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ZMTP: Hitting 52-week highs with record sales and departure of the CEO....
“It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity, it was the season of light, it was the season of darkness, it was the spring of hope, it was the winter of despair.” ? Charles Dickens, A Tale of Two ZMTP Press Releases
Zoom Telephonics Reports Record Sales of $12 Million for Q1 2020; Up 49.3% From Prior Year Quarter
GlobeNewswire
•May 11, 2020
Boston, MA, May 11, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Zoom Telephonics, Inc. (“Zoom”) (ZMTP), a leading creator of cable modems and other Internet access products, reported financial results for its 2020 first quarter ended March 31, 2020.
First Quarter 2020 Financial Highlights
Net sales were $12 million, up 49% year over year
Gross profit was $3.1 million, up 28% year over year
Gross profit margin was 25.9%, down from 30.2% in prior year first quarter
GAAP net loss was $0.8 million, a 33% improvement year over year
Non-GAAP net income was $0.7 million after adjusting for tariff expenses of $1.5 million
First Quarter 2020 Business Overview
Overall, the company produced record sales of $12 million during the quarter, despite the significant economic disruptions resulting from the Covid-19 pandemic. This level of sales has not been seen in over a decade. Consumer demand for networking products was strong throughout the quarter, supported by substantial online shipping activity. Zoom was able to ensure continuity of supply through Covid-19 disruptions experienced in Asia as early as January 2020, and supply chain conditions can be characterized as “returning to normal” at present.
The company expects to have completed the shifting of its manufacturing operations to other locations by the end of the second quarter, with the tariff expense declining to near zero by early in the third quarter. After the quarter end, Zoom announced the extension and expansion of its Motorola license. In addition to the inclusion of new product families, the license agreement now runs through 2025.
Zoom’s 2020 plan centers on an aggressive new product rollout schedule that remains very much on track. The proliferation of video-based communication services, due in part to so many people working from home, is driving an increased emphasis on optimizing home networks. The company is experiencing strong demand for its already popular gateway products, which are available through online shopping and brick and mortar platforms such as Amazon and BestBuy.
As previously reported, the company has convened a search committee to identify a CEO following the resignation of Joe Wytanis.
First Quarter 2020 Financial Review
Zoom reported an increase in net sales of 49.3% to $12.0 million for the first quarter ended March 31, 2020 up from $8.0 million for the first quarter ended March 31, 2019. The increase in sales resulted from robust demand in its ecommerce and retail channels.
Gross profit was $3.1 million or 25.9% of net sales in the first quarter of 2020, compared to $2.4 million or 30.2% of net sales for the first quarter of 2019. Tariff expenses increased cost of goods by $1.5 million in the first quarter of 2020, compared to $445 thousand in the first quarter of 2019. Excluding tariff expense, gross profit margin in the first quarter of 2020 would have been 38.4%. The company also experienced one-time increased supply-chain fulfillment costs brought on by Covid-19 disruptions in order to assure the ability to satisfy customer demand.
Operating expenses were $3.8 million, compared to $3.5 million in the year-ago quarter. The increase versus the prior year was primarily due to increased General and Administrative expenses incurred in support of Zoom’s product rollout and growth strategy.
The company ended the quarter with $5.0 million of working capital and a current ratio of 1.83x. Zoom had drawn $387 thousand on a $3.0 million line of credit; with no long-term debt; and $5.7 million of stockholders’ equity.
Conference Call Details
The conference call for this quarter, which was previously scheduled for Tuesday, May 12, 2020 – 10:00 a.m. ET, has been cancelled. The company intends to issue its first quarter 2020 earnings in its Form 10-Q quarterly report, as planned on May 15, 2020.
.................................................................................................................
Zoom Telephonics Announces CEO Transition
GlobeNewswire
•May 11, 2020
Boston, MA, May 11, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Zoom Telephonics, Inc. (“Zoom”) (ZMTP), a leading creator of cable modems and other Internet access products, today announced that Joe Wytanis has stepped down from the position of CEO. To ensure a smooth transition, Wytanis will act as an advisor to the board. Zoom’s Board of Directors has formed a CEO search committee, led by Zoom Chairman Jeremy Hitchcock.
“I am extremely proud of the team’s accomplishments throughout my tenure,” said Wytanis. “As the demand for reliable home connectivity has never been higher, Zoom is on an exciting trajectory. We’ve seen outstanding growth in e-commerce and storefront retail, inspiring Zoom to focus its product development and marketing initiatives. Accordingly, we have decided Zoom needed leadership more specialized in those areas as I pursue career opportunities closer to my home location and in the cable MSO space. I look forward to my continued involvement.”
Joe Wytanis joined Zoom in 2018 as a veteran of the Cable Multi-Network Operator (MSO) industry, serving in executive roles at High Tech Associates, Flextronics, SMC Networks, and Cisco Systems.
“On behalf of the Board, I would like to thank Joe for his exceptional leadership,” said Hitchcock. “He has expertly leveraged the company’s strengths in manufacturing, supply chain management, and talent to unlock new growth opportunities, even in the face of Covid-19 challenges. We appreciate his participation in finding his successor and wish him much success in his future endeavors.”
This management announcement follows Zoom’s recent CFO appointment last quarter. In the past year, Zoom has bolstered the executive team for a new phase of expansion. Key hires include:
• Jacquelyn Barry Hamilton, now Zoom CFO, formerly served as CFO at Modo Labs, Netcracker Technology, Intronis, and the Global Technology Division at Monster Worldwide.
• Phil Stanhope, now Zoom CTO, formerly served as VP Technology Strategy, Dyn/Oracle and VP Engineering at Yottaa, Wimba, Aspen Technology, and Adesso Systems.
• John Lauten, now Zoom SVP Operations, formerly served in operational leadership roles at SKULLY Technologies, TechCXO, FOX Factory, and Cisco.
Later today, Zoom Telephonics will be releasing Q1 2020 financial results. The earnings call previously scheduled for May 12, 2020 will be cancelled. For more information, visit http://www.zoomtel.com
N8 plans to continue to seek emergency use authorizations in other countries.
HYDI: Hydromer Accelerates Its First Responder Sanitizer Production to Meet Growing Demand While Stepping Up Its Donation Program Supporting Local Emergency and First Response Organizations
GlobeNewswire
April 30, 2020, 3:38 pm
Concord, NC, April 30, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Hydromer, Inc.® (HYDI) or “the Company” announced today that it is accelerating production of sanitizers to meet the continued demand received by hospitals, nursing homes, state and local governmental organizations, as well as the increased demand anticipated by the re-opening of the U.S. economy.
Hydromer’s First Responder® “alcohol-based” sanitizer and hand rub products are manufactured in accordance with the US FDA & World Health Organization guidelines and are effective agents against COVID-19 as well as other germs. These products have received a very positive response in the market. Hydromer® has been working actively with regional and national healthcare organizations to supply its much needed First Responder™ line of products to hospitals and other health-related institutions throughout the region and across the USA. In preparation for the imminent re-opening of the U.S. economy, Hydromer® is well positioned to meet the growing demand for sanitizing products. This product line will be essential to all public and private establishments such as, retail, offices, restaurants, banks, casinos, and other businesses to comply with health and safety standards and guidelines imposed by the federal government.
“Simultaneously, Hydromer® has increased its hand sanitizer donation program by introducing the "First Responder Pledge", under which the company will continue to proudly donate a portion of the sales to organizations within its local community that continue to be in dire need of sanitizers,” said Peter M. von Dyck, Hydromer® CEO. Visit https://www.hydromer.com/our-pledge/ to learn more and to support the cause. Hydromer® is also actively working on expanding its First Responder™ line to include other delivery formats such as, gels and sprays as well as the First Responder Strong™ line of patented, non-alcohol, triclosan-free, plant-based sanitizers that powerful to kill bacteria and viruses while being gentle on skin.
About Hydromer® www.hydromer.com
As a globally trusted partner to companies of all sizes, Hydromer® has been offering specialty polymers and surface coating technologies, contract coating services, and custom-designed equipment for diverse applications since 1981. Hydromer’s leading-edge solutions amplify products within many industries, including medical devices, industrial plastics, biotechnology, aerospace and personal care. Hydromer® personifies innovation, driven by a team of exceptional Ph.D. chemists and innovators, offering outstanding R&D, customer service, and tech support. The company continually focuses on the future by developing innovative solutions comprised of more eco-friendly and sustainable approaches. Hydromer® is an FDA registered, ISO 13485:2016 and ISO 9001:2015 certified production facility.
Contact: info@hydromer.com | Phone: 800-326-5976
MED: Gary Grobbel was a great resource for culling all the interesting news on The Microcap Kitchen before the market opened every morning.
MED was one of my first multi-baggers that fit the definition of a value microcap. We were talking about it on the Raging Bull Value Microcap's thread, then Gary sent me a PM inviting me to join the SI Microcap Kitchen, which was a turning point that greatly improved my fortunes in investing. I still post there periodically to try to keep the thread going, particularly when its an idea I got from there, that finally seems to be finding its market, like HYDI lately.
