BB&T

Newly formed ExThera Medical (Berkeley, California), a joint venture between Emergence (Berkeley) and ExThera AB (Stockholm, Sweden), is one of the next companies to pursue the device/drug combination.

The company's system, yet unnamed, is a cartridge-shaped box containing tiny beads coated with heparin, an anticoagulant. The heparin sifts through the blood, removing bacteria or cytokines — excess proteins and peptides found in the blood — which can lead to infection or sepsis.

Emergence joined with ExThera AB because of its work with heparin, according to Bob Ward, CEO for Emergence.

"It's the perfect marriage between the two companies," Ward told Biomedical Business & Technology. "Professor Olle Larm [Exthera CEO] and his team are well-known for their invention of highly effective modes for immobilizing the anticoagulant heparin on medical devices and implants."

Heparin is derived from glycosaminoglycan and is widely used as an injectable anticoagulant. It has the highest negative-charge density of any known biological molecule. It also can be used to form an inner anticoagulant surface on various experimental and medical devices such as test tubes and renal dialysis machines.

Pharmaceutical-grade heparin is commonly derived from mucosal tissues of slaughtered meat animals such as porcine intestine or bovine lung.

"It's a fortunate coincidence for us that [heparin] can serve double duty — as an anticoagulant and as a sort of cleanser of the blood," Ward said. He reported that the company is scheduled to discuss with FDA a recommended path to regulation, he added.

In the U.S., sepsis is the leading cause of death in non-coronary ICU patients, and the 10th most common cause of death overall, according to data from the Centers for Disease Control and Prevention. Sepsis is also more dangerous in elderly, immuno-compromised and critically ill patients. It occurs in 1%-2% of all hospitalizations and accounts for as much as 25% of intensive care unit (ICU) bed utilization. In ICU units worldwide it is a major cause of death, with mortality rates that ranging from 20% for sepsis to 40% for severe sepsis to more than 60% for septic shock. The annual cost of sepsis care is $17 billion.

Emergence was formed earlier this year as a spin-off from Polymer Technology Group (PTG; Berkeley, California), a biomaterials company.

"PTG has developed an entirely new generation of biomaterials and has thus been a catalyst in the advancement of some remarkable medical devices that are significantly benefiting mankind," said George Pitarra, president of Emergence and CFO of PTG.

"PTG will lend this wealth of technical and human assets to Emergence and its spin-offs, as well as invest capital in these ventures along with carefully chosen outside investors."

Emergence executives said that the company will initially focus on opportunities in tissue engineering, resorbable biomaterials and extracorporeal affinity therapies, according to PTG. Ultimately this combination illustrates an ever growing trend to bring together the skill sets of traditional engineers with biomedical engineers.

Besides offering opportunities for innovative combinations of drugs with devices, other opportunities include the development of new devices for drug delivery, such a combination potentially able to revive drugs that have been laid aside as ineffective, or a commercialized drug that has lost profitability because going off patent.