Perspective Therapeutics Profile
Perspective Therapeutics, Inc., through its wholly-owned subsidiary, Isoray Medical, Inc. (Medical), develops, manufactures, and sells isotope-based medical products and devices for the treatment of cancer and other malignant diseases.
Brachytherapy Business Operations of Isoray Medical, Inc.
In 2003, the company obtained clearance from the Food and Drug Administration (FDA) for the use of Cesium-131 (Cesium-131) radioisotope in the treatment of all malignant tumors. The FDA clearance granted in August 2009 permits loading Cesium-131 seeds into bio-absorbable braided sutures or 'braided strands' giving the company the ability to treat brain, lung, head and neck, colorectal, and chest wall cancers. As of December 31, 2022, such applications included prostate cancer, brain cancer, colorectal cancer, gynecological cancer, lung cancer, ocular melanoma and pancreatic cancer. The brachytherapy seed form (a sealed source) of Cesium-131 may be used in surface, interstitial and intra-cavity applications for tumors with known radio-sensitivity.
The company's core product is its Cesium-131 sealed source brachytherapy 'seed'. These seeds can be inserted individually or in combination into various locations in the body until the physician is satisfied with the radiation dose delivered. The company also sells seeds in strands to keep them from individually moving and to allow the physician to put multiple seeds in a row as desired. In addition, 'pre-loaded' needles may have Cesium-131 brachytherapy seeds inserted in them, or a strand with seeds in the strand, inserted into the needle. Seeds can be sold with the company's Blu Build loading device that allows clinicians to efficiently customize and configure strands in the operating room. Under a manufacturing agreement with GT Medical Technologies, Inc. (GT Med Tech), the company inserts Cesium-131 seeds into a collagen matrix which GT Med Tech's customers place in the brain.
Prostate Cancer
The company began the production and sale of Cesium-131 brachytherapy seeds in October 2004 for the treatment of prostate cancer after receiving clearance of its premarket notification (510(k)) by the Food and Drug Administration.
Gynecologic Cancer
While the company continues to supply Cesium-131 seeds for use in gynecologic cancers, the company is currently putting its focus on other cancers.
Brain Cancer
GammaTile Treatment for Brain Cancer
During 2013, the company began providing technical assistance and supported selling Cesium-131 brachytherapy seeds for embedding in collagen tiles developed by physicians at Barrow Neurological Institute (Barrow) to treat malignant meningioma, primary brain cancers, and metastases of cancers to the brain. These physicians from Barrow formed a company, GammaTile LLC, now GT Medical Technologies, Inc. (GT Med Tech), and further refined this technology, which integrates Cesium-131 brachytherapy seeds and has resulted in the issuance of multiple patents to GT Med Tech for the treatment of brain cancers.
Head and Neck Cancer
Cesium-131 brachytherapy is also used in the treatment of recurrent head and neck cancers.
In June 2020, the company announced that an agreement had been completed with a group of physicians based at the University of Cincinnati. The agreement related to support for a Phase I/IIa clinical study of recurrent or metastatic head and neck cancers treated by a combination of surgical resection, Cesium-131 brachytherapy, and blockade of the programmed cell death protein 1 (PD-1) checkpoint using pembrolizumab therapy (Keytruda from Merck & Co., Inc.).
The company has a collaboration agreement with MIM Software to deliver a treatment solution to more accurately target the placement of Cesium-131 for recurrent head and neck cancers.
The company has initiated a study with the University of Pittsburgh School of Medicine that seeks to study short-term urinary symptoms of men treated with Cesium-131 prostate brachytherapy in more detail than previously studied. This study will summarize patient-reported urinary symptoms on a monthly - rather than quarterly - basis in order to more carefully describe patients' experiences with bothersome urinary morbidity.
