Medical technology company advancing neuromodulation therapies for chronic and debilitating conditions in children and adults. NYSE American: NRXS
Carmel, Indiana
Joined September 2014
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Since 2020, the IB-Stim® Guidance and Patient Support team has assisted patients in better understanding their insurance benefits, advocated for coverage with insurance companies and improved access to treatment for eligible families.
Today, our Guidance & Patient Support (GPS) has help change 2,000+ eligible lives and counting.
Our GPS team helps treating facility staff with benefits verification, prior authorization and understanding the insurance landscape for PENFS treatment. The Program can provide financial assistance to eligible families, so patients have better access to care when needed.
IB-Stim is an FDA-cleared treatment option for patients 8 years and older with functional abdominal pain associated with IBS, functional dyspepsia (FD), and FD-related nausea symptoms.
Important IB-Stim information, including indications, precautions, instructions for use, and contraindications: ibstim.com/important-informa…
#IBStim #PediatricGI #FunctionalAbdominalPain #PatientSupport #DGBI #PediatricHealthcare
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Why can gastrointestinal sensations become painful even when diagnostic testing does not identify a structural abnormality?
Visceral hypersensitivity is one mechanism that may contribute to functional abdominal pain in disorders of gut-brain interaction.
For some patients, altered sensory processing may contribute to pain in response to gastrointestinal sensations that would not typically be painful.
IB-Stim® is an FDA-cleared treatment option for patients 8 years and older with functional abdominal pain associated with IBS, functional dyspepsia (FD), and FD-related nausea symptoms.
Important IB-Stim information, including indications, precautions, instructions for use, and contraindications: ibstim.com/important-informa…
#VisceralHypersensitivity #FunctionalAbdominalPain #PediatricGI #DGBI #Neurogastroenterology
DGBIs rarely fit into a single-lane care plan.
The FDA-cleared indication for IB-Stim® describes the device as an aid in the reduction of pain when combined with other therapies for functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia (FD).
That language reflects an important clinical principle.
The question is not necessarily “IB-Stim or everything else?”
It is how a device-based therapy may fit into an individualized plan for the patient.
For pediatric programs, that can mean coordination across gastroenterology, nursing, behavioral health, nutrition and family education, based on the needs of the individual patient.
For important IB-Stim information, including indications, precautions, IFU and contraindications, visit:ibstim.com/important-informa…
#DGBI #MultidisciplinaryCare #IBStim #PediatricGI #FunctionalAbdominalPain #PediatricHealthcare
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Clinical evidence supports the use of IB-Stim to improve nausea in patients suffering from functional abdominal pain associated with functional dyspepsia (FD).
A retrospective study evaluated 84 children and adolescents with FD who completed four weeks of PENFS. Across the cohort, validated measures of abdominal pain and nausea severity improved from baseline.¹
The study design matters: this was an observational chart review rather than a randomized, sham-controlled trial.
So does the indication.
IB-Stim® is FDA-cleared for patients 8 years and older with functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia (FD). In indicated FD patients, reduction of nausea symptoms has also been shown.
Evidence is strongest when we communicate both the findings and their limitations.
¹Santucci NR, Beigarten AJ, Khalid F, et al. Percutaneous electrical nerve field stimulation in children and adolescents with functional dyspepsia—integrating a behavioral intervention. Neuromodulation. Published online August 16, 2023. PMID: 37589640
For important IB-Stim information, including indications, precautions, IFU and contraindications, visit:ibstim.com/important-informa…
#FunctionalDyspepsia #IBStim #ClinicalEvidence #PediatricGI #FunctionalAbdominalPain #PENFS
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Clinical evidence is most useful when the study population and endpoints stay in view.
In a randomized, double-blind study subgroup of adolescents with IBS, 59% of patients receiving PENFS achieved at least a 30% reduction in worst abdominal pain after three weeks, compared with 26% receiving sham stimulation.¹
The subgroup included adolescents ages 11–18.
Today, IB-Stim® is FDA-cleared for patients 8 years and older with functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia (FD).
¹ Kovacic K et al. Lancet Gastroenterol Hepatol. 2017;2:727–737.
For important IB-Stim information, including indications, precautions, IFU and contraindications, visit:ibstim.com/important-informa…
#ClinicalEvidence #IBStim #PENFS #PediatricGI #FunctionalAbdominalPain #EvidenceBasedMedicine
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Treatment workflow matters.
