Opko Health Inc (OPK)

[tomsylver]

MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE:OPK ( http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Ffinance.yahoo.com%2Fq%3Fs%3Dopk&esheet=50959215&newsitemid=20141009005920&lan=en-US&anchor=OPK&index=1&md5=b1e202c479ab9cebfc040c74ae96f7ea ) ) announced that its investee, Neovasc, has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate the U.S. arm of its TIARA-I Early Feasibility Trial for the Company's Tiara™ transcatheter mitral valve. The TIARA-I Early Feasibility Trial is a multinational, multicenter trial being conducted to assess the safety and performance of Neovasc's Tiara mitral valve system and implantation procedure in high-risk surgical patients suffering from severe mitral regurgitation (MR).

Severe MR is a critical condition that affects millions of patients and, if left untreated, can lead to heart failure or death. This FDA conditional approval allows clinical investigators to begin enrolling patients at participating U.S. medical centers once local hospital and related approvals are in place.

"This is a significant affirmation of Neovasc's Tiara device as we believe that Neovasc is the first company to start a feasibility trial with a transcatheter mitral valve in the US," stated Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. "FDA's conditional approval and the commencement of the feasibility trial in the US is an important step towards Tiara becoming one of the first transcatheter mitral valve replacement devices available for treating U.S. patients."

The TIARA-I Early Feasibility Trial will enroll up to 30 patients globally and is being overseen by a multidisciplinary committee of internationally recognized physicians co-chaired by Dr. Martin Leon (Director, Center for Interventional Vascular Therapy Columbia University Medical Center / New York-Presbyterian Hospital) and Dr. Anson Cheung (Professor of Surgery and Director of Cardiac Transplant at St. Paul's Hospital, Vancouver Canada). With this FDA approval, TIARA-I is expected to enroll patients at three highly respected U.S. medical centers: Columbia University Medical Center / New York-Presbyterian Hospital (New York), Lenox Hill Hospital (New York) and Cedars-Sinai Medical Center (Los Angeles). The Company is now focusing on training participating clinical teams and obtaining institutional approvals with the goal of enrolling the first U.S. patients by early 2015.

TIARA-I also has received ethics committee approval at Antwerp Cardiovascular Center / ZNA Middelheim in Belgium and competent authority notification is pending. First European enrollment is expected before the end of the year. Applications are underway for additional centers in Europe and Canada.

About Tiara:

Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Significant MR can lead to heart failure and death. Conventional surgical treatments are only appropriate for about half of MR patients, who number an estimated four million in the U.S. alone. Tiara is implanted in the heart using a minimally invasive, transapical transcatheter approach and is designed to replace the diseased native mitral valve without the need for open-heart surgery or use of a cardiac bypass machine.

The first human implantations of Tiara were completed successfully earlier this year under Canadian Special Access, by the medical team at St. Paul's Hospital in Vancouver, Canada. Early clinical results of Tiara implantations have been promising, resulting in fully functional valves, with complete resolution of mitral regurgitation, and no valve leakage. There have been no device related complications observed to date in patients treated with Tiara.

About OPKO Health, Inc.

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies.

This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected benefits of the Tiara transcatheter mitral value, whether the device will be successful in treating mitral valve regurgitation, whether trials will be successful and whether the device will be commercialized at all, the timing for enrollment in U.S. and European trials, and whether the device will be one of the first transcatheter mitral valve replacement devices available in the U.S., as well as other non-historical statements about our expectations, beliefs or intentions regarding business, technologies and products, financial condition, strategies or prospects. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that compounds or diagnostic products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

OPKO Health, Inc.
Steven D. Rubin or Adam Logal, 305-575-4100

Source: OPKO Health, Inc.

