ImageIQ to Demo Mobile Imaging Clinical Trial Solution, Imaging-enabled EDC, and Custom Image Analytics at Outsourcing in Clinical Trials West Coast Conference
CLEVELAND, OHIO – January 27, 2016 – ImageIQ, an innovative Imaging Software and Contract Research Organization focused on supporting preclinical research and clinical trials, announced today it will be exhibiting at Outsourcing in Clinical Trials West Coast, Booth 21, Feb. 10 & 11th, in San Mateo, CA. ImageIQ will demonstrate its imaging-enabled electronic data capture and management system (EDCIQ), designed specifically for use in drug and device clinical trials that leverage any form of medical imaging and image anaylsis. For dermatologic or wound healing trials, ImageIQ will demo its EDCIQ-Derm solution, an imaging-enabled EDC that allows clinical trial professionals to capture medical photos via smart phones or tablets, and immediately upload them to EDCIQ-Derm for QA and further centralized processing and management. Clinical Trial Management services and imaging analytics capabilities will also be highlighted. To schedule a meeting, visit http://image-iq.com/contact-us .
To learn more, visit www.image-iq.com. ImageIQ is a Cleveland Clinic Innovations company.
Brett Hoover, VP Sales and Marketing
26801 Miles Road, Suite 103
Cleveland OH 44128
Valved stent eliminates functional mitral regurgitaiton on a beating heart
For patients with severe or irreversible moderate mitral regurgitation, NaviGate Cardiac Structures Inc. is developing a catheter-guided compressible valved stent that fits within the diseased mitral valve in a beating heart.
|NaviGate Cardiac Structures Inc.
|20412 James Bay Circle
|Lake Forest, CA 92630
|Phone: +1 (949) 381-5760
|Web Site: www.navigatecsi.com
|Contact: Neville Jeharajah, CFO
|Industry Segment: Cardiovascular Devices
|Business: Compressible stent features a tri-leaflet pericardial valvular mechanism to restore mitral valve function
|Founded: February 2011
|Founders: Rodolfo Quijano, CEO; Neville Jeharajah
|Financing To Date: $14 million
|Investors: Employees; Angel investors; Cleveland Clinic
|Board Of Directors: Rodolfo Quijano; Neville Jeharajah; R. King Nelson (Uptake Medical Corp.); Steven Dixon (Monetary Concepts Inc.); Mary Kander (Cleveland Clinic)
|Scientific Advisory Board: Jose Navia, MD (Cleveland Clinic); Samir Kapadia, MD (Cleveland Clinic); Gabriel Maluenda, MD (University of Chile, Santiago); Giacomo Delaria, MD (Scripps Clinic, La Jolla, CA)
For a great number of people worldwide, as they age, their heart may enlarge. This makes it increasingly difficult for some of the heart’s four valves to open and close properly, potentially resulting in blood flowing backwards. This condition of reverse flow, when it affects the mitral valve, is called mitral regurgitation, and it is irreversible when chronic. Although this condition can be corrected in its earliest stages by surgery, when neglected and reaching the moderate and severe stages, patients become inoperable, given the exceedingly high risk of mortality if subjected to conventional cardiac surgery.
To treat this large pool of inoperable patients, a compressible valved stent that is catheter guided and fits adequately within the diseased mitral valve in a beating heart is being developed by NaviGate Cardiac Structures Inc.
is made of metal alloy containing a biological tissue valve. The valved stent treats the diseased native valve by capturing the annulus (ring) of the native valve that has dilated excessively to a diameter between 35 mm and 45 mm (a normal mitral valve ranges in size from 25 mm to 30 mm). NCSI has created a larger mitral valve that will fit the dilated annulus. The truncated cone-shape valve also creates a shorter height profile, thus minimizing intrusion in both the upper and lower chambers of the heart, and making it easier to deliver via a catheter.
Candidates for Navi are those with irreversible moderate mitral regurgitation or more severe cases, representing about 280,000 people annually in the US, for a yearly market opportunity of roughly $5 billion. “The catheter-guided aortic valve has helped so many inoperable patients with aortic stenosis,” says Rodolfo Quijano, CEO of NCSI. “A mitral catheter-guided valve for patients with mitral regurgitation could help at least four times that number.” NCSI co-founder Quijano and Neville Jeharajah, chief financial officer, were approached by the Cleveland Clinic
in 2011 to further develop and commercialize a novel mitral replacement valve pioneered by Jose Navia, MD, a surgeon and researcher at the clinic. “We were intrigued because worldwide there may be up to 20 million people with functional mitral regurgitation,” Quijano conveys. “There was also no valve on the market for the mitral position that could be implanted minimally invasively or by a transcatheter-guided procedure.”
