Today We Witnessed Another Whale On Bid 26Milly @ .0018 Over 47K This With Other Bids In The Past Getting Filled Over 20Milly a Pop We Can Safely Assume That There's Some Entities Out There That Are Loading Up^ Big Time Behind The Scenes Right Underneath Our Noses Players!...I Can Only Imagine What Will Happen If FDA Approval Hits & These Whales Are Still Out There Lurking Trying To Get In..
It's Going To Be Pandemonium Here On ADMD... I Can See It Know Ask Gapping Up Peeps Chasing ADMD To No End!!...Don't Let This Be YOU""
So With This In Mind Take Your Time & Decipher This Monster DD That's Laid Out In Front Of You & Maybe Then You Willl Come To Your Senses!!!!...>>LMFAO!
""Pimping Hard & Keeping The Game Real""
Corporate Overview:
Advanced Medical Isotope Corporation (AMIC) (ADMD: OTCQB) is a Kennewick, Washington-based late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications. AMIC's focus is on transitioning to full operations upon receipt of FDA clearance for its patented brachytherapy cancer products.
Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. Annual sales of brachytherapy products exceed $1 billion, about half of which are in the United States. AMIC intends to outsource material aspects of manufacturing, distribution, sales and marketing for its products in the United States and to enter into licensing arrangements outside of the United States, though AMIC will evaluate its alternatives before finalizing its plans.
Since 2006, AMIC has been focused on the commercialization of medical isotope technologies. AMIC has explored technologies for the production of medical isotopes and medical applications of isotope technologies including a line of brachytherapy products incorporating patented technology licensed exclusively to AMIC by Battelle Memorial Institute, developed at Pacific Northwest National Laboratory, a leading research institute for government and commercial customers.
AMIC’s robust intellectual property position includes exclusive rights under 15 patents that cover manufacturing, processing and applications for medical isotopes.
A prominent team of radiochemists, scientists and engineers, collaborating worldwide with strategic partners, including national laboratories, universities and private corporations, lead AMIC’s development efforts. AMIC is proud to have been recognized as a leader in the development of new isotope technologies by local, state and federal agencies.
Management:
Mr.Katzoroff Is a Financial Guru Players Having This Guy @ The Helm Is Huge PLUS!...& Mr.Jolliff Is The Numbers Guy, He's The One Behind The Scenes Getting The Money We Need To Get The Product To The Market!
Mr.Stevensen The Madd Scientist...This Guy Is a GENIUS"" He'll Be The One Behind The Scenes Bringing New Products To Fruition..He's a Nuclear Pysics Expert!....& Mr.Ludwig, now This Gentlemen Has International Ties Over Seas, So It's Easy To Imagine Who He Can Bring To The Table!!!!!
""Heavy Weight Mr.Su, Now This Guy Here Is The Mastermind Behind The Scenes Of The Isotope R&D Manufacturing...He Works For Pharma GIANTS"" Like Bristol-Myers Squibb..Also Working
As a Senior Scientist For Several Bio-Technology Firms, Including NeoRx, Nycomed-Amersham,And Cellectar, He Developed Various Radiopharmaceuticals, Very Impressive Savvy Scientist Players!!..,& Last But Not Lease,
Mr. Korenko.,Very..,Very Astute Intelligent Man Who Was Educated At One Of The Most Prestigious Colleges In The World ""OXFORD"" He Was Selected As a White House Fellow For The Department Of Defense Reporting To Secretary Cap Weinberger...,So Yes This Guy Has Inside Connection o The Dept Of Health And Human Services Players!!!!!
Board Of Director's:
"" Mr.Spivak What Can I Say Other Than They Call Him The Billion Dollar Man""...,Billions In Acquisitions..,Mergers..,Financing's This Guy Has Worked With Bigg Oil Mobil..,Merrill Lynch If Anybody That Can Find The $$$$$$ This Guy Can!!!!
""Mr.Cadwell Very Successful Business Man Players Co-Founded Cadwell Laboratories Privately Owned Business In 1979 And Serves As The President Till This Day....Very Savvy Business Mind Indeed!! Visit Mr. Cadwell's Website Here Players
""Mr.Clement With His Influence Has Already Had Successful FDA Clearance With His Atrial Fibrillation Monitor, And As The CEO Of Two Very Successful Business's.., We Are Very Lucky To Have This Guy On The Board Players!
