Showing all posts written by Sabrina Wang

Sabrina Wang
Sabrina Wang
Sabrina Wang is an associate in our Orange County office.

Ms. Wang received her Bachelor's Degree in Bioengineering in 2007 from National University of Singapore. After graduation, she worked as an engineer developing orthopedic devices in Utah and Singapore.

In 2015, Ms. Wang graduated from the University of Virginia School of Law. While attending law school, Ms. Wang served on the Article Review Board of Virginia Journal of Law & Technology in her second year.

Ms. Wang was a summer associate at the firm in 2014 and joined the firm as an associate in 2015.
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BioSig Technologies Receives FDA 510(k) Clearance for Its Noninvasive Electrophysiology Information System

The Los Angeles-based medical device company BioSig Technologies, Inc. announced in a press release the FDA 510(k) clearance of its PURE EP System, which is designed to aid electrophysiology procedures, such as cardiac ablation for treating atrial fibrillation.

According to the company’s website, existing cardiac signal acquisition technology results in loss of vital information in the signal.  The company states that the PURE EP system incorporates “proprietary hardware and software . . . designed to effectively eliminate noise, artifact and baseline wander in real-time to present clearer signals during EP studies and catheter ablation” and “developed to enhance clinical decision making by revealing the most important parts of the signals.”

Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. commented:

Our PURE EP System is the culmination of many years of scientific research and business development efforts. It is our goal to provide tangible benefits to electrophysiologists and improve the current standards of EP procedures in the clinical setting.  We are excited to bring the advanced platform to the U.S. market.

According to a previous BioSig press release about the completion of a private placement, an FDA 510(k) application for the PURE EP system, the company’s first product, was submitted in late March 2018.  According to public records, BioSig is the listed assignee of, among others, a pending U.S. patent application directed to “evaluation of electrophysiology systems.”

According to that press release, BioSig has raised approximately $11,000,000 in 2018.  The company also announced that it expects to be trading on Nasdaq in 2018.

Teleflex to Acquire QT Vascular’s Coronary Products for Nearly $100 Million

According to the Straits TimesQT Vascular, a Singapore-based medical device company, reached an asset purchase and option agreement to sell its intellectual property rights to some of its non-drug coated coronary products, such as its Chocolate XD® and Glider™, to Teleflex Life Sciences Unlimited Company and Teleflex Incorporated (“Teleflex“).  The agreement gives Teleflex the option to purchase QT Vascular’s drug coated product, the Chocolate Heart, which is still being developed.

Under the agreement, Teleflex may pay up to $98.4 million in cash—$26.2 million for the non-drug coated coronary products, $65.6 million for the drug coated coronary product, and up to an additional $6.6 million upon the achievement of certain sales revenue milestones.  According to the Straits Times, the total value of the deal may be greater than $100 million, which exceeds QT Vascular’s market value of $36.3 million as of May 23, 2018.

Eitan Konstantino, CEO of QT Vascular, stated:

We are excited that Teleflex, one of the world’s leading medical device companies, chose to acquire our coronary products and to obtain a license to our extensive coronary IP portfolio.  We will work closely with Teleflex’s team to bring our pioneering drug coated coronary product, Chocolate Heart™, to the US market.

According to QT Vascular’s press release, the deal is pending approval by its shareholders.  As reported in the Straits Times, QT Vascular and Teleflex are also negotiating other business agreements, including supply agreements related to the products QT Vascular is selling to Teleflex.

The press release states that QT Vascular will independently continue its development of other products, such as a planned Investigational Device Exemption clinical trial of its differentiated drug coated percutaneous transluminal angioplasty balloon (Chocolate Touch®) in the U.S.

This deal follows the January 2018 announcement of QT Vascular’s sale of its non-drug coated Chocolate® PTA balloon catheter to Medtronics for $28 million.

