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Radient Pharmaceuticals Ships Onko-Sure(R) Test Kits to Brazil and Files Patent in Brazil
Release Source: Radient Pharmaceuticals Corporation On Tuesday August 23, 2011, 7:00 am EDT
TUSTIN, CA--(Marketwire -08/23/11)- Radient Pharmaceuticals Corporation "the Company" or "Radient" (OTCQX: RXPC.PK - News) (Pinksheets: RXPC.PK - News), a developer and marketer of In Vitro Diagnostic (IVD) cancer tests, today announced it has sold and shipped its first order of Onko-Sure® test kits to a distributor in Brazil. This initial shipment of kits will be used by the in-country distributor for regulatory approval and clinical validation of the test in Brazilian labs. Prior to the shipment of these test kits, Radient filed for patent protection for Onko-Sure® in Brazil.
The Onko-Sure® test kit is a 96-well ELISA test kit sold to clinical reference labs. Labs run individual tests prescribed by doctors. Forty tests can be run, in duplicate, on each test kit. Onko-Sure® is a non-invasive cancer blood test that has been shown, in a large body of published clinical research, to be effective in the detection of 19 different cancers.
According to Kalorama Information, Brazil spent $126 billion on healthcare in 2009. Brazil's in vitro diagnostic market has nearly doubled since 2003 and is growing at a rate that is faster than the average rate of growth for the IVD market worldwide. With a population of approximately 190 million, Brazil is by far the most populous country in South America.
Radient Chairman and CEO, Douglas MacLellan, commented, "Brazil is key for us in both addressing the cancer challenge in one of the top global emerging healthcare markets, as well as in establishing a base for expanding Onko-Sure® use into the rest of South America."
"We are actively collaborating with our Brazilian partners for rapid regulatory progress and clinical lab adoption. Our first sale of kits is supporting these important efforts," added Chris Gee, Director of International Sales and Marketing for Radient.
For additional information on Radient Pharmaceuticals Corporation and its products visit: www.radient-pharma.com or e-mail info@radient-pharma.com. For Investor Relations contact Dilek Mir at: ir@radient-pharma.com or 714-881-0244.
The following table is intended to provide the latest information on Radient's business metrics:
---------------------------------------------
RPC's Business Metrics
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Cash on hand: $720,000*
*Approximate amount as of August 19, 2011
---------------------------------------------
Shares Outstanding: 198 million*
*Approximate number as of August 19, 2011
750 million shares to be authorized
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Outstanding Warrants & Options: 111 million*
*Approximate number as of August 19, 2011
---------------------------------------------
About Radient Pharmaceuticals:
Headquartered in Tustin, California, Radient Pharmaceuticals Corporation is dedicated to saving lives and money for patients and global healthcare systems through the deployment of its FDA-cleared In Vitro Diagnostic Onko-Sure® cancer test kit for colorectal cancer treatment and recurrence monitoring. The Company's focus is on the discovery, development and commercialization of unique high-value diagnostic tests that will help physicians answer important clinical questions related to early disease state detection, treatment strategy, and the monitoring of disease progression or recurrence. To learn more about our company, products, and potentially life-saving cancer test, visit www.radient-pharma.com.
Forward-Looking Statements:
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements contained in this document include certain predictions and projections that may be considered forward-looking statements under securities law. These statements involve a number of important risks and uncertainties that could cause actual results to differ materially including, but not limited to, the performance of joint venture partners, as well as other economic, competitive and technological factors involving the Company's operations, markets, services, products, and prices. With respect to Radient Pharmaceuticals Corporation, except for the historical information contained herein, the matters discussed in this document are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements.
Radient secures distribution deal for Onko-Sure tests in India, shares rally
http://www.proactiveinvestors.com/companies/news/15356/radient-secures-distribution-deal-for-onko-sure-tests-in-india-shares-rally-15356.html
Radient secures distribution deal for Onko-Sure tests in India, shares rally
Fri 2:21 pm by Olivia D'Orazio
Radient Pharmaceuticals (AMEX:RPC) has secured a major new partnership with Super Religare Laboratories in India for the distribution of its Onko-Sure diagnostics test kits.
Super Religare is the largest diagnostics lab in India, serving over 50,000 doctors in hospitals across the country. The firm estimated that it served approximately 4.2 million patients during the nine month period ending December 31, 2010, and performs over 33,000 tests each day.
It took the company over a year to receive approval from the Indian Health Ministry to import and sell Onko-Sure tests, which detect and monitor solid tumour cancers by measuring the accumulation of certain products in the blood.
Radient said it is expected to see a benefit in its bottom line directly resulting from the distribution agreement.
"[The doctors] are all very excited and feel the low-cost cancer detection technology allows them a strong differentiation in a marketplace full of various other tests which are more expensive," the company's senior advisor for Indian operation, Dr. Umesh Bhatia, said.
Earlier this week, Radient reported a first quarter net loss of $11.4 million, or $0.13 loss per share, compared to the year-ago period's loss of $2.6 million, or $0.11 loss per share. The company's revenues were also down 17% to $30,655, compared to $36,842 in 2010.
Radient said its drop in revenues was due to lower orders for Onko-Sure, but sales are now anticipated to rise significantly following today's agreement.
The Tustin, California-based company saw its stock spike at news of the India partnership, trading on the AMEX at $0.207, a 33.48% hike as of Friday afternoon.
FEUERSTEIN THE FAILED HEDGE FUND
"""Feuerstein, who-- according to a former co-worker now employed by a major stock market news publisher in New York—once attempted to leave the news business to unsuccessfully run an investment hedge fund, has belittled and attempted to discredit the established credentials of the Indian distributor; at one point even reaching out via cyberspace to readers based in India who might be willing to help him expose more (negative) information on Gaur Diagno."""
Despite setbacks, Radient expects to see benefits from new major partnership
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Written by M.E.Garza
Friday, 10 June 2011 06:41
0digg
In early January, Radient Pharmaceuticals (Amex:RPC) and it’s exclusive India-based distribution partner Gaur Diagno, Pvt Ltd (GDL) announced that through a cancer education and screening program, the group would target over 2.2 million people in northern India. What exactly happened to that program?
In both an official press release issued in January as well as in an Expert Briefing authored by Dr. Umesh Bhatia, Ph.D,-- the senior advisor for the India Onko-sure operations-- in early March, officials outlined their plans to collaborate with Indian government agencies to establish GDL-sponsored cancer screenings.
There was both fanfare and skepticism to the announcements due to the fact that the ambitious $10 million revenue estimates announced by Radient were based on preliminary sampling responses to an initial outreach program in potentially high cancer prone districts of northern India.
Gaur Diagno had estimated to Radiant that Onko-Sure test kit usage could potentially reach 25,000 in FY 2011, but did warn that estimates were subject to change. Douglas MacLellan, Chairman and Chief Executive Officer of Radient Pharmaceuticals vigorously defended the Indian program in an interview published in this space stating: “Our effort in India through Gaur Diagno is different in the sense that they have put together the first government-backed general cancer screening program on the planet. Nobody else has done this. They are leading in a unique space to try to interdict on cancer in its earliest stages. And the reason they (Indian government) are doing it, is they have a high incidence of cancer and they are worried about it. And their constituents are worried about it so they are trying to do something.”
One attack piece and and several documented tweet and blog entries by tabloid reporter Adam Feuerstein, began to cast doubt on the entire screening program and shaved millions off the company's market cap when he convinced some readers that Gaur Diagno did not even exist. When questioned about it specifically, the tabloid reported stated that no one at India’s Ministry of Health had any records of the company and that Gaur Diagno wasn’t even mentioned in Radient's 2009 annual report filed with the SEC.
Feuerstein, who-- according to a former co-worker now employed by a major stock market news publisher in New York—once attempted to leave the news business to unsuccessfully run an investment hedge fund, has belittled and attempted to discredit the established credentials of the Indian distributor; at one point even reaching out via cyberspace to readers based in India who might be willing to help him expose more (negative) information on Gaur Diagno.
While his motivations has been questioned, it has been established that Feuerstein is compensated and encouraged by editors at TheStreet.Com (themselves a publicly traded company) to publish mostly attention grabbing, often ill-researched reports designed to draw internet traffic from millions of investors to his opinion articles (most often broken up into several pages in order to generate even more advertising revenue from banner ads) recently attacked the company’s commercialization efforts again. His report hurt the same shareholders of RPC he has repeatedly referred to as “retards,” and contained several errors and misinterpretations of the facts. These errors were discussed by Radient officials in an email which was forwarded to this publication by an advisor to the company. Radient, however, has yet to act or publish any response to that article’s errors despite the fact that their concerns all appear to be valid and supported by facts.
Even as the integrity and efforts of Gaur Diagno continue to be called into question, his group has apparently kept focus on multiple fronts in that country.
We requested an interview with Dr. Bhatia to get clarification regarding the situation in India.
“The India operations have come a long way,” explains Bhatia. “They started several years ago and achieved approval from the (Indian) Health Ministry to import and sell Onko-Sure in India. That process took about a year or so. They did several studies with major cancer hospitals which were very important to establish that Onko-Sure would give similar results in the Indian population (as those seen in other populations when checking for various cancers). Besides the government sponsored programs which we have continued to diligently work on, there is a new joint venture/partnership with Super Religare Laboratories which is the biggest diagnostics lab in India. They serve over fifty-thousand doctors in every hospital, in every state in India.”
According to Super Religare Laboratories’own website the firm performs over 33,000 tests per day and catered to approximately 4.20 million customers during the nine month period ended December 31, 2010. They offer a comprehensive range of over 3,300 diagnostic tests, from the routine to the highly specialized tests covering most known diseases.
Asked why Radient had not disclosed this positive development in recent filings or issued a press release about the new development, Dr. Bhatia said that the new partnership had been established directly through his efforts and Gaur Diagno; the exclusive India-based distribution partners of Radient- and not by Radient Phamaceuticals itself.
“We’re currently in launch prep mode. Given the massive population base, Radient should clearly benefit and sell more units, but we are the ones who established the connection and have been busy training hundreds of sales reps,” explained Bhatia. “Even this past week I have been personally helping to train sales teams who will help doctors in all those labs and hospitals adopt the Onko-Sure test. They are all very excited and feel the low-cost cancer detection technology allows them a strong differentiation in a marketplace full of various other tests which are more expensive. In fact, I’ve been asked to train more sales personnel than we had anticipated and they will be gradually deployed in this process.
In addition, we have teamed up with another government screening program in another major cancer hospital and are in very late-stage talks with them to do a joint banner program with them, this time in Southern India. This is all positive news, but I think the message here is that the efforts in India are focused on the long term success for Onko-Sure and that we all remain steadfast in our progress. ”
While Dr. Bhatia’s revelations sound promising, the original government backed screening program for Northern India which was announced so enthusiastically, has failed to launch as planned according to the most recent filing issued by Radient.
"The anticipated government project, unfortunately, has not been funded to date for several reasons that we cannot fully disclose here.” explains Dr. Bhatia. “Our team is continuing to work various political figures and entities throughout India on these efforts and, in fact, talking about expansion to other parts of the country.”
While Bhatia would not comment on the nature of the delay in the launch, multiple sources indicate that certain members of the Indian Government themselves are alarmed by the potential number of patients who will test positive once they use the non-invasive tests (which are capable of detecting up to 19 types of cancer).