Quijano, who has spent most of his career in experimental animal research in heart valves and vessels, is committed to reducing the diameter of the mitral valved stent from 40 mm to between 8 mm and 9 mm (24 French [24F] to 27F) or less. This would allow for navigation through vessels entered through the leg and reaching the mitral apparatus in the heart. “To date, we have reduced the device’s diameter to 10 mm [30 F] that can be mounted at the distal end of the catheter by using a shape-memory nitinol alloy stent,” Quijano notes. Once released from the catheter, the stent self-expands to 40 mm, which is its nominal diameter, and the valve that is within begins to function properly. The valved stent also has three leaflets because “it is easier to make a valved stent that is low in profile and height with three leaflets for opening and closing than with two leaflets,” Quijano says.
Quijano’s founded and was president of VenPro Inc. from 1997 to 2003 (the first catheter-guided valve to the pulmonary artery, now known as Medtronic PLC
); and co-founder and president of 3F Therapeutics Inc., developer of the first sutureless implantation heart valve and the original manufacturer of the now named Sapien
aortic valve, from 1999 to 2005. Quijano also founded and was president of Xenomedica AG (heart valves) from 1980 to 1987, where the first stentless valve was conceived and made (purchased by Edwards Lifesciences Corp.
's Edwards CVS
NCSI, which has seven issued and numerous pending patents, has licensed its technology from the Cleveland Clinic, for which it will pay a standard royalty upon reaching the market.
Navi will be implanted by either a cardiac surgeon with assistance from a cardiologist or by a cardiologist with help by the surgeon. There are three user components: the nitinol valved stent consisting of a truncated cone and a tri-leaflet valve made of tissue, a crimper (a plastic inverted cone to compress the stent) and a catheter delivery system.
The inpatient procedure will typically be performed under general anesthesia and take 30 to 60 minutes. Once fluoroscopy and three-dimensional echocardiography has confirmed measurements of the native valve to be replaced, the clinician chooses one of three valve diameter sizes offered by the company: 36 mm, 40 mm or 44 mm. The clinician then pushes the valve through the increasingly narrower crimper to compress the valve to about 10 mm within one to two minutes. Next, the compressed valve is pushed into the capsule of the catheter tip, where the valve is held within the capsule before the catheter enters the body.
After a small incision of the skin, the catheter is inserted through the skin and through the atrium, delivering the valve into the native mitral valve. The artificial valve is then released at the proper position into the diseased valve, expanding immediately to 35 mm to 45 mm in diameter, which can be viewed via fluoroscopy. Anchoring consists of two sets of winglets (12 each) surrounding the bottom and top of the annulus. The catheter is then removed and the incision closed. Echocardiography is used again to verify that the artificial valve is functioning well and that there are no leaks or obstruction to the blood flow out of the heart through the aorta.
“The most difficult part of the procedure is the imaging and ensuring that Navi is properly placed so that the three leaflets close and open well,” Quijano explains. The patient remains in the hospital for one week, but the company expects to perfect the system so the maximum stay will be less than three or four days. The first patient to receive Navi was a 53-year-old male with severe (grade 4+) mitral regurgitation. The surgery was performed in October 26 in Santiago, Chile. Immediately following implant, the patient showed no sign of the condition, and has continued disease-free. Dozens of other patients in Chile and Europe are scheduled for the procedure in early 2016.
NCSI says it has three main competitors in the mitral valve space: Edwards Lifesciences (Fortis
), Medtronic (Intrepid
) and Canadian-based Neovasc Inc.
). However, all of these rivals are limited to one size valve. The valves of the first two companies “are larger in height – 35 mm – and 40 mm in diameter, compared to Navi, which is 21 mm in height and in various diameters,” Quijano says. “Because our device is short in height, it does not protrude into the atrium or the lower pumping chamber. Protrusion, especially in the upper chamber, results in turbulence of blood flow and can cause clotting.” Neovasc’s device, on the other hand, is 35 mm in height and 35 mm in diameter. “This is a diameter which is smaller than most patients with moderate or severe MR require,” Quijano states.
CE mark for Navi is expected in 2017, followed by PMA in 2019. It is slated to begin selling in Europe in 2017 and the product is reimbursable, both abroad and in the US. NCSI has received $14 million in seed funding from employees and angels, with a small portion contributed by Cleveland Clinic. A venture-backed Series A of $10 million to $20 million should close in early 2016. NCSI is receptive to having a strategic partner in cardiovascular medicine, and valves if necessary, invest in the company. The most likely exit strategy is purchase by a large, multinational corporation in the cardiovascular space, at any time.
