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Kips Bay Medical: An Undiscovered Micro-Cap With Powerful Near-Term Catalysts 2 comments
Jul 3, 2014 11:00 AM | about stocks: KIPS
I discovered a next-generation medical device company that is completely off Wall Street's radar, but in fact is gaining prominence in the medical community by having developed an unique medical technology that could be the standard of care during cardiovascular surgeries: Kips Bay Medical (KIPS). Many medical experts believe this next-generation technology is the key to improving outcomes of cardiovascular surgeries. The experts I spoke with informed me they are very interested in adopting Kips Bay's technology. The market for surgical devices used for cardiovascular surgery is projected to reach $48 billion next year, yet Kips Bay Medical is valued at just $15 million. This is a similar level of irrational undervaluation as was seen with IsoRay (ISR), before my analysis hit the wires and shares multiplied in value. I believe Kips Bay Medical has all the hallmarks of a similar scenario, thus presenting investors a highly asymmetrical risk vs. reward investment opportunity.
What is Kips Bay Medical?
Kips Bay Medical is a medical device company that is developing the next-generation vein support technology called 'eSVS MESH' used in coronary artery bypass grafting - CABG - surgery. The goal of the company is to become a standard of care during CABG surgery. The eSVS MESH technology is marketed through independent distributors in selected markets. Kips Bay Medical is listed on the NASDAQ exchange.
The science
The eSVS MESH is designed to improve the long-term outcome of CABG procedures by addressing limitations of unsupported saphenous veins. The eSVS MESH is fitted like a sleeve on the outside of a saphenous vein graft to strengthen the vein and to give that vein graft the physiological attributes of an artery. Click here for an example picture of the 'sleeve'. In layman terms, CABG surgeries go basically like this: surgeons take segments of healthy blood vessels from other parts of the body, and use them to create detours around blocked coronary arteries, enabling blood and oxygen to flow freely again to the heart muscle. On average, patients require two to three bypasses per CABG surgery. Surgeons typically use the hardy internal artery from the chest wall to fashion one of those bypasses, and then harvest large saphenous veins from the legs for the others. The artery graft generally works very well. The outlook for the saphenous vein grafts is not so rosy: Almost 50 percent clog up and fail within a few years. It's like trying to connect a fire hose to a garden hose. But more importantly, the saphenous vein does not have the muscular structure of an artery, so when you put it under the high pressure of the heart, it could blow up easily.
Here's why Kips Bay's eSVS MESH should be adopted:
Number 1: The structural support from the eSVS MESH sleeve is designed to inhibit vessel expansion and resulting damage to the vessel. This should prevent a thickening of the vessel wall over time, or hyperplasia, and resulting graft failure.
Number 2: Radial constriction designed to cause the diameter of the graft, or lumen, to be consistent in size and more closely match the diameter of the target coronary artery thereby increasing blood flow velocities, reducing the potential for clot formation and inhibiting hyperplasia.
Number 3: The eSVS MESH is compatible with current CABG procedures including on-pump or off-pump procedures, and open or endoscopic saphenous vein harvest methods.
Number 4: The surgical steps to use a saphenous vein graft with the eSVS MESH are the same as would be performed for any coronary artery bypass procedure utilizing unsupported SVGs.
Manuel Villafaña, CEO, interestingly stated:
"…That is to say, if we take a look at the vein at nine months with the MESH, compared to a two or three-year image now with the MESH, we saw no difference, indicating that we saw no hyperplasia, no change in the performance. This is of course, very, very encouraging. Now to make it more interesting, we are now working towards additional follow-up angiograms for these patients, so that we can look at their graphs at five to six years after their bypass surgery. And again, if we see no changes, you'll find the baseball outside Fenway Park over the big green wall. So it will definitely be a homerun for us…"
It's a bit of a technical story if you read this for the first time, but when you dig deeper into the science, read the transcripts, etc, you will probably realize that Kips Bay Medical is sitting on something big. What I like about this technology is the fact that it is actually a pretty simple concept, that could be homerun because of the relative simplicity.
Kips Bay Medical is addressing a major problem
Today an estimated 82 million Americans suffer from 1 or more types of cardiovascular disease (CVD) and it is the cause of 1 out of every 6 deaths in the US. And every year, well over 250,000 Americans undergo CABG surgery to mitigate its effects. The total economic burden of CVD is staggering, exceeding $286.6 billion in the US. In 27 member states of the European Union the burden of CVD is also significant as it remains the main cause of death, contributing to over 2.0 million deaths each year. The death rates are generally higher in Central and Eastern Europe. The total cost of CVD to the EU economy is estimated at €192 billion a year. The same goes for regions outside the USA and EU.
