Live-nieuws • Jul 08
Vivos Wins FDA Green Light to Start Human Trials of RadioGel Cancer Therapy Vivos received U.S. FDA approval for an Investigational Device Exemption (IDE), clearing the company to begin a first-in-human clinical feasibility study of its RadioGel precision radionuclide therapy in patients with non-resectable papillary thyroid carcinoma at Mayo Clinic in Jacksonville, FL.
The IDE approval follows earlier preclinical and clinical work on RadioGel, a yttrium-90 injectable hydrogel designed for targeted cancer treatment, and represents a key regulatory step toward potential commercialization if future data support safety and effectiveness.
Vivos shares trade at about $0.09, with the stock up 48% over the past 30 days, reflecting a period of heightened investor attention around the company.
The clear read-through is that Vivos now moves from preclinical focus into human testing, which brings both an opportunity to validate its therapy and the risk that trial results or regulatory feedback may not match expectations. Aankondiging • Jul 07
Vivos Inc. Receives U.S. FDA Approval for Investigational Device Exemption to Initiate Human Clinical Feasibility Study for RadioGel Precision Radionuclide Therapy Vivos Inc. received approval from the U.S. Food and Drug Administration (FDA) for its Feasibility Investigational Device Exemption (IDE) application. This approval allows the Company to begin the US based first-in-human feasibility study using RadioGel, an innovative yttrium-90-based injectable hydrogel for the targeted treatment of cancerous tumors. The study will be conducted at Mayo Clinic in Jacksonville, FL and will evaluate the safety and feasibility of RadioGel in patients with non-resectable papillary thyroid carcinoma. The protocol is expected to initially enroll five patients. Results will help shape subsequent pivotal trials. Yttrium-90 RadioGel is designed to efficiently deliver targeted radiation to cancerous tumors while minimizing treatment-related side effects. Over many years, preclinical studies in veterinary patients (cats, dogs, and horses) and laboratory animals (rabbits) demonstrated the safety and effectiveness of Yttrium-90 RadioGel precision radionuclide therapy (PRnT) in cancer treatment. Across multiple studies, histopathology confirmed no radiation-associated adverse effects in any normal organs or tissues. The conditions of this approval will be incorporated into the protocol for Mayo IRB review. Vivos continues to advance its multi-track strategy by expanding commercial adoption of IsoPet for veterinary oncology; advancing non-U.S. clinical research and commercialization opportunities for RadioGel; pursuing international licensing and monetization opportunities for the PrecisionGel platform; and progressing RadioGel through the U.S. regulatory pathway for human cancer therapy. Aankondiging • Jun 12
Vivos Inc. Receives Washington State Radioactive Materials License for Isopet Manufacturing Vivos Inc. received its State of Washington Radioactive Materials License for the manufacturing of IsoPet. This approval represents a significant regulatory milestone for the Companys animal health division. It clears the way for in-house production of IsoPet at Vivos new domestic manufacturing facility located at the Applied Process Engineering Laboratory (APEL) in Richland, Washington. Securing the Washington State Radioactive Materials License enables it to establish reliable, compliant domestic manufacturing capabilities. This is a critical step forward in its efforts to scale production and meet the growing demand from veterinarians and pet owners across the country for its innovative, same-day cancer therapy for animals. Now that the IsoPet Radioactive Materials License has been granted, Vivos will immediately apply for an amendment to add RadioGel to the license. This amendment will support clinical trials in the United States and, as necessary, internationally. With the license now in hand, Vivos anticipates shipping its first production run in the near future. This will support the continued expansion of certified IsoPet treatment centers nationwide and help accelerate access to this non-invasive, non-surgical, and highly targeted therapy for companion animals and horses suffering from solid tumors. Aankondiging • Feb 10
Vivos Inc. Announces Significant Progress Toward FDA Investigational Device Exemption Submission for RadioGel Precision Radionuclide Therapy Vivos Inc. provided an update on its ongoing efforts to secure FDA Investigational Device Exemption (IDE) approval for human clinical trials of RadioGel® in advanced human therapy applications. RadioGel®? is a targeted radiation therapy designed to deliver precise, localized beta radiation to solid tumors via direct injection, minimizing exposure to surrounding healthy tissue and reducing systemic migration of the radiopharmaceutical agent. Over the past several years, the Company has engaged extensively with the FDA, successfully addressing feedback from more than 40 individual reviewers--many comments stemming from frequent review team changes within the Agency. Vivos has provided comprehensive data and finalized the key technical parameters related to demonstrating precision delivery of RadioGel®? to the treatment area and ensuring minimal exposure to non-target tissues. In a key strategic move, Vivos has engaged one of the top