Called "Fractional Flow Reserve", or FFR, the ability to measure the extent of blocked blood flow when deciding whether or not to place a stent and, if so, where, has been shown to improve outcomes in patients. The FAME and FAME 2 trials have provided solid evidence that functional measurement is an important tool in the armamentarium of the interventional cardiologist.
Currently, the only FFR systems available in the U.S. are manufactured by St, Jude Medical and Volcano Corporation, who basically have split the market 50/50. Their FFR systems are basically iterations of electrical sensor technology and there has been a not-insignificant number of patent lawsuits between the two companies.
Opsens has bypassed these legal issues since its system is based upon fiber-optic technology which the company uses in measuring pressure in the oil sands and other areas of oil and gas exploration.
The company has filed with the FDA for 510(k) pre-market notification, recently achieved approval in Japan and is currently sponsoring the O2 Pilot Study. Whether or not the Opsens OptoWire will be able to compete against device giant St. Jude or the field-dominating smaller company Volcano is yet to be seen, but their anticipated entry into the $250 million FFR market is definitely a significant one.
The press release from Opsens, Inc. follows:
FFR: Opsens Completes Regulatory Filing In The United States And In Europe And Reports On The Progress On The Clinical Work With Its Products
First Clinical Work on Humans - 27 Patients Successfully Diagnosed Using Opsens' FFR Products
October 7, 2014 -- Quebec City, Quebec -- Opsens Inc. ("Opsens") (TSX-V: OPS) is pleased to provide a report on the progress of its FFR clinical and regulatory activities.
Opsens received the authorization from Health Canada to conduct investigational testing in patients, pertaining to the conduct of a pilot study: "Opsens' OptoWire for Fractional Flow Reserve -The O2 pilot study". The objectives of the study are to "assess usability, functionality and safety of Opsens' OptoWire and OptoMonitor in patients with ischemic coronary artery disease who are referred for diagnostic angiography". Among the planned 50 patients to be enrolled, 27 have already been enrolled at Institut universitaire de cardiologie et de pneumologie de Québec -Quebec Heart and Lung Institute.
Preliminary results presented during the Transcatheter Cardiovascular Therapeutics Conference ("TCT") in Washington indicate that all four primary endpoints of the study were completed with success.
Dr. Olivier F. Bertrand |
During a TCT session for Late Breaking Early Human Clinical Studies and Reports, Dr. Olivier F. Bertrand, Director of the International Chair on Interventional Cardiology and Transradial Approach and principal investigator of the O2 pilot study concluded that:
- Fiber optic technology has allowed for the development of improved PCI-like floppy wire with exceptional pressure stability (no drift) and perfect connectivity;
- OptoMonitor is easy to use and ready to be integrated in the cath lab with printing and recording capabilities, although direct connection to cath lab hemodynamic system is possible; and
- Extended use of FFR and potential added clinical value should be investigated in various clinical scenarios.
Opsens plans to continue enrollment of up to 50 patients to gather additional data on the OptoWire and OptoMonitor.
Filing for 510 (k) in the United States and for CE marking in Europe
In recent months, Opsens has made significant progress in the regulatory work to obtain approval to sell its FFR products in the most valuable markets. To this end, Opsens has already filed a premarket 510(k) notification with the U.S. Food and Drug Administration ("FDA") for its FFR products. In Europe, filing for CE Marking has also been completed. "Getting approval to market our FFR products in key geographies is a priority. The recent receipt of commercial approval for Japan fuels our optimism for the next phases with government and regulatory agencies. I am extremely proud of our teams' work," said Louis Laflamme, President and CEO of Opsens.
Opsens' products on the fast track for a market launch in 2015
Opsens aims to become a key player in the guidewire FFR market with the OptoWire, a patented nitinolbased optical guidewire for FFR. The OptoWire provides intra-coronary blood pressure measurements with unique, patented technologies. It is immune to adverse effects related to blood contact, and allows easy and dependable connectivity that leads to reliable FFR measurement. The OptoWire is also designed to provide cardiologists with a guidewire delivering optimized performance to navigate coronary arteries and reach blockages with ease. Based on industry sources, the FFR market represented over US$250 million in sales in 2013 and is expected to reach US$1 billion in the medium-term. Opsens is confident that it is well positioned to capitalize on this significant growth opportunity.
About Opsens Inc. (www.opsens.com)
Focusing on two main growth markets, FFR in medical instrumentation and oil and gas, Opsens develops, manufactures and installs systems to measure pressure, temperature and others parameters using fiber optic sensing technologies. These systems are designed around patented technologies that are effective and durable in extreme conditions.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance and achievements of Opsens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.
