Medical Device Daily
In the three years since CircuLite (Hackensack, New Jersey) was formed, the early-stage cardiovascular company has seen very few road blocks and relatively quick development of Synergy, its miniature blood pump.
Early financing, reaching to more than $35 million, has contributed to what the company is calling a successful launch of the latest development for Synergy: implant of the device in the initial patient in its first-in-man European Clinical Trial, reported yesterday.
"This is our main device; Synergy is it for us, [and] this is what we have based [the company] around," Paul Southworth, CircuLite president, told Medical Device Daily .
Synergy is tiny enough to fit in the palm of your hand, or about the size of an AA battery. It is designed to provide long-term, partial circulatory support to supplement the heart's native pumping function, potentially increasing blood flow and allowing a failing heart to rest and potentially recover. The first generation of the device is driven by a six-pound ion battery pack that can be worn "discretely," the company says, beneath a sweater or sport coat.
The primary objective of the first-in-man trial is to assess its safety in patients with chronic heart failure who are waiting to receive a heart transplant.
The company reported that the first patient has had no complications and was able to return home safely.
The Phase I study, including up to three European hospitals, will enroll chronic heart failure patients whose heart function is in decline and are awaiting a donor heart. The trial will evaluate device safety for up to six months.
CircuLite developed the trial to evaluate the device in a bridge-to-transplant setting in order to collect initial data to establish clinical proof-of-concept. Further development of Synergy, it said, will focus on non-surgical, endovascular implantation as long-term therapy.
"We call [the device] Synergy because it works in conjunction with the heart — it still allows the heart to do what it needs to do," Gail Farnan, VP of marketing for the company, told MDD.
The pump itself is hemodynamically, hydrodyanmically, magnetically levitated, much like the technology used in some VAD pumps. The device is placed in the "pacemaker pocket" of the body and then connected using a minimally invasive approach to the left atrium and the subclavian artery. Though small, it is capable of delivering up to three liters of blood flow per minute.
CircuLite licensed the technology for the Synergy from the Helmholtz Institute (Aachen, Germany), where it has been under development for 7 years, Southworth said, with the system then protected by patents covering device implantation and a variety of cross-licensing agreements. Much of the engineering of the device is done at a subsidiary in Germany.
The company received funding for development for the device and the trial through a B round of $25 million in financing (Medical Device Daily , March 8, 2007), coming from existing investors, including Forbion Capital Partners (formerly ABN AMRO Life Sciences) and Oxford Biosciences Partners, as well as new partners, Foundation Medical Partners, the lead investor, and SB Life Science Ventures.
The company received A round funding of $11 million in 2004.
The company said the funds from the B round would support the company's current trial in 2007, the initiation of CircuLite's endovascular system preclinical evaluation (MDD April 24, 2007), and the initiation of the U.S. investigational device exemption (IDE) Phase I feasibility trial enrollment that it plans to launch in 2008.
By October the company said it plans to have 10 destination therapy patients enrolled in the Phase I study. After a 90-day evaluation of these patients, it then expects to add up to 30 patients for CE mark designation.
As to the status of an IDE trial, Southworth was quick to note that the company is already talking with the FDA.
"We've already had discussions with the FDA," he said. "CircuLite is now working on getting on our submission to the FDA. Synergy has passed my bar of what I wanted it to be right away."
CircuLite says that the target patient pool for the Synergy is about 2 million chronic heart failure patients worldwide who continue to be significantly symptomatic despite optimal medical and device-based therapies. While feasibility studies will examine the hemodynamic and clinical effects of the Synergy device in patients that are awaiting heart transplants, CircuLite's ultimate goal is to expand Synergy's applications to the chronic, ambulatory patient in order to improve their quality of life by giving them an elective, less-invasive option to increase cardiovascular blood flow.
In a company statement, Southworth, said, "CircuLite is striving to transform the treatment model for this condition to long-term, partial circulatory support. The commencement of this trial is an achievement that brings together over 11 years of engineering and research and demonstrates our leadership position in this space."