Release date: 2014-07-17
Greenberg, CEO of Second Sight Medical Products, recalled that two FDA executives sent a Valentine's Day gift on the phone. They informed him that the FDA had approved the Argus II retinal prosthesis system and contributed to his career in developing the system.
But when Greenberg received the call, he was surprised. After ten and a half years of hard work on this new type of equipment, his team has reached an important milestone. Initially, American patients were suffering from retinitis pigmentosa, a degenerative disease that slowly deprived them of their vision. They could buy an implant device to see black, white, and gray shadows.
Highlight
Greenberg has a background in biomedical and electrical engineering. He graduated from Johns Hopkins University in 1991 when he was invited to join an experiment involving blind people.
“In the local anesthesia of the operating room, we placed a thin wire near the retina, a little bit of current, and the patient saw a bright spot,†Greenberg said. “Actually, when we put in two wires, the patient saw two highlights.â€
This promising result - blinding the patient to see the spot - attracted Greenberg. He decided what he wanted to do in his career: to build a device that would restore vision in patients with retinitis pigmentosa.
Looking back at 1991, Greenberg saw this as a very simple project. “I am the background of an electrical engineer. For me, at this point it is just an electrical engineering project,†he said. "We only have to build a stimulator with branch electrodes, which I don't think will take more than 20 years."
The establishment of the company and the emergence of challenges
Greenberg worked at a non-profit foundation founded by medical technology entrepreneur Alfred E. Mann, when a friend of Mann's investor, Sam Williams, asked a question: Can vision be restored to use nerve stimulation? In the same way as Advanced Bionics, one of Mann's other companies, hearing can be restored with cochlear implants.
Upon hearing the Johns Hopkins experiment, Mann and Williams launched the Second Sight medical product in 1998, Greenberg wrote the original business plan and recommended the original investor, and then Mann and Williams began to operate.
After being promoted to the role of founding CEO in 1999, Greenberg quickly realized that the equipment he imagined was more than just a simple engineering project. For example, the first challenge in developing this implanted device was how to integrate the device with the precise tissue behind the eye.
"The retina is at the back of the eye, with our stimulating nerve tissue, and wants a single layer of wipes," Greenberg explained. "So it's exceptionally precise and very easy to get out of the back of the eye. So getting a thing that mechanically matches such a very thin and precise tissue is a huge challenge, after years of improvement and attempts to design with different electrode arrays. â€
In fact, it has become a real stumbling block. “The worst case is when we try to touch this single layer of moist tissue,†he recalls. “We spent a few years trying to do this. We held a board meeting, looked at the timetable, and asked ourselves: Is this too difficult? Can we not finish?â€
Another challenge is to protect the electronic devices placed in the implant. “Basically, the body is salt water,†Greenberg said. “Just throw your TV in the sea, it still works. This describes the size of the challenge.â€
While other companies founded by Mann have experience in protecting implanted electronic products, none of them have placed so many electrodes in an aspirin-sized device and protected the implanted electronic device.
Millions of investments and first generation equipment
Second Sight's groundbreaking efforts have attracted public and private interest. Throughout the process, the company raised $100 million from private investors such as Al Mann and other high net worth individuals, as well as California venture capital firm Watson Ventures.
“I have been tracking a variety of retinal nerve stimulation methods for the treatment of retinal degenerative diseases. It is clear that Second Sight has taken the lead in solving this challenging problem,†said William Link, managing director of Watson Ventures and a member of the Second Sight board of directors. “Since we invested in 2001, we have been actively involved in the development of the company on the board of directors.â€
On the public side, the company received favor from the National Institutes of Health, the US Department of Energy, and the National Science Foundation, and received $100 million in investment.
In 2002, Second Sight began clinical trials to test Argus I, the predecessor of Argus II, with 16 electrodes to stimulate the retina. Despite the success of the trial and the patient's needs, the company did not commercialize the device.
“One of the reasons is that we think the 60-electrode device is just around the corner,†Greenberg said. “But the main reason for this decision was that the surgery using this device took eight hours and required four surgeons to perform.â€
In contrast, the FDA-approved end product takes only two hours to implant the device and a surgeon to perform the process.
Argus II approved
In 2007, the FDA approved Second Sight to conduct tests on new equipment. In February of this year, the device was approved by the FDA under the humanitarian device exemption, and six years have passed since then.
Greenberg said that the PM submitted by Second Sight was as high as 10,000 pages, and the FDA finally asked a lot of questions before it passed. The European regulator had previously approved the equipment in 2011.
Now, Medicare has announced that the device is reimbursed for $144,000, the same as those for private insurers. According to Brian Mech, vice president of business development at Second Sight, they typically save $2,000 despite paying for different medical insurance patients.
Next plan
Second Sight does not eat the old one. Despite a year of beauty, the company has turned its attention to areas of potential improvement. After all, as a user of the Argus II device, the ability to see grayscale is not equal to having normal vision. It is clear that once discovered, a targeted patient can be clearly located.
Currently, companies and patients conduct color research in the laboratory and work on image enhancement. It is hoped that these improvements will be introduced as part of future software upgrades.
"One of the benefits of the device is that it has a video processor that processes images from the glasses and wirelessly transmits them to the implanted device. The video processor has software that can be upgraded, just like the operating system of a mobile phone," Greenberg said.
The company also plans to upgrade equipment; the FDA approves it based on a device with a 10-year design history. "It's a computer-based system, so you can imagine how many mobile and computer technologies are improving over the past 10 years," Greenberg added.
With this important milestone achieved in 2013, Greenberg hopes that Second Sight investors will pay off in the next six months to one year. One option is to sell Second Sight to a large company. He cites the fact that they are well-known public companies and refuse to look for potential acquirers.
But an initial public offering (IPO) is also a possibility. Greenberg said the company has successfully created the world's smallest neurostimulator, with the largest number of electrodes, 60, and there may be other potential applications. For example, current neurostimulators are exploring the treatment of a range of diseases, including Parkinson's disease, chronic pain and obesity. The IPO will provide financing to expand the application of Second Sight technology.
This year will achieve the pursuit of Second Sight employees for many years. I hope that more patients with other serious injuries can benefit from this breakthrough technology.
This news is not an accident. After all, in September 2012, the US Food and Drug Administration had unanimously decided to recommend Argus II for approval.
On February 14, 2013, Robert Greenberg was patiently waiting for the final coming.
Source: MEDTEC China Exhibition
Laser Tape Measure 2 in 1, as its name, it is one product with traditional tape measure and digital laser distance measurer. Laser measure tape can measure 40m with laser measurement and 5m of the measuring tape. Convenient, smart, accurate, laser tape measure make every measurement simple in life!
Using a laser tape measure, one can measure short distance with stiff tape measure, while just put a single button to measure long distance up to 40m and the result will show on a small LCD screen.
No need to climb up and down, crawl on the floor, save your labor and time from now on! Laser tape measure, a simple device to change your life!
Laser Tape Measuring,Laser Distance Measurer,Distance Measuring Tool,Digital Laser Tape Measure
Chengdu JRT Meter Technology Co., Ltd , https://www.rangingsensor.com