The current IB-Stim® labeling calls for:
120 hours per week.
One device per week.
Four consecutive weeks.
That makes education before the first device placement important.
Patients and families should understand the treatment schedule.
Clinicians should review relevant precautions and contraindications.
Care teams decide how IB-Stim fits alongside the other therapies being used for the patient's functional abdominal pain.
A clear pathway helps the entire care team communicate consistently throughout treatment.
For important IB-Stim information, including indications, precautions, IFU and contraindications, visit:ibstim.com/important-informa…
#IBStim #PediatricGI #FunctionalAbdominalPain #ClinicalWorkflow #DGBI #PENFS
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IB-Stim® is worn behind the ear, but the clinical rationale extends to the neural pathways involved in pain processing.
IB-Stim is a percutaneous electrical nerve field stimulation (PENFS) system applied through branches of cranial nerves V, VII, IX, and X and the occipital nerves identified by transillumination.
For patients 8 years and older with functional abdominal pain associated with irritable bowel syndrome (IBS) or functional dyspepsia (FD), IB-Stim is indicated as an aid in the reduction of pain when combined with other therapies.
For clinicians managing DGBIs, neuromodulation can be considered within a broader care plan rather than as a standalone approach.
For important IB-Stim information, including indications, precautions, IFU and contraindications, visit:ibstim.com/important-informa…
#PENFS #IBStim #Neuromodulation #FunctionalAbdominalPain #PediatricGI #DGBI
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Precision matters when we talk about disorders of gut-brain interaction in patients diagnosed with functional abdominal pain.
IB-Stim® is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) or functional dyspepsia (FD) in patients 8 years and older.
In patients with FD, IB-Stim has also been shown to reduce nausea symptoms.
Understanding IB-Stim’s clearance ensures that conversations between clinicians and patients with functional abdominal pain lead to the right care.
IB-Stim is used as an aid in the reduction of pain when combined with other therapies for IBS and FD.
For important IB-Stim information, including indications, precautions, IFU and
contraindications, visit: ibstim.com/important-informa…
#IBStim #FunctionalAbdominalPain #PediatricGI #DGBI #FunctionalDyspepsia
#Gastroenterology
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PENFS provides a non-drug, device-based approach targeting neural pathways involved in pain processing.
Preclinical research using IB-Stim® stimulation parameters demonstrated modulation of activity within central pain-processing regions.¹
IB-Stim is FDA-cleared for patients ages 8 and up with functional abdominal pain associated with IBS or functional dyspepsia.
Explore the science behind IB-Stim:
ibstim.com/how-ib-stim-works
¹ Babygirija R, et al. Neuroscience. 2017;356:11–21.
For important IB-Stim information, including indications, precautions, IFU, and contraindications:
ibstim.com/important-informa…
#PainPathways #BrainGutAxis #PediatricGI #IBStim
IB-Stim® delivers percutaneous electrical nerve field stimulation (PENFS) through branches of cranial nerves located in the ear.
Preclinical research using IB-Stim stimulation parameters demonstrated modulation of activity within central pain-processing regions.¹
IB-Stim is an FDA-cleared device for patients ages 8 and up with functional abdominal pain associated with IBS or functional dyspepsia.
Explore the PENFS research:
ibstim.com/how-ib-stim-works
¹ Babygirija R, et al. Neuroscience. 2017;356:11–21.
#BrainGutAxis #PediatricGI #FunctionalAbdominalPain #IBStim
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The FDA-cleared age range for IB-Stim® begins at age 8.
IB-Stim is cleared for patients ages 8 and up with functional abdominal pain associated with IBS or functional dyspepsia.
The non-drug device delivers percutaneous electrical nerve field stimulation (PENFS) through branches of cranial nerves located in the ear.
Learn more about the science and where IB-Stim may fit into the care pathway:
ibstim.com/how-ib-stim-works
For important IB-Stim information, including indications, precautions, IFU, and contraindications:
ibstim.com/important-informa…
#PediatricGI #BrainGutAxis #FunctionalAbdominalPain #IBStim
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Put pain in its place.
Functional abdominal pain can persist despite a reassuring diagnostic evaluation.
IB-Stim® provides a non-drug device option for patients ages 8 and up with functional abdominal pain associated with IBS or functional dyspepsia.
