InVivo Therapeutics Holdings Corp (NVIVQ)

[weedtrader420]

WOW NVIV$$$$$WOOHOOOOOOOOOOO $5 TARGET PRICE

[BesaoT35]

After all the reverse splits and falling prices the market cap for NVIV is very low. It is below $10 million. If the neuro - spinal scaffold (NSS) is a success it has to be worth more than that I think. The first trial was a success. That makes me think the Inspire 2 could be successful. This is all before even using stem cells or growth factors.

After all this time NVIV might have competitors whereas a few years ago there were no direct competitors.

What do people think NVIV would be worth after approval for use of the NSS and then use of stem cells?

I do know that management is corrupt and perhaps incompetent as well. I think our previous CEO Dr. Reynolds actually is in jail or soon to be sentenced to go to jail. That is real undeniable corruption.

This is all a shame. I think about helping patients and how all the delay has hampered finding treatment.

[steeley1]

This is a serial diluter. They keep issuing shares and then do a reverse split and then keep issuing again. Nice game of fleecing innocent investors of their hard earned money.

*hucksters*

I would stay away

see NVIV share dilution here...only facts...no BS

[BesaoT35]

Is it still at 6 patients so far? Is NVIV cautiously conserving the cash on hand. What is the monthly burn rate? Thanks in advance.

[BesaoT35]

What is the current cash on hand? What is the cash burn per month? Thanks.

[NCMadman]

New offering 3m shares at $1.75 effective immediately. Closing on Fri. Tanking after hours.

[finwizroger]

Low floater here
Could move up real fast with good news

[ClayTrader]

* * $NVIV Video Chart 04-14-2020 * *

Link to Video - click here to watch the technical chart video

[stockdawg44]

Hope all is well Xena, disregard that PM....

was a nice flip, will keep an eye for more...

2.05 to $2.65, got lucky the momo came in just now....

$2.23 now....

be well....

[XenaLives]

1 and 3 day charts - split corrected.

When TDA fails to correct for splits I always feel like there's a reason they don't want folks looking at an accurate chart. This uses Yahoo data.

[Klinsmann]

Also in - on watch for a long time already. Just have been waiting for volume

[TradeSmart.ai]

$NVIV I’m in!!! DD here:
* 570,000 public float
* $11+ in cash a share
* New updated website
* Huge gap to fill around $4
* Last offering was at $2.75

[yankees18]

Finally some vol

[BesaoT35]

Thanks Lazed. With the recent offering I think there is less than 3.5 million shares outstanding. At $1.27 NVIV market cap is around $4.2 million. The NVIV company has now $7 million in cash. The expenses are mostly paying executive salaries and bonuses.

The first spinal surgery trials showed big promise but at the very end one patient died , but the death was totally unrelated to spinal surgery. The addition of nerve growth factors and/or stem cells could increase positive patient outcomes in the future. This should be a high priority area of research.

To start to have an effective treatment for paralysis in humans , where in the past there was no treatment at all, should be worth something, but the stock market sees little or no value in the Neural spinal scaffold (NSS) it seems.

How much more money will NVIV need to spend before completion of Inspire 2.0? Do the research medical centers bill NVIV for all the surgical costs and follow up care? Is it around 24 patients total?

Thanks.

[Lazed]

Minimum 18 months before results. Likely closer to 24 months as slow as enrollments have gone so far.

They are estimating full enrollment by the end of 2020. Then you will have to wait for 6 months for the last patient to complete.

[BesaoT35]

Is the market cap now lower than the cash on hand?

What percentage of the market cap are the annual executive salaries? Perhaps these benevolent people could suspend their salary for one year to help the company survive and so shareholders do not get diluted further.

With 16 medical centers now participating in the spinal injury treatment trials how long are we expecting to wait for trial results? Thanks.

[eebbee]

Intriguing chart on this one now.

[MARINO]

I'm in for flip

[XenaLives]

NVIV was not involved in security fraud. This statement is misleading:

NVIV SEC SECURITY FRAUD...CEO ARRESTED

The truth:

Reynolds founded PixarBio after resigning as chief executive of Cambridge, Massachusetts-based biotechnology company InVivo Therapeutics Holdings Corp (NVIV.O) in 2013.

