Showing all posts written by Nathan Lee
Prior to joining the firm, Nathan attended New York University School of Law where he served as a Staff Editor of the Journal of Intellectual Property and Entertainment Law. In 2010, he received his Bachelor's Degree in Chemistry with a minor in Biology at Cornell University. Nathan also has research experience in Nanomaterials, Biomaterials, and Protein Chemistry.
Nathan worked as a summer associate at the firm in 2015 and joined the firm in 2016. Click here to read full bio
Recently, the U.S. Food & Drug Administration (FDA) announced plans to modernize FDA’s 510(k) clearance pathway, which was adopted more than 40 years ago. The FDA stated that the plans are aimed at continuing to ensure that new and existing devices meet their standard for safety and effectiveness as technology rapidly advances.
The FDA announcement reflects its focus on innovation by driving innovators toward reliance on more modern predicate devices. Under the current framework, medical device manufacturers are required to submit a premarket notification to demonstrate that the low- to moderate-risk device to be marketed is safe and effective by proving substantial equivalence to a legally marketed device (“predicate device”) that is not subject to Premarket Approval. According to the announcement, nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old, contrary to the Agency’s belief that newer devices should be compared to the benefits and risks of more modern technology.
The Agency announced that it is considering, in the next few months, publishing on CDRH’s website those devices that have been cleared on the basis of demonstrated substantial equivalence of predicate devices that are more than 10 years old. The Agency also said that they are developing proposals to potentially subset certain older predicates and promote the use of more modern predicates. Following up on the announcement, FDA Commissioner Scott Gottlieb, M.D., stated,
As devices become increasingly complex, it’s important that they meet the latest standards for cybersecurity, interoperability, biocompatibility and usability engineering. The FDA has recently advanced policies on these issues, and we know that older predicates often don’t meet our more recent expectations.
Even though the announcement lacks details on these proposals, according to the announcement, in early 2019, the FDA intends to finalize guidance establishing an alternative 510(k) pathway that allows manufacturers of certain well understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products.
The Food and Drug Administration (FDA) recently unveiled the Quality in 510(k) (“Quik”) Review pilot program, aimed at reducing the time it takes to review moderate-risk medical devices by one-third. The pilot, dubbed as “a Turbo Tax for information submitted in 510(k)s,” by FDA Commissioner Scott Gottlieb, will allow device manufacturers to submit premarket notifications electronically using “eSubmitter” software, as long as the device is classified under one of the specific product codes included in the pilot program and is not a combination product. In addition to lower risk devices, the pilot program includes some higher risk Class II devices, such as surgical lasers, certain endoscopic equipment, and certain imaging devices (e.g., MRI and stationary X-rays).
The FDA’s stated goal is to review 510(k) applications for devices that meet the eligibility requirements within 60 days, rather than the typical 90 days for traditional applications.
FDA Commissioner Scott Gottlieb also commented:
“As technology evolves, patients have the opportunity to access more innovative medical devices that can help improve their health. To advance that progress, the FDA must also modernize its own review and submission process to make sure that our programs continue to be efficient, consistent and scientifically rigorous.”
Envision Healthcare Corporation (“Envision”) recently announced an agreement to be acquired by KKR & Co. L.P. (“KKR”) for about $5.5 billion in cash. The transaction is valued at $9.9 billion, including the assumption or repayment of debt. The transaction remains subject to regulatory and shareholder approvals, but is expected to close in the fourth quarter of 2018.
Envision, based on Nashville, TN, is a national physician staffing company and provider of physician services, including post-acute care and ambulatory surgery. KKR is a global private equity firm headquartered in New York, NY. The agreement to acquire Envision follows KKR’s 2017 acquisition of American Medical Response, an ambulance business subsidiary of Envision, for $2.4 billion.
