By Allison Kaplan Sommer Israel21c April 10, 2005

Whether it is fixing teeth by making dental implants adhere to the bone or making us look younger by filling in wrinkles, ColBar LifeSciences is a rapidly expanding Israeli biotechnology company that is harnessing collagen to revolutionize reconstructive medicine and tissue engineering.

ColBar has perfected a technique by which collagen, the principal building block in all living organisms, can be purified and transformed to produce a variety of products for medical application.

The company began with a discovery by Prof. Sandu Pitaru and Dr. Mati Nof, both from Tel Aviv University. In 1995, they founded the company with their own money.

“Our two founders had been exploring biomaterials and their usefulness in the various aspects of health care for quite some time. Their investigations dealt with how building block proteins like collagens behave differently in tissues, and how their production and structure can be controlled by various mechanisms,” Dorit Sokolov, the company’s director of business development, told ISRAEL21c

In 1998, Pitaro happened to bring his diabetic father to the doctor, who pointed out that his father’s skin was stiff with collagen, as a result of the increased sugars in his body.

This got Pitaro thinking about how susceptible collagen seemed to be to the effect of glucose in the body, and brought the concept to the lab — he wanted to see how the glycation mechanism could be controlled outside the body.

“So instead of controlling collagen with chemicals and radiation which is how it had been manipulated until then, he tried to mimic the way that collagen was crosslinked with the body. He found that the process with glucose was too slow, but with another natural sugar it was faster,” Sokolov said.

The ColBar core technology platform that resulted, Glymatrix, is capable of producing collagen-based biomatrices. The ability to program biological materials to perform in a manner appropriate to different applications provides ColBar with the opportunity to develop a number of bio-surgical product applications to address a variety of medical needs.

With a focus on the repair of damaged tissue in the human body like soft tissue, bone and skin, the question in the company’s early years was where to begin. Collagen can be used in dermatology, orthopedics, dentistry or any field requiring construction of infrastructure and the building and rehabilitation of some type of tissue. While the marketing began with dermatological cosmetics, collagen is currently used in 15 separate applications, including patches for preventing surgical hemorrhaging, dental applications, urology surgery, the digestive tract, and orthopedics. It is that tremendous potential for various uses and huge sales that have caused investors to put $31 million in the company to date.

As Pitaro was a dentist by training, it was natural to focus first on a dental product. ColBar’s first commercial product, Ossix is used to help in generating the extra bone mass required in certain dental implant procedures (Guided Bone Regeneration.) It is sold worldwide, including in the United States, where it received FDA approval in 2000. Ossix is sold and marketed by ColBar’s partner 3i Implant Innovations, Inc. (3i), a worldwide leader in dental implants.

The Ossix membrane is used as a base for dental implants. The material resembles a band-aid, while contact with water makes it very similar to biological material. It is placed beneath the implant, which it matches with the existing bone.

But right now, all eyes are on ColBar’s second product, EVOLENCE, the company’s new flagship product — a uniquely formulated natural collagen injection for the correction of soft tissue contour deficiencies and deformities.

The European CE mark for EVOLENCE was granted in October 2004 and the product was launched in Europe in November at the 13th European Academy of Dermatology and Venereology Congress in Florence.

Events designed to introduce and demonstrate EVOLENCE to doctors and medical practitioners have taken place in Spain, Italy, France, Germany, Belgium and the UK.

“It is still very early — but so far reception has been good,” said Sokolov. “We’re very optimistic about this product and we really think it’s a revolution with an incredible sales potential.”

EVOLENCE is not yet approved for sale in the US, where it is restricted for Investigational Use Only, although the FDA has already approved initiation of a clinical study under an investigational device exemption (IDE).

When it does receive FDA approval, one can expect that it will be embraced with open arms by the movie star set — and other Americans interested in preserving a youthful look.

Its superiority to current collagen treatments is that it can control the protein?s biodegradation rate in the body. Since the body identifies the collagen as part of itself, it simply assimilates it over time in a way that makes it difficult to control the rate of the process. Without control, the tightening effect of cosmetic injections into wrinkles vanishes in a few months, which is why it now requires frequent repeat injections.

“Unlike current collagen treatments to eliminate wrinkles and facial lines, that require 3-6 injections per year, EVOLENCE maintains its aesthetic corrective effects for a period of at least 12 months,” explained Sokolov.

The Evolence product is an opaque gel comprising collagen at a concentration of 35 mg/ml, supplied in a one ml pre-filled syringe that can be stored at room temperature.

The company has invested over $5 million in building the company’s plant in Rehovot Biotech Industrial Zone with state-of-the-art R&D labs and two production lines for both solid and injectable products.

ColBar currently has 60 employees based in its headquarters in Herzliya and its plant in Rehovot. The company is financially backed by Biomedical Investments, Genesis Partners, Pitango Venture Capital and Evergreen Venture Partners. The company recently completed a fourth round of financing and has raised a total of $31 million since its establishment.

In addition to its first two products on the market, ColBar has several other products in the pipeline, in various stages of preclinical development, designed for the urology, gastroenterology, orthopedic and cardio-vascular therapeutic areas.

This entry was posted on Tuesday, April 12th, 2005 and is filed under news.