Obtaining U.S. FDA approval and pursuing insurance coverage
First written in FY2016. 18 of 25 entries say "Advanced", first in FY2017-Q1. Latest entry: FY2024.
No other company in this theme has enough history to compare yet.
- FY2024AdvancedAnnual report
「In May 2024, the Company obtained from the U.S. Food and Drug Administration (FDA), ahead of the rest of the world, marketing authorization for a small model of medical HAL® and approval to expand the indications to cerebral palsy for patients aged 12 and older. Medical device approval of the small model makes treatment with medical HAL® available to patients between 100 cm and 150 cm tall, for whom use of the conventional model, intended for patients at least 150 cm tall, was difficult. The Company also obtained approval to expand the indications to HTLV-1-associated myelopathy (HAM) and hereditary spastic paraplegia, for which approval had already been obtained in Japan.」
In the U.S. business following FDA approval, the Company reached approval of the small model and expanded indications to cerebral palsy, HAM, and hereditary spastic paraplegia, broadening the patient population eligible for treatment. - FY2024-Q3RestatedAnnual report
「As a platform for its consumer medical services business, the subsidiary RISE Healthcare Group (RHG) has been progressively expanding its locations in Southern California and entered Northern California in February 2023. As of 31 December 2023, it operated 28 locations, an increase of 12 from the time of acquisition. Combined services incorporating the Company's innovative medical technologies using HAL® are currently offered at 4 locations, with a phased transition to formal services beginning in January 2023.」
Following FDA approval, the Company has reaffirmed the rollout of RHG's U.S. medical services business at 28 locations and combined HAL services at 4 locations. - FY2024-Q2AdvancedAnnual report
「As a platform for its consumer medical services business, the subsidiary RISE Healthcare Group (RHG) has been progressively expanding its locations in Southern California and entered Northern California in February 2023. As of 30 September 2023, it operated 28 locations, an increase of 12 from the time of acquisition. Combined services incorporating the Company's innovative medical technologies using HAL® are currently offered at 4 locations, with a phased transition to formal services beginning in January 2023.」
In the U.S. medical services business, RHG had 28 locations as of 30 September 2023, an increase of 12 from the time of acquisition. Combined services with HAL are offered at 4 locations. - FY2024-Q1AdvancedAnnual report
「As a platform for its consumer medical services business, the subsidiary RISE Healthcare Group (RHG) has been progressively expanding its locations in Southern California and entered Northern California in February 2023. As of 30 June 2023, it operated 27 locations, an increase of 11 from the time of acquisition. Combined services incorporating the Company's innovative medical technologies using HAL® are currently offered at 4 locations, with a phased transition to formal services beginning in January 2023.」
In the U.S. medical services business, RHG increased its locations by 11 from the time of acquisition to 27 and is in the process of making the combined services with HAL available as formal services at 4 locations. - FY2023-Q3AdvancedAnnual report
「The healthcare services subsidiary RISEヘルスケアグループ (RHG) operates 26 locations in Southern California, an increase of 10 from the time of acquisition, and plans to expand into Northern California. Combined services using the company's innovative medical technology based on HAL® are currently being trialled at 4 locations, with a phased transition to full-scale services beginning in January 2023.」
In the U.S. business following FDA approval, RHG expanded to 26 locations, began trials of combined services with HAL at 4 locations, and started transitioning to formal services in January 2023. - FY2023-Q2AdvancedAnnual report
「RISE Healthcare Group (RHG), the medical services subsidiary, plans to add several locations during the year from its current 21 locations, an increase of 5 since the beginning of the year. Trials of combined services incorporating the Company's innovative medical technologies using HAL® have also expanded from San Diego to Los Angeles since September 2022.」
RHG's U.S. locations increased by 5 from the beginning of the year to 21, and the area for trials of combined services with HAL expanded from San Diego to Los Angeles. - FY2023-Q1AdvancedAnnual report
「RISE Healthcare Group (RHG), the medical services subsidiary, is continuing to expand from its current 20 locations, an increase of 4 locations since the beginning of the year, while conducting trials of combined services incorporating the Company's innovative medical technologies.」
