Breaking News Just Hit The Wire on NRXS
Stock Could Continue Its Surge?
My latest premium alert (NRXS) surged in volume yesterday and closed at the high of the day.
Today they just dropped bombshell news that could give the stock another big JOLT!
NeurAxis Announces Publication of Prospective Study Showing IB-Stim™ Improves Quality of Life of Adolescents with IBS
CARMEL, Ind., Sept. 12, 2023 (GLOBE NEWSWIRE) -- NeurAxis, Inc. ("NeurAxis," or the "Company") (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today announced the publication of Prospective study of the effect of auricular percutaneous electrical nerve field stimulation on quality of life in children with pain related disorders of gut-brain interaction, a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of IB-Stim™ in children with post-concussion symptoms, featured in the September 2023 Frontiers in Pain Research.
The publication, led by investigators from Children's Hospital of Orange County, investigated changes in gastrointestinal symptoms and quality of life in 31 adolescent patients aged 11 – 18 years with functional abdominal pain disorders (FAPDs) before and after treatment with IB-Stim. The patients were treated for 4 weeks and data were collected prospectively from both the patient and the parents using validated questionnaires. Following IB-Stim™ treatment, the study noted that:
patients reported significant reductions in abdominal pain, nausea, disability, and anxiety from baseline to week 4 (p < 0.05); parent assessments reported significant improvement in the child's quality of life based on physical function, psychosocial function, and generic core scale scores (p < 0.05); and
parents also reported reduced abdominal pain, functional disability, and somatization in their child. The global health scores also significantly improved based on both patient and parent reports (p < 0.05).
Dr. Adrian Miranda, Chief Medical Officer of NeurAxis said, "We are pleased that outcomes post IB-Stim treatment continue to be replicated at centers of excellence across the country. Further, this study is unique in that it not only found improvements in gastrointestinal symptoms, but also in the child's quality of life based on the parent's report." Dr. Miranda added, "The ability to improve a child's quality of life is something that NeurAxis is extremely proud of and we will continue to work tirelessly towards our goal to ensure that every child has access to necessary treatment."
Potential Gain of 250%+ According To Research Report
NeurAxis, Inc. (NYSE: NRXS), is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway.
NeurAxis, Inc. (NYSE: NRXS) Announces Over
$8 Million in IB-Stim™ Revenue
CARMEL, Ind., Aug. 17, 2023 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (NYSE American: NRXS) ("NeurAxis" or the "Company"), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today announced it has generated over $8 million in revenue following the commercial launch of its proprietary IB-Stim™ technology. Sales began after NeurAxis received FDA clearance for IB-Stim™ in the pediatric treatment of functional abdominal pain and irritable bowel syndrome. NeurAxis is conducting clinical trials with IB-Stim™ for four additional pediatric indications, including chronic nausea, post-concussion syndrome, chemotherapy induced nausea and vomiting, and cyclic vomiting syndrome.
Approximately $2 Million of the over $8 Million in IB-Stim™ Revenue
Through March 31, 2023 was generated in 2020 and 2019.
Brian Carrico, Chief Executive Officer of NeurAxis, said, "We are pleased to have reached over $8Mln in sales of our proprietary IB-Stim™ technology and look forward building upon our momentum with the funds received from our recently completed IPO. We continue to drive increasing adoption of our IB-Stim™ therapy, supported by a significant and growing body of positive clinical data and commercial large health insu∙rance company payor support. We believe the growing movement of patients gravitating towards non drug related therapies, especially for children, will continue to fuel our rapidly increasing adoption and the market for our new indications."
NRXS Has "6" Key Potential Breakout Catalysts
That Provide A Very Bullish Outlook:
Innovative medtech provider NeurAxis, Inc. went public in a successful IPO on August 9, 2023, and it appears that substantial upside exists Future, exponential top-line growth appears to be driven by a series of new insu∙rance companies payer coverages, which exponentially increases the market oppor∙tunity with each new ins∙urer.
The Company's flagship product, is the first FDA cleared therapy for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. With a first mover advantage, and highly efficacious evidence-based results in studies, broad adoption appears set to occur.