The device delivers percutaneous electrical nerve field stimulation (PENFS) through branches of cranial nerves located in the ear.
Learn more about IB-Stim:
ibstim.com/how-ib-stim-works
For important IB-Stim information, including indications, precautions, IFU, and contraindications:
ibstim.com/important-informa…
#PediatricGI #FunctionalAbdominalPain #BrainGutAxis #IBStim
ALT Put pain in its place. Functional abdominal pain can persist despite a reassuring diagnostic evaluation. IB-Stim® provides a non-drug device option for patients ages 8 and up with functional abdominal pain associated with IBS or functional dyspepsia. The device delivers percutaneous electrical nerve field stimulation (PENFS) through branches of cranial nerves located in the ear. Learn more about IB-Stim: https://ibstim.com/how-ib-stim-works For important IB-Stim information, including indications, precautions, IFU, and contraindications: https://ibstim.com/important-information
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Preclinical research using IB-Stim® stimulation parameters demonstrated modulation of activity within the amygdala.¹
The findings provide a mechanistic [TC1] context for the central pain-processing pathways associated with PENFS.
IB-Stim is an FDA-cleared device for patients ages 8 and up with functional abdominal pain associated with IBS or functional dyspepsia.
Explore the preclinical science behind PENFS:
ibstim.com/how-ib-stim-works
¹ Babygirija R, et al. Neuroscience. 2017;356:11–21.
For important IB-Stim information, including indications, precautions, IFU, and contraindications:
ibstim.com/important-informa…
#PediatricGI #BrainGutAxis #Neuromodulation #ClinicalEvidence
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For patients with functional abdominal pain associated with IBS or functional dyspepsia, IB-Stim® offers a non-drug device option.
The small, wearable device provides percutaneous electrical nerve field stimulation (PENFS) through branches of cranial nerves located in the ear.
IB-Stim is FDA-cleared for patients ages 8 and up.
Learn more about the technology and clinical evidence behind IB-Stim:
ibstim.com/how-ib-stim-works
For important IB-Stim information, including indications, precautions, IFU, and contraindications:
ibstim.com/important-informa…
#PediatricGI #FunctionalAbdominalPain #IBStim #PENFS
ALT For patients with functional abdominal pain associated with IBS or functional dyspepsia, IB-Stim® offers a non-drug device option. The small, wearable device provides percutaneous electrical nerve field stimulation (PENFS) through branches of cranial nerves located in the ear. IB-Stim is FDA-cleared for patients ages 8 and up. Learn more about the technology and clinical evidence behind IB-Stim: https://ibstim.com/how-ib-stim-works For important IB-Stim information, including indications, precautions, IFU, and contraindications: https://ibstim.com/important-information
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The treatment history of patients enrolled in the PENFS clinical study is notable.
In a randomized, double-blind, sham-controlled study of adolescents with functional abdominal pain disorders, 70% of participants had failed to improve after trialing an average of four medications prior to treatment.¹
IB-Stim® is an FDA-cleared device for patients ages 8 and up with functional abdominal pain associated with irritable bowel syndrome (IBS) or functional dyspepsia(FD).
Review the clinical evidence behind IB-Stim:
ibstim.com/how-ib-stim-works
¹ Kovacic K, et al. Lancet Gastroenterol Hepatol. 2017;2:727–737.
For important IB-Stim information, including indications, precautions, IFU, and contraindications:
ibstim.com/important-informa…
#ClinicalEvidence #PediatricGI #FunctionalAbdominalPain #IBStim
ALT The treatment history of patients enrolled in the PENFS clinical study is notable. In a randomized, double-blind, sham-controlled study of adolescents with functional abdominal pain disorders, 70% of participants had failed to improve after trialing an average of four medications prior to treatment.¹ IB-Stim® is an FDA-cleared device for patients ages 8 and up with functional abdominal pain associated with irritable bowel syndrome (IBS) or functional dyspepsia(FD). Review the clinical evidence behind IB-Stim: https://ibstim.com/how-ib-stim-works ¹ Kovacic K, et al. Lancet Gastroenterol Hepatol. 2017;2:727–737. For important IB-Stim information, including indications, precautions, IFU, and contraindications: https://ibstim.com/important-information
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Pain is more than a gut signal.
