美国Advanced BioHealing (ABH)
该公司开发了Dermagraft,是已获的FDA批准的治疗糖尿病足溃疡的皮肤替代品。
Advanced BioHealing (ABH) develops and commercializes living cell therapies, a cornerstone technology in the field of regenerative medicine. Living cell therapies repair damaged human tissue and enable the body to heal itself. A privately-held company, ABH participates in the rapidly growing diabetes market through the manufacturing and marketing of its lead cell-based therapy, Dermagraft®, a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body's natural healing process. Dermagraft is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial for the treatment of venous leg ulcers.
Corporate fact sheet
BackgroundAdvanced BioHealing (ABH) was founded in 2003 to develop and commercialize bioengineered tissue products. By 2005, two rounds of venture financing totaling $10.4 million had been raised to help fund product development. During this time ABH operated as a truly virtual company with two full-time employees and a collection of consultants performing various tasks.
In late 2005, when U.K. based Smith & Nephew announced the sale of assets related to their bioengineered tissue business, the opportunity to purchase their products (Dermagraft & TransCyte) seemed to fit perfectly with the ABH strategy. The most intriguing aspect was that both products were already approved for sale in the U.S. (and a number of other countries) thus providing ABH an "instant" commercial opportunity. The challenge was that manufacturing and promotion of the products had already been stopped.
After evaluating the commercial opportunity and tasks for re-starting manufacturing, it was clear there were many reasons to purchase the global rights to these outstanding products and the decision was made to proceed. The deal was finalized in May 2006.
Once the agreement was signed, the original 70,000 square-foot manufacturing facility in La Jolla, California was renovated, revalidated and began manufacturing Dermagraft again. During this time, a new commercial team was also put in place for the U.S. market.
The first pieces of ABH-manufactured Dermagraft were shipped to U.S. customers on February 15, 2007.
Also in the first quarter of 2007, a Series C round of financing composed of $30 million in venture investment and $10 million in venture debt was finalized. This capital has enabled the company to build a fully integrated operation with research, manufacturing and commercial capabilities.