I also still give to the Capuchin Soup Kitchen in Detroit in Gary's memory, his drive for charity when everyone was thanking him for their successes, really distinguished him as a good guy in this game. I used to thing "ggg" could stand for Greed for Greater Good. The investment world could use more people like him out there to keep peoples priorities aligned.
Health Canada expands emergency use of the CeraShield™ Endotracheal Tube to all hospitals in Canada
NEWS PROVIDED BY
N8 Medical, LLC
Apr 23, 2020, 13:47 ET
May help prevent deadly ventilator-associated bacterial infections and complications in COVID-19 patients
DUBLIN, Ohio, April 23, 2020 /PRNewswire/ -- N8 Medical, LLC (N8) today announced that Health Canada has granted emergency use access marketing approval of the company's CeraShield™ Endotracheal Tube for all Canadian mechanically-ventilated COVID-19 patients. FDA has previously designated the CeraShield ETT as a "breakthrough" device. N8 plans to continue to seek emergency use authorizations in other countries.
N8's CeraShield™ tube has a patented anti-fouling coating designed to prevent deadly bacterial infections that frequently occur in ventilated patients. Conventional endotracheal tubes allow pathogenic bacteria to rapidly grow on the tube surfaces and are a source of infection that may lead to acute kidney injury, sepsis and death.
"There is growing concern over the reported high death rates among mechanically ventilated COVID-19 patients. Death rates as high as 50% in China and 80% in New York have been reported. Patients infected with the COVID-19 virus who require mechanical ventilation are highly susceptible to exposure to bacterial pathogens and ventilation complications. The coating on the CeraShield tube prevents the formation of biofilms that routinely foul the plastic surfaces of unprotected conventional endotracheal tubes and lead to bacteria growth," said Carl Genberg, N8's Chief Scientific Officer.
"N8's CeraShield™ Endotracheal Tube may reduce secondary bacterial infections, save lives and expand ventilator resource capacity by getting patients off ventilators sooner," said Ronald Bracken, N8's President and Chief Operating Officer. "We are pleased that Health Canada is now allowing all hospitals to have access to this potentially life-saving technology."
If you are a Canadian clinician or facility desiring to access CeraShield™ Endotracheal Tubes, please contact the company promptly at covid@n8medical.com as supplies are currently limited.
N8 has partnered with Hydromer Inc. (www.hydromer.com) and its wholly owned subsidiary and med-tech division, Biosearch Medical Products, Inc., in connection with material supply and production of the CeraShield™ Endotracheal Tubes for this important effort.
ABOUT N8 MEDICAL
N8 Medical, LLC (www.N8Medical.com), headquartered in Dublin, Ohio, is a rapidly-growing, privately-held clinical stage biotechnology company developing a platform of anti-fouling medical devices designed to have significant, life-saving clinical impact through reduction of infection, related complications and mortality. Key publications are available at www.N8Medical.com.
CAUTION: In United States, the CeraShield™ Endotracheal Tube is investigational and has not been granted marketing approval. These statements have not been evaluated by Health Canada or FDA.
SOURCE N8 Medical, LLC
Related Links
http://www.n8medical.com
HYDI: Hydromer's partner's news release was more detailed, the timing for this news to break on Friday afternoon was not ideal for investors, but Health Canada granting countrywide Emergency Use Authorization (EUA) just three weeks after granting the EUA to only the pricipal investigator for their clinical trial, seems quite possitive....hopefully its making a possitive impact for those who need it.
https://news.yahoo.com/amphtml/health-canada-expands-emergency-cerashield-174700979.html
Health Canada expands emergency use of the CeraShield™ Endotracheal Tube to all hospitals in Canada
PR Newswire
April 23, 2020, 1:47 pm
May help prevent deadly ventilator-associated bacterial infections and complications in COVID-19 patients
DUBLIN, Ohio, April 23, 2020 /PRNewswire/ -- N8 Medical, LLC (N8) today announced that Health Canada has granted emergency use access marketing approval of the company's CeraShield™ Endotracheal Tube for all Canadian mechanically-ventilated COVID-19 patients. FDA has previously designated the CeraShield ETT as a "breakthrough" device. N8 plans to continue to seek emergency use authorizations in other countries.
N8 Medical, LLC Logo (PRNewsfoto/N8 Medical, LLC)
N8 Medical, LLC Logo (PRNewsfoto/N8 Medical, LLC)
N8's CeraShield™ tube has a patented anti-fouling coating designed to prevent deadly bacterial infections that frequently occur in ventilated patients. Conventional endotracheal tubes allow pathogenic bacteria to rapidly grow on the tube surfaces and are a source of infection that may lead to acute kidney injury, sepsis and death.
"There is growing concern over the reported high death rates among mechanically ventilated COVID-19 patients. Death rates as high as 50% in China and 80% in New York have been reported. Patients infected with the COVID-19 virus who require mechanical ventilation are highly susceptible to exposure to bacterial pathogens and ventilation complications. The coating on the CeraShield tube prevents the formation of biofilms that routinely foul the plastic surfaces of unprotected conventional endotracheal tubes and lead to bacteria growth," said Carl Genberg, N8's Chief Scientific Officer.
"N8's CeraShield™ Endotracheal Tube may reduce secondary bacterial infections, save lives and expand ventilator resource capacity by getting patients off ventilators sooner," said Ronald Bracken, N8's President and Chief Operating Officer. "We are pleased that Health Canada is now allowing all hospitals to have access to this potentially life-saving technology."
If you are a Canadian clinician or facility desiring to access CeraShield™ Endotracheal Tubes, please contact the company promptly at covid@n8medical.com as supplies are currently limited.
N8 has partnered with Hydromer Inc. (www.hydromer.com) and its wholly owned subsidiary and med-tech division, Biosearch Medical Products, Inc., in connection with material supply and production of the CeraShield™ Endotracheal Tubes for this important effort.
ABOUT N8 MEDICAL
N8 Medical, LLC (www.N8Medical.com), headquartered in Dublin, Ohio, is a rapidly-growing, privately-held clinical stage biotechnology company developing a platform of anti-fouling medical devices designed to have significant, life-saving clinical impact through reduction of infection, related complications and mortality. Key publications are available at www.N8Medical.com.
CAUTION: In United States, the CeraShield™ Endotracheal Tube is investigational and has not been granted marketing approval. These statements have not been evaluated by Health Canada or FDA.
HYDI's partner for Emergency Use Approval for antimicrobial ET tubes: https://news.yahoo.com/amphtml/health-canada-expands-emergency-cerashield-174700979.html
Hydromer and N8 Medical Partner to Bring Life-Saving Coated ET Tubes for COVID-19 Patients
GlobeNewswire•April 24, 2020
CONCORD, NC, April 24, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – Hydromer (OTCQB: HYDI) announced today that it will be the exclusive coating supplier and manufacturing partner for N8 Medical’s CeraShield™ Endotracheal Tube. Health Canada has granted emergency use access marketing approval for the CeraShield™ Endotracheal Tube for all Canadian mechanically-ventilated COVID-19 patients.
N8's CeraShield™ tube has a patented anti-fouling coating to prevent deadly bacterial infections that frequently occur in ventilated patients. Conventional endotracheal tubes allow pathogenic bacteria to rapidly grow on the tube surfaces and are a source of infection that may lead to acute kidney injury, sepsis and death.
“N8’s CeraShield™ Endotracheal Tube may reduce secondary bacterial infections, save lives and expand ventilator resource capacity by getting patients off ventilators sooner,” said Ronald Bracken, N8’s President and Chief Operating Officer. “We are pleased that Health Canada is now allowing all hospitals to have access to this potentially life-saving technology.”
CAUTION: In the United States, the CeraShield™ Endotracheal Tube is investigational and has not been granted marketing approval. These statements have not been evaluated by Health Canada or FDA.
About Hydromer® www.hydromer.com
Hydromer® is a leading global surface modification and coatings solutions provider. As a trusted partner to companies worldwide, our solutions add value to our clients’ products so that they can stand out in the marketplace. We are an innovation-driven, customer-centered organization with a focus on meeting our clients’ needs. Hydromer is also manufacturing their own brand of hand sanitizer under the First Responder™ brand.
About N8 Medical www.n8medical.com
N8 Medical, LLC (N8 Medical) is a clinical-stage medical device company focused on commercializing medical devices that incorporate a novel class of active compounds called ceragenins.
If you have an interest in coating your devices or the CeraShield™ endotracheal tubes, please contact us right away!
Email us at info@hydromer.com Or call us at 800-326-5976.
Key point here is that Health Canada's Emergency Use authorization now extends across all of Canada, where as N8's April 2nd PR indicated "that Health Canada has granted Dr. John Muscedere of Kingston General Hospital's emergency request to begin using the N8 Medical CeraShield™ Endotracheal Tubes in mechanically-ventilated COVID-19 patients."