These numbers are mind-boggling, and emphasize the urgent need for improving the outcomes of CABG surgery.
4 near-term catalysts
There are a couple of important near-term catalysts that could send shares substantially higher. Here's an overview:
Number 1: Wall Street has yet to discover this stock
At this stage, virtually no investor even knows this company exists. There has been no Seeking Alpha article, and I could not find any research reports on other websites. Stock market history has shown that money can be made by investing in an undervalued and unknown stock before the general investment community jumps on board. In other words, when Wall Street becomes aware of Kips Bay Medical's potential, and realizes the level of undervaluation, shares could surge quickly and substantially.
Number 2: Next stage FDA approval
Kips Bay Medical is currently conducting a clinical feasibility trial which should be concluded later this year. The FDA recently granted an expanded approval allowing Kips Bay to enroll more US patients and add more US study sites in this eMESH I clinical feasibility trial. In its prior approval, the FDA indicated that it would allow the enrollment of 15 patients at up to 4 sites in the United States. With this expanded approval, the FDA has now increased the allowed number of U.S. patients from 15 to 27 and increased the allowed number of U.S. sites from 4 to 10. The FDA has also approved a combination of changes in the application of the eSVS MESH to the saphenous vein graft, or SVG, and to the surgical implant technique for the eSVS MESH treated graft. In addition, Kips Bay believes these changes will simply the process of applying and implanting the eSVS MESH thereby reducing procedural costs.
Overall, Kips Bay expects to enroll up to 120 patients at 10 international and 10 US sites. I expect Q4 this year to mark the end of the feasibility trial, and the beginning of the filing of a request for an investigational device exemption (IDE) to perform a larger pivotal study, that is planned to commence in 2015. The pivotal study is required to demonstrate clinical effectiveness and support a request for final FDA approval to sell the eSVS MESH in the United States. Obviously, obtaining this final FDA approval is the goal that opens the door for commercialisation.
Number 3: CE Mark renewal
The company is also in the process of requesting an updated CE Mark approval for the new implant technique approved by the FDA in March 2014. This updated CE Mark approval is required in order for the European sites to enroll patients using the new implant technique. One additional international site has received its ethics committee approval and is in the process of finalizing its clinical trial agreement in order to begin enrollment. According to the CEO, the company is close to obtaining the updated approval. I expect this to happen within 3 months.
A valid CE mark is important, because it allows Kips Bay Medical to sell its product in 31 European countries. Similar to the FDA, this extension greatly enhances revenue potential and increases the company's valuation.
Number 4: Patent approval
As of March 1, 2014, Kips Bay Medical has twelve issued patents covering the eSVS MESH, including five issued in the United States, two each issued in Japan, South Africa, Canada and one European patent. The European patent has been validated and is enforceable in eight European countries. In addition, there are currently three patent applications pending in the United States, including one for which a notice of allowance was made public in February 2014, and five patent applications pending in countries outside the United States. I expect one or more of these pending patents to be validated later this year, which should boost the company's valuation.
First eSVS MESH commercial implants performed successfully
The company has recently successfully applied the eSVS MESH technology in the operating room, both in Austria and Poland. Dr. Grzegorz Suwalski MD PhD, Poland, commented:
"I was very pleased with how easily the eSVS MESH was applied to the vein graft and I believe that the eSVS MESH technology represents a new tool for cardiac surgeons that has the potential to significantly improve the long-term outcomes for cardiac bypass surgery patients."
Dr. Lyle Joyce, a cardiothoracic surgeon from the Mayo Clinic in Rochester that bears no relationship with Kips Bay Medical, stated:
''...The eSVS MESH is unique. To my knowledge, there is nobody who is working on that particular concept. It seemed an external support would not necessarily be the same as having the internal biological makeup of an artery versus a vein. But as Villafaña - the CEO - has presented specimens and studies to surgeons at various meetings, I must admit, I'm very surprised and quite impressed...."
I believe this is just the beginning. Kips Bay Medical has planned more commercial implants and demonstrations, in alignment with the feasibility trials.
Virtually no competition
According to the CEO, Kips Bay Medical's technology is treading in unchartered territory. He stated that if this company was developing a new pacemaker or new heart valve, it would be going against really tough terrain, with 10 to 30 competitors. But the eSVS MESH is absolutely brand new.
I could only find 1 other company that appears to be potential competitor: Vascular Graft Solutions (VASC). This Israeli company is developing a product called the VEST expandable external support system which is designed to reduce vein graft failures in CABG surgery. Vascular Graft Solutions concluded patient enrollment in its first in-human trial at three centers in the United Kingdom. But the results of this study are at this point not known nor did Vascular Graft Solutions commence any sales activities yet.