The Cleveland Clinic's '10 Commandments' of Innovation
A new book about the Cleveland Clinic distills what it has learned from pioneering several medical innovations, including the first hospital-based kidney dialysis unit in the 1950s, the first coronary bypass surgery in the 1960s, the first successful larynx transplant in the 1990s, and the first near-total face transplant in 2008, among others. Innovation the Cleveland Clinic Way, by Thomas J. Graham, MD, shares its approach to innovation and offers suggestions to any organization that wants to take a more disciplined approach to innovation.
Biogennix Utilizes ImageIQ for PreClinical Image Analysis for FDA 510(k) Marketing Approval
CLEVELAND--(BUSINESS WIRE)--ImageIQ, an innovative Imaging Software and Contract Research Organization focused on supporting preclinical research and clinical trials, announced today that it has successfully supported Biogennix in completing its recent long-bone fracture healing and spine fusion preclinical studies. Both of these studies generated data that resulted in 510(k) marketing approvals by the US Food and Drug Administration (FDA).
Biogennix products are indicated for voids or gaps in the extremities, posterolateral spine and pelvis that are not intrinsic to the stability of the bony structure. The product provides bone void filler that resorbs and is replaced with bone during the healing process. Biogennix selected ImageIQ to support these studies because of ImageIQ’s history of leveraging its 2D and 3D imaging expertise, combined with its unique approach to software-based quantitative image analysis, to generate imaging data that is more quantitative and objective than traditional approaches. Specifically, ImageIQ provided histology and micro-computed tomography quantitative imaging and analysis to strengthen the Biogennix 510(k) submissions, and provided data for a more objective and quantitative product efficacy claim.
“Our work with ImageIQ played a major role in receiving our 510k marketing approvals,” said Biogennix CTO, Timothy Bumbalough. “Their knowledge of what was necessary to support our FDA submissions was what first impressed us. They immediately understood how to leverage imaging analysis and data acquisition to demonstrate efficacy of our products to the FDA, and subsequently, to our potential end users.”
“It was a delight to work with the Biogennix team,” said Tim Kulbago, ImageIQ CEO. “Our mission to help our clients deliver clear and concise data that supports their science. We are looking forward to continuing to be a part of the Biogennix success story.”
ImageIQ is an Imaging Contract Research Organization (ICRO) providing image management software, image analysis capabilities and professional services for imaging in drug and device clinical trials and preclinical research. We combine software engineering with biomedical and imaging expertise to provide quantitative, visual analysis and operational efficiency. Our mission is to enhance R&D and product efficacy/safety testing for research, medical device, and pharmaceutical organizations. By advancing the speed of research, ImageIQ clients can extend their expertise and abilities and complete work quickly, allowing innovative staff members to focus on creative solutions to research. www.Image-IQ.com or @ImageIQ via Twitter
Biogennix is located in Irvine, California, just 45 miles south of Los Angeles and 90 miles north of San Diego. Irvine is home to over 16,000 businesses and several industry clusters, including medical device manufacturers and bio-medical companies, and is in the heart of Southern California’s “Technology Coast.” Biogennix is a manufacturer of implantable, Class II medical devices, primarily bone graft extenders used in posterolateral spine surgery. The products are used by surgeons as a resorbable, osteoconductive matrix for bone reconstruction, serving as an off the shelf, pre-sterilized bone graft substitute. In 2015, a moldable form of the original osteoSPAN granule product (osteoSPAN Morpheus) was cleared for use by the FDA as a bone graft extender in posterolateral spine. The company also recently introduced its first spinal hardware device, an "ALIF" spacer system that is offered in individually packaged sterile units for added convenience and traceability.
Brett Hoover, VP Sales and Marketing, 855-462-4347
Cleveland Clinic's Former Chief Innovation Officer: Why Health Systems Must Become Innovation Test-Beds
Earlier this month, McGraw-Hill and the Cleveland Clinic announced the publication of a new book, Innovation the Cleveland Clinic Way: Transforming Healthcare by Putting Ideas to Work, by Thomas Graham, M.D., an orthopedic surgeon who until December had been chief innovation officer at the Cleveland Clinic organization since 2010. This month, he became chairman of the Lake Nona Institute in Florida.
BRIEF - Lifewatch acquires Flexlife Health Inc., an INR monitoring company
* Acquisition of Flexlife Health Inc., an INR monitoring company co-founded by the Cleveland clinic
* Parties have agreed to keep terms of transaction confidential
* Expects to commence activities already in December 2015 with a full launch in U.S. at beginning of 2016 Source text for Eikon: Further company coverage: (Gdynia Newsroom)
Cleveland Clinic picks top 10 innovations for 2016
Topping the list of the Top 10 Medical Innovations for 2016 are new, faster methods of creating vaccines, a process for rewriting genetic code, and a water purification system for the developing world.