A Medical Device Daily

Japanese imaging giant Pentax has placed a first-year order worth more than A$5 million with Optiscan Imaging (Melbourne, Australia) for miniaturized microscope components that will be used to produce a new type of medical instrument called a flexible endo-microscope.

Optiscan and Pentax have collaborated over the past three years on the development of the new device, which combines Pentax's miniaturized camera endoscope technology and Optiscan's miniaturized microscope technology.

Pentax, which expects to have the new instruments available for sale to physicians during the first half of this year, will market and sell the flexible endo-microscopes into an annual global market for flexible endoscopes estimated at about $900 million.

Optiscan said the number of flexible endo-microscope systems Pentax will purchase from it in the first year of market release for the new product exceeds its initial estimate of 40 to 80 such units.

Matthew Barnett, CEO of Optiscan, said, “We are thrilled with the size of this order, as it is greater than our upper-end forecast of 80 units. It shows that Pentax is committed to this technology and is a measure of their confidence for its success in the market.“

Optiscan will supply Pentax with miniaturized microscope scanner inserts and laser confocal control box sub-systems. Under its collaboration with Pentax, Optiscan supplies those core components for Pentax to assemble into finished flexible endo-microscope systems.

Revenue generated for Optiscan from deliveries against this order are expected to occur mostly in the 2005-2006 fiscal year.

The Pentax-Optiscan flexible endo-microscope procedure was featured as the cover story in the September 2004 issue of the peer-reviewed journal, Gastroenterology, after clinical trials established what Optiscan described as “excellent medical utility“ in diagnosing very early-stage colon cancers.

The device was granted clearance in October by the FDA for the U.S. market and CE mark clearance for Europe, as well as being approved for sale in several other world markets.

Market introduction is anticipated in time for the important Digestive Disease Week Congress (DDW), scheduled to be held Chicago in May.

“This is a defining moment for Optiscan,“ said Barnett. “Our engineers have successfully miniaturized our powerful microscopes to create an endo-microscope, doctors have established the value of the endo-microscopes through clinical trials, the necessary regulatory clearances have been achieved and now significant revenues are starting with imminent worldwide market release.“

Optiscan said it is in discussion with a number of international companies for further licensing of its miniaturized confocal microscope technology in other fields, including rigid endoscopy.

Injectible scaffold development agreement

BioLineRx (Jerusalem) said it has signed an in-license agreement for the development of BL-1040, an injectible scaffold that reduces cardiac damage after heart attack. The exclusive global license agreement was signed with Ben-Gurion University (Beer Sheva, Israel) through its business company, BGN Technologies.

BioLineRx said it plans to develop the project through BioLine Innovations Jerusalem and to submit the project for funding by the Israeli Office of the Chief Scientist under the National Biotech Grant that BioLineRx received in November last year. BioLineRx said it anticipates an investment of about $9 million in order to achieve clinical proof of safety and efficacy.

The material, developed by Smadar Cohen and Jonathan Leor, professors in the department of biotech and biomedical engineering at Ben-Gurion University, is a biodegradable polymer that is injected directly into the area damaged by the heart attack. Within minutes, the material intercalates between the cells and fibers of the heart and rapidly forms a scaffold.

The scaffold enhances the mechanical strength of the heart muscle during recovery and repair, reduces the size of the scar after the heart attack, and may stimulate the growth of new blood vessels and encourage cardiac regeneration. In experimental heart attack models, the polymer has been shown to improve outcome, resulting in reduced cardiac dysfunction and reduced mortality.

“This agreement continues our commitment to building a strong diverse pipeline of novel treatments for unmet medical needs,“ said Dr. Morris Laster, CEO of BioLineRx. “We believe this new technology developed by Ben-Gurion researchers represents a breakthrough for the treatment of patients that have undergone heart attacks by regenerating cardiac tissue.“

Netta Cohen, CEO of BGN Technologies, added: “This agreement with BioLineRx brings us a step closer to realizing the great potential of this innovative research for saving lives.“

Founded in 2003, BioLineRx partners with researchers, universities and biotech companies to further the commercialization of promising compounds.

BGN serves as a link between industry and academic research, assisting the university and its faculty in translating their inventions and academic results into commercially valuable products.

It offers the life sciences industry inventions in the fields of biotechnology and medical devices, pharmaceuticals and drug delivery, information technology, security, electro-optics, nanotechnologies, chemical processes, agro-technology, environment and energy.

Biopure terminates Tshepo contract

Biopure (Cambridge, Massachusetts) said that it has signed an agreement formalizing the termination of its contract with Tshepo Pharmaceuticals (Pretoria, South Africa), the former registration holder and marketing and distribution agent in that country for Biopure's oxygen therapeutic, Hemopure [hemoglobin glutamer - 250 (bovine)], thereby effecting the transfer of the registration and resolving a long delay in the company's ability to market the product in that country.

Biopure has appointed an interim registration holder and has selected a warehousing and shipping agent to physically distribute the product in South Africa. Biopure also is seeking to register itself as a pharmaceutical marketing company in South Africa so it can directly hold the product registration.