Showing all posts written by Shuchen Gong

Shuchen Gong
Shuchen Gong
Shuchen Gong is an associate in our San Francisco Office. Her practice focuses on the preparation and prosecution of patent applications. Shuchen received her law degree from Cornell Law School and her B.S. in Chemistry and B.A. in Economics from the University of California, Berkeley.

Shuchen joined the firm in 2017.

Abbott Obtains FDA Approval for HeartMate 3 Device

Abbott announced on October 19, 2018 that its HeartMate 3 Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. Physicians now can offer the HeartMate 3 system to patients not eligible for a transplant. The HeartMate 3 LVAD can serve as a permanent implant, allowing patients to live with the device for the rest of their lives.

The MOMENTUM 3 study, which included more than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure and which followed patients for a short-term endpoint of six months and a long-term endpoint of two years, supported HeartMate 3’s FDA approval. It was reported that during the study, patients with the HeartMate 3 LVAD had a survival rate of 82.8 percent at two years. It was also reported that the rate of suspected pump thrombosis (clotting of blood) remained low, at 1.1 percent, at two years and that the stroke rate was low, at 10 percent, at two years.

According to Abbott, the HeartMate 3 uses magnetic levitation technology. This technology has been designed to reduce trauma to the blood passing through the pump.

Cyberattacks and the Value of Medical Data

On July 20, 2018, SingHealth, a Singapore healthcare institution consisting of four public hospitals, five national specialty centers and a network of nine polyclinics, reported that it had been the target of a cyberattack resulting in the information of around 1.5 million individuals being compromised.

This is not an isolated incident as statistics compiled from the U.S. Department of Health and Human Services (HHS) indicate that more breaches involving healthcare data were reported in 2017 than any other year since records first started being published. In Experian’s 2018 Data Breach Industry Forecast, Experian noted that from January through June of 2017, 233 healthcare data breach incidents were reported to HHS, the media or state attorney generals. For the 193 attacks for which there are numbers, 3,159,236 patient records were affected. In a 2016 Data Breach Industry Forecast, Experian predicted that healthcare companies remain one of the most targeted sectors by attackers, driven by the high value that compromised data can command on the black market, along with the continued digitization and sharing of medical records.

Forbes reported that, on the black market, the going rate for a social security number is 10 cents and a credit card number is 25 cents, while electronic medical health records could be worth hundreds or even thousands of dollars because such medical data contains a wealth of exploitable information, such as names, addresses, work history, family member names, financial information, as well as more sensitive information relating to medical history.

 

Microbot Medical to Acquire CardioSert’s Technology

Microbot Medical Inc. announced that it entered into an agreement with CardioSert Ltd. to acquire CardioSert’s patented guidewire technology, including R&D information, technical know-how, and intellectual property.

Microbot expects the acquisition to close in April 2018, at which time Microbot expects to have a patent portfolio of 25 issued/allowed patents and 15 pending patent applications worldwide, including CardioSert’s one issued patent (U.S. Pat. No. 9,586,029) and three pending patent applications. According to CardioSert, CardioSert’s technology offers capabilities such as steering and adjustable stiffness to guidewires used in interventional cardiology, radiology and vascular surgery. These features give physicians the ability to control the tip curvature, to adjust tip stiffness in a gradually continuous manner, and to produce impacts with the tip for negotiating calcified segments.

Microbot believes the technology has uses in other spaces, including peripheral intervention, neurosurgery, and urology. Microbot also believes the technology, when added to its existing robotic capabilities, will be consistent with its strategy to develop micro-robotic technologies for surgeries utilizing the natural and artificial lumens in the human body, expand and enhance its intellectual property portfolio, and allow it to enter adjacent medical spaces and applications.

Microbot reports that CardioSert will receive 100,000 restricted shares of Microbot’s common stock, cash payments totaling $300,000 (including $50,000 paid at signing), the potential for future milestone payments based on development progress and regulatory approvals, as well as royalties from futures sales related to the technology.