District Court Awarded Ultrasound Device Maker Verasonics $5.6 Million And World-Wide Injunction In Trade Secret Case

The United States District Court of Western District of Washington entered a judgment in a trade secret case, Verasonics, Inc. v. Alpinion Medical Systems Co., Ltd. (Case No. 2:14-cv-01820-JCC). The district court confirmed the final arbitration award, giving Plaintiff Verasonics, Inc. $5.6 million in damages, including fees and costs, and enjoining Defendant Alpinion Medical Systems Co., Ltd. from using Verasonics’ trade secret, including marketing or selling any devices using the trade secret for five years.

Verasonics, Inc. describes itself as a Kirkland, Washington-based company that specializes in ultrasound devices and technology.  In the complaint filed on November 26, 2014, Verasonics alleged that Alpinion, headquartered in Seoul, South Korea, showed interest in “licensing, co-development or investment” opportunities with Verasonics starting from 2010.  Alpinion allegedly “induced” Verasonics into revealing its trade secrets and confidential information to Alpinion as the two parties entered into a series of Non-Disclosure Agreements (“NDAs”), and lease agreements for Alpinion to lease two research ultrasound systems from Verasonics.  The complaint also alleged that Alpinion made a below-market offer to Verasonics, which was rejected, and that Alpinion represented that its interest was in commercial ultrasound products, not in research ultrasound devices.

However, Alpinion later announced its own eCube-12R ultrasound platform specifically designed for the research market.  Verasonics sued Alpinion for trade secret misappropriation under the Washington State Uniform Trade Secret Act in addition to breach of contract claims in the Western District of Washington.

In 2015, the case at the district court was stayed pending a binding arbitration at the American Arbitration Association (case name ICDR No. 01-15-0002-9484).  The arbitrator found that Alpinion breached the parties’ NDAs and lease agreement, and violoated the Washington Uniform Trade Secret Act.  The arbitrator issued a partial final arbitration award of $2.9 million in compensatory damages and a five-year injunction against Alpinion on March 2, 2017.  The partial arbitration award was filed under seal and not publicly available.  According to Davis Wright Tremaine LLP, the law firm representing Verasonics in this matter, the injunction against marketing and sales of the accused product is worldwide.  The arbitrator subsequently issued a final award on June 26, 2017, ordering Alpinion to pay Verasonics another $2.7 million in attorneys’ and arbitration fees and other expenses.

According to a press release made after the partial final award, Lauren Pflugrath, president and CEO of Verasonics, said:

We are grateful for the arbitrator’s decision to issue the Final Award so clearly in our favor.  We continue to expand and build positive collaborative partnerships, but must insist on protecting our intellectual property.

Senate’s Vote to Reopen Government Also Suspends Medical Device Tax For Another Two Years

According to National Public Radio, the U.S. Senate voted 81-18 on Day 3 of the Federal government shutdown to advance a continuing resolution that would fund the government until February 8, 2018.  New articles indicate that the Senate’s vote included pausing the medical device tax for another two years.

We previously wrote about a two-year-long suspension of the medical device tax, which ended on January 1, 2018.  With no legislation having been passed during those two years on the medical device tax, taxpayers are required to resume making semimonthly tax deposits to the Internal Revenue Service (IRS), with the first deposit due by January 29, 2018 to cover the first 15 days of January.  The IRS published a notice in January 2018, indicating that the IRS will provide temporary relief from the late payment penalty for the first three calendar quarters of 2018 if certain conditions are met.

New articles indicate that the House is also expected to include the medical device tax suspension in its vote, as the House already agreed to do so last week before the government shutdown.

If the final continuing resolution passes both the Senate and the House, the 2.3% medical device tax would once again be suspended – just days before the first check to the IRS becomes due.

Researchers Announced A New Implantable Energy Storage System Powered By The Patient’s Body

Researchers Announced A New Implantable Energy Storage System Powered By The Patient’s Body

UCLA announced that scientists from UCLA and University of Connecticut designed a new form of energy storage for powering implantable medical devices that do not require a battery.  According to the announcement, this design makes it possible for implantable medical devices to be powered by a patient’s own body.

