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Wait until the 10q's. You may be correct after that.
Yes...they can use it right now. Just need a license
Of course it's hopeful and the FDA will NOT, NOT, NOT be approving it.... Because it is absolutely unnecessary. Let's move on.
Beautifully written LJ!
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SOURCE: IntelliCell BioSciences, Inc.
IntelliCell BioSciences, Inc.
August 01, 2014 13:52 ET
IntelliCell BioSciences Files Pre-IND With FDA for Osteoarthritis Lead by Dr. James Andrews
NEW YORK, NY--(Marketwired - Aug 1, 2014) - IntelliCell BioSciences, Inc. ("IntelliCell" or the "Company") (OTCQB: SVFC), a regenerative medicine company utilizing adult autologous stomovascular cells (SVCs) derived from the blood vessels found in adipose tissue, announced today that it has filed its pre-IND with the FDA for a clinical trial in osteoarthritis of the knee under an Investigational New Drug Application (IND). Dr. James Andrews, the legendary orthopedic surgeon will be the principal investigator for the study. inVentiv Health Clinical will serve as the Clinical Research Organization (CRO) for the conduction of this clinical trial in osteoarthritis of the knee in accordance of an Investigational New Drug.
IntelliCell BioSciences and Dr. James Andrews are developing the investigational clinical study protocols in collaboration with inVentiv Clinical, functioning as the CRO. The clinical trial will be conducted at the Pensacola Center of the Andrews' Research and Educational Institute in conjunction with Dr. Adam Anz and Dr. Josh Hackel, prominent physicians at the Institute. To date, IntelliCell's technology for isolating stromal vascular fraction cells from the vasculature of adipose tissue has been used to successfully treat over 60 knees with results lasting as long as 5 years.
IntelliCell's Chief Executive Officer, Dr. Steven Victor, remarked, "This is a pivotal point for IntelliCell BioSciences as it will be what we believe to represent the first of many clinical trials that the company will undertake and establish the company as a leader in the cellular therapy segment of the biotech industry. This IND study is important for verifying the company's patented technology of utilizing Ultrasonic Cavitation as a method of separating stromal vascular fraction cells from lipoaspirate. We believe that IntelliCell's Stromal Vascular Fraction Cells will offer people with OA a new and improved approach to gaining significant improvements in their qualities of life. We at IntelliCell are excited to have this opportunity to work with the distinguished Sports Medicine Orthopedic Surgeon, Dr. James Andrews, who will be the principal investigator of this clinical trial."
According to Raymond Hill, President of inVentiv Clinical, "inVentiv Clinical has extensive therapeutic experience in general pain and osteoarthritis programs and a focus on partnering with innovative bioscience companies. We are looking forward to our working with Dr. Andrews and contributing to advances in the treatment of osteoarthritis in knees."
Dr. James Andrews said, "We are excited that we will have the opportunity to work with inVentiv Clinical Health as the CRO for our IND study of osteoarthritis of the knee using IntelliCell's technology. It will be research like this at the Andrews' Research and Educational Institute in collaboration with IntelliCell BioSciences and inVentiv that will further our research in the use of the biologics for the treatment of the osteoarthritic knee. We believe, based on antidotal evidence of others, that this cellular therapy has the potential to be a game changer."
About IntelliCell Biosciences
IntelliCell is a pioneering regenerative medicine company focused on the expanding regenerative medical markets using adult autologous stromal vascular fraction cells (SVFCs) derived from the blood vessels in the adult adipose tissue. IntelliCell BioSciences has developed its own patented technology and protocol to separate adult autologous vascular cells from adipose tissue without the use of enzymes. IntelliCell will also be seeking to develop technology-licensing agreements with technology developers, universities, and international business entities.
About Dr. James Andrews
Dr. James Andrews is internationally known and recognized for his scientific and clinical research contributions in knee, shoulder and elbow injuries, as well as his skill as an orthopedic surgeon.
Dr. Andrews is a founding partner and medical director for the Andrews Institute in Gulf Breeze, Florida. In addition, he is a founding member of the American Sports Medicine Institute (ASMI).
Dr. Andrews has been the mentor for more than 250 orthopedic/sports medicine fellows and more than 45 primary care sports medicine fellows. Involved in education and research in sports medicine and orthopedic surgery, he has made major presentations on every continent, and has authored numerous scientific articles and books.
About Osteoarthritis Arthritis of the Knee
Osteoarthritis (OA) also known as degenerative arthritis or degenerative joint disease or osteoarthrosis, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone. Symptoms may include joint pain, tenderness, stiffness, locking, and sometimes an effusion. As a result of decreased movement secondary to pain, regional muscles may atrophy, and ligaments may become more lax.
