Kennewick, WA, United States
Kennewick, WA, United States

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Basal cell carcinoma and squamous cell carcinoma (skin cancers) selected, representing over 5,500,000 diagnoses annually in the US alone, making it the most prevalent cancer today KENNEWICK, WA / ACCESSWIRE / February 28, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a cancer therapeutics company focused on the commercialization of their RadioGel™ device, a tumor-injectable and biodegradable radiation that remains focused at the treatment site, today released the third letter in a four letter series outlining AMI's push towards FDA submittal and commercialization from its new President & CEO, Dr. Mike Korenko. After two months of dynamic experience-based discussions among our Medical Advisory Board Members and other senior doctors we have selected our first indication for use which we will present to the Food and Drug Administration. After thorough review to prioritize indications, we have selected basal cell and squamous cell carcinoma (skin cancers). The reasons for this important selection relates to our criteria below: This cancer is in the skin and therefore easy to access. Single injections for small tumors are easy and we have already demonstrated our parallel injection procedure in the cat at Washington State University for larger tumors. b. Therapeutic ratio (ratio of the dose to the tumor target tissue relative to dose to adjacent normal tissue) and responsiveness to radiation: Yttrium-90 is a beta emitter in RadioGel has a much higher therapeutic ratio than any gamma emitter or external beam therapy. Since Y-90 delivers high-energy beta-rays, it has an average penetration path of 4 to 5 mm (less than a quarter inch), which is ideal for skin cancer therapy. There is minimal irradiation of normal surrounding tissue. As an added bonus, the patient can go home immediately with no irradiation risk to themselves or family members. We can treat with very high doses, so response to radiation would not be an issue. (As a comparison, external beam radiation can deliver 60 to 80 Gy. Yttrium-90 in RadioGel can go to 700 Gy or higher). As discussed above, there is very low risk of collateral damage. In addition, the skin is not located next to a major organ, for example if you were injecting near spinal tumors. Because of the low collateral risk and because of the therapeutic effects that would be relatively easy to see in three months, the Medical Advisory Board felt this might be an easier device for the FDA to approve and in a shorter timeframe. In addition, some of our animal testing, that will start in about two months, are already treating similar cancers. We intentionally avoided applying to the FDA for melanoma, since it is highly metastatic and goes deep into the tissue. There are a much smaller number of cases for this cancer type (around 300,000). In addition, there are three new immunotherapy products on the market to treat melanoma cancer. They can have serious side-effects, but they are promising. That violates our next criterion below. Some skin cancers require several-hour long surgeries in which the tumor is removed, one layer at a time, and then sent for biopsy. They then require a skin graft that can lead to an infection. On tumors of the face this can be disfiguring. As people get older their skin gets thinner, which increases the difficulty. Our Advisory Board felt that for these cases in particular RadioGel has a significant therapeutic advantage. It would benefit the patient and contribute to reducing the cost of health care. 3. CAN BE PROFITABLY EMBRACED BY THE MEDICAL COMMUNITY: One out of every three new cancers in the United States is a cancerous skin lesion. The two skin cancer types that we selected are the most common. There are 3.3 million patients in the United States with 5.5 million tumors (some patients have more than one tumor.) About 1 million of these are squamous cell cancers located near the surface of the epidermal skin layer, and greater than 4 million are basal cell cancers in the deep layer of the epidermis. I would never say that we can treat them all; that would just be marketing hype, but I believe that this will be the preferred treatment in a substantial number of cases in a very large market. b. Ease of acceptance by the medical community, Medicare reimbursement: The potential lower cost of RadioGel therapy coupled with the potential very large number of patients satisfied this criterion. To further test the criterion, we are in discussions with a major private clinic with several skin treatment centers. This client believes this is a great new tool for their toolbox. They are also advising us on the obstacles that will have to be overcome, such as our Medicare reimbursement criterion. Since we believe RadioGel therapy will reduce the cost to Medicare we are confident that will not be an obstacle. There are other cancer types on our list of eighteen potential indications of use for RadioGel, and we have already prioritized to present them to the FDA in the future. Unfortunately, in the meantime, those patients will not be benefiting from this technology. As I have reported in my last shareholder letter, I am aligning the veterinarian animal testing with the human skin cancer. Specially, the University of Missouri will be focusing on the treatment for surface soft cell lesions, and Colorado State University will be refining the therapies for oral squamous cell