Even a casual observer of the healthcare industry can see the increasing popularity of drug/device combinations. This rapidly growing sector — which in the drug-eluting stent market alone has produced yearly sales of $5 billion to $6 billion — is expected to reach $11.5 billion by 2010. But this hardly accounts for all the permutations of drug/device combinations.

Newly formed ExThera Medical (Berkeley, California), a joint venture (j-v) between Emergence (Berkeley) and ExThera (Stockholm, Sweden), falls into this rapidly expanding sector with its new sepsis care offering.

The yet unnamed system is a cartridge-shaped device 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.

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 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 Medical Device Daily. “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.

Emergence was formed earlier this year as a spin-off from Polymer Technology Group (PTG; Berkeley, California), a biomaterials company (MDD, Sept. 26, 2007).

“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.

ExThera AB develops pharmaceuticals and medical devices based on biologically active carbohydrates. It is a technology transfer partner of the Karolinska Institute (Stockholm).

Ultimately this combination illustrates an ever growing trend to bring together the skill sets of traditional engineers with biomedical engineers, according to a recent panel discussion at the Biotechnic Partnering Conference in Hanover Germany.

Besides offering opportunities for innovative combinations of drugs with devices, other opportunities include the development of new devices for drug delivery, with some of these new combinations potentially able to revive drugs that have been laid aside as ineffective. Additionally, a new drug-device combination may be used to renew a drug that has lost profitability because going off patent.

Medtronic (Minneapolis) has established several partnerships with drug companies. It has been working with Genzyme (Cambridge, Massachusetts) since 2004 on a joint venture to accelerate the development of cell therapies for cardiovascular disease using Medtronic’s delivery devices and Genzyme’s biological approaches to cardiac repair.

And, in July, Medtronic expanded its 2005 deal with Alnylam Pharmaceuticals (Cambridge, Massachusetts), to develop drug/device combination products using RNAi for central nervous system diseases, with an initial focus on Huntington’s disease.

A wide number of examples can be found in the expanding wound care market where materials such as collagens are matched with scaffolds to create grafting and healing products. As just one example, BioCore Medical Technologies (Elkridge, Maryland) manufactures Medifil particles, pads and gels containing collagen and used on a variety of wound types. Its Skin Temp product is a porous collagen membrane attached to a non-adherent backing for wound care.

Another novel approach to combination modalities is being pursued by HeiQ Materials (Zurich, Switzerland) which produces a suite of powders with antimicrobial, antifungal or UV protection functionalities embedded in an inert matrix used in various applications.