Treatment generally involves a combination of exercise, lifestyle modification, and analgesics. If pain becomes debilitating, joint replacement surgery may be used to improve the quality of life. OA is the most common form of arthritis, and the leading cause of chronic disability in the United States. It affects about 1.9 million people in Australia, 8 million people in the United Kingdom and nearly 27 million people in the United States.
About inVentiv Health Clinical
inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies, offering therapeutically specialized capabilities for Phase I-IV clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. inVentiv Health Clinical is part of inVentiv Health, Inc., a life science knowledge and services company purpose-built for the new healthcare marketplace. inVentiv has created a new model by converging a vast range of essential services to fully align with our client's development and commercialization goals. For more information, visit www.inventivhealthclinical.com.
Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements." Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning," "expect," "believe," "will likely," "will reach," "will change," "will soon," "should," "could," "would," "may," "can" or words or expressions of similar meaning. Such statements are not guarantees of future performance and are subject to risks and uncertainties that could cause the company's actual results and financial position to differ materially from those included within the forward-looking statements. Forward-looking statements involve risks and uncertainties, including those relating to the Company's ability to grow its business. Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties include, among others, the Company's limited operating history, the limited financial resources, domestic or global economic conditions, activities of competitors and the presence of new or additional competition, and changes in Federal or State laws. More information about the potential factors that could affect the Company's business and financial results is included in the Company's filings, available via the United States Securities and Exchange Commission.
CONTACT INFORMATION
Contact:
IntelliCell BioSciences, Inc.
Investor Relations
Anna Rhodes
Email Contact
Stem cells, like other medical products that are intended to treat, cure or prevent disease, ***GENERALLY••• require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.
From you quoted section. I would argue that Intellicell's will not.
Up to .02
If they cited the company in guidance they will.
Intellicell owns SVFC. Simple fact
You may call the FDA now.
Thank you! Also important to balance with: https://maxim.bluematrix.com/sellside/EmailDocViewer?encrypt=d55ec1b6-7819-4681-8faf-088d353592b4&mime=pdf&co=maxim&id=svictor@intellicellbiosciences.com&source=mail
Fda steps out of the way!
Updated: Tennis Star Nadal to Get "Stem Cell" Treatment. PRP? Lab-grown MSCs? Both? What are the risks? ipscell.com/2014/11/tennis… #stemcells
03:38 PM - 11 Nov 14
Responding to trend analysis. It's just reasonable given what we are watching. MMs are busting up the price, not the technology.
Okay: when the financials demonstrate intellicell's improving status(and they do) how will that change the prediction factors, leaving the current facts alone?
Facts....so...if the 10q, new, financing, etc changes SVFC's outlook and predictions regarding the launch towards 0.02 turn out to be true, how would that alter the current factual landscape (without making the current facts less true)?
Reality- it's always what part of the elephant you attend to and what parts you might choose to ignore. (I'm using "you" in the general sense.) there are fundamentals of this company that should not be ignored any more than #'s.
SVFC will soon prevail on fundamentals and #'s are improving!!!
Time marches on. As luck has it, not all history repeats itself. The restated financials and Intellicell's learning seems to suggest that they are learning. The BOD is improving. Regardless of who/how the audit was required, it reflects a path to correction. Improved revenues, licenses, etc, will result in increases in the PPS. The Toxic Debt Spriral....
Is
Going
Away
Get on the train.
Remember: http://m.bizjournals.com/pittsburgh/blog/morning-edition/2014/05/hoge-joins-board-of-intellicell-biosciences.html?r=full
Other athletes will be following
When a company builds a technology and investors invest, hope follows. It's pretty easy to say it won't succeed for one of a hundred reasons. In this case, Intellicell appears to be emerging from a very difficult period with a much improved plan and having learned a lot from its past. The next 10q is an important one for all of us, but not while ignoring the other things that are also transporting. Refinancing, IND, FDA acquiescence, licensing, new board members, interim CFO, appearances of interest to merge/venture or be acquired...
Interesting times. I for one would rather be long. ??
Whether about his derm practice or Intellicell, news is news. The media teams job is to convert his opportunities for face time into product identification. It's coming. Wait. Remember, we have restated financials, two good firms working w us now, a PR firm that's been hired, and an FDA that will step out of the way. The $ is coming.
Hot Medical Stocks To Own Right Now: Intellicell Biosciences Inc (SVFC)
Intellicell Biosciences, Inc., formerly Media Exchange Group, Inc., incorporated on March 8, 1999, is engaged in regenerative medicine company focused on the expanding regenerative medical markets using a process to separate adult autologous vascular cells (AAVC's) from blood vessels in adult adipose (fat) tissue. The Company is also exploring and undertaking, either on its own or in collaboration with a third party, providing a service for the collection, processing and storage of autologous cells for future use. As of December 31, 2011, the Company has developed technologies that allow reproducible separation of stromal vascular fraction (IntelliCell) containing adipose stem cells that can be performed in tissue processing centers and in doctors??offices. On June 3, 2011, the Company completed the acquisition of Intellicell Biosciences, Inc. The Company formed a wholly-owned subsidiary, ICBS Research, Inc.