It has been reported that other private equity firms including a consortium of Carlyle Group LP and TPG global competed for Envision. According to a report by Bain & Co., the value of private equity deals in healthcare across the globe reached $42.6 billion in 2017, up 17% from $36.4 billion in 2016.
Regarding its acquisition of Envision, Jim Momtazee, Head of KKR’s Health Care investment team states:
Envision has a very strong reputation for delivering high-quality, patient-focused care through its network of 25,000 clinical professionals at thousands of hospitals, surgery centers and alternate sites of care across the country. We are excited to partner with the outstanding team lead by Chris Holden to help build upon the strong foundation in place and accelerate Envision’s growth going forward.
The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De Novo premarket review pathway. According to the press release, Banyan BTI is the first in vitro diagnostic blood test for the evaluation of mild traumatic brain injuries (mTBI), commonly referred to as concussions, authorized for marketing by the FDA.
According to Banyan Biomarkers, more than 90 percent of patients presenting to the emergency department with mTBI receive a negative CT scan. Banyan BTI purports to identify two brain-specific protein biomarkers that rapidly appear in the blood after a brain injury, providing information to assess patients with suspected mTBI. According to the FDA, availability of a blood test for concussions will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients.
With respect to approval of Banyan BTI, FDA Commissioner Scott Gottlieb, M.D. stated:
“A blood-testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests.”
Basil Leaf Technologies recently presented their DxtER device at the 69th AACC Annual Scientific Meeting & Clinical Lab Expo in San Diego. The DxtER device has been compared to the Star Trek medical Tricorder, winning first place in the Qualcomm Tricorder Xprize competition, a global contest inspired by the popular science fiction series.
According to Basil Leaf Technologies, the DxtER device weighs less than five pounds and is designed to enable consumers to monitor five real-time health vital signs and diagnose 34 diseases using artificial intelligence. Basil Leaf Technologies reports that the DxtER device is currently undergoing clinical trials for FDA approval.
According to AACC CEO, Janet B. Kreizman, “DxtER is the first consumer-friendly mobile health device to combine vital sign monitoring with an extensive diagnostic testing menu, and it could lead to a huge leap forward in patient care.” While the DxtER device may not be available in the immediate future, Dr. Gene Friedman, assistant professor of biomedical engineering at Johns Hopkins University School of Medicine, estimates that “in the next 10 to 20 years it’s going to be a big revolution in personal healthcare.”
Becton Dickinson (“BD”) recently announced an agreement to acquire C.R. Bard for $24 billion in cash and stock. The transaction remains subject to regulatory and shareholder approvals, but is expected to close in the fall of 2017.
Both BD and Bard are century-old (BD was founded in 1897 and Bard was founded in 1907) medical device companies based in northern New Jersey. Bard offers devices for vascular medicine, urology, oncology and surgery, whereas BD provides syringes and infusion products, including those for diabetes management, and products for collecting and transporting diagnostic specimens. According to BD, Bard will expand BD’s focus on the treatment of disease states beyond diabetes to include peripheral vascular disease, urology, hernia and cancer.
The agreement to acquire Bard follows BD’s 2015 acquisition of San Diego-based CareFusion Corp. for $12 billion. The acquisition of CareFusion expanded BD’s product offerings to include devices used for administering and managing medication. Regarding its acquisition of Bard, Vincent Forlenza, Chairman and chief executive officer of BD states:
Combining with Bard will accelerate our ability to offer more comprehensive, clinically relevant solutions to customers and patients around the globe…We expect the transaction to contribute meaningfully to BD’s plans for revenue growth and margin expansion, and generate outstanding value both near- and long-term for shareholders.
Additionally, BD says the acquisition of Bard which registered approximately 500 products internationally in 2016 will accelerate the company’s growth in emerging markets outside of the U.S., including $1 billion in annual revenue in China. Tim Ring, Bard’s chairman and chief executive officer explains that: “our fast-growing portfolio in emerging markets can significantly benefit from their well-established international commercial infrastructure.”