A Medical Device Daily

Cyberkinetics Neurotechnology Systems (Indianapolis) reported that it has agreed to acquire, through a merger with one of its wholly owned subsidiaries, Andara Life Science (Indianapolis). Andara is a privately held company developing a portfolio of programs related to the repair and regeneration of neural tissues developed at the Center for Paralysis Research at Purdue University (West Lafayette, Indiana).

With completion of the deal, a wholly owned subsidiary of Cyberkinetics will acquire all of the outstanding stock of Andara in exchange for $3.075 million of unregistered shares of Cyberkinetics common stock and $1.5 million of unregistered restricted stock. The merger has been approved by the boards of both companies.

Andara has developed the Andara OFS (Oscillating Field Stimulator) Device, which takes advantage, it said, of the ability of weak electrical fields to prevent the dieback of, and promote the growth of, nerve fibers.

The device, about the size of a lipstick container, is implanted within days of the injury and removed 14 weeks later.

Andara reported testing of the device in two randomized, sham device controlled trials in naturally injured dogs. Preliminary results from Andara's first clinical trial have been reported in the January 2005 issue of Journal of NeuroSurgery: Spine, indicating that participants paralyzed by spinal cord injury were able to regain sensation and some motor function following treatment with the Andara OFS.

Cyberkinetics said it expects to submit to the FDA this year an application for approval of the Andara OFS Device under a Humanitarian Device Exemption, based on a recent 10-participant clinical trial for those with acute spinal cord injury and preclinical studies. The studies, it said, demonstrated the device's ability to stimulate regeneration of nerve fibers in the spinal cord.

The device addresses a group of neural stimulation markets: traumatic brain injury, stroke, peripheral nerve damage and spinal cord injury. Cyberkinetics said that analysts estimate the market for neural stimulation devices at more than $1.6 billion annually, expected to grow to more than $10 billion within 10 years. It estimates the acute spinal cord injury market alone at more than $500 million worldwide.

Mark Allen Carney, president and CEO of Andara, has joined Cyberkinetics as executive vice president and a director. He will lead the effort to commercialize the Andara OFS Device and manage activities related to other technologies acquired in the transaction.

Richard Ben Borgens, PhD, chief scientific officer of Andara and the Mari Hulman George Professor of Applied Neuroscience and director of the Center for Paralysis Research at Purdue University – recognized for his expertise in spinal cord injury and the use of stimulation devices – will be scientific advisor to Cyberkinetics.

“We are excited about the opportunity to combine Cyberkinetics' innovative brain interface technology with Andara's proprietary neural stimulation therapy to build a leading neurotechnology company,“ said Carney. “[W]e're moving one step closer to providing real quality of life improvements for those who suffer central nervous system injuries and neurodegenerative diseases.“

“This acquisition is a pivotal moment in our drive to create a profitable, high-growth neurotechnology company,“ said Timothy Surgenor, president and CEO of Cyber-kinetics.

Cyberkinetics develops neural stimulation, sensing and processing technology for those with paralysis resulting from spinal cord injuries, neurological disorders and other conditions of the nervous system.

Its pipeline includes the FDA-approved NeuroPort System, a neural monitor designed for acute inpatient applications and labeled for temporary recording and monitoring of brain electrical activity; and the BrainGate System, designed to provide communication and control of a computer, assistive devices, and, ultimately, limb movement.

In other dealmaking activity:

• AMS Homecare (Vancouver, British Columbia) reported signing an exclusive 20-year North American licensing agreement with V (Richmond, Virginia) to apply Nemesyscos Layered Voice Analysis (LVA) software technology into the North American residential and residential care security market.

V is the North American licensee of Nemesysco's LVA. Terms of the agreement were not disclosed.

AMS said it intends to develop a hardware telecommunications device with a voice component to incorporate the LVA technology within its existing Integrated Emergency Response monitoring system and within a general home security system.

AMS also has the right to apply to V for the use of LVA in other applications, such as medical and general investigation. The company says that the technology can reveal psychological parameters in the voice to determine degrees of deception, stress, voice manipulation and other traits useful in conjunction with other psychological testing to determine the health or risk of a patient or to analyze the degree of truthfulness of witness statements in any litigation or court proceeding.

LVA was originally developed for military applications but has been adapted for non-military uses.

AMS is a provider of mobility equipment, durable, disposable medical products and patient monitoring technology and is a U.S. retailer with its own pharmacy/durable equipment store.

• Medical device incubator and technology brokerage firm Hatch Medical (Duluth, Georgia) reported that it has entered into an agreement with Greg Nordgren to broker his company's patent-pending high-flow valve platform, FloTec.

Developed by Nordgren, a biomedical engineer with 23 issued and six pending patents, the FloTec valve features elements enabling high-pressure injections and over-the-wire placement without compromising valve integrity. Its applications include PICC lines, hemodialysis catheters and other central venous catheters. Nordgren estimates that the FloTec valve could enhance the performance of an estimated 5 million vascular access catheters used globally on an annual basis.

Paul Gianneschi, managing principal and founder of Hatch, said that Nordgren has been involved with the design and development “of virtually every commercially available valved vascular access product, including the industry-standard Groshong valved catheters.“

Nordgren said, “FloTec's molded components allow for simplified manufacturing and testing while producing higher yields in production than comparable products. In addition, our vastly improved flow rates allow for high-pressure injections and secure over-the-wire placement without compromising valve integrity.“

The FloTec may be licensed or acquired by third parties through an agreement with Hatch.

• Health Management Associates (HMA; Naples, Florida) said it has withdrawn its non-binding offer to Ascension Health to acquire St. Joseph Hospital (Augusta, Georgia). It provided no reason for the withdrawal, but said it had hoped to complete the transaction by March 31.

HMA operates non-urban, general acute-care hospitals in communities throughout the U.S.