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Uncle’s DD Note#

OPKO FORM 10-K ( http://investor.opko.com/secfiling.cfm?filingID=944809-14-3&CIK=944809 )
Filed 03/03/14

pg15. In August 2011, we made a $2.0 million investment in Neovasc Inc. (“Neovasc”), a medical technology company based in Vancouver, Canada, and a publicly-traded company in Canada. Neovasc is developing devices to treat cardiovascular diseases and is also a leading supplier of tissue components for the manufacturers of replacement heart valves. In connection with our investment, we also entered into an agreement with Neovasc to provide strategic advisory services to Neovasc as it continues to develop and commercialize its novel cardiac devices. As of December 31, 2013 , we own approximately 6% of the outstanding common stock of Neovasc.

pg86. Neovasc, In August 2011, we made an investment in Neovasc, a medical technology company based in Vancouver, Canada, a Canadian publicly traded company. Neovasc is developing devices to treat cardiovascular diseases and is also a leading supplier of tissue components for the manufacturers of replacement heart valves. We invested $2.0 million and received two million Neovasc common shares, and two -year warrants to purchase an additional one million shares for $1.25 a share. We recorded the warrants on the date of the grant at their estimated fair value of $0.7 million using the Black-Scholes-Merton Model. Prior to the warrants being readily convertible into cash, we recorded an unrealized gain of $0.2 million in Other comprehensive loss. During the year ended December 31, 2013 , we exercised the warrants and paid $1.2 million .We record changes in fair value for the Neovasc warrants in Fair value changes of derivatives instruments, net in our Consolidated Statements of Operations. We also entered into an agreement with Neovasc to provide strategic advisory services to Neovasc as it continues to develop and commercialize its novel cardiac devices. In connection with the consulting agreement, Neovasc granted us 913,750 common stock options. The options were granted at (Canadian) $1.00 per share and vest annually over three years. We valued the options using the Black-Scholes-Merton Model at $0.8 million on the date of grant and will recognize the revenue over four years as Other revenue. In August 2012, Neovasc granted us an additional 86,250 common stock options. The options were granted at (Canadian) $1.30 per share and vested immediately. We valued the options using the Black-Scholes-Merton Model at $0.1 million on the date of grant and will recognize the revenue over three years as Revenue from services. We record changes in the fair value of Neovasc options as an unrealized gain or loss in Other comprehensive loss each reporting period.

FORM 10-Q ( http://files.shareholder.com/downloads/OPKO/3533141941x0xS944809-14-11/944809/filing.pdf )
Filed 08/11/14 for the Period Ending 06/30/14

Neovasc
pg19 In 2011, we made an investment in Neovasc, a medical technology company based in Vancouver, Canada. We invested $2.0 million and received two million Neovasc common shares, and two -year warrants to purchase an additional one million shares for $1.25 a share. During the year ended December 31, 2013 we exercised the warrants and paid $1.2 million . We accounted for the warrants as an investment, available for sale and recorded the warrants at fair value on the date of acquisition. We recorded the changes in the fair value of the warrants in Fair value changes of derivatives instruments, net in our Condensed Consolidated Statements of
Operations. We have determined that our related parties can significantly influence the success of Neovasc through our board representation and voting power. Accordingly, as we and our related parties have the ability to exercise significant influence over Neovasc’s operations, we account for our investment in Neovasc under the equity method.

pg32 In August 2011, we made an investment in Neovasc. Dr. Frost and other members of our management are shareholders of Neovasc. Prior to the investment, Dr. Frost beneficially owned approximately 36% of Neovasc, Dr. Hsiao owned approximately 6% , and Mr. Rubin owned less than 1% . Dr. Hsiao and Mr. Rubin also serve on the board of directors of Neovasc.

NEOVASC Reducer ( http://www.youtube.com/watch?v=LdK0CXdhgDo )

OneMedRadio: Alexei Marko, CEO and Director of Neovasc ( http://www.youtube.com/watch?v=VaW7UASGlCk )

NEOVASC Reducer Medical Animation ( http://www.youtube.com/watch?v=8z2Au8JCXlc )