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Does BNY Mellon’s Crypto Plans Have Hamilton Rolling Over in His Grave?

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Image Credit: Todd Martin (Flickr)

The United States Oldest Bank Embraces Safekeeping Cryptocurrency Alongside Other Assets

The nation’s oldest bank, founded in 1784, began taking deposits of cryptocurrency today. BNY Mellon, with roots in the Bank of New York and Alexander Hamilton, is now the first large U.S. bank to custody client’s bitcoin and ether.

The bank will store the keys required to access and transfer crypto and provide the same bookkeeping services on digital currencies it offers for stocks, bonds, commodities, and other assets. BNY Mellon is one of the largest and most trusted in the business of traditional safekeeping; they now have made history by adding this additional service for investment managers to clear, service and safe keep digital assets.

As America’s oldest bank, BNY Mellon has a 238-year legacy on which to build. As a company it provided the first loan to the U.S. to fund the Revolutionary War and has weathered as many different financial eras as the country that it has helped build. Back in February 2021, BNY Mellon formed its enterprise Digital Assets Unit to develop services for digital asset technology. The goal was to launch the industry’s first multi-asset platform that provides safekeeping for digital and traditional assets.

“Touching more than 20% of the world’s investable assets, BNY Mellon has the scale to reimagine financial markets through blockchain technology and digital assets,” said Robin Vince, Chief Executive Officer and President at BNY Mellon. “We are excited to help drive the financial industry forward as we begin the next chapter in our innovation journey.”

Image Credit: Mark Holler (Flickr)

BNY Mellon recognizes the significant institutional demand for a resilient, scalable financial infrastructure designed to accommodate digital assets alongside traditional ones. The bank had previously surveyed money managers that use their safekeeping services and found almost all institutional investors (91%) are interested in investing in tokenized products. Additionally, 41% of institutional investors hold cryptocurrency in their portfolios today, with an additional 15% planning to hold digital assets in their portfolios within the next two to five years. Safekeeping them all under one system will benefit clients.

BNY Mellon has been working closely with market-leading fintech firms. The firm tapped digital asset technology specialists Fireblocks and Chainalysis to integrate their technology in order to meet the present and future security and compliance needs of clients across the digital asset space.

 BNY Mellon is a global investment company helping its clients manage and service their financial assets throughout the investment lifecycle. Clients include institutions, corporations, and individual investors. It delivers investment management, wealth management, and investment services in 35 countries. As of June 30, 2022, BNY Mellon had $43.0 trillion in assets under custody and/or administration and $1.9 trillion in assets under management. BNY BNY Mellon is the corporate brand of The Bank of New York Mellon Corporation (NYSE: BK).

“As the world’s largest custodian, BNY Mellon is the natural provider to create a safe and secure Digital Asset Custody Platform for institutional clients,” said Caroline Butler, CEO of Custody Services at BNY Mellon. “We will continue to innovate, embrace new technology and work closely with clients to address their evolving needs.”

“With Digital Asset Custody, we continue our journey of trust and innovation into the evolving digital assets space, while embracing leading technology and collaborating with fintechs,” said Roman Regelman, CEO of Securities Services & Digital at BNY Mellon.

Take Away

The world is changing, and even the oldest bank in the U.S. is getting on board with the changes. The addition of BNY Mellon as a holder of cryptocurrency keys is a big nod to the crypto management industry. Portfolio managers of all sizes are now able to provide statements with a wider variety of asset classes held. Does this mean the newcomers that now transact and hold cryptocurrency will either be bought or lose potential large customers? That remains to be seen.

 Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.bnymellon.com/us/en/about-us/newsroom/press-release/bny-mellon-launches-new-digital-asset-custody-platform-130305.html

https://www.wsj.com/articles/crypto-could-threaten-financial-system-federal-risk-panel-warns-11664826496?mod=article_inline

https://www.wsj.com/articles/americas-oldest-bank-bny-mellon-will-hold-that-crypto-now-11665460354?mod=djemalertNEWS

The Week Ahead – FOMC Minutes and CPI Late Week

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Potential for a Change in Sentiment if Suprised by this Week’s FOMC Minutes, Jobs, and Inflation

When the world’s trading partners move interest rates in concert with each other, their actions are much smoother, this is because currency flows, which influence exchange rates, are less inclined to reprice dramatically. The U.S. has been comparatively aggressive in raising rates. This is part of why the Bank of England (BOE) shoring up its bond market, and the Japanese hawkish hesitancy has created disruptions and a historically strong U.S. dollar.

This week begins with Columbus Day; the bond markets are closed, and so are the banks. Stock market participants shouldn’t expect guidance from interest rate moves related to bond trading. The futures market will be active; moves from Interest rate futures from tickers such as ZB=F can be helpful while bonds are silent.  

Monday 10/10

  • 1:30 PM ET Federal Reserve Vice Chair Lael Brainard discusses restoring price stability at the National Association of Business Economics (NABE). Attend via Zoom.
  • Columbus Day, the potential for thin trading and big price swings.

Tuesday 10/11

  • NY Fed 5-year inflation expectations for one- and three-year-ahead inflation expectations had posted steep declines in August, from 6.2 percent and 3.2 percent in July to 5.7 percent and 2.8 percent, respectively. Investors will be watching to see if the declining expectations continue.
  • NFIB Small Business Optimism Index (NFIB), is a monthly survey that asks small businesses if they have plans to increase employment, plans to expand capital spending, increase inventories, expect economic improvement, expect higher retail sales, is now a good time to expand, current job openings, and earnings trends in their business. Health in small businesses can be an indicator of overall economic health and stock market strength. This report is released at 6 am last month, the index was 91.8, and the consensus is 91.5.
  • The Labor Department’s JOLTS has, in recent years, been referred to as the “Quits” report. The report tracks monthly changes in job openings and contains rates of hiring and quitting. The word JOLTS stands for Job Openings and Labor Turnover Survey.

Wednesday 10/12

  • The Producer Price Index (PPI) from the Bureau of Labor Statistics (BLS) is an inflation gauge that measures the average change over time in the prices received by U.S. producers of goods and services. The prices are typically considered input costs for final products and can impact CPI, it may also impact company costs of production and, therefore, profits. The trend has been lower, YOY PPI has been running at 8,7%, the consensus is for 8.4%.
  • The Mortgage Bankers Association (MBA) creates a statistic from several mortgage loan indexes. The Mortgage Applications index measures applications at mortgage lenders. It’s considered a leading indicator and is especially important for single-family home sales and housing construction. Both are considered foundational in a strong economy. L
  • ast week, the Purchase Index was -12.6%.
  • 10 Year Treasury Note Auction is held in the middle of each month and settles on or around the 15th (depending on weekends). The yield is a benchmark for 30-year mortgages and has recently been noted by investment markets because it has been trading at a yield lower than shorter maturities; this inversion of the yield curve has some market players suggesting a recession is expected in the future. Any surprises at the auction will reverberate through the stock market.
  • FOMC minutes (September meeting) – We’d all love to be a fly on the wall at the Fed’s meetings. The minutes detail the issues debated and the consensus among policymakers. This, of course, has ramifications if the contents of the minutes demonstrate an above-average hawkish or dovish change in tone. The Federal Open Market Committee issues minutes of its latest meeting three weeks after the meeting.

