Medical Miracles -
The Age of Bionic Reconstruction Arrives

Magic Pixie Dust -- that is what the media calls it.

Doctors and researchers call it an extra-cellular matrix (“ECM”) tissue graft derived from naturally occurring porcine urinary bladder, which acts as a scaffold for epithelial and progenitor cell attachment and proliferation.

Bottom line: It works. ECM heals wounds and helps to regenerate skin, muscle, tendons and other living tissue. ECM products from various manufacturers have been successfully used on humans to heal surgical wounds, diabetic ulcers, and damaged muscles and ligaments. The products have even been used to facilitate reconstruction of urinary tracts, rotator cuffs and other anatomical surfaces.

Furthermore, they have been successfully used on animals to treat extremely serious injuries, such as significant burns and degloving (which occurs when large areas of skin are sheared or torn off completely).

There is no telling how many applications ECM products might have, as doctors and veterinarians have only started using them in recent years. But CNN, 60 Minutes, Oprah, Fox News, the BBC and more than 170 peer-reviewed papers have attested to the seemingly miraculous healing potential of ECM.

In fact, you can find literally dozens of published reports about the use of ECM in soldiers returning from battle or civilians who have had ligaments or fingertips mangled by bombs, chain saws, model airplane propellers and other devices. Patients with damaged fingers have even regrown their nails and fingerprints while recovering sensation.

When a 51-year old Nebraska man lost the tip of his thumb in a chain saw accident, his doctor sent away for 20 powdered applications of the ACell MatriStem® ECM product. The patient described the result as miraculous. “The best one thousand bucks I ever spent in my life,” he reportedly said after the finger grew back almost entirely.

Miles Grody, Senior Vice President and General Counsel for ACell Inc., says that the impressive performance of MatriStem technology “has made ACell one of the fastest growing medical device companies in the country.”

He explains that a MatriStem graft, which microscopically looks like complex webs of biological string, works by “providing a platform for recruitment of adult stem cells.” These cells swarm to the ECM scaffolding at the injury or wound, “assisting in tissue growth and diversification into specialized cells of whatever kind is needed at the site.”

ACell’s MatriStem products, which are harvested from pig bladders (a waste item from the meat processing industry) and processed to isolate a discrete acellular tissue layer known as the epithelial basement membrane, are rich in laminin, biometric proteins, collagens, polysaccharide connective tissue and other growth factors that catalyze the growth of specialized living cells at the injury site.

“Because of these properties, MatriStem products promote rapid repair and remodeling of damaged tissue, can be totally resorbed by the body, and leave little or no scar tissue or calcification,” Grody says, explaining the product’s superior healing properties.

He notes that MatriStem products are currently cleared for human use in many applications, including general and plastic surgery, wound care (including diabetic ulcers) and esophageal reconstruction.

An application for human burn treatment is also being rolled out now, and orthopedic, cardiovascular and neurological applications are expected to follow, providing ACell with a total revenue opportunity that could potentially exceed $40 billion in the U.S. alone.

Grody notes that it all began with the work of ACell’s late founder, Dr. Alan R. Spievack, a surgeon, researcher and inventor who dedicated much of his life to regenerative medicine. Spievack conceived of an ECM composition featuring the epithelial basement membrane of pig bladders, which led to the creation of ACell in 1999.

Just a few years later, CEO James DeFrancesco jump-started the transition of Dr. Spievack’s invention from laboratory research to commercial product with rounds of angel investor financing, but the initial applications of the product were largely in the veterinary field.

“This was obviously a safer place to launch it with less demanding hurdles on getting to market,” Grody says, noting that ACell’s ECM performed even better than expected in animals. “When race horses are injured, they rarely get back to form, but veterinarians injected a powdered form immersed in saline into lesions in the tendons and ligaments of race horses, and they made a full recovery, returning to a high level of performance,” Grody says, adding that more than 1,000 competitive jumping horses have been treated with ACell’s ECM.

But Grody also recalls some dark days in the company’s early history when it was battling for its life in the courts. He credits the survival of ACell’s valuable patent portfolio largely to Dr. Ronda Moore, an intellectual property lawyer at Burns & Levinson, who procured and bullet-proofed the company’s early patents for Dr. Spievack.

“Ronda helped us to obtain a broad patent portfolio to protect, enhancing our opportunity to commercialize a platform technology that has multiple applications,” Grody says, adding that she also provided critical assistance during a three-year legal battle that resulted in a successful Federal Circuit appeal of an adverse patent infringement ruling.

“With her help, we were able to explain to the court how our invention includes material that was excluded from [the plaintiff’s] patents,” he adds.

Not long after the infringement battle concluded, an anonymous petition for re-examination of ACell’s core patent was filed in the Patent and Trademark Office (the “PTO”), and Moore was called upon again. “She was the lead attorney who successfully persuaded the PTO examiner that our technology was both novel and non-obvious even though the petitioner had cleverly mischaracterized prior art references.”

Grody calls Moore “one of the greatest assets we have at ACell,” noting that “she not only has the needed expertise in patent law, but as a certified veterinary pathologist she understands both the science and the law relating to our products.”

“Ronda treats our company like it is her own, and I have no doubt that she has the company’s interests foremost in her mind at all times,” Grody adds. “She helped position us for rapid growth and gave us an opportunity for multiple shots on goal.”

If ACell can score on all of its goals, there will be new and potentially unbounded hope for patients with serious injuries, wounds and organ defects.

- John O. Cunningham, freelance writer/editor