Image credit: Neuralink
Yesterday Neuralink announced that its Blindsight Device had been granted “Breakthrough Device” designation by the FDA. According to Elan Musk, the device “will enable even those who have lost both eyes and their optic nerve to see.”
Details about the Blindsight Device or commencement of a clinical trial are scarce at this time.
Pixium Vision’s Prima System. Image Credit: Images by Pixium Vision
Science – the company recently started by Neuralink’s co-founder Max Hodak announced that it is acquiring Pixium Vision‘s assets.
Pixium Vision’s Prima system to treat vision loss is implanted in 47 subjects across Europe and the United States. However, it ran out of cash, and was in danger of abandoning the study. Science’s acquisition of Pixium’s technology includes the three ongoing clinical trials in late-stage macular degeneration.
Image Credit: Composite of images by Science
On its side, Science is developing the “Science Eye,” which is a combination device comprising Optogenetic gene therapy and an implantable, high-resolution display. The first part of the procedure consists of a protein nanoparticle used to deliver a gene to some of the retinal ganglion cells, making them light-sensitive at a specific wavelength. Then, a very small, flexible, high-resolution display film is implanted over the retina to allow fine control of the newly light-sensitive ganglion cells.
In the announcement, Max Hodak stated about the acquisition of Pixium’s competing technology:
“What does this mean for our optogenetic gene therapy and the Science Eye? It’s too early to know which approach, electrical or optogenetic, will work best in the retina long term as these technologies mature. But whichever is used 20 years from now, there is a huge amount of good all of these early devices can do today. They represent very different approaches that make different tradeoffs and at least initially will probably target different patient subpopulations. We would love to be able to offer a range of products to match each individual patient’s needs with the best of what’s available over time.”
Image Credit: Second Sight
IEEE published a damning report on Second Sight’s lack of support for patients who were implanted with their Argus and Argus II retinal prostheses. It is unfortunate that investors and creditors are placed in font of patients who act as subjects to advance our Industry. As the IEEE report puts it:
“After Second Sight discontinued its retinal implant in 2019 and nearly went out of business in 2020, a public offering in June 2021 raised US $57.5 million at $5 per share. The company promised to focus on its ongoing clinical trial of a brain implant, called Orion, that also provides artificial vision. But its stock price plunged to around $1.50, and in February 2022, just before this article was published, the company announced a proposed merger with an early-stage biopharmaceutical company called Nano Precision Medical (NPM). None of Second Sight’s executives will be on the leadership team of the new company, which will focus on developing NPM’s novel implant for drug delivery.”
This is not the first time that the fate and interest of patients have been been placed behind that of investors and creditors. James Cavuoto, the Editor of Neurotech Reports proposed solutions a few years ago after a number of neurostim companies closed their doors:
‘Bankruptcy courts should put implanted patients high on the priority list of creditors. Firms or institutions that volunteer to support existing patients should get IP priority on any technology that was used. And the government should underwrite funds needed for ongoing care of orphaned patients. We owe it to patients to live up to the adage, “Do no harm.” ‘
Back in March of 2020, Second Sight Medical announced that it was winding down its operations. Second Sight developed implantable devices intended to create an artificial form of useful vision for blind individuals. However, because of the impact of COVID-19 on its ability to secure financing, it laid off the majority of its employees as a first step to an orderly wind-down of its operations.
The company had developed the Orion implant, which is placed directly onto the visual cortex of the patient’s brain. Signals received from a miniature camera integrated within a pair of glasses are fed to the implant and interpreted as “vision” by the brain. At the time of the closure announcement, the company was conducting a feasibility study with the Orion device implanted in six blind patients. Second Sight had been working towards a larger “pivotal” trial of the Orion implant, while all of the patients taking part in the small-scale study had reached the 12-month mark.
On January 6, 2021, Second Sight and France’s Pixium Vision announced that they have entered into a definitive business combination agreement pursuant to which Pixium Vision will, following the contribution to Second Sight of all of its assets and liabilities in relation to its neuromodulation technology used in the treatment of blindness, become the controlling shareholder of the new combined company, owning 60% of the total equity before the capital raise. The combined company will focus on retinal stimulation through Pixium’s Prima System. As part of the transaction, a new subsidiary will be created to focus on cortical stimulation through Orion. The new combined company will own 40% of the new subsidiary and will also have a first option to exclusive global marketing rights for Orion.
Pixium Vision’s Prima System. Image Credit: Images by Pixium Vision
Image Credit: Second Sight Medical
Second Sight Medical Products, a developer, manufacturer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision for blind individuals, announced in March that because of the impact of COVID-19 on its ability to secure financing, it would lay off the majority of its employees as a first step to an orderly wind-down of its operations.