regulatory experts in the field of brachytherapy and combination radiotherapy devices, with deep experience guiding such products through the FDA's Center for Devices and Radiological Health (CDRH). This expert's prior role at the FDA and proven track record of successful IDE approvals for Class III implantable radiation device, several reviewed by the same branch overseeing RadioGel®?, have provided invaluable guidance. With this expert's analysis of FDA feedback patterns, the Company is bolstering its IDE submission by: Fully addressing all outstanding FDA concerns and adopting a submission format and structure proven effective by regulatory experts for similar devices. Incorporating additional information from clinical human data that has become available since the Company's last IDE submission, further strengthening the evidence package. Reformatting and summarizing pre-clinical data in a manner that more directly and effectively addresses the remaining FDA concerns. Leveraging extensive veterinary clinical data from IsoPet®? commercial use: Integrating comprehensive treatment outcomes from over 100 safely administered therapies across diverse tumor types and species, with zero reportable serious adverse events attributable to the product, to provide additional real-world safety and efficacy evidence supporting the Precision Radionuclide Therapy platform. Highlighting specialized equine ocular applications: Including detailed case data on successful treatments of ocular squamous cell carcinoma in horses (with injections near or into the cornea), showing no major side effects in adjacent critical structures, to further demonstrate the therapy's precision, minimal effectiveness, and favorable risk profile in challenging anatomical locations. These enhancements maintain the intended use while maximizing the submission's clarity, completeness, and alignment with Agency expectations. These recommendations required substantial effort to incorporate into next submission. Vivos remains fully committed to advancing RadioGel®? toward human clinical trials in the United States and continues its strong collaborations for future indications for use. The Company has plans to submit the IDE by the end of the first quarter or in April. Aankondiging • Feb 04
Vivos Inc. Updates Human Therapy Progress in India Vivos Inc. provided shareholders with a positive update on the ongoing human therapy demonstrations in India using RadioGel®? Precision Radionuclide Therapy™?. Initiated in December 2024, a prominent physician in India began treating patients to demonstrate safety and measure efficacy with RadioGel®?. Patients have continued to attend their scheduled regulatory follow-up visits in accordance with the protocol. To date, no reports of serious adverse events have been received. Several patients have now completed their one-year follow-up examinations and continue to show no reported adverse effects at these timepoints. Preliminary observations from the treated patients have included instances of tumor size reduction observed over short intervals, with no recurrence noted in those specific cases during the available follow-up period. The protocol has also allowed evaluation of RadioGel®? in cases involving tumors near critical structures, with no reported damage to those adjacent organs observed to date. The therapist and facility have been selected for the planned larger-scale clinical trial, which is intended to support potential future regulatory and commercial pathways in India. Vivos Inc. remains excited and fully committed to submitting the comprehensive results from these India human therapy demonstrations. This key step continues to progress steadily as part of ongoing efforts to share valuable scientific insights with the broader medical community, and look forward to advancing through the standard phases of data finalization, regulatory considerations, and peer-review processes that are typical in high-quality clinical research. Aankondiging • Aug 14
Vivos Inc. Announces Investigational Device Exemption (Ide) Application for Human Clinical Trials At Mayo Declined by FDA Vivos Inc. Following the 30-day review period, the FDA declined approval of the Radiogel®? IDE submission. Vivos remains committed to pursuing approval for Radiogel®? in the US market. Aankondiging • Jul 15
Vivos Inc. Submitted the Investigational Device Exemption Application for Human Clinical Trials At Mayo Clinic Vivos Inc. announced the submission of its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for RadioGel®?, a novel hydrogel-based radioactive therapy designed to deliver targeted radiation to solid tumors. This comprehensive submission, supported by extensive animal and human data, marks a significant milestone in Vivos Inc.'s mission to provide innovative cancer treatments. RadioGel®? is a novel medical device that enables precise radiation delivery to tumors, while minimizing damage to surrounding healthy tissue. The IDE application, developed through months of close collaboration with the FDA under the Breakthrough Device sprint process, addresses regulatory concerns with robust evidence of RadioGel's safety and promising efficacy. The Breakthrough Device designation expedites development for devices that address life-threatening conditions with unmet medical needs. Aankondiging • Apr 15