Advisory Boards:
Dr. Pressman is Professor and Chairman of the S. Mark Taper Foundation Imaging Center and Department, and Chief of the Section of Neuroradiology and Head and Neck Radiology at Cedars-Sinai Medical Center, located in Los Angeles, Ca.
Dr. Pressman is a past President of The American College of Radiology, the Western Neuroradiological Society, as well as past President of the California Radiological Society. Currently he is a member of the American Society of Neuroradiology and the American Society of Pediatric Neuroradiology.
Dr. Pressman earned his medical degree Cum Laude from Harvard Medical School after graduating Summa Cum Laude from Dartmouth College. After a surgical internship at Harvard's Peter Bent Brigham Hospital in Boston, he completed a diagnostic radiology residency at Columbia-Presbyterian Medical Center in New York and a Neuroradiology fellowship at George Washington University Hospital. During this period, he wrote many original papers for Computer Tomography(CT).
"I am delighted to be appointed to Chair the newly formed Medical Advisory Board (MAB) for AMIC. I anticipate rapid expansion of our MAB, initially focusing on the potential for the Company's brachytherapy products," said Pressman.
James C. Katzaroff, CEO of AMIC, stated, "It is with great pleasure I welcome Dr. Pressman's guidance in assisting the Company to enter the commercial marketplace with its therapeutic products. As AMIC expands beyond the distribution and the production of stable and diagnostic radioisotopes, to the manufacturing of therapeutic products with AMIC's own product line, Dr. Pressman will be instrumental in providing a nationally-recognized practitioner's perspective and expertise that will enable the company to meet the growing needs of a dynamic nuclear medicine marketplace."
"" Mr.Fisher Is The Isotope GURU"..,Holds Several Patents Including Patents Licensed By AMIC For It's Brachytherapy Products...,Very Knowledgeable In The Isotope Field Of Technology!!!!.,& Finally Mr. Waltar Who By All Rights Holds The Key To ADMD He Has Ties With India & China, And Will Be Instrumental In Bringing The Y-90 RadioGel™ Device To Market Players!!!!!
Research & Development:
Does Nuclear Medicine Save Lives?
Yes! More than 20 million Americans benefit each year from nuclear medicine procedures used to diagnose and treat a wide variety of diseases. The use of radiation in these procedures— with low risks—offers a safe and cost-effective means to provide doctors with information that would otherwise require exploratory surgery, necessitate more costly and invasive procedures or simply be unavailable. The risks of not performing a needed medical exam are usually much greater than the risks of the radiation exposures associated with the exam.
Nuclear medicine can be used to: determine whether or not organs are functioning normally, show whether the blood supply to the heart is adequate, detect cancers at an early stage, determine the extent of cancer and assess the response of cancer to treatment, discover whether the heart can pump blood adequately, identify abnormal brain lesions without exploratory surgery, detect whether the brain is receiving an adequate blood supply and if brain cells are functioning or not, check whether or not kidneys are functioning normally and whether the stomach is emptying properly, ascertain lung function and bone density and locate a bone fracture before it can be seen on an X-ray.
Brachytherapy:
Brachytherapy is the use of radiation to destroy cancerous tumors by placing a radiation source inside or next to the treatment area. According to Global Industry Analysts, by 2016 the U.S. brachytherapy market will reach $2 billion. It is estimated that the U.S. market represents approximately half of the global market. AMIC believes there are significant opportunities in prostate, breast, liver, pancreatic, head and neck cancers. The 2013 U.S. estimated new cases according to the American Cancer Society are 240,000 prostate cancer, 235,000 breast cancer and 31,000 liver cancer. AMIC’s Brachytherapy Products AMIC has exclusively licensed Yttrium-90 (Y-90) polymer composite technology from *Battelle Memorial Institute, developed at Pacific Northwest National Laboratory, a leading research institute for government and commercial customers.
Subject to receipt of all required regulatory approvals from the FDA in the United States and analogous regulators outside of the United States, AMIC plans to introduce a new Y-90-based brachytherapy product line for a range of applications for the delivery of a prescribed dose of radiation to a target site.
•Y-90 RadioGel™ device - combines Y-90 particles with a polymer carrier that may be injected directly into the tumor.