cancers. After this selection, our next step is to prepare for the FDA pre-submittal meeting. We will request that meeting after we complete the test plans that will answer their previous questions. Until we complete these plans I can only estimate that our pre-submission to the FDA would be in June. I am really happy that we have engaged John Smith from Hogan Lovells to be at our side through this FDA process. I am excited and relieved that this selection decision had been made and I wanted to thank the members of our Medical Advisory Board – Chairman Dr. Barry D. Pressman, Dr. Albert DeNittis, Dr. Howard Sandler, and Dr. Darrell Fisher. I would also like to thank Dr. Ricardo Paz-Fumagalli and Dr. Beau Bosko Toskich from the Mayo Clinic for their valuable advice. In addition to the important developments discussed above, we continue to believe that the public markets are significantly undervaluing our company. With a fully diluted enterprise value of less than $10 million, there remains very large upside potential. As we progress on our plan, I intend to work vigorously to educate and inform the medical and investment community as to the therapeutic benefits our core technology as well as the economic model that can generate significant revenue and profits. We are committed to pursuing an uplisting to a national exchange as soon as possible in order to gain wider exposure and credibility in our pursuit of the multi-billion-dollar addressable market for Radiogel™, that can both significantly improve patient outcomes and reward shareholders. Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for cancer treatment. The IsoPet Solutions division is focused on utilizing RadioGel for a cancer therapy in animals. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company 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 the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.


Basal cell carcinoma and squamous cell carcinoma (skin cancers) selected, representing over 5,500,000 diagnoses annually in the US alone, making it the most prevalent cancer today KENNEWICK, WA / ACCESSWIRE / February 28, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a cancer therapeutics company focused on the commercialization of their RadioGel™ device, a tumor-injectable and biodegradable radiation that remains focused at the treatment site, today released the third letter in a four letter series outlining AMI's push towards FDA submittal and commercialization from its new President & CEO, Dr. Mike Korenko. After two months of dynamic experience-based discussions among our Medical Advisory Board Members and other senior doctors we have selected our first indication for use which we will present to the Food and Drug Administration. After thorough review to prioritize indications, we have selected basal cell and squamous cell carcinoma (skin cancers). The reasons for this important selection relates to our criteria below: This cancer is in the skin and therefore easy to access. Single injections for small tumors are easy and we have already demonstrated our parallel injection procedure in the cat at Washington State University for larger tumors. b. Therapeutic ratio (ratio of the dose to the tumor target tissue relative to dose to adjacent normal tissue) and responsiveness to radiation: Yttrium-90 is a beta emitter in RadioGel has a much higher therapeutic ratio than any gamma emitter or external beam therapy. Since Y-90 delivers high-energy beta-rays, it has an average penetration path of 4 to 5 mm (less than a quarter inch), which is ideal for skin cancer therapy. There is minimal irradiation of normal surrounding tissue. As an added bonus, the patent can go home immediately with no irradiation risk to themselves or family members. We can treat with very high doses, so response to radiation would not be an issue. (As a comparison, external beam radiation can deliver 60 to 80 Gy. Yttrium-90 in RadioGel can go to 700 Gy or higher). As discussed above, there is very low risk of collateral damage. In addition, the skin is not located next to a major organ, for example if you were injecting near spinal tumors. Because of the low collateral risk and because of the therapeutic effects that would be relatively easy to see in three months, the Medical Advisory Board felt this might be an easier device for the FDA to approve and in a shorter timeframe. In addition, some of our animal testing, that will start in about two months, are already treating similar cancers. We intentionally avoided applying to the FDA for melanoma, since it is highly metastatic and goes deep into the tissue. There are a much smaller number of cases for this cancer type (around 300,000). In addition, there are three new immunotherapy products on the market to treat melanoma cancer. They can have serious side-effects, but they are promising. That violates our next criterion below. Some skin cancers require several-hour long surgeries in which the tumor is removed, one layer at a time, and then sent for biopsy. They then require a skin graft that can lead to an infection. On tumors of the face this can be disfiguring. As people get older their skin gets thinner, which increases the difficulty. Our Advisory Board felt that for these cases in particular RadioGel has a significant therapeutic advantage. It would be comparatively benefit the patient and contribute to reducing the cost of health care. 3. CAN BE PROFITABLY EMBRACED BY THE MEDICAL COMMUNITY: One out or every three new