Vivos Inc. Reports Continued Progress in India Human Clinical Trial for RadioGel Precision Radionuclide Therapy Vivos Inc. share new developments in its ongoing human clinical trial in India for RadioGel Precision Radionuclide Therapy, an FDA-designated Breakthrough Device for the treatment of solid tumors. The latest results highlight both technical progress and growing clinical validation. This update builds upon the initial results released in February 2025, which confirmed the safety of RadioGel®? in the first five patients. As of this report, ten patients with cancerous nodes have now been successfully treated, further establishing a strong safety profile while generating promising early evidence of efficacy. Every patient in the trial has met the primary safety endpoint, confirmed through PET imaging showing precise retention of the therapeutic Yttrium-90 isotope at the injection site--with no observed adverse events. Patients continue to recover well with no complications, monitored under disciplined clinical follow-up protocols. Importantly, two of the ten patients presented with tumors in direct contact with the trachea and carotid artery, anatomical regions often considered inoperable or high-risk for radiation damage. Yet, RadioGel®? achieved successful treatment without injured adjacent critical tissues, underscoring the therapy's high Therapeutic Ratio and the core rationale behind the FDA's Breakthrough Device designation. These outcomes affirm the unique advantage of RadioGel®?: internal, highly localized beta radiation delivered directly within the tumor, sparing healthy tissue and enabling outpatient treatment with minimal post-procedure restrictions. Led by a highly experienced principal investigator in India, the clinical team has introduced new technical references to the treatment methodology, including deep-needle injection techniques, precision image guidance, and the use of saline spacers to enhance dose control and organ protection. These protocol advancements are being actively reviewed in discussions with Mayo Clinic investigators who are preparing for a parallel clinical study in the United States. The study in India, has been approved to treat 30 patients. A formal request is being prepared for the Ethics Committee to approve up to 50 patients, enabling evaluation of RadioGel®? In a broader range of tumor types, including those located deeper in the body such as lung and pancreatic cancers. Vivos is concurrently laying the groundwork for a permanent operational footprint in India, including plans to open a corporate office and to establish a regional manufacturing facility for yttrium phosphate microparticles. This infrastructure will support the clinical rollout and eventual commercial availability of RadioGel®®? in India--serving as a strategic hub for future global expansion. The results of the India trial, including comprehensive clinical and imaging data, will be submitted for peer-reviewed publication later this year. This milestone is expected to significantly enhance the therapy's visibility among physicians and oncologists and support regulatory submissions globally. Building on the FDA "Breakthrough Device" status of Radiogel®? Precision Radion Blvdide Therapy™?, Vivos is sharing preliminary India trial data directly with the FDA to support the company's goal to submit an Investigational Device Exemption (IDE) within the next 90 days. While the company is encouraged by its regulatory progress, it also acknowledges the inherent unpredictability of the U.S. regulatory environment, particularly amid shifting priorities and evolving review protocols under the new FDA administration. As such, Vivos continues to pursue a multi-track global strategy to ensure momentum regardless of domestic regulatory timing. Importantly, the clinical and commercial potential for RadioGel®? outside the U.S. is significant, particularly in regions with streamlined regulatory pathways and increasing demand for innovative, minimally invasive cancer therapies. The company are witnessing precise, safe, and promising therapy outcomes in tumors that traditionally pose high treatment risk. These results not onlyforce confidence in the technology, but also validates the FDA's designation of RadioGel®? as a Breakthrough Device. The company are optimistic about what lies ahead in India and globally--as move toward making this therapy accessible to patients in urgent need of new cancer treatment options. The company's Precision Radionuclide Therapy (PRnT™?) platform delivers targeted internal radiation from the U.S. Aankondiging • Feb 04
Vivos Inc. Reports Encouraging Human Clinical Trial Results Vivos Inc. reported that the first five patients demonstrated the safety of RadioGel Precision Radionuclide TherapyTM by satisfying the criteria in the Clinical Study Plan, including confirmation via PET imaging that the Y-90 remained at the point of injection and no adverse events reported by any of the initial five patients since the initial treatment date. Additionally, 30-day PET/F-18 imaging of a local patient—a young teacher with a cancerous node near the trachea—revealed an over 80% reduction in both tumor size and metastatic activity. Other treatment options would have jeopardized her voice, making this outcome particularly meaningful. While the trial’s primary objective is to establish safety, these early signs of efficacy are highly encouraging. Expansion