Medical Device Daily Associate

Tissue processing and bio-surgical device company CryoLife (Kennesaw, Georgia) – embattled but on the come-back trail – took another step towards regaining its former share of the processing market with its report yesterday of the first human implant of its cryopreserved orthopedic tissues using the Clearant Process.

The tissues were implanted to reconstruct the anterior cruciate ligament (ACL) and the posterior cruciate ligament (PCL) of a patient’s knee. In this case, two tibialis tendons were used to replace the patient’s damaged ACL and PCL. David Caborn, MD, performed the surgery at Jewish Hospital (Louisville, Kentucky).

The company said it plans to make available cryopreserved patellar, tibialis, achilles, quadricep, and peroneus tendons treated with the Clearant Process to orthopedic surgeons for knee reconstruction surgery.

The Clearant Process was licensed to CryoLife by Clearant (Los Angeles) in December 2003 (Medical Device Daily, Dec. 17, 2003). The technology is based on gamma irradiation and a radioprotectant designed to inactivate pathogens, including microorganisms, while maintaining tissue integrity.

Joseph Schepers, vice president of corporate communications for CryoLife, explained the multi-month gap between the Clearant license and the first implant employing the technology, to Medical Device Daily. “The validation is a process where you test tissues over and over again so that you have a consistent result. We wanted to make sure that everything was validated with the outcomes that we were looking for.”

The company elected to add the Clearant Process as an extra layer of protection in the wake of an FDA warning letter in June 2002 (Medical Device Daily, June 25, 2002) concerning a link between the company’s cadaver-derived tissue products and about 26 cases of fungal and bacterial infection, including the rare Clostridium sordellii. That bacterium was attributed to the death of a 23 year-old Minnesota man who received an implant of the company’s soft tissue during knee surgery in November 2001.

The FDA also issued a recall of all of the company’s implants derived from human cartilage, tendons, arteries, veins and some heart tissue processed since Oct. 3, 2001 (MDD, Aug. 15, 2002).

At the time, the FDA’s action was attributed to what that agency said was the company’s failure to correct violations unearthed in previous inspections and an inability to guarantee that the recalled tissue was free from any fungus or bacteria.

The most serious allegation that the agency noted was an improper distribution of tissue. Apparently, the company distributed tissue from a donor even after the company confirmed the presence of harmful microorganisms from that very same donor.

The Centers for Disease Control and Prevention (CDC; Atlanta, Georgia) also investigated the company separately and was responsible for establishing the link between CryoLife’s products and the Minnesota death.

The company believes it has put the troubles of the past behind it. In fact, Schepers pointed out that the company was probably now at the vanguard of allograft safety. He said the company has made a number of product safety improvements in the past 12 months and is in a good position to meet the FDA’s “Good Tissue Practice” rule, which is scheduled to be implemented this month.

Aside from the first Clearant implant, Schepers said that since the beginning of the year the company has gotten accreditation from the American Association of Tissue Banks (AATB; McLean, Virginia) and become the only company in the business to cryopreserve osteoarticular [OA] allografts.

Currently, the company is using the new sterilization process only in its orthopedic tissues, but Schepers said that CryoLife is evaluating its use in its vascular products, such as the more delicate reprocessed heart valves.

“The implant of our first cryopreserved orthopedic tissue treated with the Clearant Process and the recent implant of our cryopreserved osteoarticular allografts are evidence of the company’s ongoing commitment directed toward the surgical repair and reconstruction of sports injuries,” said Steven Anderson, president and CEO of CryoLife in a company statement. He added that since the company was founded in 1984, “more than 100,000 patients have received our cryopreserved human tissue for reconstructive cardiac, vascular, and orthopedic surgeries.”

As proof of the company’s ongoing resurgence in the much depleted orthopedic implant sector, Schepers pointed to the company’s 4Q04 and full-year 2004 earning report, released in February. In that report, the company said orthopedic tissue processing revenue for 4Q04 was $1.2 million compared to $166,000 in 4Q03, and $2.9 million for the full year 2004 compared to $1.1 million for full year 2003.

With its 1Q05 earnings report, Anderson noted that orthopedic tissue processing revenues increased in each quarter of 2004, and he projected orthopedic revenues in 2005 to be $6 million to $8 million.

The company had a net loss of $18.7 million for 2004, with a 1Q05 loss of $1.5 million.