Thursday 10/13

  • US Consumer Price Index (CPI) is the inflation indicator most widely broadcast. With inflation being a primary focus, this will be the big number coming out this week. The number represents a basket of goods considered typical for an urban consumer and is taken as the change in the cost of that basket of goods. A percentage is derived from the change. CPI is also reported with food and energy removed as it is considered that other non-economic factors influence these prices. The August report indicated CPI rose 0.6% for the month and 8.3% YOY. Expectations are for a slowing to 0.4% for September and a YOY rate of 8.1%.
  • U.S. Jobless Claims, which represent the prior weeks of employment are expected to have increased to 225,000 from 219,000. From jobless claims, investors can gain a sense of how tight or how loose the job market is. If wage inflation takes hold, interest rates will likely rise, and bond and stock prices will fall.  Remember, the lower the number of unemployment claims, the stronger the job market, and vice versa.

Friday 10/14

  • U.S. retail sales have been lackluster, neither rising nor falling. As we head toward Thanksgiving and Black Friday sales levels, the market will be taking more and more interest in how strong the consumer is. Expectations for September are a rise of 0.2 percent overall, down 0.1 percent when excluding vehicles and up 0.4 when also excluding gasoline. The number is released at 8:30 am.
  • Business inventories are expressed in dollar value held by manufacturers, wholesalers, and retailers. The level of inventories in relation to sales is an important indicator of the near-term direction of production activity. Rising inventories can be an indication of business optimism that sales will be growing in the coming months. However, if unintended inventory accumulation occurs, then production will probably have to slow while those inventories. The consensus is for a 0.9% increase after only increasing 0.6% for August.
  • U.S. Baker Hughes Rig Count tracks weekly changes in the number of active operating oil & gas rigs. Rigs that are not active are not counted. Components in the data are the United States and Canada, with a separate count for the Gulf of Mexico (which is a subset of the U.S. total). A significant increase or decrease could have ramifications on energy costs in North America. The rig count for the prior period in North America was 977, with 762 of those being from the U.S.

What Else

It is a light week for economic releases and Fed governor addresses, but late week could see a dramatic change in market sentiment as the Fed Minutes, CI, and even employment has the potential to impact thinking.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.federalreserve.gov/newsevents/calendar.htm

http://global-premium.econoday.com/byweek.asp?cust=global-premium

https://www.channelchek.com/news-channel/noble_on_the_road___noble_capital_markets_in_person_roadshow_series

Release – Tonix Pharmaceuticals Announces Oral Presentations Involving TNX-1500 (Fc-Modified Anti-CD40L mAb) at the International Congress of The Transplantation Society (TTS 2022)

Posted on by cpatches

Research, News, and Market Data on TNXP

CHATHAM, N.J., Sept. 06, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced three oral presentations by academic collaborators at the 29th International Congress of The Transplantation Society (TTS 2022) being held September 10-14, 2022 in Buenos Aires, Argentina, and virtually. Copies of the presentations will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.

Oral Presentation Details

Title:Long-term rejection free renal allograft survival with Fc-modified anti-CD154 antibody monotherapy in nonhuman primates
Date:Monday, September 12, 2022
Time:4:35 p.m. EDT (17:35 ART)
Session:Campfire Session: Models, mechanisms & therapies
PresenterGrace Lassiter, M.D., Research Fellow of the Kawai Lab
  
Title:Monotherapy with TNX-1500, a Fc-modified anti-CD154mAb, prolongs cardiac allograft survival in cynomolgus monkeys
Date:Tuesday, September 13, 2022
Time:3:25 p.m. EDT (16:25 ART)
Session:Mini-Oral Abstracts Session: Snap-shots of thoracic transplantation
PresenterKohei Kinoshita, M.D., Research Fellow of the Pierson Lab
  
Title:Long-term (>1 year) rejection/TMA free survival of kidney xenografts with triple xenoantigen knockout and multiple human transgenes in nonhuman primates
Date:Wednesday, September 14, 2022
Time:10:00 a.m EDT (11:00 ART)
Session:Mini-Oral Abstracts Session: Xenotransplantation
PresenterGrace Lassiter, M.D., Research Fellow of the Kawai Lab

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the first half of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform. A Phase 1 study of the COVID-19 vaccine is expected to be initiated in the second half of 2023.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
[email protected] 
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
[email protected] 
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
[email protected] 
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.Released September 6, 2022