The Company's process involves the application of ultrasonic cavitation (sound waves) to the extracted adipose tissue, which results in the separation AAVC's from the blood vessels in adult adipose (fat) tissue. This AAVC, or stromal vascular fraction (IntelliCells), are removed from the patient at the point of care, and separated at the point of care under the supervision of its certified technicians following current good manufacturing practices (cGMPs) and current good tissue practices (cGTPs), and the cells are then returned to the medical professionals at the point of care for use a patient's own body (autologous treatment), by way of a same-day clinical procedure for homologous use of these cells.
Intellicell Biosciences, Inc., formerly Media Exchange Group, Inc., incorporated on March 8, 1999, is engaged in regenerative medicine company focused on the expanding regenerative medical markets using a process to separate adult autologous vascular cells (AAVC's) from blood vessels in adult adipose (fat) tissue. The Company is also exploring and undertaking, either on ! its own or in collaboration with a third party, providing a service for the collection, processing and storage of autologous cells for future use. As of December 31, 2011, the Company has developed technologies that allow reproducible separation of stromal vascular fraction (IntelliCell) containing adipose stem cells that can be performed in tissue processing centers and in doctors??offices. On June 3, 2011, the Company completed the acquisition of Intellicell Biosciences, Inc. The Company formed a wholly-owned subsidiary, ICBS Research, Inc.
The Company's process involves the application of ultrasonic cavitation (sound waves) to the extracted adipose tissue, which results in the separation AAVC's from the blood vessels in adult adipose (fat) tissue. This AAVC, or stromal vascular fraction (IntelliCells), are removed from the patient at the point of care, and separated at the point of care under the supervision of its certified technicians following current good manufacturing practices (cGMPs) and current good tissue practices (cGTPs), and the cells are then returned to the medical professionals at the point of care for use a patient's own body (autologous treatment), by way of a same-day clinical procedure for homologous use of these cells.
The Company competes with Cytori Therapeutics, Stem Cell Assurance, Inc., Osiris, Aastrom Biosciences, Aldagen, BioTime, Baxter International, Celgene, Geron, Harvest Technologies, Mesoblast, Regenexx, NeoStem, X-Cell Center, Stem Cells, Athersys, and Tissue Genesis, Life Technologies, Asterand, pacific biosciences of california inc. and AllCells, LLC.
My prediction: the ASK will continue to thin...the 10q will be out on time, and the financials will continue to improve. YA will be shown the door,but will have profited. New financing is on the wing if not present. 8k's are coming...with new coordinated media.
I like the .02 goal previously mentioned. Pretty reasonable in the short term. Nice pick up for those of us that loaded down here.
DAMN!
They won't have the debt load. They will have better financial backing that understands their product and the industry. Coming are IND's, licensing, patents, media campaigns, for the very best technology available. This is undervalued and will be discovered quickly...and soon. IMO...but duh.
We are waiting for a KNOWN, media cycle to start. Known! It's coming. Just like the coming 8ks that will give us good news and a better 10K. The CEO position will ultimately change sometime and patents/licenses and IND ARE coming. Intellicell is NOT going bankrupt and, IMO, there is no risk of a lost of patent to anyone. No R/S and toxic financing will be a thing of the past. New partners will emerge and revenues will continue to rise.
Intellicell ... hang on. This will be fun. Just wait a little while longer (30 million shares & adding + long.)
What if...it's not Intellicell selling shares? I think Intellicell is not dumping shares. I also think their patents are safe, their is no chance at bankruptcy, and a media campaign is getting ready to start. None of this is conjecture on my part. I'm just waiting for the 8k, the Patents, the licenses, more news, the turn around that's coming...and my $. That's about it. ??
I picked up 9+ million shares moments ago. Couldn't help myself. I'm averaged down to .0012 with 30+ million shares. I sure wish I had started purchasing at trip 1 and 2.... But I didn't. I'd have share collections like many of you longs.
This technology has me very excited. The silence related to what they must due financially is understandable. The PR and media are coming - I'm certain of this (like I know the sun will rise tomorrow). IND, Patents, licenses are all on the real event horizon. They won't be small. This is the real thing and we just have to wait patiently. Ignoring stupidity or distraction is part of being able to lead. If we do this, we lead others into a remarkable investing opportunity. Imo
Completely false.
This morning I spoke w someone at Intellicell. It's very clear to me that things are energetically moving forward in a very positive way on a number of fronts. First and foremost, the toxic debt is being retired. It will be done before March 15---with certainty. There is a very well designed, professional medial campaign coming, likely to be launched before early December. The BOD will become much more active and apparent in their activity shortly after the debt has been retired.
