Mic ll
4 years ago
Update on NEW in coming Chapter 11 candidates:
Nexeon Medsystems Inc (NXNN) and VGTel, Inc. (VGTL) are headed into Chapter 11 to shed debt and restructure. Follow our page Chapter 11 Updates for details
TGRR, BLUU, and FTWS are entering into the final stage of the Chapter 11 process. Companies are planning to file the Plan and Disclosure Statement. This document will consist of all company's disclosures, facts, backgrounds, plans, etc. All aforementioned information will be disclosed to all shareholders and the market
esloane
7 years ago
Täglich Brothers Initiating Coverage with Speculative Buy rating and 12-month price target of $3.00 per share.
Nexeon Medsystems has substantial growth potential with its Neurostimulation SystemTM that is targeting the Deep Brain Stimulation (DBS) market. Consulting firm Crystal Market Research projects the global DBS market to reach $3.2 billion by 2025 from approximately $720 million in 2016, due primarily to an increasing number of people diagnosed with Parkinson’s disease and increased awareness about neurological disorders.
One of the primary advantages Nexeon’s Neurostimulation System should have is the ability to record how a body reacts to neurostimulation, providing doctors data on how a patient responds to the therapy being provided. The company anticipates European approval no earlier than 3Q18 with US trials beginning in 2019.
In September 2017, NXNN through a series of transactions acquired Medi-Line a Belgian-based, global provider of medical device solutions. Medi-Line had revenue of $7.2 million in the 12-month period ended March 31, 2017.
We anticipate the company has approximately $5 million in non-dilutive funding available primarily through European subsidies and grants, which should be sufficient to fund operations through 2018.
For 2017, we project a net loss of $3.5 million or ($0.14) per share on sales of $2.8 million. Our sales forecast reflects four months of Medi-Line revenue, as well as revenue from neurostimulation research units sold to Galvani Bioelectronics in 3Q17.
For 2018, we project a net loss of $3.5 million or ($0.13) per share on sales of $7.4 million. Our sales forecast reflects the operations of Medi-Line and sales of neurostimulation research units. We anticipate gross margin of 40% and operating expense margin of 83.8%. We are excluding potential sales from the Nexeon Neurostimulation System until European approval is received, which could occur as early as 3Q18.
http://www.taglichbrothers.com/equityuniverse/nexeon_medsystems.php
esloane
7 years ago
Nexeon Keeps Developments Flowing with New Clinical Study Treating Atrial Fibrillation
Source: https://www.baystreet.ca/stockstowatch/2405/Nexeon-MedSystems-Keeps-Developments-Flowing-with-New-Clinical-Study-Treating-Atrial-Fibrillation
Normally an acquisition and commencing a clinical trial are productive events for a small company, especially those in the hot "medtech" sector, but that hasn't been the case for Nexeon MedSystems Inc. (OTCQB:NXNN). The Belgium-based bioelectronics medical device company with an emphasis on neurological diseases has seen shares slide since they began trading less than a month ago from $2.00 each to under $1.00.
On August 9, Nexeon announced getting its ticker symbol from FINRA, eventually beginning trading on the OTCQB Marketplace on September 28. Concurrent with the listing, the company said it raised $1.165 million to further build out its pipeline. The company has had no shortcoming of high profile investors previously, including the likes of Boston Scientific (NYSE:BCX), Abbott Ventures and Surmodics to name a few. Nexeon further disclosed that they have applied to move to the OTCQX Marketplace, the top tier of OTC Markets with listing requirements similar to NASDAQ's Capital Market and NYSE American requirements.
About two weeks before it began trading as a public entity, Nexeon said it acquired Nexeon MedSystems Belgium, SPRL, a developer of neurostimulation products that recently acquired Medi-Line, a profitable, 25-year old Belgian medical device maker with 34 medical devices in its product bag being sold across 16 countries. Customers of Medi-Line include Fortune 500 companies, according to Nexeon.
Furthermore, Nexeon said it has been awarded a two-year, Phase II Small Business Research Innovation (SBIR) grant from the National Heart, Lung and Blood Institute, part of the National Institutes of Health that will fund up to $600,000 in preclinical research for developing nanocomposite drug-eluting balloon technology and other intellectual property related to precision medicine. This is on top of a 3.4 million euro award previously from the Walloon Region government of Belgium.