Hydromer and N8 Medical Partner to Bring Life-Saving Coated ET Tubes for COVID-19 Patients
GlobeNewswire
April 24, 2020
CONCORD, NC, April 24, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – Hydromer (OTCQB: HYDI) announced today that it will be the exclusive coating supplier and manufacturing partner for N8 Medical’s CeraShield™ Endotracheal Tube. Health Canada has granted emergency use access marketing approval for the CeraShield™ Endotracheal Tube for all Canadian mechanically-ventilated COVID-19 patients.
N8's CeraShield™ tube has a patented anti-fouling coating to prevent deadly bacterial infections that frequently occur in ventilated patients. Conventional endotracheal tubes allow pathogenic bacteria to rapidly grow on the tube surfaces and are a source of infection that may lead to acute kidney injury, sepsis and death.
“N8’s CeraShield™ Endotracheal Tube may reduce secondary bacterial infections, save lives and expand ventilator resource capacity by getting patients off ventilators sooner,” said Ronald Bracken, N8’s President and Chief Operating Officer. “We are pleased that Health Canada is now allowing all hospitals to have access to this potentially life-saving technology.”
CAUTION: In the United States, the CeraShield™ Endotracheal Tube is investigational and has not been granted marketing approval. These statements have not been evaluated by Health Canada or FDA.
About Hydromer® www.hydromer.com
Hydromer® is a leading global surface modification and coatings solutions provider. As a trusted partner to companies worldwide, our solutions add value to our clients’ products so that they can stand out in the marketplace. We are an innovation-driven, customer-centered organization with a focus on meeting our clients’ needs. Hydromer is also manufacturing their own brand of hand sanitizer under the First Responder™ brand.
About N8 Medical www.n8medical.com
N8 Medical, LLC (N8 Medical) is a clinical-stage medical device company focused on commercializing medical devices that incorporate a novel class of active compounds called ceragenins.
If you have an interest in coating your devices or the CeraShield™ endotracheal tubes, please contact us right away!
Email us at info@hydromer.com Or call us at 800-326-5976.
Positron has been dark to the market since recovering from bankruptcy. Dark companies can trade at significant discounts because there is no clarity of their financial position. This is the risk we are taking here, but it also offers potential significant upside.
The point of me positing that article was to show the demand for PET-only scanners, Positron's new PET only Atrius system sells for $400 - $600k depending what options are selected.
Reviewing industry information leads me to believe Positron is still a respected competitor in the cardiac PET business, possibly even a market leader who developed the most widely used cardiac PET software.
E-Trade hasn't converted my shares yet, so I called them to make sure the process was moving along. E-trade says they haven't received the shares from DTC yet, they expect to receive them today, so that they may be tradeable by tomorrow at latest.
As for my opinion, I like this reverse split. The company had too many shares out to expect to achieve a respectable share price. It makes sense to get this done before any other news is released, so the company can begin to build value from its smaller capital structure now. As a trading tools company, they need to have a respectable equity of their own, otherwise no one in the brokerages and institutions would take them seriously. I think this helps the company appear as more attractive partner for institutional investors interested in using their trading system.
This article explains the opportunity Positron has ahead it. Positron is the only one making those PET-only systems they say providers are looking for:
https://www.cardiovascularbusiness.com/topics/cardiovascular-imaging/making-case-cardiac-pet-buying-evaluate-clinical-business
HYDI partner news: Health Canada Grants Emergency Use Authorization for N8 Medical CeraShield™ Endotracheal Tubes in Mechanically Ventilated COVID-19 Patients
Evaluating potential for reduction of secondary bacterial infections and mechanical ventilation days to improve patient outcomes and optimize use of scarce ventilators
N8 Medical, LLC Logo (PRNewsfoto/N8 Medical, LLC)
NEWS PROVIDED BY
N8 Medical, LLC
Apr 02, 2020, 09:55 ET
DUBLIN, Ohio, April 2, 2020 /PRNewswire/ -- N8 Medical, LLC (N8 Medical) today announced that Health Canada has granted Dr. John Muscedere of Kingston General Hospital's emergency request to begin using the N8 Medical CeraShield™ Endotracheal Tubes in mechanically-ventilated COVID-19 patients.
N8 Medical's CeraShield™ Endotracheal Tube has a patented anti-fouling coating that is designed to prevent deadly bacterial infections that frequently occur in ventilated patients with respiratory viral infections. In contrast, conventional endotracheal tubes allow pathogenic bacteria to grow on the tube surfaces within hours and form slime-like aggregations of millions of pathogenic cells as a biofilm. In the 1918 influenza pandemic, 95% of influenza patient deaths were caused by secondary bacterial infections. Bacterial infections are a major source of mortality among ICU patients. According to recently published reports, the mortality in COVID-19 patients requiring advanced respiratory support (ventilators) ranges from 66% to 86%. N8 Medical believes that use of the CeraShield™ Endotracheal Tube may reduce this rate of mortality.
"Biofilm growth on endotracheal tubes may lead to deadly secondary bacterial infections and exaggerated inflammatory responses requiring 8 to 9 days of additional mechanical ventilation. Preventing virally-infected patient exposure to bacterial biofilms on the endotracheal tube is critically important," said Carl Genberg, N8 Medical's Chief Scientific Officer. "In a time of severe shortage of mechanical ventilators, we believe that use of the CeraShield™ Endotracheal Tube has the potential to both reduce mortality and optimize ventilator capacity by getting patients off the ventilator sooner. We thank Dr. Muscedere for his efforts to secure use of the CeraShield™ Endotracheal Tube and the Canadian Government for granting his emergency request," said Carl Genberg, N8 Medical's Chief Scientific Officer.
Frost & Sullivan recently issued its Product Innovation of the Year Award to N8 Medical for its platform technology designed to prevent hospital acquired infections. FDA has designated the CeraShield™ Endotracheal Tube as a "breakthrough device" pursuant to the 21st Century Cures Act. The device is currently an investigational product.
Dr Muscedere is an Intensivist at Kingston General Hospital, and Co-Chair of the Canadian Critical Care Trials Group (CCCTG) Knowledge Translation Committee. Dr. Muscedere was the Principal Investigator in a clinical feasibility study of the CeraShield™ Endotracheal Tube of ten patients at Kingston General who were intubated with the CeraShield™ Endotracheal Tube. That study indicated that use of the CeraShield™ Endotracheal Tube does not have adverse side effects and was able to prevent dangerous pathogenic bacteria from growing on the tube and in endotracheal tube aspirates.
N8 medical is currently in discussions with other physicians regarding emergency use during this ventilator resource-straining pandemic.
ABOUT N8 MEDICAL
N8 Medical, LLC (www.N8Medical.com), headquartered in Dublin, Ohio, is a rapidly-growing, privately-held biotechnology company developing a platform of anti-fouling medical devices designed to have significant, life-saving clinical impact through reduction of infection, related complications and mortality. N8 Medical's CeraShield™ technology is based upon novel compounds called ceragenins (also referred to as CSAs). There are over 90 peer-reviewed journal articles regarding the ceragenin technology, which was invented by Professor Paul B. Savage, Professor of Chemistry and Biochemistry at Brigham Young University (Provo, UT). Key publications are available at www.N8Medical.com.
CAUTION: In Canada and the United States, the CeraShield™ Endotracheal Tube and has not been granted marketing approval. These statements have not been evaluated by Health Canada or FDA.
SOURCE N8 Medical, LLC
Related Links
http://www.n8medical.com
HYDI partner news: Health Canada Grants Emergency Use Authorization for N8 Medical CeraShield™ Endotracheal Tubes in Mechanically Ventilated COVID-19 Patients
Evaluating potential for reduction of secondary bacterial infections and mechanical ventilation days to improve patient outcomes and optimize use of scarce ventilators
N8 Medical, LLC Logo (PRNewsfoto/N8 Medical, LLC)
NEWS PROVIDED BY
N8 Medical, LLC
Apr 02, 2020, 09:55 ET
DUBLIN, Ohio, April 2, 2020 /PRNewswire/ -- N8 Medical, LLC (N8 Medical) today announced that Health Canada has granted Dr. John Muscedere of Kingston General Hospital's emergency request to begin using the N8 Medical CeraShield™ Endotracheal Tubes in mechanically-ventilated COVID-19 patients.
N8 Medical's CeraShield™ Endotracheal Tube has a patented anti-fouling coating that is designed to prevent deadly bacterial infections that frequently occur in ventilated patients with respiratory viral infections. In contrast, conventional endotracheal tubes allow pathogenic bacteria to grow on the tube surfaces within hours and form slime-like aggregations of millions of pathogenic cells as a biofilm. In the 1918 influenza pandemic, 95% of influenza patient deaths were caused by secondary bacterial infections. Bacterial infections are a major source of mortality among ICU patients. According to recently published reports, the mortality in COVID-19 patients requiring advanced respiratory support (ventilators) ranges from 66% to 86%. N8 Medical believes that use of the CeraShield™ Endotracheal Tube may reduce this rate of mortality.