“Sadly, they are afraid that public government hospitals are simply not equipped to handle the case loads that are projected based on the initial responses to the 64-point questionnaire which they have been distributing,” said one person who attended a closed door meeting with Indian officials to discuss the problem. “They’re scrambling to slow the launch and spread the screening program out over three years and they’re trying to do it quietly so as not to mount even more political pressure from their constituents who continue developing cancer and dying at alarming rates.”
There are a reported 2.2 million people in these potentially high cancer prone districts of northern India.
The program, which was set to administer RPC's Onko-Sure cancer tests through widespread deployment of mobile cancer screening laboratory units and to cancer patients contacted through Physician-referrals in order to help reduce the incidence of fatal cancer via early detection.
But it seems Radient officials are not willing to discuss the nature of delays. Perhaps that approach is for the best given the risk of injuring political relationships they are counting on for future and pending business deals in that country.
“All I can say at this point is that the program is not funded,” explains Dr. Bhatia. “We actually got that news over the last six weeks or so, but we are still anticipating that we will be able to execute some of these government programs and the team in India is working diligently to make that happen.”
Dr. Bhatia was asked if he had read the most recent article attacking his team’s efforts.
“Yes, I’ve looked at that and the reporting seemed biased to me,” Dr. Bhatia responded calmly. “I think that over time people, including the folks at TheStreet.com, will see that the India operations are real and that the team is working hard on both the private and government programs. These things take time, but our focus is on long-term success. On the projections side, I think that we should expect the second half of the year to look much better than the first half.”
On the surface, at least, it sounds like Bhatia and his team have now found a way to offset some of the early projection misses. Note and debt holders who are working with company officials to make sure that Radient shows up to their upcoming follow-up meeting with little or no debt on their balance sheet have taken notice of the news and appear to be "95% of the way towards securing an agreement that will be very beneficial towards Radient and it's shareholders."
Stay tuned. The drama continues.
Radient Outlook on India Partner Dims
http://www.thestreet.com/story/11141691/1/radient-outlook-on-india-partner-dims.html?kval=dontmiss
Radient Accused by Amex on Mayo Link
By Adam Feuerstein03/22/11 - 10:28 AM EDT
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TUSTIN, Calif. (TheStreet) -- Regulators at the NYSE Amex have accused Radient Pharmaceuticals(RPC_) of allegedly misleading investors and the exchange about the company's relationship with the Mayo Clinic, the company admitted Tuesday.
Radient has claimed in public statements that it was working with the Mayo Clinic on a clinical validation study of the company's cancer-screening test Onko-Sure. Those statements led investors to believe that the prestigious research hospital was an active partner with Radient on Onko-Sure's development. However, as reported first by TheStreet,, Mayo Clinic denied working with Radient on the Onko-Sure clinical trial, explaining that the hospital only sold blood samples to Radient for use in the Onko-Sure study.
Radient claims it has been truthful in reporting the nature of the company's relationship with the Mayo Clinic, according to statements issued in response to TheStreet's story.
NYSE Amex halted trading in Radient's stock for more than 24 hours following publication of TheStreet's story on March 7. Nine days later, on March 16, regulators at the NYSE Amex sent Radient a notice informing the company of its failure to comply with the exchange's disclosure requirements for "allegedly omitting material information" in a written submission to the exchange, according to an 8-K filed by Radient on Tuesday with the Securities and Exchange Commission.
In its 8-K filing, Radient admits that NYSE Amex regulators specifically accuse the company of allegedly misleading investors about the company's relationship with the Mayo Clinic. Radient omitted any mention of the Mayo Clinic in a press release issued Tuesday regarding the NYSE Amex matter, referring instead to a "collaboration with a third party not-for-profit group practice."
The new accusations leveled against Radient by regulators at the NYSE Amex add to the company's troubles. Radient is already facing delisting from the Amex for failing to meet the exchange's listing standards. Radient is trying to appeal the delisting notice. Tuesday, Radient said a previously scheduled appeal hearing was postponed and is being rescheduled.
In addition to its troubles with NYSE Amex, Radient is facing a class-action lawsuit accusing the company of misrepresenting its dealing with the Mayo Clinic over the Onko-Sure test. Radient hired the law firm DLA Piper to represent the company in the class-action lawsuit.
Radient shares were down 8% to 40 cents a share in early Tuesday trading.
--Written by Adam Feuerstein in Boston.
The Rosen Law Firm Announces Investigation of Securities Claims Against Radient Pharmaceuticals Corporation – RPC
Press Release Source: The Rosen Law Firm, P.A. On Monday March 7, 2011, 9:00 pm EST
NEW YORK--(BUSINESS WIRE)-- The Rosen Law Firm, P.A. announces that it is investigating potential securities fraud claims against Radient Pharmaceuticals Corporation (AMEX:RPC - News) resulting from allegations that the Company may have issued materially inaccurate statements about the involvement of the prestigious Mayo Clinic in one of the Company’s clinical trials.
On January 18, 2011, Radient issued a press release announcing “progress on its clinical study with the Mayo Clinic…” In connection with the clinical study the Company claimed that samples were being tested by the Company and the Mayo Clinic to directly compare the efficacy of the Onko-Sure test with another test.
On March 7, 2011, TheStreet.com issued an article refuting claims that the Mayo Clinic was conducting a clinical trial with Radient. In the article, a Mayo Clinic spokesperson is quoted as stating that: “Mayo is not engaged in clinical studies with Radient and does not have a partnership agreement with Radient.” The Mayo Clinic spokesperson added that: “The services Mayo was required to provide to Radient have been fulfilled. Any clinical study results about Onko-Sure would be provided by Radient, not Mayo Clinic.” As a result of this adverse news, the price of Radient stock on March 7, 2011 fell, damaging investors.
The Rosen Law Firm is investigating a securities class action lawsuit on behalf of Radient investors. If you purchased Radient stock between January 18, 2011 and March 7, 2011, please visit the website at http://www.rosenlegal.com for more information. You may also contact Laurence Rosen, Esq., or Phillip Kim, Esq. of The Rosen Law Firm toll free at 866-767-3653 or via e-mail at lrosen@rosenlegal.com or pkim@rosenlegal.com.
The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
Who is right about Rexahn? Big stakes bring attention to undervalued biotech player
http://biomedreports.com/2011020863456/who-is-right-about-rexahn-big-stakes-bring-attention-to-undervalued-biotech.html
Brean Murray Analyst reiterates BUY rating for RNN PDF | Print | Written by M.E.Garza
Tuesday, 08 February 2011 10:09
1diggdiggDespite a Wall Street tabloid's efforts to misrepresent the facts from their own "sketchy" report to investors, a Wall Street Investment research firm who has been recommending Rexahn Pharmaceuticals, Inc (AMEX: RNN ) to various funds and institutional clients has re-iterated a BUY rating this morning.
Ling Wang, CFA at Brean Murray, Carret & Co., feels that Detailed Phase 2a data for Serdaxin does show promising preliminary efficacy in severe
depression patients - Rexahan recently presented concept trial evaluating its leading CNS compound Serdaxin of Neuropsychopharmacologists (ACNP) Annual Meeting (data slides were posted on the company’s website). In this multi-center, randomized, double parallel group trial, Serdaxin achieved mean % reduction in MADRS score of 46.0%, 37.9% and 41.4% for 5, 10 and 15 mg Serdaxin, respectively, compared to 43.1% of the placebo patients (Exhibit 1A).
Brean Murray, Carret & Co., LLC follows are emerging growth companies whose securities typically involve a higher degree of risk and more volatility than the securities of more established companies.
They join BioMedReports, Motley Fool, Louis Navellier (whose report also appears at TheStreet.Com) and other analysts who believe RNN is set to continue higher.
Our full report about Rexahn Pharmaceuticals, Inc (AMEX: RNN) is set to be published in this space later today. In the meantime, readers can access the newly published Brean Murray analysis here: http://alturl.com/4vaia
Disclosure: Long RNN
Read the full report: http://biomedreports.com/2011020863438/breen-murray-reiterates-buy-rating-for-rnn.html#ixzz1DNoo5g6z
[updated] Technical Analysis: Rexahn Pharmaceuticals PDF | Print | E-mail
Written by M.E.Garza
Tuesday, 08 February 2011 00:00
1diggdiggYesterday, we issued a technical trade alert for Rexahn Pharmaceuticals (AMEX:RNN) to our subscribers. Are prices headed higher for RNN? This afternoon, we will issue a fundamental analysis report on the stock, but let's start by taking a look at key technical analysis data this morning, in case prices continue to break-out higher as anticipated.
On Monday, we spotted a trend in which the shares had been trading with a range inside a rising channel pattern. As predicted, the share price moved to the top of the trading channel- providing our readers with an excellent opportunity to make a good trade based on technical analysis.
Early this morning, the same tabloid writer who has a $250 million lawsuit filed against him for libel has opened himself up to libel again after repeating blatant misrepresentations regarding the efficacy of RNN's drug candidate despite a correction by the company's CEO about data discovered in an early dosing (not efficacy) study involving a small sub set group of 14 patients.
This same tabloid writer attacked the stock and out recommendation despite the fact that another, more well versed analyst was touting the company last week, calling it one of Six biotech Stocks for the Biotech Boom. Just days ago, another publication recently touted the stock on multiple occasions, even putting it on Wall Street's Buy List. Does that makes sense? It does if you're known for leading bear raids and respresenting the shorts who get smoked every time the stock goes higher. Obviously, we aren't the only ones who beleive the stock is headed higher. Brean Murray recently initiated coverage on the stock with a "Buy" recommendation.
Would TEVA invest millions into the company, as they did just weeks ago, if the company's drug technologies weren't showing tremendous promise?
After we first reported the possibilities of a partnership with big Pharma last year, Rexhahn's management walked away from a $20 million dollar up-front deal with $1 billion in milestones being offered by one of six pharmaceutical companies. The company and their financial advisors opted, instead, to raise just enough money to take their drug candidate through phase IIb- after which they will re-visit those offers armed with more data.
A full fundamental analysis report including all of these facts, and many more will be publshed this afternoon. For now the stock continues to trade higher than where we alerted our subscribers about it and we continue to believe that it is headed higher.
As reported by Smart Trend, on February 3rd the high of the day pierced the 3-day high of $1.51 on volume of 757,000 shares last week. (See: http://www.zacks.com/research/get_news.php?id=034l8555). At that point, they issued an alert saying that shares of RNN were expected to trade within a new higher trading range with support at $1.51 and move along with its peers in the Biotechnology industry.
If prices head higher now that shares have pierced resistance at the high of the trading channel which we identified, then prices could be headed higher. In addition, a "Golden Cross" may be forming on the stock chart:
As we've discussed in the past, there is a lot to be said about the 50/200 Day moving averages on a daily stock chart because this is one of the most commonly overlooked, yet accurate technical leading indicators. It is simple but proven and should be watched with a disciplined eye.
The Golden Cross occurs when the 50 day moving average crosses above the 200 day moving average. That is when the stock most often begins a bullish mode as its price continues to rise. The indicator comes down to two relatively simple to learn concepts:
When the 50 day moving average dips beloow the 200 day moving average. This could be the beginning of a downward trend and would be very cautious about buying, possibly sell if profit has already been made.
When the 50 day moving average passes through (rises above) the 200 day moving average. This could be the beginning of a upward trend that may be sustainable and possibly signals a buy at that point.
As long-term indicators carry more weight, the Golden Cross indicates a bull market on the horizon and is reinforced by high trading volumes- which is certainly the case with RNN. Additionally, the long-term moving average becomes the new support level in the rising market.