cancers in the United States is a cancerous skin lesion. The two skin cancer types that we selected are the most common. There are 3.3 million patients in the United States with 5.5 million tumors (some patients have more than one tumor.) About 1 million of these are squamous cell cancers located near the surface of the epidermal skin layer, and greater than 4 million are basal cell cancers in the deep layer of the epidermis. I would never say that we can treat them all; that would just be marketing hype, but I believe that this will be the preferred treatment in a substantial number of cases in a very large market. b. Ease of acceptance by the medical community, Medicare reimbursement: The potential lower cost of RadioGel therapy coupled with the potential very large number of patients satisfied this criterion. To further test the criterion, we are in discussions with a major private clinic with several skin treatment centers. This client believes this is a great new tool for their toolbox. They are also advising us on the obstacles that will have to be overcome, such our Medicare reimbursement criterion. Since we believe RadioGel therapy will reduce the cost to Medicare we are confident that will not be an obstacle. There are other cancer types on our list of eighteen potential indications of use for RadioGel, and we have already prioritized to present them to the FDA in the future. Unfortunately, in the meantime, those patients will not be befitting from this technology. As I have reported in my last shareholder letter, I am aligning the veterinarian animal testing with the human skin cancer. Specially, the University of Missouri will be focusing on the treatment for surface soft cell lesions, and Colorado State University will be refining the therapies for oral squamous cell cancers. After this selection, our next step is to prepare for the FDA pre-submittal meeting. We will request that meeting after we complete the test plans that will answer their previous questions. Until we complete these plans I can only estimate that our pre-submission to the FDA would be in June. I am really happy that we have engaged John Smith from Hogan Lovells to be at our side through this FDA process. I am excited and relieved that this selection decision had been made and I wanted to thank the members of our Medical Advisory Board – Chairman Dr. Barry D. Pressman, Dr. Albert DeNittis, Dr. Howard Sandler, and Dr. Darrell Fisher. I would also like to thank Dr. Ricardo Paz-Fumagalli and Dr. Beau Bosko Toskich from the Mayo Clinic for their valuable advice. In addition to the important developments discussed above, we continue to believe that the public markets are significantly undervaluing our company. With a fully diluted enterprise value of less than $10 million, there remains very large upside potential. As we progress on our plan, I intend to work vigorously to educate and inform the medical and investment community as to the therapeutic benefits our core technology as well as the economic model that can generate significant revenue and profits. We are committed to pursuing an uplisting to a national exchange as soon as possible in order to gain wider exposure and credibility in our pursuit of the multi-billion-dollar addressable market for Radiogel™, that can both significantly improve patient outcomes and reward shareholders. Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for cancer treatment. The IsoPet Solutions division is focused on utilizing RadioGel for a cancer therapy in animals. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company 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 the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control. Basal cell carcinoma and squamous cell carcinoma (skin cancers) selected, representing over 5,500,000 diagnoses annually in the US alone, making it the most prevalent cancer today KENNEWICK, WA / ACCESSWIRE / February 28, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a cancer therapeutics company focused on the commercialization of their RadioGel™ device, a tumor-injectable and biodegradable radiation that remains focused at the treatment site, today released the third letter in a four letter series outlining AMI's push towards FDA submittal and commercialization from its new President & CEO, Dr. Mike Korenko. After two months of dynamic experience-based discussions among our Medical Advisory Board Members and other senior doctors we have selected our first indication for use which we will present to the Food and Drug Administration. After thorough review to prioritize indications, we have selected basal cell and squamous cell carcinoma (skin cancers). The reasons for this important selection relates to our criteria below: This cancer is in the skin and therefore easy to access. Single injections for small tumors are easy and we have already demonstrated our parallel injection procedure in the cat at Washington State University for larger tumors. b. Therapeutic ratio (ratio of the dose to the tumor target tissue relative to dose to adjacent normal tissue) and responsiveness to radiation: Yttrium-90 is a beta emitter in RadioGel has a much higher therapeutic ratio than any gamma emitter or external beam therapy. Since Y-90 delivers high-energy beta-rays, it has an average penetration path of 4 to 5 mm (less than a quarter inch), which is ideal for skin cancer therapy. There is minimal irradiation of normal surrounding tissue. As an added bonus, the patent can go home