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Welcome to our comprehensive profile on Positron Corp.
(OTCBB: POSC)
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PET - POSITRON EMISSION TOMOGRAPHY TECHNOLOGY
The PET imaging process begins with the injection of a radiopharmaceutical (a drug containing a short-lived radioactive agent) by a trained medical person into a patient's bloodstream. After being distributed within the patient's body, the injected radiopharmaceutical undergoes a process of radioactive decay, whereby positrons (positively charged electrons) are emitted and subsequently converted along with free electrons into two gamma rays or photons. These paired gamma events are detected by the POSICAM™ systems as coincidence events. The source of the photons is determined and is reconstructed into a color image of the scanned organ utilizing proprietary reconstruction & image processing software. Since certain functional processes, such as blood flow, metabolism or other biochemical processes, determine the concentration of the radiopharmaceutical throughout the body, the intensity or color at each point in the PET image directly maps the vitality of the respective function at that point within an organ.
In cardiology, PET imaging is an accurate, non-invasive method of diagnosing or assessing the severity of coronary artery disease. Unlike other imaging technologies, PET technology allows a physician to determine whether blood flow to the heart muscle is normal, thereby identifying narrowed coronary arteries, and whether damaged heart muscle is viable and may benefit from treatment such as bypass surgery or angioplasty. In addition, dynamic and gated imaging can display and measure the ejection fraction and wall motion of the heart.
In neurology, PET imaging is now being used as a surgical planning tool to locate the source of epileptic disturbances in patients with uncontrollable seizures. In other neurological applications, PET is used in the diagnosis of dementia, Alzheimer's disease, Pick's disease and Parkinson's disease, and in the evaluation of stroke severity. PET imaging is becoming an important tool in the development of drugs for neuron-psychiatric disorders.
In oncology, PET imaging has historically been used to measure the metabolism of tumor masses before and after surgery or chemotherapy. Clinical experience has shown that PET is more accurate than CT scans or MRI in determining the effectiveness of chemotherapy and radiotherapy in the early detection and treatment of cancer. PET scans are becoming commonly used to assess suspected breast cancer and whether the lymph system has become involved. Whole body PET scans are now routinely performed to survey the body for cancer. This application enables oncologists to see the total picture of all metastases in a patient, thereby allowing them to properly tailor the most effective course of treatment. PET imaging is gaining importance in detecting early response to chemotherapy, and as a test giving early prediction of potential cure for cancer patients.
The radiopharmaceuticals employed in PET imaging are used by organs in their natural processes, such as blood flow and metabolism, without affecting their normal function, and quickly dissipate from the body. Radiopharmaceuticals used in PET procedures expose patients to a certain amount of radiation, which is measured in units of milliRad. Exposure to radiation can cause damage to living tissue, and the greater the radiation exposure, the greater the potential for damage. Certain PET procedures expose a patient to less radiation than would be associated with other imaging technologies. A PET cardiac scan, using the radiopharmaceutical Rubidium-82, results in exposure of approximately 96 milliRads, while a neurological PET scan using 18-FDG, results in exposure of approximately 390 milliRads. In contrast, a typical chest X-ray results in exposure of approximately 150 milliRads and a CT scan results in exposure of approximately 500 to 4,000 milliRads, depending on the procedure.
The Attrius™, Positron next generation device is being co-developed with their JV partner in China – Neusoft Medical Systems, which allows them to significantly reduce their COGS to be able to compete in the market.
The Attrius™ dedicated cardiac PET scanner
While all the other vendors have gotten out of the dedicated PET business, as they cannot support more than one or two product lines per modality and thus forcing the customers to buy “generic” and expensive PET/CT scanner that don’t really provide good results for cardiology, Positron is the only vendor on the market that is offering a dedicated cardiac PET scanner that is entirely geared for cardiac imaging.
The Attrius™ is their high-end nuclear cardiology product, which will provide the best possible results for the cardiologist and his/her patients, while maintaining a very competitive price tag (around $600K USD, which is a typical price for a well-equipped general purpose SPECT scanner offered by the “big 3” vendors). The technology has to be submitted to the FDA for 510k approval. The company anticipates receiving their FDA 510k before the end of the year.
