A small Massachusetts-based company with hopes of bringing its acute spinal cord injury product to market may not get there. Negative feedback from the FDA about its flagship product, no cash in the bank and stock that's worth less than a penny a share are enough to fell any struggling start-up.

Earlier this year Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) President/CEO Timothy Surgenor told Medical Device Daily that the company was immersed in its third round of submissions to the FDA (MDD, Feb. 20, 2008). "If we are successful, that will be the first product FDA has approved for spinal cord injuries," Surgenor said at the time. His company was banking on the spinal cord injury indication, a potential $100 million market.

But now Cyberkinetics has filed a report with the Securities and Exchange Commission with the following news: "Based on our most recent informal communication with the FDA, we do not anticipate that we will receive approval of the Andara HDE before the end of 2008, if at all. The FDA has indicated to us that they are planning to issue a letter communicating additional concerns about the data we have provided to date. We do not have any specific information about the content or any estimate of the timing of this letter."

Cyberkinetics was also seeking a Humanitarian Device Exemption from the FDA for its implantable Andara OFS (Oscillating Field Stimulator) System.

In its report to security regulators, the company said that it has "... no information from the FDA as to what additional information or data might be required to receive such approval."

Surgenor had not returned calls to MDD by the closing time for this edition.

The Andara OFS technology is designed to restore sensory and motor function through the use of low voltage, direct current, electrical stimulation that promotes and directs the nerve fibers to grow across the area of injury. Results from a Phase Ia trial in patients with recent spinal cord injuries indicated statistically significant improvements in sensory and motor function at 12 months after treatment. The company was also planning to apply the same technology to a different, broader market for peripheral nerve injury.

But given the negative feedback from FDA, Cyberkinetics would have to do a lot more work to prove the technology. A lack of funding will make that impossible.

"We have been unsuccessful in raising any additional capital and do not anticipate being able to raise additional capital to continue operations due to the uncertainty concerning what might be required to obtain FDA approval, combined with current market conditions," according to the SEC filing. "Our existing cash and cash equivalents are only sufficient to meet our projected operating requirements for approximately 30 days."

In a last-ditch effort, Cyberkinetics is in the process of negotiating with its secured creditor, General Electric Capital (GEC; Stamford, Connecticut) "... to allow us to proceed with an orderly wind down of the company. If we are not successful in our efforts to develop a mutually acceptable wind-down plan with GEC, we plan to cease operations and we may seek bankruptcy protection."

Late last month, two members of the company's board of directors resigned and Cyberkinetics said that it did not intend to fill those vacancies.

The company has been struggling for a while to keep its head above water, awaiting FDA communications, and in May sold its Salt Lake City-based Research Products business to I2S Micro Implantable Systems (Salt Lake City) for $982,000 in cash, with Cyberkinetics retaining roughly $570,000 in accounts receivable.

That part of the business provided neurotechnology equipment, including neural recording arrays, array insertion devices and data acquisition systems to academic researchers around the world.

"This divestiture provides capital to support our streamlined operations as we continue to focus on our strategic priority: obtaining FDA approval and launching the Andara," Surgenor said at the time in a company statement.

In an article that appeared last week in the Indianapolis Star, Surgenor was quoted as saying he still believes in the value of Andara. He added that the company's primary focus right now is survival. "It's a difficult message," Surgenor said, "but that's where we are."

At midday Tuesday, the company's stock was trading at $0.008 per share, down from a high of $0.54 within the last 52 weeks.