Medical Device Daily National Editor
It pays to be nimble. It pays to be quick.
Derrick Johns, president/CEO of the newly launched company DiFusion Technology (Austin, Texas), says that the company is one of those start-ups that is nimble and that plans to be very quick to market with its new technology.
That technology is a device for preventing surgical site infections (SSIs) following orthopedic surgeries and thus capable of saving the U.S. healthcare system $100,000 per SSI incidence, adding up to millions of dollars in savings every year.
DiFusion reported its official rollout today, though the primary idea for the technology "began percolating" just two years ago, Johns told Medical Device Daily. And Johns said that DiFusion is expecting to get its product to market in just about six months via the 510(k) pathway.
DiFusion's technology is a basic interbody "cage" type of device used in orthopedics, but impregnated with an infection-fighting compound that Johns says is "picket-fence"- protected by strong patents.
As a case study of the need for this combination, Johns cites the sports fan-familiar case of Tom Brady, the quarterback of the pro football New England Patriots who was sidelined this year as the result of knee surgery and follow-on infection (a Pats fan himself, Johns admits that his friends might be getting a little tired of lamenting this particular medical case).
He notes reports of further complications and repeat procedures which may keep Brady off the field in the '09 season. And these complications are costly, very famously to NFL quarterbacks but also to every hospital where these surgeries take place.
DiFusion says the compound formulation used in its device – which it has dubbed "super silicate" – is capable of killing off 650 types of bacteria, including MRSA (methicillin-resistant Staphylococcus aureus), in the local surgical wound up to four weeks following the procedure.
"In large studies, five out of 100 spine cases result in SSIs, often leading to second surgeries that are extremely costly and difficult for the patient," said Matthew Geck, MD, an Austin orthopedic surgeon who is a member of DiFusion's board.
Rather than being a drug product, the material, Johns told MDD, is a silicate molecule "that we compound into the plastic [of the cage] itself. We load that with different ions, with antimicrobial components."
This material then will "diffuse in and around the soft tissue within four to six weeks," he said," and that the rate of diffusion can be "fine-tuned – like an FM radio – parts-per-billion to alter the dose and time frame.
"We can now effectively tune that molecule to elute silver and zinc ions to help the bone growth process."
DiFusion licensed the compound from AGion Technologies (Wakefield, Massachusetts) – providing silver-based anti-microbials for everything from air conditioning ducts to Yoga mats. Johns said the super-silicate compound was not being developed by AGion and was just "sitting on the sidelines," though strongly patent-protected.
"The controlled delivery of cationic elements possible with our 'super-silicate' offers multiple promising applications, from infection control to bone growth," said Gary Ghiselli, MD, a Denver orthopedic surgeon and chair of the DiFusion scientific advisory board.
Ghiselli cites figures indicating that SSIs cost the U.S. healthcare system $5 billion annually and that DiFusion's system could save "$150 million in the spine segment alone."
Besides helping to avoid expensively treated infections, the technology fits the recent new wave created by the Centers for Medicare & Medicaid Services which will deny payment to hospitals for the treatment of infections that could have been avoided.
This may be another reason why DiFusion expects the FDA to give the technology fairly rapid clearance via the 510(k) pathway.
Johns said the company has held pre-filing meetings with the FDA to share its data and that a 510(k) filing should enable marketing some time near the end of the first half of this year.
He said the company then has two options: utilizing partnerships it has developed with an array of distributors around the U.S., or selling the product to a larger company, such as one of the major orthopedic firms.
DiFusion has already begun conversations with those larger firms, but that this remains a "Plan B" type of opportunity, Johns said.
The company received $840,000 in seed-state venture funding last July and said it is hoping for additional funding of up to $2 million to carry it into the marketing stage.