"Biofilm growth on endotracheal tubes may lead to deadly secondary bacterial infections and exaggerated inflammatory responses requiring 8 to 9 days of additional mechanical ventilation. Preventing virally-infected patient exposure to bacterial biofilms on the endotracheal tube is critically important," said Carl Genberg, N8 Medical's Chief Scientific Officer. "In a time of severe shortage of mechanical ventilators, we believe that use of the CeraShield™ Endotracheal Tube has the potential to both reduce mortality and optimize ventilator capacity by getting patients off the ventilator sooner. We thank Dr. Muscedere for his efforts to secure use of the CeraShield™ Endotracheal Tube and the Canadian Government for granting his emergency request," said Carl Genberg, N8 Medical's Chief Scientific Officer.
Frost & Sullivan recently issued its Product Innovation of the Year Award to N8 Medical for its platform technology designed to prevent hospital acquired infections. FDA has designated the CeraShield™ Endotracheal Tube as a "breakthrough device" pursuant to the 21st Century Cures Act. The device is currently an investigational product.
Dr Muscedere is an Intensivist at Kingston General Hospital, and Co-Chair of the Canadian Critical Care Trials Group (CCCTG) Knowledge Translation Committee. Dr. Muscedere was the Principal Investigator in a clinical feasibility study of the CeraShield™ Endotracheal Tube of ten patients at Kingston General who were intubated with the CeraShield™ Endotracheal Tube. That study indicated that use of the CeraShield™ Endotracheal Tube does not have adverse side effects and was able to prevent dangerous pathogenic bacteria from growing on the tube and in endotracheal tube aspirates.
N8 medical is currently in discussions with other physicians regarding emergency use during this ventilator resource-straining pandemic.
ABOUT N8 MEDICAL
N8 Medical, LLC (www.N8Medical.com), headquartered in Dublin, Ohio, is a rapidly-growing, privately-held biotechnology company developing a platform of anti-fouling medical devices designed to have significant, life-saving clinical impact through reduction of infection, related complications and mortality. N8 Medical's CeraShield™ technology is based upon novel compounds called ceragenins (also referred to as CSAs). There are over 90 peer-reviewed journal articles regarding the ceragenin technology, which was invented by Professor Paul B. Savage, Professor of Chemistry and Biochemistry at Brigham Young University (Provo, UT). Key publications are available at www.N8Medical.com.
CAUTION: In Canada and the United States, the CeraShield™ Endotracheal Tube and has not been granted marketing approval. These statements have not been evaluated by Health Canada or FDA.
SOURCE N8 Medical, LLC
Related Links
http://www.n8medical.com
Hydromer mentions their antimicrobial coatings in that headline, but not in the news.
This news from N8 Medical is from December, sounds like we could there's potential for more interesting news soon:
https://www.mddionline.com/can-breakthrough-medical-device-reduce-risk-hospital-associated-infections
HYDI: Hydromer Inc. Now Active in the COVID-19 Emergency Response with Availability of its Sanitizers and Antimicrobial Coatings
GlobeNewswireMarch 26, 2020
Concord, NC, March 26, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Hydromer, Inc. (“Hydromer®” or the “Company”) (OTCQB: HYDI) announced today that it is actively engaged in the fight against COVID-19 by immediately scaling up manufacturing of its various hand sanitizers during the current extreme demand and short supply of those critical products. Hydromer is commercializing a variety of sanitizer solutions, including a US FDA & World Health Organization-mandated “alcohol-based” sanitizer version, which is widely needed across the entire spectrum of healthcare, safety, first response and many other critical functions. Hydromer is also rejuvenating its patented “non-alcohol”, plant-based sanitizing and cleaning product line that can provide enhanced benefits over the traditional alcohol-based products. During the current epidemic and COVID-19 outbreak, Hydromer is working with private and public sector entities, including various State and Local government organizations to supply first responders and essential workers with much needed sanitizing products.
“Hand sanitizers are in incredible demand and although the regulations to manufacture them are in some cases temporarily being eased to address the current massive shortage of alcohol, we also see the World Health Organization (WHO) and the FDA seeking to tighten up specifications to ensure quality and authenticity in the labeling and the proper use of ingredients at the right levels,” said Martin von Dyck, Chief Operating Officer (COO). “With this in mind, we see that Hydromer’s 40 year track record, as an FDA certified facility and maker of innovative medical technologies for products that serve the Intensive Care Units and nursing homes will bring precision, credibility, and alternatives to those within this emergency response and with future outbreaks,” said Peter M. von Dyck, Chief Executive Officer (CEO).
Hydromer is actively seeking partnerships, suppliers and sources of alcohol to ensure a steady supply of hand sanitizers, to the healthcare market. Hydromer has also secured a special permit from the ATF (Bureau of Alcohol, Tobacco, Firearms). As an essential business worker and qualified healthcare ICU/emergency response support provider, Hydromer continues its manufacturing operations to supply its regular customers with much needed healthcare, ICU and emergency care products during this time of great need.
Hydromer, Inc. is an innovative ISO 9001:2015 technology-focused company engaged in the business of inventing, developing, patenting, licensing, manufacturing and selling hydrophilic polymer-based products for commercial markets including Medical Device, Pharmaceutical, Biotechnology, Industrial Plastics, Cosmetic and Personal Care. Hydromer also provides highly specialized medical coating services to industry through its FDA registered and ISO 13485:2016 certified Medical Products subsidiary. For the latest information about Hydromer, Inc. and its products, please visit our web site at www.hydromer.com
Or contact us now via phone or email
Hydromer Inc.
1-800-287-5208
Info@hydromer.com
HYDI: Hydromer Inc. Now Active in the COVID-19 Emergency Response with Availability of its Sanitizers and Antimicrobial Coatings
GlobeNewswireMarch 26, 2020
Concord, NC, March 26, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Hydromer, Inc. (“Hydromer®” or the “Company”) (OTCQB: HYDI) announced today that it is actively engaged in the fight against COVID-19 by immediately scaling up manufacturing of its various hand sanitizers during the current extreme demand and short supply of those critical products. Hydromer is commercializing a variety of sanitizer solutions, including a US FDA & World Health Organization-mandated “alcohol-based” sanitizer version, which is widely needed across the entire spectrum of healthcare, safety, first response and many other critical functions. Hydromer is also rejuvenating its patented “non-alcohol”, plant-based sanitizing and cleaning product line that can provide enhanced benefits over the traditional alcohol-based products. During the current epidemic and COVID-19 outbreak, Hydromer is working with private and public sector entities, including various State and Local government organizations to supply first responders and essential workers with much needed sanitizing products.
“Hand sanitizers are in incredible demand and although the regulations to manufacture them are in some cases temporarily being eased to address the current massive shortage of alcohol, we also see the World Health Organization (WHO) and the FDA seeking to tighten up specifications to ensure quality and authenticity in the labeling and the proper use of ingredients at the right levels,” said Martin von Dyck, Chief Operating Officer (COO). “With this in mind, we see that Hydromer’s 40 year track record, as an FDA certified facility and maker of innovative medical technologies for products that serve the Intensive Care Units and nursing homes will bring precision, credibility, and alternatives to those within this emergency response and with future outbreaks,” said Peter M. von Dyck, Chief Executive Officer (CEO).
Hydromer is actively seeking partnerships, suppliers and sources of alcohol to ensure a steady supply of hand sanitizers, to the healthcare market. Hydromer has also secured a special permit from the ATF (Bureau of Alcohol, Tobacco, Firearms). As an essential business worker and qualified healthcare ICU/emergency response support provider, Hydromer continues its manufacturing operations to supply its regular customers with much needed healthcare, ICU and emergency care products during this time of great need.
Hydromer, Inc. is an innovative ISO 9001:2015 technology-focused company engaged in the business of inventing, developing, patenting, licensing, manufacturing and selling hydrophilic polymer-based products for commercial markets including Medical Device, Pharmaceutical, Biotechnology, Industrial Plastics, Cosmetic and Personal Care. Hydromer also provides highly specialized medical coating services to industry through its FDA registered and ISO 13485:2016 certified Medical Products subsidiary. For the latest information about Hydromer, Inc. and its products, please visit our web site at www.hydromer.com
Or contact us now via phone or email
Hydromer Inc.
1-800-287-5208
Info@hydromer.com
Hydromer Inc. Now Active in the COVID-19 Emergency Response with Availability of its Sanitizers and Antimicrobial Coatings
GlobeNewswireMarch 26, 2020
Concord, NC, March 26, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Hydromer, Inc. (“Hydromer®” or the “Company”) (OTCQB: HYDI) announced today that it is actively engaged in the fight against COVID-19 by immediately scaling up manufacturing of its various hand sanitizers during the current extreme demand and short supply of those critical products. Hydromer is commercializing a variety of sanitizer solutions, including a US FDA & World Health Organization-mandated “alcohol-based” sanitizer version, which is widely needed across the entire spectrum of healthcare, safety, first response and many other critical functions. Hydromer is also rejuvenating its patented “non-alcohol”, plant-based sanitizing and cleaning product line that can provide enhanced benefits over the traditional alcohol-based products. During the current epidemic and COVID-19 outbreak, Hydromer is working with private and public sector entities, including various State and Local government organizations to supply first responders and essential workers with much needed sanitizing products.