•Y-90 Fast-Resorbable Polymer Seeds - Y-90 contained within a polymer seed, as opposed to metal or glass. This product would be used in place of treating cancers with currently marketed titanium or glass seeds.
•Y-90 Polymer Topical Paste – designed to be applied directly to tissue surfaces after surgical tumor removals (also referred to as “resections”) to treat residual tumor cells.. Based upon its studies and analyses, or general application of experience with current brachytherapy devices and Yttrium-90, AMIC believes that its brachytherapy products are likely to offer the following benefits, among others, for patients and medical professionals:
•Maximizing Therapeutic Index: The short-range beta particles emitted by Y-90 deliver radiation energy within a tight range. This enables radiation to be selectively delivered to target tissues while minimizing radiation dose to nearby normal tissues. High therapeutic indices imply that more radiation energy may be imparted to target tissues, with less radiation reaching adjacent normal tissues.
•Half Life: Y-90 has a half-life of just 2.7 days. Many traditional brachytherapy products use isotopes with longer half-lives such as 9.7 days for cesium-131, and sixty days for iodine-125.
•Optimized Delivery Method: Current brachytherapy devices place permanent metal seeds in the prostate by using up to 30 large needles. By contrast, AMIC’s Y-90 RadioGel™ device is designed to be administered in a minimally invasive procedure with small-gauge needles.
•No Permanent Seeds Remaining: Current brachytherapy devices place permanent metal seeds in the tumor. AMIC’s Y-90 RadioGel™ device utilizes a biodegradable, non-toxic polymer that is ultimately absorbed by the body. This eliminates the possibility of a long-term seed migration or other problems that may sometimes arise when seeds remain in the body.
•Good Safety Profile: Many traditional brachytherapy devices utilize isotopes that emit x-rays (akin to gamma radiation). X-rays or gamma radiation travels within and outside of the body and have long half-lives. AMIC’s brachytherapy products use the Yttrium-90 isotope, which is a beta-emitter. The Yttrium-90 beta-emissions travel only a short distance and has a short half life of 2.7 days.
•Potential Lower Cost: Yttrium-90 supplies are readily accessible and are relatively inexpensive. The elimination of the metal or glass enclosures used in traditional brachytherapy seeds greatly reduces manufacturing costs.
Products:
""The Cream Of The Crop Players Yttrium 90 RadioGel™ and Polymer Seeds, Is The Future Of Radioactive Brachytherapy, And Is What We Are Waiting On The FDA To Approve....With Battelle In Our Corner There Should Be No Problem Getting This Done....(More On Battelle In a Moment)
Advanced Medical Isotope Corporation has obtained an exclusive license to eight (8) patents for injectable RadioGel™ technology for use in high-dose radiation therapy. The license was granted by *Battelle pursuant to an option between Battelle and AMIC announced in February 2011.
The Agreement grants AMIC an exclusive license to make, have made, use and sell a RadioGel™ system including an injectable, water-based biodegradable polymer that delivers Yttrium-90 microspheres directly into tumor tissues. The solution warms to body temperature quickly after injection and then polymerizes into a lattice that traps the Yttrium-90 microspheres in place. High-energy beta particles from Yttrium-90 efficiently irradiate cancer cells within the targeted volume but very little radiation escapes. This feature maximizes the overall radiation dose to cancer cells while minimizing radiation exposure and associated side-effects in nearby normal tissues.
The injectable radiogel may also be administered transdermally or intraoperatively when treating solid tumors that cannot be removed safely by surgical excision, such as inoperable liver cancer, brain tumors, head and neck tumors, kidney tumors, and pancreatic cancer. Levels of activity may be accelerated to treat radiation-resistant solid tumors that may not respond well to conventional external-beam therapy. The injectable radiogel may also be administered transdermally or intraoperatively when treating solid tumors that cannot be removed safely by surgical excision, such as inoperable liver cancer, brain tumors, head and neck tumors, kidney tumors, and pancreatic cancer. Levels of activity may be accelerated to treat radiation-resistant solid tumors that may not respond well to conventional external-beam therapy.
Yttrium-90 is a well-established medical isotope with many applications in cancer treatment. The combination of insoluble Yttrium-90 microspheres and the radiogel carrier offers physicians an opportunity to deliver a safe, effective treatment option at a low cost.
