Showing all posts written by Sean Kim

Sean Kim
Sean Kim
Sean S. Kim is an associate in the firm's Orange County office. He practices intellectual property law with an emphasis on patent prosecution, due diligence, and portfolio management in the mechanical and medical device practice areas.
Sean received his Bachelor's Degree in General Engineering from Harvey Mudd College and attended University of Illinois College of Law. During law school, Sean served as president of Asian American Law Students Association and as a production editor of Journal of Law, Technology & Policy. Prior to law school, he worked for a start-up company that designed and manufactured fuel cells and wafer manufacturing equipment company.

FDA Clears Mobile Medical Application for Patients with Opioid Use Disorder

On December 10, 2018, the U.S. Food and Drug Administration (FDA) announced that it granted clearance of the reSET-O™, a mobile medical application to help increase retention of patients with Opioid Use Disorder (OUD) in an outpatient treatment.

Developed under an agreement between Pear Therapeutics and Sandoz Inc., a division of Novartis, reSET-O™ is said to be the first FDA-cleared Prescription Digital Therapeutic (PDT) for patients with Opioid Use Disorder.  It is a mobile device application that provides a 12-week interval PDT for patients with OUD. Utilizing Community Reinforcement Approach (CRA), reSET-O™ provides a series of training, monitoring, and reminder tools and/or lessons for patients and health care providers alike.  A clinical trial sponsored by National Institute of Drug Abuse (NIDA) found statistically significant increase in patient retention in a treatment program for 12 weeks who used the reSET-O™ program.

President and CEO of Pear Therapeutics, Corey McCann, M.D., Ph.D, reiterated the importance of the FDA clearance of the reSET-O™ for treating patients with OUD.

Nearly 50,000 drug overdose deaths involving opioids . . . took placed in the U.S. in 2017. Thereis an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking decision by the FDA ushers in a new standard for treating patients with Opioid Use Disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy.

FDA Commissioner Scott Gottlieb, M.D. addressed the FDA’s continued commitment to promote the development of medical device that could help treat addiction:

As part of our efforts to address the misuse and abuse of opioids, we’re especially focused on new tools and therapies that can help more people with opioid use disorder successfully treat their addition. Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in contributing to these treatment efforts.

Sandoz, per the terms of the agreement, has already launched reSET®, Pear’s PDT for the treatment of Substance Use Disorder, in November 2018 and plans to launch reSET-O™ soon.

 

 

Apple Watch Receives Clearance from FDA as an Over-the-Counter ECG-monitoring Device

On September 12, 2018, Apple released its new Apple Watch Series 4 with a new ECG app that can take an electrocardiogram (ECG). Apple’s new Apple Watch Series 4 has been granted De Novo classification by the FDA, which allows Apple to provide its Series 4 Apple Watches as an over-the-counter ECG-monitoring device.

Jeff Williams, Apple’s chief operating officer, noted Apple’s continued desire to make Apple Watch a more useful healthcare device for the public:

“The completely redesigned Apple Watch Series 4 continues to be an indispensable communication and fitness companion, and now with the addition of groundbreaking features, like fall protection and first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health.”

According to Apple, Apple Watch Series 4 is designed to intermittently analyze heart rhythms in the background and look for any irregular heart rhythm, such as atrial fibrillation (AFib). If a user’s heart rate exceeds or falls below a specified threshold, Apple Watch Series 4 can generate an alert. Electrical impulses are analyzed to generate ECG waveform and to determine AFib classification, which are automatically stored in Apple Watch’s Health app.

AliveCor received FDA clearance for its KardiaBand application for use with the Apple Watch last November. KardiaBand’s press release indicates that it includes a wearable band and a monitoring system integrated to Apple Watch.

However, according to The Verge, there are some important caveats to the FDA’s grant of de novo classification. First, both the ECG app and the irregular rhythm notification feature are not intended for people under the age of 22. Second, the irregular rhythm notification feature is not intended for people who have previously been diagnosed with atrial fibrillation. Moreover, the FDA does not intend to replace existing diagnostic methods and treatments for atrial fibrillation with Apple Watch. The FDA clearly states that “the feature is not intended to replace traditional methods of diagnosis or treatment.”

 

FDA Approval for Auris’ Robotic Endoscopy Platform

On March 23, Auris Health, Inc. announced FDA clearance for the Monarch Platform, Auris’ new system for robotic endoscopy. According to Auris Health, the Monarch Platform “integrates the latest advancements in robotics, micro-instrumentation, endoscope design, sensing, and data science into one platform.”

Josh DeFonzo, Auris’ Chief Strategy Officer, noted some challenges with endoscopy and need of better control for endoscopic systems:

Endoscopy requires a lot of skill, but also you’ve got to be very facile in maneuvering a device – a device that’s anywhere from approximately a meter to, in the case of colonoscopy, three meters long.

