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Ellipse Spine Device Ready for Europe, FDA Talks On

Irvine-based medical device startup Ellipse Technologies Inc. is making a push for its products to play a leading role in treating spinal and orthopedic disorders in a less-painful way.

Ellipse is gearing to sell its lead product, Magec, in Europe. The device is used to treat early onset scoliosis, or a spine curvature found in children.

“The whole world of medical technology has gone to less-invasive surgery, less-invasive approaches,” Ellipse Chief Executive and Chairman Michael Henson in an interview from Copenhagen last week, where the company was making a presentation at the International Meeting on Advanced Spine Technologies.

“Ellipse takes it to the next level,” Henson said. “You don’t even need to invade the patient at all.”

Remote Control

Ellipse’s devices are controlled remotely after they are implanted, which allows surgeons to make adjustments in office procedures that don’t require anesthesia.

“It’s kind of the next-generation approach to medical device development,” Henson said.

Traditionally, early onset scoliosis has been treated with rods that are implanted in a child’s curved spine and often require multiple surgeries.

“The average child (with early onset scoliosis) has between eight and nine surgeries from the age of say, 2 to 12, or from 6 to 16,” Henson said. “It’s a very difficult life that they lead.”

Ellipse is in talks with the Food and Drug Administration for outlining U.S. approval of Magec, Henson said.

Leg Device

• Headquarters: Irvine

• Founded: 2006

• Business: medical devices

• Yearly revenue: pre-revenue

• Notable: well-established industry investor, entrepreneur Michael Henson is chairman, lead device sold in Europe, seeking FDA approval here

Another Ellipse device, called Precice, is used to lengthen leg bones. Like Magec, Precice is controlled remotely.

Precice is used in what’s called “limb-lengthening” procedures. Limb lengthening is used to treat medical conditions such as shortened legs caused by congenital abnormalities, major leg fractures and diseases such as cancer, among others.

Ellipse was founded five years ago and plans to sell its devices to spinal surgeons, pediatric surgeons and orthopedic trauma surgeons.

The company is going to use a mix of distributors and its own salespeople overseas.

If Ellipse’s devices are approved domestically it will hire a sales staff here, Henson said.

Other Orange County medical device makers are working on different spinal conditions.

Vertos Medical Inc. in Aliso Viejo has developed a procedure and devices to treat lumbar spinal stenosis, or a narrowing of the spinal canal.

Longtime Investor

Ellipse is pre-revenue and has eight workers.

It’s the latest creation for Henson, a longtime investor and entrepreneur in the county’s medical device industry. He has founded or served as chief executive, chairman or director for 16 medical device or biotechnology companies.

Six of Henson’s startups were privately held and eventually bought by multinational companies.

Five have had initial public offerings, while the remainder are closely held private companies.

As for Ellipse, “its technology is so fundamental and so different, and the clinical value is so compelling, that it has the capability of being a fully standalone company,” Henson said.

Henson created the MedFocus Fund some 10 years ago with venture capital from the Japan Asia Investment Fund and undisclosed private investors.

In March, a product that MedFocus developed and did clinical trials on, the Embrella, was sold to Irvine heart device maker Edwards Lifesciences Corp., Henson said.

Full Resumé

Other companies Henson’s founded include MiCardia Corp., an Irvine company that makes a device to treat mitral valve regurgitation.

He also helped start and grow EndoSonics Corp., which was sold in 2000 to Netherlands-based device maker Jomed NV, and InnerDyne Inc., a Sunnyvale company which was sold to Tyco Healthcare, now Covidien Ltd.

Henson runs the MedFocus industry incubator in Irvine, where he began working with Behrooz Akbarnia, a clinical professor of orthopedics at the University of California, San Diego, on the idea for Ellipse’s devices.

He also serves as principal manager for four private investment funds and as an advisor to two others.

All of those funds focus on early- and mid-stage medical device startup companies.

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