According to the criminal complaint, Reynolds in a 2015 email to potential investors claimed PixarBio had a $1 billion valuation that was expected to increase as “we prepare to replace morphine in the clinic in late 2017 or early 2018.”

In reality, PixarBio was never worth $1 billion and had not even finished the work required to seek permission to conduct human drug trials, the complaint said.

In January 2017, at Reynolds’ direction, PixarBio issued a press release entitled “It’s Time to Make US Pharma GREAT Again,” announcing a $77 million takeover bid for Invivo, the complaint said.

https://www.reuters.com/article/us-biotech-pixarbio-court/biotech-ceo-two-associates-accused-by-u-s-of-securities-fraud-idUSKBN1HV2YO

[XenaLives]

Clinical trial, last update 2/3/2020

Brief Summary:
This is a randomized, controlled, single-blind, multicenter, two Arm (Treatment or "Scaffold" Arm; Standard of Care or "Comparator" Arm) of a Neuro-Spinal Scaffold to evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12 spinal cord injury as compared to standard of care open spine surgery.

Condition or disease Intervention/treatment Phase
Injury, Spinal Cord
Device: Neuro-Spinal Scaffold
Not Applicable

Detailed Description:
This is a randomized, controlled, single blind, two-arm, multicenter Humanitarian Device Exemption (HDE) study to evaluate the safety and probable benefit of the poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold ("Scaffold") in subjects with thoracic AIS A traumatic spinal cord injury at neurological level of injury of T2-T12 as compared to standard of care open spine surgery. Subjects will be randomized in a blinded manner to one of two study arms, the Treatment or "Scaffold" Arm and the Standard of Care or "Comparator" Arm. Subjects in the Scaffold Arm will have the Scaffold implantation immediately following standard of care open spine surgery. Subjects in the Comparator Arm will have standard of care open spine surgery and will not receive the Scaffold. The subjects will be blinded to their study arm for the duration of the study.

Primary Objective: To evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12 spinal cord injury as compared to standard of care open spine surgery.

Regulatory Objective: To enhance the clinical evidence for the Scaffold in the treatment of complete thoracic spinal cord injuries.

Intended Use: The Scaffold is intended for use in patients age 16-70 years diagnosed with a T2-T12 neurological level of injury functionally complete (AIS A) spinal cord injury for whom open spine surgery, (e.g., laminectomy, spine stabilization) which allows access to the dura of the injured spinal cord, is recommended as an option. The Scaffold is intended to be implanted in a cavity at the epicenter of the spinal cord contusion during open spine surgery. The Scaffold is intended for use in recent (=7 days) spinal cord injuries that do not involve penetrating injury to the cord or complete severing of the cord.

https://clinicaltrials.gov/ct2/show/NCT03762655?term=invivo+scaffold&draw=3&rank=3#contacts

[XenaLives]

Interesting charts post R/S..

[420man]

.12

[ClayTrader]

* * $NVIV Video Chart 01-21-2020 * *

Link to Video - click here to watch the technical chart video

[XenaLives]

Institutional ownership:

 
  
 Security	NVIV / InVivo Therapeutics Holdings Corp (46186M209) 
 Industry	Surgical and Medical Instruments and Apparatus 
 Institutional Owners	28 
 Institutional Shares	692,766 - 7.28% 
 Common Shares Outstanding	9,519,570 shares (as of 2019-09-30) 
 Institutional Value	$ 342,000 USD 
  
 File Date	Form	Investor		Opt	Avg Share Price	Shares	Shares Changed 
   
   
 2019-11-13	13F	Renaissance Technologies LLC		0.62	481,354	10.00	241	-25.62			 
 2019-11-14	13F	VANGUARD GROUP INC			0.63	85,892	0.00	44	-31.25			 
 2019-11-14	13F	BRIDGEWAY CAPITAL MANAGEMENT INC	0.64	25,000	0.00	13	-31.58			 
 2020-01-15	13F	IMS Capital Management			23,472		5				 
 2019-11-08	13F	BlackRock Inc.			       0.60	19,955	0.00	10	-28.57			 
 2019-11-13	13F	NORTHERN TRUST CORP			0.63	15,074	0.00	8	-27.27			 
 2019-11-14	13F	UBS Group AG			       0.26	13,488	23,563.16	7				 
 2019-10-30	13F	Paulson Wealth Management Inc.		0.58	11,250	0.00	6	-14.29			 
 2019-11-12	13F	GEODE CAPITAL MANAGEMENT, LLC		10,036		5				 
 2019-11-14	13F	MORGAN STANLEY			       0.69	4,295	-0.79	2	-50.00			 
 2019-11-12	13F	Next Capital Management Llc		0.88	1,139	0.00	1	0.00			 
 2019-11-13	13F	Advisor Group, Inc.			0.54	923	0.00	0	-100.00			 
 2019-10-15	13F	Valeo Financial Advisors, Llc		0.00	454	0.00	0				 
 2019-11-14	13F	LADENBURG THALMANN FINL SERVICES INC	0.00	181	0.00	0				 
  
