2017.06.20 update

【News】 The Application for Market Approval of Medical HAL as a Medical Device Used for Innovative Cybernics Treatment has been Submitted to the US FDA

In accordance with the 510(k) process (Class II)*1 format, CYBERDYNE, INC. (the “Company”) has submitted an application to the United States Food and Drug Administration (“FDA”) on June 19, EST towards obtaining approval for marketing the Medical HAL as a medical device.

Anticipating the effects on business developments after obtaining medical device approval in the US, the Company has continued to clarify and explain the designed purpose, technical characteristics and clinical benefits of Medical HAL since its first 510(k) submission on June 22, 2015 EST in an effort to deepen the FDA’s understanding of the device. More specifically, the Company has explained that Medical HAL is considered to be an innovative Cybernic Treatment*2 device that attempts to actively improve and regenerate the patient’s functions of brain-nerve-physical systems, instead of an orthosis that physically supports patients to walk or a robot that repeatedly performs specific movements for its patients. As a result of continued discussions with the FDA after the submission of a Pre-Submission*3 that took place on November 4, 2016 EST, the Company has decided to resubmit a 510 (k) application.

Supplemental explanation
1. Difference between the application resubmission and the previous 510(k) (class II) application that was submitted on June 22, 2015 EST.
 Though the application resubmission is for the same product, the discussions with the FDA were taken into account and the content of the application was restructured in order to properly identify Medical HAL as a medical device used for innovative Cybernic treatment, while remaining in line with FDA regulations. The final details of the application will be disclosed once the FDA completes their review and approval is obtained

2. Expected time from application to approval
 According to the guidance document for 510(k) applications, the reviewing period by the FDA is stated to be 90 days. However, if additional questions are sent from the FDA during the process, the entire process could go over the aforementioned 90-day period. The Company will coordinate with its U.S. subsidiary in order to move the process forward smoothly.

3. Evaluation of Medical HAL
 In 2013, Medical HAL received medical device certification in Europe (conformity to the Medical Device Directive determined by a Notified Body; certification for medical device CE marking) as the world’s first robotic treatment device for the treatment of patients with brain-nerve-muscle diseases. In Germany, the cost of treatment for patients with diseases like spinal cord injury using Medical HAL is covered in full by public worker’s compensation insurance. In support of this development, an academic paper was published in May 2017 that compared the pre-post effects of treatment with Medical HAL on 55 chronic spinal cord injury patients (minimum of 1 year post-injury), and showed a statistically significant effect of treatment (10-meter walk test, 6-minute walk test) †1. In Japan, a physician-initiated clinical trial was conducted for the effect of treatment with Medical HAL on patients with slowly progressive rare neuromuscular diseases, and the results showed a significant functional improvement effect. As a result, since September 2016, it has been offered as a clinical treatment procedure covered by public health insurance that is differentiated from and therefore processed differently than other traditional rehabilitation procedures provided. Furthermore, with promising results from clinical studies on Medical HAL’s effect on stroke patients that suggest ambulatory functional improvement greater than what is seen from traditional rehabilitation, a physician-initiated clinical trial on stroke patients has been ongoing since September 2016†2.

†1 ”Against the odds: what to expect in rehabilitation of chronic spinal cord injury with a neurologically controlled Hybrid Assistive Limb exoskeleton. A subgroup analysis of 55 patients according to age and lesion level” JNS – Neurosurgical Focus (2017)

Explanation of Terminology
*1 On the 510(k) procedure:
This is a procedure to obtain market clearance for class I and certain class II medical devices in the US. Through this process, the FDA reviews whether the applicant has demonstrated that the submitted device is at least as safe and effective as a legally marketed device, and provides approval for market clearance. This process will also review the unique aspects of Medical HAL such as the designed purpose, technological characteristics, and clinical benefits of treatment that differ from the legally marketed device.

*2︎ On Cybernic Treatment:
Cybernic Treatment is described as “Functional Regenerative Medicine” realized by devices like Medical HAL that are developed using Cybernic Technology, and it is an innovative treatment technology that promotes the functional improvement/regeneration of the brain-nerve-physical systems†3. HAL establishes interactive biofeedback by moving based on intension-based motion information from the brain-nervous system and activating sensory systems like muscle spindle fibers to form a neural loop between the brain-nerve system and the musculoskeletal system. Even if the patient is unable to generate enough muscle strength to move due to motor dysfunction, the treatment is able to repeatedly realize actual movement that is in sync with the motion intent of the brain while avoiding excessive burden on the brain-nerve-muscle systems, thus making functional improvement/regeneration possible. A physician can intervene by tuning the many adjustable parameters related to the patient’s motor and neurological information built into the device, in a way that appropriately circulates the patient’s neurological information through the neural loop between the brain-nerve system and the musculoskeletal system.
Treatment with Medical HAL has been approved by the regulatory authorities in Japan and has been listed as a new treatment procedure that is distinct from other traditional rehabilitation procedures, with a different reimbursement price.

†3 Cybernic Treatment is not limited to Medical HAL and can be administered by other Medical Cybernic Systems that take on various forms using Cybernic Technology.

*3 On the Pre-Submission:
A Pre-Submission is defined as a formal written request from an applicant/sponsor for feedback from FDA to be provided in the form of a formal written response or, if the manufacturer chooses, a meeting or teleconference in which the feedback is documented in meeting minutes. A Pre-Submission is appropriate when FDA’s feedback on specific questions is necessary.