(EDITOR’S NOTE: Arkis BioSciences held a grand opening of its new offices last week. That event was captured in this teknovation.biz article.)
By Tom Ballard, Chief Alliance Officer, PYA
The last year can best be characterized as one of great progress for Chad Seaver and the team at Arkis BioSciences.
The company has three products in the market, a new home in the privately-funded building at the University of Tennessee’s (UT) Cherokee Farm Innovation Campus, a robust relationship with UT’s Joint Institute for Advanced Materials (JIAM), 10 employees on its team, and plans for Series B funding round.
“We’re very grateful to be in the market with this kind of demand for our products and to have retired quite a bit of risk,” Seaver told us recently.
He’s Co-Founder and Chief Executive Officer (CEO) of the company that was founded in 2013. For Arkis BioSciences’ first couple of years, he was the only employee after taking the plunge, quitting his full-time job at Siemens, and going “all-in” at the start-up.
Today, the company founded to focus on better treatment for patients with intracranial hypertension issues including hydrocephalus, traumatic brain injury and strokes, has just moved into bright, new space on the second floor of the building on Cherokee Farm. Arkis BioSciences had been located in cramped space in the nearby UT Business Incubator.
Its first product – the Arkis Tunneling GuidewireTM – provides a less invasive method to remove fluid from the cranial cavity to the abdomen. Unlike the products of competitors, it requires just two incisions, lowering the probability of surgical site infection.
“We introduced the Arkis Tunneling GuidewireTM last November,” Seaver said. “We’ve had wonderful success with the device. The feedback and demand have been great.”
As a result, Arkis BioSciences has also introduced a handheld model that surgeons requested. Dubbed the Arkis Subcutaneous GuidewireTM, it is a multipurpose handheld guidewire for efficient contour tunneling.
“We recently completed its first usage at a hospital in Columbia, SC,” Seaver said.
Rounding out the current tunneling product line is the Arkis Precision TunnelerTM, a disposable stainless-steel stylette and cannula with a robust handle featuring an interlocking cannula mechanism for precise steerability.
All three, which can be found at this link, are what Seaver describes as “minimally invasive surgical instruments.” As such, they are defined by the U.S. Food and Drug Administration (FDA) as Class 1 instruments and are classified as “listed.” That’s the fastest to market of the FDA review processes.
Arkis BioSciences just secured FDA “clearance,” a more rigorous requirement, for its CerebroFlo™ EVD Catheter with Endexo®. “That was a huge milestone for us,” Seaver said of the FDA designation that was announced on August 31.
“We are not a manufacturer of these products,” the CEO explained. “We’re the specification holder in the eyes of the FDA.” Actual manufacturing is predominantly done in the Northeast, a well-known medical device strong bed, with final assembly in Oak Ridge.
To continue to fuel its growth and demand, Arkis BioSciences is planning a Series B round. The goal would be $5 to $8 million raised by the end of the first quarter of 2018. Seaver says the funds would be used to boost sales and marketing, grabbing more market share in the U.S., plus securing international certification for its products.
“We have a lot of demand that we can and need to service,” he says. “Once you have a good product that is in demand, along with good intellectual property, you have a barrier to entry for others.” As such, moving quickly is of critical importance.
Seaver says the availability of UT’s JIAM and the work that he was able to do using the facility’s advanced X-Ray photo-spectroscopy made the decision to move to Cherokee Farm a no-brainer.
“We are going to continue to advance catheter materials,” he says, underscoring his desire to continue to collaborate with researchers at JIAM.