Disclosure: Long RNN
Read the full report: http://biomedreports.com/2011020863399/technical-analysis-rexahn-pharmaceuticals.html#ixzz1DNgZJgVV
SmarTrend expects the share price to rebound toward the $0.72 resistance level. Afterwards, we expect it to move downward with its peers in the SmarTrend Drug Manufacturers- Other industry.
SMARTREND WATCHING FOR POTENTIAL REBOUND IN SHARES OF RADIENT PHARMACEUTICALS AFTER 9.46% LOSS (RPC)Print Share Jan 28, 2011 (SmarTrend(R) News Watch via COMTEX) -- Radient Pharmaceuticals (AMEX:RPC) traded in a range yesterday that spanned from a low of $0.58 to a high of $0.70. Yesterday, the shares fell 9.46%, which took the trading range below the 3-day low of $0.72 on volume of 15.3 million shares. Often times after large one-day declines, short-term traders may play for some degree of mean revision.
Shares of Radient Pharmaceuticals are currently trading below their 50-day moving average (MA) of $0.68 and below their 200-day MA of $0.82. Look for the MA to provide resistance for a short-term rebound in the shares.
SmarTrend currently has shares of Radient Pharmaceuticals in an Downtrend and issued the Downtrend alert on January 07, 2011 at $1.02. The stock has fallen 27.8% since the Downtrend alert was issued.
SmarTrend expects the share price to rebound toward the $0.72 resistance level. Afterwards, we expect it to move downward with its peers in the SmarTrend Drug Manufacturers- Other industry.
Write to Chip Brian at cbrian@tradethetrend.com
http://www.zacks.com/research/get_news.php?id=028l2849
Cell Therapeutics: Buy, Sell or Hold?
Posted by BeaconEquity.com on Jan 21, 2011 | 2 comments
The small-cap biotech arena is a wild and woolly world. Driven by innovation and genius, but with success controlled by a sometimes capricious and arbitrary FDA, extreme volatility is an accepted fact of life in the price of these firm’s shares. In fact, volatility can be such a factor, that when I traded professionally, my firm had a list of biotechs that would result in immediately firing if traded — and that’s regardless if the trade was a money maker or not. Some of these companies simply subjected the firm to too much risk, win or lose.
Now with my risk speech out of the way, an interesting biotech company came up on the stock screener yesterday. Cell Therapeutics Inc. (Nasdaq: CTIC), a Seattle, Washington-based biopharmaceutical company that develops, acquires and commercializes oncology products for the treatment of cancer. It is developing pixantrone, a phase III single-agent clinical trial product for the treatment of non-Hodgkins lymphoma and various other hematologic malignancies, solid tumors and immunological disorders; OPAXIO, a phase III clinical trial product for the treatment of ovarian, esophageal, and non-small cell lung cancer; and brostallicin, a phase I/II clinical trials product for the treatment of sarcoma. The company also has licensing and collaboration agreements with the giant pharmaceutical company Novartis International (NYSE: NVS)
What makes this company any different than the scores of others in the same space? Last April, the FDA rejected the company’s Lymphoma drug Pixuvir. The company appealed the decision and is awaiting a ruling supposedly arriving within the first quarter of 2011. Not one to sit and hope, Cell Therapeutics has prepared a new drug trial to submit should the FDA not reverse its decision. This delay has resulted in the company having a high cash burn rate of about $70 million over the last 12 months, depleting its battle chest. Should the FDA reverse its decision, shares will rocket higher. If not, investors will be back in the waiting game. In order to enhance survival, the company just entered a security purchase agreement to sell $25 million worth of shares to a single institutional investor.
While the above is interesting and makes this firm a potential but risky bet for the upside, what really caught my eye is institutional interest. Institutions presently own 66,346,504 shares, up 16.73% from three months ago. This is a key factor, as it appears that smart money is accumulating the company.
Radient Pharmaceuticals Corporation (AMEX: $RPC) A Big Move May Be Around The Corner!
http://stockpreacher.com/2011/01/19/radient-pharmaceuticals-corporation-amex-rpc-a-big-move-may-be-around-the-corner/
$FCSC ($10M Cap) Files Response to CRL - possible PDUFA date of 6/17/11
http://www.biorunup.com/articles/fcsc
My neighbor had this happen to his brand new computer. The only way I could get rid of it was do a complete system restore to the original factoy condition as it was shipped.
Ed
Question about the future price of POSC
What will really move this stock?
1) Will it be the partnership news?
2) Revenue from sales?
3) A buyout?
Thanks
WOW! look at the monthly rotation of buyers vs. sellers
http://data.cnbc.com/quotes/POSC/tab/8
American Society of Nuclear Cardiology (ASNC) annual meeting
INDIANAPOLIS, Oct. 1, 2010 (GLOBE NEWSWIRE) -- Positron Corporation (OTCBB:POSC - News), a leading molecular imaging company specializing in the field of nuclear cardiology, is pleased to report its attendance at the American Society of Nuclear Cardiology (ASNC) annual meeting was met with great enthusiasm and interest. The conference took place in Philadelphia, PA, September 23-26, where Positron held a special cardiac PET symposium featuring K. Lance Gould M.D. as keynote speaker.
The ASNC is a well-known, leading source of information in the nuclear cardiology community. This year's annual meeting presented an abundance of data and research pertaining to cardiac PET applications, more so than any other prior forum. Of particular focus at the conference was the move from qualitative to quantitative imaging by measuring absolute coronary flow reserve (CFR). As a pioneer in the field of cardiac PET, the Positron symposium was a well-attended event. Dr. K. Lance Gould, from the University of Texas, presented to a standing-room only crowd his life's work on CFR.
"We were thrilled by the overwhelming response and interest in our technology, which only serves to reinforce and validate the strong commitment we've made to developing industry leading, cardiac-specific PET technology. We were honored to have Dr. Gould present on our behalf, as his passion and experience in the field is simply unrivaled.
"We are confident that Positron's Attrius is the ideal PET scanner for physician groups and hospitals looking to enter into cardiac PET imaging, and expect our sales growth will be reflective of that in both the coming quarters and over the long-term," Joseph Oliverio, CTO of Positron stated.
Traffic at Positron's display booth was at an all-time high at this year's conference, giving further credence to the industry acceptance and validity of its business strategy in introducing cost-effective dedicated PET optimized for cardiovascular imaging. Positron has remained focused on cardiac imaging and believes that significant investments made in both time and capital are paying off. Positron currently has intellectual property exclusivity rights with the University of Texas where Dr. Gould has completed and transferred his CFR software for Positron to immediately commercialize for future release.
The 2006 Henry N. Wagner Lecture: Of Mice and Men (and Positrons)—Advances in PET Imaging Technology*
http://jnm.snmjournals.org/cgi/content/full/jnumed;47/11/1735
The 2006 Henry N. Wagner Lecture: Of Mice and Men (and Positrons)—Advances in PET Imaging Technology*
Simon R. Cherry
Center for Molecular and Genomic Imaging, Department of Biomedical Engineering, University of California–Davis, Davis, California
Correspondence: For correspondence or reprints contact: Simon R. Cherry, PhD, Department of Biomedical Engineering, Center for Molecular and Genomic Imaging, University of California–Davis, 1 Shields Ave., Davis, CA 95616. E-mail: srcherry@ucdavis.edu
ABSTRACT
TOP
ABSTRACT
INTRODUCTION
THE PAST: A REVIEW...
THE PRESENT AND THE...
THE FAR FUTURE: WHOLE-BODY...
CONCLUSION
References
There have been major advances in PET technology that cumulatively have helped improve image quality, increased the range of applications for PET, and contributed to the more widespread use of PET. Examples of these technologic advances include whole-body imaging, 3-dimensional imaging, new scintillator materials, iterative reconstruction algorithms, combined PET/CT, and preclinical PET. New advances on the immediate horizon include the reintroduction of time-of-flight PET, which takes advantage of the favorable timing properties of newer scintillators; the integration of PET and MRI scanners into a dual-modality imaging system; and the possibility of further significant improvements in spatial resolution in preclinical PET systems. Sensitivity remains a limiting factor in many PET studies. Although, conceptually, huge gains in sensitivity are still possible, realizing these gains is thwarted largely by economic rather than scientific concerns. Predicting the future is fraught with difficulty; nonetheless, it is apparent that ample opportunities remain for new development and innovation in PET technology that will be driven by the demands of molecular medicine, notably sensitive and specific molecular diagnostic tools and the ability to quantitatively monitor therapeutic entities that include small molecules, peptides, antibodies, nanoparticles, DNA/RNA, and cells.
Key Words: instrumentation • molecular imaging • PET • positron emission tomography • PET/MRI • time-of-flight
INTRODUCTION
TOP
ABSTRACT
INTRODUCTION
THE PAST: A REVIEW...
THE PRESENT AND THE...
THE FAR FUTURE: WHOLE-BODY...
CONCLUSION
References
On the surface, the design of PET scanners appears to have changed little over the past 15 years. However, beneath the sleek exteriors, there has been a revolution in the technologies and methods that are now used. Many talented scientists in academia and industry have contributed to the conception of these ideas and have then worked hard to reduce them to practice—in the process dramatically improving the spatial resolution, sensitivity, and counting rate performance of PET systems and, in doing so, expanding the range of applications in which PET can provide effective information, whether that be in the context of a clinical diagnostic study, in clinical or basic human research, or in preclinical research.
In the first part of this discussion, I will take a retrospective look at some of the key advances in PET technology over the past 20 years and the impact they have had on our field. This discussion will demonstrate the continued and sustained innovation that has been instrumental in making PET the powerful translational molecular modality that it has unquestionably become. In the second part, I will look to the near future and highlight 3 emerging themes in PET technology that in my opinion have the possibility of becoming the key advances of the next several years. Finally, I will take some wild guesses regarding the design and ultimate performance of the PET scanners of the far future. Naturally, this is a highly selective viewpoint that reflects the author's own biases and interests and with which some, and perhaps many, readers will disagree. So, the reader is forewarned! But if it generates scientific discussion and debate and stimulates enthusiasm for tackling the many technologic (and in some cases economic) barriers that prevent us from realizing the theoretically achievable performance of molecular imaging with PET, then it will have served its purpose. A final disclaimer is that this is not a review article; therefore, the references cited are highly selective and are not intended to serve as an encyclopedic record of the many contributions in the literature relevant to each of the topics covered.
THE PAST: A REVIEW OF MAJOR ADVANCES IN PET TECHNOLOGY SINCE 1990
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ABSTRACT
INTRODUCTION
THE PAST: A REVIEW...
THE PRESENT AND THE...
THE FAR FUTURE: WHOLE-BODY...
CONCLUSION
References
Presented here, in rough chronologic order, are what I consider to be some of the most influential advances and changes in PET instrumentation and methods over the past 20 years (Fig. 1). In addition, there have of course been tremendous developments in computational power—and a migration from analog electronics to sophisticated digital electronics—that have been thoroughly exploited in modern PET scanners and have been enabling factors in many of the changes. Cumulatively, all these advances have had a positive impact on every application of PET.
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FIGURE 1. Images and photographs illustrating the major advances in PET instrumentation and methods since 1990 discussed in text: whole-body PET (image courtesy of Dr. Magnus Dahlbom, UCLA) (A), 3D PET (B), LSO and related scintillators (photograph courtesy of Dr. Charles Melcher, Siemens) (C), iterative reconstruction methods (images courtesy of Dr. Richard Leahy, USC) (D), PET/CT (image courtesy of Dr. David Townsend, University of Tennessee) (E), and preclinical PET (mouse image courtesy of Dr. Craig Abbey, UCSB) (F).