So it seems Kips Bay Medical is addressing a multi-billion dollar market with only 1 (in)direct potential competitor in its rear view. This is a very important factor, because it leaves a wide open space for the eSVS MESH, that should enable the company to capture a sizeable market share.
What is Kips Bay Medical worth today?
The best way to assess what Kips Bay Medical is worth is to take a look at comparable (pre-FDA approval) medical device companies:
Atossa (ATOS): $40 million valuation
Cardica (CRDC): $100 million valuation
Harvard Apparatus (HART): $75 million valuation
Kips Bay Medical (KIPS): $15 million valuation
This comparison shows how undervalued Kips Bay Medical is, especially if you consider eSVS MESH's huge market potential. Based upon this comparison, I believe Kips Bay Medical should be valued at a minimum $50 million today, which equates to a $1.50 share price.
How much could Kips Bay Medical be worth?
Once Kips Bay Medical has approval to sell its product, what could Kips Bay Medical be worth? Worldwide, about 800k coronary bypass procedures are done annually, requiring on average 3 vein grafts each. That makes an annual 2.4 million units market potential. I estimate a $200 revenue per each unit, based upon the latest financial statements and a phone call to the company, which sums up to a total annual revenue of $500 million. Also, the eSVS MESH technology could also be used other parts of the body (apart from the heart), which are large markets as well. This amplifies the revenue potential.
Due to the lack of competition, Kips Bay Medical could capture a sizeable market share; let's say an annual $200 million revenue is reasonable. Companies in the medical devices industry trade on a price/sales ratio of 3 on average. An annual $200 million revenue would then equate to a $600 million market capitalization, significantly higher than today's $15 million valuation.
Here's what I like about this story: because no market share is currently priced in the stock, even a small market share could reward shareholders tremendously.
Another way to determine the potential valuation is to look how some medical devices companies, that already have FDA approval and/or a renewed CE Mark, are valued:
IsoRay (ISR): $140 million, no material revenue.
Unilife (UNIS): $310 million, no material revenue
Vascular Graft Solutions (VASC): $360 million, material revenue with their other medical devices.
TearLab (TEAR): $150 million, low revenue.
If Kips Bay Medical obtains both an FDA approval and an updated CE Mark, and if it would be valued similarly, its valuation should rise well above $100 million, which equates to a $4 share price minimum. This scenario could unfold as early as next year, and underlines the stock's big upside potential.
Kips Bay Medical's CEO is highly successful
CEO Manuel Villafaña has more than 37 years of experience in the medical sector. He founded the following companies:
Cardiac Pacemakers, served as its President and Chairman from 1972 to 1976.
Co-Founded GV Medical to develop, manufacture and market the LASTAC System. He served as the Chairman of the Board of CABG Medical since January 2001; GV Medical from 1983 to 1987; and ATS Medical from 1987 to May 2004.
Jude Medical and served as its Chairman and President from 1976 to 1982.
ATS Medical and served as its Chief Executive Officer from 1987 to 2001.
Kips Bay Medical in 2007.
He turned all these companies into successful multi-million dollar enterprises, and I believe his capabilities, experience and knowledge should make Kips Bay Medical a success story as well.
His feats were recognized as he has received numerous awards and honours for his accomplishments, including the "Living Legend of Medicine" award from the International Society of Cardiothoracic Surgeons and the Ellis Island Medal of Honour.
World renowned heart surgeon joins Kips Bay Medical
A couple of weeks ago, the company announced Lawrence H. Cohn, M.D. has been engaged as a consultant to provide medical advisory services. His resume is nothing short but amazing. Here are some excerpts: Dr. Cohn has been a professor of surgery at Harvard Medical School since 1980 and in 2000 was awarded the first endowed Chair in Cardiac Surgery. He has performed over 10000 cardiac surgical operations and is a world-renowned expert in the field of valve repair and replacement surgery and minimally invasive heart valve surgery. He has published over 440 original scientific articles, 105 book chapters and 12 text books, and these books are the most referenced in adult cardiac surgery today.
CEO Manny Villafaña stated:
"We're excited to have such an accomplished and distinguished heart surgeon join our team as an advisor who can help us in the further development and promotion of our eSVS MESH for bypass surgery."
A very interesting development to say the least, that such a prominent figurehead and expert decided to join this company. Common sense tells me he wouldn't do this if he didn't believe in Kips Bay Medical's technological capabilities and likelihood this company will be a successful enterprise. On top of this, according to the CEO the feedback Kips Bay Medical receives from the medical community is extremely positive. This was confirmed by the medical experts I spoke with in the field.
Management is putting their money where their mouth is
The insider trading report reveals a pattern that I love to see: only buying, and no selling. Everybody knows insider buying is a bullish signal, but if insiders don't sell at all as well, that's even better.
