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Cardiac PET vs. SPECT imaging?

The cardiology community is moving to a flow-based approach for coronary imaging.  When comparing PET to SPECT, Cardiac PET has the ability to quantify absolute myocardial perfusion at rest and stress.  Which provides a clear answer earlier in the diagnostic process by indicating which patients have limited flow and which do not, better identifying revascularization candidates. PET is the future of cardiovascular imaging due to its enhanced image quality with fewer artifacts, higher interpretive/diagnostic certainty, and less radiation exposure to the patient. The increased accuracy of PET vs. SPECT has been shown to reduce the need for unnecessary downstream procedures thereby saving healthcare dollars.  Reimbursement is also higher for PET vs. SPECT, setting the stage for an economic incentive for physicians to make the change.  This is an advantage for Positron, being the only company that offers a dedicated PET system.

 

Cardiac PET imaging is positioned to gain significant market share from SPECT, how large is the PET

There are approximately 14,000 SPECT scanners and 140 dedicated PET systems currently performing cardiac scans in the US. In recent years, there has been an evolution within nuclear cardiology from SPECT to PET. The basis for this shift is due in part to an increased demand for better medicine that has a greater long-term economic impact, as evident in the increase in cardiac PET reimbursement and subsequent decrease in SPECT reimbursement.  With an estimated growth of between 2,000 to 5,000 PET systems over the next decade, PET is the future of nuclear cardiology. At a minimum, imaging hardware is a multi-billion dollar market and a significant growth industry.  The market for pharmaceuticals (as reported by a 2010 Bio-tech Systems report) put US sales of SPECT and PET radiopharmaceuticals at $1.16 billion in 2009, with projections to rise to $4.76 billion by 2017. Through Positron’s products, positioning and full solutions model, management believes that it will capture a significant portion of the nuclear cardiology imaging market.

 

Does PET compete with CT and/or MRI?

These modalities are not direct competitors but rather complimentary tests.

PET is a nuclear medicine imaging procedure that provides information about the function and metabolism of the body’s organs; CT and MRIs primarily show anatomy and structure. PET is also growing in its use for Myocardial Perfusion Imaging (MPI), a non-invasive test that utilizes a small amount of radioactive material (radiopharmaceutical) injected into the body to detect the distribution of blood flow to the heart. MPI is used to identify areas of reduced blood flow (perfusion) to the heart muscle. The test is typically conducted under both rest and stress conditions, after which physicians examine and compare the two scans and predict whether the patient has significant coronary artery disease. Although SPECT is most commonly used for MPI, PET imaging has gained considerable support and use in the field of cardiovascular imaging, as it offers many advantages to SPECT, including higher spatial and contrast resolution, which results in higher image quality and improved diagnostic precision, accurate attenuation correction and risk stratification.  The introduction of measuring blood flow with PET is profound and will revolutionize the way cardiology patients are managed in the future.

 

Do any other companies offer a dedicated PET system?

Positron’s Attrius® is the only NEW dedicated PET system offered in the United States. The Attrius® has many virtues that make it the system of choice for cardiac imaging, and a valuable tool in all imaging modalities. The Attrius® offers high sensitivity, small footprint and is less expensive in unit cost, service/maintenance and operational expenses compared to PET/CT. The Attrius® is approved by the FDA and has been awarded Frost and Sullivan’s 2010 “Most Innovative Medical Device”.

 

What is Positron’s relationship with Neusoft Medical Systems?

Neusoft Medical, headquartered in Shenyang, China, is a leading supplier of medical equipment, medical IT solutions and healthcare services.  Positron formed a joint venture with Neusoft Medical in 2005 named Neusoft Positron Medical Systems (NPMS). Through its joint venture, Neusoft and Positron have redesigned, developed and manufactured the Attrius® PET system. NPMS ownership structure is 99% Neusoft Medical / 1% Positron Corporation. Only the two NPMS JV partners can purchase systems at a pre-determined percentage point above costs of goods, known as the transfer price. Positron has exclusive selling rights for PET systems in North America, while Neusoft has exclusivity in China.

 

Why should cardiologists choose the Attrius®?

For over 25 years, Positron has been the leader in enabling physicians to provide high quality Positron Emission Tomography (PET) images with their proven technology. Positron offers the latest in cardiac PET imaging with the addition of the Attrius® to their product portfolio. The Attrius®, a dedicated PET system, is optimized for molecular imaging of the heart, making it the ideal solution for cardiologists and hospitals looking to add high accuracy and cost effective technology to their offerings.

While PET is a more costly procedure than SPECT imaging, the use of PET in cardiac nuclear medicine has been shown to reduce long-term costs and resolve clinically complicated cases. The accuracy of PET helps reduce the need for unnecessary angiograms. Cardiac PET can also reduce bypass surgeries by more accurately diagnosing risk-stratifying patients that may require the invasive procedure from those that might benefit from alternative therapies. This modality has also been shown to quantitatively monitor therapy, which helps provide a personalized medical plan for each patient. PET, specifically without CT, has shown to have the lowest radiation exposure for the assessment of coronary disease.

Taking advantage of these trends, Positron strategically introduced the industry’s first cardiac optimized PET scanner. Positron’s Attrius® system is designed to provide a significantly lower cost of ownership, when compared to PET/CT.  The Attrius has a much smaller footprint, fewer boards, easier access to the detector modules, less power consumption, and automated tuning features imbedded within the gantry. This product can easily integrate into practices of all sizes.