IB-Stim® uses percutaneous electrical nerve field stimulation (PENFS), delivered through branches of cranial nerves located in the ear. This stimulation targets brain areas that process pain and helps reduce functional abdominal pain associated with Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD).
IB-Stim is:
· FDA-cleared
· For patients 8 and older
· A drug-free method for treating functional abdominal pain associated with IBS and functional dyspepsia (FD)
· One device per week, worn 120 hours (5 days) per week, for 4 consecutive weeks
See the science behind IB-Stim:
ibstim.com/how-ib-stim-works
For important IB-Stim information, including indications, precautions, IFU, and contraindications:
ibstim.com/important-informa…
#PediatricGI #BrainGutAxis #FunctionalAbdominalPain #IBStim
ALT See the science behind IB-Stim: https://ibstim.com/how-ib-stim-works For important IB-Stim information, including indications, precautions, IFU, and contraindications: https://ibstim.com/important-information
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Pain intensity is just one part of a patient's overall symptom burden. Evaluating pain frequency, severity, and duration can provide a more comprehensive assessment of treatment response.
In a randomized, double-blind, sham-controlled clinical trial, adolescents treated with IB-Stim® experienced statistically significant improvements in Pain Frequency-Severity-Duration (PFSD) composite scores compared with sham treatment. The difference between treatment groups increased over the course of the study, with the greatest separation observed at Week 3.
IB-Stim is FDA-cleared for patients ages 8 years and older with functional abdominal pain associated with irritable bowel syndrome (IBS) or functional dyspepsia.
In patients with functional dyspepsia, IB-Stim has also been shown to reduce associated nausea symptoms.
Reference:
Kovacic K, et al. Lancet Gastroenterology & Hepatology. 2017; 2:727-737. pubmed.ncbi.nlm.nih.gov/2882…
Learn more: ibstim.com/how-ib-stim-works
For important IB-Stim information, including indications, precautions, IFU, and contraindications, visit:ibstim.com/important-informa…
#ClinicalResearch #FunctionalAbdominalPain #FunctionalDyspepsia #Gastroenterologist #GutBrainConnection #EvidenceBasedMedicine #DGBI #PENFS
ALT Learn more: https://ibstim.com/how-ib-stim-works For important IB-Stim information, including indications, precautions, IFU, and contraindications, visit:https://ibstim.com/important-information
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For pediatric GI practices, IB-Stim® may be relevant when patients have tried multiple approaches and functional abdominal pain remains difficult to manage.
As a non-drug device, IB-Stim may offer another option to consider within an individualized treatment plan for appropriate patients.
IB-Stim is FDA-cleared for patients ages 8 and up with functional abdominal pain associated with IBS and functional dyspepsia, used in conjunction with other therapies.
Learn more: ibstim.com/how-ib-stim-works
For important IB-Stim information, including indications, precautions, IFU, and contraindications, visit: ibstim.com/important-informa…
#PediatricGI #FunctionalAbdominalPain #IBStim
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For pediatric GI clinicians managing functional abdominal pain associated with IBS or functional dyspepsia, neuromodulation may offer a non-drug option to consider for appropriate patients.
IB-Stim® delivers percutaneous electrical nerve field stimulation (PENFS). Preclinical research has demonstrated that PENFS can modulate activity in central pain-processing regions, including the amygdala.¹
IB-Stim is FDA-cleared for patients ages 8 and up with functional abdominal pain associated with IBS and functional dyspepsia, used in conjunction with other therapies.
Learn more: ibstim.com/how-ib-stim-works
For important IB-Stim information, including indications, precautions, IFU, and contraindications, visit: ibstim.com/important-informa…
Reference
Babygirija R, et al. Neuroscience. 2017;356:11-21.
#BrainGutAxis #PediatricGI #Neuromodulation
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For pediatric GI teams considering non-drug options, IB-Stim® provides an FDA-cleared device option for appropriate patients.
IB-Stim is FDA-cleared for patients ages 8 and up with functional abdominal pain associated with IBS and functional dyspepsia, used in conjunction with other therapies. In patients with functional dyspepsia, IB-Stim has also been shown to reduce associated nausea symptoms.
Learn more: ibstim.com/how-ib-stim-works
For important IB-Stim information, including indications, precautions, IFU, and contraindications, visit: ibstim.com/important-informa…
#IBStim #FunctionalAbdominalPain #PediatricGI
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