Medical Device Daily Staff Reporter
Imagine stemming the harmful affects of tooth decay without using surgical procedures — or a drill. Consider cancer treatments without chemotherapy.
Such ideas seem far-fetched but could become a reality thanks to a two-year research agreement between Raydiance (Petulma, California) and the FDA, just reported by the company, that seeks to unlock the potential of Raydiance’s UltraShort Pulse (USP) laser system.
First developed in the 1980s, USP lasers are extremely brief light pulses of power that, unlike continuous wave lasers, instantly vaporize any material without heat or residual damage to surrounding areas at very precise scales, down to the micron level.
Raydiance incorporates several fields that have been pulled together into a single USP laser platform vision. These include “chirped pulse amplification,” developed in the late 80’s and 90’s to create high-power picosecond and femtosecond pulses; the fiber optics revolution from the late 1990’s and early 2000’s that was the driver of the telecom boom; “structured” fibers developed in very recent years specifically for USP lasers and IT technology and communications, and embedded software.
“The laser itself is an open-source platform and is based on a fiber laser technology,” Greg Spooner, PHD, principal applications engineer of Raydiance, told Medical Device Daily.
The FDA’s research on the Raydiance USP laser platform will initially focus on the use, safety and effectiveness of USP lasers in:
• ophthalmic applications, including tissue interactions that occur with ablation of corneal tissues associated with USP laser applications in refractive surgery and corneal repair;
• light therapy applications, including the kinetic processes of light therapy that may be employed in new treatments for important diseases including cancer, cardiovascular disease and diabetes;
• gene transfection applications, including the administration of gene therapy;
• and dental applications, such as the removal of dental composite material without reducing tooth enamel, the optical inspection of teeth and the control of decay with non-surgical, non-drilling technologies.
The agreement “is sort of an early spark for other possible techniques in the future,” Spooner said.
The company is saying that some of this research might yield to some alternative treatments to cancer —thereby possibly eliminating chemotherapy in some instances.
Up until now most USP systems have been extremely expensive, very large and usable only by trained photonics experts. This has severely limited experimentation to highly-specialized university and government research labs and made commercialization of meaningful applications nearly impossible. Because of its size, people were apprehensive about developing the bulky device for medical purposes,
It was that apprehensive attitude of the technology by other companies that allowed a small arm of the Defense Advanced Research Projects Agency (DARPA) to become a multi-million dollar company called Raydiance, three years ago. The first innovation was the desktop Ultra Short Pulse laser — which was out within 18 months of the company’s creation.
“The company started out as a DARPA project,” Scott Davison, president of Raydiance told MDD. “Because of its availability the UltraShort Pulse lasers were only used for defensive purposes nothing medical related. The technology was too bulky – but had potential. The problem is that people look at the way technology exists not what it could be. But we brought a different approach about the technology and what it could do.
“It’s been like a fairy tale ride.”
That approach includes the company owning the core engine and having users own the applications derived from the engine.
“It’s like Microsoft in a way, “Davison said. “ Microsoft owns the program, but the spreadsheets and applications spun out of [the programs] are owned by the user.
Current applications that Raydiance partners are working on include tissue being rapidly ablated at micron-scale by a focused USP laser beam that is simultaneously analyzed by spectroscopy that characterizes the flash of light accompanying each tiny ablation event.
This approach can allow, for example, selective removal of non-viable tissue from viable tissue. Other initiatives include: Pigment agnostic the destruction of tattoo inks below the skin surface; USP laser phototherapy which has cancer and other cells targeted for growth suppression, allowing potential treatments in cancer, autoimmune diseases; and skin rejuvenation.
“For us to capture the attention of the FDA is great for us. We see it as a win-win situation all the way around,” Davison told MDD .
The company said from a business standpoint the agreement means the FDA will become familiar with Raydiance’s technology and presumably be better able to evaluate and approve specific devices that are powered by Raydiance. But there is a bigger implication that could change the way the medical community looks at lasers.
“When it comes to using laser technology doctors are very skeptical,” Davison said. “There has been a lot of hype and broken promises ... But having the FDA be a part of this is really helping people see the benefit of further developing the USP.”