Brain Cancer Treatment Options
On July 6, 2018, the company and GT Med Tech received FDA 510(k) regulatory clearance for the brachytherapy technology, known as GammaTile Therapy that incorporates proprietary Cesium-131 seeds within customizable collagen-based carriers for the treatment of recurrent brain tumors. On January 27, 2020, GT Med Tech announced that it had received clearance from the FDA for an expanded indication that will allow patients of newly diagnosed malignant brain tumors to be treated by GammaTile Therapy.
Medical and GT Medical Technology executed a Collaborative Development Agreement and an exclusive ten-year supply agreement for GammaTile Therapy in 2018. On April 26, 2019, the company and GT Med Tech amended and restated the Manufacturing and Supply Agreement, which now expires in April 2029. GammaTile leverages Cesium-131's unique ability to deliver a highly targeted dose of intense radiation treatment while limiting radiation exposure to surrounding tissue. On November 17, 2021, the parties entered into Amendment No. 3 to the Amended and Restated Manufacturing and Supply Agreement to change the nature of the services to be provided by Medical to GT Med Tech from preparation of GammaTiles containing Cesium-131 seeds to instead only supplying Cesium-131 seeds to GT Med Tech so that GT Med Tech may handle the assembly of GammaTiles in house. Pursuant to this amendment, Medical will manufacture and supply Cesium-131 brachytherapy seeds to GT Med Tech rather than GammaTiles. Additionally, the amendment modified the prices to be paid by GT Med Tech for rush orders and for Cesium-131 seeds and modified how order cancellations are processed.
On July 14, 2017, the company entered into an agreement with a distributor in Russia that provides for the ability to sell the entire product line in Russia. In 2020, the company entered into a three-year agreement with a distributor in India that provides for the ability to sell Cesium-131 brachytherapy seeds in different configurations within India.
The company markets the CS-1 Cesium-131 brachytherapy seed for the treatment of prostate cancer, brain cancer, lung cancer, head and neck cancers, gynecological cancer, pelvic/abdominal cancer, and colorectal cancer. The company intends to market Cesium-131 for the treatment of other malignant diseases as opportunities are identified in the future through the use of existing proven technologies that have received FDA-clearance.
Cesium-131 is a radioactive isotope that can be produced by the neutron bombardment of Barium-130 (Ba-130). To produce the Cesium-131 brachytherapy seed, a proprietary chemical separation is performed that results in 99.9% pure Cesium-131 isotope.
In August 2008, the company obtained its initial ISO 13485:2003 certification and has subsequently been ISO certified under various compliance standards since then. In April 2018, the British Standards Institute (BSI) certified the company's successful transition to ISO 13485:2016.
In January 2022, the FDA conducted a voluntary Remote Regulatory Assessment (RRA) of Perspective Therapeutics' Quality Management System (QMS), and did not find any major nonconformances, and there was no issuance of a FDA Form 483.
In January 2021, BSI conducted a remote surveillance assessment audit of the company's quality management system. The company successfully passed the audit with three minor non-conformances. The minor non-conformances were subsequently resolved.
In February 2022, BSI conducted a remote surveillance audit. The company successfully passed the audit with two minor non-conformances. The minor non-conformances were subsequently resolved.
In January 2023, BSI conducted the ISO 13485:2016 re-certification microbiology audit. The company successfully passed the audit with zero non-conformances.
In February 2023, BSI conducted the ISO 13485:2016 re-certification audit of the QMS. The company successfully passed the audit with four non-conformances.
The Federal Aviation Administration (FAA) also conducted an unannounced audit in May 2016. Because Perspective Therapeutics ships hazardous materials on flights in the U.S., Perspective Therapeutics is subject to regulation by the FAA.
During 2019, the company elected to not renew its CE Mark due to no sales activity in the European Union, limited interest in Cesium-131 due to the pricing and reimbursement environment and changing European Union registration requirements that would have required significant investment into additional clinical trials.