The table limit was increased to 450lbs., permitting larger patients to be imaged. The table is also capable of loading patients from the front or back, improving the position options for imaging. Further, Positron’s cardiac PET scanner is one of the highest 2D sensitivity systems on the market today. It features more uniformity achieved in its slice sensitivity, consistency in the quantitation from slice-to-slice, and the ability to more accurately define the locale of a lesion or perfusion defect. The system is designed to provide concurrent acquisition, reconstruction, image processing and display, as well as, other functions such as data archiving, without interference. The Attrius® includes many key features in its design: uniform spatial resolution in all three planes; true dynamic and gated 82Rb acquisition capability; and a unique staggered detector design for optimal quantitative results.

The Attrius® also includes a robust, cardiac specific, imaging software package designed to ensure effortless interpretation for today’s most challenging clinical cases for nuclear cardiologists who value high quality PET imagery at an affordable price. Additional features include heart disease specific software with the ability to monitor therapy, coronary artery overlay display, open architecture for new protocol development and customization and motion correction software.

 

Is Ammonia (13N) an alternative to Rubidium (82Rb)?

Yes, the use of 13N ammonia has been well established in professional literature and is approved by Medicare for reimbursement with similar indications to 82Rb.  Due to its short half-life, Ammonia is limited to institutions that have a cyclotron on site or within very close proximity, thereby inhibiting routine use for high throughput facilities.  There are companies developing small cyclotrons enabling physician groups or hospitals to enter into this market more cost effectively.

 

Radiopharmaceuticals are a large market, how significant are they to Positron?

Radiopharmaceuticals are very significant to Positron’s business model. Our objectives are to provide PET systems, workstations, radiopharmaceuticals, innovative financing structures, clinical/technical guidance, thereby offering a total solution to private practices, pharmacies and hospitals.

 

What are the advantages of the PosiRx™ system?

Positron has identified a market need to provide a simplified solution for performing the many steps involved in unit dose preparation for SPECT pharmaceuticals.  The PosiRx™ system grants its users full control and freedom over their facility’s radiopharmaceutical supplies and schedules.  Doses can be customized and drawn as needed, reducing operational costs and improving patient management. For Positron, this system provides a way to generate revenue through the sale of the equipment or sales of the radiopharmaceuticals provided.  Positron will work with partners to install PosiRx™ systems on a global scale, including radiopharmacies, hospitals and independent imaging facilities.

 

What is Positron’s relationship with Covidien?

Positron has a co-development agreement to develop and custom manufacture automated nuclear pharmacy equipment that functions with Covidien radiopharmaceutical products.  Positron continues to work with Covidien under the terms of this agreement.

 

Is Positron waiting for any regulatory approvals for manufacturing of radiopharmaceutical products?

Positron is developing Indium Oxyquinoline at the facility and plans to file this product with the FDA in the 2nd quarter of 2012.  Initially our Indium Oxine product will be sold to customers as a USP grade radiochemical.  This project signifies Positron’s entrance into direct radiopharmaceutical manufacturing and sales.

 

Why did Positron choose Indium Oxine as a product?

Positron chose to develop Indium Oxine for a number of reasons. Indium Oxine is available as a generic drug and only offered by a single supplier, whereby creating an opportunity to enter an existing market and expand through better economics and efficiencies.  Positron has the expertise through its relationship with Dr. Mathew Thakur, who pioneered the development of Indium Oxine for blood cell labeling.  Indium Oxine is an optimal radiopharmaceutical, whereby allowing Positron to develop the internal expertise and procedures for manufacturing and preparing submissions of a cGMP radiopharmaceutical product. These key attributes are critical components for Positron’s future expansion plans in radiopharmaceuticals.

 

What is being manufactured at the Crown Point facility?

Positron is currently developing the cGMP manufacturing process for indium 111In Oxyquinoline (Indium Oxine), an approved generic radiopharmaceutical widely used for the radiolabeling of blood cells. Positron will produce and market a radiochemical grade of Indium Oxine and will offer a radiopharmaceutical grade upon FDA approval. The product will be available to market as a radiochemical in the first quarter of 2012 and will be submitted for FDA approval in the second quarter of 2012. This product provides the foundation for Positron’s further expansion into the radiopharmaceutical manufacturing market, a key strategy for the Positron’s business objectives.

 

What are the advantages of the Tech-Assist™ and what is its target market?

The Tech-Assist™ is a PET unit dose infusion and shielding system, which reduces personnel exposure during FDG or other PET radiopharmaceutical injections. Positron is focusing on imaging facilities that are experiencing excessive hand dose exposure and facilities looking to utilize future F-18 cardiac agents.

 

Does Positron still offer a SPECT camera?

Positron has a SPECT camera in its product line, the Pulse CDCC®. Currently, Positron is not manufacturing the camera however, the international cardiac imaging market is developing and experiencing growth and may be part of Positron’s plans in the future. In many international markets, the combination of Positron’s Pulse CDCC® camera and the PosiRx™ system may provide the solution necessary to expand an imaging network.  Positron does sell remanufactured systems and maintains service contracts of existing systems in North America.

 

What is the total number of employees and consultants at Positron Corporation?

As of December 2011, there are currently 30 employees and approximately 10 consultants and/or consulting firms which advise Positron on business and industry matters in both domestic and international markets.

 

Are there plans for a reverse split?

No, not at this time. In the future, Positron intends to increase its authorized shares to meet the needs of its capitalization structure. Positron may seek board approval for a reverse split in the future should it be deemed in the best interest for the Company.

 

Patents?

Positron has several domestic and international patents pertaining to PET, SPECT, solid-state photo-detector and radiopharmaceutical shielding technologies. Positron intends to file additional patents on all critical intellectual property.