Medical Device Daily And MDDs

Retina Implant (Reutlingen, Germany), developer of a sub-retinal chip for restoring partial vision in people suffering from certain forms of retinal degeneration, has become a corporation ahead of an expected intial public offering (IPO).

Details about the IPO for the newly formed Retina Implant have not been disclosed, although changing the form of organization prepares the company for expected investments to support its plans for an initial expansion to Western Europe markets, followed by an entry to the U.S.

“We are optimally equipped with the private equity financing of a German business angel, but have no definite date in mind for going public,” said CFO Reinhard Rubow, who added that further clinical tests are necessary to confirm the results of recent trials and to improve the product.

Several companies have introduced prosthesis devices to restore sight, such as a stimulator chip from the Massachusetts Institute of Technology (Cambridge) that sits on the retina and receives signals beamed from a camera mounted on a pair of glasses

But Retina Implant is on the leading edge of a worldwide competition to find a commercial application for nanotechnologies to restore sight.

The other leading developer with a device in clinical trials is Optobionics (Naperville, Illinois), a privately held company supported in part by Medtronic (Minneapolis) that received FDA authorization to implant an artificial silicon retina (ASR) device designed to stimulate damaged retinal cells and allow them to send visual signals again to the brain.

The Optobionics ASR microchip contains 3,500 solar cells that detect light and convert it into electrical impulses and does not require the use of external wires or batteries.

The Retina Implant amplifies images with a power boost. The chip uses a microphotodiode array of 1,500 light-sensitive microelectrodes that collect incident light and transform it into an amplified electrical current to stimulate the retinal ganglion cells. A wire from the device runs from the eye socket to behind the ear and is connected to a battery.

The chip measures 3 millimeters, with a thickness of 50 microns.

Animal trials were conducted beginning in 2000 to validate the Retinal Implant technology and the project entered clinical trials in 2005.

Early in 2007 a team of surgeons at the University of T bingen in Germany announced they had implanted a chip behind the retina of one eye in seven legally blind patients between the ages of 26 and 58. The chips restored limited vision to three of the patients, they reported.

The company reports these three patients can perceive light in certain shapes and patterns and can recognize sources of light and contrast patterns, such as a light-colored plate on a dark table.

By 2009, Retina Implant hopes to launch a fully functional chip after winning quality control certification essential for authorization to market the device.

The Economist estimates the cost of the device will be around $35,000, which company CEO Walter Wrobel says is less than the expense of training a guide dog.

B&L launches Stellaris at congress

Bausch & Lomb (B&L; Rochester, New York) launched its Stellaris Vision Enhancement System in Europe at this week’s congress of the European Society of Cataract and Refractive Surgeons in Stockholm, Sweden.

The Stellaris system is the cornerstone of B&L’s micro-incision cataract surgery (MICS) platform. The company said the system is “ideal for all techniques, particularly 1.8 mm biaxial and 1.8 mm coaxial procedures.”

B&L said its Stellaris EQ fluidics management technology “allows surgeons to choose either a flow-vacuum module or an advanced vacuum module.” Using the flow-based module, surgeons can switch between flow and vacuum modes for optimal surgical flexibility and efficiency, according to the company.

“The inherent safety of the Stellaris system stems from the EQ technology, which balances aspiration dynamics in flow and vacuum modes for exceptional chamber stability,” B&L said in a statement.

“Bausch & Lomb’s successful surgical business has continued to gain momentum in recent years, thanks in part to our Millennium Microsurgical System and Akreos acrylic intraocular lens,” said Alan Farnsworth, corporate senior vice president and president, Europe, Middle East and Africa Region. “With the launch of the Stellaris Vision Enhancement System and our Akreos MI60 microincision lens, we’re poised to further enhance our leadership position.”

Leading European surgeons presented their first clinical experiences with the Stellaris system in both B-MICS and C-MICS procedures at Bausch & Lomb’s MICS Symposium, held on Monday.

“The system lets surgeons operate at our own pace when using smaller incisions, without compromising speed or efficiency, while delivering excellent optical outcomes,” said H. Burkhard Dick, MD, of the Universit ts-Augenklinik Center for Vision Science at Ruhr University. “It limits complications, reduces the rehabilitation time for the patient and provides excellent results directly after surgery. After more than 50 cases with the Stellaris system, I continue to be impressed.”

In addition to the Stellaris system, Bausch & Lomb showcased new advancements in refractive surgery during the meeting, including:

• The Zyoptix ACE Advanced Control Eyetracking technology, which the company said is designed to further improve the accuracy and predictability of refractive surgery outcomes by dynamically compensating for intraoperative cyclotorsion (eye rotation).

• The Zyoptix XP Epi Separator, a forthcoming epithelial separation technology for the Zyoptix XP microkeratome platform that will support both LASIK and Epi-LASIK surgery, a procedure that B&L said “may be more appropriate for certain patients, such as those with thin corneas, higher refractive errors or dry eyes.”

Artimplant names marketing manager

Biomaterials maker Artimplant (Vastra Frolunda, Sweden) has named Kauko Haapasaari marketing manager, effective Oct. 1.

Haapasaari presently is director of business development at Raisio Diagnostics and previously has held marketing and sales positions at Conpharm, SP-Maskiner, Swedish Trade Council, Instrument Lambda and KabiVitrum.

Hans Rosen, CEO of Artimplant, said his firm will benefit from Haapasaari’s experience in international marketing and sales within the life science industry.

Artimplant produces degradable implants for treatment of osteoarthritis in the hands and feet, for shoulder and other soft-tissue injuries as well as oral applications.