During 2021, the company received FDA 510(k) clearance for use of C4 Imaging's Sirius positive-signal MRI (Magnetic Resonance Imaging) Markers with the company's Cesium-131 brachytherapy seeds (510(k) No. K202267). Sirius Markers is implanted during the treatment of prostate cancer with the Cesium-131 seeds and is used to facilitate seed localization within the prostate utilizing a single post-implant MRI procedure. The company launched a product performance evaluation on this technology in its first quarter of fiscal year 2022 (year ended December 31, 2022). The expanded full market release was launched in August 2022.
Product Offerings
In addition to providing loose seeds to customers, most brachytherapy manufacturers offer their seed product to the end user packaged in various configurations provided in a sterile or non-sterile package depending on the customer's preference. These include:
Pre-loaded needles (loaded typically with three to five seeds and spacers);
Pre-loaded Mick cartridges (fits the Mick applicator);
Strands of seeds (consists of seeds and spacers in a bioabsorbable rigid 'carrier sleeve');
Preloaded strands (strands of seeds loaded into a needle);
Strands of seeds with Sirius MRI markers (consists of seeds and Sirius MRI markers in a bioabsorbable rigid 'carrier sleeve');
Preloaded strands with Sirius MRI markers (strands of seeds with Sirius MRI markers loaded into a needle);
Pre-loaded braided strands (seeds loaded into a flexible bioabsorbable braided suture);
Pre-loaded braided strands attached to bioabsorbable mesh (creates planar implants out of braided sutures and bioabsorbable mesh); and
Intraoperative real-time loading device sold as Blu Build (loader that allows custom seed and spacer loading).
In fiscal year 2022, the company delivered approximately 46% of its Cesium-131 seeds to customers configured in Mick cartridges, approximately 26% of its Cesium-131 seeds configured in stranded and pre-loaded in a needle form, 19% of its Cesium-131 seeds configured in a braided strand form, 2% of its Cesium-131 seeds sold in a loose configuration, and the remaining 7% configured in either a pre-loaded needle, Blu Build, or stranded form.
Strategy
The key elements of the company's strategy are to continue to invest in sales and marketing development activities; commercialization of GammaTile therapy for the treatment of primary and recurrent brain metastases; increase the utilization of Cesium-131 in the treatment of other solid tumor applications, such as brain, gynecological, and other cancers; maintain more favorable reimbursement codes; support clinical research and sustained product development; and targeted expansion into international markets.
Sales and Marketing
The company's marketing plan with regard to non-prostate segments includes identifying and exhibiting at scientific meetings attended by specialty physicians who perform procedures related to its product offerings, direct sales contact with such physicians (for example thoracic surgeons and neuro-surgeons), the development and dissemination of training videos and other media that outline the company's products, and the implementation of local training events to provide product and procedure information to potential customers.
Further, the company is partnering with key clinicians within each application to support early experiences and identify additional facilities that may be interested in the applications. The company continues to work with its existing radiation oncology physician customers and to educate them as to additional or new company products and expand utility of Cesium-131 within the facility and across different disease sites.
Sales and Distribution
In the prostate cancer market, the company's sales team targets radiation oncologists, and medical physicists, as well as urologists and facility administrators as key clinical decision-makers in the type of radiation therapy offered to prostate cancer patients. As the urologist plays a key role in influencing the ultimate treatment for each prostate cancer patient, the company's sales team is expanding efforts to raise interest in brachytherapy within the urology community, both in direct effort and through the urology referrals at existing facilities. The company will continue to work with its existing clinicians to raise awareness in their referral community about the benefits of Cesium-131 brachytherapy.
With respect to non-prostate applications, the company targets neurosurgeons, thoracic surgeons, gynecologic oncologists, and other surgeons in addition to radiation oncologists. After these clinicians identify the value of the company's Cesium-131 products, the company then also needs support for the procedure from the medical physicists on staff and facility administrators.