Voyager Digital (VYGVF) – Declaration of CEO Stephen Ehrlich

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Thursday, July 07, 2022

Voyager Digital (VYGVF)
Declaration of CEO Stephen Ehrlich

Voyager Digital Ltd.’s (TSX: VOYG) (OTCQX: VYGVF) (FRA: UCD2) US subsidiary, Voyager Digital, LLC, is a fast-growing cryptocurrency platform in the United States founded in 2018 to bring choice, transparency, and cost-efficiency to the marketplace. Voyager offers a secure way to trade over 100 different crypto assets using its easy-to-use mobile application. Through its subsidiary Coinify ApS, Voyager provides crypto payment solutions for both consumers and merchants around the globe. To learn more about the company, please visit https://www.investvoyager.com.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

First Day. We spent yesterday going through Voyager Digital’s Chapter 11 petitions and first day motions. The filings provide an overview of recent events behind the Chapter 11 filing, the current state of the Company, and the Company’s efforts to reorganize, both prior to the Chapter 11 filing and its plans for a standalone restructuring.

The Cliff Note. According to the Declaration of Voyager CEO Stephen Ehrlich, Voyager faced a short-term “run on the bank” due to the downturn in the cryptocurrency industry generally and the default of the 3AC loan. Ultimately, Voyager filed for chapter 11 relief to protect customers and preserve the value of the business….

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Axcella Therapeutics (AXLA) – Long COVID Enrollment Completed; OHE Trial Suspended

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Tuesday, May 31, 2022

Axcella Therapeutics (AXLA)
Long COVID Enrollment Completed; OHE Trial Suspended

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Axcella announced that its Phase 2a trial testing AXA-1125 in Long Covid has reached full enrollment. This placebo-controlled trial that enrolled 40 patients with data expected in late 3Q22.  It also announced that the Phase 2 trial for AXA1125 in NASH (non-alcoholic steateohepatitis) is continuing with data announcement expected in early 3Q222, and that the Phase 2 trial in Overt Hepatic Encephalopathy (OHE) has been terminated.

Phase 2a Trial In Long COVID Data Expected In Early 3Q22.  This placebo-controlled trial enrolled 40 patients with  Long COVID symptoms.  Long COVID is estimated to affect about 20% to 30% of the patients who were infected, recovered or were asymptomatic, then develop post-infectious symptoms of fatigue, muscle aches, and clouded thinking (“brain fog”).  AXA1125 has shown improvement in metabolic function that improve energetics and reduce symptoms….

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Townsquare Media (TSQ) – Growth Appears To Be Accelerating

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Tuesday, May 31, 2022

Townsquare Media (TSQ)
Growth Appears To Be Accelerating

Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for approximately 26,800 SMBs; a robust digital advertising division, Townsquare IGNITE, a powerful combination of a) an owned and operated portfolio of more than 330 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data, and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 321 local terrestrial radio stations in 67 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com, and NJ101.5.com and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com and Loudwire.com.

Michael Kupinski, Director of Research, Noble Capital Markets, Inc.

Patrick McCann, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Non-deal road show highlights: This week Townsquare Media hosted a meeting for investors in St. Louis. Bill Wilson, CEO, accompanied by Stuart Rosenstein, CFO, and Claire Yenicay, EVP, highlighted the unique value proposition that the company brings to its local markets, in which its broadcasting business provides a launchpad for Townsquare’s digital media and digital marketing solutions businesses. Management expects to grow Digital revenue at 11.5% CAGR from 2021-2024. 

Small market sweet spot. Management noted that the company’s focus on markets outside the top 50 allows it to bring sophisticated digital marketing solutions to markets where it was very unsophisticated. Notably, since these markets are too small for larger operators, Townsquare has limited competition for its services….