The late Dr. Robert Schenter, AMIC's Former Chief Scientific Officer, stated, "AMIC continues to develop the Yttrium-90 RadioGel™ line with Pacific Northwest National Laboratory, operated by Battelle. We believe that this product optimizes treatment of radiation-resistant tumors in vivo. We expect the RadioGel™ to become a therapeutic agent that provides physicians with the ability to effectively treat tumors that cannot be removed surgically or that cannot be treated by any other means."
According to AMIC the primary advantages of licensing these Yttrium-90 radiogels are multifold:
This treatment provides the ability to deliver a highly localized radiation therapy without irradiating nearby normal tissues - thereby achieving desired high therapeutic indices. We are able to provide dose homogeneity within a solid tumor. Because Yttrium-90 is a beta emitter, there is improved radiation safety for hospital personnel who prepare and handle the product.
Medical Isotopes:
AMIC is developing innovative approaches to the use, production and distribution of medical isotopes for advanced diagnostic and non-surgical therapeutic applications. A medical isotope is a radioactive substance used in very small quantities for safe, cost-effective medical imaging and treatment of disease.
The cornerstone equipment selected for the AMIC Production Facility is a proton linear accelerator. This proton linear accelerator is designed to replace large and cyclotron systems with significant infrastructure and utility requirements, such as electrical and air-handling, for the production of positron emitting isotopes. Large amounts of fluorine-18, carbon-11, nitrogen-13, and oxygen-15 can be produced for synthesis into compounds used in oncology, cardiology, neurology, and molecular imaging. The radio-labeled glucose analog, FDG, can be synthesized and distributed for use in Positron Emission Tomography. AMIC believes that no other accelerator in North America has sufficient flexibility to produce the full spectrum of PET imaging radioisotopes, as well as other high-demand isotopes, both short and long lived, for diagnostic and therapeutic applications.
From 2008 through 2013, AMIC manufactured and sold F-18 FDG from its Production Facility in its local region around Kennewick, WA. F-18 is an important isotope in the radiopharmaceutical industry, and is primarily synthesized into fluorodeoxyglucose (FDG) for use in positron emission tomography (PET) scans. FDG is the primary PET imaging isotope. It is used for medical and diagnostic purposes, such as cancer detection, heart imaging, and brain imaging. AMIC’s linear accelerator is capable of producing a variety of isotopes and future manufacturing and sales could expand beyond F-18 FDG. AMIC’s accelerator is currently off-line for maintenance and is expected to resume operations in late 2014.
Products & Solutions:
AMIC To Focus on Yttrium-90 (Y-90) Brachytherapy Products AMIC is engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area.
AMIC also is engaged in the development of other medical isotopes for therapeutic and diagnostic purposes and has engaged in limited operations consisting of the operation of a nuclear accelerator and the sales of third party isotopes. AMIC is considering other regional production facilities throughout the U.S. and abroad, including a larger cyclotron production facility in Southern California in partnership with a major medical facility.
After the receipt of regulatory approvals to launches its brachytherapy products, AMIC intends also to continue the development and then commercialization of other isotopes, technologies and businesses intended to help improve the diagnosis and treatment of cancer and other illnesses. Among the projects already commenced by AMIC are potential solutions for the impending severe shortages of Molybendum-99 and its derivative product Technetium- 99m, the most widely used isotopes for diagnostic purposes and the recycling of nuclear waste for medical applications.
AMIC’s overall objective is to empower physicians, medical researchers, and ultimately, patients, by providing them with new isotope technologies and essential medical isotopes that, until now, have not been practical or economical to produce, in an effort to detect, manage, and cure human disease, and improve the lives of patients.
""Ok Players Wrap Your Heads Around This Brachytherapy Is a 1B$ Industry That Has The Ability To Grow Higher Than That Now That The Baby Boomers Have Reached Retirement Age....This Number Is Staggering Check This Financial Report Slide Show Below:
KENNEWICK, Wash., Dec. 23, 2014 /PRNewswire/ -- Advanced Medical Isotope Corporation ("AMIC") (OTCQB: ADMD), a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications, today announced that it has filed a de novo submission with the Food and Drug Administration ("FDA") for marketing clearance for its patented Y-90 RadioGel(TM)
device pursuant to Section 513(f)(2) of the U.S. Food, Drug and Cosmetic Act (the "Act").