of Clinical Trial: After completing the detailed assessment of the available data from the patients, the results will be presented to the Ethics Committee. The lead investigator intends to request authority to increase the study from 30 patients to 50 patients. The expanded trial will provide valuable data on a variety of cancers and include the utilization of new deep injection technology being installed and tested in the treatment hospital in India. This advanced deep-needle CT-guided precision injection device, designed for use with RadioGel®, will enable precise treatment of deeper-seated tumors, including lung and pancreatic cancer nodules. Under the current timeline, The company anticipates completing the initial 30-patient trial by June 30 and the expanded trial by year-end. Consistent with the previous disclosure, the trial’s comprehensive data will be submitted under the guidance of the lead investigator for publication in leading medical journals. Additionally, as results emerge, they will be shared with the FDA to further support RadioGel®’s safety profile and reinforce the Investigational Device Exemption (IDE) submission and advance expanded indications for use in the United States. Aankondiging • Dec 24
Vivos Inc. Announces Launch of Groundbreaking RadioGel Precision Radionuclide Therapy Human Clinical Trial Vivos Inc. announced the initiation of its first human clinical trial for RadioGel® Precision Radionuclide Therapy™ in India. This milestone trial, which has commenced with the successful treatment of five patients with cancerous lymph nodes, represents a transformative step in advancing innovative cancer therapies. This initial trial in India closely aligns with the protocol designed for Vivos' planned study at the Mayo Clinic in the United States. In the initial phase, five patients with cancerous nodes in the neck have been successfully treated, with a primary focus on demonstrating the therapy's safety. Imaging has confirmed precise placement of the RadioGel® treatment, and the patients are currently recovering well without complications. Vivos continues active discussions with the FDA to initiate human clinical trials at the Mayo Clinic. These trial results will be shared with the U.S. Food and Drug Administration (FDA) to reinforce RadioGel®'s safety profile, support Vivos' Investigational Device Exemption (IDE) submission, and advance expanded indications for use in the United States. The company's dual-track international strategy is accelerating the global introduction of this cutting-edge cancer therapy. The study has received regulatory approval to expand to 30 patients, targeting cancerous nodes throughout the body, enabling broader therapeutic applications. Upon anticipated completion of this trial in the first half of 2025, the trial's comprehensive data will be submitted for publication in a leading medical journal under the guidance of the lead investigator. Key Milestones Enabling the Clinical Trial in India: The successful launch of this clinical trial reflects the dedication, expertise, and strategic planning of the Vivos team. Key achievements include: Regulatory Approvals: Secured clearances from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health & Family Welfare, and was issued the Clinical Trial Registry-India (CTRI) number required for publishing results; Logistical Coordination: Acquired liability insurance, expanded the treatment institution’s radioactive material license to include RadioGel, and established robust international shipping protocols and an alternate contingency shipping path for the Yttrium-90 (Y-90)-based product; Protocol Development: Finalized the Clinical Trial Protocol, incorporating Mayo Clinic study designs and feedback from FDA pre-submission discussions; Operational Readiness: Re-validated RadioGel manufacturing at IsoTherapeutics to ensure compliance with Quality Management System standards and FDA sterility and validation recommendations; Administrative Preparations: Signed agreements with the Ethics Committee and treatment institution while confirming trademark and patent protections in the region; Training and Certification: Conducted comprehensive certification training for the treatment team. Aankondiging • Jul 30
Vivos Inc. Provides IDE Submission Status Update – Conversion to Pre-Sub Filing Accepted by the FDA Vivos Inc. provided IDE Submission Status Update The FDA has been working diligently to review the extensive amount of material that company provided in IDE submission within the 30-day statutory time limit. Company have been in regular communication with the FDA and provided responses to five sets of Interactive Review Requests. Based on communication with the FDA on Friday, company concluded that there was not sufficient time for completion of the IDE review process within the 30-day statutory period. Therefore, with the consent of the FDA, Vivos has elected to convert the IDE submission (G240159) to a Pre-Sub filing (Q241925). This strategic decision allows to address the FDA's feedback comprehensively and effectively, while maintaining open communication through quick review sessions made available to Vivos with the FDA. Based on current discussions with the FDA, this week company should receive follow-up questions to fully analyze the risk/benefit device assessment of Radiogel. Company are confident that thus far submissions