The announcement notes that many powered implantable medical devices, such as pacemakers, contain traditional batteries, which limit the lifespan of a device to the lifespan of the battery.  According to the Mayo Clinic, the battery of a pacemaker typically lasts five to 15 years, and needs to be replaced by surgery when it runs out. According an editorial in the BMJ (formerly the British Medical Journal), “[o]ver half of all patients with pacemakers require a replacement procedure because the batteries have reached their expected life. Some 11-16% need multiple replacements.”  Moreover, the article notes that batteries make the implantable device bulky and contain toxic chemicals, which can be harmful to the patient if they leak.

According to UCLA, the new energy storage system is called a biological supercapacitator, which operates on electrolytes in the patient’s body, for example, in blood and urine, and eliminates the need for a traditional battery in an implantable medical device.  The researchers state that the biological supercapacitator can be combined with “an energy harvester” to also convert heat and motion of the patient into electricity to be captured by the supercapacitator.

Although the announcement states that supercapacitators are currently not widely used in implantable device technology, Maher El-Kady, a UCLA postdoctoral researcher and a co-author of the study, commented:

In order to be effective, battery-free pacemakers must have supercapacitors that can capture, store and transport energy, and commercial supercapacitors are too slow to make it work.  Our research focused on custom-designing our supercapacitor to capture energy effectively, and finding a way to make it compatible with the human body.

More details of the research team’s design can be found in a paper recently published in Advanced Energy Material.

Smith & Nephew, Arthrex Settled Suture Anchor Patent Dispute Before Trial

On February 14, 2017, U.S. District Judge Michael Mosman of the United States District Court, District of Oregon granted a Joint Stipulated Motion for Dismissal with Prejudice submitted by Plaintiffs Smith & Nephew, Inc. and John O. Hayhurst, M.D. (inventor) and Defendant Arthrex, Inc. subject to the terms of a Settlement and License Agreement.  Information about the settlement terms is not publicly available.

This agreement ends a 12-year long dispute between Smith & Nephew and Arthrex over Smith & Nephew’s U.S. Patent No. 5,601,557, which is directed to a method and apparatus for anchoring cartilage within a joint.

In 2004, Smith & Nephew sued Arthrex and alleged that certain products of Arthrex’s SutureTak® and PushLock® suture anchor families infringed the ‘557 patent (case number 3-04-cv-00029).  According to the United States Court of Appeals for the Federal Circuit’s opinion of March 18, 2015, the parties had gone through three jury trials and two previous appeals.  The third jury trial in 2011 produced a verdict of willful infringement and damages awards.  Arthrex moved for Judgment as a Matter of Law (JMOL) of noninfringement, which was granted by the district court without an opinion.  The Federal Circuit reversed and remanded the JMOL and reinstated the verdict in its S&N II opinion in 2013.

We previously reported the district court’s entering of judgment in favor of Smith & Nephew on remand, awarding a total of $88 million in damages and granting a permanent injunction against Arthrex.  The judgment was affirmed by the Federal Circuit in its March 18, 2015 opinion.  In June 2015, Smith & Nephew reported receiving a $99 million patent infringement payment from Arthrex.

In 2008, Smith & Nephew also sued Arthrex and alleged that different products from the same SutureTak® and PushLock® families infringed the ‘557 patent (case number 3:08-cv-00714).  Judge Mosman granted in-part Smith & Nephew’s motion for summary judgment of infringement and denied Arthrex’s motions for summary judgment as of non-infringement.  He also granted Smith & Nephew’s motion for summary judgment as to reasonable royalty damages.

According to the court’s public record, a jury trial was set for February 13, 2017 for the remaining issues in the lawsuit filed in 2008.  On February 10, 2017, Judge Mosman vacated the jury trial, followed by the parties’ Joint Stipulated Motion for Dismissal with Prejudice.