(click to enlarge)
Most transactions were direct purchases in the open market. Here's another interesting factor; they bought at 70 and 80 cents, whereas we can buy at 40 cents.
Institutional investors already established positions
(click to enlarge)
While most individual investors do not know this company even exists, it is quite remarkable that a vast number of institutional investors (smart money) are already long. This tells me two things: (a) these guys perform some very thorough diligence, especially in the territory of micro-caps, and they wouldn't be invested if they didn't think it's probable Kips Bay Medical will be a success story, and (b) it increases the likelihood more institutional investors will come on board and existing investors will expand their positions when Kips Bay Medical obtains more regulatory approvals. Limited supply and pent-up demand should drive shares much higher.
Akin to the insiders, these institutional investors established positions at prices much higher than today's levels.
Key financials
By my analysis, the company currently has $4 million in cash, $2.5 million short-term investments, no debt and a $400k monthly burn. The company's financials are pretty solid for a developmental stage company.
Clean share structure
Let's analyze the share structure:
There is a limited number of classes of common shares being used for equity issuances and stock option grants. Pursuant to SEC rules, the company may only sell up to one-third of the market cap held by non-affiliate stockholders in any 12-month period. Current shares outstanding totals about 33 million, of which a good portion is owned by insiders and institutions. There are no separate voting or non-voting common-shares at play.
There are only a few shareholders - the insiders - holding stock options.
Management has implemented a stock option plan that provides potential financial advantage to all key employees who continue to work with the business to build shareholder value.
There are rules in place that force the company to obtain shareholder approval to issue new investor shares in exchange for cash investment, nor to obtain amendments to any legal documents or the capital structure accordingly.
The float is only $20 million.
The share structure does not have toxic convertible notes or warrant overhead that is very common in this type of companies.
The share structure appears to be very clean. Obviously, this is beneficial to shareholders, as it de-risks the investment.
Why Kips Bay Medical is such an ideal trade
Kips Bay Medical is such an ideal trade, because due to the extreme undervaluation, the stock is hard-pressed to trade even lower. If you back out the cash, the company's enterprise value is a mere $10 million. This is ridiculously low considering all the facts and figures so far. The upside - the flip side of the coin - is huge though, making the trade highly asymmetrical. I hold the view that the best way for individual investors to consistently outperform the market is to buy virtually unknown stocks like Kips Bay Medical at extremely low valuation levels, and subsequently lock in (big) profits when the risk vs. reward becomes neutral or even unfavourable.
Chart indicates excellent entry point
(click to enlarge)
Risks involved
Even the most undervalued stocks have risks, and so has Kips Bay Medical:
- A primary risk is any delay in the roll-out of its trials. Clinical trial delays are not uncommon in the medical devices landscape, and I have no idea of knowing whether Kips Bay Medical will experience delays.
- As long as Kips Bay Medical keeps incurring losses, management may be forced to dilute shares, although the company currently has a solid cash balance. I don't anticipate any near-term financing. If the share price would go beyond $1.50, management could be wise to initiate a financing, however investors who got in today will have realized substantial profits by that point.
- Although the clinical trial results have been very positive thus far, I have no idea of predicting the outcome of current trials.
- Although eSVS MESH has no real competition at this stage, potential competitors could create a competitive landscape in the longer term.
- The company probably won't report a significant profit and/or material revenue in the near future. The developmental status adds to the riskiness of the stock, although the extreme undervaluation increases downside protection.
You can read all SEC filed risks here.
Conclusion
Kips Bay Medical provides investors a rare and highly asymmetrical opportunity to invest in the most advanced and unique medical technology used in CABG surgery, a $48 billion market. This NASDAQ stock has all the features for a great trade:
- Undiscovered
- Extreme undervaluation
- Numerous near-term catalysts
- Impressive management
- Novel product
- Virtually free of competition
- Multi-billion addressable market
- Obvious medical need for their product
- Multi-year low share price
Developments so far indicate Kips Bay Medical's science will prevail and could become the standard of care. In shareholders terms, there is a high probability the company's valuation will be multiple of today's low $15 million. Investors who buy at today's level are thus likely to realize significant gains.
For full disclosure and disclaimer information click here
To join my free stock pick alert service click here
Disclosure: The author is long KIPS.
Stocks: KIPS
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Sujan Lahiri wrote SA article today
Sujan has a pretty good following and great track record. Last recommendation I got into was ISR which went from about 1.50 to over 3.25.
He has had others too.
Medicare/Medicaid Coverage
is great info. Thanks for finding and posting.