Whole-Body PET
In the 1980s, many PET studies were focused on the brain or the heart, and the design of most PET scanners reflected these applications, with an axial field of view just barely large enough for these organs, and with data acquired at 1 bed position. Although the idea of moving the bed through the scanner and acquiring data at a set of contiguous or overlapping bed positions seems obvious in retrospect, this concept and its implementation (1,2) were to change PET forever. The ability to view the whole body opened up clinical applications involving disseminated disease and, in particular, the use of PET for whole-body surveys for finding both primary tumors and metastasis (3) and for monitoring response to chemotherapy. Whole-body imaging therefore directly led to the primary clinical application of PET today and to reimbursement. In the future, the role of whole-body PET can be expected to grow, because it will likely also be critical for monitoring some cellular, DNA- or RNA-based, and immunologic therapies, and roles also can be foreseen in imaging systemic disease, for example, infectious disease, vulnerable plaque, and inflammation.
3-Dimensional (3D) PET
Human PET has been limited largely by scanner sensitivity for many years, with improvements in the spatial resolution of the detectors outstripping gains in counting statistics. Thus, there has been a downward trend in the number of counts detected per detector pair or resolution element with time. Three-dimensional PET, which involved removal of the slice-collimating septa used in many PET systems in the 1980s and early 1990s (4,5), allowed coincidences to be formed between any detector ring in the PET scanner, producing an approximately 5- to 7-fold increase in sensitivity without any increase in the number of detectors in the system. A number of dedicated 3D scanners also were developed around this time (e.g., (6,7)). Three-dimensional PET found an immediate application in the brain but has seen slower acceptance in the rest of the body, because 3D acquisition results in much higher counting rates, higher scatter fractions, and higher numbers of random coincidences, such that with relatively dim and slow scintillators such as bismuth germanate (BGO), significant benefits were not necessarily readily obtained. But with the advent of bright, fast scintillators, in which better energy and timing resolution can be obtained, and in which pulses can be integrated for a shorter time, these effects can be mitigated and more of the sensitivity benefit of 3D PET can be realized. Many people contributed to the development of 3D PET, through early design of 3D-only scanners and modification of traditional 2-dimensional BGO scanners to enable 3D data acquisition, as already discussed (4–7), and through development of reconstruction algorithms that could properly use the 3D data (e.g., (8–11)). Nonetheless, the clinical systems of today, even in 3D mode, still rarely realize their full resolution potential (typically 4–6 mm), because sensitivity is still a limiting factor that results in reconstruction of most clinical studies somewhere in the 8- to 12-mm range to provide signal-to-noise ratios (SNRs) acceptable for diagnostic interpretation.
New Scintillator Materials
In the early 1990s, there was a dilemma in choosing a detector material for use in a PET scanner. The 2 main choices for scintillator material were NaI(Tl), traditionally used in -cameras, and BGO (Table 1). But neither has ideal properties. As mentioned, the slow decay time and low light output of BGO leads to relatively poor timing and energy resolution, yet the high stopping power provides good detector efficiency at 511 keV. The performance of BGO PET scanners in 3D mode was clearly limited by dead time, randoms, and scatter. NaI(Tl) provides better energy resolution (allowing the use of a higher energy threshold to reduce the scatter content of 3D datasets) and was used successfully in several 3D-only PET systems (e.g., (6)); however, timing resolution is still relatively poor, dead time is high, and the stopping power is considerably worse than for BGO. Therefore, a major breakthrough has been the development of new scintillator materials, particularly lutetium oxyorthosilicate (LSO) (12) and related materials such as LYSO (LSO doped with a small amount of yttrium) (13), mixed lutetium silicates, and lutetium fine silicates (14). These scintillators are dense, bright, and fast, yielding excellent timing resolution and reasonable energy resolution (not as good as one might predict for their brightness, because of nonlinearities in the production of scintillation light), and they have a stopping power only slightly inferior to that of BGO. These properties, when coupled with fast, high-throughput electronics, significantly improve the performance of 3D PET scanners made using these materials. Because they are brighter than BGO, these scintillators also permit more crystal elements to be decoded per photomultiplier tube, thus helping control costs as the trend toward more detector elements in a PET scanner has continued.
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TABLE 1 Properties of PET Scintillators
Iterative Reconstruction Methods
Filtered backprojection methods, including 3D reconstruction algorithms based on filtered backprojection (8–11), have the attractive properties of being linear, and computationally fast, but can easily lead to significant artifacts caused by a combination of low statistics (both in the original emission data and with additional possible contributions from normalization, attenuation correction, and randoms correction) and sampling considerations. These methods also simplistically model the geometry of the scanner with perfect pointlike detectors and give the same weight to projection elements containing large numbers of counts as to those containing just a few counts. For these reasons, much effort has been devoted to developing iterative reconstruction algorithms that weight the data according to their statistical quality and that accurately model the geometry of the imaging system, including effects such as intercrystal scatter and depth of interaction effects and nonuniform sensitivity along a line of response. These methods can also handle the incorporation of corrections for attenuation and normalization in a statistically optimized fashion. The net result is that, in general, iterative algorithms result in reconstructed images that have a more favorable tradeoff between SNR and spatial resolution and in which streak artifacts, common with filtered backprojection methods (e.g., around the bladder in 18F-FDG studies), are effectively eliminated (15–17). Thus, these methods have now been widely adopted. The largest drawback has been the computational cost of these algorithms, which, because of the rapidly increasing number of detectors in PET scanners, has increased even faster than can be kept up with by advances in the speed of computers. Fortunately, accelerated versions of these algorithms are available that render them practical for routine use (18).
PET/CT
The introduction of combined PET and CT scanners in a tandem configuration in the latter part of the 1990s (19,20) led to a paradigm shift in the practice of clinical PET. By providing registered PET and CT data, this configuration enabled regions of increased 18F-FDG accumulation on the PET image to be directly correlated with their anatomic locations on the CT scan, improving the sensitivity and specificity of PET for lesion detection. The dramatic impact of this technology is best appreciated by observing that within 5 years of the introduction of the first PET/CT scanners, they were accounting for greater than 90% of all PET scanner sales. The combination of PET and CT has important secondary benefits as well. The CT scan, with appropriate consideration for differences between the spectrum of x-ray energies produced in CT and the monoenergetic 511-keV photons detected in PET, can be used to correct for photon attenuation in PET (21), eliminating the need for PET transmission sources and scans. The CT scan also has the potential to be used to estimate the scattered events in the PET scan and to correct for partial volume errors. Although the adoption of this technology has been rapid and widespread, several important technical challenges remain, including the differing effects of physiologic motion in PET and CT because of the different acquisition protocols (22) and the effect of CT contrast agents when using the CT for PET attenuation correction (23,24).
Preclinical PET
Although PET has been used for research studies in animals for a long time, most applications were in large-animal models such as the pig and dog for cardiovascular research and the nonhuman primate for neuroscience research. Most of these studies were performed on human PET scanners, and little work was done in rodent models because the resolution of clinical scanners was insufficient for all but the crudest of studies. The combination of large PET scanners and expensive animal models also restricted these types of studies to the largest research centers. But the development of high-resolution, dedicated animal PET scanners during the 1990s (25–28) brought PET technology to a whole new set of investigators in the biologic sciences and, as a preclinical tool, to the pharmaceutical and biotechnology industry. Just as with human PET scanners, this technology has progressed from academic laboratories to small companies and now to the major medical imaging corporations. Although small-animal scanners are based on the same technologies as are used in clinical systems, the requirements (high resolution, high sensitivity, small field of view) and the imaging environment (low attenuation, low scatter, low counting rates) are quite different, leading to very different tradeoffs in the design. Preclinical PET has now become firmly established as a discipline in its own right and has helped position PET as a leading translational tool in the field of molecular imaging, allowing PET tracers and quantitative assays to be used seamlessly across species, from mouse to patient.
THE PRESENT AND THE NEAR FUTURE
TOP
ABSTRACT
INTRODUCTION
THE PAST: A REVIEW...
THE PRESENT AND THE...
THE FAR FUTURE: WHOLE-BODY...
CONCLUSION
References
Over the years, there have been several moments at which one might have felt that PET technology had reached its full potential and that perhaps the major innovations were behind us, but as the 6 examples just given illustrate, there have continued to be breakthroughs over the past 20 years that have fundamentally changed the practice and application of PET. We find ourselves asking the same question today—that is, Has PET technology now matured to a level at which we can expect only incremental changes, or will there be yet another wave of major breakthroughs? Predicting the future is fraught with danger, but nonetheless, some developments already well under way are likely to significantly affect PET over the next few years, and I have selected 3 promising areas to explore in more detail. But first, for the reader to appreciate some of the points that will be made, a quick review of basic PET physics is in order.
Figure 2 shows an 18F-FDG molecule inside the body. When the radioactive 18F atom on the molecule decays, a positron is emitted and interacts with surrounding electrons and atoms in the tissue, scattering off them and quickly losing energy. Within a short distance and time, the positron will have slowed to thermal energies and will undergo annihilation, with a nearby electron (in the process the 2 particles disappear) producing 2 back-to-back annihilation photons, each of which carries away an energy of 511 keV. Annihilation is a wonderful example of Einstein's famous E = mc2 equation, where the summed masses (m) of the positron and electron are converted into energy (E), with a constant of proportionality equal to the speed of light (c) squared. What we actually image in PET is the distribution of annihilation sites in the body, but because the distance from the decaying molecule to the annihilation site (known as the positron range) is fairly short, this distribution is a good approximation of the distribution of the radiolabeled molecules that we actually seek to image.
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FIGURE 2. Basic physics of PET. 18F atom (yellow) on FDG or FDG-6-phosphate molecule decays, emitting positron that scatters in tissue until it loses enough energy to undergo annihilation with an electron, in which mass of positron and electron are converted into 2 back-to-back 511-keV photons.
Time-of-Flight (TOF) PET
In conventional PET, a valid event is formed when the 2 coincident 511-keV annihilation photons are detected within some prespecified timing window, typically on the order of 8–14 ns for detectors based on scintillators such as BGO and NaI(Tl). The 2 detectors in which interactions are measured determine a line along which the original annihilation site must lie (Fig. 3A). The location of the annihilation site along that line is unknown and must be recovered by image reconstruction. The image reconstruction algorithm, with no other information at its disposal, assumes that all possible locations of the annihilation site along the line are equally likely (Fig. 3B).
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FIGURE 3. Illustration of TOF PET: detection of 2 annihilation photons in PET scanner (A), uniform-probability weighting of annihilation site in standard PET (B), and use of TOF information to constrain location of annihilation site during image reconstruction (C).
In TOF PET, the actual time difference in the arrival of the 2 annihilation photons at the detectors is recorded (29). The time difference increases the farther the annihilation site is from the point midway between the 2 detectors. Modern clinical PET scanners typically are capable of an isotropic spatial resolution in the 4- to 6-mm range. Therefore, if we wanted to use the TOF effect to pinpoint the annihilation site to about 5 mm and completely eliminate the need for image reconstruction, then the photon arrival times (given that the speed of light is 3 x 108 m/s) would need to be recorded with a precision of approximately 30 ps! Detectors and electronics capable of such a timing resolution are not available; however, a timing resolution of a few hundred picoseconds is feasible. This can be used to constrain the reconstruction algorithm, because it localizes the annihilation site to within a few centimeters, and thus the reconstruction of that event can be weighted accordingly (Fig. 3C). The approximate improvement in SNR over that obtained with non-TOF PET is given by
(Eq. 1)
where D is the diameter of the object being imaged, c is the speed of light, and t is the timing resolution of the system.