Wednesday afternoon, Nexeon announced completing an initial series of clinical studies evaluating the utilization of transcutaneous auricular vagus nerve stimulation (aVNS) for the relief of paroxysmal atrial fibrillation, the the most common heart arrhythmia that typically last for more than 30 seconds. It's not uncommon for people to progress from paroxysmal aFib to chronic aFib. Now Nexeon is moving forward with a 20-patient clinical study evaluating aVNS as a therapy for the uncomfortable heart condition.
While making it clear that the short-term goal is improved alternatives for aFib patients aside from today's current options of medication, pacemakers, ablations and cardioversions, Nexeon CEO Dr. Navid Khodaparast said that he recognizes the greater opportunities of monitoring and potentially modulating patients suffering from chronic diseases and managing multiple co-morbidities, opportunities that can present themselves through successful initial trials such as the upcoming study.
The news release from NXNN came late in the day and may have played a role in shares rising from 80 cents to 90 cents in the last hour of trading, although shares were still of 10 percent for the trading session.
ALERTS100%to10000%GAIN
7 years ago
NXNN~~Nexeon Receives Research Grant from National Institutes of Health
6:09 am ET August 9, 2017 (PR Newswire) Print
Nexeon MedSystems (OTCQB:NXNN) today announced that it has been awarded a two-year, Phase II Small Business Research Innovation (SBIR) grant from the National Heart, Lung and Blood Institute (NHLBI), part of the National Institutes of Health (NIH). The Company recently completed the Phase I FastTrack research plan associated with this proprietary system. The Phase II grant was awarded due to successful completion of corresponding Phase I milestones, and it will fund up to $600,000 of critical preclinical research and process development activities, including the completion of a pre-IDE meeting with the U.S. Food and Drug Administration.
https://mma.prnewswire.com/media/543523/Nexeon_MedSystems_Pulsus_Technology.jpg
The SBIR program is a highly competitive, awards-based program that encourages businesses to develop innovative solutions to existing problems and then incentivizes them to commercialize those solutions to achieve profitability. By stimulating high-tech innovation, the government-backed program has created an environment that allows companies of any size to compete based on the value of their ideas, and more importantly, the potential impact these ideas have on improving patient outcomes.
Nexeon was originally founded in 2005 by Mark C. Bates, MD, DSci (Hon), a thought-leader in interventional cardiology and a medical device inventor with more than 50 issued and pending patents. Dr. Bates formed the Company with the goal of changing how innovative ideas in the medical device industry move from concept to reality. Pulsus Medical, LLC has since been formed as a spinout from Nexeon to focus on the ongoing development and commercialization of its proprietary balloon, catheter, and filter technologies used in precision medicine systems.
Specific to this Phase II grant, the technology in development is a nanocomposite-based polymer balloon with microperforations that enables precise, pulse delivery of therapeutic drugs directly at the site of an intravascular lesion. Unlike present-day solutions, which are limited to certain drugs and utilize passive delivery only, this approach is hypothesized to enable more efficient drug delivery directly to the diseased site, reducing the potential for systemic toxicity from downstream drug loss.
Nexeon CEO Will Rosellini explained that early last year, he and Dr. Bates combined teams, IP, clinical programs, shareholders, among other things, because of a shared vision that could be enhanced via shared infrastructure. Their vision, as explained by the CEO, is the automation of closed-loop medical device-based systems that will support healthcare providers in the swift delivery of personalized chronic disease therapy with minimized side effects regardless of where patients are in the world.
"While our management and engineering teams have been focused on executing our commercialization plan for our deep brain stimulation system," said Rosellini, "Dr. Bates and the scientists in our internal R&D program have made great strides in the development of our other proprietary products. This technology has outperformed our expectations. So the spinout allows this now-valuable asset to get the time and attention it needs from a devoted team to reach its next inflection point."