  
 

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

[XenaLives]

Repost of linked post frin 4/18

NVIV EX CEO ARRESTED FOR SECURITIES FRAUD>>

In January 2017, at Reynolds’ direction, PixarBio issued a press release entitled “It’s Time to Make US Pharma GREAT Again,” announcing a $77 million takeover bid for Invivo, the complaint said.
PixarBio in fact lacked the ability to make the bid, the complaint said, yet a day later announced it had upped its offer to $100 million. The SEC subsequently suspended trading in PixarBio.

[XenaLives]

InVivo Therapeutics Announces Enrollment of First Two Patients into the INSPIRE 2.0 Study for the Treatment of Acute Spinal Cord Injury
May 29, 2019 08:00 AM Eastern Daylight Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that the first two patients have been enrolled into The INSPIRE 2.0 Study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury).

“We appreciate the investigators’ continued focus and willingness to support not only this trial, but also this underserved patient population. Ultimately, we hope to address a large unmet medical need for spinal cord injury patients”

Tweet this
“Having the first two patients enrolled into the INSPIRE 2.0 Study is a critical milestone for the company and for the spinal cord injury patient population, as there continues to be inadequate treatment options for these patients. With eight clinical sites now open for enrollment, we remain optimistic about continuing to execute on the INSPIRE 2.0 study and will provide updates when appropriate,” commented Richard Toselli, M.D., President and Chief Executive Officer of InVivo.

The INSPIRE 2.0 Study is a two-arm 20-patient (10 subjects in each study arm), randomized, controlled trial designed to provide clinical data that will supplement the existing clinical results from the company’s previous single-arm study (INSPIRE 1.0). The definition of study success for the INSPIRE 2.0 Study is that the difference in the proportion of subjects who demonstrate an improvement of at least one grade on ASIA Impairment Scale (AIS) assessment at the six-month primary endpoint follow-up visit between the Scaffold Arm and the Comparator Arm must be equal to or greater than 20%.

“We appreciate the investigators’ continued focus and willingness to support not only this trial, but also this underserved patient population. Ultimately, we hope to address a large unmet medical need for spinal cord injury patients,” concluded Dr. Toselli.

INSPIRE 1.0 Study Results

As previously announced by InVivo, 7 of 16 (44 percent) patients who reached the six-month primary endpoint visit in the INSPIRE 1.0 Study had an AIS conversion at 6 months, which is the primary endpoint of the INSPIRE 1.0 Study (defined as improvement in AIS grade from baseline for all evaluable patients at the six-month visit). Altogether, 19 patients were implanted with the Neuro-Spinal Scaffold in the INSPIRE 1.0 Study, which is officially closed. Three patients died within two weeks of implantation, each death deemed unrelated to the Neuro-Spinal Scaffold or implantation procedure by the respective site’s Principal Investigators. The Objective Performance Criterion (study success definition) for the INSPIRE 1.0 Study was a 25 percent AIS conversion rate based on the published conversion rates for thoracic spinal cord injury reported in the literature

https://www.businesswire.com/news/home/20190529005268/en/InVivo-Therapeutics-Announces-Enrollment-Patients-INSPIRE-2.0

[XenaLives]

Where did the $16 million go?

Why the need to raise $840K

 
 CAMBRIDGE, Mass. (November 22, 2019) – InVivo Therapeutics Holdings Corp. (NASDAQ: NVIV) today announced the closing of its previously announced public offering of 7,000,000 shares of its common stock, par value $0.00001 per share, at a price to the public of $0.12 per share. The gross proceeds from this offering are $840,000, before deducting the fees and estimated offering expenses payable by InVivo Therapeutics. The offering closed on November 22, 2019. 
  