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Comstock Mining Inc. (LODE) – Tapping into Major Growth Opportunities

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Tuesday, May 31, 2022

Comstock Mining Inc. (LODE)
Tapping into Major Growth Opportunities

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Annual General Meeting. Comstock hosted a well-attended annual general meeting on May 26 in Reno, Nevada. Management showcased its renewable energy businesses, including small-scale models of planned biorefinery and lithium-ion battery recycling facilities. Its renewable fuels division is advancing technologies to commercialize the conversion of woody biomass into advanced cellulosic fuels. Its lithium-ion battery (LIB) recycling business, LiNiCo, is commercializing a process to crush and separate lithium-ion batteries, extract lithium, nickel, cobalt, and graphite, and use the recovered metals to produce 99% pure cathode active precursor products.

Shareholder voting. Shareholders elected seven nominees to the Board, ratified the appointment of Comstock’s accounting firm, approved an advisory resolution for executive compensation, approved a change to the articles of incorporation, and approved the company’s 2022 equity incentive plan. With respect to the articles of incorporation, shareholders approved changing the corporate name to Comstock Inc. from Comstock Mining Inc. to better reflect the expanded scope of its business activities….

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

FDA Program May Help Investors Uncover Breakthrough Medical Technology

Posted on by cpatches

The FDA Breakthrough Devices Program may be a starting point for investors exploring the medical space. It’s designed to create a quicker path for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversible conditions. There are significant benefits for the companies granted access to the program. Lists of devices after the companies have been granted a marketing authorization are available on the FDA website.

While new pharmaceuticals tend to grab headlines quicker than devices, investors looking for public companies, that may be uncorrelated to the pace of US economic growth or the financial markets, may visit the website and then research the companies on Channelchek.

Image Credit: US Food and Drug Administration (Flickr)

Benefits of the Breakthrough Devices Program

The purpose of the Breakthrough Devices Program is to provide patients and health care providers with timely access to novel medical devices by speeding up their development, assessment, and review. At the same time, it preserves the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

Manufacturers have the opportunity to interact with the FDA’s experts through several different program options to efficiently address issues that present themselves during the FDA premarket review phase. This feedback from the FDA helps shorten the agreement phase. The company can also expect a prioritized review of its submission. This can have the effect of speeding the product to market with less cost and fewer problems.

How this Works

Pulling an example from the Channelchek library of videos from NobleCon18, we can use Perimeter Medical Imaging AI (PYNKF) to understand what a candidate looks like and how it may bring value to the patient, medical provider, and possibly investors.

Perimeter is an early-stage medical device company that expects its flagship product to address unmet cancer treatment needs. Initially, the device is expected to change the way breast cancer is treated and evaluated to improve outcomes and minimize the chance of recurrence or having to reoperate. In order to apply for the FDA designation, Perimeter’s device was indicated for breast cancer. However, the applications are expected to extend well beyond and into other major cancers in the $3.7 billion total market.

This FDA designation makes for a much more clear regulatory pathway. Perimeter meets the first guideline in that its product has unique technology (breakthrough) that is solving problems with a different method on a scalable platform. The procedures are expected to reduce the cost to patients, minimize the need for repeat surgery and be self-funding from the hospitals’ standpoint. This is because about 20 to 25% of cancer patients now need to return for a re-operation that costs approximately $16,000. Hospitals that adopt the Perimeter AI technology could serve patients better and stand to recover their costs while reducing overall patient costs on average.

Take-Away

There are many ways to uncover companies that are “on the move.” Reviewing those the FDA is likely to help along toward a full “go-ahead” is just one of them. For a more detailed look at Perimeter, their unique business model,  and technology, watch the 20-minute video below. For more on understanding the FDA Breakthrough Device Program in order to uncover companies that could change medicine, go to FDA.gov .

To evaluate small and growing companies, explore Channelchek beginning here.

Paul Hoffman

Managing Editor, Channelchek

Long-story-short-declining-oil-demand-expected-to-continue-into-2020

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Will the Oil Slowdown Provoke a Renewable Energy Takeover? 

