Citron Research Exposes the Clinical Study Cyberdyne Does Not Want You To See- We Reaffirm Price Target 300¥
For background see
In this recent report, Citron exposes the clinical study conducted by Cyberdyne that shows that patients who use the HAL have minimal better outcomes than those who use a simple hospital hoist system. The clinical report also details that over 65% of people who use HAL experience some adverse events. Citron believes this is the reason why the company has not submitted anything to the FDA and more importantly the reason why the HAL has not achieved any meaningful sales in either Japan or Europe. We believe this clinical study to be the smoking gun on why Cyberdyne is on its way to 300¥ per share.
In our first two reports, Citron explained that hat Cyberdyne (7779.T-JP) , despite exaggerated promotional efforts by its CEO, has failed to deliver any meaningful revenues or unique technology over the past 4 years. More importantly, we have shown that Cyberdyne with a market cap of 225.B¥ significantcantly lags behind its competition Rewalk and Ekso Bionics in both innovation and penetration in the United States yet the competition market caps are 7 Bil¥ and 10 Bil¥
What has been most disturbing to Citron is that Cyberdyne has avoided any clear disclosure on its FDA approval timeline. Citron will now expose why Cyberdyne has not disclosed any communication with the FDA, and the real reason we have not seen any meaningful revenues worldwide.
Because Cyberdyne conducted this clinical trial we assume that this study was intended to show the HAL in its best possible performance. The trial itself is very questionable, given it is not blinded and vulnerable to biases both from clinicians and patients. Also, the sample size exceptionally small with only 11 patients in one control group and 13 patients in the other control group.
For all of the hype Cyberdyne created around their product, it barely even works better than a common hospital mechanical device that has no robotic or “brain reading” ability. More troubling, the trial results also shows a 63.3% incidence of adverse physical outcome from wearing the HAL. Injuries include myalgia, contact dermatitis (burning from electrode contact), abrasion, back pain, falls, bruising, pain in extremities, soreness, osteoarthritis of the hip, arthralgia, erythema, and peeling skin……No wonder no one wants to use it.
It is Citron’s opinion that that Cyberdyne has never submitted a “de novo” application to the FDA because they knew this clinical trial would never get approval in the United States, because the trial shows the product barely works and puts patients in danger.
Cyberdyne then tried to latch onto competitor FDA applications in form 510(k) (despite claiming that their exoskeleton is different), but the FDA seems to have denied them this route to approval.
There is a reason the HAL robot has not sold widespread through Europe and Japan. There is also a reason why Cyberdyne cannot give us straight answers to its status with the US FDA. The reason all comes down to the results of their own clinical trial. Despite its high cost, the HAL robot does not work much better than a typical hospital hoist and the HAL robot comes with a high chance of injury to the patient. We believe the stock will trade down to 300¥.
See the full report below