The company expects to continue to explore the opportunity to extend its customer base outside the U.S. market through use of established distributors in target markets of other countries. As of April 2023, the company had independent distributors in Russia, India, and Peru to focus on prostate and centers in the targeted markets. Although it has international distribution agreements in place, due to the COVID-19 global pandemic, the company continues to experience difficulties in generating sales of Cesium-131 products through its international distributors. With the launch of the virtual learning platform, the company looks forward to re-engaging with its international distributors.
Seasonality
Some seed implantation procedures are deferred around physician vacations (particularly in the summer months), holidays, and medical conventions and conferences resulting in a seasonal influence on the company's business. These factors cause a momentary decline in revenue, which is ultimately realized in prior or following periods. Because a material portion of the company's business is dependent on two customers, physician practices or facilities, simultaneous or extended vacations by the physicians at these facilities or by the company's single largest physician whose total revenue alone represents a material portion of the company's business has caused and could continue to cause significant drops in the company's productivity during those reporting periods.
Proprietary Rights
Certain aspects of the company's seed design and construction techniques are patentable innovations. These innovations resulted in a patent granted by the USPTO under Patent Number 7,410,458, in August 2008, with an expected expiration date in 2025. Four patents have been granted by the USPTO relating to methods of deriving Cesium-131 developed by Isoray employees: Patent Number 7,479,261, with a expected expiration date in 2027; Patent Number 7,531,150, with a expected expiration date in 2027; Patent Number 7,316,644, expected to expire in 2025; and Patent Number 7,510,691, expected to expire in 2027. One patent has been granted by the USPTO relating to a device for loading brachytherapy seeds: Patent Number 10,328,278, expected to expire in 2038. The company has two patents that were issued on April 23, 2014 and are in force in Canada (Canada 2576907 and 2571349), both of which expire in 2025. The company has three patents granted in Russia, which expire at various times in 2024 and 2025. The company has a single patent granted in each of the EU, Hong Kong, the Netherlands, and India, which expire various times in 2024 and 2025. The company has a patent application pending in the U.S. and a single patent application filed for the Patent Cooperation Treaty. The company is continuing its efforts to develop and patent additional methods of deriving Cesium-131 and other isotopes.
Research and Development
During the two and a half year period ended December 31, 2022, the company and its subsidiaries incurred approximately $5.3 million in costs related to research and development activities.
Customers
The company's customers include El Camino, Los Gatos, and other facilities comprising 7.7% of total sales; and GT Medical Technologies Inc. comprising 26.4 % of total sales for the six months ended December 31, 2022.
Suppliers
On August 26, 2020, a new supply contract was signed with The Open Joint Stock Company (JSC Isotope) for a term of August 2020 to December 2021 as the company had purchased the maximum amount of Cesium-131 permitted under the prior agreement. On February 10, 2021, an addendum was signed updating delivery locations. On March 18, 2021, the company entered into a new supply contract with JSC Isotope pursuant to which it will purchase Cesium-131 for a term from March 18, 2021 through March 31, 2023. On July 29, 2021, an addendum was signed that adds a manufacturer, adds a shipper of goods, and increases the amount of Cesium-131 the company can purchase. On August 19, 2021, an addendum was signed that adds MedikorPharma-Ural LLC, a company incorporated in accordance with the laws of Russia (Medikor), as a supplier to supply enriched barium carbonate for the manufacture of Cesium-131 to JSC Isotope on behalf of the company. On April 11, 2022, an addendum was signed that adds Moving Forward International GmbH, a company incorporated in accordance with the laws of Germany (Moving Forward), as a consignee to assist in delivery of Cesium-131 to Medical.