The TAM for the current indication and a series of other pediatric indications in the pipeline represents $9Bln. NRXS also boasts a proprietary technology platform, Percutaneous Electrical Nerve Field Stimulation (PENFS), along with 8 patents and 18 pending.
Analyst Report forecasts' that NRXS revenue could jump from $5M in 2023 to $22Mln in 2025. With an enviable 88% gross margin, meaningful operating margin and positive EPS should be recorded beginning in 2024, WestPark Capital Initiated Coverage of NeurAxis (NASDAQ: NRXS) issuing a $7.50 price target with B∙uy Recommendation.
Goldman Research Initiated 6-12-month price target is $14, more than double the IPO price. This target is based on a price/sales multiple on our 2024 sales forecast of $12.7Mln.
Important Details You Must Know Regarding
NeurAxis, Inc. (NYSE: NRXS)
On August 9, 2023, Carmel, Indiana-based NeurAxis, Inc. (NYSE American: NRXS) went public at $6Mln and had a solid first day of trading. Looking ahead, we believe NRXS is poised to revolutionize treatment strategies for children and adults who suffer from chronic and debilitating conditions.
The Company boasts a first-mover advantage, strong IP, deep evidence-based studies of hundreds of published patients, a total addressable market of $30Bln, and an FDA-cleared product that serves a major need in a badly underserved market.
Plus, its flagship product carries an 88% gross margin and insu∙rance payer coverage by ins∙urers across the US is growing rapidly---representing a series of major catalysts to drive the shares in the coming months. Against this backdrop, Goldman Research projects substantial revenue growth, with operating pr∙ofit set to occur, beginning in 2024, and a higher valuation ahead.
The Product, The Tech, The Market, The Pipeline
The Company's First FDA-cleared product, IB-Stim™, is based on Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, which was developed internally by the Company. IB-Stim™ is intended for patients 11-18 years of age with functional abdominal pain (FAP) associated with Irritable Bowel Syndrome (IBS). IB-Stim™ aids in pain reduction via neuromodulation to branches of Cranial Nerves to improve the quality of life of pediatric patients. Unlike drug and surgical device therapies, IB-Stim™ is non-drug, non-surgical that can be placed in patients in an outpatient clinic.
The device is worn for 120 hours per week for up to 3-4 consecutive weeks, with device replacement each week until the end of the therapy. The current targeted pediatric market is estimated to represent $1Bln and lacks FDA-approved treatment options, with many drugs used off-label and leveraging 8 patents and 18 pending, NRXS is focused on additional pediatric indications using its core PENFS technology.
These include chronic nausea, post-concussion, and chemotherapy-induced nausea and vomiting, which combined represent a $9Bln TAM. Following the planned deployment in the pediatric market, NRXS plans to enter the adult market for FAP IBS and similar indications to the ones noted above.
Looking ahead, the Company is set to publish updated data in a paper for peers, will establish a lab ahead of launching its offering, and commence full commercialization, with reimbursement coverage in 2025. It should be noted that management is also in the early stage of testing for other indications, including early-stage lung cancer and localized prostate cancer.
Financial Forecasts and Valuation NeurAxis, Inc. (NYSE: NRXS)
Read More Regarding The Goldman Research Report Below
For the full year 2023, they currently forecast sales of $5Mln, a nearly 100% year-over-year inc∙rease. Sa∙les are projected to be driven by recent and new insu∙rance payer coverage for the IB-Stim™ therapy. Our model assumes an operating and net loss of ($3.7Mln) and ($5.4Mln), respectively. In 2024, we project $12.7Mln in sales (IB-Stim™) and operating pr∙ofit of $826K, for a healthy 6.5% margin. EPS of $0.14 for the year is currently forecasted but this figure could be modified slightly as we get a better handle on non-opex expenses.
At this time, they have elected to introduce preliminary projections for 2025, which could also include first meaningful sales of the Company's chronic nausea product currently in R&D. Their 2025 sales estimate is $22Mln, with a strong operating margin of 26.5% and net income of $4.2Mln, or $0.61.
