A Medical Device Daily

Organogenesis (Canton, Massachusetts) said last month that it has signed a memorandum of understanding with China’s National Tissue Engineering Center (NTEC; Shanghai), a stem cell and regenerative medicine consortium.

Organogenesis formed the three-phase agreement with NTEC in early December while visiting China as a delegate of Massachusetts Gov. Deval Patrick’s trade mission to that country.

“We are excited about this new development, and see this partnership as an opportunity to open up the Chinese market for our company’s technologies,” said Geoff Mackay, CEO of Organogenesis. “The National Tissue Engineering Center is an ideal partner for Organogenesis, as international leaders in the fields of cell therapy and plastic surgery, with strong support from the Chinese government.”

The NTEC is a central government-funded private company. Its founder, Professor Yiling Cao, is a well-known plastic surgeon who was trained at Harvard and the Massachusetts Institute of Technology (Boston) where, coincidentally, Organogenesis was originally founded.

The NTEC comprises more than 70 scientists and growing teams of regulatory, production and commercial professionals and has recently completed the development of a new facility in a Shanghai Technology Park with manufacturing, R&D laboratories and business offices.

According to the agreement between the two firms, the first phase of the partnership will begin immediately and will include the commercialization and exporting of existing Organogenesis technology – including its signature product, Apligraf – in the Chinese market, and eventually throughout Asia.

Currently, the field of use in the memorandum of understanding covers wound healing and scars, but performance milestones may expand the scope of the agreement to include broader surgical uses.

Organogenesis said Phases II and III will follow, triggered by milestones achieved between the two companies. Phase II will include manufacturing existing Organogenesis cell therapies via a manufacturing site in Shanghai, necessary due to the short shelf life of living cell technology, including Apligraf.

Phase III will include the co-development of new technologies, which may be custom-designed for Chinese market needs. As a parent company of the partnership, Organogenesis will hold the commercial rights for all Western markets for new technology developed.

Long-term study backs LASIK

A decade-long study carried out by researchers in Spain and Turkey on patients who had laser surgery to treat high myopia, or nearsightedness, indicated that the treatment is safe and effective in the long term, with a re-treatment rate of less than 30% reported.

Published in the January issue of the American Journal of Ophthalmology, the follow-up study was conducted by researchers from Miguel Hernandez University Medical School (Alicante, Spain) and from Ankara University School of Medicine (Ankara, Turkey).

Laser eye surgery has been conducted since the early 1990s. The two main types for correcting myopia are photorefractive keratotomy, for low-to-moderate myopia, and laser in situ keratomileusis, or LASIK, for high myopia.

The study found that in the long term, LASIK was a safe and effective procedure for patients with pre-operative myopia of more than -10 diopter. The researchers evaluated 196 eyes of 118 patients that needed at least 10 D corrections to achieve 20/20 vision before receiving laser surgery. The extent of the preoperative myopia was a mean of -13.95 plus or minus 2.79 D.

The patients studied all received LASIK surgery at the Instituto Oftalmologico de Alicante in Spain between April 1992 and December 1995. They had check-ups after three months, one, two, five and 10 years.

The study said results showed that after 10 years, 42% of the eyes studied were within plus or minus 1.00 D, 61% were within plus or minus 2.00 D, 27.5% of the eyes were retreated because of under-correction or regression, or both.

Lead investigator Jorge Alio said, “These results are extremely encouraging considering that this refractive correction implies the maximum limit of application of this technique.”

In an editorial in the same issue, Dr. George Waring, of Emory University and Inview (both Atlanta), generally supported the findings, and said that LASIK and other vision correction procedures have improved significantly in the last 10 years, with some recent studies on LASIK reporting correction to plus or minus 0.5 D in more than 90% of eyes.

Given makes Israel royalty payment

Given Imaging (Yokneam, Israel) reported that it has paid its outstanding royalty obligation and accrued interest of about $5 million to Israel’s Office of the Chief Scientist of the Ministry of Industry, Trade and Labor (OCS).

The company was committed to pay royalties to the OCS for several programs on proceeds from sales of products that the Israeli government participated in by way of research and development grants. It said the repayment will result in a one-time charge of about $5.7 million to its income statement in 4Q07.

“Given Imaging has a solid cash balance of over $100 million, enabling us to make an earlier repayment of this interest-bearing obligation, and we expect this will have a positive impact on future earnings,” said CFO Yuval Yanai.

The company also said that based on an acceleration of the termination of a cooperation agreement with Ethicon Endo-Surgery (Cincinnati), it has revised its estimates of the financial effects. Given now expects to record a pre-tax gain of about $23 million in 4Q07, and another pre-tax gain of some $5.4 million in 1Q08.

Given is the developer of the PillCam technology platform for optical detection of gastrointestinal disorders.

Nasdaq warns pSivida on share price

pSivida (Perth, Australia), a drug delivery company, said it received a letter from Nasdaq noting that, for the last 30 consecutive business days, the bid price of its American Depositary Shares has closed below the minimum $1 per share required for continued listing on the Nasdaq Global Market.

The company has 180 calendar days, or until June 24, to regain compliance.

“[We are] committed to regaining compliance, and are pursuing various strategies, including the potential of non-dilutive capital,” said Managing Director Dr. Paul Ashton.

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