Doing business in med-tech is at once both complicated and simple. As an example of the latter, a nod from the FDA is all a company needs to make some serious headway in the market.
Take Cardica (Redwood City, California) for example. Shares for the California-based company shot up more than 35% at $10.70 a share on the same day it issued a press release noting 510(k) clearance to market its PAS-Port Proximal Anastomosis System for use in cardiac bypass surgery in the U.S.
Until now, the system was limited to sales in Europe and Japan, but FDA approval opens up a floodgate of patients who're looking for a safer, less-intrusive means of cardiac bypass surgery.
During a Tuesday morning conference call, company executives went into great detail regarding PAS-Port, but didn't give out a specific price for the device.
"With the introduction of the PAS-Port system in the U.S., cardiothoracic surgeons are now provided with a complete package of reliable, automated revascularization systems for use in CABG procedures," President/CEO Bernard Hausen, MD, PhD, said during the call.
He added, "We believe that by replacing hand-sewn sutures, our automated proximal and distal anastomoses systems can help cardiovascular surgeons perform consistent, reliable anastomoses with even the smallest of vessels, giving surgeons greater ability to use minimally invasive techniques for cardiac surgery."
Hausen said Cardica plans to launch PAS-Port in the U.S. in the next several weeks with "a systematic and deliberate roll-out to surgeons and [we] look forward to training 50 to 60 surgeons per quarter, as we previously have discussed."
The device creates a secure connection between the body's main artery and vein grafts. It differs from the current method of connecting a bypass graft vessel to the aorta in CABG surgery, which often requires that the aorta be clamped and utilizes time-consuming, hand-sewn sutures. When the clamp is released, tiny blood clots or particles from the aortic wall can be released, which can travel to the brain and cause stroke and other neurologic complications.
The company said the PAS-Port system allows a surgeon to complete an automated proximal anastomosis without the need to clamp and manipulate the aorta. Eliminating the clamp may greatly reduce the risk of particle release and ensuing neurocognitive events, it said.
Put another way, this means an attachment to a vessel of 3 mm or more in diameter, using a clamping or "coupling" approach, compared to connection to a vessel of just 1 mm in diameter, using the delicate stapling method.
"PAS-Port leaves no metal or aluminum in the graft and it reduces occurrences of restenosis," Hausen said, calling the device a "major milestone". The system's design allows surgeons to load the bypass graft into the system and rapidly complete the anastomosis, typically in about a minute.
This reduces the time required for the anastomosis while providing a consistent, reliable connection. The bypass graft is loaded into the system without damaging endothelial cells, while maximizing the orifice, which is especially important with a small graft. No metal is within the lumen of the graft vessel.
According to results from the pivotal clinical trial of the PAS-Port system, anastomosis surgical time is significantly reduced compared with hand-sewn anastomoses. Patient outcomes may be improved due to shortening of surgery times and hospital stays and reducing complications associated with aortic clamping.
Cardica conducted a 220-patient, prospective, pivotal, randomized trial of PAS-Port at 12 sites in the U.S. and Europe. The trial compared venous bypass graft vessel connections to the aorta made using the PAS-Port system versus those made using conventional hand-sewn sutures. Results showed that the study met its primary endpoint of non-inferiority to hand-sewn anastomoses, as well as all other primary and secondary endpoints.
As of June 30, more than 8,800 PAS-Port systems had been sold worldwide, with the vast majority of units deployed in Japan. According to Cardica's Japanese distributor, the PAS-Port system is used in more than 20% of all proximal anastomoses performed using a vein bypass graft during CABG surgeries in Japan.
Cardica expects to have 50 to 60 surgeons trained to use the device per quarter.
The company also said that it can produce an adequate amount of devices based on patient's needs.
"We can do 3,000 units a month and we have an inventory of PAS-Ports built up," CFO Bob Newell said during the conference call. "We'll run (the availability of the device) off procedures and we wouldn't anticipate big inventory build-ups."
The FDA approval comes as a breath of financial fresh air for the company, which has projected a loss of from $16 million to $18 million for FY08 (Medical Device Daily, May 1, 2008).
The small med-tech that could has had support, however. Cardica reported receiving $2 million in January from Cook Medical (Bloomington, Indiana) and more recently another $445,000 in milestones for further development efforts under the Cook Vascular Closure Device and patent foramen ovale license, development and commercialization agreements — these agreements providing potential extension of the company's technology to other cardiovascular applications.
The company has said in the past that it has a good fiscal foundation: $28 million in cash and a monthly burn of just $2.4 million.