In a story last week, I took a look at the county? makers of intraocular lenses?evices 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?t 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?n the surface of the eye?ather than deeper in the eye where the natural lens is.
While intraocular lenses often are used in cataract surgery, Presbylens isn? designed for that, Chief Executive J. Randy Alexander said.
Presbylens is implanted through a small, laser-created opening in a patient? cornea. It? 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.
?he FDA approval process is quite lengthy, so it looks like we?l 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 de-ciding 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? open to either being acquired or going public?cenarios that would be more likely after Presbylens?commercialization.
?arly technology is worth a lot less than once it? 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 Mag-na 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? related to the company? minimally invasive Sapien valve, which is sent to a patient? 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? annual meeting in Boston.
The EndoDirect system allows surgeons to stop a patient? 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 ?ounterpulsation technology,?which in-creases blood flow out of the heart, increases oxygenated blood flow to the heart and decreases the heart? 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.
Bits and Pieces:
Ensign Group Inc., a Mission Viejo-based nursing home operator, said its Mount Ogden Health and Rehabilitation Center in Ogden, Utah, graduated from the Centers for Medicare and Medicaid Services?special focus facility program, which focuses on turning around nursing homes that have problems. Ensign said in a statement that Mount Ogden was added to the program ?ased largely on events that occurred prior to Ensign? arrival.?An Ensign operating subsidiary bought Mount Ogden in 2006 ?Zoll Medical Corp. of Chelmsford, Mass., completed its previously announced purchase of Irvine-based Alsius Corp.? assets for $12 million. Alsius makes catheters and other instruments used in hospitals to control patients?body temperatures. Zoll said it plans to consolidate Alsius?operations at a new facility in the Bay Area.