The Organization of the Petroleum Exporting Countries cut its demand forecast for the second consecutive month on Wednesday. The OPEC reduced the expected use for the remainder of the year to 1.02 million barrels per day, which is down 80,000 b/d from the August estimate. This decrease is attributed to the weaker-than-expected economic data in the first half of the year.

FEATURE: Artificial Intelligence | Gold-mining

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Artificial Intelligence: Can an algorithm do what you do? AI will likely shape your future in more ways than you’d expect. More

Tribune
Publishing (TPCO) Behind
The Curtain Of The Company’s Surprisingly Good 2019 Guidance. More

Townsquare Media (TSQ) What Will It Take For The Shares To Break Out? More

Investors are still waiting for a gold-mining merger wave. Small and midsize gold miners need to join forces to survive, investors say. More


Energy Fuels Inc. (UUUU), a leading producer of uranium and vanadium in the United States, issues letter to shareholders. More

Tribune Publishing (TPCO), a media company, reports fourth quarter and full year 2018 results. Company delivers year-over-year net income growth driven… More

Harte-Hanks (HHS), a data-driven, omni-channel marketing solutions and logistics company, beats Q4 earnings and revenue estimates. More

FEATURE: Gene Editing | Townsquare | KeyW | Salem | Energy Fuels | Gene Therapy…

Posted on by Admin


CRISPR-Cas9: The Gene-Editing Tool That Could Fix Disease and Eradicate Cancer.
Is CRISPR-Cas9 the most influential scientific discovery of our generation? More 

Townsquare Media (TSQ) A Premium Valuation Appears Warranted. More

KeyW Holding Corporation (KEYW) Are needle moving contracts on the horizon. More

Salem Media Group (SALM) Why Investors Should Look Past The Soft Q1 Guidance. More

Energy Fuels (UUUU) Focusing On Vanadium Until Uranium Markets Improve; Trump To The Rescue? More


Making Profits, Saving Lives With Gene Therapy. After thirty years of development, gene therapy is seeing a surge of progress and profitability. Genprex Inc. (GNPX), Dyadic International Inc (DYAI), TrovaGene Inc. (TROV) and others… More 

TrovaGene, Inc. (TROV) , a clinical-stage, oncology therapeutics company, receives approximately $3.0 Million from exercise of warrants. More

Salem Media Group, Inc. (SALM), multimedia company specializing in Christian and conservative content, announces fourth quarter 2018 total revenue of $67.2 Million. More

NobleConXV Panel – Marketing Early-Stage Natural Resource Companies to Investors

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Voices of Experience: Marketing Early-Stage Natural Resource Companies to Investors.

We would like to invite you to watch the Natural Resources panel from NobleConXV (
January, 2019), hosted by Noble Capital Market’s two senior natural resource equity analysts, Mark Reichman and Michael Heim. This panel focuses on the challenges early-stage exploration companies face when raising capital in the public market and how to overcome these challenges. Mr. Reichman and Mr. Heim question five executives of exploration stage mining and oil and gas companies on alternative ways to raise money, the importance of a strong management team/board, the future of commodity prices, government influence/risks, technical reports, and other topics.

Panelists

•             Dr. Keith Barron, Chairman and Chief Executive Officer, Aurania Resources Ltd. (TSXV: ARU)

•             Mr. Gregory Crowe, President, Chief Executive Officer
and Director, Silver One Resources Inc. (TSXV: SVE)

•             Mr. Henk van Alphen, Chief Executive Officer and Director, Wealth Minerals Ltd. (
TSXV : WML)

•             Mr. John Brda, President
and Chief Executive Officer, Torchlight Energy Resources, Inc. (NASDAQ: TRCH)

•             Mr. Douglas Bartole, President and CEO, InPlay Oil Corp. (TSXV: IPO)

 

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Today on Channelchek

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