Many will recall that TOF PET was all the rage in the mid-1980s but, after careful investigation, was soundly rejected as an approach in clinical PET systems. So why, some 20 years later, is TOF PET making a comeback, and why is it likely here to stay this time? The difference is due to the scintillators now available, together with improved fast timing electronics. In 1990, the only scintillators fast enough to provide any reasonable level of TOF information for PET were BaF2 and CsF (Table 1). With both these scintillators, a timing resolution of around 550–750 ps was achieved in PET systems. Unfortunately, the modest SNR gain at this timing resolution, predicted by Equation 1, was more than offset by the much lower efficiency of these scintillators compared with that of BGO (reducing the number of counts detected for a given dose and reducing SNR). There were also many issues with the stability of these early systems (29).
Recently, it has become clear that excellent timing resolution can be achieved with some of the newer scintillators such as LSO and LYSO, and because these materials have good stopping power, there is no compromise in detector efficiency. With a single pair of detectors, a timing resolution of 220 ps has been measured with LSO (Bill Moses, written communication, 2006), and in a recent commercial LYSO TOF PET system (Philips), a 600-ps timing resolution has already been achieved. A TOF PET system based on LaBr3 also is being developed (30) and promises an even better timing resolution coupled with outstanding energy resolution, albeit with some compromise in sensitivity because of the lower stopping power of LaBr3 relative to that of LSO and LYSO.
It now appears possible to actually realize the gains predicted by Equation 1, and in a patient, these gains are significant indeed. For example, if one takes a fairly favorable scenario of a 40-cm-diameter patient, imaged on a TOF PET scanner with 300-ps timing resolution, one would expect an SNR gain of a factor of 3. In a less favorable scenario, of a 30-cm-diameter patient, with 600-ps timing resolution, then the SNR gain is still predicted to be a factor of 1.8. These gains are larger than the true gain realized with the introduction of 3D PET and will make a significant difference to the practice of PET (31,32), permitting some combination of faster imaging, lower injected dose, improved SNR, or improved spatial resolution. It is also worth noting that the improvements from TOF PET actually are greater in larger patients (larger D in Eq. 1). Given that image quality is a major problem in heavier patients (more attenuation and scatter), that obesity is on the rise, and that obesity leads to health-related problems that may require diagnostic PET scans, TOF PET may be an even more important advance than we currently realize.
Very-High-Resolution Preclinical PET
The requirement of imaging small structures in animal PET has helped to push the spatial-resolution frontiers for PET. Before the introduction of dedicated preclinical PET scanners, it was commonly accepted that the resolution of PET was limited to approximately 2 mm (it turns out, for human whole-body imaging, that this is correct). But preclinical PET scanners that can reconstruct images with a spatial resolution of 1 mm or less already exist (e.g., (28,33–35)); therefore, this limit clearly does not apply to animal studies. So, the question is, What is the difference between animal imaging and patient imaging that permits higher spatial resolution, and how much further can the spatial resolution be improved in preclinical applications?
Spatial resolution in PET is determined by several factors. The first factor, positron range, is the distance the positron travels from its point of emission to its point of annihilation, as defined in Figure 2. Because the annihilation sites, and not the site of the radioactive atoms, are imaged by PET, some blurring is introduced into the image. The amount of blurring depends on the energy with which the positrons are emitted and is radionuclide-dependent. A second factor, non-colinearity, is a result of nonzero momentum of the positron and electron at the time of annihilation, resulting in a slight angular deviation of the 2 annihilation photons about the assumed 180°. This factor is illustrated, in exaggerated form, in Figure 4; the amount of blurring due to non-colinearity is given roughly by 0.022 x detector separation. A third factor is detector geometry. A detector of width d results in a triangular coincidence response function with a full width at half maximum of d/2. Thus, achieving a 2-mm resolution would require that the detector elements be smaller than 4 mm. The thickness of the detector (typically 1–3 cm) also has some influence on spatial resolution through parallax errors. In a typical ring-geometry scanner, this influence leads to degradation of spatial resolution as one moves away from the central axis of the scanner. A fourth factor is detector interaction physics. Unfortunately, even when one uses the scintillator with the highest stopping power available (BGO), the most likely interaction in the detector at 511 keV is Compton scatter, where the photon will interact, deposit just some of its energy, change direction, and then, particularly in thick detectors, have a significant probability of interacting in adjacent detectors. Thus, the energy is deposited at 2 or more locations in the scanner, and there is no simple method to determine the first point of interaction that corresponds to the desired positional information. The result is some additional data blurring that depends on the scintillator material and the thickness of the detectors.
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FIGURE 4. Illustration of non-colinearity of annihilation photons in PET. Angle is greatly exaggerated; distribution of angles around 180° is gaussian, with SD of only 0.25°.
Let us examine how these factors contribute in a typical clinical PET scanner. Assume that the study uses 18F-FDG as the radiotracer, that the scanner has a ring diameter of 80 cm, and that the scanner comprises 2-cm-thick LSO detectors. Figure 5A shows the blurring of a pointlike source of 18F caused by a positron range, non-colinearity, and detector scatter. The convolution of these 3 factors provides an estimate of the limiting resolution (based only on physics) for clinical PET. Note that we are assuming infinitely small detectors and that therefore there is no contribution from the detector size. The result is that we estimate the best resolution achievable to be about 2 mm, in agreement with conventional wisdom. What might be surprising, however, is that this achievement is completely dominated by the non-colinearity effect. Scatter in the detector material and positron range are very small factors.
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FIGURE 5. Contribution of physics factors (positron range, non-colinearity, and detector scatter) to resolution attainable in PET: clinical PET scanner, with detector ring diameter of 80 cm, consisting of 2-cm-thick LSO detectors, and imaging radiotracer labeled with 18F (A); small-animal PET scanner, with detector ring diameter of 8 cm, also consisting of 2-cm-thick LSO detectors and imaging 18F-labeled radiotracer (B). Contribution of positron range, non-colinearity, and detector scatter is shown in each case.
Figure 5B shows the same simulation for a small-animal PET scanner, using the same detectors and the same radionuclide, 18F. The only difference is that the detector separation has been reduced to 8 cm, a distance easily sufficient to accommodate a 2-cm-diameter mouse. As Figure 5B shows, this change in geometry has a dramatic effect on the resulting spatial resolution, because the blurring caused by non-colinearity is directly proportional to the detector separation and therefore is reduced by a factor of 10 relative to the clinical scanner. This reduced blurring leads to a predicted limiting resolution of just 0.4 mm. One can also see that the positron range, non-colinearity, and detector scatter effects contribute in a more balanced way to the overall resolution limits and that no single effect dominates.
The next question is how small the detectors in an animal PET scanner need to be in order for the physical detector size not to be a limiting factor and for a spatial resolution close to the predicted 0.4 mm to be reached. It turns out that a detector size of around 0.25 mm is required (36), much smaller than the detectors used in even the latest-generation systems (typically 0.8–1 mm). Thus, there is clearly a potential for much better spatial resolution (roughly a factor of 5 in volumetric resolution) in small-animal PET studies if more finely segmented detectors can be developed. We recently obtained data with 0.5-mm-pixel LSO arrays that produce a spatial resolution of about 0.6 mm (37), indicating that smaller detectors do indeed lead to further improvements in spatial resolution, as predicted. Unfortunately, it is difficult to reliably manufacture scintillator arrays on such a fine pitch—in particular, thick arrays made with scintillators such as LSO and LYSO—and therefore alternatives, such as directly detecting the annihilation photons with relatively dense semiconductor materials such as cadmium telluride, should be pursued. Once such detectors are developed, we can anticipate that the preclinical PET scanners of the future will reach approximately 0.5 mm in spatial resolution, which will open up applications currently out of the range of PET because of resolution limitations, obvious examples being the delineation of several structures in the mouse brain and an improved ability to image early lesions and metastasis in mouse models of cancer.
Although we talk of "limits" of resolution, it should be understood that, in principle, all the physical and geometric factors discussed earlier can be deconvolved, or modeled within iterative reconstruction algorithms, and can be compensated for to a certain extent. Thus, the estimated numbers are not a hard limit but, rather, a limit to what can be achieved without software compensation—bringing us to an issue conspicuous by its absence in this discussion: the subject of sensitivity. To achieve a resolution of 0.5 mm in vivo, and to be able to even contemplate correcting for some of the residual blurring using software approaches, will require a large increase in the number of counts collected in a study. Radiation dosimetry for mouse imaging is not favorable (38), and the molecular targets of interest can easily become saturated if too much mass is injected (39). Therefore, it is not possible simply to inject more radiotracer to get sufficient counts. Rather, large improvements in scanner sensitivity are required. Such improvements are somewhat easier to realize in a small-animal system than in a human scanner, because the animal can almost be surrounded by detectors, without requiring an unreasonable amount of detector material (thus ensuring that almost all photon pairs intersect the detector system). When detectors that measure depth of interaction are used (e.g., (40–42)), thicker detectors (thus ensuring that photons passing through the detectors interact) can be placed close to the animal, reducing the resolution degradation due to parallax errors. Increases in sensitivity on the order of 5- to 10-fold should be possible using a combination of these approaches.
Dual-Modality PET/MRI Scanners
As discussed earlier, PET/CT scanners have become widely adopted in the clinic and now account for most sales of PET scanners. Interestingly, research on another multimodality combination, PET/MRI, started at roughly the same time as PET/CT, in the mid-1990s (43,44). The development of PET/MRI has, however, been much slower, for 2 reasons. First, PET/MRI is technologically more challenging than PET/CT because radiofrequency interference between the 2 imaging systems has to be avoided and the PET detectors must work in relatively high magnetic fields. The fact that most PET detectors are based on photomultiplier tube technology, which is adversely affected by even minimal magnetic fields, poses an immediate problem. But a second difficulty is that, for reasons not completely clear, all developers of PET/MRI systems so far have chosen to position the PET scanner within the magnet of the MRI system to permit simultaneous or near-simultaneous PET and MRI studies, rather than opting for the tandem approach, currently used in PET/CT, in which the 2 scanners are placed next to each other with a common bed. This geometry complicates things much more by creating the additional requirements that the presence of the PET detectors in the magnet not perturb the homogeneity of the magnetic field and that the PET detectors be able to operate in the high fields of the main magnetic field, not just in the fringe field. There are also significant constraints in working in the small space between the gradient coils and the radiofrequency coils within the MRI scanner.
The immediate questions that come to mind regarding PET/MRI are whether it is technically possible and what it will be used for. The earliest motivation for combined PET/MRI was the fact that strong magnetic fields can reduce the positron range effect, discussed earlier, in 2 of the 3 dimensions (43,45,46). Positrons are charged particles and therefore will tend to "spiral" around the magnetic field force lines, reducing their average range before annihilation. However, significant resolution improvements are realized only at high fields (4.7 T or higher) and then only for those positron emitters that emit high-energy positrons. The effect on 18F, and therefore on FDG, is small and not by itself a sufficient motivation for developing combined PET/MRI scanners.