Separate from the internal R&D team, Nexeon's engineers are finalizing the latest firmware and software upgrades for its deep brain stimulation system prior to submission for regulatory approval. The implantable-device-based system is used in the treatment of symptoms associated with Parkinson's disease and will be eligible for reimbursement under existing EU and US codes. The Company has previously detailed its strategy to achieve initial revenues from the 2018 European commercial launch of this product with a US PMA trial working in parallel.
About Nexeon MedSystems Inc. -- Nexeon MedSystems Inc. is a global medical device company focused on providing innovative neurostimulation products that improve the quality-of-life of patients suffering from debilitating neurological diseases. Nexeon has developed and commercialized a neurostimulation system that can be utilized to treat a variety of neurological diseases.
Forward-Looking and Cautionary Statements: Statements in this press release that are not strictly historical may be "forward-looking" statements, which involve risks and uncertainties, and Nexeon undertakes no obligation to update any such statements to reflect later developments. These risks and uncertainties include Nexeon's ability to successfully complete on the terms and conditions contemplated, and the financial impact of, its strategic portfolio repositioning actions, as well as economic and currency conditions, market demand, pricing, protection of intellectual property, and competitive and technological factors, among others, as set forth in Nexeon's subsequent reports filed with the SEC.
View original content with multimedia:http://www.prnewswire.com/news-releases/nexeon-receives-research-grant-from-national-institutes-of-health-300501854.html
SOURCE Nexeon MedSystems Inc.
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ALERTS100%to10000%GAIN
7 years ago
NXNN~~Nexeon MedSystems "OTCQB:NXNN" Acquires Belgian Manufacturer
8:46 pm ET September 6, 2017 (PR Newswire) Print
Nexeon MedSystems ("Nexeon" or "the Company") (OTCQB: NXNN) announced today that it has exercised its option to acquire Nexeon Medsystems Belgium, SPRL ("NMB"). This Belgian-based company has been operating since 2013 developing neurostimulation products. NMB recently acquired Medi-Line, a Belgian medical device manufacturer with financing support provided by KBC and CBC Bank. Medi-Line has expertise in active and non-active implants, and it has been profitable for its complete 25-year corporate history. For more information about the transaction, please review the Form 8-K.
http://mma.prnewswire.com/media/552725/Nexeon_MedSystems_Belgian_Manufacturer_Acquisition.jpg
"We have focused our careers on building a company with a reputation for consistent and high quality delivery, a community-based team of talented employees, and well-executed long-term international contracts," said Medi-Line founder Henri DeCloux. "We've been working with Nexeon and other neurostimulation companies on various components of their devices for a number of years now."
Medi-Line currently serves 34 medical device customers in 16 countries including multi-year contracts with Fortune 500 companies. The Belgian manufacturer owns state-of-the-art facilities, which features two validated clean rooms (one assembly cleanroom Class ISO 7 or C and one extrusion/injection molding cleanroom Class ISO 8 or D) and 600m2 of production space.
"Upon closing, we have no intentions of changing the business," said Nexeon Chairman and CEO Will Rosellini. "But rather, our focus will be on utilizing Mediline's expertise to expedite our neurostimulation product launches and support our growing business providing platform technology to other neurostimulation companies such as Galvani Bioscience and collaborators via the NIH SPARC program. This is the fourth investment we have made in Belgium, which is considered a hotbed of innovation in neurostimulation."
Most recently, NMB and Mediline have received a subsidy from the Region Walloone and BioWin, which continues a long history of Rosellini's investment in the Walloone Region. The Company's CEO explained that the additional capacity and expertise provided by Medi-Line will de-risk its first product launch and dramatically shorten the time to market for a second product line.
The Company is in final stages of product development prior to European regulatory approval submission for its deep brain neurostimulation system for the treatment of symptoms associated with Parkinson's disease. The Company has previously identified a 2018 European commercial launch of this product with a US PMA trial enrolling in parallel.
About Nexeon MedSystems Inc: Nexeon Medsystems, Inc. is a global medical device company focused on providing innovative neurostimulation products that improve the quality-of-life of patients suffering from debilitating neurological diseases. Nexeon has developed and commercialized a neurostimulation system that can be utilized to treat a variety of neurological diseases.
