Showing all posts written by Show Wang

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

In 2009, Mr. Wang graduated with a degree in Biomedical Engineering from Duke University, where he researched and built low-cost wireless ECG machines. After graduation, Mr. Wang worked at a hedge fund before helping a biomedical startup model the thermal profiles of surgically-implantable cooling chips.

While attending law school, Mr. Wang spent some time at the USPTO as an examiner extern. Mr. Wang graduated from New York University School of Law in 2014.

Mr. Wang was a summer associate with the firm in 2013, and joined the firm as an associate in 2014.
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Boston Scientific Acquires Cosman Medical

Boston Scientific Corporation announced today that it has acquired Cosmon Medical, Inc. for an undisclosed amount.

Cosman Medical is a privately held manufacturer of radiofrequency ablation (RFA) systems used to treat patients with chronic pain, the leading cause of disability for adults in the United States. According to the press release, RFA has been used over the last 50 years as a procedure for providing relief for patients with chronic pain by applying heat to small areas of nerve tissue to interrupt pain signals.

According to Boston Scientific, the Cosman Medical team and products will become part of Boston Scientific’s Neuromodulation business, which currently offers Spinal Cord Stimulator (SCS) systems to treat patients with chronic pain. Spinal cord stimulation involves sending electrical signals to the spinal cord in order to mask pain signals from reaching the brain. Some patients find effective relief from RFA, whereas other patients turn to SCS to manage pain. Thus, the acquisition of Cosman Medical adds to Boston Scientific’s portfolio of non-opioid solutions for chronic pain.

Boston Scientific is headquartered in Marlborough, Massachusetts, and the company is a worldwide developer, manufacturer and marketer of medical devices. The company states that its products are used in a range of interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology.

FDA grants Emergency Use Authorization to Quest Diagnostics for Zika Test

According to Medical Device Daily, the US Food and Drug Administration (FDA) has authorized the emergency use of a diagnostic molecular test developed by Quest Diagnostics subsidiary, Focus Diagnostics Inc., in response to growing concerns over the recent Zika virus outbreak. According to the report, this is the first test from a commercial lab to receive emergency use authorization to test U.S. patients for the Zika virus. It could potentially significantly broaden the access of U.S. physicians to diagnose the virus, as previously Zika tests were limited to qualified CDC-designed laboratories. As a result, more patients can be screened and individuals with the disease can be identified earlier.

According to the FDA, Quest’s Zika Virus RNA Qualitative Real-Time RT-PCR test is intended for the qualitative detection of Zika virus RNA in human serum approximately 4-7 days following onset of symptoms, which include fever, joint pain, rash, or conjunctivitis. In particular, the CDC recommends testing for individuals with symptoms suggestive of Zika infection who have traveled within the last two weeks to an area with ongoing transmission, asymptomatic pregnant women with a history of residence in or travel to areas of active Zika infection, asymptomatic pregnant women whose male sexual partners have traveled to or lived in an area of active Zika infection, and infants born to mothers who live in or traveled to areas with Zika virus transmission during their pregnancy – including both molecular and serologic testing of infants who are being evaluated for evidence of a congenital Zika virus infection.

 

Medtronic Launches FDA-Cleared OsteoCool RF Ablation System

According to Medtronic, the OsteoCool RF Ablation System has received U.S. Food and Drug Administration (FDA) 510(k) clearance and they are launching the device in the United States.

However, this news may not be surprising to some.  According to MedCityNews, the OsteoCool RF Ablation System was originally developed by Baylis Medical as a device for treating cancers that metastasize to the spine. Baylis Medical received 510(k) clearance for the original OsteoCool device in March 2012, a second version of the device in June 2015,  and a third version of the device in November, 2015.

Medtronic purchased the OsteoCool RF Ablation System from Baylis Medical on December 16, 2015 for an undisclosed amount. According to Medtronic, the two companies have decided to partner up in order to further innovate the OsteoCool System.

Radiofrequency ablation systems use probes that deliver targeted radiofrequency energy to destroy cancer cells. According to Medtronic, the OsteoCool System uses a pair of internally water-cooled radiofrequency probes to ablate cancerous legions in the spine that have metastatized from other cancers. The water cooling controls the temperature of the probes and prevents overheating of surrounding tissue during the procedure. The pair of bipolar probes in the OsteoCool System may also be used simultaneously and are available in various lengths, allowing for the OsteoCool System to be configured to accommodate a variety of patient and procedural needs.

According to StreetInsider, this means that the OsteoCool System is currently the only cooled radiofrequency (RF) ablation technology that offers simultaneous, customizable dual-probe capability to allow for procedural flexibility and repeatability.

According to its website, Minneapolis-based Medtronic, Inc. is a global leader in medical technology that employs over 40,000 people. The company develops, manufactures, and markets medical devices that include implantable pacemakers and cardioverter defibrillators (ICDs), heart stents and valves, spinal discs, insulin pumps, continuous glucose monitoring systems, deep brain stimulation, neurostimulation for chronic pain, and remote monitoring and diagnostic products for chronic disease management.

According to its website, Baylis Medical Company is a supplier of high-technology cardiology, endovascular, and oncology products. Some of the products developed by Baylis include RF Puncture Systems and Devices such as the NRG RF Transseptal Needle for transseptal punctures in cardiac and vascular tissue.

 

 

Greatbatch, Inc. Completes $1.73 Billion Acquisition

Greatbatch, Inc. recently announced that it has acquired Lake Region Medical (previously known as Accellent Inc.) pursuant to a deal valued at about $1.73 billion.  Reuters reports that Greatbatch will pay $478 million in cash, issue 5.1 million shares of stock to Lake Region Medical shareholders, and assume $1 billion of Lake Region Medical’s debt.

According to The Buffalo News, Lake Region Medical is a private company and OEM manufacturer of minimally invasive medical devices in the Cardio & Vascular and Advanced Surgery markets.  Lake Region Medical collaborates with the world’s leading medical device companies to help develop medical devices from concept to point-of-care.

Greatbatch states that the acquisition will create one of the world’s largest medical device OEM suppliers that serves the cardiac, neuromodulation, vascular, orthopedic, and advanced surgical markets.  Greatbatch’s press release states that the newly combined entity will employ over 9,000 employees worldwide and generate annual revenues of about $1.5 billion.  The combination also adds diversification and scale across product lines, customers, industries, and geography, with the combined entity being able to offer a more comprehensive portfolio to customers backed by a single point of support. According to Greatbatch, the transaction is expected to be finalized in the fourth quarter of 2015 subject to customary closing conditions and pending completion of all necessary regulatory reviews.

Greatbatch is a publicly-traded company (NYSE: GB) that describes itself as providing,  developing, and manufacturing medical devices for the cardiac, neuromodulation, vascular and orthopedic markets, as well as batteries for high-end niche applications in the portable medical, energy, military, and environmental markets. According to Buffalo News, Greatbatch has its corporate headquarters in North Texas but maintains a large presence in Western New York, where it has research and production facilities staffed by 750 employees.

The Vygon Group Acquires Perouse Medical to Expand Vascular Access Products Portfolio

The Vygon Group, a France-based manufacturer of single-use medical products has acquired Perouse Medical for an undisclosed amount, according to press releases.

According to its website, Vygon designs, manufactures, and markets single-use medical devices for healthcare professionals in hospitals, and for private and independent practitioners. Vygon’s website lists among its offerings vascular access catheters, I.V. administration sets and accessories, anesthesia needles, ventilation tubes, and feeding tubes. According to the press release, Vygon generated revenues of $285 million in 2014 and has a presence in over 100 countries through a network of 25 subsidiaries and 79 distributors.

According to its website, Perouse Medical is a French company that designs, manufactures, and markets medical products for the cardiovascular, interventional imaging, and oncology fields. Perouse’s website states that its product offerings are directed towards cardiovascular medical devices (stents, vascular grafts and patches, radial compression and inflation systems, hemostatic valves, and angiographic syringes) and long-term vascular access devices (implantable ports, PICCs, Huber needles, and catheter maintenance dressings). The press release notes that Perouse Medical generated revenues of $31.4 million in 2014 and has a presence in 90 countries through a network of 200 distributors.

The press release states that the acquisition expands both Vygon’s product portfolio and Vygon’s patent portfolio, strengthening Vygon’s position in the long-term vascular access market, a market worth $2.3 billion and growing annually at 12 percent. Perouse Medical will be the cardiovascular and long-term vascular access specialist unit within the Vygon Group. According to the press release, Perouse Medical’s patent portfolio of 162 patents will also become property of Vygon.

Intact Vascular raises $39M in venture capital funding to further develop its Tack Endovascular System

Intact Vascular raises $39M in venture capital funding to further develop its Tack Endovascular System

Intact Vascular, Inc. is a Wayne, Pennsylvania-based developer of medical devices for treating patients with peripheral artery disease. According to its website, the privately-held company primarily develops minimally invasive peripheral vascular products, such as the Tack Endovascular System, which is stated to optimize percutaneous balloon angioplasty results in the treatment of peripheral artery disease.

According to a press release, Intact Vascular has raised $38.9 million in a Series B venture capital financing led by New Enterprise Associates (NEA), with participation from Quaker Partners, H.I.G. BioVentures, and other existing investors. NEA Parner Justin Klein, MD, JD, has joined Intact Vascular’s Board of Directors as a result of the deal.

The press release indicates that the funds will be used to further develop and refine the Tack Endovascular System implant and delivery system, which has already been put through three international clinical trials and has resulted in a CE-Mark.

According to Intact Vascular’s website, the Tack Endovascular System is designed to effectively spot treat and repair arterial dissections in peripheral arteries following angioplasty using a minimal metal implant.

Intact Vascular’s website lists several features of the Tack Endovascular System that are purported to be unique. The website indicates that minimal use of metal reduces the amount of foreign material left behind in the body, resulting in reduced inflammation. The design also places less force on the vessel wall, which reduces vessel trauma and reaction. Other stated benefits of the design include allowing physicians to focus treatment only on the areas of the vessel where dissections are present, and allowing for the device to fit a wide range of artery diameters — eliminating the need to precisely size the device to a specific arterial diameter, an improvement over conventional stents.

This Tack Endovascular System has room to make a big impact: peripheral artery disease currently affects more than 200 million people worldwide, and over 19 million people in the U.S., with the numbers increase annually due to obesity, diabetes, and advancing age. However, newly-appointed member of the Board of Directors, Dr. Justin Klein, is optimistic. He states that: “Intact Vascular’s approach to peripheral artery disease is truly novel and has the potential to significantly improve treatment of this rapidly growing disease.”

Only time will tell if the Tack Endovascular System is able to meet this potential.

Intellirod Spine Signs Licensing and Distribution Agreements With X-Spine Systems Inc.

Intellirod Spine LLC is, according to its website, a medical device company developing wireless sensing technologies for use in spinal care.  According to Orthopedic Design and Technology, Loadpro is the company’s forthcoming disposable microelectronic sensor, which is designed to be used in conjunction with rod-based pedicle screw systems for corrective spinal surgeries.  During the surgery, the Loadpro system clamps onto a spinal rod and allows surgeons to monitor rod strain levels. The Intellirod website indicates that their system based on measuring strain is “patented” and references U.S. Pat. No. 7,357,037.

According to Richard Navarro, CEO of Intellirod, the Loadpro system is expected to provide surgeons the information they need to balance loads and perform more consistent corrective procedures, resulting in improved outcomes, fewer complications, and lower post-operative care costs.

News5 reports that on March 24, 2015, Intellirod Spine entered into licensing and distribution agreements with X-Spine Systems Inc. to use X-Spine’s rod-based pedicle screw system, Fortex, in conjunction with the Loadpro.  Intellirod Spine plans to test the pairing in initial alpha site launches later this year, with the hopes that it will lead to FDA approval of Loadpro later this year.