The current motivation appears driven by biomedical applications, both clinical and preclinical. PET/MRI may have advantages over PET/CT in certain applications in which MRI is the anatomic imaging modality of choice, and PET/MRI also has the advantage of reducing the overall radiation dose to the subject by replacing CT with MRI. On the other hand, the use of MRI to compute the attenuation correction for the PET study is not as straightforward (although almost certainly still possible). But it is likely that the major initial use of PET/MRI scanners will be in research, both human and animal. The ability to use PET simultaneously with standard MRI, functional MRI, spectroscopic MRI, and MRI using nanoparticles and targeted contrast agents opens up many interesting possibilities for interrogating a biologic system, some of which may ultimately find clinical translation. Nonetheless, it is fair to say that the applications that are needed to drive the commercial success of PET/MRI are not immediately clear and that a certain assumption of "build it and they will come" underlies much of the research in this area.
Although one can debate how PET/MRI might ultimately be used, there is no doubting the technologic breakthroughs over the past 2 years that are now clearly demonstrating that simultaneous PET/MRI is possible. The earliest attempts at PET/MRI used optical fiber technology to pipe light from scintillators in the bore of a magnet to photomultiplier tubes, with good magnetic field immunity, in the fringe field outside the bore of the magnet (44,47,48). This approach, although successful at producing the first examples of simultaneous PET and MR images, was limited by the low sensitivity and axial coverage of the single-slice PET scanner, and the bulk of optical fibers that needed to be extracted from the magnet prevented any serious thoughts of scaling up the approach for a multiring scanner or for human imaging. The recent surge in interest has been fueled by the availability of avalanche photodiodes (APDs) as a replacement for the magnetic-field–susceptible photomultiplier tube. APDs are light-sensitive detectors that can tolerate high magnetic fields and that perform competitively with photomultiplier-tube–based detectors for PET applications. UC Davis and the University of Tübingen are collaborating on 2 related APD approaches, one using position-sensitive APDs along with short optical fiber coupling (49) and the other using a 3 x 3 array of single-channel APDs without optical fiber coupling (50). Data from both centers already demonstrate the ability to acquire PET and MRI data simultaneously, and for standard anatomic MRI at least, there seems to be no degradation in the performance of either modality. Figure 6 shows a photograph of the completed UC Davis MRI-compatible PET insert, designed to fit inside the bore of a BioSpec 70/30 animal MRI system (Bruker BioSpin). Development of a human PET/MRI scanner for brain imaging is also well under way (51), with plans for extension to a whole-body PET/MRI system. Alternative approaches using novel split magnets, in which the PET detectors reside in the gap between the 2 magnets (52), and a field-cycled MRI system, in which PET data are taken as the magnet is cycled (53), also are under development. From all these efforts, it is now clear that fully functional PET/MRI systems, both for animal and for human applications, will be rolling out over the next 1–3 years, and so the interesting question becomes, What will be the impact of this new technology, and what will be its role in clinical diagnostics, clinical research, molecular imaging, and drug development?
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FIGURE 6. Photograph of MRI-compatible PET insert based on arrays of LSO scintillator coupled through short lengths of optical fibers to position-sensitive APDs and MRI-compatible electronics. This insert fits inside bore of 7-T animal MRI scanner, permitting simultaneous PET and MRI studies.
THE FAR FUTURE: WHOLE-BODY PET/MRI?
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ABSTRACT
INTRODUCTION
THE PAST: A REVIEW...
THE PRESENT AND THE...
THE FAR FUTURE: WHOLE-BODY...
CONCLUSION
References
If predicting the near future is dangerous, predicting the far future is probably foolish. Nonetheless, it is interesting to speculate what PET instruments might look like some 5–10 years from now. The success of whole-body PET in oncology has demonstrated that PET is well suited to studies of systemic disease and therapies, and thus, one can perhaps anticipate an expanding role for PET in systemic applications such as inflammation, infectious disease, and vascular disease and for the monitoring of systemic therapies, including targeted molecular therapies, cellular therapies, gene therapies, and nanoparticle-based therapies.
Human whole-body PET today is clearly limited by low sensitivity and the resulting low SNR produced in the reconstructed images. Only rarely are studies limited by the resolution of the detectors (typically 4–6 mm) in clinical PET scanners. Thus, breakthroughs in whole-body imaging will require significant increases in sensitivity. At first glance, such increases may not seem easy to achieve; however, some simple calculations perhaps suggest otherwise.
In 3D mode, current scanners have a system sensitivity of roughly 5% at the center of the field of view. That is, 5% of the annihilation photon pairs emitted from a point source at the center of the scanner, in the absence of attenuation and scatter, produce valid coincidence events. When averaged over the entire axial field of view of the scanner, which for the sake of this example we will assume to be 15 cm, the average sensitivity for the portion of the body within the scanner is around 2.5%. Unfortunately, only one eighth or less of the body is in the field of view of our typical clinical scanner at any one time (Fig. 7A). Thus, the effective sensitivity for whole-body imaging is less than about 0.3%! It is also important to point out that these low sensitivities are not principally due to the limited efficiency of the detectors. Typical BGO or LSO detectors with a thickness of 2–3 cm stop on the order of 70%–90% of the 511-keV annihilation photons; thus, relatively little is to be gained by improving the detector efficiency.
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FIGURE 7. Schematic illustration of current configuration and sensitivity for 3D whole-body PET (A) compared with configuration in which whole body is within field of view (B). Axial extent of PET detectors is indicated by blue, and sensitivity is indicated by the intensity of red.
Large increases in sensitivity can come only by placing much more detector material around the patient, thereby increasing the chance that annihilation photons emitted from the patient actually intersect the detectors. If one conceives of a PET scanner with an axial field of view long enough to contain the whole patient within the scanner (Fig. 7B), the effective sensitivity for imaging the whole body, even if one maintains the same axial acceptance angle, approaches the full 5%. This system sensitivity is roughly an improvement by a factor of 16 with respect to current systems and would improve the SNR in whole-body PET images, all other things being equal, by roughly a factor of 4. If we now add TOF capability to this scanner, another factor of 2–3 is added to SNR, as discussed earlier. So now we have an improvement in SNR that is roughly 1 order of magnitude. And one could argue that this estimate is on the conservative side, because by opening the axial acceptance angle on the large-field-of-view scanner and making the system "fully 3D," the sensitivity could be increased even more. Simplistically, this kind of increase in SNR allows the PET study to be acquired in one hundredth of the time or with one hundredth of the dose. Alternatively, the increased SNR could be used to improve the spatial resolution of whole-body PET significantly. The trend toward scanners with longer fields of view is already evident, with development of a scanner already having a 68.5-cm axial field of view by Hamamatsu (54), development of LSO panel detectors having a 52-cm axial field of view (55), and simulation studies that examine the performance of scanners with long axial fields of view (56).
Clearly, one would want to integrate this whole-body PET system with high-resolution anatomic imaging, so why not take advantage of the advances in MRI that now permit whole-body imaging to be completed in about 10–20 min and place the entire PET scanner inside a whole-body magnet (Fig. 8)? Imagine the ability to obtain whole-body kinetic studies showing the underlying anatomy, with the obvious applications in whole-body drug pharmacokinetics, dosimetry for radioimmunotherapy, and cell-trafficking studies, and the possibility of implementing quantitative PET tracer kinetic modeling protocols, perhaps even in the clinic, using the left ventricular blood pool as the input function for distant tissues and avoiding the need for arterial blood samples.
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FIGURE 8. Concept of whole-body PET/MRI scanner, and images that such a system might produce (PET image courtesy of Siemens Medical Solutions; whole-body T1-weighted MR image courtesy of Dr. Heinz-Peter Schlemmer, University of Tübingen).
The obvious objection to such a system is one of expense in a financially restricted health care setting. To realize such a system in anything other than an elite medical research environment would require significant reductions in cost. But putting cost aside, technically, it is likely that the PET component of such a system could be built even with current technology, and as outlined here, the combination of PET and MRI is looking increasingly feasible. There are certainly technologic challenges that would need to be addressed to fully realize the kinds of gains in PET that have been suggested. These challenges include the need to control the contribution of scattered coincidences (detectors with excellent energy resolution and perhaps some limited axial collimation) and random coincidences in a scanner that encompasses the whole body, the need for high-speed coincidence electronics to keep up with high data rates, and the need for fast and accurate iterative reconstruction algorithms to provide high-quality images in a reasonable time. But all of these challenges seem within our grasp.
CONCLUSION
TOP
ABSTRACT
INTRODUCTION
THE PAST: A REVIEW...
THE PRESENT AND THE...
THE FAR FUTURE: WHOLE-BODY...
CONCLUSION
References
Whether this is a reasonable view of the future or a piece of pure science fiction is debatable. Although it is almost certain that this vision of the future will be wrong in many, if not all, of its details, I believe that the spirit of the message will not be wrong and that we will continue to see major advances and improvements in PET technology for some time to come. Clearly, the future will ultimately be determined by the direction that medicine takes and the diagnostic and therapeutic monitoring needs that are generated. The scenario presented here is only one of many possibilities, but generally one can anticipate that an era of targeted molecular, genetic, and immunologic therapies, if it should come to pass, will be good news for nuclear molecular imaging technologies and will provide many opportunities for the further development and effective deployment of our imaging systems. Future advances in PET instrumentation may come from unlikely and unforeseen sources and be driven by applications that are as yet unappreciated or unknown, but they will come.
ACKNOWLEDGMENTS
I would first like to thank all the students, staff, and postdoctoral fellows who have worked in my laboratory and inspired me over the years. I specifically acknowledge the work of Ciprian Catana, Dr. Bernd Pichler (PET/MRI scanner), and Dr. Jennifer Stickel (resolution limits in PET) for their research that inspired certain sections of this article.
I want to thank my 3 close faculty colleagues and friends at UC Davis, Dr. Ramsey Badawi, Dr. Jinyi Qi, and Dr. Julie Sutcliffe, for numerous insightful discussions and for helping to create an energetic, enthusiastic, and enjoyable environment for PET imaging research at our institution. I am also deeply grateful to 2 long-time collaborators, Dr. Richard Leahy (USC) and Kanai Shah (Radiation Monitoring Devices Inc.), without whom many of our ideas and interests would never have come to fruition.
I thank my many colleagues throughout academia and industry who have long been helpful and generous, providing advice, suggestions, guidance, and material support. In particular, I acknowledge the many contributions of Dr. Michael Phelps, Dr. Bill Moses, Dr. Joel Karp, Dr. Paul Marsden, Dr. Lars Eriksson, Dr. Robert Nutt, Dr. Ronald Nutt, Dr. Tom Lewellen, Dr. David Townsend, Michael Green, Chris Thompson, Chuck Stearns, James Colsher, and, above all, the late Dr. Edward Hoffman, my mentor for many years.
Support for research originating in our laboratory was generously provided by the Department of Energy, the National Cancer Institute, and the National Institute of Biomedical Imaging and Bioengineering.
FOOTNOTES
* Based on the presentation given for the Henry Wagner Distinguished Lectureship, 53rd annual meeting of the Society of Nuclear Medicine, San Diego, California, June 2006.
References
TOP
ABSTRACT
INTRODUCTION
THE PAST: A REVIEW...
THE PRESENT AND THE...
THE FAR FUTURE: WHOLE-BODY...
CONCLUSION
References
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Received for publication August 4, 2006. Accepted for publication September 6, 2006.
From Yahoo Board:Rooneys Response to email
To: investor@positron.com<investor@positron.com>;
Hello,
I’m a very concerned investor with over 160,000 shares. I feel great about Positrons technology and partnership, and feel Positron is on the verge of a paradigm shift in the radiopharmaceuticals industry with the Pharm-Assist and technologies. I also think Positron could be a leader in this industry someday.
