A Million Bucks Helps Warm the Heartand the Kidneys

A young company seeks to topple the gold standard in preserving organs for transplantationFREEHOLD – Private investors have helped keep Lifeblood Medical in circulation with a $1.2 million infusion of second-round funding. The Freehold medical-products company, which now has attracted some $2.2 million in financing, will use the money to work toward regulatory approval of its lead product, Lifor.

The cash was difficult to find in New Jersey, says Joseph Fischer, Lifeblood’s CEO. So he headed west to Milwaukee, where private-placement firm Frederick and Co. tapped its network of private investors.

“Frederick and Co. went along with our valuation of the company and we didn’t have to divest controlling interest of Lifeblood, which is critical for a small company,” says Fischer of last month’s transaction.

Lifor is a patented liquid that extends the useful life of kidneys and hearts that have been harvested for transplantation. It also shows promise as a blood substitute for emergency transfusions and a preservative for bone marrow awaiting transplant. If approved, the company foresees having a major impact on the transplantation industry.

While Lifeblood is banking on eventual FDA approval of Lifor, the privately held firm did bring in some $200,000 last year, says Fischer, mostly from licensing its other product, LiforCell, to German pharmaceutical company Oncoscience. Researchers use LiforCell as a tissue and cell preservative.

But the heart of Lifeblood’s business plan is a challenge to the current gold standard for preserving transplantable organs. Fischer says that product is ViaSpan, a solution made by a division of Barr Pharmaceuticals, a drug company with executive headquarters in Woodcliff Lake.

“There are two things I like about Lifeblood Medical,” says Phillip Chan, an associate at Mount Laurel-based NJTC Venture Fund, which has not invested in the company. “One is Joe Fischer. He’s a very smart and tenacious entrepreneur. He has a lot of corporate and industry experience. He’s definitely an asset to the company.”

The second is Lifor, which, according to Chan, “has a lot of great attributes. It addresses a need in the solid-organ transplant industry. It has the potential to improve the success rates of organ transplants and make the logistics of organ transplant much easier.”

Fischer says his product is better than ViaSpan because it can preserve harvested organs at room temperature—22 degrees Celsius—for 72 hours, while ViaSpan and other preserving solutions must be used in colder settings. “Right now all organs are held at 2 degrees to 8 degrees Celsius [roughly 35 degrees to 46 degrees Fahrenheit],” says Fischer.

The cold damages organs and in the case of the heart, severely limits shelf life, he says: “A refrigerated heart at 2 degrees to 8 degrees Celsius only lasts two to four hours. It can’t tolerate the cold.”

Further, ViaSpan “doesn’t have any nutrients in it,” he says. Between the nutrients and the oxygen that Lifor contains, says Fischer, the solution restores the normal functioning of stored organs.

“That’s what makes ours extremely different [from ViaSpan],” he says. “That’s how it can last a long time at elevated temperatures.”

Fischer says Lifeblood, working with the Medical College of Wisconsin, has “shown that we can hold the heart for six to eight hours at room temperature, which is remarkable because no one has ever done that before. We want to get it to between 16 and 20 hours.”

Twenty hours would allow enough time for a heart to be removed from a body, matched to a waiting recipient, tested for viability and viral infections, and still survive shipment to a distant medical facility and implantation in a patient, says Fischer. Many hearts go unused or are not even harvested because their short shelf life requires a readily available recipient.

Anything that might make more organs available would be valuable. There are 2,941 people across the country on a waiting list for a heart transplant, according to the Organ Procurement and Transplantation Network. Overall, there are nearly 100,000 people on the network’s U.S. list who are waiting for kidneys, livers, pancreases, hearts, lungs and intestines. Those numbers would go up significantly if preserved organs lasted longer because many people with no hope of getting an organ in time are left off of such lists, says Fischer.

About 70% of the people on the list are waiting for kidneys, an area where Lifeblood has had good results. In another experiment done at the Medical College of Wisconsin, Fischer says a harvested kidney bathed in Lifor was held at the standard cool temperature for three hours. On transplantation it worked as well for the patient as one taken directly from a live donor.

This experiment positions the product to go head-to-head against ViaSpan and possibly win FDA approval as a generic, says Fischer. Although Lifor has its own patent because it is different from ViaSpan, he says generic approval would let the firm “pick up revenue a lot faster.” Once that happens, he says the company can focus on getting approval based on Lifor’s biggest strength: its ability to preserve organs at room temperature. Fischer says Barr’s patent on ViaSpan ran out last month.

Lifeblood, founded in 2001, has five employees. It outsources most of its operations including manufacturing, sales and distribution to U.S. companies.

Chan says NJTC Venture Fund—an $80 million fund that specializes in early-stage companies—first noticed Lifeblood several years ago but chose not to invest because of the firm’s limited product line. “We saw it early in its development,” he says. “As a single-product company it was more amenable to angel financing rather than venture financing then. He [Fischer] has certainly made a lot of progress in addressing some of those issues.”

Chan has not ruled out another look at Lifeblood. “I’ve been keeping in touch with the company over the past couple of years. I’d be interested in continuing those discussions with Joe.”

E-mail to tgaudio@njbiz.com