In the U.S. medical services business, RHG increased its locations by 4 to 20 and advanced to the trial stage for combined services incorporating innovative medical technologies such as HAL. - FY2022-Q3AdvancedAnnual report
「Through this business combination, the Company aims to develop a treatment services business centered on RISE Healthcare Group, Inc. and accelerate the spread of innovative cybernics treatment in the world's largest U.S. market.」
Regarding U.S. expansion following the FDA's approval of expanded indications, the business advanced to developing treatment services centered on RISE Healthcare Group. - FY2022-Q1RestatedAnnual report
「In the United States, because medical device approval was obtained from the U.S. Food and Drug Administration (FDA) in October last year for stroke and neuromuscular intractable diseases, the Company is promoting initiatives to secure insurance coverage and expand non-insured medical services.」
Following the FDA's approval of expanded indications, the Company has reaffirmed its policy of promoting insurance coverage and the expansion of non-insured medical services in the United States. - FY2021-Q2AdvancedAnnual report
「In October 2020, the U.S. FDA approved expanded indications for medical HAL® beyond spinal cord injury to stroke and neuromuscular intractable diseases.」
Following FDA marketing authorization, the approved indications for medical HAL expanded from spinal cord injury to stroke and neuromuscular intractable diseases. - FY2020AdvancedAnnual report
「In the United States, with insurance coverage for cybernics treatment in view, the Company is developing partnerships with medical institutions participating in clinical research, including a keynote address by President Sankai (山海) at Neuroscience Convergence 2019, hosted by Mayo Clinic, ranked No. 1 among the outstanding hospitals in the United States, in November 2019.」
In the United States, building on the treatment center's track record, the business is advancing marketing and sales activities with insurance coverage in view through a keynote address at an event hosted by Mayo Clinic and collaboration with clinical research partners. - FY2020-Q2AdvancedAnnual report
「In the United States, based on the results achieved by cybernics treatment at the BROOKS CYBERNIC TREATMENT CENTER in Jacksonville, Florida, the Company has been advancing marketing and sales activities for medical HAL®, including a keynote address by President Sankai (山海) at Neuroscience Convergence 2019, hosted by Mayo Clinic, ranked No. 1 among the outstanding hospitals in the United States, in November 2019.」
In the United States, the business has progressed from the treatment center's track record to marketing and sales activities, including a keynote address at an event hosted by Mayo Clinic. - FY2020-Q1AdvancedAnnual report
「In the United States, based on the results achieved by cybernics treatment at the BROOKS CYBERNIC TREATMENT CENTER in Jacksonville, Florida, the Company began sales activities for medical HAL®.」
In the United States, based on the results achieved at the treatment center, the business advanced from operating the center and preparing for nationwide expansion to beginning sales activities for medical HAL. - FY2019RestatedAnnual report
「The Group will continue to promote the expansion of cybernics treatment throughout the United States and work to secure private insurance coverage. It will also launch clinical trials for stroke and work to expand the application of cybernics treatment to stroke.」
The Company continues to promote nationwide expansion in the United States following FDA approval, private insurance coverage, and expansion of the indications to stroke. - FY2019-Q2AdvancedAnnual report
「In March 2018, the Company opened the BROOKS CYBERNIC TREATMENT CENTER in Jacksonville, Florida, and is developing a base for cybernics treatment and personnel training in the United States. As the second stage, it is selecting management personnel to oversee the U.S. business and preparing to strengthen its sales organization in order to accelerate nationwide business expansion.」
The business has advanced from operating a treatment and personnel-training center in the United States to selecting management personnel to oversee nationwide expansion and preparing to strengthen the sales organization. - FY2019-Q1AdvancedAnnual report
「In addition, based on the fact that the authorization clearly specified that the intended use was to improve patients' walking ability itself through treatment with medical HAL® and recognized its therapeutic medical effects, discussions are under way regarding coverage by private workers' compensation insurance and other insurance programs.」