Dawson James is doing its job and there is excitement building about this.
Finally, Dr Vic recognizes the value of having another person serve as CEO. Selecting that person requires a little more time. However, he is getting excellent counsel now from his board, attorneys, Dinosaur, and Dawson James.
They have had an independent valuation done for Dawson James. It won't be published, but it was considerably higher than what is currently published. The goal for Dawson James is to get the PPS to at least equal to industry peers.
Man...hang on. This is not your ugly uncle 's sub penny stock!!!!!
I feel better and better about my investment. Much. This ship will turn.
Did my share, increased my portfolio and averaged down today. Who buys huge shares...and keeps large blocks of a dying company? Too many smart people on this board know that there are companies, etc in accumulation mode.
Like the rest of the longs, I am just waiting for news that we know will come. The "facts" that are repeated here also include recent FDA guidance that KEEPS the door open for what Intellicell has been doing- references to the need for a "stamp of approval" from the FDA are simply false. It is NOT needed - particularly not now with the clarifying guidance. Intellicell gets to move on -> without interference from the FDA if they continue to harvest and return stem cells in the current manner. Period. End of story. Let's talk about something else.
The BOD is advancing...not retreating. Recent financials and 8k's point to an improving portrait. This stock has been manipulated and ravaged. Now new players are taking over. It will be interesting to see how much $ they make and...how much longs will profit now. I think we all know it's coming.
Raymond Hill is not a industry hack. Neither is Andrews. More attention to the former - interesting that shortly after the inclusion of Hill on the BOD that financials were assertively reassessed and new financial arrangements were constructed (ultimately with the result of cleaning up the toxic debt). Interesting
Obviously this is full of my opinion - observations of evolving trends.
SVFC- massively undervalued compared to its industry peers. Duh. I can't wait until it's valuation just hits ½ of its peer group!
Nov 15. It will show continued improvement. MO.
Thank you for continuing to inject sanity into this quagmire.
It's important to continue to point out that early entrance into biotech landscape is terribly difficult for any company. In this case, Dr Vic is a good doc and maybe not such a great CEO. *However*, he was smart enough to surround himself w good attorneys and weathered the IR fiasco. He has associated himself with Andrews and now Raymond Hill. The new Interim CFO + accounting firm, financial restatements, looming licensing arrangements, IND, patents, restructured financial relationships, reduced debt, a technology that makes sense, an anticipated media campaign, .... come on...can anyone really ignore that something positive regarding pps is coming too?
This is an easy read. Cheap investment, minimal risk/downside now, and remarkable potential for $.
My take: this is why Inventive is involved now.
In my opinion, the new financiers are buying up most of the existing float as a kind of preemptive buyback. Cheap! This leaves a small amount of stocks on the table for retail to drive the pps up. YA will be paid off, iND will start, patents will come, new board, media campaign, and rapid escalation of PPS with licensing agreements.
Imo.
Finally, I presume Hubiak left because it was simpler for Roshe to deal with the board if the man they let go was gone. At this point, Vic may only be a figure head.
Sure, why not? Makes my wallet happy.
Not so far. I've asked for millions....if I can get them.
Is this related at all to what people are discussing now...
Meeting Of The Minds_Roche CEO To Meet With IntelliCell BioSciences (SVFC) BOD In New York City Next Monday Predicts Sierra World Equity Review
Latest Projections: Meeting Of The Minds_Roche CEO To Meet With IntelliCell BioSciences (SVFC) BOD In New York City Next Monday Predicts Sierra World Equity Review. Shares of SVFC were unchanged during Monday's session. Look for the official news coming, when it breaks remember Sierra World Equity Review called this first!
I think we have been suspecting Roche or Merck for sometime. It would be nice to get Toe's money back. ??
When it reverses, the dilution stops, the PPS rises (a lot) and continues beyond the initial reactive dumping, we will all be happy. Very.
You are absolutely correct. Evidence of the game we have been watching. Svfc will leave the gate and run when it's time. Not before. When it does, those of us holding long shares will breathe a sigh of relief.
This presumes that this company is like 99% of penny stocks, without the technology, etc to back it up. However, aside from starting to turn revenues, SVFC appears on the verge of IND, patents, has a rapidly improving BOD, declining debt, at least one license and likely more in the pipeline, a national sales director with an anticipated media campaign, etc.
So...we are waiting. I'm feeling pretty positive with my bank of shares. Sure I wish I had bought them all at .0003, but I didn't. I'll live.
IMO, this stock will reward the patient and punish the hasty.
If Hill became CEO, Andrews opened, Gautamala opens, the patents come through, the media campaign starts and we get a full time CFO...0.25. Yes, a quarter.
(Now on 1 post per day)
Are you being rhetorical or making an important point? Please be direct.