Let's do this. Let's imagine the development of the next modern medical miracle, equivalent, say, to the development of X-ray and MRI, heart transplants and artificial hearts or the yet unrealized cure for diabetes.
How about helping the blind to see?
That is exactly the fairly near-term goal of IIP-Technologies (IIP; Bonn, Germany), which has just reported groundbreaking results of its initial “early human trial“ using the first-generation Learning Retinal Implant (LRI). With the implant and associated instrumentation, patients in this small study who were blind – one for more than 50 years – were able to able to perceive light and visual patterns, including left/right orientation of those patterns.
“Understandably, they reacted emotionally to their visual experience,“ said Hans-Juergen Tiedtke, CEO of IIP – surely a bit of understatement.
The ability to generate this level of vision – slight perhaps for the ordinarily sighted, but a revelation to the four subjects in the trial – is the product of neural cell stimulation technology used to “excite“ the damaged retina. The initial research on this technology was launched out of the University of Bonn and then developed into the LRI system by IIP's parent company, Intelligent Medical Implants (Zug, Switzerland).
Speaking by phone from Germany Friday, Tiedtke told Medical Device Daily that the next step will be a pivotal trial involving 10 patients, with the intent to help them see objects in the real world.
The system is made up of three sub-systems.
The first is a stimulating device that is implanted in the eye. The second is a pair of glasses the individual wears, serving as a transmitter of wireless signals to the implanted stimulator. And thirdly, connected to the glasses by a cable is a processor worn on the waist. The processor sends programmed signals to the glasses which are then delivered to the implant so as to stimulate the act of seeing.
The processor is an intelligent “learning“ feature of the device, enabling use of patient feedback to “tune“ the system for best results.
In the first-in-man study, the signals sent to the individuals enrolled consisted primarily of laptop-generated geometrical patterns, Tiedtke explained. In the follow-on 10-person study, a camera will be added, he said, thus attempting to generate in blind persons views of the world that the normally-sighted person sees.
IIP banners the early trial as “the first time in the history of artificial vision that completely wireless transmission of data and energy into an implant in the eye of long-time blind persons has resulted in pattern recognition.“
The initial clinical target is those with retinitis pigmentosa (RP), one of the two most common causes of vision loss in persons over the age of 50 by hereditary degenerative retinal diseases. More than one million persons worldwide are affected by RP, a hereditary disease in which the light-sensitive cells of the retina slowly degenerate and die. However, in many patients, certain adjoining nerve cells remain intact even in those blinded, and thus can be stimulated by a retinal device.
The first IRL implant occurred in late-November, and the clinical testing of the IMI device commenced in January at the University of Hamburg Medical School under principal investigator Gisbert Richard, professor of ophthalmology. Each of the implantations has been “extremely well-tolerated“ and fixation of the implant has been “stable, with no inflammatory reactions,“ according to Richard.
The company first unveiled its first-in-man plans last September (MDD, Sept. 28, 2005).
Tiedtke described the procedure to do the implant as “difficult but not undoable.“ While not a “typical“ procedure, it is “not uncommon to ophthalmologists“ and similar to replacement of a glaucoma valve, he said.
Following the 10-patient pivotal trial, the company plans to move forward with a 20-patient trial and use data from the experience of the 30 patients to seek European regulatory okays.
He said the company has already begun discussions with the FDA and has received a go-ahead that avoids further preclinical study. And application for an investigational device exemption is expected in the second half of 2007.
“Each of these blind persons had no visual perception at all,“ Tiedtke said of the initial four-person trial group, including a 65-year-old woman who had been blind for more than half a century. From childhood she has suffered from RP – the target application first being pursued. But Tiedtke said that in her first pattern recognition test, she had a visual perception.
Looking ahead to when the company's system is fully mature, what might blind persons, with its assistance, see?
Tiedtke first noted that the term “fully mature“ would depend much on the development of future materials and follow-on generations of the technology. The first generations of the LRI device uses 49 electrodes, with the company already working to produce a system employing 231 electrodes.
But even at full maturity, the system's “border,“ he said, is the human face.
What they will “see,“ he said will be “most probably pixelized“ and “rough“ but enough to convey “precise orientation in an unknown environment,“ so as to give them an unprecedented level of autonomy.
In the very best case, they may be able to see, he said, “a chair, a plate, a cup of coffee, but I'm not sure they'll be able to recognize a face.“
Tiedtke clearly hopes that the company's reports of its first human trial will serve as an equity magnet. Currently, he reports enough cash to carry the company through this quarter and the next, and indicated ongoing talks with potential new investors.
IIP is hardly alone in this rather daunting effort. Others attempting to develop systems as retinal substitutes include Second Sight (Sylmar, California), OptoBionics (Naperville, Illinois), Retina Implant (Tub ngen, Germany) and researchers at the Stanford School of Medicine (Palo Alto, California) with funding from refractive surgery player VISX (Santa, Clara, California).