- Goal of FDA Breakthrough Device Program is to speed up development by giving priority to devices that treat life-threatening or irreversibly debilitating conditions

- Company preparing to begin SAVVE U.S. pivotal trial for VenoValve

- VenoValve is a potential treatment for approximately 2.4 million U.S. patients that suffer from severe Chronic Venous Insufficiency in the deep veins of their legs

IRVINE, CA / ACCESSWIRE / August 3, 2021 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI) ("Hancock Jaffe" or the "Company"), a developer of medical devices that restore cardiac and vascular health, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation status to the VenoValve®, the Company's lead product, which is currently set to begin its U.S. pivotal trial. The FDA's Breakthrough Devices Program was established to enable priority review for devices that provide more effective treatment or diagnosis of life threatening or irreversibly debilitating diseases or conditions.

The VenoValve is a potential treatment for a condition called Chronic Venous Insufficiency (CVI), a disease that afflicts approximately 2.4 million people in the U.S. CVI occurs when valves inside of the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and creating increased pressure inside of the veins of the leg (venous hypertension). CVI is a debilitating condition that can make everyday tasks such as bathing, sleeping, and walking extremely difficult for patients. There are currently no effective treatments for deep venous CVI.

"We are very pleased to have the opportunity to work with the FDA on an expedited basis as we try to bring relief to the millions of patients who suffer from deep venous CVI and who currently have no effective treatment options," said Hancock Jaffe CEO Robert Berman. "The VenoValve significantly improved the lives of the patients in our first-in-human study, and we hope to replicate that success in our SAVVE U.S. clinical trial."

Data from the VenoValve first-in-human study, presented in December of 2020, indicated that average patient improvement in reflux was 54 percent, average improvement in disease manifestations (measured by rVCSS scores) was 56 percent, and average improvement in pain (measured by VAS scores), was 76 percent, all at one-year post-VenoValve surgery compared to pre-surgery levels. In addition, there were no material adverse events (MAEs) at 30 days post-VenoValve implantation.

The primary endpoints for the Company's SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal trial will be the same as for the first-in-human trial: the primary safety endpoint is the occurrence of MAE in less than 10 percent of patients at 30 days post-VenoValve implantation, and the primary effectiveness endpoint is improvement of reflux equal to or greater than 30 percent at six months following VenoValve surgery. MAEs are defined as the composite of all-cause mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis (DVT), or pulmonary embolism. Improvement of VCSS and VAS scores are also included in the SAVVE study as secondary endpoints.

Preparation to begin enrollment of 75 patients at up to 20 centers throughout the U.S. for the SAVVE pivotal trial are being finalized, with the first patient expected to be enrolled in the study within the next 60 days. Interested patients can learn more about the SAVVE trial by visiting www.venovalve.com.

The goal of the FDA's Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving the Agency's mission to protect and promote public health.

Vote it up in the left top corner

https://www.reddit.com/r/wallstreetbets/comments/n5ydj4/10x_to_100x_multibagger_sos_price_targets_share/?utm_source=share&utm_medium=ios_app&utm_name=iossmf

Next GME with a borrow rate of 2.5 percent?
https://iborrowdesk.com/report/EBON

You should check SOS.
https://iborrowdesk.com/report/SOS

3.5 BTC, 63 ETH per day.
BTC: 64500 ; ETH: 2380.

375,690 dollar/day.
11,270,700 dollar/month.
137,126,850 dollar/year.

In their PR in February they announced the moment the third delivery is installed and up and running (now they are running on 65% capacity) they would be able to produce 3.5 BTC and 67 ETH per day.
Estimated back than at 200,000 dollar per day.

With today's prices that makes 366,000 dollar per day.

Third delivery shipment expected this week.

New videos of mining rigs online on their website

https://service.sosyun.com/sos_en/sosVideo.html

just got business news related to $idex from Taijiang district, (Fuzhou, Fujian Province, CN) government Weibo acc.
It settled business agreements with two local companies to provide financial technology, cold supply chain transportation logistics and new energy vehicle supports pic.twitter.com/RCbUtvcaG5

— topstarnec (@topstarnec) December 5, 2020

Easy predictable gap filing. Check at 3 minutes 24 seconds, this is the moment the bulls were waiting to load up more.

https://finance.yahoo.com/news/sunesis-pharmaceuticals-viracta-therapeutics-announce-123000277.html

I'm indeed here for the long game, my average is at 1.57.
But will not sell at 2, 3 or 4.

If the extra shares are used to acquire beautiful companies we shouldn't care.
Companies need money to grow.

Does anyone has an idea of the price of such a device?

Charles Pegelow, a patient who went through 2 stenting procedures and a major surgery, before finally getting successfully treated with Lumivascular Technology.
Discover his journey...

https://hubs.li/H0w9Vr40

CEO already said once that getting the FDA approval is not the key for other big pharma companies, but the data of their trials they do on patients in Colombia (Bogota).
Goal is to rather sell the company instead of bringing their products themself to the market.
Potential merger with similar companies can boost the value of the company ofcoure and the posibility of a buy out.

Great interviewer indeed, he asked really critical questions and wasn't afraid to put them on the table.

I'm already looking forward to the earning report of Q3 and Q4.

Like CEO said, some of the orders they reported in their PR's some months ago, are now getting full-filled.

Potential Catalyst:
$PRPO
Business Update Conference Call:
(Recently reported inline EPS & a sales beat of $1.65M vs $900.00K Estimate.

https://twitter.com/osuboy4/status/1295059618574598145/photo/1

=> This is big for BOXL

Up 15% in the premarket

On 11 August,the New Energy Vehicle and Renewable Energy Integration Forum opened in #Qingdao. The forum will focus on the trend, key techs, and applications of new energy vehicles and renewable energy integration. #China #EV #renewableenergy pic.twitter.com/wTJSR8tui0

— Qingdao Today (@QingdaoToday) August 11, 2020

Announced Review of Strategic Alternatives. In July, the Company announced plans to review strategic alternatives tomaximize shareholder value that can include asset in-licensing, partnering, and mergers and acquisitions. There can be noassurance that the strategic review will result in any transaction or other outcome. The Company does not currently intend topublicly discuss or disclose further developments of the strategic review unless and until its Board of Directors has approved atransaction or otherwise determined that further disclosure is appropriate

They have now 36 million in cash compared to 2.6 million previous quarter

They worked hard on their current cash position so i'm not afraid of that.

Almost zero revenues, seems like they transferred some streams to another company maybe?

Also, buy outs are announced by the acquiring party, not the company who gets buyed out.

Management and acquiring party must have picked up the rumours too.

Can't imagine they will wait too long to announce something if that is the next step.

https://fintel.io/so/us/snss

So Aisling Capital bought more than 10 million shares yesterday ;)

Fishy, ha!

CEO updated the end date of his carreer at SNSS from current to July.


This guy on twitter went over to the building where SNSS is located.
https://twitter.com/tluongg
Very little action overthere.

HR deparment is laid off, debts are gone, a lot of ongoing recommandations from employees on Linkedin.

Connect the dots ...

In May the had their earnings published on the 14th while the call was on the 19th.

I expect them to publish the ER tomorrow or thursday.

The real name is State Grid Corporation of China, the leading electric utility company in the world (refers to SGCC)
Just to let u know, this company made the Tesla gigafactory in china come alive🔌⚡️https://t.co/hu8cCueY2y pic.twitter.com/O9a9gSf6Gf

— Folken911 (@Folken911) August 9, 2020

https://www.kansas.com/news/business/biz-columns-blogs/carrie-rengers/article244214537.html

What a bullshit.
Tell me which companies that didn't start with debts to build up their market?
Some companies became big because of the huge debts they have.