have provided 90-95% percent of the information they require and that Vivos will be able to resubmit the refined IDE application with high quality responses demonstrating a compelling risk/benefit analysis to the FDA within the next 45 days. Company have been in regular contact with collaboration partners at the Mayo Clinic and are well positioned to promptly submit, following receipt of the IDE from the FDA, treatment plan to Mayo Clinic’s Independent Review Board (IRB). As previously discussed, the initial treatment target with Mayo for Radiogel® will be treating solid metastatic tumors in lymph nodes associated with papillary thyroid cancer. Company remain dedicated to achieving full compliance and are confident that Company will demonstrate a compelling risk/benefit profile to the FDA. Aankondiging • Jun 30
Vivos Inc. has filed a Follow-on Equity Offering in the amount of $9 million. Vivos Inc. has filed a Follow-on Equity Offering in the amount of $9 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 60,000,000
Price\Range: $0.15 Aankondiging • Dec 21
Vivos Inc. Announces Radiogel(TM) Precision Radionuclide Therapy(TM) Receives FDA Breakthrough Device Designation Vivos Inc. announced that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program. The FDA’s Breakthrough Devices program facilitates accelerated development and expedites the review of breakthrough technologies to help patients potentially gain timely access to technologies that can provide more effective treatment options. Aankondiging • Jan 12
Vivos Inc Files A New Patent on Alternate Particles for Precision Radionuclide Therapy Vivos Inc. announced that the company filed a utility patent application on a range of particles for precision radionuclide therapy as a follow-up to its provisional patent filed on January 15,2022. This patent was filed in the USA and internationally via the Patent Cooperation Treaty, PCT. This includes Canada, the European Union, Japan, Australia, Brazil, China, India, South Korea, and the Russian Eurasian (Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Tajikistan, and Turkmenistan). Aankondiging • Jan 04
Vivos Inc. Files New Patent on Precision Radionuclide Therapy Support System Equipment Vivos Inc. announced that they filed a provisional patent application on the system equipment to support precision radionuclide therapy. This includes the shipping containers, the shielded vial holder, the Peltier chiller, and the syringe shields. These device designs are integrated into production standardization effort. They can be used for treating a range of tumor sizes from 0.5-gram human lymph nodes to half-pound equine tumors. This equipment was just tested at recent equine therapy in NY. Eliminated the can and the lead pig containers and designed the shielding of the new plastic container to improve the ease of unpackaging and to ensure that can ship to White 1 label (UN2910) standards to reduce the Fed Ex shipping costs and logistics. Incorporated stability in securing the vials while filing the syringes and maximized the vial holder wall thickness to further reduce the relatively low radiation. Designed to chill the vial holders and the syringes with a plug-in system. Avoids the potential contamination from ice baths, which was a Mayo Clinic concern for human clinical trials. Contains an imbedded magnetic stirrer to keep the IsoPet solution particles in suspension. Each syringe port can be dedicated to a specific human lymph node, a specific VX-2 tumor in the animal testing, or as a staging center for treating larger animal tumors. Maximized the diameter of the syringe shield to reduce radiation while designing the finger position to maintain the optimum ergonomics. Received very positive feedback from the therapists about the ergonomics. This flexibility is important to ensure the accuracy in precision injections. Aankondiging • Sep 15
Vivos Inc. Files A New Patent on the Hydrogel Component of Isopet®/Radiogel™ Vivos Inc. announced that they filed a patent application on their hydrogel component of IsoPet/RadioGel in the USA (16309: 17/943,311) and internationally (16389: PCT/US22/43274) under The Patent Cooperation Treaty (PCT). Over the last eighteen months team has worked with polymer contracting experts to optimize hydrogel component. the objectives were to maximize production output, to refine specifications to yield the optimum gelation and resorption characteristics, to demonstrate reproducibility and to ensure that any residual solvents were minor and well below the FDA specifications limits for human therapy. As part of improved Quality Management System, are confident that the new Vivos Inc. Standard Operating Procedure for Polymer Production will meet GMP/FDA Specifications. Aankondiging • Aug 17
Vivos Inc. Announces a New IsoPet® Precision Radionuclide Therapy Regional Clinic for Equine Therapy Vivos Inc. reported that it just certified the New England Equine Practice in Patterson, NY to administer Precision Radionuclide IsoPet® therapy for treating solid tumors in horses. IsoPet® is a next generation treatment option, providing a same day therapy, using relatively low activity to deliver a high therapeutic dose that stays at the injection site with no contamination in the urine or feces. This is an important feature as horses should not be trailered more than eight hours or they can develop serious medical respiratory issues called “trailer fever” the following day. Aankondiging • Feb 25
