Medical Device Daily Associate

OmniGuide (Cambridge, Massachusetts) reported what it said is the first-ever FDA clearance for photonic bandgap technology – a type of very efficient mirror – in a surgical system.

The company said the FDA granted 510(k) clearance of its OmniGuide BeamPath CO2 Mark I laser beam delivery system, designed to enable flexible fiber delivery of a CO2 laser light, for minimally invasive surgery, through a flexible or rigid endoscopes.

The system is cleared for multiple indications, including incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues, in a variety of medical specialties. These include: general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic and open surgical procedures related to gynecology, otorhinolaryngology, gastroenterology, neurosurgery, and pulmonary surgery for surgical and aesthetic applications.

The company’s new fiber system is completely different from anything else on the market, according to Gil Shapira, director of marketing and business development for OmniGuide.

“What you have today is fibers that are solid-core, meaning light gets transmitted through material,” Shapira told Medical Device Daily.

And in order to transmit, for example a CO2 laser, “you need a material which is transparent at the relevant wavelength,” he said.

Steve Sheng, PhD, president and CEO of OmniGuide, said the clearance of the BeamPath system is a “huge step forward” for his company. “This is the first step in establishing a diversified medical product portfolio based on OmniGuide’s revolutionary fiber technology. The clearance will allow OmniGuide to fully engage the human surgical market and drive new minimally invasive treatment modalities in multiple specialties.”

While the company noted that the CO2 laser has been used for surgical procedures for more than 30 years, until now, there has been no adequate flexible delivery mechanism for CO2 laser beams.

“All the [current] CO2 lasers have rigid or semi-rigid delivery methods, based on mirrors or prisms,” Shapira said. “They don’t have a fiber solution, and that greatly limits what you can do with a CO2 laser.”

OmniGuide said it has overcome this challenge by developing a hollow-core fiber based on photonic bandgap technology developed at the Massachusetts Institute of Technology (MIT; also Cambridge) by Yoel Fink, PhD.

The company’s new optical fibers are based on Fink’s work with photonic bandgap reflectors, a type of dielectric mirror that can reflect light and can display extremely low losses. Unlike other dielectric mirrors – which reflect light only for a very narrow angle of incidence at a specific wavelength – photonic bandgap reflectors are capable of very high reflectance for any angle of incidence for a large band of wavelengths.

Fink, along with John Joannopoulos and Edwin Thomas, all faculty members at MIT, and Uri Kolodny, founded OmniGuide in May 2000 in order to commercialize the patented research on these omnidirectional reflectors conducted at MIT.

What they came up with are fibers that have the ability to deliver flexible CO2 laser delivery, thus opening up their use in both the minimally invasive enhancement of existing procedures performed using laser surgery and enabling new modalities of treatment.

According to Shapira, the FDA clearance has laid the groundwork for use of the BeamPath as a platform technology.

“You can think of this a general cutting tool for soft tissue,” he said, adding that the system is extremely precise and localized.

“You induce very little thermal damage beyond the immediate point of contact, so you are able to actually perform cuts that are, in accuracy, even below 100 microns.” Additionally, he noted that the device allows for essentially bloodless procedures since it cauterizes the tissue at the treatment site.

While the essential technology can be used in most specialties, Shapira said different handpeices and other tools would probably have to be developed in order to deliver the laser in specialized applications. Additionally a prospective customer has the option of either purchasing a new laser system from OmniGuide or retrofitting an existing CO2 laser system via a kit provided by the company.

The company’s next step, according to Shapira, is to engage several clinical sites in order to generate some quality research data, with the first target markets being the ENT and head and neck surgery sectors.

One institution that almost certainly will be on the clinical site list is the Wake Forest University Baptist Medical Center (Winston-Salem, North Carolina), where Omni-Guide completed its first human treatment last November, using the fiber to treat a patient suffering from an acute case of recurrent respiratory papilloma involving the larynx and the trachea.

That new treatment modality was performed, based on a “compassionate use” request, by Jamie Koufman, MD. The patient was treated in the office trans-nasally, with local anesthesia, vs. the standard of care, which requires general anesthesia and a visit to the operating room.

OmniGuide has an exclusive license from MIT on omnidirectional reflectors.

To date, the company has raised $29.5 million in three rounds of private financing, with the most recent $15 million round gathered in December 2003. In September of that same year, the company also received commitments for $450,000 in government R&D grants from the National Institute of Health (Bethesda, Maryland) and other government agencies.

Even though OmniGuide says it intends to market the technology itself, it is in the happy position of not being hard-pressed for cash. “We don’t see any immediate needs for additional funding,” Shapira said.