Smith & Nephew and Arthrex filed a similar Joint Stipulated Motion for Dismissal with Prejudice in the 3-04-cv-00029 case, and in another lawsuit in the Eastern District of Texas relating to Arthrex’s patents (case number 2:15-CV-1047).  The motion was granted by the Eastern District of Texas court, but denied as moot in the 3-04-cv-00029 case, which was closed when the September 2013 judgment was entered.

Symfony Lens

First Extended-Range Intraocular Lens Receives FDA Approval

The U.S. Food and Drug Administration (FDA) has approved Abbott’s Tecnis Symfony Intraocular Lenses (IOL) for treating cataracts.  According to Abbott, the Tecnis Symfony lenses are currently the only lenses in the United States that “provide a full range of continuous high-quality vision following cataract surgery, while also mitigating the effects of presbyopia by helping people focus on near objects.”  Outside the United States, Abbot states that the Symfony lens is approved in more than 50 countries and has been implanted in more than 2,000 eyes as part of clinical studies.

Cataracts are a medical condition in which clouding of the eye’s lens affects vision.  The condition becomes more common with increasing age.  In fact, the National Eye Institute explains that a majority of Americans have cataracts or have undergone cataract surgery by the age 80.

Surgeons can replace the natural lens of a patient’s eye with an IOL implant, such as a monofocal lens, during a cataract surgery.   However, while monofocal lenses can improve patients’ long distance vision, they are less effective at improving short range vision.  Abbott uses its proprietary diffractive echelette feature to improve short range vision (see illustration below).

According to Thomas Frinzi, Senior Vice President of Abbott’s vision business:

Abbott is focused on improving people’s vision and their lives by helping them stay healthy and active.  Symfony offers patients, including those with astigmatism, an option for crisp, clear vision at all distances.  This is an important addition to our portfolio of lenses, as we expect many patients to choose a Symfony lens over a standard monofocal lens, given its benefits.  We are happy that we can offer more people around the world this new category of lenses.

The FDA approval also includes Abbott’s Tecnis Symfony Toric IOL for patients having astigmatism.

First U.S. Implant of St. Jude’s First-to-Market “CRT-D”

St. Jude Medical, Inc. recently announced the U.S. launch and the first U.S. implant of its Quadra Assure MP cardiac resynchronization therapy defibrillator (CRT-D).  The Quadra Assura MP features St. Jude Medical’s first-to-market  MultiPoint Pacing (MPP) technology.  The device received CE Mark Approval for MRI Compatibility in December 2015 and the MPP technology received U.S. FDA approval earlier this year.  According to the press release, the first implant of the Quadra Assura MP took place at Saint Francis Hospital in Hartford, Connecticut.

Heart failure patients frequently experience ventricle contraction or beating that is out of sync.  CRT synchronizes the ventricle contraction.  According to the press release, the first-to market MPP technologies allow physicians to pace multiple locations on the left side of the patient’s heart.  According to the American Heart Association, “heart failure (HF) is a chronic, progressive condition in which the heart muscle is unable to pump enough blood through to meet the body’s needs for blood and oxygen.”  The condition affects over 5.8 million in the USA and over 23 million worldwide.  Despite the success of CRT, according to a recent study, one third of the HF patients fail to respond to CRT.  The same study shows that MPP optimizes the response of such non-responsive patients to CRT.  According to St. Jude, MPP is also featured on St. Jude Medical’s Quadra Allure MP CRT-pacemaker (CRT-P) and two new Quartet Quadripolar LV Leads.

Regarding the first implant, Dr. Mark D. Carlson, Chief Medical Officer and Vice President, Global Clinical Affairs, at St. Jude Medical, stated:

St. Jude Medical developed and established a new standard of care for CRT with quadripolar pacing. We are excited to bring the next-generation MultiPoint Pacing technology to market, giving physicians additional options to improve patient response.

Dr. Neal Lippman, electrophysiologist with Arrhythmia Consultants of Connecticut, added:

We are now able to offer St. Jude Medical’s new MultiPoint Pacing technology for our patients whose heart failure condition is difficult to manage. It is important for us to have this option to individualize patient care and help improve response to therapy.

