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October 18, 2015 | Tom Ballard

Arkis Biosciences has first product in pre-production

Arkis BiosciencesBy Tom Ballard, Chief Alliance Officer, Pershing Yoakley & Associates, P.C.

There’s been a great deal of progress made at Knoxville-based Arkis BioSciences since we posted our initial article about the company almost two years ago.

“We have our first product in pre-production and plan to launch it this fall,” Chad Seaver, Chairman and Chief Executive Officer, told us recently when we sat down for an update at the start-up’s offices in the University of Tennessee Business Incubator.

What we learned is the company has several more products in the queue to launch in the next couple of years and is rapidly outgrowing space where it is currently located. After initially raising $1.5 million in seed funding, Arkis is nearing completion of a Series A round that will bring in $3 million.

The company was founded four years ago with a focus on better treatment for patients with intracranial hypertension issues including hydrocephalus, traumatic brain injury and strokes. In addition to Seaver, other Founders are James Killeffer, a local neurosurgeon who is Chief Medical Officer, and Chris Arnott, Chief Innovation Officer.

Seaver explained that brain pressure is always an issue for patients afflicted by hydrocephalus, and a shunt is almost always implanted to reduce the pressure. Furthermore, he indicated that for patients suffering from traumatic brain injury or hemorrhagic strokes, an externalized form of shunting is often used to temporarily relieve high brain pressure, or intracranial hypertension.

“Unfortunately, half of the shunts fail in the first two years,” Seaver explained. This means that patients go through a lifetime of surgeries to replace failed shunts. This is where Arkis’ innovative approaches enter the picture.

“We recognized the problem several years ago and wanted to develop a better solution,” he said. “Our first surgical invention required several refinements before it was successful.”

The first product – a device called the Tunneling Guidewire – reduces by one-third the number on incisions necessary to implant a ventriculoperitoneal shunt in a patient. The current protocol requires three incisions – one each in the abdomen, on the top of the head, and in the neck area right behind the ear.

“Our device removes the intermediary incision,” Seaver said in reference to the one behind the ear. “In one pass, it (the Arkis device) routes the shunt tubing from the head to the abdomen.”

The approach results in reductions in surgical time, risk of infection, and repeated scars on a patient’s neck.

“It is a clear value proposition to the patient and the provider,” Seaver notes.

Arkis has three patents pending for the Tunneling Guidewire that is a U.S. Food and Drug Administration-listed Class 1 Device.  Additionally, the company has six other distinct patents for other treatment devices ranging from pending to granted.

As Seaver and the team look to the future, the next offering is a technology that complements the company’s core focus. Arkis recently in-licensed EndexoTM, an anticoagulant additive for shunts inserted into humans, from Interface Biologics, Inc., a Canadian firm.

“It’s not a coating but an additive,” Seaver said, explaining that the product “has been shown to reduce obstructions in other treatment catheters by up to 75 percent.”

Arkis has an exclusive worldwide license to EndexoTM for devices designed to address conditions affecting the central nervous system. With new investment, Seaver expects the product to be available in late 2016.

There are plans to offer another device for patients with hydrocephalus in 2017. It will be a first-of-its-kind device allowing for regular monitoring of brain pressure, just as individuals can do today for high blood pressure.

Sounds simple, doesn’t it? Seaver explains that the only method for pressure assessment currently available to patients with intracranial hypertension is admission to a hospital intensive care unit. That’s both dreadful and expensive. Arkis’ upcoming solution will provide for non-invasive smartphone monitoring of brain pressure for reducing costly emergency interventions and for improving pressure regulation overall.

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