http://www.allbusiness.com/legal/health-care-law-drug-medical-devices-approval/12361525-1.html

Publication: Orange County Business Journal

Local Eye Lens Maker Looks To Add Itself to Fray

By Reed, Vita

Date: Monday, May 18 2009

In a story last week, I took a look at the county's makers of intraocular lenses devices that are implanted in the eye to replace the natural lens.

The county is a hub for lens makers, with big names such as Santa Ana-based Abbott Medical Optics Inc. and Bausch & Lomb Surgical in Aliso Viejo dominating the pack.

Then there are several smaller companies quietly rolling along in the background.

Lake Forest-based Revision Optics Inc. is one such company - it is conducting a domestic clinical trial of its Presbylens corneal inlay lens.

Presbylens is different than an intraocular lens in that it is implanted in the cornea - on the surface of the eye - rather than deeper in the eye where the natural lens is.

While intraocular lenses often are used in cataract surgery, Presbylens isn't designed for that, Chief Executive J. Randy Alexander said.

Presbylens is implanted through a small, laser-created opening in a patient's cornea. It's geared to people 45 to 60 years old with presbyopia, a condition where the eye loses its ability to focus close-up as it ages.

Presbylens still is a while away from launching in the U.S.

"The FDA approval process is quite lengthy, so it looks like we'll be (launching domestically) in 2011, at the earliest," Alexander said.

Before Presbylens is approved, regulators require that it is implanted in at least 300 eyes and for the patients to be followed for at least one year and possibly two, according to Alexander.

Revision will start selling Presbylens in Europe within the next six months. Alexander said the company still is deciding whether it will sell Presbylens through its own sales people or by partnering with a larger company.

Revision, which raised $25 million of venture financing in 2007, still has $10 million in the bank and will be looking to raise another round later this year or in early 2010, Alexander said.

It's open to either being acquired or going public - scenarios that would be more likely after Presbylens' commercialization.

"Early technology is worth a lot less than once it's been proven in the marketplace," he said.
New Valve, Technique Irvine-based Edwards Lifesciences Corp. is introducing a heart valve and a minimally invasive way of implanting it.

Edwards said it received Food and Drug Administration approval a few weeks ago for its Carpentier-Edwards Perimount Magna Ease aortic heart valve.

Perimount Magna Ease is designed for easier implantation in the heart, Edwards said in a statement. It is inserted via a small incision.

The Perimount Magna Ease isn't related to the company's minimally invasive Sapien valve, which is sent to a patient's heart via a catheter. Edwards is in a major clinical trial for Sapien with an eye toward U.S. launch in 2011.

Edwards introduced Perimount Magna Ease, as well as its Port Access EndoDirect system at the American Association for Thoracic Surgery's annual meeting in Boston.

The EndoDirect system allows surgeons to stop a patient's heart and keep it at rest while the patient is having heart valve surgery. The system also prevents the need for an incision down the middle of the chest.

Clinical Trial Under Way Sunshine Heart Inc., an Australian medical device maker with U.S. headquarters in Tustin, said that its C-Pulse device, which treats people with moderate heart failure, was implanted in its first two patients in a 20-person clinical trial.

The trial is taking place at the Ohio State University Medical Center in Columbus, Ohio.

The C-Pulse, which is implanted on the aorta, reduces heart failure symptoms through the use of what Sunshine calls "counterpulsation technology," which increases blood flow out of the heart, increases oxygenated blood flow to the heart and decreases the heart's workload.

Sunshine is venture-backed. Its major investors are GBS Venture Partners and CM Capital, a pair of Australian venture capital firms. Three Arch Partners, a Northern California venture firm, owns shares but is not an active venture investor, Sunshine said.

The device maker is looking for American venture capitalists and private equity firms to help fund an upcoming clinical trial, it said.