Author | Snow is stubborn
Edit | Jingyu
"I really want to tell people that it was a great experience and that the product was a success. But I can't do it."
Linda Kirk, 72, suffers from degenerative diseases of the retina and went blind as a teenager. Five years ago, she implanted an artificial retina, and with the corresponding equipment, she could obtain "artificial vision" - the bionic eye could not achieve normal vision, but could only perceive the shape, movement and chiaroscuro of objects. But this effect is exciting enough for many visually impaired people.
This complex bionic eye system is called Argus. After the operation, Kirk became the face of positive media coverage of the technology, and second Sight, the company behind the bionic eye, became a star company, and was used as the savior of the visually impaired.
But in fact, Kirk discovered argus after using it for a while. The bionic eye is more likely to distract people than the visual effect. A few years later, she was out of service.
The problem doesn't stop there. In addition to side effects such as vertigo, a brief power outage, a bug during a system upgrade, or a bad line contact can instantly take away people's hope of regaining their light.
What's even more frightening is that Second Sight began to phase out the Argus system in 2019 due to the company's financial losses and the departure of the senior management team. On the verge of bankruptcy in 2020, the company announced a merger with another biopharmaceutical company, NPM (Nano Precision Medical), abandoning Argus altogether and focusing on developing new devices for NPM.
Second Sight declared a failure, and the bionic eye and those implanted in the retina were more obfuscated than ever before.
Technology is technology, and business is business. The story of Second Sight is a wake-up call: When a technology leaves the lab and into the real business world, people who rely heavily on technology are still vulnerable. Technology brings hope, but it can also lead people to new dilemmas.
Inspired by the operating room
Second Sight was founded from the founder's inspiration while observing the surgery.
In 1991, Robert Greenberg, a turned medical student from electrical engineer, stood next to the operating table and watched as a retinal surgeon inserted a tiny wire into the eye of a visually impaired patient under local anesthesia.
When the wires touched the patient's retina and made a slight electrical vibration, the patient said a bright spot appeared in his otherwise dark field of vision. After the doctor inserts the second wire, the patient can see two spots.
This was an inspiration for Greenberg. He thought that if two spots could be artificially created, it would be just a matter of quantity. When the number of spots is large enough, the image can be composed in the patient's field of vision.
Greenberg thus decided what he wanted to do in his career: develop a technological device to help patients with retinitis pigmentosa regain their vision.
Robert Greenberg, co-founder of Second Sight. Image source | IEEE Spectrum
With a dual background in biomedicine and electrical engineering, Greenberg initially thought it was a simple electrical engineering project that could be achieved by designing a stimulator with branched electrodes.
But the truth was far more difficult than he had imagined. While working for a nonprofit that develops biomedical devices, he spent a lot of time and effort developing the technology. In 1998, Greenberg wrote a business plan and received investment, and with two other co-founders, he founded Second Sight, headquartered in Los Angeles.
At that time, the founding team still had many technical difficulties that had not been solved. For example, how electrode devices can be matched to thin, sophisticated retinal implants. For example, the water in the human body contains salt, how to make the electronic devices in the implant not damaged in the salt water, but also work normally.
In 2002, Second Sight began clinical trials of the first-generation product Argus I. The trial was a success and there was a market demand, but the company had no intention of commercializing the device at the time.
Argus I has 16 electrodes to stimulate the retina, and the procedure takes four surgeons 8 hours. Greenberg felt that this was not an ideal state.
Five years later, Argus II entered clinical trials. The second generation has 60 electrodes, the procedure time has been reduced to about 3 hours, and only one doctor is required.
A Argus II bionic eye system consists of three parts: a retinal implant, a camera mounted on a special sunglasses, and a portable device, the Video Processing Unit (VPU), which is usually worn on the patient's belt.
Composition of the Argus II bionic eye system. Image source | IEEE Spectrum
The Specific Mode of Operation of the Argus II is this: the camera on the sunglasses transmits the captured image information to the VPU, which compresses the image into a pattern of 60 black and white pixels and sends it back to the transponder in the glasses. The transponder wirelessly transmits the received black-and-white pixels to an external antenna, whereby the signal enters an array of 60 electrodes on the retinal implant. These electrodes stimulate the eye multiple times per second in different modes, producing flashes of light corresponding to low-resolution video signals.