According to Bloomberg Businessweek, the Monarch Platform, instead of the traditional, antiquated one-handed interface requiring twist and control maneuvers, features robotic arms that doctors can control using a controller that on the surface resembles a game console controller. DeFonzo further stated that “Auris’ system allows for more direct control through a game-like controller.”

Dr. Fred Moll, CEO of Auris Health, Inc., said in an interview that Auris is currently focused on lung cancer for two reasons: (1) lung cancer is the deadliest cancer in the world; (2) lung provides a perfect “proving ground” because it comprises a complex network of tunnels.  According to Dr. Moll, the Monarch not only can navigate nimbly through the lung, but also can improve over time thanks to its navigation software.

Auris Health, Inc. is led by CEO Dr. Fred Moll, also known for his Da Vinci Surgical System, a top-selling surgical robot used in laparoscopic surgeries. According to DeFonzo, the company anticipates a limited launch of the Monarch across the U.S. and commencement of its pilot studies later this year.

Technology has advanced significantly since the development of the earliest robotics platforms used in medicine. The Monarch platform is designed to address the limitations of current technology with the introduction of a new era of flexible robotics. With this FDA clearance, we intend to deliver on the promise of improving patient care, starting with earlier and more accurate diagnosis of pulmonary nodules. We envision additional uses for the technology across future endoscopic clinical indications.

Auris has recently raised $280 million in a Series D round of financing, and also acquired Hansen Medical, which Dr. Moll cofounded, back in 2016.

Boston Scientific Announces Acquisition of EMcision

Boston Scientific Announces Acquisition of EMcision

On March 5, 2018, Boston Scientific announced its acquisition of EMcision, a privately held company in the United Kingdom and Canada. According to Boston Scientific, this acquisition will expand its range of medical devices in the field of minimally invasive endoluminal procedures as alternatives to conventional surgery. According to Art Butcher, Senior Vice President and President of the Endoscopy Division of Boston Scientific:

As we continue to search for ways to treat pancreaticobiliary cancers, we also seek to improve the quality of life for patients living with a cancer diagnosis today. We are committed to exploring innovative options to help increase the chance of earl diagnosis, improve treatment and advance the ability to remove cancers located in challenging areas of the gastrointestinal tract.

According to EMcision, EMcision was founded by an internationally renowned surgeon and medical device inventor, Professor Nagy Habib, and has developed proprietary medical devices utilizing RF technology for applications such as percutaneous procedures, and open, laparoscopic, vascular, and endoscopic surgeries. EMcision’s devices help patients with advanced cancers located in challenging areas of the gastrointestinal tract for whom surgery is not an option.

EMcision’s website states that EMcision’s flagship product, the Habib™ EndoHPB, is a novel endoscopic bipolar radiofrequency (RF) probe that was the world’s first endoscopic device for tumour ablation via ERCP. The Habib™ EndoHPB has been cleared by the U.S. Food and Drug Administration (FDA) and received CE mark from the EU. EMcision devices are currently being sold in 38 countries around the world and used in most of the top cancer centers in the United States.

With regards to the acquisition, Cherif Habib, EMcision’s outgoing CEO, stated: “By partnering with Boston Scientific, we will continue delivering on our mission of improving the quality of life of cancer patients on much larger scale. Boston Scientific has the resources and the know-how to further improve our technology, expand clinical indications and make it available to may more patients.” According to Yahoo Finance, Boston Scientific’s Endoscopy division revenues rose 14.8% year over year to $436 million in the last reported quarter.

FDA Clears New Surgery Infection Control System

FDA Clears New Surgery Infection Control System

The FDA recently cleared Prescient Surgical’s CleanCisionTM  Wound Retraction and Protection System (CleanCisionTM), a retractable device designed to prevent surgical site infection. According to Prescient Surgical, CleanCisionTM is “a novel, first-in-class, advanced intraoperative infection control system” that utilizes an active cleansing technology.

Traditionally, practices for preventing surgical site infections (SSIs) involve administering drugs, controlling patient’s blood glucose level, maintaining optimal temperature and tissue oxygenation, using skin prep agents, and using plastic wound protectors.

The press release states that unlike traditional methods, ClearCision combines wound protection and wound cleansing. Retractable plastic sleeves protect the wound while providing direct access to the surgical site. Irrigation system continuously cleans the wound edge using sterile irrigant solution and removes contaminant using suction. Insoo Suh, cofounder of Prescient Surgical, noted that ClearCision is “a proactive approach to clearing contamination during surgery.”

The press release also notes that SSIs can be caused by bacteria entering the surgical incision site, and lead to significant financial burdens on teh healthcare system.

Jonathan Coe, cofounder, president, and CEO of Prescient Surgical, said in the press release that the company is “initially focusing on abdominal surgery and particularly colorectal surgery, where the risk, frequency and severity of [SSI] is high and the need is acute.”