Vivos Inc. Files Its Particle Patent in Several Countries Vivos Inc. reported that it filed its particle patent in several countries. New patent team filed the particle patent in the USA, Canada, the European Union, Japan, Australia, Brazil, China, India, South Korea, and the Russian Eurasian (Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Tajikistan, and Turkmenistan). Patent counsel will also be pursuing amendments to increase the number of claims related to the particle patent. Aankondiging • Dec 03
Vivos Inc. Obtains Feedback from the FDA on Clinical Testing of RadioGel™ Vivos Inc. met with the Food and Drug Administration to obtain suggestions on improving the current draft of the Investigational Device Exemption, which is necessary to initiate clinical testing in humans. Two physicians from Mayo Clinic, Dr. Paz Fumagalli and Dr. Beau Toskich did an excellent job presenting the need for Radiogel™ to treat recurrent thyroid cancer and to answer a range of questions from the new FDA review team. The FDA was very supportive and had suggested this Q-Submission path for rapid turnaround and dialog. The FDA provided many helpful suggestions on a range of subjects from labeling to dosimetry to the Mayo protocol for clinical testing, and the need for some additional specific testing. They suggested having another Q-Sub Review and conference call dedicated to the details of the dosimetry calculations. Aankondiging • Sep 23
Vivos Inc. Files Early Feasibility IDE Application with FDA for Radiogel™ Vivos Inc. submitted the IDE, Investigational Device Exemption for The Early Feasibility Medical Device Study, First in Human Study for Y-90 RadioGel™, to the Food and Drug Administration as part of a pre-submission meeting process. The FDA recommended this path to facilitate enhanced ongoing communication with Vivos and to increase the efficiency of the review process. This review typically takes several iterations and will continue with biocompatibility testing in parallel. Aankondiging • Jun 25
Vivos Inc Initiates Isopet® Therapy in Horses Vivos Inc. has completed the first IsoPet® therapy on an equoid tumor. It was administered at the University of Missouri on a horse that was transported from Ohio. This is an exciting extension of Isopet®, offering an important and unique treatment alternative for larger animals such as horses. The procedure was conducted under mild sedation with a therapy design that, as always, results in no contamination. This first patient is doing well and already the tumor has stopped growing. Aankondiging • May 25
Vivos Inc Enhances Radiogel™ Manufacturing Process Vivos Inc. announced that during the past few months Vivos has made significant enhancements to the manufacturing process for Radiogel™. These enhancements are crucial in aligning with FDA requirements for future clinical trials and licensing to international markets. Hydrogel and Y-90 particle production processes are safe and efficient and are being used to produce IsoPet® for animal therapy. Full FDA pedigreed pre-clinical testing and clinical trials require Good Manufacturing Practice (GMP) protocols described in detail in FDA regulations. The production improvements for Radiogel™ discussed were identified as part of establishing the GMP protocols for the IDE submission to the FDA. This has been a substantial effort, including fifteen polymer runs to bound the design specifications, incorporation of more than fifty new Quality Management System documents, installation of new precision process control equipment, and a newY-90 particle sterilization process. The company is also assessing a contract with an international company that has the potential to produce a substantial amount of GMP RadioGel™ and IsoPet® both domestically and internationally. This effort has strengthened the internal proprietary intellectual property. The company discovered non-obvious and novel polymer/hydrogel production techniques that are significant and not published or mentioned in any patents. The company is currently evaluating whether to keep these discoveries as a proprietary trade secret or to file additional patents. These manufacturing details have been incorporated in revisions to the Standard Operating Procedures for Hydrogel and Particle Production. With the essential elements of these enhancements now completed, it will accelerate the pre-clinical testing and now anticipate filing the IDE with the FDA in the next 90-120 days. Submitting the IDE after these manufacturing process enhancements were completed creates a much stronger submission with FDA and greatly reduces the risk and expense of having to do repeat testing. Aankondiging • Nov 21
Vivos Inc. Applies for Breakthrough Device Designation for Radiogel™ Vivos Inc. announced that it has completed its submission to the FDA seeking Breakthrough Device Designation for Radiogel™. This is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval or De Novo marketing authorization. The Breakthrough Designation process takes priority over other FDA meetings, so elected to submit this application prior to planned FDA Pre-Submission meeting. It intend to schedule the pre-submission meeting in the near future, with no impact to overall IDE submission effort. It gives time to gather more data to share with FDA.