However, I, and many other investors are very concerned about the increase of shares outstanding in the last year. This comes right off the sec documents:
Aug 23, 2010 10-Q
Shares Outstanding: 773,452,547
Aug 14, 2009 10-Q
Shares Outstanding: 212,316,863
Obviously I feel the shares I bought have been diluted, and I would like to know the reason for the massive dilution. Will this continue, will the dilution stop? I think these are valid questions that should be answered.
HI Lou,
We are very aware of the increase in shares and have only increased the share issuance to operate, get 100% cleaned up on the debt and grow. This is how you get award winning products and partners/alliances that change the world with and for you.
You will see in 2009 that the cash was very low. This is not the case today. We are selling PET products and launching pharma products through our dispensing technologies and actual pharmaceuticals are on the short term horizon.
Any dilution has been 100% attributed to growth and growth of a healthier company.
We only issue shares to grow existing businesses and as need as we enter into new markets….I believe this expansion has been evident.
The increase in our value as a company is much greater than any increase.
Please let me know if this helps.
Thank you
Patrick Rooney
Positron Corporation
CEO
Reverse split
Does anyone think we will be getting this down the road?
Positron to Present at Rodman & Renshaw Annual Global Investment Conference
Positron to Present at Rodman & Renshaw Annual Global Investment Conference; 12th Annual Healthcare Conference
INDIANAPOLIS, Aug. 23, 2010 (GLOBE NEWSWIRE) -- Positron Corporation (OTCBB:POSC), a molecular imaging and solutions company specializing in nuclear cardiology and a leader in cardiac PET, announced today the Company is scheduled to present at the Rodman & Renshaw Annual Global Investment Conference, held on September 12-15, at the New York Palace hotel in New York City.
Patrick Rooney, chief executive officer of Positron Corporation, will be presenting on Tuesday, September 14th. Details surrounding the presentation and audio webcast will be made available in the coming weeks.
For more information about the Rodman & Renshaw 12th Annual Healthcare Conference, go to: http://www.rodmanandrenshaw.com/conferen...
iCAD (NASDAQ: ICAD): Early Cancer Detection
by Andy Obermueller, editor Fast-Track Millionaire
iCAD (NASDAQ: ICAD), the leader in computer-assisted detection of cancer and a Fast-Track Millionaire portfolio holding, announced that the FDA has cleared VeraLook, its virtual colonoscopy product.
VeraLook uses sophisticated technology to identify polyps in between 1,200 and 1,500 images produced from a non-invasive CT scan.
Though the timing was never certain, the FDA's move, which followed European approval last year, was expected.
The virtual procedure is safer, more accurate, does not require sedation and is in general far more comfortable than a traditional optical colonoscopy. VeraLook also has been shown to generate far less frequent false positives.
iCAD chief executive Ken Ferry said 40 million Americans who should have colonoscopies do not get them and said iCAD's break-through technology could prompt more people to undergo the examination.
As with all forms of cancer, early detection is the key to successful treatment. The American Cancer Society says colorectal cancer is the No. 2 cause of cancer-related deaths in the United States, where it claims 51,000 lives a year.
While today's news is certainly good news, let me be clear: It marks the beginning for iCAD, not the end.
As this technology gains wide acceptance -- I think it will become the standard diagnostic protocol nationwide -- iCAD's earnings will soar.
Thousands of hospitals, the vast majority of which already have CT machines or access to them, will adopt iCAD's virtual colonoscopy software. Over the near future, I think iCAD can become a $20 stock.
Action to Take --> Interested investors should not sit on the sidelines, though I'd suggest waiting for a slight pullback, as they often come in the days following a major announcement.
But the reality is I think this is a $20 stock and it is extraordinarily cheap right now given the future of the virtual colonoscopy and the company's very strong other diagnostic divisions.
http://www.istockanalyst.com/article/viewarticle/articleid/4394787
Positron Announces Opening of cGMP Manufacturing Facility
Facility to Focus on Production of Positron Emission Tomography Pharmaceuticals
Press Release Source: Positron Corporation On Tuesday August 10, 2010, 9:33 am
INDIANAPOLIS--(BUSINESS WIRE)--Positron Corporation (OTCBB:POSC - News), a molecular imaging and solutions company specializing in Nuclear Cardiology and a leader in Cardiac PET, announced today the opening of a cGMP ready (current good manufacturing practices) facility in Indiana for the manufacturing of both radioactive and non-radioactive pharmaceutical products and devices.
“The opening of this facility marks a significant milestone in Positron’s expansion into the consumables market that began with the acquisition of Dose Shield in 2008,” stated John Zehner, COO of Positron. “Radioactive and non-radioactive pharmaceutical products are a key component of our Company’s growth strategy; the opening of such a facility affords us significant advantages in every aspect of our business, which enables us to remain competitive in the future. The opening of this manufacturing facility was critical to our plan, as we are now equipped with the staff, equipment and space necessary to manufacture a variety of radioactive and non-radioactive pharmaceutical products. While the Company’s plan is to focus on small batch, radioactive PET products, the facility will also be utilized to support current and future Positron equipment, as well as, expand into new markets. We are presently in discussions with several entities that can utilize our contract manufacturing services,” concluded Mr. Zehner.
The Company noted the approximate 10,000 square foot facility, with room for expansion, contains ample clean room space and laboratory equipment to support the production of pharmaceutical and support products for both industrial and medical use. These products will meet or exceed Food and Drug Administration (FDA) current good manufacturing practices (cGMP’s). This will allow for the production of products under 510k’s, ANDA’s, NDA’s and IND’s, as well as, certified compounding products for pharmacy use.
Pharm Assist..the BIG picture!
The company's Nuclear Pharm-Assist® technology is set to reshape the radiopharmaceutical distribution in the nuclear cardiac imaging space. Analysts believe Positron will generate extraordinary revenues selling radiopharmaceutical consumables to the large customer base that exists today for SPECT radiopharmaceuticals (7,000+ opportunities) and will leverage the same base as the SPECT industry migrates to PET as the #1 cardiac imaging modality in the world.
"The device is like a large refrigerator that is an automated virtual pharmacy," explains Rooney. "The way the world works now, is that if you are looking for an image of your heart, your doctor calls the radio pharmacy and they order a dose syringe cocktail. It arrives and you get an injection with it. Currently, companies like Cardinal Health and GE Healthcare control this market and radio pharmacies deliver the radio pharmaceuticals. What our device does is that it compounds what you need on site, so literally we can install these devices at your cardiologist's office and when you walk in, they don’t say 'Hey, come back tomorrow so we can order you a does of radioactivity. With us, you hit some buttons and it comes out of this vending machine, if you will.
"So now literally, instead of opening up brick and mortar for $3 million and selling pharmaceuticals, we can install this inexpensive automated device that is compliant with all United States regulations on exposure issues and you can literally walk in; they hit some buttons and boom! A cocktail comes out in a syringe. They inject you and you get imaged on the spot. It works in emergency rooms- obviously that would work well- but it also works in cardiology offices where it's about patient management, It provides inventory control, it lower exposure issues and, quite frankly, it lowers cost across the board because there is less drive time, less gas consumption, etc.
"We're ready to bring in the imaging, and now we can also bring in the dose dispensing. We're going to have the full solution so that we can say 'hey doctor, we'll install the PET camera as either a rental or a sell and as far as dispensing pharmaceuticals, here's your vending machine. And just like someone who puts in a vending or soft-drink machine, we sell the products and make our profits there. This device is just basically handed out. It's the same methodology and what happens is that now, we bring everything together. We can sell drugs and cameras to the cardiologist and all of it at a better price, with more efficiency and more effectiveness. That's how we deal with our market."
M&M'S shakeing out the weak hands??
Looks like the same game they played with some of my other stocks.
Just an article I found. Take ti for what its worth. I am long and holding proud.
ED
POSC.OB: Tread lightly
Posted by Patrick On Friday, June 18, 2010 3 comments
They just put out a new press release(here) and it appears Biomedreports.com is going to ride them again. Sounds like the same old story to me. Not much has changed. Just looking at their recent 10-Q makes me curious where all the money is going.
For the quarters ending
Operating expenses: Mar 31, 2010 Mar 31, 2009
Research and development 121 30
Selling and marketing 210 16
General and administrative 3,099 609
The company claims they have 21 employees. Yet somehow, they managed to burn through $3.1 million dollars in a quarter. Clearly, something is out of line and someone doesn't know what they are doing. Their "General and Administrative costs" have increased 500% since March 31, 2009; yet they've only doubled their profits and increased revenues by 27%. Does that make sense to you? Yes, most of this was through stock-based compensation; but who is paying for that? Shareholders. They've had increased G&A costs the past 4 quarters in a row. They've increased by 400%. Where is the explanation for that? I just think they are spending far too much capital paying employees and having nothing to show for it.
Additionally, from the 10-Q, we have more dilution. "During the three months ended March 31, 2010, investors converted 636,860 shares of Series B Preferred Stock into 63,686,000 shares of common stock."
I understand they are transitioning from a development to manufacturing company and getting sales can be tough, especially in this economy. Obviously, this "mysterious partner" could really change their fortunes. I am not going to advertise shorting this company, but if you do find yourself considering to buy, make absolutely certain you have done your research. They could be like the other million OTC stocks and never end up going anywhere or there really could be something there. Right now, POSC.OB is a wild card or lotto play. I would only play with what I am willing to lose. I am not confident in the management and they have yet to prove me wrong. It's sad, since the Attrius really could be useful out there.
It's also important for people to realize what BMR is in the business of doing: pumping. Several recent failures include NBS and NWBO.OB. Ever since the brains behind all of their so-called great picks left (Mike Havrilla), they have yet to deliver. I consider RPC a fluke.
Posted by Patrick at 10:24 AM
Labels: POSC
http://www.chasingthealpha.com/2010/06/poscob-tread-lightly.html
e-mail response from Rooney (From Yahoo Board)
Hi ,
Due to the growth opportunity in the industry we are looking to expand. I expect us to add 2-3 employees per month throughout the year. For 2011 the growth may exceed this number depending on the growth of pharma. We and you will see this progression month by month as we move forward in 2010. We also have 5 consultants from FDA to nuclear scientists to strategy experts.
Thanks
Pat
From:
Sent: Friday, June 11, 2010 10:29 AM
To: Patrick G. Rooney
Subject: Hello from an investor
Hi Patrick,
I have a question on Positrons expansion. I read on the 10k that the company has 21 employees, and I just read a PR about the addition of a Sales rep. Can you let me know how many new employees you are planning to hire? If you could give info on what they would be working on would be great.
Regards,
Positron Corp. (OTC:POSC) Climbs Up Again On Partnership Rumors
By Violeta Slavtchevska
Date: Jun 14, 2010
Expectations about favorable PR to come out soon raised the stock of Positron Corp. (OTC:POSC, POSC message board) on Friday. Investors started buying up again, as high volatility followed the longer period of sideways activity and no reaction to the press releases of the company.
Positron jumped 26.32% up on Friday and closed at $0.12 for a share. Investor demand for the under $1 stock of the biotechnology company is growing, but Friday's volume increase was not impressive and around 2.5 million shares were traded. It looks like news are overdue and the market expects important announcements to come out soon.
Although Positron is already extremely overvalued with $9.1 million in liabilities compared to $1.7 million in assets, investors still look for a sudden increase and expect the stock to bounce off the $1 barrier.