Following FDA marketing authorization, discussions are under way regarding insurance coverage in the United States, including private workers' compensation insurance. - FY2018AchievedAnnual report
「In December 2017, the Company obtained marketing authorization from the FDA (U.S. Food and Drug Administration) for medical HAL® (lower-limb type) as a medical device.」
U.S. FDA marketing authorization was completed, and the business has moved to treatment services and commercialization activities in the United States following approval. - FY2018-Q3AdvancedAnnual report
「In the United States, marketing authorization as a medical device was obtained from the FDA (U.S. Food and Drug Administration) in December 2017. The authorization clearly specified that the intended use was to improve walking ability after treatment with medical HAL®, recognizing its therapeutic medical effects.」
Marketing authorization as a medical device was obtained from the FDA in December 2017, bringing the approval process to the authorization stage. Meanwhile, securing insurance coverage remains an ongoing issue. - FY2018-Q2AdvancedAnnual report
「In June 2017, we submitted the marketing approval application documentation for medical-use HAL® to the FDA under the 510(k) process (Class II), and the review is under way.」
Following the submission of the 510(k) application to the FDA, it was disclosed that the review is under way and that the approval process has advanced to the next stage. - FY2018-Q1AdvancedAnnual report
「Following the submission of a Pre-Submission to the FDA in November 2016 and repeated formal consultations, we submitted the documentation for marketing approval of medical-use HAL® to the FDA on 19 June 2017 (U.S. time) under the 510(k) process (Class II).」
Following consultations with the FDA and submission of the Pre-Submission, we submitted the marketing approval application documentation for medical-use HAL through the 510(k) process on 19 June 2017. - FY2017RestatedAnnual report
「Our Group is consulting with the FDA to obtain approval in a form that identifies medical-use HAL® as a unique and novel robotic treatment device, in view of the innovative nature of the device. We will continue to pursue this strategically, anticipating business development after approval, including various forms of insurance coverage in the U.S.」
We continue to pursue development in anticipation of FDA approval and insurance coverage in the U.S. after approval. - FY2017-Q3RestatedAnnual report
「Based on the results of discussions with the FDA, we determined that the FDA's understanding had deepened regarding the innovative nature of brain and nervous system functional improvement and functional regeneration treatment using the cybernics technology of medical-use HAL®. To obtain approval in a form that identifies it as a unique and innovative robotic treatment device, we submitted a Pre-submission to the FDA on 4 November 2016 and are proceeding with the resubmission process.」
We reiterate that we are proceeding with the resubmission process following submission of the Pre-submission to the FDA. - FY2017-Q2AdvancedAnnual report
「Based on discussions with the FDA, we determined that the FDA's understanding had deepened regarding the innovative nature of brain and nervous system functional improvement and functional regeneration treatment using the cybernics technology of medical-use HAL®. To obtain approval in a form that identifies it as a unique and innovative robotic treatment device, we submitted a Pre-submission to the FDA on 4 November 2016 and began the resubmission process. In anticipation of medical device approval from the FDA, we established CYBERDYNE USA Inc. and began business operations in September 2016.」
Following discussions with the FDA, we submitted a Pre-submission on 4 November 2016, began the resubmission process, and the U.S. entity also began business operations in September. - FY2017-Q1AdvancedAnnual report
「In the U.S., while beginning procedures to establish a U.S. entity (CYBERDYNE USA Inc.) in anticipation of medical device approval from the FDA, we are positioning various forms of insurance coverage as important milestones for our U.S. business and pursuing them strategically.」
We began procedures to establish a U.S. entity in anticipation of FDA approval and are pursuing insurance coverage as an important milestone. - FY2016First statedAnnual report
「While seeking early FDA approval, we will position various forms of insurance coverage as important milestones for our U.S. business and pursue them strategically.」
We are advancing the application for medical device approval in the U.S. and treating insurance coverage as an important business milestone. The text also refers to a market size equivalent to 39% of the medical device market.