Second Sight had created the only FDA-approved implantable visual prosthetic treatment (Argus II) for severe retinitis pigmentosa. To date, more than 350 patients have received an Argus II implant. More recently, the company developed the Orion implant, which is placed directly onto the visual cortex of the patient’s brain. Signals received from a miniature camera integrated within a pair of glasses are fed to the implant and interpreted as “vision” by the brain. At the time of the closure announcement, the company was conducting a feasibility study with the Orion device implanted in six blind patients. Second Sight had been working towards a larger “pivotal” trial of the Orion implant, while all of the patients taking part in the small-scale study had reached the 12-month mark.
The closure announcement was made shortly after Second Sight provided its 2019 financials that showed an operating loss of $34 million during the year, on sales of less than $4 million. Operating capital came mostly from $35 million cash that the company raised in a shareholder rights issue about a year ago.
On May 5, 2020, Second Sight closed an offering of its common stock worth approximately $6.8 million. Second Sight intends to use the proceeds for “accrued expenses, working capital and general corporate purposes. Those expenditures may include partnerships, business combinations, acquisitions or investments.”
Second Sight Medical’s assets are going up for auction tomorrow (June 25):
“The auction will feature Second Sight’s medical device manufacturing equipment, laboratory assets and office furniture located in Sylmar, Calif. Items available include laser systems, oscilloscopes, spectrum analyzers, scientific microscopes, laboratory refrigerators and freezers, ultrasonic cleaners, vacuum pumps, probe systems, computers, office equipment and more, according to a auction company GA Global Partners.”
On Jan 29, 2014, Second Sight Medical announced that it had performed the first commercial implants of the Argus II visual prosthetic at the University of Michigan’s Kellogg Eye Center. Second Sight plans to provide updates during a press conference at the American Society of Cataract and Refractive Surgery conference in April, after the patients complete about three months of rehabilitation and training. The retinal implant, approved by the FDA in 2013, is designed to enhance vision in patients who have been progressively blinded by the condition retinitis pigmentosa.
Retina Implant AG published study results on its Alpha IMS Implant for functional vision restoration. According to the press release, “Retina Implant AG, the leading developer of subretinal implants for patients blinded by retinitis pigmentosa (RP), announced results from part of its multicentre study were published today in the peer-reviewed journal Proceedings of the Royal Society B. The research found that, during the course of a three to nine month observation period, functional vision was restored in the majority of nine German patients implanted with a subretinal microchip as part of the first module of the Company’s second human clinical trial. In addition, visual acuity for two of the nine patients surpassed the visual resolution of patients from the Company’s first human clinical trial.
On February 4, 2013, after more than 20 years of research and development, Second Sight Medical Products, Inc., announced that its Argus® II Retinal Prosthesis System (“Argus II”) has received U.S. market approval from the Food and Drug Administration (FDA) to treat individuals with late stage retinitis pigmentosa (RP). This announcement follows receipt of the European approval in 2011, and a unanimous recommendation by the FDA’s Ophthalmic Devices Advisory Panel in September 2012 that this revolutionary product be made available to treat this patient population in the U.S.
Bionic Vision Australia researchers announced on August 30, 2012 that they successfully performed the first implantation of an early prototype bionic eye with 24 electrodes.
According to the press release:
Image Credit: Monash Vision Group, Monash University, Australia
Engineers from the Monash Vision Group (MVG) have begun trialling the ASICs for a direct-to-brain visual prosthesis that is expected to enter human clinical trials in 2014.
The prosthesis will consist of a tiny camera mounted into a pair of glasses, which acts as the retina; a pocket processor, which takes the electronic information from the camera and converts it into signals enabling the brain to build up a visual construct; and cortical implants of several tiles which will be the portal for the stimulation of the visual cortex. Continue reading
Second Sight Medical Products, Inc., located in Los Angeles, CA, was founded in 1998 by Alfred Mann to develop a retinal prosthesis to provide sight to patients blinded from outer retinal degenerations, such as Retinitis Pigmentosa.
Second Sight’s Argus II Retinal Prosthesis System is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals. The implant is an epiretinal prosthesis surgically implanted in and on the eye that includes an antenna, an electronics case, and an electrode array. The external equipment includes glasses, a video processing unit (VPU) and a cable.
Alfred E. Mann holds B.A. and M.S. degrees in physics from the University of California, Los Angeles and honorary doctorate degrees from the University of Southern California, The Johns Hopkins University, Western University and the Technion Institute (Israel), as well as, Research Professor, University of Southern California, and Adjunct Professor, Dept. of Bioengineering, University of California Los Angeles.
Alfred Mann has founded 17 companies in his career. The AIMD companies currently within his control are: