Gilead Sciences, Inc. recently announced an agreement to acquire Kite Pharma, Inc. for $11.9 billion. According to the announcement, Kite Pharma focuses on cell therapy treatment for cancer, which involves the genetic engineering and reintroduction of a patient’s own cells to better identify and combat cancers.
(Graphic from Kite Pharma website)
With the announcement, Gilead’s President and CEO stated that “cell therapy has advanced very quickly, to the point where the science and technology have opened a clear path toward a potential cure for patients[,]” and the acquisition “establishes Gilead as a leader in cellular therapy[.]” The announcement notes that Kite Pharma’s treatment for non-Hodgkin lymphoma is currently under review by the FDA, with a target action date of November 29, 2017.
Kite Pharma, Inc. is based in Santa Monica, CA and Gilead Sciences, Inc. has its U.S. headquarters in Foster City, CA.
The FDA, according to its website, currently supports eight consortia that provide advice and funding to help commercialize technologies for pediatric care. The FDA defines “pediatric” as encompassing devices used for patients who are 21 years of age or younger at the time of diagnosis or treatment.
Many of the consortia hold innovation competitions where winners are awarded grants and support services. For example, PR Newswire reports that the New England Pediatric Device Consortium (NEPDC) has awarded three companies grants and in-kind services for products aimed at preventing the dislodgement or unintended removal of catheters or tubing. According to NEPDC’s Request for Abstracts, the grants are up to $50,000 each. NEPDC offers quarterly grant opportunities; the next abstract deadline for grant funding is October 9, 2017, with applications due on October 23, according to PR Newswire.
The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) has narrowed a record number of 98 applications from across the globe down to twelve finalists, according to PR Newswire. This is the 5th annual Pediatric Device Innovation Symposium hosted by NCC-PDI, a FDA-funded consortium led by the Sheikh Zayed Institute for Pediatric Surgical Innovation and A. James Clark School of Engineering at the University of Maryland according to the competition’s homepage. NCC-PDI highlights that up to six finalists will be awarded up to $50,000 each after the presentations held on September 24, 2017.
Another consortia, the Atlantic Pediatric Device Consortium (APDC), announced that it will hold Round 1 winner presentations at its 7th annual Pediatric Device Innovation Competition on September 25, 2017. The proposal deadline was July 31, 2017, and award winners will be notified on October 30, 2017, according to APDC.
Also, in January of 2017, the Philadelphia Pediatric Medical Device Consortium (PPDC) announced that it chose three companies from eight finalists to receive seed grants of $50,000 each. The PPDC announced that the Request for Applications for its next Sponsored Project Proposals begins on September 11, 2017.
According to a 2016 FDA review, the FDA-funded pediatric consortia have advised 406 pediatric device projects and innovators since 2013, and as of the first fiscal quarter of 2016 there were 10 patents obtained and 5 devices available for use in the care for pediatric patients.
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.”
Wayne, Pennsylvania-based Teleflex Inc. announced it will purchase privately-held NeoTract Inc. for approximately $1.1 billion. According to the press release, Teleflex will pay NeoTract $725 million when the deal closes and an additional $375 million upon NeoTract hitting certain sales goals through 2020. The companies said they expect the deal to close within the next 30 days.
According to its website, Teleflex is a global provider of medical technologies in surgical, anesthesia, cardiac care, urology, and respiratory care fields. NeoTract describes itself as a company dedicated to developing minimally-invasive and clinically-effective devices that address unmet needs in the field of urology. NeoTract’s device, the UroLift® System, is said to treat benign prostrate hyperplasia (BPH) by using small implants to hold the enlarged prostate tissue out of the way of the urethra.
Teleflex’s CEO Benson Smith characterized NeoTract as “a truly unique company with a differentiated technology that targets a greater than $30 billion addressable market.” Smith also stated that a second-generation UroLift® System is expected to launch in the second half of 2018. NeoTract’s revenue is expected to be between $115 million to $120 million this year, compared to about $51 million in 2016, and is expected to increase at least 40 percent in 2018, the companies said in a joint statement.
Reuters notes that the deal is Teleflex’s 23rd since 2008 and follows its $1 billion acquisition of Vascular Solutions in December. Teleflex expects the NeoTract deal to slightly diluteTeleflex’s adjusted earnings this year, be neutral to profits next year, and be accretive starting in 2019.