Essentially, these electrodes replace photoreceptor cells in healthy eyes. These cells can respond to light and send information to the brain.
In 2011, Argus II received Regulatory Approval from Europe. In 2013, the Argus II was approved by the FDA (United States Food and Drug Administration) for the treatment of retinitis pigmentosa.
Argus II does not provide normal vision to patients, for whom the therapeutic effect is a completely new visual experience.
After receiving treatment, patients can perceive the appearance and disappearance of gray shadows when turning their heads, identify the white stripes of the crosswalk, and perceive the bright light on the face of the person next to them when they turn their heads to face them. But they have a hard time seeing basic patterns and shapes, let alone colors. Second Sight officials say that most patients have enough vision after treatment to achieve basic exercise.
Obviously, in the eyes of healthy people, the effect of this treatment is very rough. But for the patient, it is already gratifying. "It's not normal vision, but it's much better than I used to be." Patient Ross Doerr said before the operation.
After all, they have no other treatment options.
A business that doesn't make money
Technological innovation breakthroughs are not the same as commercial success.
On July 18, 2019, Second Sight wrote to patients treated with Argus that it would phase out retinal implantation technology to lay the foundation for the development of the next generation of brain implant technology, Orion.
"Management at the time decided that Argus couldn't be profitable." Greenberg said, "I understand their decision, the market is much smaller than we thought."
According to Second Sight's website, the second-generation Argus currently has more than 350 people implanted worldwide.
Greenberg's relationship with investors has long deteriorated. In 2015, he resigned as CEO of the company and was "forced to leave" the board in 2018.
According to Greenberg, the Argus II sells for about $150,000 in the U.S., five times more expensive than other neuromodulatory devices. But even so, Second Sight is still losing money, and "the cost of sales and operations is a big expense.".
In the letter, Second Sight assured patients that the company's support for Argus would not change: "As in the past, we will retain a full team of customer service and vision rehabilitation specialists and take every measure to ensure that your ongoing demand for equipment is met."
This commitment is more like a beautiful word to stabilize the patient's mood. A former engineer at the company, speaking on condition of anonymity, told the media: "Since then, we haven't really supported Argus and the company is no longer producing and selling."
Worse things are yet to come.
In February 2020, Argus' Senior Director of R&D left, followed by the CEO. In March of the same year, Second Sight laid off most of its remaining staff and announced that it plans to phase out operations due to the COVID-19 pandemic affecting the company's ability to raise capital. In the weeks that followed, most of the company's physical assets were auctioned off.
One of the eyes of patient Dürr had been operated on by Argus II in 2019, which allowed him to see the flashing lights on the Christmas tree. At the beginning of 2020, he was very happy to learn that he was eligible for system upgrades. However, with the massive outbreak of COVID-19, Dürr heard rumors that Second Sight was in crisis. He called his rehab therapist to confirm that he had just been fired and that he had no chance of getting an upgrade.
Patient Dürr wears an Argus II bionic eye device. Image source | IEEE Spectrum
In June 2021, Second Sight raised $57.5 million at a price of $5 per share. At the same time, the company announced that it is conducting clinical trials of a new generation of brain implant technology, Orion, which can also provide artificial vision for patients. At one point, the stock price fell to about $1.50.
In February, Second Sight announced a proposed merger with Nano Precision Medical (NPM), a biopharmaceutical company. Second Sight's original leadership team will step down from the new management and the new team will focus on developing NPM's drug delivery device.
The day after the merger was announced, NPM's CEO told the media that he didn't know what contractual obligations the combined company would have for Argus patients and didn't promise a schedule for the progress of orion for brain implants. NPM strives to do what is "morally correct," but the past has nothing to do with the new future.
Greenberg has said that Second Sight's long-term plan is to bypass retinal implants in the eye entirely and move to brain implants that directly stimulate the visual cortex. Brain implants can help more people with vision problems, such as those who cannot receive Argus II due to severe damage to the retina or optic nerve. Unfortunately, neither Greenberg nor Second Sight achieved their goals.
People who struggle to break free from the darkness, or are forced to return to the darkness
For patients, Second Sight is a devastating roller coaster ride.