 H.C. Wainwright & Co. acted as exclusive placement agent for the offering. 
  
 A registration statement on Form S-3 (File No. 333-234353) relating to the shares of common stock offered in the offering was filed with the Securities and Exchange Commission, or the SEC, and was declared effective by the SEC on November 14, 2019. The offering was made only by means of a prospectus supplement and accompanying base prospectus, which are part of the effective registration statement. A final prospectus supplement related to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, via e-mail at [e-mail] or via telephone at [phone]. 
  
 This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. 
  
 

https://www.invivotherapeutics.com/press-releases/invivo-therapeutics-announces-closing-of-public-offering-of-common-stock/

[XenaLives]

They seem to be able to raise money as needed:

As of 4/19 - see replied to post:

We have $16.66 million in cash and our market cap is $14 million.

[XenaLives]

OK - they have the science...

From the intro:

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit http://www.invivotherapeutics.com.


Management: http://www.invivotherapeutics.com/about-us/our-team/
Ongoing Human Trials: https://clinicaltrials.gov/ct2/results?term=%22invivo+therapeutics%22&Search=Search
SEC Filings: http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001292519&owner=exclude&count=40&hidefilings=0
Recent News: http://finance.yahoo.com/q/h?s=NVIV+Headlines
Share Structure: http://www.otcmarkets.com/stock/NVIV/profile

[CyrusDaVirus]

Hmm i dont like what I am seeing

[CyrusDaVirus]

Nice

[ClayTrader]

* * $NVIV Video Chart 01-06-2020 * *

Link to Video - click here to watch the technical chart video

[FooBarAndGrill]

No news. No updates at https://clinicaltrials.gov/ct2/show/NCT03762655

Pump and dump.

[ClayTrader]

* * $NVIV Video Chart 12-30-2019 * *

Link to Video - click here to watch the technical chart video

[TraderUsa]

Low float here!

[TraderUsa]

Kabooom! Next stop in $0.45!!!

[ClayTrader]

* * $NVIV Video Chart 12-03-2019 * *

Link to Video - click here to watch the technical chart video

[willlbone]

Dilution at 12 cents.

[BesaoT35]

Perhaps it is the fear of probable reverse splits and subsequent dilution that causes potential investors here to take a pause. I totally believe in the science and the observed results in animals and people. Once we add stem cells and nerve growth factors it could have a dramatic positive result. We do not have a direct competitor to my knowledge. At some point a stock like this should start to move up in price.

[kingofthepuppies]

Prior trial had 43% of paralyzed patients converting. Current FDA trial has 9 sites recruiting. No competition. SP $0.70 not $7.00.

[kingofthepuppies]

Prior trial had 43% of paralyzed patients converting. Current FDA trial has 9 sites recruiting. No competition. SP $0.70 not $7.00.

[BesaoT35]

Two patients have been enrolled. This was announced 5/29. NVIV is down after that news. This is counterintuitive.

[FooBarAndGrill]

It's no secret.
https://clinicaltrials.gov/ct2/show/NCT03762655?term=invivo+scaffold&draw=3&rank=3#contacts

[BesaoT35]

In the proxy the company ,NVIV, wants me to authorize 1,000,000 shares of “blank check” preferred shares. Is this a good idea? What is the meaning of blank check preferred shares?

[DDobserver]

Jesi latest video. Amazing results from a few years ago.
https://es-la.facebook.com/jesistracham/

I had the same experience with this stock. Now it is a tax write off. Management milked this one dry. However, Jesi's results are fantastic.

[Spudskie]

Ditto.

[GrannyAnnie]

I bought shares of NVIV at initial opening a few years ago. My cost was $1500.00 and today is worth $5.50. Beware of this company. Someone is getting rich, it is not me.

[Lazed]

When they had 30 sites they could only manage to enroll one per month. It also matters which sites they have. There were plenty of sites that never enrolled a patient and some sites that enrolled 2-4

[BesaoT35]

My understanding is that 5 medical centers are open for patient enrollment. My question is why are there no new patients that have been enrolled? Are suitable patients turning down treatment?

[BesaoT35]

We have $16.66 million in cash and our market cap is $14 million.