immediately with no irradiation risk to themselves or family members. We can treat with very high doses, so response to radiation would not be an issue. (As a comparison, external beam radiation can deliver 60 to 80 Gy. Yttrium-90 in RadioGel can go to 700 Gy or higher). As discussed above, there is very low risk of collateral damage. In addition, the skin is not located next to a major organ, for example if you were injecting near spinal tumors. Because of the low collateral risk and because of the therapeutic effects that would be relatively easy to see in three months, the Medical Advisory Board felt this might be an easier device for the FDA to approve and in a shorter timeframe. In addition, some of our animal testing, that will start in about two months, are already treating similar cancers. We intentionally avoided applying to the FDA for melanoma, since it is highly metastatic and goes deep into the tissue. There are a much smaller number of cases for this cancer type (around 300,000). In addition, there are three new immunotherapy products on the market to treat melanoma cancer. They can have serious side-effects, but they are promising. That violates our next criterion below. Some skin cancers require several-hour long surgeries in which the tumor is removed, one layer at a time, and then sent for biopsy. They then require a skin graft that can lead to an infection. On tumors of the face this can be disfiguring. As people get older their skin gets thinner, which increases the difficulty. Our Advisory Board felt that for these cases in particular RadioGel has a significant therapeutic advantage. It would be comparatively benefit the patient and contribute to reducing the cost of health care. 3. CAN BE PROFITABLY EMBRACED BY THE MEDICAL COMMUNITY: One out or every three new cancers in the United States is a cancerous skin lesion. The two skin cancer types that we selected are the most common. There are 3.3 million patients in the United States with 5.5 million tumors (some patients have more than one tumor.) About 1 million of these are squamous cell cancers located near the surface of the epidermal skin layer, and greater than 4 million are basal cell cancers in the deep layer of the epidermis. I would never say that we can treat them all; that would just be marketing hype, but I believe that this will be the preferred treatment in a substantial number of cases in a very large market. b. Ease of acceptance by the medical community, Medicare reimbursement: The potential lower cost of RadioGel therapy coupled with the potential very large number of patients satisfied this criterion. To further test the criterion, we are in discussions with a major private clinic with several skin treatment centers. This client believes this is a great new tool for their toolbox. They are also advising us on the obstacles that will have to be overcome, such our Medicare reimbursement criterion. Since we believe RadioGel therapy will reduce the cost to Medicare we are confident that will not be an obstacle. There are other cancer types on our list of eighteen potential indications of use for RadioGel, and we have already prioritized to present them to the FDA in the future. Unfortunately, in the meantime, those patients will not be befitting from this technology. As I have reported in my last shareholder letter, I am aligning the veterinarian animal testing with the human skin cancer. Specially, the University of Missouri will be focusing on the treatment for surface soft cell lesions, and Colorado State University will be refining the therapies for oral squamous cell cancers. After this selection, our next step is to prepare for the FDA pre-submittal meeting. We will request that meeting after we complete the test plans that will answer their previous questions. Until we complete these plans I can only estimate that our pre-submission to the FDA would be in June. I am really happy that we have engaged John Smith from Hogan Lovells to be at our side through this FDA process. I am excited and relieved that this selection decision had been made and I wanted to thank the members of our Medical Advisory Board – Chairman Dr. Barry D. Pressman, Dr. Albert DeNittis, Dr. Howard Sandler, and Dr. Darrell Fisher. I would also like to thank Dr. Ricardo Paz-Fumagalli and Dr. Beau Bosko Toskich from the Mayo Clinic for their valuable advice. In addition to the important developments discussed above, we continue to believe that the public markets are significantly undervaluing our company. With a fully diluted enterprise value of less than $10 million, there remains very large upside potential. As we progress on our plan, I intend to work vigorously to educate and inform the medical and investment community as to the therapeutic benefits our core technology as well as the economic model that can generate significant revenue and profits. We are committed to pursuing an uplisting to a national exchange as soon as possible in order to gain wider exposure and credibility in our pursuit of the multi-billion-dollar addressable market for Radiogel™, that can both significantly improve patient outcomes and reward shareholders. Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for cancer treatment. The IsoPet Solutions division is focused on utilizing RadioGel for a cancer therapy in animals. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company 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 the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.