In the patient's world, Argus is the dawn of a dark life, and outside of this world, it is just a product that has been eliminated.
In fact, the threshold for patients who want to be treated with Argus II is not low. Willing patients need to call the company first and fill out the evaluation form online. After the candidate's eligibility is determined, the patient needs to go to the treatment center for an in-person vision assessment, and the medical professional determines whether the patient is eligible for implant surgery. Once the conditions are met, insurance specialists and doctors work together to ensure that the patient's treatment plan meets safety standards.
All in all, it is up to the specialist doctor to ultimately decide whether a patient can be treated with Argus II. Eligible patients must agree and guarantee participation in subsequent postoperative follow-up visits, device programming, and vision rehabilitation programs.
In terms of treatment costs, some patients have calculated an account: the total cost of equipment, surgery and rehabilitation is nearly $500,000, and part of the cost can be paid by the insurance company, depending on the patient's insurance plan.
Of Argus' few patients, Terry Byland is the only one with two bionic eyes.
In 2004, Bylander implanted the first-generation Argus retina in his right eye. Eleven years later, he implanted the Argus II in his left eye. He has told the media about his experiences and the changes Argus has brought. "I went from being a tester to a product spokesperson." He said.
The number of electrodes in both generations jumped from 16 to 60, which really improved Bylander's vision.
In 2016 and 2017, the University of Southern California and Second Sight conducted a series of tests. Byland was told that with software upgrades and a new VPU, the original treatment could be improved by a factor of 4. Once again he was persuaded.
It wasn't until 2018 that Byland's attitude towards Argus changed. Second Sight continues to invite him to visit the experience, but technical testing has slowed down and there is no sign of new technology. He felt that Second Sight was not so sincere.
In fact, despite fda approval, the effectiveness of argus II treatment has not been proven.
The company's official website publicly states the contraindications, precautions, treatment risks and adverse reactions of Argus II. For example, even if a patient has Argus II, they will need other mobility aids such as a cane and a guide dog; household appliances and devices with antennas may cause a temporary interruption in the efficacy of argus II; and patients may face medical complications such as retinal tearing and retinal thickening.
Officially, argus II has a 10-year security and durability verification. Once the patient is implanted with a retinal prosthesis, he does not need to undergo additional surgery in the future, and can enjoy more advanced treatment effects by relying on software and hardware upgrades.
Aries Arditi, a senior researcher in vision science, has decades of experience working with visually impaired patients. He felt that patients were often willing to try everything that might work, and even had absolute hope for it.
"It's disturbing that Second Sight is selling these devices with unproven performance to patients." In Alditi's view, the actual results delivered by this technology are not as good as the promise to patients.
He conducted a study that involved nearly all U.S. patients who had participated in the Argus II clinical trial. Studies have shown that the visual quality provided by the device is "weak". According to Alditi, Second Sight disagreed with his analysis and prevented him from publishing the findings.
In 2020, Bylander discovered that the company had abandoned Argus altogether and was on the verge of bankruptcy. Although his retinal implants are still working, it is unclear how long this can last.
Second Sight told the media that during the financial difficulties, the company could not continue to support Argus II users at the original level due to layoffs, and the supply of VPU and glasses for replacement was limited.
To make matters worse, the retina itself that has been implanted in the patient's body cannot be repaired or replaced. If the patient wants to remove it, they not only have to suffer physical pain, but also have to pay an expensive fee.
Bylander was upset: "As long as it's okay, I'll be fine." But once it goes wrong, I'm done. Because it can't be fixed."
In a way, Second Sight is an honest company: setting up patient screening criteria and publicly stating the effects and risks of surgery. However, these are only external factors. What Second Sight never mentions is what patients do if the company itself is finished.
In the process of innovation, failure is inevitable. There is no doubt that argus II's progress and experience as an innovative technology is of great value to other companies that are developing bionic vision systems. However, The stories of Second Sight and these patients are also a reminder that when the technology you rely on is obsolete like an older version of consumer electronics, new problems will follow.
For a company that runs a medical product, its future is more than just a business success or failure. Business can be torn down and restarted, but products that have been implanted in the human body are difficult to withdraw. When technology involving human health becomes a commodity, companies need to be more cautious at every step they take.
Head image source: IEEE Spectrum