On December 12, 2022, Isoray Medical, Inc. (Medical), a wholly owned subsidiary the company, entered into a supply contract (the New 2023 Agreement) with Joint Stock Company 'Isotope', a Russian company (JSC Isotope). Pursuant to the New 2023 Agreement, Medical will purchase Cesium-131 manufactured by Joint Stock Company ‹‹Institute of Nuclear Materials›› and sold by JSC Isotope, at the quality standards, volume, and pricing indicated in the New 2023 Agreement. The New 2023 Agreement is dated November 28, 2022, effective December 12, 2022, for shipments beginning January 1, 2023, and terminates March 31, 2024. Medical and JSC Isotope previously entered into a separate supply contract, dated March 18, 2021, as subsequently amended by six addenda that modified minor shipping, manufacturing, and payment terms (together, the Prior Agreement). Although the Prior Agreement remains in effect until March 31, 2023, Medical has or will shortly purchase the maximum amount of Cesium-131 permitted under the Prior Agreement and the New 2023 Agreement has a new price. Therefore, Medical will make all future purchases of Cesium-131 under the New 2023 Agreement.
Additionally, on December 12, 2022, Medical entered into a supply contract (the New 2024 Agreement) with JSC Isotope. Pursuant to the New 2024 Agreement, Medical will purchase Cesium-131 manufactured by Joint Stock Company ‹‹Institute of Nuclear Materials›› and sold by JSC Isotope, at the quality standards, volume, and pricing indicated in the New 2024 Agreement. The New 2024 Agreement is dated November 28, 2022, effective December 12, 2022, for shipments beginning January 1, 2024, and terminates March 31, 2025.
On September 9, 2021, Medical entered into a Consignment Agreement with MedikorPharma-Ural LLC (Medikor) pursuant to which Medical purchased 6,000 mg of enriched barium carbonate, which is needed for the manufacture of Cesium-131 and consigned this inventory to Medikor.
Beginning in October 2021, Medikor started to use the barium carbonate consigned by the company (along with barium carbonate consigned under the original agreement) and contract with a third-party manufacturer to produce Cesium-131.
On March 31, 2022, the company entered into two agreements with Medikor to purchase enriched barium carbonate.
Government Regulation
Within the United States, the company's therapeutic radiological devices must comply with the U.S. Federal Food, Drug and Cosmetic Act, which is enforced by the U.S. Food and Drug Administration (FDA). The company is also required to adhere to applicable FDA Quality System Regulations, also known as the Good Manufacturing Practices, which include extensive record keeping and periodic inspections of manufacturing facilities. The company's predecessor obtained FDA 510(k) clearance in March 2003 to market its Cesium-131 seed for the treatment of localized solid tumors and other malignant disease and the company obtained FDA 510(k) clearance in November 2006 to market preloaded brachytherapy seeds and in August 2009 for preloading flexible braided strands and bioabsorbable mesh. In July 2018, the company obtained 510(k) clearance for the GammaTile Therapy, which it subsequently transferred to GT Med Tech per the Collaborative Development Agreement executed in March 2017.
The company is also subject to other federal and state laws and regulations, including the Occupational Safety and Health Act and the Environmental Protection Act.
As a registered medical device manufacturer with the FDA, the company is subject to inspection to ensure compliance with FDA's current Good Manufacturing Practices (cGMP).
The Medical Device Reporting regulation requires that the company provides information to the FDA on deaths or serious injuries alleged to be associated with the use of its devices, as well as product malfunctions that are likely to cause or contribute to death or serious injury if the malfunction were to recur.
In the United States, as a manufacturer of medical devices and devices utilizing radioactive byproduct material, the company is subject to extensive regulation by not only federal governmental authorities, such as the FDA and FAA, but also by state and local governmental authorities, such as the Washington State Department of Health, to ensure such devices are safe and effective. In Washington State, the Department of Health, by agreement with the federal Nuclear Regulatory Commission (NRC), regulates the possession, use, and disposal of radioactive byproduct material as well as the manufacture of radioactive sealed sources to ensure compliance with state and federal laws and regulations. The company's Cesium-131 brachytherapy seeds constitute both medical devices and radioactive sealed sources and are subject to these regulations.
History
The company was founded in 1998. It was formerly known as Isoray, Inc. and changed its name to Perspective Therapeutics, Inc. in February 2023.
