Ex-Harvard Bio Prez Leads Spin-Off’s Plan to Make Engineered Organs

2/18/14Follow @benthefidler

David Green had led Holliston, MA-based Harvard Bioscience (NASDAQ: HBIO) for almost two decades when he was faced with a big career choice. The company was about to spin off a new firm that would take with it an ambitious technology Harvard Bio had been developing to make engineered organs—a high-risk, high-reward project. Green had the chance to lead either one company or the other, but not both.

“It’s genuinely exciting stuff,” Green says of the organ project. “It makes great cocktail party conversation, it’s a great story to tell your children.”

Suffice it to say, Green chose to go with the spin-off. Late last year, he became the president, CEO, and chairman of the newly-created Harvard Apparatus Regenerative Technology (NASDAQ: HART). In his new role he’s spearheading a mission worthy of science fiction: to create replacement organs that incorporate a patient’s own cells.

It’s a big departure from Green’s previous post at the stable Harvard Bio, a 113-year-old company that’s best known for selling scientific instruments used in various researcher labs. HART, in contrast, is now developing artificial tracheas for patients whose own windpipe was damaged by injury or disease. It’s the first step in a big plan to offer a whole line of engineered organs, including hollow ones such as esophagi, heart valves, and even eventually whole hearts or lungs.

The potential benefit of such technology for patients who need transplants is huge. Donor organs are notoriously scarce and those lucky enough to receive one must take powerful immunosuppressants for the rest of their lives to prevent rejection. If HART’s plan succeeds it could provide a virtually limitless supply of replacement organs that, because they’d be built with each patient’s own cells, would eliminate the risk of rejection.

But HART is still at the stage where the risk of failure is very real. None of the company’s technology is yet approved by regulators in either the U.S. or Europe, though it has been used to treat a handful of people on an experimental basis or under “compassionate use” exemptions, which are granted for gravely ill patients with no other options. HART still has to conduct the necessary trials, amass clinical data, and prove its engineered organs are safe and effective—not to mention convincing surgeons to try them—before its vision can become a commercial reality.

HART president and CEO David Green

HART president, CEO, and chairman David Green

It wouldn’t be the first time that Green pulled off a dramatic transformation. He first joined Harvard Bio—then known as Harvard Apparatus—as its president in 1996, after multi-year stints as a brand manager for household products with Unilever and as a consultant with Monitor Co. He co-led a management buyout of the company with then CEO Chane Graziano, took the company public in 2000, and then engineered a variety of acquisitions and licensing deals. The net result: Harvard Bio, which generated about $8 million in annual revenue when Green got there, took in more than $100 million last year.

Along the way, Green took on an unusual project, a stab at regenerative medicine that didn’t necessarily fit with the core business of Harvard Bio. Green says that Harvard Bio had been selling equipment used to test the physiology of organs while they’re preserved outside the body—a method commonly used by pharmaceutical companies to see the impact a drug candidate might have on, say, a heart or a lung. But in 2008, a Massachusetts General Hospital surgeon named Harald Ott called Harvard Bio and asked if the company could tweak that organ research equipment so it could be used to help regenerate organs instead.

The company obliged, and started working with the hospital on technology that could be used to grow organs outside the body. Around that time, Green read a paper in The Lancet, a top-tier medical journal, from a team led by Paolo Macchiarini, then a thoracic surgeon at Hospital Clinic in Barcelona, Spain. The group had prepared a new trachea for a woman named Claudia Castillo with the help of a new type of bioreactor—a device that could keep cells sterile and alive long enough to grow into and around a scaffold.

This wasn’t a typical transplant, in which an organ would be harvested from a deceased donor and transferred directly to the patient. Macchiarini and his colleagues instead … Next Page »

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at bfidler@xconomy.com Follow @benthefidler

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