Hires Expert FDA Device Submission Firm; Outlines In-Parallel FDA Data Collection Strategy; Expands Medical Advisory Board with Doctors from 2 Top Cancer Hospitals; Narrows Indication List from 18 to 6 KENNEWICK, WA / ACCESSWIRE / February 14, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a cancer therapeutics company focused on the commercialization of their RadioGel™ device, a tumor-injectable and biodegradable radiation that remains focused at the treatment site, today released a letter from its new President and CEO, Dr. Mike Korenko: With my first letter on January 11, I shared AMI's plans for our near-term future. With this letter, I will discuss the progress on that plan in the medical sector of our business over the last month. PATH FORWARD WITH THE FOOD AND DRUG ADMINISTRATION (FDA) In order to maximize our expertise in communicating with the FDA, I spent a lot of time locating the correct FDA expert to be at our side. We have engaged Hogan Lovells. They have 21 lawyers in the field of FDA devices and are very familiar with the personnel at the FDA. We are thrilled to have the input of senior partner John Smith, M.D., J.D. As both a physician and a lawyer, John combines clinical and regulatory experience relating to the FDA with a practical approach to addressing the regulatory issues. He places a particular focus on bringing device-based technologies to market. John and his lawyers have just completed the review of all our previous FDA communications and our supporting data. Based on their recommendations with respect to interacting with the FDA, we intend to: 1. Introduce AMI's new leadership and let them know we have listened; we are narrowing our indication for use to secure our first approval and completing the test plans to answer their previous questions for their review. 2. Present our specific test plans and data in a Pre-Submission meeting to clarify the final application. 4. With the FDA's permission, submit a de novo application for approval (FDA.gov De Novo Application FAQs). The FDA classification of RadioGel™ as a device increases our chances of a timely FDA approval exponentially. The critical path on the overall schedule to approval is, first, to complete laboratory testing concurrent with veterinary animal studies, then into human clinical trials. It is my intent to align the animal treatments in our veterinarian business division to support the animal testing required for the FDA to synergize the two divisions, and potentially create time and cost savings. In this parallel strategy, the company looks to move to first-in-man trials as soon as possible, while aggressively pursuing near-term revenues through the veterinary division, IsoPet, and through licensing. Our Medical Advisory Board has been expanded. Under the Chairmanship of Dr. Barry Pressman (a neuroradiology expert at Cedars-Sinai Medical Center in Los Angeles and Past-President of the American College of Radiology), the Board now includes Dr. Albert Denittis (Chief of Radiation Oncology Lankenau Medical Center), and Dr. Howard Sandlin (Ronald H. Bloom Chair in Cancer Therapeutics, Professor and Chair, Department of Radiation Oncology, Cedars-Sinai Medical Center). Their combined medical experience adds up to over 125 years. We have also been harvesting advice from other doctors, including two from the Mayo Clinic. The focus of the Advisory Boards is to prioritize our indications for use (which cancer types to treat first) in order to present them one at a time, in sequence to the FDA. The Board has selected 18 cancers that are good candidates for treatment with RadioGel™. To me, this large number is a confirmation of our belief that RadioGel has broad potential to treat a variety of tumors. From a business standpoint, it set the stage for incremental growth for many years into the future. In the near-term, we are prioritizing this list down to our top three therapy targets based on specific criteria. 1. Potential for FDA approval and successful therapy: a. Accessibility in the body, ease of application b. Therapeutic effectiveness in response to radiation c. Potential collateral risks from injection d. FDA Testing requirements 3. Business considerations a. Number of patients diagnosed yearly b. Ease of acceptance by the medical community c. Medical Insurance and Medicare reimbursement To paraphrase: 1) It works; 2) Nobody has a better mousetrap; and 3) It has to be profitable to the medical business sector. There have been other great products that made it through the FDA and failed, since the medical community did not see a profitable way to adapt the new technology. The medical community cares about saving lives, but they are in a business. We did not want to be surprised by that reality. As of today, we are down to six near-term candidates. We hope to have our final selection before the end of February. This is an important decision, so we need to get it right. I will send out another shareholder letter when we select our first indication for use. I will also discuss our veterinarian sector's business plan, as well as some updates in a near-term communication to you. I hope this was not too much detail, but I am not a big fan of fluff. Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for cancer treatment. The IsoPet Solutions division is focused on utilizing RadioGel for a cancer therapy in animals. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company 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 the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners, and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control. Hires Expert FDA Device Submission Firm; Outlines In-Parallel FDA Data Collection Strategy; Expands Medical Advisory Board with Doctors from 2 Top Cancer Hospitals; Narrows Indication List from 18 to 6 KENNEWICK, WA / ACCESSWIRE / February 14, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a cancer therapeutics company focused on the commercialization of their RadioGel™ device, a tumor-injectable and biodegradable radiation that remains focused at the treatment site, today released a letter from its new President and CEO, Dr. Mike Korenko: With my first letter on January 11, I shared AMI's plans for our near-term future. With this letter, I will discuss the progress on that plan in the medical sector of our business over the last month. PATH FORWARD WITH THE FOOD AND DRUG ADMINISTRATION (FDA) In order to maximize our expertise in communicating with the FDA, I spent a lot of time locating the correct FDA expert to be at our side. We have engaged Hogan Lovells. They have 21 lawyers in the field of FDA devices and are very familiar with the personnel at the FDA. We are thrilled to have the input of senior partner John Smith, M.D., J.D. As both a physician and a lawyer, John combines clinical and regulatory experience relating to the FDA with a practical approach to addressing the regulatory issues. He places a particular focus on bringing device-based technologies to market. John and his lawyers have just completed the review of all our previous FDA communications and our supporting data. Based on their recommendations with respect to interacting with the FDA, we intend to: 1. Introduce AMI's new leadership and let them know we have listened; we are narrowing our indication for use to secure our first approval and completing the test plans to answer their previous questions for their review. 2. Present our specific test plans and data in a Pre-Submission meeting to clarify the final application. 4. With the FDA's permission, submit a de novo application for approval (FDA.gov De Novo Application FAQs). The FDA classification of RadioGel™ as a device increases our chances of a timely FDA approval exponentially. The critical path on the overall schedule to approval is, first, to complete laboratory testing concurrent with veterinary animal studies, then into human clinical trials. It is my intent to align the animal treatments in our veterinarian business division to support the animal testing required for the FDA to synergize the two divisions, and potentially create time and cost savings. In this parallel strategy, the company looks to move to first-in-man trials as soon as possible, while aggressively pursuing near-term revenues through the veterinary division, IsoPet, and through licensing. Our Medical Advisory Board has been expanded. Under the Chairmanship of Dr. Barry Pressman (a neuroradiology expert at Cedars-Sinai Medical Center in Los Angeles and Past-President of the American College of Radiology), the Board now includes Dr. Albert Denittis (Chief of Radiation Oncology Lankenau Medical Center), and Dr. Howard Sandlin (Ronald H. Bloom Chair in Cancer Therapeutics, Professor and Chair, Department of Radiation Oncology, Cedars-Sinai Medical Center). Their combined medical experience adds up to over 125 years. We have also been harvesting advice from other doctors, including two from the Mayo Clinic. The focus of the Advisory Boards is to prioritize our indications for use (which cancer types to treat first) in order to present them one at a time, in sequence to the FDA. The Board has selected 18 cancers that are good candidates for treatment with RadioGel™. To me, this large number is a confirmation of our belief that RadioGel has broad potential to treat a variety of tumors. From a business standpoint, it set the stage for incremental growth for many years into the future. In the near-term, we are prioritizing this list down to our top three therapy targets based on specific criteria. 1. Potential for FDA approval and successful therapy: a. Accessibility in the body, ease of application b. Therapeutic effectiveness in response to radiation c. Potential collateral risks from injection d. FDA Testing requirements 3. Business considerations a. Number of patients diagnosed yearly b. Ease of acceptance by the medical community c. Medical Insurance and Medicare reimbursement To paraphrase: 1) It works; 2) Nobody has a better mousetrap; and 3) It has to be profitable to the medical business sector. There have been other great products that made it through the FDA and failed, since the medical community did not see a profitable way to adapt the new technology. The medical community cares about saving lives, but they are in a business. We did not want to be surprised by that reality. As of today, we are down to six near-term candidates. We hope to have our final selection before the end of February. This is an important decision, so we need to get it right. I will send out another shareholder letter when we select our first indication for use. I will also discuss our veterinarian sector's business plan, as well as some updates in a near-term communication to you. I hope this was not too much detail, but I am not a big fan of fluff. Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for cancer treatment. The IsoPet Solutions division is focused on utilizing RadioGel for a cancer therapy in animals. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company 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 the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners, and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.


