Medical Device Daily Executive Editor

The FDA doesn't normally issue press statements concerning its 510(k) clearances.

Thus, Tepha (Cambridge, Massachusetts) scored some major points this week with the agency's release of a statement that it has cleared the TephaFLEX Absorbable Suture made by the company, the agency calling it the first absorbable polymer suture made from material "isolated from bacteria modified by recombinant DNA technology."

And Ajay Ahuja, MD, director of business development for Tepha, underlined the fact that the clearance isn't exactly the normal sort.

"Because of the properties of this novel material and its characteristics," Ahuja told Medical Device Daily, "the FDA thought there was no substantially equivalent device on the market. So it was first designated as Class III [high-risk], and we applied for and received a down-classification to a Class II [moderate risk] device."

The suture material is indeed unique.

Ahuja explained: "We make our TephaFLEX polymer via a biological fermentation process, similar to the way biotech companies make biologically produced drugs. Our material is not a protein therapeutic, but rather a polymer that can be processed similar to other polymers and constructed into medical devices."

He said that it is not an "animal-direct product, per se," but is made of "typical strains of e coli that are used in biotech."

"Some wild type strains of bacteria produce this material naturally, and we have utilized a proven strain of bacteria in the biotech industry and used recombinant DNA techniques to produce this material in significant quantities."

He added: "It's not a protein, it's not translated from the DNA. The bacteria make the enzymes that then produce this protein, and we are able to harvest the polymer material from the microorganism and purify and process it into a polymer to be used in medical devices."

Its characteristics, he said, are "significant strength, extensibility, as well as good biocompatibility to make it suitable for use in absorbable medical devices" — that complete absorbability being one of its primary features and benefits.

He said that the company has developed its own processes for manufacturing the TeleFLEX sutures at its own facility in Cambridge.

Circumspect about the future roll-out, Ahuja said that would come some time "in the coming months," with the target market being a broad one, any physicians or surgeons using absorbable sutures.

Ahuja also noted that the TeleFLEX material is so leading edge that an FDA guidance for producing similarly-made products is currently "in process."

The TephaFLEX Absorbable Suture "is made from material that uses the latest DNA technology," said Daniel Schultz, MD, director of the Center for Devices and Radiological Health at the FDA. "This approach could have broader applications for medical devices that use this novel manufacturing technology."

The FDA said it based its decision on the company's laboratory and animal testing that examined chemical composition, biological safety and mechanical performance of the polymeric suture. The company provided data to show that the suture could be manufactured in a consistent and safe manner, it said.

FDA reviewed safety and effectiveness information for the device under the de novo petition process. De novo petitions were added under the FDA Modernization Act of 1997 to find a way for novel but less risky products to get to market. The agency said that the suture material is contraindicated in patients allergic to the cells or the growth media used to produce the absorbable polymeric material.

Formed in 1998 as a spin-out from Metabolix (Cambridge), Tepha employs genetic engineering technologies first developed at the Massachusetts Institute of Technology, with its intellectual property underpinning, it says, potential developments and other uses of the TeleFlex material in mesh and patch products; devices for ligament, tendon and cartilage repair; cardiovascular stents, vascular grafts and tissue-engineered heart valves; and drug delivery products.

It has previously reported a handful of "commercial partners" in helping it to develop some of those applications.

It has licenses for medical applications of its material directly from Metabolix and additional sublicenses, through Metabolix, to MIT intellectual property in the area of various medical applications, Ahuja said.

It received a series A round of $4.3 million in equity financing led by The Vertical Group in late 2004 (MDD, Nov. 23, 2004). Other investors included Integra Ventures (Seattle) and Novartis Venture Fund (Basel, Switzerland).

Ahuja told MDD that the company has just received Series B funding, with the details of that financing soon to be released.

In 2002, Tepha and Children's Hospital Boston (Boston) have received a $2 million grant from the Advanced Technology Program of the U.S. Department of Commerce to support the development of engineered biomaterials and cell technologies to create new cardiovascular tissue. At the time, Tepha said that the biomaterials would be fabricated into scaffolds able to guide and support the formation of new cardiovascular tissues.