“Hand sanitizers are in incredible demand and although the regulations to manufacture them are in some cases temporarily being eased to address the current massive shortage of alcohol, we also see the World Health Organization (WHO) and the FDA seeking to tighten up specifications to ensure quality and authenticity in the labeling and the proper use of ingredients at the right levels,” said Martin von Dyck, Chief Operating Officer (COO). “With this in mind, we see that Hydromer’s 40 year track record, as an FDA certified facility and maker of innovative medical technologies for products that serve the Intensive Care Units and nursing homes will bring precision, credibility, and alternatives to those within this emergency response and with future outbreaks,” said Peter M. von Dyck, Chief Executive Officer (CEO).
Hydromer is actively seeking partnerships, suppliers and sources of alcohol to ensure a steady supply of hand sanitizers, to the healthcare market. Hydromer has also secured a special permit from the ATF (Bureau of Alcohol, Tobacco, Firearms). As an essential business worker and qualified healthcare ICU/emergency response support provider, Hydromer continues its manufacturing operations to supply its regular customers with much needed healthcare, ICU and emergency care products during this time of great need.
Hydromer, Inc. is an innovative ISO 9001:2015 technology-focused company engaged in the business of inventing, developing, patenting, licensing, manufacturing and selling hydrophilic polymer-based products for commercial markets including Medical Device, Pharmaceutical, Biotechnology, Industrial Plastics, Cosmetic and Personal Care. Hydromer also provides highly specialized medical coating services to industry through its FDA registered and ISO 13485:2016 certified Medical Products subsidiary. For the latest information about Hydromer, Inc. and its products, please visit our web site at www.hydromer.com
Or contact us now via phone or email
Hydromer Inc.
1-800-287-5208
Info@hydromer.com
HYDI: Hydromer Inc. Now Active in the COVID-19 Emergency Response with Availability of its Sanitizers and Antimicrobial Coatings
GlobeNewswireMarch 26, 2020
Concord, NC, March 26, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Hydromer, Inc. (“Hydromer®” or the “Company”) (OTCQB: HYDI) announced today that it is actively engaged in the fight against COVID-19 by immediately scaling up manufacturing of its various hand sanitizers during the current extreme demand and short supply of those critical products. Hydromer is commercializing a variety of sanitizer solutions, including a US FDA & World Health Organization-mandated “alcohol-based” sanitizer version, which is widely needed across the entire spectrum of healthcare, safety, first response and many other critical functions. Hydromer is also rejuvenating its patented “non-alcohol”, plant-based sanitizing and cleaning product line that can provide enhanced benefits over the traditional alcohol-based products. During the current epidemic and COVID-19 outbreak, Hydromer is working with private and public sector entities, including various State and Local government organizations to supply first responders and essential workers with much needed sanitizing products.
“Hand sanitizers are in incredible demand and although the regulations to manufacture them are in some cases temporarily being eased to address the current massive shortage of alcohol, we also see the World Health Organization (WHO) and the FDA seeking to tighten up specifications to ensure quality and authenticity in the labeling and the proper use of ingredients at the right levels,” said Martin von Dyck, Chief Operating Officer (COO). “With this in mind, we see that Hydromer’s 40 year track record, as an FDA certified facility and maker of innovative medical technologies for products that serve the Intensive Care Units and nursing homes will bring precision, credibility, and alternatives to those within this emergency response and with future outbreaks,” said Peter M. von Dyck, Chief Executive Officer (CEO).
Hydromer is actively seeking partnerships, suppliers and sources of alcohol to ensure a steady supply of hand sanitizers, to the healthcare market. Hydromer has also secured a special permit from the ATF (Bureau of Alcohol, Tobacco, Firearms). As an essential business worker and qualified healthcare ICU/emergency response support provider, Hydromer continues its manufacturing operations to supply its regular customers with much needed healthcare, ICU and emergency care products during this time of great need.
Hydromer, Inc. is an innovative ISO 9001:2015 technology-focused company engaged in the business of inventing, developing, patenting, licensing, manufacturing and selling hydrophilic polymer-based products for commercial markets including Medical Device, Pharmaceutical, Biotechnology, Industrial Plastics, Cosmetic and Personal Care. Hydromer also provides highly specialized medical coating services to industry through its FDA registered and ISO 13485:2016 certified Medical Products subsidiary. For the latest information about Hydromer, Inc. and its products, please visit our web site at www.hydromer.com
Or contact us now via phone or email
Hydromer Inc.
1-800-287-5208
Info@hydromer.com
HYDI: Hydromer Inc. Now Active in the COVID-19 Emergency Response with Availability of its Sanitizers and Antimicrobial Coatings
GlobeNewswireMarch 26, 2020
Concord, NC, March 26, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Hydromer, Inc. (“Hydromer®” or the “Company”) (OTCQB: HYDI) announced today that it is actively engaged in the fight against COVID-19 by immediately scaling up manufacturing of its various hand sanitizers during the current extreme demand and short supply of those critical products. Hydromer is commercializing a variety of sanitizer solutions, including a US FDA & World Health Organization-mandated “alcohol-based” sanitizer version, which is widely needed across the entire spectrum of healthcare, safety, first response and many other critical functions. Hydromer is also rejuvenating its patented “non-alcohol”, plant-based sanitizing and cleaning product line that can provide enhanced benefits over the traditional alcohol-based products. During the current epidemic and COVID-19 outbreak, Hydromer is working with private and public sector entities, including various State and Local government organizations to supply first responders and essential workers with much needed sanitizing products.
“Hand sanitizers are in incredible demand and although the regulations to manufacture them are in some cases temporarily being eased to address the current massive shortage of alcohol, we also see the World Health Organization (WHO) and the FDA seeking to tighten up specifications to ensure quality and authenticity in the labeling and the proper use of ingredients at the right levels,” said Martin von Dyck, Chief Operating Officer (COO). “With this in mind, we see that Hydromer’s 40 year track record, as an FDA certified facility and maker of innovative medical technologies for products that serve the Intensive Care Units and nursing homes will bring precision, credibility, and alternatives to those within this emergency response and with future outbreaks,” said Peter M. von Dyck, Chief Executive Officer (CEO).
Hydromer is actively seeking partnerships, suppliers and sources of alcohol to ensure a steady supply of hand sanitizers, to the healthcare market. Hydromer has also secured a special permit from the ATF (Bureau of Alcohol, Tobacco, Firearms). As an essential business worker and qualified healthcare ICU/emergency response support provider, Hydromer continues its manufacturing operations to supply its regular customers with much needed healthcare, ICU and emergency care products during this time of great need.
Hydromer, Inc. is an innovative ISO 9001:2015 technology-focused company engaged in the business of inventing, developing, patenting, licensing, manufacturing and selling hydrophilic polymer-based products for commercial markets including Medical Device, Pharmaceutical, Biotechnology, Industrial Plastics, Cosmetic and Personal Care. Hydromer also provides highly specialized medical coating services to industry through its FDA registered and ISO 13485:2016 certified Medical Products subsidiary. For the latest information about Hydromer, Inc. and its products, please visit our web site at www.hydromer.com
Or contact us now via phone or email
Hydromer Inc.
1-800-287-5208
Info@hydromer.com
Hydromer Inc. Now Active in the COVID-19 Emergency Response with Availability of its Sanitizers and Antimicrobial Coatings
GlobeNewswireMarch 26, 2020
Concord, NC, March 26, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Hydromer, Inc. (“Hydromer®” or the “Company”) (OTCQB: HYDI) announced today that it is actively engaged in the fight against COVID-19 by immediately scaling up manufacturing of its various hand sanitizers during the current extreme demand and short supply of those critical products. Hydromer is commercializing a variety of sanitizer solutions, including a US FDA & World Health Organization-mandated “alcohol-based” sanitizer version, which is widely needed across the entire spectrum of healthcare, safety, first response and many other critical functions. Hydromer is also rejuvenating its patented “non-alcohol”, plant-based sanitizing and cleaning product line that can provide enhanced benefits over the traditional alcohol-based products. During the current epidemic and COVID-19 outbreak, Hydromer is working with private and public sector entities, including various State and Local government organizations to supply first responders and essential workers with much needed sanitizing products.