Goldman Research Report states the 6-12-month price target of $14 reflects a 6.7x price/sales multiple on our forecasted 2024 sales forecast of $12.7Mln. On the surface, Goldman states this P/S ratio may appear a bit aggressive. Conversely, he believes it is quite reasonable, given inherent competitive advantages including first mover positioning, exponential sales growth led by a likely exponential market growth oppor∙tunity via new insu∙rance plan reimbursement.
The Company's approach is a quality-of-life improvement that could lead IB-Stim™ to emerge as a first line therapy or standard of care. Finally, with software-like gross margins, meaningful pr∙ofit is around the corner. Goldman Research Report states "Thus, our $14 target is within reach in the coming months, in our view."
Game-Changing Medtech Disruptor
NeurAxis, Inc. (NYSE: NRXS)
As the First FDA-cleared treatment for pediatric FAP/IBS, Goldman believes' that NRXS is sitting in the catbird seat due to the FDA process itself. The IB-Stim™ was an FDA De Novo clearance and the stated classification was actually the Company's PENFS technology---a major credibility enhancer for pediatric gastroenterologists and pediatricians alike.
The novel treatment targets the brain and with more than 300 published patients using the device, it clearly has extended, longer term, efficacious advantages over other well known neuromodulation techniques such as TENS (Transcutaneous electrical nerve stimulation). TENS technologies are not highly regarded due to a lack of clinical evidence although they appear to offer an incrementally and temporarily favorable effect for patients with pain. In Goldman's view, PENFS is light years ahead of other neuromodulation approaches since its method sends gentle electrical impulses into cranial nerves thereby stimulating the brain areas involved in processing pain. Many competing approaches seek to only provide temporary relief at the pain site.
IB-Stim™ is intended for patients 11-18 years of age with functional abdominal pain (FAP) associated with Irritable Bowel Syndrome (IBS) and is the first FDA cleared product for this indication. Unlike drug and surgical device therapies, IB-Stim™ is non-drug, non-surgical therapy that can be placed in patients in an outpatient clinic. While the device is placed in patients by a trained technician, unlike an invasive procedure whereby the patient may be placed under anesthesia, this device is attached using microneedles.
The device is worn for 120 hours per week for up to 3-4 consecutive weeks, with device replacement each week until the end of the therapy. The patient has no restrictions while wearing it---he/she can engage in sports, bathe, etc. In addition to its efficacy, the side effect profile of competing therapies to IB-Stim™ are a bit concerning.
NeurAxis (NYSE: NRXS) IB-Stim Research By The Numbers
The Company has 4 ins∙urer plans with a total of 4.75Mln lives covering the product and firms totaling an additional 10Mln currently in the review phase. With every new ins∙urer coming on board with a CPT billing code, it should have a meaningfully favorable potential impact on the stock, especially if the carrier is of size.
Meanwhile, the Company's direct sales force is in contact with the 260 children's hospitals in the US, which represent low-hanging fruit considering most of the decisions and device placement are made by physicians in these facilities. In addition, the Company seeks to reach out to the 33,000 pediatricians as a number of them may not be familiar with the Company's flagship, or its deep, evidence-based research.
NeurAxis (NYSE: NRXS) Looking Ahead Timeline Explosive Growth
Looking ahead, leveraging its 8 patents and 18 pending, NRXS is focused on additional pediatric indications using its core PENFS technology. These include chronic nausea, post-concussion, and chemotherapy-induced nausea and vomiting, which combined represent a $9Bln TAM.
Following the planned deployment in the pediatric market, NRXS plans to enter the adult market for FAP IBS and similar indications to the ones noted above. At this time, we believe a 510(k) submission for the chronic nausea indication could occur in 2024, with decisions on timing of the adult market to be determined.
Thus, NRXS focus is on the $9Bln pediatric market, for which no FDA cleared products exist and utilize the Company's PENFS technology, which should give investors confidence in additional approved products. Moreover, management's likely confidence in future indications comes from the fact that NRXS would be treating conditions affected by the exact same pathophysiology.
I'm urging you and all of my 10X community to keep a very close eye on NRXS this morning because of the recent news just released.
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