In February 2014, the FDA rejected the Company's request for marketing clearance for the same device under Section 510(k) of the Act. The FDA determined that the device was not substantially equivalent, concluding that the device is classified by statute as a Class III medical device, unless the device is reclassified.
By filing the de novo submission, the Company is seeking reclassification of the product to Class II.
""Time Is Getting Near For This Decision Players, So Load'em Deeep Before All The Whales Start Sucking Up^ Everything In There WAKE""
The FDA has 120 days in which to make a decision, though the period will be extended for any time AMIC requires to respond to FDA requests for additional information.
If the de novo submission is granted, the device may be immediately marketed in the United States, though the Company would have to secure funding and commercial arrangements before marketing could commence. If the de novo submission is declined, the Company will explore steps toward seeking approval for the device as a Class III medical device. Generally, the time period and cost of seeking approval as a Class III medical device is materially greater than the time period and cost of seeking approval as a Class II medical device.
KENNEWICK, Wash., Dec. 19, 2014 /PRNewswire/ -- Advanced Medical Isotope Corporation ("AMIC") (OTCQB: ADMD), a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications, today announced that a Life Sciences Discovery Fund (LSDF) Proof of Concept Grant has been awarded for which AMIC is the commercialization partner.
The award was made to Washington State University (WSU) for the proposal titled "Optimized Injectable Radiogels for High-dose Therapy of Non-resectable Solid Tumors," submitted by Principal Investigator Dr. Darrell Fisher, in the amount of $250,000.
AMIC will receive a portion of the award by supplying product to WSU for the study as well as providing scientific and technical support. AMIC plans to use the data generated during the study to support the commercialization of the Company's brachytherapy products. Dr. Darrell Fisher serves on the AMIC Medical Advisory Board.
""Brachytherapy a 2B$ Industry By 2016""....Now That's a BIGG NUMBER Players.....With FDA Clearance ADMD Will Get a Big Chunk Of That PIE!!!
Brachytherapy is the use of radiation to destroy cancerous tumors by placing a radiation source inside or next to the treatment area. According to Global Industry Analysts, by 2016 the U.S. brachytherapy market will reach $2 billion.
AMIC CEO and Chairman James C. Katzaroff stated: "We are delighted to be working with one of the nation's top Veterinary schools, Washington State University College of Veterinary Medicine. We are appreciative to the LSDF for their recognition of the importance of the commercialization of our patented brachytherapy technologies that aim to improve lives by offering better treatment alternatives for certain cancers."
The LSDF recently announced $1.2 million in Proof of Concept grants to Washington-based organizations to foster the advancement of promising health-related technologies to commercial products. The LSDF Board of Trustees selected the awardees following review of proposals for scientific and technical merit, commercial potential, and health and economic benefits to Washington. Awards are contingent pending final Grant Agreement execution and availability of funds.
KENNEWICK, Wash., Sept. 16, 2014 /PRNewswire/ -- Advanced Medical Isotope Corporation ("AMIC") (OTCQB: ADMD), a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications, today announced that a patent was awarded for technology related to its brachytherapy products.
""This News Is Very..,Very Imprortant Players, And Here's Why! Battelle Owns 11% Of ADMD And I Believe Battelle Will Be Instrumental On Bringing The Y-90 RadioGel™ To Market...They Have The Resources & The Connections To Get This DONE!!!
AMIC's rights for the newly issued patent arise from its license from Battelle, under which AMIC exclusively licensed technologies developed at Pacific Northwest National Laboratory and the University of Utah for its proposed brachytherapy products. The patent awarded, US 8,821,364 B2, relates to AMIC's brachytherapy seed product and is entitled: Brachytherapy Seed with Fast Dissolving Matrix for Optimal Delivery of Radionuclides to Cancer Tissue. AMIC will support Battelle in further patent protection for additional markets consistent with AMIC's overall global commercialization strategy.
Brachytherapy is the use of radiation to destroy cancerous tumors by placing a radiation source inside or next to the treatment area. According to Global Industry Analysts, by 2016 the U.S. brachytherapy market will reach $2 billion.
