Alpha IMS awarded CE mark in Europe
Wireless subretinal microchip recovers vision in patients blinded by retinitis pigmentosa.
Retina Implant AG’s Alpha IMS received CE mark approval, representing the first European regulatory certification awarded to the device and the company, according to a press release.
“We are delighted that our subretinal implant has received CE marking, validating the safety and potential benefits of our revolutionary product to patients and physicians,” CEO of Retina Implant AG, Walter G. Wrobel, PhD, said in a press release. “We look forward to working with clinicians across Europe interested in offering their patients a new pathway to regain vision.”
The Alpha IMS is a 3 mm × 3 mm 1,500 pixel wireless subretinal implant designed to restore vision without externally visible equipment.
Placement of the camera chip plays a major role in visual results, making visual outcomes different than when camera devices are fixed to the head, according to Wrobel.
The major difference is how images are perceived through scanning or moving of the head, he said.
“The visual outcome is very different because the camera chip is directly in the eye,” Wrobel said. “Eye-hand coordination is facilitated because the image moves with the position of the eye.”
One in 4,000 people carry the gene for retinitis pigmentosa, which puts them in jeopardy of losing their vision. Retina Implant AG intends to concentrate marketing efforts in countries with well-developed health care systems, which includes approximately 1 billion people, potentially 250,000 implantations, according to Wrobel.
At about $130,000 per implant, the estimated market size is about $33 billion, he said. The company is working with insurance companies to determine reimbursement for the device.
“We have to talk to insurance companies country by country for reimbursement,” Wrobel said.
The implant is currently available to patients across the European Union and in some other countries that accept the CE approval who are willing and able to pay out of pocket, he said.
“If you assume that implantation of the already living patients is spread over 25 years, total annual revenue could be about €1billion [$1.33 billion],” Wrobel said.
Research and development
The costs of research and development will not decrease. Instead, the focus will be on design improvement, Wrobel said.
Wrobel said that revenues are currently close to zero but are expected to surpass expenses in the coming years.
The CE mark enables Retina Implant AG to distribute the Alpha IMS throughout Europe. The company is in the process of recruiting and training additional centers, he said.
Retina Implant AG has also partnered with Wills Eye Hospital in Philadelphia.
“The results of the subretinal approach in Europe demonstrate the great potential this implant has to impact dramatically the quality of life for our patients here in the United States,” Ophthalmologist-in-Chief Julia A. Haller, MD, said in a press release. “Patients involved in previous clinical trials have achieved extraordinary success in their ability to regain useful vision.”
According to Wrobel, Wills Eye Hospital anticipates beginning a clinical study using the subretinal implant. – by Christi Fox