Reborn, ACell enters medical wound healing

Jessup firm successfully appealed a 2005 court ruling alleging patent infringement

Friday, Nov. 10, 2006

Alan Spievack, surgeon and founder of ACell Inc., is ‘‘just delighted” that his company is joining the emerging field of tissue-regenerating products for wound healing — for the second time.

The Jessup company resumed operations this month following what Spievack called a ‘‘very difficult” three-year round of court battles to protect its patented wound-healing technologies, made from pig bladders.

Spievack started ACell in 1999 and soon thereafter started marketing its products to veterinary markets, including trainers of thoroughbred and steeplechase horses. The privately owned company had sales of $1 million between June 2004 and June 2005.

The company had to shut down in July 2005, however, when a U.S. district judge in Lafayette, Ind., ruled it was guilty of infringing on patents owned by Cook Biotech Inc. of nearby West Lafayette, a company associated with Purdue University.

But in August, a federal appeals court overturned the verdict, and last month it denied Cook Biotech’s petition to reconsider the decision.

ACell is primed to re-enter the lucrative human-wound-healing market, said Miles Grody, the company’s COO and general counsel. He said he is fielding inquiries from venture capital firms and potential marketing partners in the pharmaceutical industry. The global wound care market was worth $1.49 billion in 2004 and is expected to reach $3.05 billion by 2011, according to the 2005 book ‘‘Global Advanced Wound Management Markets.”

‘‘Our technology has applications across a broad range of medical fields: wound care, general surgery, urology, gynecology, orthopedics, plastic surgery and cardiovascular and others,” Grody said.

The company’s urinary bladder matrix is a parchment-like sheet made the bottom layer of pig bladder and the adjacent connective tissue. ACell also sells a wet form of the sheets and a powder form called ACell Vet, which, according to the trade journal Horse Care, is effective in healing injured ligaments and tendons of sport horses.

ACell, with 13 employees, is not the only Maryland company in the wound-healing field.

BioElectronics Corp. of Frederick, RegeneRx Biopharmaceuticals Inc. of Bethesda and BioSurface Engineering Technologies Inc. of Rockville all are trying to tap the market.

BioSurface develops synthetic peptides that boost tissue healing and aids the body’s responses to medical device implants.

RegeneRx is developing a specialized human peptide to heal bedsores, chronic skin lesions, heart damage, eye corneal conditions and other sores.

And BioElectronics has developed ActiPatch, a disposable skin patch with an embedded battery-powered microchip designed to promote faster healing after surgery.

Golf, poison ivy, a bladder

The saga of ACell, parts 1 and 2, began when Spievack got poison ivy playing a round of golf near his home and work at Harvard Medical School’s hospital system in Boston.

Instead of using Calamine lotion, he took a dog bladder out of his basement refrigerator and applied it to the sores on his skin. The bladder cured the poison ivy wounds, he said.

While not everyone with a wound has a handy animal bladder stored in the fridge — the owner of a dying dog had donated the organ to the Harvard hospital system — Spievack’s discovery rekindled his ‘‘sideline research,” he said.

He had begun his research in college with studies of how salamander newts regenerate severed body parts.

Soon after his itchy golf round, Spievack met Purdue University’s chief inventor of bio-engineered tissues, Stephen F. Badylak, at a scientific meeting.

They created ACell to qualify for licensing the university’s tissue regenerating patents and receive research loans. Since fired from Purdue during the trials, Badylak is now ACell’s chief scientific officer. Spievack is vice president and director of technology.

Spievack’s research is still in Boston. And ACell’s manufacturing plant is near some pig slaughterhouses in LaFayette. But it will maintain its sales, marketing and investment office in Jessup, which is convenient to medical and federal facilities in the region, Grody said.

Before the litigation, ACell was ‘‘on track for a million dollars in annual sales,” Grody said.

But big money was also at hand for Cook Biotech and the Purdue Research Foundation, which is responsible for the university’s technology-transfer program and its Purdue Research Park, home of Cook Biotech. The foundation has received more than $15 million for more than 75 of its patents for its technology for extracellular matrices as a platform for tissue engineering, the inventions by Badylak and others.

ACell’s technology is only one of many such matrix technologies, Spievack said.

‘‘That is why we are delighted” to be past the court battles, he said. ‘‘Not only are we vindicated as a scientific advancement, but hopefully we can finally grow a very good company, which, if it works the way the government wants it to, will [generate] a lot of tax money.”

Applying ‘‘these new dermal substitutes for wound care is a trend now,‘‘ said Dr. Marvin Leneau, director of wound care at the Veterans Hospital in Baltimore and clinical director of the Diabetic Foot Center at the University of Maryland, Baltimore. He said such technologies as the pig bladder product heal a wound faster and often with less risk for infection than conventional treatment.

But ACell and Cook Biotech continue to jab publicly at each other.

Grody said the only appeal left to Cook is to the U.S. Supreme Court ‘‘and they won’t do that.”

However, Cook has not ruled that out, said spokesman David McCarty. ‘‘At this time, we are considering all options and cannot comment on any particulars of the legal case,” he said.