“Hand sanitizers are in incredible demand and although the regulations to manufacture them are in some cases temporarily being eased to address the current massive shortage of alcohol, we also see the World Health Organization (WHO) and the FDA seeking to tighten up specifications to ensure quality and authenticity in the labeling and the proper use of ingredients at the right levels,” said Martin von Dyck, Chief Operating Officer (COO). “With this in mind, we see that Hydromer’s 40 year track record, as an FDA certified facility and maker of innovative medical technologies for products that serve the Intensive Care Units and nursing homes will bring precision, credibility, and alternatives to those within this emergency response and with future outbreaks,” said Peter M. von Dyck, Chief Executive Officer (CEO).
Hydromer is actively seeking partnerships, suppliers and sources of alcohol to ensure a steady supply of hand sanitizers, to the healthcare market. Hydromer has also secured a special permit from the ATF (Bureau of Alcohol, Tobacco, Firearms). As an essential business worker and qualified healthcare ICU/emergency response support provider, Hydromer continues its manufacturing operations to supply its regular customers with much needed healthcare, ICU and emergency care products during this time of great need.
Hydromer, Inc. is an innovative ISO 9001:2015 technology-focused company engaged in the business of inventing, developing, patenting, licensing, manufacturing and selling hydrophilic polymer-based products for commercial markets including Medical Device, Pharmaceutical, Biotechnology, Industrial Plastics, Cosmetic and Personal Care. Hydromer also provides highly specialized medical coating services to industry through its FDA registered and ISO 13485:2016 certified Medical Products subsidiary. For the latest information about Hydromer, Inc. and its products, please visit our web site at www.hydromer.com
Or contact us now via phone or email
Hydromer Inc.
1-800-287-5208
Info@hydromer.com
Great news buried under a boring headline:
Hydromer, Inc. Announces Postponement of Shareholders Meeting
GlobeNewswire GlobeNewswire•March 23, 2020
CONCORD, NC, March 23, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Hydromer, Inc. (“Hydromer®” or the “Company“) (HYDI) announces that due to the emerging public health impact of the coronavirus outbreak (COVID-19) and to support the health and well-being of its partners and shareholders, its board of directors has decided to postpone indefinitely and until further notice the Company’s Annual Meeting of Shareholders scheduled to be held on March 31, 2020. Shareholders will not be able to attend the Annual Meeting.
Shareholder are urged to vote and submit their proxy in advance until March 31, 2020 online by visiting www.investorvote.com/HYDI, over the phone by calling toll free 1-800-652-VOTE (8683) within the USA, U.S. territories and Canada, or over the mail by forwarding the completed voting cards to Computershare, Meidinger Tower, Attn: Proxy, 462 S 4th St. Louisville, KY 40202.
Although the shareholder meeting has been postponed, Hydromer® continues to diligently work in supporting our community to fulfill the extreme demand for hand sanitizer during the COVID-19 outbreak. Hydromer is actively supplying and making available to the community our broad range of sanitizing products that offer various benefits in infection control, personal and public hygiene control and protection against illnesses, among many more benefits.
Even in times of extreme need such as these, our company continues to support our regular customer base providing our surface coatings that enhance the performance of various life-saving medical devices to provide critical support to the healthcare ICU and emergency response sector.
Hydromer Inc.
1-800-287-5208
Info@hydromer.com
Contact:
Okay, so if your're not interested in the razor blades, what are your shaving cream stocks?
Well in a razor & razor blade model, the ventilator is the razor and the endotraceal tubes (ET) are the razor blades. With a little looking I found a couple public companies selling ETs. Looks like the market has already found Bactiguard (BACTI-B.ST) which is an interesting infection control company that concentrates in ETs...wish I would have bought that 6 months ago. Teleflex (TFX) is larger and more diversified....Avanos (AVNS) a little more concentrated in respiratory expendables, but maybe not enough to overcome its other weaknesses?
Ventilator associate pneumonia (VAP) is one of the worst Healthcare Acquired Infections (HAIs) and the CDC & FDA HAI action plans prioritize VAP solutions. For that reason, I built a core position in Hydromer, Inc. (HYDI) about a year ago, their partner N8 Medical has a compelling antibacterial coating that provides superior infection resistance compared to other coating tech. that was scheduled to complete enrollment for their trial by 10/30/2019. I wrote it up in MicrocapClub and the HYDI board about a year ago....super thin share structure...they might be worth watching for potential FDA approval news soon.
Heavy volume and strong price action here in light of the current market.
Maybe they're close to finalizing the move of their manufacturing, or maybe the are close to their first order from a service provider to use their Motorola products as customer premises equipment (CPE)? ...or maybe its just the knuckleheads chasing ZOOM thinking it was ZM have now found ZMTP, lol!
Interesting someone is buying at the ask here. eom.
Hydromer has been posting on LinkedIn about their products that could be beneficial for COVID-19, so I made an inquiry about their HerbaSafe antimicrobial product line through their online chat agent and received the response below.
I was initially interested in their HerbaSafe antimicrobial soaps and sanitizers that have tested to be more effective than alcohol-based hand sanitizers, but his last comment about their partner, N8 Meidical's Endotracheal Tube (ETT) actually struck me as even more compelling, considering how COVID-19 associated pneumonia is causing a spike in ventilator use, coupled with the CDC's recent prioritization of Ventilator Associated Events (VAE) within the framework of the National Action Plan to Prevent Health Care-Associated Infections.
As you can see from clinicaltrials.gov, N8 Medical's ETT was previously designated and FDA "breakthrough device" and should have completed their study by October 30, 2019.....I think they have a good case for expedited review here and hope a favorable decision could be coming soon!
.........................................
Hello Paul,
Good morning – hope you are well. I recall meeting you in person in one of the earlier board meetings.
Glad to receive your email inquiry about Hydromer’s HerbaSafe line.
Yes, we are aggressively marketing these products through Social Media while discussing with medical, hospital, retail and other channels of markets.
Please note that per FDA guidelines, only three ingredients - Benzalkonium Chloride, Ethyl Alcohol, and Isopropyl Alcohol (with alcohol content of a minimum of 60% over longer term use by a consumer)– are approved as OTC Hand Sanitizers for use by a consumer.
See details in this link:
https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-consumer-hand-sanitizers
We are actively working on a few large inquiries of hand sanitizers and they are all requiring alcohol based products. Based on the market need, our R&D/Manufacturing team is working to quickly put together an alcohol-based hand sanitizer formula to add to this line, so we can provide multiple options. We are also continuing to push the benefits of the non-alcohol line and have some opportunities lining up for selling this down the road – although, everyone is right now looking for an alcohol-based sanitizers.
We are also working on medical device coatings combining with antimicrobials, especially with our partner N8 Medical with their unique technology on ET tubes, through various government agencies for emergency approvals as an alternate solution for the Coronavirus outbreak. Will keep you posted on this development and how quickly we can see business growth.
Please let me know if you need any additional information.
Best regards,
Ravi
Ravi Rangarajan
VP Sales, Marketing & Biz Development
Why waste good news in a crap market? Hopefully the company can get their financials reported soon, which needs to be first for anyone to take a serious look at this as an investment, then can keep up with its current reporting of material events.
Where's the best place to buy bullion and coins?
I remember several years ago, Bobwins posted a miners website that sold their bullion online at, or very near, spot prices.
Silver seems pretty cheap here and I'd like to dip my toe in and buy my first physical silver holdings here.
All suggestions welcome.
Stay safe everyone!
IPATF: Now that's a company that's going to need more financing soon and this statement at the end of their 2.20/2020 PR seems to have tempered any enthusiasm for the upside:
There is no assurance that the Company will be successful in the development of a vaccine and/or therapeutic against the new coronavirus. In particular, the development of a vaccine and/or therapeutic requires significant capital, which will require additional financing by the Company, successful clinical trials and extensive regulatory approvals.
https://finance.yahoo.com/news/immunoprecise-launches-coronavirus-vaccine-therapeutic-193900358.html
I also know a few of their long-term investors, who are skeptical that their relatively new CEO, Jennifer Bath, hasn't put much of any skin in the game yet....even at these depressed prices.
APDN just had another volume surge on no news.
I think you are overestimating their need for financing, they have enough cash now to cover their burn rate for the next year.
The CEO also said at least one of their 14+ pharmaceutical company prospects is close to signing a licensing agreement with an up front retainer and milestone payments for their LineaRx division to produce DNA for pre-clinical development programs.
I also like the potential for their iCTC platform to be developed into a new cancer testing platform, given the results Tyme has published about earlier detection and more accurate correlation to actual cancer development than the standard antibody tests.
HYDI has a great product for this Coronavirus outbreak, that is truly scientifically proven to be more effective than alcohol-based hand sanitizer. I hope a partner steps up to market it:
https://www.linkedin.com/posts/hydromer-inc%2E_outbreak-epidemic-antimicrobial-activity-6641360389412003841-v4gq
Dark stocks are difficult to research, if you can't even find the company's actual website, or recent news, you probably aren't cut out for investing in dark companies.
Here is a link to their news in 2018 that they made a sale of a PET scanner:
http://www.positron.com/updates/post/positron-announces-sale-of-attrius-pet-scanner
A deeper look into market news shows that the company is alive and well, but they are not up to date with SEC filings, and have gone dark on the news wires until they get caught-up.