SPECT Technology
A scintillation, or gamma, camera is a diagnostic medical imaging system that detects radiopharmaceuticals injected into the human body. The most widely used imaging acquisition technology utilizing gamma cameras is single photon emission computed tomography, or SPECT. Gamma cameras are used in the diagnosis of heart disease, cancers and a variety of other disorders. A mechanical frame (a gantry) rotates an electronic detector head around a patient in order to take a series of clinical images of the inside of the body. Different from images from x-ray machines which show anatomy, nuclear medicine images show how cells and organs function by displaying the concentration and distribution of the injected radiopharmaceutical. Gamma camera is markedly inferior to PET imaging with a purpose designed PET scanner, as it has poorer sensitivity and spatial resolution. However, given the low cost of a gamma camera and its additional flexibility compared to a dedicated PET scanner, this technique is useful where the expense and resource implications of a PET scanner cannot be justified.
According to industry sources, every year in the United States approximately 10 million procedures are performed with gamma cameras in cardiology to provide diagnostic information concerning the flow of blood to, through and from the heart as well as the condition of the heart muscle and approximately 8 million procedures are performed in oncology and organ imaging to provide diagnostic information on tumor location and size or on the condition and function of various organs.
PulseCDC™ SPECT
The Company’s signature SPECT product is its PulseCDC™ compact digital cardiac camera. The key features of the PulseCDC™ include: smallest footprint in the industry, best performance specifications, lower cost single head version is field upgradeable to dual head, remote servicing capabilities are built in, FDA510K cleared for mobile installations and all digital event positioning. It also offers a unique reclining imaging chair/bed that improves patient comfort while allowing for supine and/or prone imaging in 180° or a full 360°. The Company has more than 175 cameras in operation, primarily in the United States but also in the UK, Germany, the Netherlands, Australia and China.
The sales of PulseCDC™ can be significantly increased with an enhanced marketing and sales programs developed by Positron. Part of the proceeds of this Offering will finance the rollout of these programs and be used to increase the working capital necessary for the growth of manufacturing.
The Nuclear Pharm-Assist® is sold to both centralized nuclear pharmacies, as well as, imaging providers. Centralized nuclear pharmacies are facing new burdens from regulations known as USP- 795, USP-797 and USP-823. These USP guidelines are intended to increase safety to the patient. USP-797 applies to all pharmacies that dispense sterile injectables medications. USP-797 requires that sterile compounding pharmacies comply with strict air handling guidelines. This is new to nuclear pharmacy and will cost several hundreds of thousands of dollars. The Nuclear Pharm-Assist® is a cost effective platform to assist in compliance with the various USP guidelines, especially USP-797.
Imaging providers will benefit from the Nuclear Pharm-Assist® line by having “Unit Dose” with the reliability of an “In-House” supply. The Nuclear Pharm-Assist® line for imaging providers has the ability depending on the upgrade to automatically elute generators, compound kits, perform quality control, fill a syringe or vial, assay the dose in the syringe and dispense the dose in the syringe ready for patient injection. The Nuclear Pharm-Assist® line replaces typical “Hot” lab equipment and acts as a “virtual” nuclear pharmacy with “Unit Dose” availability, at the touch of a button, 24/7. The Nuclear Pharm-Assist® is a self-contained device that provides a platform for compliance with all regulations that involve compounding and dispensing sterile injectables. Single patient doses can be compounded from various “Cold” kits, as needed, to meet customer specifications for each patient.
Technologist Injection Applications
The Tech-Assist™ is a heavy duty syringe shield designed to assist Nuclear Medicine Departments to reduce or eliminate radiation exposure and lifting issues while injecting patients.
The Tech-Assist™ has been fabricated from tungsten to maintain the strictest safety and shielding requirements. The Tech-Assist™ is attached to an articulating arm, similar to a dental x-ray machine, which makes the Tech-Assist™ seem weightless allowing for effortless handling during patient injections.
The Tech-AssistTM will be displayed debuted at this month’s Society of Nuclear Medicine meeting in New Orleans.
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