When RBC Capital Markets analyst Phil Nalbone hosted a session titled “Tissue, Blood & Bone: Advanced Implants & Surgical tools“ at the firm's first annual healthcare conference in New York last week, he said the focus of the “very eclectic panel“ was mainly the repair and regeneration of human tissues and organs.

And that was the focus, with three out of four of the companies on the panel being developers of systems for repairing tissue defects or promoting healing.

But Jacqueline Eastwood, president/CEO of TissueLink Medical (Dover, New Hampshire) — the fourth company included on the Tissue, Blood & Bone panel — took more than her share of the Q&A spotlight in describing the company's devices designed to reduce surgical blood loss, using saline-enhanced radio/frequency (RF) technology.

“Early on, when the company was formed [in 1999] we said, 'Well, nobody is going to believe us if we go out and tell them that you can do surgery and the patients won't bleed,'“ Eastwood said.

So TissueLink had to figure out an early application where it could best demonstrate the value of its technology.

For its first application TissueLink started talking to major cancer centers in the U.S. because it knew that removing tumors from solid organs such as a liver was difficult, involved a lot of blood loss and a high mortality rate.

“So we thought if we came into this very difficult environment and could show the surgeons that we could make a very simple, disposable device that would control the bleeding we could then establish the value in other areas,“ Eastwood said.

TissueLink's technology can reduce transfusions by 77%, Eastwood said, which she said not only saves the institution the $766 cost of each blood unit that's transfused, but also improves the cancer patient's survival.

The key to TissueLink's technology is that it uses radio frequency energy delivered through a generator while also introducing saline at “an appropriate rate“ along with the energy, Eastwood said. That strategy couples the energy to the tissue being treated but also keeps the temperature cool, enabling a dramatic reduction in bleeding during the procedure.

Over the past couple of years, TissueLink also has been designing devices for orthopedic and spine surgeons.

“Just like Jesse James went to the bank because that's where the money was, we went to the hospitals and said, 'Okay, who uses the most blood in here?' and found it was in the orthopedic area,“ Eastwood said.

In its clinical trials, the company has been able to show a 62% reduction in transfusions when TissueLink is used in a hip procedure, a 63% reduction when it's used in a knee procedure, Eastwood said.

Acknowledging that RF has been around for years, Nalbone asked Eastwood what makes TissueLink's technology so different.

“Over the years,“ Eastwood said, “there have been a number of attempts to use radio frequency in a variety of methods, either to destroy tissue, to remove tissue or to ablate tumors — literally kill the tumors – but if you can control the temperature as you enter, use the saline to control the temperature, you can shrink collagen in the natural tissue,“ which closes the vessels and stops the bleeding.

The company's biggest challenge is getting surgeons to try it out, she said.

“We run up against 'This is the way I've always done it', 'It's not a problem for me,' 'I know how to treat the blood after I lose it,' the cell-savers, etcetera, etcetera,“ Eastwood said. But what has given TissueLink traction is its robust clinical data.

“It's not just a cost issue, these patients do better,“ she said. “These patients are out of the hospital faster.“

Take, for example, a typical knee surgery.

During a knee operation, Eastwood said, the surgeon puts a tourniquet on the patient's leg, opens up the knee, puts in the metal implant, sews it back up and puts in a drain. Then when the tourniquet is taken off, she said, all the blood that the tourniquet has held back has to be drained out before the patient has enough range of motion in the knee to be released from the hospital.

“Our patients are getting out the next day. There's no blood in there. There's nothing to drain out. There's less swelling, less pain and more rapid healing. It should be very interesting to see how this technology enables [surgeons] to not only save money for the hospital but get the patients happier sooner. We're counting on it.“

Other companies on the “Tissue, Blood & Bone“ panel were Aastrom Biosciences (Ann Arbor, Michigan), TEI Biosciences (Boston, Massachusetts) and LifeCell (Branchburg, New Jersey).

George Dunbar, CEO of Aastrom, stressed the company's use of Tissue Repair Cells (TRC).

“These are patient-specific autologous, very safe, they're your cells, taken from you, sent to Aastrom to be processed,“ Dunbar said.

Aastrom's TRC-based products are a mixture of stem and progenitor cell populations produced from a small amount of bone morrow taken from the patient. At Aastrom the cells are processed, frozen and shipped back by appointment to the patient's physician for reinsertion or injection back into the tissue repair site.

“We're basically harnessing the body's own natural mechanism for tissue repair up to a point for major areas. The platform technology we have, the TRC technology, we think will augment what the body is trying to do for itself anyway,“ Dunbar said.

Dunbar said Aastrom, a development-stage company, hopes to be among the first true stem cell companies to get FDA approval for its first indication.

Similarly, LifeCell is focused on the repair and replacement of various types of soft tissue deficits, according to Paul Thomas, company president/CEO and chairman. The company is also focused on challenging types of hernia repair and breast reconstruction.

“We believe that with LifeCell we are getting true tissue regeneration because we are able to preserve the essential components of the extra cellular matrix, both the structural components as well as the biochemical components, that enable us upon transplantation to get a very rapid revascularization of that material, a repopulation with normal host cells and then a remodeling to the host tissue,“ Thomas said.

Building on Dunbar's comments, Thomas said, “We're capitalizing on the body's ability to repair itself if you give it the appropriate environment to do so.“

TEI Biosciences, another development-stage company, makes biological devices for the repair or replacement of failed human tissues and organs. The company has six FDA-cleared products to date.