If you were capable of researching the market for cardiac PET, you would see cardiac PET testing is gaining traction and is expected to take market share from SPECT in the coming years.
taxibabe, it seems you overthought this and missed he obvious right in front of you.
Follow some of the links posted here recently and see that coronary PET scans are being validated as providing more useful information with less radiation exposure than the current industry standard, SPECT imaging. This company has been at the forefront of developing the software with leading researchers, including Lance Gould, MD at the University of Texas:
https://www.uth.tmc.edu/pet/about-dr-gould.htm
Looks like traders won the short-term trade on the news here; but I bought in for more than the Coronavirus vaccine, their LineaRx platform holds even greater potential to make more significant news in the coming weeks according to comments in their last conference call:
Now our iCTC platform has been used to characterize over 6,000 samples and has been the beneficiary of funding by over $7 million from the National Cancer Institute, with whom we have a current application pending.
It is clear that the accumulation of epigenetic mutations in invasive CTC cells renders them potently metastatic. In fact, when transplanted into xenographic mice that allow human tissues to grow, a small number of ITCs lead to disseminated metastasis. To get the same number of metastasis from the primary tumor requires 1,000x as many cells.
This makes the invasive CTCs extremely valuable to companies who are trying to develop drugs to stop metastasis or to fight cancer in general. Based on our relationship with Tyme pharmaceuticals, we are already talking to companies who want to use our invasive CTC platform in drug development and subsequent clinical trials.
Now iCTCs can also be used to monitor therapies and to predict therapeutic outcomes for patients. This is really a remarkable study reproduced in the upper box in this slide. It's a patient with ovarian cancer, and she has the tumor mass measured by a CT scan, which is plotted by the blue line. As she begins therapy and has surgery, the tumor mass and the invasive CTC counts drop to 0. Makes sense, but unfortunately, this cancer is about to recur.
Remarkably, a full 6 months before the image of the tumor can be detected by imagery, the rebound, in the red line, in iCTCs made it clear the tumor was recurring, again 6 months before the image could reveal it. Hence, the use of our platform can provide the oncologist with the evidence to make the decision to change therapy much earlier, which is extremely valuable. Hence, we believe our invasive CTC platform poses great potential as a companion diagnostic to follow the course of specific cancer therapies. In fact, we plan to pursue applications as a companion diagnostic in the future.
In 2019, our assay was leveraged successfully by Tyme pharmaceuticals in a prostate cancer trial. Tyme states that our [iCT] assay is a better indicator of disease than the PSA biomarker, which is the classic biomarker used to detect prostate cancer. In 2020, Tyme is leveraging our iCTC assay in a Phase III clinical trial for the treatment of pancreatic cancer. It is our goal to position our assay across more clinical trials, and we are investing accordingly.
Finally, in this study of drug development to treat prostate cancer, iCTCs were able to predict that a drug was not working 3 months before detection by the accepted biomarker, PSA, and 3 months before imagery. We believe this platform will have great value in future. As we seek regulatory approvals, we believe we have great potential in genomic analysis, drug development, cancer diagnosis and in monitoring therapy.
Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [2]
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If you can talk a little bit about -- a little bit more about LineaRx. And I know that you had mentioned previously that you had 14 or so existing customers; and you just -- on the back of JPMorgan, which we thought was a really productive conference this year for the first time in a while; that you came out with 3 new orders from what seems to be large cap -- larger-cap groups.
What does it take to go from the development stage where you supply them with whatever product they're requesting of you for them to then evaluate that product and even take it into a preclinical development stage? Because that's really the benchmark we're looking at in terms of turning things into a potential contract manufacturing or some sort of partnership that becomes public with Applied. Can you talk a little bit about what those time lines look at and if you expect anything like that could occur in 2020?
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James A. Hayward, Applied DNA Sciences, Inc. - President, CEO & Chairman [3]
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Sure. First of all, in terms of the head count, I decided after I used that number, 14, that I really didn't want to put myself in the position of providing a serial head count quarter-to-quarter. Suffice it to say it actually has increased.
And typically, when those biotech, biopharma customers come to us at first, it's in a CRO relationship, where they're looking for a quantity of DNA larger than their average production in-house but not beyond the CRO level so that they can do their experiments in vitro and begin to contemplate experiments in mice, for example.
And we have -- we are in the process now of just signing our first longer-term agreement with a large pharmaceutical company. And that agreement should allow us to get to animal studies, which means more stringent DNA production conditions and greater quantities and typically more hoops to leap through. So that -- it for us means a higher level of revenue.
I would say, for most CRO customers, the time required to make that transition is anywhere between 6 and 12 months. We earn money during that time period but at a lesser rate. As we go to the CMO level, there should be periodic requirements for what is now a selected DNA as opposed to a panel of DNAs. But those are produced under more stringent conditions, leading to an increase in revenue to us and over a longer period of time.
So we're already there, quite honestly, beginning to see those transitions happen. And we're seeing 1 or 2 companies, on the heels of the success we've had with others, skipping the CRO stage and moving further up the progressive ladder more quickly.
--------------------------------------------------------------------------------
Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [4]
--------------------------------------------------------------------------------
Right. And like from our -- from my perspective, revenue generation is one thing and -- but on the linear side, I don't really view the company really ready to be benchmarked on a revenue level. For me, what's important is, one, those development what -- those development time lines for your potential or your existing customers and when it could potentially become public.
Because as a biotech, which is Applied, half the business is a biotech business now. What drives valuations tends to be news flow and being hitched in a way to larger-cap biotech and pharmas, to us is a big deal and to investors, I think, is a big deal.
So I guess my question is, when do you think some of those names that you're working with could potentially become publicized? Is it an Applied issue, or is it completely in the hands of your customers to decide that?
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James A. Hayward, Applied DNA Sciences, Inc. - President, CEO & Chairman [5]
--------------------------------------------------------------------------------
So we're now in a position to be a little more demanding about our need to let our investors know with whom we are working. And I think we are going to find ourselves in that position for the first time this quarter, and then I think it will occur more frequently as time goes on.
And I also feel we'll be signing those relationships that involve retainer fees, followed by significant milestones, as they ask us to achieve more and more difficult armchair molecular engineering and to make it real.
Covalon has something to add in the battle against COVID-19. As a long-term owner with a high level of confidence in the company's technical capabilities, I can't wait to see what it is....and may add back some shares I had peeled off my position the last time it was over $5.
COVALON ANNOUNCES FIRST QUARTER FISCAL 2020 RESULTS
MISSISSAUGA, Ontario--(BUSINESS WIRE)-- Covalon Technologies Ltd. (the "Company" or "Covalon") (TSXV: COV; OTCQX: CVALF), an advanced medical technologies company, today announces its first quarter fiscal 2020 results.
Brian Pedlar, Covalon’s President and CEO, said, “I am pleased that Covalon’s first quarter performance is very much on track in executing on our fiscal 2020 plan. The entire Covalon team is working diligently to achieve increased sales, operational efficiencies, and technological advances in response to changes that occurred to our Middle East business in 2019. We are adapting as quickly as possible and are making progress. Our lifesaving products continue to be well received by medical practitioners and patients alike. At the same time, we continue to advance our technology portfolio. I plan to make our shareholders more aware of these achievements during 2020.
“This quarter’s revenue was heavily influenced by our success in the United States, which accounted for 81% of our revenue in the first quarter of 2020, compared to 76% last year in the same quarter. Our revenue in the United States was up 17% compared to last year and represents growth in both our sales to hospitals and our advanced wound care distribution channel. We are continuing to build awareness of our infection prevention products in our new 1,900 United States hospital and medical centre customer base.
“Our Middle East business, at $0.9 million, was down in the first quarter by $0.7 million compared to last year. It is still very difficult to predict the volume and timing of business in Saudi Arabia, particularly in light of the current regional uncertainty. We continue to plan as if all shipments to Saudi Arabia are upsides and not part of our base operating plan. We are taking steps to strengthen our business in the region and I look forward to providing further updates as they occur.
“Many companies have recently announced that they have been, or expect to be, negatively impacted by the effects of coronavirus COVID19 on their supply chain, workforce, and customers. Fortunately, the majority of our infection prevention products, including IV Clear, AquaGuard, and our ColActive Plus family of advanced wound care products, are manufactured in the United States, and the supply chains for these products are not anticipated to be adversely affected by COVID-19. Some of our CovaWound line of advanced wound care products are manufactured in China, and we have experienced some delays in shipments. In fiscal 2019, approximately 8% of our revenue was derived from products manufactured in China. Covalon continues to assess the impact that a prolonged pandemic outbreak may have on our business.”