I hope the company issues a PR about this, or in the very least maybe Benzinger will pick up on it like they did the Aetna news the other day.
GLTA
Go ISR
Tracking Prescriptions
Is there a website we can go to, to see the weekly/monthly prescriptions filled/refilled?
Will APRI give us a PR with this info on regular/irregular basis?
TIA
Rebalancing Russell Index takes place on 6/27
I copied this from a Q & A regarding the rebalancing procedure.
Q: When is reconstitution this year?
A: The 2014 reconstitution of the Russell Indexes will occur June 27. All our index families will go through reconstitution simultaneously (except Russell/Nomura and Russell Australia Indexes). Provisional indexes will be published beginning on June 13 to allow investors to begin to track the new indexes prior to reconstitution, and legacy indexes will be published beginning on June 27 to allow investors to continue to track the old U.S. indexes. We provide these indexes before and after the official reconstitution date to allow investors to choose their own timing on when they want to execute their index trades.
Q: What's the basic process?
A: On the last trading day in May (this year May 30), all eligible securities globally are ranked by their total market capitalization. Companies whose stocks are listed on eligible stock exchanges in eligible countries and who pass minimum liquidity and other investability rules are considered for inclusion in the indexes. Beginning on June 13, preliminary lists for the additions and deletions to the indexes are communicated to the marketplace. These changes go into effect after the close on Friday, June 27. All Russell indexes are subindexes of the Global Index.
blackbandit....
is this procedure only for spinal cord injuries or can it be used in degenerative patients?
How long will it take for each trial to furnish results and what will they be looking for.
Followed you over from another board.
TIA
Benzinger reporting JnJ Chat room rumors
JnJ interest in ISR ???
I wonder if it is true.
price and volume have spiked since this report came out.
Anyone hear anything?
DTC Chill Removed at Ameritrade
I made my purchase as I said, when I said. If you are having trouble on line,perhaps you should learn how to use your computer. Or instead of lashing out, call them live and ask for assistance.
It Definitely is Rory Reid...
Found this in Wikepedia
Rory Jason Reid (born July 11, 1963[1]) is an American attorney and politician. He served as elected Chairman of the Clark County Commission in Clark County, Nevada and was an unsuccessful candidate for Governor of Nevada in the 2010 gubernatorial election.[2] Reid is a member of the Democratic Party and a son of United States Senator Harry Reid. In 2007, the Las Vegas Sun called Reid a political "rising star" in Nevada.[3]
Reid declined to run for Governor of Nevada again in 2014.[4]
Biography
Reid was born on July 11, 1963 in Alexandria, Virginia and raised in the Las Vegas area where he attended Ed W. Clark High School.[5] He graduated from Brigham Young University (BYU) with a degree in international relations and Spanish, and then furthered his education in law school, graduating in 1987.[3]
As a teenager, he worked as a sportswriter for the Las Vegas Sun and interviewed Muhammad Ali prior to the boxer’s fight with Larry Holmes in 1980.[6] Later, he served as a member of the Nevada Taxicab Authority. During the 1990s, he also served as senior vice-president and general counsel for Lady Luck Gaming.[7]
He and his wife Cindy have three children.
Clark County Commission
Reid was elected to the Clark County Commission in 2002. As Chairman of the Commission, he updated the master plans of the county to reduce non-conforming zone changes.[8] Reid was reelected in 2006 with 62 percent of the vote.[9] In 2008, Reid served as chairman of Hillary Clinton's presidential campaign for the state of Nevada and an adviser on Western issues.[10]
2010 Nevada Gubernatorial Race
Main article: Nevada gubernatorial election, 2010
Reid kicked off his run for Governor of Nevada in Las Vegas on October 15, 2009,[11] with a second event in Reno the following day as part of an effort to gain recognition in Northern Nevada.[12]
Reid campaigned on diversifying Nevada’s economy and promoting alternative energy, both in an effort to create jobs.[13]
Reid has disagreed with his father (Harry Reid) on some issues, including by supporting Hillary Clinton in the 2008 Democratic caucuses when Sen. Harry Reid backed Barack Obama. Clinton won the Nevada caucus. In October 2009 he had a differing opinion of a pair of proposals for rail projects in Nevada.[14]
In June 2010, Reid dropped his last name from the heading of many campaign advertisements. His campaign literature then simply said, "Rory 2010."[15]
Reid was defeated by Brian Sandoval on the November 2, 2010 general election.
I bought thru Ameritrade this afternoon with no problems. Transaction went thru just as any other trade.
Go MYEC!!!
Chill Removed at Ameritrade
Purchased some today at Ameritrade with no problems.
ASCO Meeting 5/30-6/1
Anybody know if ISR will be presenting at this conference this weekend?