It was the rumors about a partnership with a billion dollar company to upgrade Positron's production that attracted investor attention last week. It is not quite unreasonable to expect another rally, if the management again decides to say what the market wants to hear.
After such rumors have been previously circulating in April, Patrick G. Rooney, the Chairman of the Board of Positron, finally confirmed in a press release that discussions with a potential partner from the industry were actually running. April's PR rally was slowed down afterword by the filing of the financial results for the last quarter in the middle of May.
The slightly higher revenues are still unable to cover the expenses and the company reported a nearly 500% higher loss from operations. This was not due to much more intensive research, but to a spike in the administrative expenses, resulting from the fact that Positron granted 2.5 million preferred stock options to its employees as a compensation.
With a total of 14.9 million shares of redeemable and convertible preferred stock and a weak cash position, further capital will have to be raised soon. Thus, the dilution risks for Positron are high and the only hopes for recurring revenues and future profits are put on the launch of the new Attrius Cardiac PET system and on the sales of radiopharmaceuticals using the Nuclear Pharm-Assist systems.
The Attrius Cardiac PET technology has been approved by the FDA in April 2009, but as it seems Positron has not been able to market it yet and despite management's confidence, there are no guarantees for success.
www.hotstocked.com/article/2271/positron...
Feds offering $1 billion stimulus to small biotechs
By Thomas Gryta
Dow Jones Newswires
Posted: 05/22/2010 01:00:00 AM MDT
NEW YORK — The U.S. government outlined plans for a $1 billion stimulus for small biotechnology, medical-device and diagnostics developers that could hand up to $5 million to qualifying companies, both public and private.
The program, part of the health care overhaul approved in March and detailed by the Treasury Department on Friday, is aimed at producing new therapies and creating jobs in a sector that has been hard hit in the economic slowdown and credit crisis because of its high capital needs.
The funds will come in the form of tax credits or as a grant for unprofitable companies. It will cover 50 percent of development costs in 2009 and 2010, giving up to $5 million to companies with qualifying projects and fewer than 250 workers.
"Funding for these stages is critical, but it is not always easy to find, especially in the current climate where venture capital is harder to come by," Francis Collins, director of the National Institutes of Health, said in a press briefing.
The $1 billion will be evenly divided among those companies that are deemed to qualify. Applications for multiple programs are allowed, but the amount awarded cannot exceed $5 million per firm over the two tax years.
Although the government's details refer specifically to the biotech industry and efforts to cure cancer, an administration official made it clear that the program is also open to medical device and diagnostics companies.
Under the plan, a "qualifying therapeutic discovery project" is one that has "significant potential" to produce a therapy, address unmet medical needs, and cut the growth of health care costs.
http://www.denverpost.com/business/ci_15138184
Positron Sees Tenfold Increase in Quote Proposals Written by Staff and Wire Reports
Saturday, 22 May 2010 11:22
Shares of Positron Corporation (OTCBB:POSC), the molecular imaging solutions company focused on Nuclear Cardiology, rose nearly 16% after they stated that over the first 4 months of 2010 that it has seen tremendous interest in their Attrius™ dedicated cardiac PET scanner. The Attrius™ was introduced in the 4th quarter of 2009 and has been met with critical acclaim throughout the molecular imaging industry.
Patrick G. Rooney, Positron Corporation’s CEO states, “The Nuclear Cardiology industry is experiencing a shift from SPECT to PET as a result of molly shortages combined with changes in reimbursement. Positron is in an ideal position to capitalize on this shift more so than any other imaging company. The Attrius™ is a state of the art, Frost & Sullivan New Product Innovation Award winning, device that was designed to be optimized for Cardiac imaging allowing physicians an easy transition to PET. Our pipeline for PET systems has had significant increases each month since we launched the Attrius™ late last year.
Our current pipeline has over 55 potential and/or pending sales with the second half on the year still too follow. We have done a very good job of positioning Positron to meet this new demand. Based on the current interest we believe we will meet or exceed our projected system sales moving forward. Positron’s objective is to be the leader in cardiac PET solutions. We believe we will continue to see substantial growth from both devices and radiopharmaceuticals."
http://biomedreports.com/articles/most-popular/41290-positron-sees-tenfold-increase-in-quote-proposals.html
Report: Covidien looks to expand
May 9, 2010 — 3:30pm ET | By Liz Jones
Covidien (NYSE: COV), which has snapped up more than a dozen small companies in the past three years, may scout for larger acquisitions as the industry consolidates, the Boston Globe reports.
The company has shied away from blockbuster deals since it was spun out of parent Tyco International in 2007, but it has sought to fill gaps in its product line through more modest buyouts. The largest was its $440 million purchase last year of VNUS Medical Technologies, which makes devices for minimally invasive treatment of venous reflux disease, the Globe notes.
Matthew Dodds, director of institutional research for Citigroup, says Covidien probably won't stray outside of its four areas of market focus. "It's really going to depend on what opportunities show up, and whether they make sense,'' Dodds explains. "What I don't see from Rich [Meelia] is the necessity to add another leg to their business. They have plenty to work with. There's no obvious larger candidates out there on the radar screen in some of their core business areas, like surgery, because they already have critical mass.''
Covidien had $1.7 billion in cash on its balance sheet at the end of March, and has told analysts it plans to spend about $750 million annually on acquisitions. It also wants to position itself in Asia, where it can tap into the continent's innovation and low-cost manufacturing.
Depsite Covidien's continued success, it is projecting that May will be challenging as the molybdenum-99 shortage continues; however, the outlook is significantly improved in June, HealthImaging.com reports. There has been a global shortage of medical isotopes following last year's shutdown of the National Research Universal Reactor in Canada.
- see the story from the Boston Globe
- check out HealthImaging.com's coverage
Related Articles:
Covidien recalls tracheostomy tubes after deaths
Covidien road trip promotes laparoscopic device
ALSO: Covidien has received 510(k) clearance from the FDA to expand the Puritan Bennett 840 ventilator's minimum delivered tidal volume down to 2 mL. This feature will enable the Puritan Bennett 840 ventilator to provide ventilatory support for neonates weighing as little as 300 grams. Release
Read more: http://www.fiercemedicaldevices.com/story/report-covidien-looks-expand/2010-05-09?utm_medium=rss&utm_source=rss#ixzz0oTAJe45N
threatened them?????
""At one point, one of Positron's newest allies had apparently even "threatened them" before deciding that joining forces might be a better way to respond to their innovative nuclear medicine's dispensing and distribution technology. The bonding experience with that company is still shaky, but much more friendly now according to those familiar with the situaiton and it definitely played into why the company decided against the public revelations."""
Just wondering what kind of "Threats" were made at them?]
Here is a good article on the Attrius from:
http://www.auntminnie.com/index.asp?sec=...
Positron has had its ups and downs, to say the least, over the past decade, but the PET device developer thinks it now has a strategy and product to become a more prominent player in the nuclear medicine market.
Fishers, IN-based Positron is banking on the appeal of Attrius, its PET-only device designed for cardiac imaging at community and rural hospitals as well as cardiology practices.
Attrius and the novel strategy behind it are the brainchild of Positron president Joseph Oliverio and medical director Dr. Michael Merhige. Merhige came from a cardiac group in Buffalo, NY, which began using cardiac PET imaging in an outpatient setting in 1995, around the time Medicare began to reimburse for such scans.
In 2003, the pair was recruited by a community hospital in Niagara County, NY, which had one of the worst coronary disease death rates per county in the U.S. Like many community hospitals in the country, the facility had a difficult time competing against larger tertiary care centers, Oliverio said, and didn't have a unique cardiovascular offering to stop the migration of patients to other facilities, or to attract patients from other hospitals.
With the help of cardiac PET, the facility was successful in reducing the heart attack and cardiac death rate in the county, as well as the number of angiograms that were being performed, by providing a more accurate diagnosis of cardiac disease through PET, Oliverio said.
What took you so long?
"""Orders for PET scanners have also increased from remote parts of the world that previously lacked the technological expertise to pursue PET. Growth of the international market should help cushion the downturn in the U.S for PET manufacturers. By 2016, the market for PET scanners in the U.S. should grow to about 360 units and worldwide orders should reach about 900 units.""""""
The Market for PET Radiopharmaceuticals & PET Imaging 9-May-10 02:47 pm The PET Report Includes:
Present and Emerging Markets for PET Imaging
Analysis of Current and Future FDG Sales
New Prospects for PET Procedures
New Targeted Tracers and Molecular Probes for PET
US and Worldwide Markets for PET Scanners
Growth of Rubidium PET Market for Cardiology
Market Trends Toward High Performance PET-CT Scanners
Continued High Demand for PET Internationally
Technological Trends and Competitive Challenges
Market Assessment and Sales Forecasts to 2016
The report has a strong focus on new products and technology and emerging market opportunities. This includes prospects for FDG sales and expanding markets in oncology, cardiology and neurology as well as rubidium PET for cardiology. The report provides a detailed analysis of opportunities in each area and covers the US and worldwide markets for PET scanners, indicating the dominance of high priced multi-slice PET-CT’s. The proportion of international sales for PET has increased steadily as the technology becomes more readily available and the distribution of FDG improves. New PET tracers are also in late stage development for diagnosing Alzheimer's disease and assessing myocardial perfusion in cardiology. In addition, new oncology agents will help in treatment monitoring and therapy planning for most common cancers, increasing the utilization of PET worldwide.
GROWTH OF PET PROCEDURE VOLUME AND SALES OF FDG
The demand for PET procedures grew 7% in 2008 to about 1.8 million including rubidium studies. Procedure growth has slowed down in the past two years due to lower reimbursement. However, growth should recover to some extent in 2009 and 2010 and should reach 5.4 million procedures by 2016. Expanded applications of PET in oncology coupled with effective use of the NOPR PET Registry should help to broaden the base for PET. Although the dominant focus of PET is still in oncology, cardiology applications are increasing, including rubidium PET studies for myocardial perfusion. In addition, new PET perfusion agents are being developed for cardiology that will help expand the base for PET in this area. Several agents are also in development for diagnosing Alzheimer's disease that should be approved within the next few years. Furthermore, there are a number of novel oncology agents in development that will also stimulate procedure growth. Although reimbursement issues will have to be dealt with, it is likely that PET will eventually qualify for open coverage similar to CT and MR, which will add stimulus to the market for both PET scanners and radiopharmaceuticals.
SALES GROWTH OF PET IMAGING SYSTEMS
In 2008, U.S. sales of PET scanners declined 14% compared with 2007. Manufacturers took orders for 182 systems including refurbished units. Refurbished systems were priced at about half of the new scanners and accounted for 17% of the units ordered. Orders have been declining since 2006 as users try to adjust to reimbursement pressures. Nevertheless, technical advances have propelled the average unit price of new systems to $1.8 million, with many systems priced at over $2 million. These high technology scanners achieve resolution in the range of 2-3 mm, which is quite an accomplishment. Worldwide orders for PET scanners were also down but not quite as much as in the U.S. There were 271 scanners ordered internationally, with a worldwide total of 453 scanners including refurbished systems. International orders declined about 7% from the previous year, which was a smaller drop than in the U.S. Orders for PET scanners have also increased from remote parts of the world that previously lacked the technological expertise to pursue PET. Growth of the international market should help cushion the downturn in the U.S for PET manufacturers. By 2016, the market for PET scanners in the U.S. should grow to about 360 units and worldwide orders should reach about 900 units.
http://www.biotechsystems.com/reports/30...