KENNEWICK, WA / ACCESSWIRE / December 20, 2016 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a late stage radiation oncology focused medical device company, announced that Dr. Michael Korenko, Ph. D., who formerly served as an advisor to the Board, was named as AMI's interim President and Chief Executive Officer, replacing James Katzaroff. Mr. Katzaroff remains a member of the Board. Additionally, Carlton Cadwell, a current member of the Board, was named Chairman of the Board and Secretary of the Company. Mr. Cadwell has served on the Board since 2006. Dr. Korenko formerly served as Vice-President of Westinghouse, where he was tasked with overseeing 300 and 400 areas, including the Fast Flux Testing Facility (FFTF) and all engineering, safety analysis, and projects for the Hanford site. He also served as Executive Vice President of Closure for Safe Sites of Colorado at Rocky Flats. His most previous assignment was as Chief Operating Officer for Curtiss-Wright, producer of the nuclear components for all the United States submarine and aircraft carriers, as well as components for commercial nuclear power companies. Dr. Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a White House Fellow for the Department of Defense, reporting to Secretary Cap Weinberger. Dr. Korenko currently is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year. Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for the treatment of non resectable tumors. The IsoPet Solutions division is focused on establishing the infrastructure necessary to provide product to veterinary clinics including regulatory clearances and compliance as well as providing product awareness and education to veterinary oncologists. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company 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 the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.


KENNEWICK, WA / ACCESSWIRE / December 20, 2016 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a late stage radiation oncology focused medical device company, announced that Dr. Michael Korenko, Ph. D., who formerly served as an advisor to the Board, was named as AMI's interim President and Chief Executive Officer, replacing James Katzaroff. Mr. Katzaroff remains a member of the Board. Additionally, Carlton Cadwell, a current member of the Board, was named Chairman of the Board and Secretary of the Company. Mr. Cadwell has served on the Board since 2006. Dr. Korenko formerly served as Vice-President of Westinghouse, where he was tasked with overseeing 300 and 400 areas, including the Fast Flux Testing Facility (FFTF) and all engineering, safety analysis, and projects for the Hanford site. He also served as Executive Vice President of Closure for Safe Sites of Colorado at Rocky Flats. His most previous assignment was as Chief Operating Officer for Curtiss-Wright, producer of the nuclear components for all the United States submarine and aircraft carriers, as well as components for commercial nuclear power companies. Dr. Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a White House Fellow for the Department of Defense, reporting to Secretary Cap Weinberger. Dr. Korenko currently is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year. Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for the treatment of non resectable tumors. The IsoPet Solutions division is focused on establishing the infrastructure necessary to provide product to veterinary clinics including regulatory clearances and compliance as well as providing product awareness and education to veterinary oncologists. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company 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 the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control. KENNEWICK, WA / ACCESSWIRE / December 20, 2016 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a late stage radiation oncology focused medical device company, announced that Dr. Michael Korenko, Ph. D., who formerly served as an advisor to the Board, was named as AMI's interim President and Chief Executive Officer, replacing James Katzaroff. Mr. Katzaroff remains a member of the Board. Additionally, Carlton Cadwell, a current member of the Board, was named Chairman of the Board and Secretary of the Company. Mr. Cadwell has served on the Board since 2006. Dr. Korenko formerly served as Vice-President of Westinghouse, where he was tasked with overseeing 300 and 400 areas, including the Fast Flux Testing Facility (FFTF) and all engineering, safety analysis, and projects for the Hanford site. He also served as Executive Vice President of Closure for Safe Sites of Colorado at Rocky Flats. His most previous assignment was as Chief Operating Officer for Curtiss-Wright, producer of the nuclear components for all the United States submarine and aircraft carriers, as well as components for commercial nuclear power companies. Dr. Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a White House Fellow for the Department of Defense, reporting to Secretary Cap Weinberger. Dr. Korenko currently is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year. Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for the treatment of non resectable tumors. The IsoPet Solutions division is focused on establishing the infrastructure necessary to provide product to veterinary clinics including regulatory clearances and compliance as well as providing product awareness and education to veterinary oncologists. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company 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 the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.