Bikini Ready Started advertising
Bikini Ready had half page ads in this weekends supplements. Advertised the stores available and offered $3 off. Ad featured a "Rear" view of Ashlely in a compact bikini with part of her right cheek coming out, not blantantly, but in good taste!
CN ...Thanks eom
CN...Regarding CBD supplements
After they devise the proper formula, how long afterwards do you think they could go into production? Will they get their CBD product from TRTC or another source or several? Where will they be manufactured? And most important of all, where can they be sold? Will they utilize a spokesperson (Khardashian, Theisman, Willie Nelson)? Since it is MJ based will they be allowed to be sold in all states?
Will they need FDA approval?
As always, Thanks in advance.
tutter Great info. Thanks
Medical Marijuana???
With this news will medical marijuana be in the future?
Today's Conference presentations
Sure hope they print transcripts or issue videos. If anyone finds them would you please post a link? Thanks in advance
Stayfocused...TRTC PR Does Include NRTI
The extractor is designed for botanical and nutraceutical extractions and will be utilized to extract CBD in an effort to have complete control and consistency as they continue to work with Inergetics in the creation of a CBD-based nutritional supplement. This key piece of equipment utilizes CO2 as a solvent, which is superior because it is non-flammable and non-toxic mitigating negative environmental impacts as well as several safety concerns that have been associated with butane extraction. This process allows for the selective extraction of compounds from a variety of botanicals, which possess potent antioxidant as well as neuroprotectant properties.
MSE Advertising Discount Coupons
NRTI advertising MSE products again with a double manufacturer's coupon. $5.00 off the purchase of any 1 MSE. Both coupons expire Oct 31, 2014.
The familiar ad with Martha's picture and text shows save $5.00 pay $9.99 or less with money saving coupons!.. And it states $2.00 off coupon in box.
Available at Walgreens, Harris Tweeter, Shop Rite and at other fine retailers...
or go to marthastewartessentials.com and use promo code MARTHAS
dmcc..Thanks for all your intel and videos
Have you thought about inviting Gupta and the people from Bloomberg and Fox who interviewed him?
Thanks again.
regarding your comments:I am doing everything possible to get Jim Cramer, CNBC and other networks to attend TRTC 5 acre facility ribbon cutting ceremony
dmcc posted this TRTC interview from The Street several weeks ago..
CEO, Derek Peterson mentions NRTI and MSE very prominently.
Worth watching again and check it out if it is the first time for you. Mr Peterson appears to be a very sharp individual with a game plan. It's no wonder that Mr James and him get along so well. They both have great foresight..
Hope this link works..
VIDEO TRTC CEO talks about NRTI Partnership! AWESOME GUYS
http://www.thestreet.com/_yahoo/video/12342684/marijuana-investing-terra-tech-ceo-tells-how-to-get-a-buzz.html?cm_ven=YAHOOV&cm_cat=FREE&cm_ite=NA&s=1
from the Street
On2... Thank you for posting The Street interview
Would you be kind enough to post it on the NRTI message board? I own both TRTC and NRTI and would not have seen that interview that mentions Inergetics if you had not posted it here. Thanks for sharing.
Also watched live the Derek Peterson interview on Bloomberg Friday. He is a very sharp business man and see big things for TRTC. And NRTI
Looking forward to Mondays interview. Anyword if TRTC will be issuing any PRs about these interviews?
Thanks in advance for posting it to the other board.
GLTA
Question for the board.
Earlier today I tried purchasing some shares of MYEC thru TD Ameritrade and my order was not allowed to go thru. Anyone else have the same problem and why? Obviously, with so much volume, some firms are allowing it. I'd like to know who is..
TIA
Regarding the FDA lawsuit...
In your opinion, how long before this suit is heard and then how long before any decision is handed down?
AND how many millions of dollars will this cost AMRN?
Differences between medical device classifications
Found this information on the web....
Classification of Medical Devices
You may ask yourself what is a medical device class and what’s the difference between class I, II and III. The answer, in simple terms, is medial devices are categorized by class for the purpose of informing patients, doctors and manufacturers the amount of risk involved and the intention for the medical device.
Classification of Medical Devices
A medical device is designed to improve patient’s health in diagnosis, therapy or surgery which are monitored and under strict regulations by the food and drug administration, FDA. Medical devices are classified into three classes based on the US classification system, which defines the amount of risk involved with the medical device and proper procedures that must be followed when using and manufacturing the device.
What Is a Class I Medical Device?
Class I Medical Devices are simple in design and have little to no potential risk. Medical devices classified as type I must follow general FDA policy which includes registering the medical device, proper branding and labeling, proper manufacturing techniques and the FDA must be notified prior to marketing the device. Class I Medical Devices include tongue depressors, elastic bandages, hand held dental instruments and examination gloves.