View original content:http://www.prnewswire.com/news-releases/nexeon-medsystems-otcqbnxnn-acquires-belgian-manufacturer-300515246.html
SOURCE Nexeon MedSystems
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ALERTS100%to10000%GAIN
7 years ago
NXNN~~Nexeon MedSystems Begins Trading as NXNN
2:25 pm ET September 28, 2017 (PR Newswire) Print
Nexeon MedSystems, Inc. (OTC:QB NXNN) announced today that it has commenced "regular way" trading on the OTC Market (OTC:QB) under the symbol "NXNN". The Company is finalizing development of its deep brain stimulation system for the treatment of symptoms associated with Parkinson's disease.
https://mma.prnewswire.com/media/564077/Nexeon_MedSystems_Brain_Computer_Interface.jpg
"I'm proud of our management team for implementing and delivering on innovative financing strategies in much the same fashion as our engineers do," said Nexeon CEO Will Rosellini. "Our next step is to uplist to a major exchange, we hope to accomplish this as soon as possible."
In June 2017, the Securities and Exchange Committee (SEC) declared effective the Company's S-1 Registration Statement. The S-1 registered 5,332,496 shares of the Company's common stock. Nexeon has previously reported it has just over 26M issued and outstanding shares.
Trading has commenced after recent announcements that include acquisition of profitable Belgian manufacturer, published analyst research pointing to $2.40 target price, and awarded research funds from the National Institutes of Health.
The Company is finalizing development of its deep brain stimulation system for the treatment of symptoms associated with Parkinson's disease. A former generation of the technology received a CE Mark, but Nexeon has since improved and added features to the system based on inputs from key opinion leaders in preparation for a commercial launch in Europe in 2018.
About Nexeon MedSystems Inc: Nexeon Medsystems, Inc. is a global medical device company focused on providing innovative neurostimulation products that improve the quality-of-life of patients suffering from debilitating neurological diseases. Nexeon has developed and commercialized a neurostimulation system that can be utilized to treat a variety of neurological diseases.
Forward-Looking and Cautionary Statements: Statements in this press release that are not strictly historical may be "forward-looking" statements, which involve risks and uncertainties, and Nexeon undertakes no obligation to update any such statements to reflect later developments. These risks and uncertainties include Nexeon's ability to successfully complete on the terms and conditions contemplated, and the financial impact of, its strategic portfolio repositioning actions, as well as economic and currency conditions, market demand, pricing, protection of intellectual property, and competitive and technological factors, among others, as set forth in Nexeon's subsequent reports filed with the SEC.
View original content with multimedia:http://www.prnewswire.com/news-releases/nexeon-medsystems-begins-trading-as-nxnn-300527790.html
SOURCE Nexeon Medsystems, Inc.
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Big Brother
7 years ago
I wish they would have started it out around $1.50 and not did the whole 'slow' IPO deal.
Would have rather they just have brought it up normally, start it @ around $1.50 and bring it up in small increments, offering a handful of shares at each level up, rather than just slapping a ton on @ $2.00, IMO got to appeal to both traders and investors as a penny stock.
However, I guess they are trying to avoid the stock running up fast, then crashing(ie see BRTI), like many new issue tickers do and I can understand that as well.
Big Brother
7 years ago
I'm kind of surprised it isn't getting more action than it is. I spent an hour or so looking into it this weekend and IMO this is a pretty promising company, with a boatload of patents, and working with the British pharma giant, GlaxoSmithKline.
http://www.fiercebiotech.com/medical-devices/gsk-partners-belgian-neurostim-startup-bioelectronic-medicine-research
Now I'm still not entirely clear on the exact relationship between Nexeon and Nuviant, it's confusing, they are very closly interconnected, but it appears as though they have acquired their working relationship with GSK and their patents/products, including Synapse, which really looks like it has a lot of potential.
http://www.zenso.be/medical-solutions/1/nuviant-medical/
https://medcitynews.com/2016/09/nexeon-medsystems-take-likes-medtronic-readies-go-public/
Nexeon also benefits from having probably the most highly educated CEO, I've personally ever seen in a penny stock company officer, 5 Masters degrees and a Juris Doctor degree (J.D.) in Law.....crazy.
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stocktrademan
6 years ago
shanak10
6 years ago
TenKay
6 years ago
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