Implantica’s Solution to Acid Reflux, RefluxStop^®

RefluxStop^® treats acid reflux without affecting the food passageway, an innovative method that will possibly create a paradigm shift in acid reflux treatment. This ingenious device is a non-active implant and is placed on the upper part of the stomach through laparoscopic (key hole) surgery. CE mark approval was granted August 8, 2018, on the strength of a multi-center clinical investigation in which the safety, effectiveness, and performance of the device in patients was demonstrated.

RefluxStop^® treats acid reflux without affecting the food passageway, an innovative method that possibly will create a paradigm shift in acid reflux treatment.

Acid reflux is the second largest treatment field in the world, with over 1 billion sufferers globally¹. RefluxStop^® treats the symptoms of acid reflux by eliminating the regurgitation of stomach fluid.

 

1. 1 Nirwan, J.S., Hasan, S.S., Babar, ZUD. et al. Global Prevalence and Risk Factors of Gastro-oesophageal Reflux Disease (GORD): Systematic Review with Meta-analysis. Sci Rep 10, 5814 (2020). https://doi.org/10.1038/s41598-020-62795-1

Acid reflux sufferers consumed drugs for USD 24 billion in 2010². We expect the surgical treatment addressable market to grow substantially to reach a couple of million operations yearly³, and the clinical trial results support that RefluxStop^® has the potential to completely change the treatment of acid reflux.

We expect the addressable market to reach 2.4 million operations yearly³.

1. 1. Johnson 2009; Stuart 2005
2. 2. AstraZeneca 2010
3. 3. The Karolinska Institute Review Article, 2017, not yet published

Acid reflux complications, progression, and cancer risk

Acid reflux creates precancerous changes in the lower esophagus, called Barrett’s esophagus, by iterative damage caused by stomach fluid found in 10-15% of acid reflux patients⁴. For daily sufferers the incidence is even higher probably at 20%⁵. The most common treatment method, drug therapy, does not prevent acid reflux but only reduces the acidity in the regurgitating stomach fluid, and the majority of patients continue to experience heartburn now and then. 59% of drug users continue to intermittently have acid reflux⁶ and only 1 out of 9 become completely symptom free.⁶

The current standard of care surgical treatments of acid reflux often lead to complications, such as swallowing problems, because they encircle the food passageway. RefluxStop^® has a unique mechanism of action and does not encircle the food passageway thereby reducing complications, as supported by the clinical investigation.

Acid Reflux is a progressive disease and if left untreated, can lead to serious health consequences, including for some, esophageal cancer.

The stages of progression of untreated GERD:

Disclaimer: There is no clinical data showing that RefluxStop^® can lower a patient’s risk of developing cancer.

1. 4. Cossentino MJ, Wong RK. 2003. Barrett’s esophagus and risk of esophageal adenocarcinoma. Semin Gastrointest Dis.; Schlottmann F, Molena D, Patti MG. 2018. Gastroesophageal reflux and Barrett’s esophagus: a pathway to esophageal adenocarcinoma. Updates in Surgery
2. 5. Modiano N, Gerson L. 2007. Barrett’s esophagus: Incidence, etiology, pathophysiology, prevention and treatment. Therapeutics and Clinical Risk Management
3. 6. Raghunath AS, Hungin AP, Mason J, Jackson W. 2009. Symptoms in patients on long-term proton pump inhibitors: prevalence and predictors. Alimentary Pharmacology & Therapeutics
4. 7. Yousef F et al. 2008. The incidence of esophageal cancer and high-grade dysplasia in Barrett’s esophagus: a systematicc review and meta-analysis. Am. Jour. of Epedimiol.
   

Benefits of RefluxStop^®

Treats GERD without affecting food passageway

RefluxStop^® successfully treats acid reflux by restoring and maintaining the body’s natural anatomy without encircling the food passageway, thereby minimizing common side effects commonly associated with standard of care acid reflux surgical procedures.

Successful 4-year clinical trial results:

• 95% of patients did not need to take daily PPI medication

• 95.5% (42/44) of subjects had no or minimal/occasional episodes of regurgitation, and all (100%) subjects experienced improvement in regurgitation compared to baseline

• GERD-HRQL score decreased by 90% from a baseline of 29.5 (24–33) to 3.0 (0–9.2) at 4-year follow-up

• 95.5% (42/44) of patients were satisfied at 4 years

• 93% of patients had resolution or improvement in gas-bloating

Safety issues during the clinical trial

• No complications related to the RefluxStop^® device during the entire study period
• No device deficiencies
• No deaths related to RefluxStop^® and its procedure
• No device explantations
• No migration/erosion
• No esophageal dilatation required

Field Description

Acid reflux or gastroesophageal reflux disease (GERD) is the term describing a condition in which liquid, acid content of the stomach, regurgitates (or refluxes) up to the esophagus, the tube connecting the stomach with the throat. The condition is common and almost everyone experiences this from time to time. Acid reflux affects people of all ages and backgrounds. The condition turns into the chronic disease gastroesophageal reflux disease, commonly referred to as GERD, when the frequency of acid reflux is abnormal.

GERD is one of the most highly prevalent diseases in the world with 31% of people suffering on a weekly basis⁸ and around 375 million with daily problems⁹. GERD has a considerable financial impact on society¹⁰.

The most common symptom of GERD is heartburn, a burning pain from behind the sternum, the breastbone. Other symptoms in more advanced cases are chest pain, difficulty swallowing, pain when swallowing, coughing, wheezing and/or vomiting. Sleeping disorder often becomes part of these patients’ everyday life as lying down increases the risk of acids entering the esophagus. For all GERD patients, their quality of life is severely affected.

1. 8. Zebrowski & fox-tucker, 2006
2. 9.Johnson 2009; Stuart 2005
3. 10. Brook et al. 2007; El-Serag, 2007

Existing Treatment

The most common way to treat GERD is through pharmaceutical treatment. Proton pump inhibitors, PPI drugs, are proven to be the most efficient non-surgical treatment for GERD, even though they only treat the symptoms and not the cause – reflux with lower acidity is still present. Also 59% of the drug users experience heartburn now and then.¹¹ 

Since the 1950’s the standard surgical treatment of GERD has been the fundoplication procedure, even though side effects are common. This procedure is when the top part of the stomach is wrapped around the ring muscle closing between the stomach and esophagus, the lower esophageal sphincter (LES). 

All of the fundoplication methods have one major drawback – they all compress the food passageway – thereby causing swallowing problems and the inability to belch and vomit. Implantica’s new device treats acid reflux without affecting the food passageway at all.

The substantial size of this treatment field can be concluded from the annual drug consumption of USD 24 billion in 2010.¹⁴ Yet only 1 out of 9 drug consumers become completely symptom free, thus there is a large need for a complication-free surgical procedure.

1. 11. Raghunath AS, Hungin AP, Mason J, Jackson W 2009
2. 12. The Karolinska Institute Review Article, 2017, not yet published
3. 13. ISS, Integrated Scientific Services 2018
4. 14. AstraZeneca 2010