News Article | December 2, 2016
Site: marketersmedia.com

KENNEWICK, WA / ACCESSWIRE / December 2, 2016 / Advanced Medical Isotope Corporation ("AMI") (OTC: ADMD), a late stage radiation oncology focused medical device company, announced today that it has been awarded in the Superior Court of the State of Washington in and for Benton County, a total judgment of five-hundred-twenty-seven-thousand-eight-hundred-seventy-five-dollars and seventy-four cents ($527,875.74 USD), with interest accruing at the rate of twelve-percent (12%) until paid in full against BancLeasing, Inc. The interpretation and application of the terms for finance leases from BancLeasing, Inc. to AMI for laboratory equipment, a linear accelerator, and tenant improvements have been contested by AMI since early in the contract. After failed attempts to settle the matter out of court, AMI filed a lawsuit and was recently awarded default judgment. "The Company is actively pursuing collection efforts, and while we can give no assurance as to the final amount and when we might collect, AMI will utilize every avenue possible to collect on this judgment." Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for the treatment of non resectable tumors. The IsoPet Solutions division is focused on establishing the infrastructure necessary to provide product to veterinary clinics including regulatory clearances and compliance as well as providing product awareness and education to veterinary oncologists. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company 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 the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control. KENNEWICK, WA / ACCESSWIRE / December 2, 2016 / Advanced Medical Isotope Corporation ("AMI") (OTC: ADMD), a late stage radiation oncology focused medical device company, announced today that it has been awarded in the Superior Court of the State of Washington in and for Benton County, a total judgment of five-hundred-twenty-seven-thousand-eight-hundred-seventy-five-dollars and seventy-four cents ($527,875.74 USD), with interest accruing at the rate of twelve-percent (12%) until paid in full against BancLeasing, Inc. The interpretation and application of the terms for finance leases from BancLeasing, Inc. to AMI for laboratory equipment, a linear accelerator, and tenant improvements have been contested by AMI since early in the contract. After failed attempts to settle the matter out of court, AMI filed a lawsuit and was recently awarded default judgment. "The Company is actively pursuing collection efforts, and while we can give no assurance as to the final amount and when we might collect, AMI will utilize every avenue possible to collect on this judgment." Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for the treatment of non resectable tumors. The IsoPet Solutions division is focused on establishing the infrastructure necessary to provide product to veterinary clinics including regulatory clearances and compliance as well as providing product awareness and education to veterinary oncologists. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company 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 the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.


Trademark
Advanced Medical Isotope | Date: 2016-10-06

Isotopes for veterinary use; radio-isotope markers for veterinary use.


Trademark
Advanced Medical Isotope | Date: 2013-11-14

Isotopes for medical purposes; radio-isotope markers for therapeutic or diagnostic use. Distributorship services in the field of isotopes for medical purposes and radio-isotope markers for therapeutic or diagnostic use. Custom production for others of isotopes for medical purposes and radio-isotope markers for therapeutic or diagnostic use. Product development in the field of isotopes for medical purposes and radio-isotope markers for therapeutic or diagnostic use.


News Article | November 30, 2016
Site: marketersmedia.com

CEO, Chairman and Founder, James Katzaroff will be presenting, as well as meeting with investors on Tuesday, December 6th as well as Wednesday, December 7th. All interested parties are kindly asked to schedule a private meeting through the conference meeting system. The LD Micro Main Event is the largest independent conference for small/microcap companies and will feature 240 presenting names. To review a copy of Advanced Medical Isotope's Investor deck, click here: ADMD Investor Deck Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for the treatment of non resectable tumors. The IsoPet Solutions division is focused on establishing the infrastructure necessary to provide product to veterinary clinics, including regulatory clearances and compliance, as well as providing product awareness and education to veterinary oncologists. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company 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 the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our websites: www.isopetsolutions.com and www.isotopeworld.com. LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space. What started out as a newsletter highlighting unique companies has transformed into an event platform hosting several influential conferences annually (Invitational, Summit, and Main Event). In 2015, LDM launched the first pure microcap index (the LDMi) to exclusively provide intraday information on the entire sector. LD will continue to provide valuable tools for the benefit of everyone in the small and microcap universe. For those interested in attending, please contact David Scher at david@ldmicro.com or visit www.ldmicro.com/events for more information. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.

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