Subject to receipt of required regulatory approvals from the FDA in the United States and analogous regulators outside of the United States, AMIC plans to introduce an innovative yttrium-90 (Y-90) based brachytherapy product line for a range of applications for the delivery of prescribed doses of radiation to target sites. The initial proposed products consist of:
Y-90 Fast-Resorbable Polymer Seeds - Y-90 contained within a polymer seed, as opposed to metal or glass.
Y-90 RadioGel(TM) device - combines Y-90 particles with a polymer carrier that may be injected directly into the tumor.
Y-90 Polymer Topical Paste – designed to be applied directly to tissue surfaces after surgical tumor removals (also referred to as "resections") to treat residual tumor cells. Based upon its studies and analyses, AMIC believes that once approved for commercial use by the FDA and other regulators, its brachytherapy products are likely to offer numerous benefits for patients and medical professionals including:
High Therapeutic Index: This implies that more radiation energy may be imparted to target tissues, with less radiation reaching adjacent normal tissues.
Half Life: Y-90 has a half-life of just 2.7 days. Many traditional brachytherapy products use isotopes with longer half-lives such as 9.7 days for cesium-131, and sixty days for iodine-125.
No Permanent Seeds Remaining: Current brachytherapy devices place permanent metal or glass seeds in the tumor. AMIC's Y-90 brachytherapy seed utilizes a biodegradable, non-toxic polymer that is absorbed by the body.
Good Safety Profile: Many traditional brachytherapy devices utilize isotopes that emit x-rays (akin to gamma radiation). X-rays or gamma radiation travels within and outside of the body. AMIC's brachytherapy products use the yttrium-90 isotope, which is a beta-emitter. The yttrium-90 beta-emissions travel only a short distance.
Potential Lower Cost: Yttrium-90 supplies are readily accessible and are relatively inexpensive. The elimination of the metal or glass enclosures used in traditional brachytherapy seeds greatly reduces manufacturing costs.
AMIC CEO and Chairman James C. Katzaroff stated: "We are delighted that the U.S. Patent office has awarded this patent related to our brachytherapy seed product. We believe that there is a strong market for this product and that it offers significant benefits to patients and healthcare providers over existing brachytherapy seed products."
KENNEWICK, Wash., July 7, 2014 (PRNewswire) – Advanced Medical Isotope Corporation ("AMIC") (OTCBB: ADMD), a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications, today announced that
""This Is Mega News That Happened Nearly a Year Ago , And The Effects Of This PR Reaches Up To This Very Day, Because I Believe As I Said Before Battelle Will Help ADMD Manufacture Their Y-90 RadioGel™ And Bring It To Market....Why Else Would They Get Involve With ADMD....Battelle Is a Multi-Million Dollar Company With Ties All Over The World & With The Government..Check Out There Website Here! Click Here For Battelle Website
Battelle, has acquired approximately 11% of AMIC’s outstanding Common Stock. Battelle is a leading international science and technology enterprise that explores emerging areas of science and develops and commercializes technology.
In 2011, AMIC entered into license agreements with Battelle for 10 patents related to AMICs brachytherapy products; and in 2012, AMIC entered into an exclusive license agreement with Battelle for use of Battelle’s patented brachytherapy gel technology.
AMIC CEO and Chairman James C. Katzaroff stated: “AMIC and Battelle’s joint commercialization effort was nationally recognized in 2013, when AMIC received the Federal Laboratory Consortium Award for Excellence in Technology Transfer, a prestigious honor recognized by the US Secretary of Energy and U.S. Senator Patty Murray. We continue our close collaboration with Battelle and look forward to commercializing this exciting technology.”
Battelle acquired its interest in AMIC by converting a note previously issued for partial consideration of studies conducted at PNNL. Details are reported in the Company’s Form 8K filed with the Securities and Exchange Commission.
As previously announced, AMIC is in the process of securing FDA approval for its Y-90 RadioGel™ brachytherapy device. As AMIC recently announced, the FDA has determined that the RadioGel™ brachytherapy product is a Class III medical device, unless reclassified as a Class II device. That determination is being reviewed, along with the steps AMIC should take for approval. AMIC is engaged in discussions with the FDA through the Pre-Submission process, including an in person meeting.
About Battelle
Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. Battelle operates Pacific Northwest National Laboratory in Richland, Wash., for the U.S. Department of Energy.
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