Aren't these so called 'insider sell of' just execution of options being part of a bonusplan?
If you read the documents, than you see they have received these in 2018 and some are executed at each of every quarter.

https://www.benzinga.com/analyst-ratings/analyst-color/20/04/15896943/workhorse-has-huge-opportunity-with-usps-analyst-says-in-bullish-initiation

https://www.theverge.com/2020/5/14/21259037/usps-coronavirus-pandemic-next-generation-mail-truck-program-delay

Allegations against IDEX include that: (i) Ideanomics' Mobile Energy Global Division in Qingdao, China (the "MEG Center") was not "a one million square foot EV expo center" as the Company had stated in press releases; (ii) the Company had been using doctored or altered photographs of the purported MEG Center in Qingdao; (iii) the Company's electric vehicle business in China was not performing nearly as strongly as Ideanomics had represented; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.

LOL, is this the only proper thing they have?

100.000 square meter is still huge !
That's 350 meter on 300 meter !
(1km on 1km was not realistic to me so i thought already that it was is a miscommunication from the start to be honest)

$PDSB PDS Biotech is a seriously interesting stock

I bought for the Cancer therapeutic potential personally but the Vaccines and in particular potential COVID19 countermeasures make it look silly cheap at $2.50 ($40m Mkt Cap)pic.twitter.com/61ZlOElSfl

— Stockonomist (@Stockonomist) June 29, 2020

Know what you are buying

https://threadreaderapp.com/thread/1277279682564698112.html

Go IDEX

Have you lost money with financial advisor Mark Beloyan of Davie, Florida? We are investigating allegations made by FINRA, the Financial Industry Regulatory Authority, against Mark Beloyan. FINRA filed a regulatory complaint against Beloyan and TradeSpot Markets, Inc., in which Beloyan is the President, Chief Operating Officer, Chief Compliance Officer, and owner.



FINRA alleged that Beloyan and another financial advisor at TradeSpot Markets recommended penny stocks to customers without complying with Rule 15g-9 of the Securities and Exchange Act of 1934. FINRA further alleged that Beloyan failed to make affirmative determinations of suitability, in violation of this rule. FINRA notes that this conduct occurred while trading shares of Mondial Ventures, Inc. and STW Resources Holding Corp. It was alleged that Beloyan often entered information on the customer’s suitability form after the customer had signed it. FINRA seeks to fine Beloyan and TradeSpot Markets for this conduct.



Mark Beloyan is a financial advisor and registered representative of TradeSpot Markets, Inc. from 1992 to the present. He works at a branch office in Davie, Florida. Beloyan has been in trouble twice before with FINRA regarding sales practices violations, including at least once for penny stock issues.



Brokerage firms like TradeSpot Markets have a responsibility to adequately supervise all representatives who are registered through their firm. Brokerage firms also must take steps to ensure that their financial advisors follow all securities rules and regulations, as well as internal firm policies. When brokerage firms fail to adequately supervise their registered representatives, they may be liable for investment losses sustained by customers.



Israels & Neuman PLC is a securities and investment fraud law firm with offices in Denver, Colorado and the Seattle area. We represent investors in FINRA arbitration proceedings in all 50 states, including investors in Florida. Our attorneys have represented over one thousand investors against many brokerage firms in the past, including LPL Financial, Merrill Lynch, Morgan Stanley, Smith Barney, Stifel Nicolaus & Company, UBS Financial Services, Oppenheimer, Charles Schwab, Wells Fargo Advisors, Ameriprise Financial Services, Raymond James, ProEquities, Securities America, National Securities Corp., and many others.

http://www.israelsneuman.com/warning-impending-investigation-mark-beloyan-and-tradespot-markets-inc/

Seems like mark beloyan is still scamming people.

My Belgian bank doens't allow pink sheets OTC any longer.
I need to sell or give them to the bank itself.
Not a single belgian bank is allowing to store these kind of shares anylonger. (unless you pay 200 euros per year)
I guess giving them away for free is the best solution, as this dead body is already eaten.
Unfortunately i'm again confronted with this fucking scam who destroyed a lot in my young life.

Well actually in Belgium tap water already has around 8+ PH value, so there is no need for this I think.

Hi longs..
It all sounds good but still the share price doesn't react..
Hope to hear some PR from the compnany soon..


ps: if this stock survives and goes to my entry point ever again, I'll go on a pilgrimage..

promised

We have a 11,200 volume so far

PING ALERT !!!