Mr. Pedlar continued, “COVID-19 also provides Covalon with an opportunity to help protect healthcare workers and the public from contracting COVID-19 and other viral and bacterial infections. We are actively working on a technology to help reduce the spread of COVID-19 and other viruses. Our technology has been shown to be highly effective at killing and deactivating similar viruses to COVID-19, as well as antibiotic resistant bacteria and other pathogens. I look forward to discussing this technology further in the next several weeks.”
Q1 Fiscal 2020 Financial Results
Revenue for the three months ended December 31, 2019 was $7.9 million, 9% or $687,073 more than the prior year. Gross profit was 61% in Q1 fiscal 2020, compared to 63% in Q1 fiscal 2019. Net loss was $1.2 million or $0.05 per share (diluted), compared to a loss of $1.9 million or $0.09 per share (diluted) in Q1 fiscal 2019.
Revenue in the United States for the quarter was up 17% year-over-year in Q1 to $6.4 million, which included increases in product revenue, including AquaGuard product sales and development services, licenses, and royalties.
Middle East first quarter revenue of $0.9 million was down by $0.7 million compared to last year.
Latin American, European, and other international regions revenue was $0.6 million compared to $0.2 million last year.
Product revenue increased $.8 million or 13% while services revenue was down slightly to $ .8 million from $0.9 million last year as a result of the timing of revenue recorded under our development contracts.
Operating expenses were down by $390,550 or 6% compared to last year in the first quarter.
Conference Call Scheduled
A conference call to discuss Covalon’s Fiscal 2020 Q1 Financial Results will be held Tuesday March 3rd 2020 at 9:00am EST. To participate in the call, please dial:
Toll-Free: 833.299.8117
International: 647.689.4535
Conference ID Code: 1181198
A recording of the call will be available from March 3rd, 2020, at 12:00pm EST until March 17th, 2020, at 11:59pm EST by calling 855.859.2056 or 404.537.3406 and entering the conference ID code 1181198.
About Covalon
Covalon Technologies Ltd. researches, develops, and commercializes new healthcare technologies that help save lives around the world. Covalon's patented technologies, products, and services address the advanced healthcare needs of medical device companies, healthcare providers, and individual consumers. Covalon's technologies are used to prevent, detect, and manage medical conditions in specialty areas such as infection control, vascular access, surgical procedures, advanced wound care, and medical device coatings. To learn more about Covalon, visit our website at www.covalon.com
APDN: Applied DNA Sciences Updates on COVID-19 Collaboration with Takis Biotech, 4 Preclinical LinearDNA™ Vaccine Candidates Designed
Business Wire
March 2, 2020, 4:00 am
– Applied DNA Expected to Enter Large-Scale Production of Candidates in March; Preclinical Testing in Animals by Takis Biotech Anticipated to Begin in Calendar Q2 2020–
–Candidates Inspired by the Sequence of Viral Spike Protein; Designed to Prevent Entry of Coronavirus into Human Host’s Cells -
Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development, and liquid biopsies for cancer diagnostics, and Takis Biotech ("Takis"), a company focused on the development of cancer vaccines, and founded by scientists from Merck Research Laboratories, announced today that the design of 4 DNA vaccine candidates will be produced for preclinical animal testing via the Company’s proprietary PCR-based DNA ("LinearDNA") manufacturing systems.
The companies’ announcement follows their statement on February 7, 2020 announcing an expanded Joint Development Agreement (JDA) between the Company’s majority-owned subsidiary, LineaRx, Inc. and Takis Biotech to include the preclinical development of a PCR-produced LinearDNA vaccine against COVID-19.
"Since expanding our JDA to include the pursuit of a COVID-19 vaccine, the virus has appeared on almost every continent. We expect delivery of the 4 preclinical vaccine candidates from Takis in this month. Within weeks of arrival we expect to immediately scale up PCR-based production of each vaccine candidate and ship them back to Takis who will determine each vaccine’s relative abilities to provoke an immune response in vaccinated mice," stated Dr. James A. Hayward, president and CEO of Applied DNA and LineaRx.
The two firms have designed 4 preclinical vaccines on the basis of the "Spike" protein structure (the proteins responsible for the "crown" on the virus surface, and from whence its name derives). It is the Spike protein that enables uptake of the coronavirus, by binding to specific receptors on the host cells. One of the 4 candidate vaccines is the entire spike gene; the remaining 3 are variants based upon epitope mapping (identifying the likely antigenic portions of the protein) and assembling the corresponding parts of the ‘S’ gene into a new synthetic LinearDNA gene, and codon optimization (to ensure the new LinearDNA vaccine genes are efficiently expressed as proteins, once the genes have been delivered to a small percentage of the nuclei of the patient’s muscle cells.) Additionally, Applied DNA has proprietary means, which are the subject of pending patent applications, for genetic ensembles that increase the expression, folding efficiency and compartmentalization of proteins that can be built into the putative vaccine constructs if the results obtained in animal studies warrant this consideration.
Continued Dr. Hayward, "Our patented and proprietary platform for the production of LinearDNA not only empowers rapid development and large-scale production, but we believe it has the potential to yield an effective vaccine with fewer risks than other currently utilized DNA production platforms. As is typical for RNA viruses, coronaviruses mutate at rapid rates that require constant surveillance. We believe that one of the many benefits of PCR-produced LinearDNA is the rapidity at which a putative vaccine can be revised to accommodate mutational drift."
Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech, stated: "Our original collaboration under the JDA on a pan cancer vaccine that will soon enter trials for the treatment of companion animals has already proven the ability of PCR-produced LinearDNA to induce powerful immune responses in animal models. For the induction of antibodies that can neutralize COVID-19, it is essential to use reliable, effective technologies that can be quickly adapted in the face of shifting pathogens, and we believe that is the advantage that Applied DNA’s platform affords us over traditional vaccine development and other modern DNA-based vaccines. This global emergency requires a swift response."
Under the terms of the amended JDA, Takis will use the scaled-up LinearDNA synthetic genes produced by Applied DNA for each of the four putative vaccines to inoculate mice, whose sera will be tested for the presence of antibodies that bind to the purified Spike proteins. Those positive candidates that bind to Spike will be tested for their ability to neutralize COVID-19 by preventing uptake of the virus in cells in culture and in animal models.
The potential advantages posed by PCR-produced LinearDNA vaccines, as opposed to the circular DNA obtained from more traditional plasmid sources, include the speed of production, the absence of antibiotics and their resistance genes, the purity of the DNA, the simplicity of design, the powerful immunogenicity proved in a prior LinearDNA vaccine, the absence of any bacterial contaminants and the fact that the vaccine gene is effective without insertion into the patient’s genome.
Applied DNA and Takis make clear that no commercial partner has been identified to take the coronavirus vaccine to market nor is there any indication that the Company’s applications to develop countermeasures would be approved by regulators.
About Takis Biotech.
Takis is a Biotech Company created by a group of scientists from Merck Research Laboratories (MRL). The group has more than 15 years of experience and an established track record in drug discovery in Oncology and is recognized for the conception and implementation of a number of innovative technologies. One of the main assets of Takis is the expertise in in vivo electro-gene-transfer, which can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis pipeline include four Cancer Vaccine candidates based on this technology. Takis is also actively involved in the generation of humanized monoclonal antibodies for use in Oncology and Infectious Diseases.
Visit www.takisbiotech.it for more information.
About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, diagnostics and pre-clinical nucleic acid-based therapeutic drug candidates.
Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list. Common stock listed on NASDAQ under the symbol APDN.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc
APDN: Volume spike today, already at nearly 8x their trailing 3 month average volume on no news.
The company had a bigger spike on February 7th when they announced a collaboration with an Italian biotech, Takis, to develop a Coronavirus vaccine based on their linear DNA platform:
https://finance.yahoo.com/news/applied-dna-sciences-subsidiary-linearx-152000681.html
Takis has been making news in Italy about it:
linkedin.com
It seems someone is expecting a follow-up to that news, or possibly speculating on some of these other forward looking statements made in their recent earnings cc, like this from the Q&A with the CEO:
So we're now in a position to be a little more demanding about our need to let our investors know with whom we are working. And I think we are going to find ourselves in that position for the first time this quarter, and then I think it will occur more frequently as time goes on.
And I also feel we'll be signing those relationships that involve retainer fees, followed by significant milestones, as they ask us to achieve more and more difficult armchair molecular engineering and to make it real.
SMSI: I bought @ the close today, not sure why this has been hit so hard since announcimg the acquisition of their biggest competitor and risk with the Sprint/T-Mobile merger, Circle's Family Mode that T-Mobile resells. This effectively removes the risk of the merged Sprint/T-Mobile going with Circle and increases and all but assures SMSI's market reach will increase by 2-fold....not to mention their deal with Coolpad that started the rally in January. Yes, they are due to renegotiate with Sprint and Circle was getting lower revenue share from T-Mobile, but Circle also wasn't offering IOT tracking thingies.
I also don't see how Coronavirus hurts their business in any fundamental way.
Finally, the chart also looks like it
has formed a nice cup over the past year...a possitive earnings surprise could be a fundamental reason for it to form the handle.