What Is a Class II Medical Device?
Class II Medical devices are more complicated in design and pose a minimal risk. Medical devices classified as type II must follow general policy and special labeling, mandatory performance standards and post market surveillance. Most medical devices fall into the Class II medical devices category such as X-ray machines, powered wheelchairs, infusion pump and surgical and acupuncture needles.
What Is a Class III Medical Device?
Class III Medical Devices are intricate in design and have the strictest guidelines because they pose the greatest risk. Class III Medical Devices must follow Class I and Class II guidelines but must also be pre-market approved by the FDA and a scientific review of the medical device must be made prior to marketing. Class III medical devices support or sustain human lives therefore malfunction is absolutely unacceptable. Class III Medical Devices include implanted pacemakers, heart valves and implanted cerebral simulators.
So how do we interpret this PR?
I am a little confused.. In the PR it states:
"The FDA, which previously advised AMIC that it would review the product as a medical device, has further advised AMIC that it has determined that the product is classified by statute as a Class III medical device, unless the device is reclassified. The Company intends to work with the FDA to seek such reclassification, unless the additional steps required for approval of this product as a Class III medical device are more efficient. The Company has obtained input from the FDA regarding its alternatives and will seek further input to expedite the process."
What is the difference between a medical device and a Class III medical device??? Which is better and quicker to obtain?
How much of a delay will this cause?
Are they satisfied with the way it works or is there a problem??
Why does the company have to seek further input and from whom, to expedite the process? Why couldn't the FDA make it easy and tell them upfront what needs to be done?
Jeff, thanks for your clarification...However..
What is the monograph process (per the PR) and how long does it take to get approved..
Thanks in advance...
And that's the very reason I posted the info.
If there are other companies out there with less "friendly" applications, how does Apricus get onto the same show(s) and let the country know that they are working on something much more user friendly?
My only point is that if they are working with the FDA, let somebody know about it other than us shareholders..
Volume and Share Price picking up!!
Over 11 cents on 400,000+ shares at 11:24
Eicoman.. I know it is not approved
Neither is Femprox.. I was merely posting it for informational purposes to let the board know what others are doing.
Sorry about the double post...Didn't think the first one went thru.
OT -- Dennis next time you are at the SA article
When we posted replies, the article site automatically checks it so we receive notifications.. Just uncheck the check mark at the top of where the comments section begins.. and then no more alerts to you on that article..
Dennis Was that you?
Was that you responding to my post on the SA article about PHOT.. I was just passing along info about our strategic partnership with TRTC when a Dennis then posted additional facts. Good JOB! Great teamwork....
APRICUS needs to contact Good Morning America
The following article was printed on AOL detailing a segment on GMA.. Would be nice if APRI could get some time too. FEMPROX could use some publicity..
'Good Morning America' reports that 50 million American women are having trouble between the sheets -- but a a new shot might be able to help.
'Good Morning America's ays that while men have 24 FDA approved medications for sexual dysfunction, women have a whopping zero.
Called the O-shot, the injection is filled with calcium-enriched platelets that are injected into the vagina to stimulate the growth of new cells.
One doctor says it's improved the sex lives of 85 percent of the 80 women to whom he has given the injection.
The inventor of the O-shot, Dr. Charles Runels, talked to WCMH about how it works: 'Remember when you scuffed your knee as a child and there's a scab there and that yellow goo there? That yellow goo is what caused the skin to regrow, and there's a way to make that in about 10 minutes while drawing your blood.'
Basically, once your blood is drawn, the platelets are injected with some calcium and form that yellow substance. It is then injected into the vagina to rejuvenate and create more cells.
Marcia, 64, said that after about 3 weeks of treatments, the results were like 'fireworks.'
'It has enhanced my response and my enjoyment more than I ever enjoyed it.'
As for safety, one urologist and expert in women's health issues told ABC News:
'Injecting growth factors into the genital tract of a woman has risks associated with it and the benefits have not been teased out.'
The shot costs roughly $1,500 and is not covered by insurance.
What do you think? Is that too much to spend, or is a satisfying sex life priceless?
crookedneck
Can't say thank you enough for all the information you provide to us.
This latest today was completely out of left field, but very happy it is happening.
I was a little concerned this past week as I saw the price skidding backwords, but this new relationship with TRTC is phenominal, IMO.
When you speak with him, perhaps he could give you a time frame for when we actually could see product hitting the shelves. What distribution channels will be utilized.
I presume it would only be sold in those 20 states approved for medical mj.
Thanks for that article you posted before. Any chance that NRTI will issue a PR mentioning that we were in that magazine?
