealth technology. Implantica will lead eHealth development when this launches.
Being The First Choice
What separates Implantica’s solution from existing surgical methods is that RefluxStop™ restores and maintains the body’s normal physiologic anatomy to treat acid reflux. Existing surgical techniques only address part of the problem. Some encircle the food passageway to close the LES to cure acid reflux, whereas others are decades old with high complications and failure rates. RefluxStopTM is designed to treat acid reflux without causing the complications of swallowing difficulties and gas bloating that occur with existing surgical procedures.
RefluxStopTM, unlike PPIs, tackles acid reflux’s cause rather than simply relieving its symptoms. Implantica believes that RefluxStopTM when widely adopted, will provide an important impact on the incidence of esophageal adenocarcinoma, which is caused primarily by acid reflux and kills 48,000 people in the US and EU alone.
As it was believed that acid reflux was caused by the comprised function of the LES, current surgical treatments for acid reflux focus on physically helping the LES to close. These solutions are simply not sufficient or perfect. They may work for some people, but they encircle and put pressure on the esophagus, causing a list of side effects, including swallowing difficulties, gas bloating, and the inability to belch and vomit. These poor outcomes and side effects have led to a lack of referral of patients for the larger set of surgical anti-reflux treatment options.
Outside of surgical solutions, PPIs are often used as the first-line treatment for acid reflux. PPIs reduce stomach acidity, making stomach material that enters the esophagus less acidic and, therefore, less damaging. This works for occasional, brief acid reflux. However, long-term usage of PPIs for chronic reflux can lead to cardiovascular disease, kidney damage, cancer, and infections/parasites because bacteria no longer die from acid.
RefluxStopTM, unlike current solutions, does not affect the food passageway, avoiding several surgical adverse effects. It restores the body’s natural anti-reflux barrier and supports it by keeping it in place. This innovative device eliminated most post-anti-reflux surgery problems with promising results. Implantica believes RefluxStopTM could potentially create a paradigm shift in anti-reflux surgery as clinical and real-world data accumulate.
The Unique Customer Experience Strategy
RefluxStop’s results are impressive, according to medical journals and conferences. The solution is well-received by most surgeons and patients. Implantica’s vision for RefluxStopTM is for it to become a new evidence-based standard of care for acid reflux therapy, unleashing its huge business potential.
To achieve positive market access decisions and faster adoption in clinical practice, superior clinical outcomes against the standard of care are needed both from randomized clinical trials and real-world observational studies. To that end, the Implantica team has already commissioned a well-designed real-world observational registry study, and we are planning a large multi-national randomized controlled trial. According to surgeons performing the RefluxStop procedure, it has given a real treatment option to some of the most difficult patient categories that previously would not have been considered for surgery and for whom treatment options were limited. As the RefluxStop™ device does not encircle or put pressure on the food passageway, physicians have been using it on a broader patient population with significant unmet needs, and the outcomes are great, to say the least.
Conclusion
Team Implantica is focusing on commercializing RefluxStopTM step by step, receiving regulatory and reimbursement approval in more and more countries. Implantica’s goal is for RefluxStopTM to continue to grow year after year. Implantica’s two-year goals are to file the PMA with the FDA and seek US clearance using their European clinical data. This is their main objective. Reimbursement in the US and key European markets is the second. They have an excellent team that is set to break boundaries and deliver exceptional growth in the coming years.
Beyond US launch planning, they’re commencing the process to gain Japanese regulatory approval. They will also focus on Canadian regulatory approval and compensation. On the new product development front, they will continue to improve their key eHealth products, such as UriRestore® for patients with the inability to urinate who can avoid inserting a catheter in their bladder five times a day and UriControl® for urinary leakage. In addition, AppetiteControlTM, which controls appetite like the body to treat obesity, and StomaRestore®, which will connect the gut to the anus with an internal reservoir and open, close, and empty functions to remove stoma bags. All of these products are designed to treat massive healthcare needs.
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