According to its website, St. Jude Medical is a global medical device manufacturer, headquartered in St. Paul, Minnesota and focuses on six key treatment areas: heart failure, arrhythmias, vascular disease, structural heart, chronic pain, and neurological diseases.

Roche Adds FDA-Approved HIV-1 Assay To Its Cobas® 6800/8000 Systems

Roche Adds FDA-Approved HIV-1 Assay To Its Cobas® 6800/8000 Systems

Swiss biotech company Roche announced on December 21, 2015 that the FDA has approved the Cobas® 6800 and 8800 Systems from its Pleasanton, California-based Roche Molecular Diagnostics (RMD) for the Cobas® HIV-1 viral load test.

According to the announcement, Cobas® HIV-1 is an in vitro nucleic acid amplification test for quantifying human immunodeficiency virus type 1 (HIV-1) in HIV-1-infected individuals.  According to Paul Brown, Head of Roche Molecular Diagnostics:

“The cobas® HIV-1 test is based on Roche’s unique dual-target technology to simultaneously amplify and detect two separate regions of the HIV-1 genome, which are not subject to selective drug pressure.  The addition of this test on the fully automated cobas® 6800/8800 Systems provides laboratories with a comprehensive virology menu to support physicians in making informed treatment decisions for HIV-1 patients undergoing antiretroviral therapy.”

According to Roche, the cobas® 6800 and 8800 Systems are automated molecular testing systems in the areas of donor screening, viral load monitoring, women’s health and microbiology.  Roche states that the systems are based on Nobel-prize winning PCR technology and can process 384 results for the 6800 System and 960 results for the 8800 System in an eight-hour shift, with up to 96 results within the first 3.5 hours.

FDA previously approved the two systems for viral load tests for hepatitis B (Cobas® HBV) and hepatitis C (Cobas® HCV) in October 2015 .  According to the press release, Roche plans to expand the menu to include a viral load test for cytomegalovirus (CMV) and other quantitative assays.

St. Jude Medical Completes Acquisition of Thoratec

St. Jude Medical, Inc. recently announced that it has completed its acquisition of Thoratec Corporation. In July 2015, St. Jude Medical announced its offer to buy Thoratec shares at $63.50 per share. The transaction is valued at about $3.3 billion.

Prior to the acquisition, St. Jude Medical’s heart failure portfolio included its CardioMEMS heart failure (HF) monitoring device, which received a limited FDA approval in 2014 specifically for use “in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year.” Acquiring Thoratec augments that portfolio with Thoratec’s HeartMate II and Heartmate 3 LVADs (Left Ventricular Assist Devices), the CentriMag and PediMag Blood Pumps, and the Thoratec PVAD (Paracorporeal Ventricular Assist Device). The HeartMate II received FDA approval in 2008 for use in “patients awaiting further, perhaps more complex treatment, such as transplants” and in 2010 for use in “severe heart failure patients who are not acceptable candidates for heart transplantation.” Thoratec’s Heartmate 3 is a chronic mechanical circulatory support (MCS) device currently being considered for a CE Mark in Europe.

Regarding the acquisition, St. Jude Medical’s Chief Operating Officer and incoming President and Chief Executive Officer, Michael T. Rousseau stated:

St. Jude Medical is excited to bring together two companies that are considered heart failure therapy leaders and build on our established franchise that is now uniquely positioned to offer physicians and patients innovative solutions across the heart failure continuum. We believe this acquisition represents a tremendous opportunity and we welcome Thoratec’s employees as we look forward to changing the way the world views the treatment of this expensive epidemic disease.

According to its website, St. Jude Medical is a global medical device manufacturer, headquartered in St. Paul, Minnesota and focuses on six key treatment areas: heart failure, arrhythmias, vascular disease, structural heart, chronic pain, and neurological diseases.

Thoratec is a Pleasanton, California-based company focusing on mechanical circulatory support therapies for heart failures.