Growing Windpipes with Harvard Apparatus (HARTV)
In previous posts we discussed companies such as Organovo and EnvisionTec which are developing 3D printers that one day are expected to 3D print human organs. This concept of growing organs is not only feasible through the use of 3D printers but also through bioreactor technology. A company focused on commercializing this type of technology began trading on the NASDAQ exchange this week, Harvard Apparatus Regenerative Technology. In their now withdrawn S-1, the company listed Organovo as one of their competitors.
Harvard Apparatus Regenerative Technology (NASDAQ:HARTV) is a spinoff from publicly traded Harvard Bioscience, a $179 million market cap company that provides life sciences products in two main areas; ADMET testing and molecular biology. HARTV began trading on the NASDAQ exchange earlier this week and commands a current market cap of $50 million. While Harvard Bioscience originally planned to spin off HARTV through an initial public offering, they withdrew the IPO because of unfavorable market conditions.
HARTV’s lead prodcuts are a bioreactor and a synthetic scaffold that can be used by surgeons to create a replacement trachea, or airway, for patients who need an airway transplant. Most human organs draw their shape from an internal scaffold of collagen and proteins. Harvard Apparatus has developed a scaffolding material that is strong and flexible and won’t be rejected by the body. The surgeon then uses the patient’s own bone marrow cells to seed the scaffold and regrow the organ, in this case, the trachea.
The company believes their products are the first to enable the application of regenerative medicine techniques to the production and transplant of complex, three-dimensional human organs like the trachea. Their bioreactor technology has been used in six successful human airway transplant surgeries, including what they believe to be the world’s first transplant of a regenerated airway. Their second surgery was the world’s first transplant of a regenerated airway using a synthetic scaffold. An article published in the Wall Street Journal yesterday highlighted that five years after a 30-year-old woman was implanted with the world’s first tissue-engineered trachea grown in a bioreactor, she still lives complication-free.
Combining patients with trachea cancer, trachea trauma and tracheal agenesis, the company estimates the total addressable patient population for trachea transplants using their products at approximately 6,500 per year. Should the company receive regulatory approval, they estimate the total potential market could exceed $300 million per year if they were able to charge at least $50,000 per procedure for their trachea products. This estimate also excludes what they believe to be a much larger pool of existing potential patients.
Time to Market
Based on HARTV’s initial review of FDA and EU regulatory precedent, the company expects to receive regulatory approval to market their regenerated trachea transplant products in the EU by the end of 2015, and assuming accelerated review, they expect to receive FDA approval by the end of 2016. While the potential target market for tracheas may not be that large, it will be exciting to see the progress made in this area along with other organs the company may choose to grow as seen by the below product roadmap published in their withdrawn S-1:
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