Again, thanks for all you do.
Martha Stewart and her MSE is inconsequential now...
Lets get Wilson, or Sherman from the Seattle Seahawks, or the whole team to be spokesmen for our new hemp based nutritional products.
Re: Joint Venture
Does this mean they can start selling NOW?
UPLISTING Tomorrow.!!!!!
Alliqua to List on the NASDAQ Capital Market on January 28, 2014
LANGHORNE, Pa.-- Alliqua, Inc. (OTCQB: ALQA) (“Alliqua” or the “Company”) has received approval from NASDAQ’s Listing Qualifications Department to list its common stock on the NASDAQ Capital Market. The Company anticipates that its common stock will commence trading on the NASDAQ Capital Market on January 28, 2014 under the same ticker symbol “ALQA”. Until that time, the Company’s common stock will continue to trade on the OTC Markets under the ticker symbol “ALQA”.
“We are extremely honored to have our stock trade on the NASDAQ Capital Market,” stated David Johnson, Chief Executive Officer of Alliqua. “We have made significant progress expanding our product lines, distribution activities and strategic partnerships over the past year. Additionally, we have strengthened our management team and improved our corporate governance across the board. These actions position us well to sustain the positive momentum we have achieved so far in our business. We believe that having our stock trade on NASDAQ will increase our visibility in the market, and ultimately increase our shareholder base.”
About Alliqua, Inc.
Alliqua is a provider of advanced wound care solutions. Through its extensive sales and distribution network, together with its proprietary products, Alliqua provides a suite of technological solutions to enhance the wound care practitioner’s ability to deal with the challenges of healing both chronic and acute wounds.
In addition, Alliqua has both custom manufacturing and transdermal drug delivery capabilities. Alliqua can provide a custom manufacturing solution to partners in the medical device and cosmetics industry, utilizing its proprietary hydrogel technology. Alliqua is also actively developing opportunities to use this same hydrogel technology as a transdermal drug delivery vehicle.
Alliqua currently markets its line of hydrogel products for wound care under the SilverSeal® and Hydress brands, as well as the sorbion sachet S and sorbion sana wound care products. It also has the right to develop and market the advanced wound care products Biovance® and Extracellular Matrix (ECM), as part of its agreement with Celgene Cellular Therapeutics. Alliqua's electron beam production process, located at its 16,000 square foot GMP manufacturing facility in Langhorne, PA, allows Alliqua to develop and custom manufacture a wide variety of hydrogels. Alliqua's hydrogels can be customized for various transdermal applications to address market opportunities in the treatment of wounds as well as the delivery of numerous drugs or other agents for pharmaceutical and cosmetic industries. Additionally, Alliqua's drug delivery platform, in combination with certain active pharmaceutical ingredients, can provide pharmaceutical companies with a transdermal technology to enhance patient compliance and potentially extend the patent life of valuable drug franchises.
For additional information, please visit http://www.alliqua.com. To receive future press releases via email, please visit http://ir.stockpr.com/alliqua/email-alerts.
Any statements contained in this press release regarding our ongoing research and development and the results attained by us to-date have not been evaluated by the Food and Drug Administration.
Legal Notice Regarding Forward-Looking Statements
This release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of our control that can make such statements untrue, including, but not limited to, inadequate capital, adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, adverse federal, state and local government regulation, termination of contracts or agreements, technological obsolescence of our products, technical problems with our research and products, price increases for supplies and components, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists and other specific risks. We currently have no commercial products intended to diagnose, treat, prevent or cure any disease. The statements contained in this press release regarding our ongoing research and development and the results attained by us to-date have not been evaluated by the Food and Drug Administration. There can be no assurance that further research and development, and/or whether clinical trial results, if any, will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that we will be able to develop new products on the basis of our technologies. In addition, other factors that could cause actual results to differ materially are discussed in our Annual Report on Form 10-K/A filed with the SEC on May 16, 2013, and our most recent Form 10-Q filings with the SEC. Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise.
Alliqua, Inc.
Brian M. Posner, 215-702-8550
Chief Financial Officer
bposner@alliqua.com
or
Investor Relations:
Dian Griesel Int'l.
Cheryl Schneider, 212-825-3210
cschneider@dgicomm.com
or
Public Relations:
Dian Griesel Int'l.
Susan Forman or Laura Radocaj, 212-825-3210
sforman@dgicomm.com
lradocaj@dgicomm.com
Source: Alliqua, Inc.
Released January 27, 2014
Lemon... I see that Banner add all the time,
including today.
I am wondering if others see it too. As a matter of fact, I see it on several Ihub boards I follow.
Anyone else seeing it too?
Just wondering!!!
Think we will hear anything soon, about Anything?