PRNewswire notes that an implantable version of the sensor, the Accuvista, is also currently in development to aid surgeons in monitoring rod strains, even after the surgery has been completed (such as during a routine post-operative visit).

AliveCor, Inc., Maker of Smart Phone-Based ECG Device, Receives FDA Clearance for Two New Algorithms that Provide Users Immediate Feedback

AliveCor, Inc., Maker of Smart Phone-Based ECG Device, Receives FDA Clearance for Two New Algorithms that Provide Users Immediate Feedback

San Francisco-based AliveCor,Inc. recently announced that the U.S. Food and Drug Administration (FDA) granted the company clearance for two new algorithms for its Smart Phone-based ECG device, the AliveCor Heart Monitor and its accompanying AliveECG app.

The press release states that:

AliveCor’s new analysis processes (algorithms) include a Normal Detector that identifies when no abnormalities are detected in an ECG recording and an Interference Detector that identifies if factors have affected the recording making the ECG unreadable. Together with the previously cleared atrial fibrillation (AF) detection algorithm (AF Detector), these two new detectors will continue to ensure patients and their healthcare providers receive accurate and relevant real-time interpretations of mobile ECG recordings.

According to the press release, these algorithms are designed to provide immediate notification to patients, which allows them to alleviate anxiety over arrhythmias when they are reassured that their ECG is normal, and allows for the delivery of more efficient care and follow-up by allowing healthcare providers to focus on reviewing ECGs that are the most concerning.

The press release further states that the AliveCor Heat Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health conscious individuals in order to record, store and transfer single-channel ECG rhythms. AliveCor’s website notes that the AliveCor Heart Monitor and its accompanying AliveECG app are compatible with all iOS and most Android OS mobile devices.

US and EU Regulatory Agencies Approve $43B Medtronic & Covidien Merger

Med Device Online reports that Medtronic has been cleared by the Federal Trade Commission (“FTC”) and EU’s European Commission to merge with Covidien.  Also according to Med Device Online, the companies had to agree that Covidien would sell Stellarex, its drug-coated balloon stent business division, to Spectranetics for $30M USD in order to obtain FTC and European Commission approval for the merger.

The FTC originally issued an administrative complaint against the merger. The FTC noted in its complaint that C.R. Bard, Inc. is currently the only supplier of drug-coated balloon catheters indicated for the femoropopliteal artery.  In addition, Medtronic and Covidien are the only two companies seeking FDA approval for drug-coated balloon catheters indicated for the femoropopliteal artery (both companies are now in clinical trials).  Therefore, in its complaint the FTC held that without the sale of Stellarex, Medtronic’s acquisition of Covidien would likely create an unfair and anti-competitive advantage for the companies in that market space.  On Nov. 26, 2014, following the companies’ agreement to sell Stellarex, the FTC cleared the merger on unanimous approval.

The European Commission noted that Stellarex, which recently obtained promising results from its first clinical trials, competes directly with Medtronic’s leading drug-coated balloon device, the “In.Pact.”  Therefore, despite (or perhaps due to) there being few active competitors in that market, the European Commission found it likely that Covidien would have competitively constrained Medtronic and that the acquisition would remove a credible future competitor from an already-dense market, thereby reducing innovation in the field of drug-coated balloon catheters.  Following the FTC’s lead, the European Commission gave its approval of the merger on Nov. 28, 2014.

According to Medtronic, the deal is scheduled to close in early 2015.

According to its website, Medtronic is headquartered in Minneapolis, Minnesota, and operates in more than 140 countries. Medtronic is the world’s 3rd largest medical device company, developing and manufacturing devices and therapies to treat more than 30 chronic diseases, including: heart failure, Parkinson’s disease, urinary incontinence, Down’s syndrome, obesity, chronic pain, spinal disorders, and diabetes.

According to its website, Covidien is headquartered in Dublin, Ireland, and also operates globally.  The company, which was spun off from Tyco International in 2007, develops and manufactures medical devices and supplies, for varied applications, including: vascular therapy, airway and inhalation therapy, oximetry and medical monitoring, soft tissue repair, and general surgery.