MEDICAL DEVICE INNOVATION - Medical Device Daily

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88 Attendees at meeting enjoy its targeted, intimate setting By HOLLAND JOHNSON Medical Device Daily Managing Editor SAN FRANCISCO — While much of the action in town this week was down the street at the packed J.P. Morgan Healthcare conference, only a block up Powell Street at the Sir Francis Drake Hotel, the OneMedPlace Finance Forum gave attendees a glimpse at some private and smaller public companies that are on the cutting edge of medicine, and in a much more intimate setting. Attempting to bring to market a product to improve the surgical repair of mitral valve regurgitation is a company called Neochord (Minnetonka, Minnesota). John Seaberg, the company’s president/CEO said the company has developed a device that eliminates the need for a sternotomy and cardiopulmonary bypass. The company licensed the technology from the Mayo Clinic (Rochester, Minnesota) that was invented by a cardiac surgeon while in practice there. The tool is designed to allow for the use of minimally invasive use surgical techniques for the implantation of artificial chordae tendineae on a beating heart. During normal function, the chordae tendineae tether the mitral valve leaflets, ensuring correct closure during ventricular contraction. Rupture of the chordae due to myocardial infarction or degenerative disease is a common cause of mitral leaflet prolapse and subsequent mitral regurgitation. Seaberg said the company is currently looking for investors to top off a $3.5 million Series A round, the funds of which will be used to carry the company through the completion of its human feasibility trial which it intends to begin in May 2009. While the company plans to pursue those people who are already prime surgical candidates, Seaberg said NeoChord’s ultimate goal is to tap into the U.S. patient population of more than 2 million people with mitral regurgitation who have not been treated because the risks of the current procedure are currently deemed to be too high compared to the severity of their disease. These people, he said, are in need of a minimally invasive treatment option. “Current patients will be treated with less trauma, lower risk and less cost and frankly, that more patients will be treated because of the less invasive technology.” According to Seaberg, the clinical literature has shown that it is much better to treat patients in this sector while they are still relatively symptom-free. He noted that nearly 42% of asymptomatic patients died from complications related to this disease within five years. “It is a silent killer,” he said. Seaberg said the company is hoping to have FDA approval for the technology sometime in 2012. MEDICAL DEVICE INNOVATION 2010 Developing a photonic-based platform technology for the diagnosis and treatment of various diseases is InfraReDx (Burlington, Massachusetts). The private company is initially focusing on the creation of a system that will enable the diagnosis of lipid-core containing plaques in the coronary arteries. The company received FDA clearance for its catheterbased LipiScan coronary imaging system last April (Medical Device Daily, April 30, 2008). The LipiScan device uses nearinfrared (NIR) spectroscopy to identify lipid core containing plaques of interest in the coronary arteries in patients already undergoing cardiac catheterization. Such plaques, which cannot be detected by commonly used tests such as a treadmill exam and even coronary angiography, are suspected to be the cause of most sudden cardiac deaths and non-fatal heart attacks. This condition recently attracted heightened attention due to the death last June of Meet the Press host Tim Russert. James Muller, company founder and president/CEO said that NIR spectroscopy is used to measure the chemical composition of unknown substances. The LipiScan system uses optical technology, much of it developed for telecom uses, to deliver and retrieve NIR light from coronary plaques. Muller said the light reflected back at different wavelengths is analyzed to detect the chemical composition of the coronary plaques. At the completion of the catheter pullback, the LipiScan console instantly displays the scan results on a “chemogram,” a digital color-coded map of the location and intensity of lipid core containing plaques of interest in the artery. The company believes that the vulnerable plaque diagnostic market will exceed $2 billion by 2013. Muller said the company’s primary customers include interventional cardiologists, and its secondary market extends its reach to clinical research for drug and medical device development. According to Muller, the company is preparing a second generation of the device that can visualize and determine the chemical composition of lipid-rich plaques. InfraReDX has currently raised more than $87 million in private funds and is in the process of raising a $20 million C-2 round that Mueller said “will get us to financial breakeven.” Symphony Medical (Laguna Hills, California) is looking to treat heart failure, post-operative atrial fibrillation and other cardiac abnormalities with its biopolymer and biotherapeutic devices. The company’s CEO, Raymond Cohen, noted that the company’s goal is to deliver biocompatible polymers to specific areas of the heart during either open chest surgery or via a minimally invasive procedure. He said the biopolymers are engineered to achieve clinical benefit by locally modifying cardiac physiology. The company currently has two products in its late- To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 89 stage development pipeline. Algiysl-LVR is a treatment to prevent or reverse the progression of chronic heart failure and mitral regurgitation. The other product, Plexisyl-AF, is a prophylactic method of preventing sustained post-operative atrial fibrillation, a common side effect of the roughly I million coronary bypass and cardiac valve replacement surgeries performed each year. Cohen described how the company’s lead product, Algiysl-LVR, is delivered to achieve ventricular augmentation. He said the polymer is administered as an inert compound into the left ventricular wall of the heart where it reshapens and thickens the tissue. By restoring the shape of the ventricle from more of a “basketball shape to more of a football shape,” Cohen said pumping efficiency is reestablished and cardiac wall stress is also reduced. Essentially, the strategically placed biopolymer reconstructs the heart chamber so that it assumes its more natural, healthy form. Cohen said the implanted material does not cause negative immune reactions and it coexists permanently with the heart muscle. Cohen said the company is planning a first-in-man study of the Algiysl-LVR product sometime this quarter. The company filed an IDE for the product in December. The Plexisyl-AF product has advanced to human clinical trials, and a human clinical study was completed in Europe in May 2008. The company plans to file an IDE for that product sometime this quarter, and a U.S. clinical study is planned for 2H09. (This story originally appeared in the Jan. 20, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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