According to a regenerative medicine article published online on August 07, 2017 in the journal Nature Nanotechnology titled “Topical tissue nano-transfection mediates non-viral stroma reprogramming and rescue”, Researchers at the Ohio State University Wexner Medical Center and College of Engineering have developed a technology that has the potential to generate any cell type of interest for treatment within a patient’s body. According to the article, the researchers call their technology Tissue Nanotransfection (“TNT”), and state that a chip-sized device may be used to repair injured tissue or restore the function of aging tissue. This can include, for example, organs, blood vessels and nerve cells.
Dr. Chandan Sen, the director of Ohio State’s Center for Regenerative Medicine & Cell Based Therapies and the executive director of Ohio State’s Comprehensive Wound Center states that “by using our novel nanochip technology, injured or compromised organs can be replaced. We have shown that skin is a fertile land where we can grow the elements of any organ that is declining.”
Sen further states that “This is difficult to imagine, but it is achievable, successfully working about 98 percent of the time. With this technology, we can convert skin cells into elements of any organ with just one touch. This process only takes less than a second and is non-invasive, and then you’re off. The chip does not stay with you, and the reprogramming of the cell starts. Our technology keeps the cells in the body under immune surveillance, so immune suppression is not necessary.”
According to the Nature Nanotechnology article, the TNT chip-sized device has two major components – (1) a nanotechnology-based chip that sits on the skin, and (2) biological cargo contained within to affect the tissue underneath.
As illustrated in the figure above, the chip is said to deliver pre-programmed DNA or RNA non-invasively into living skin cells using a high-intensity, focused electric field and converting it into whatever type of cells chosen. “This technology does not require a laboratory or hospital and can actually be executed in the field,” Sen said. “It’s less than 100 grams to carry and will have a long shelf life.” “We are proposing the use of skin as an agricultural land where you can essentially grow any cell of interest,” Sen said.
According to the article, initial testing on mice has been promising. The researchers reported that they were able to reprogram skin cells into vascular cells on a mouse that had a badly injured leg with no blood flow. The article noted that as shown in the figure below, after one week of treatment, blood vessels appeared around the leg and within two weeks the leg had been completely restored.
Furthermore, the article noted that a mouse that suffered a stroke regained neurologic function, demonstrating that this technology could also be applied to organs and nerve cells.
According to researchers, the aforementioned technique is said to be unique as it skips the usual intermediary step of creating pluripotent stem cells. Furthermore, the article notes that because the process is non-invasive and the reprogrammed cells are part of the patient’s body, there are no concerns regarding immune suppression.
Researchers find broad potential application of the disclosed technology. For example, it is said to have the potential to save lives of car crash victims, deployed soldiers injured on site, and potentially find cures to Alzheimer’s and Parkinson’s disease.
Additional details regarding the technology are discussed in the video below:
For opponents of the 2.3 percent medical device tax, it looked like the repeal/replacement of the Affordable Care Act would alleviate their concerns. However, following the failure of repeal legislation that would have killed off, or delayed, the tax, the tax is on pace to be reinstated on January 1st, 2018 after a two-year gap.
Regardless of the status of the Affordable Care Act, news articles have indicated that companies and lawmakers opposed to the tax are considering pursuing a number of different options, such as adding tax delay language into other bills. Accordingly, a group of conservative action groups are pushing Congressional leaders to pursue a repeal of the tax, including preparing a letter to House speaker Paul Ryan and Senate majority leader Mitch McConnell. Further, the Advanced Medical Technology Association will be running digital and social media ads throughout this month in a number of states, hoping for tax repeal once lawmakers are back in session in September.
While it can be difficult to truly define a correlation between job performance and the medical device tax, a member survey performed by the Medical Device Manufacturers Association found that 70% of companies added jobs in 2016-2017 and R&D increased by 19% on average. On the other hand, in 2015 the Congressional Research Service found that there were no significant losses due to the tax.
According to news sources, the tax applies to hospital and physician medical equipment, but excludes many consumer medical items (eyeglasses, hearing aids, etc.).
K2M Group Holdings, Inc. recently announced its acquisition of a portfolio of 17 issued and pending patents for expandable interbody technology. According to K2M, the company is a global leader in the medical device industry and provides complex spine and minimally invasive solutions to help patients with difficult spinal pathologies achieve three-dimensional (i.e., axial, coronal, and sagittal) Total Body Balance™. K2M explains that the acquisition of the “comprehensive patent portfolio” allows the company to expand its portfolio of 3D-printed spinal solutions.
In the same press release, K2M also announced its plan to integrate its 3D printing technology, Lamellar 3D Titanium Technology™, into new products developed with the recently acquired intellectual property. According to K2M’s Platform Technologies page, Lamellar 3D Titanium Technology™ utilizes an advanced 3D printing method to grow implants from titanium powder through selective application of a high-energy laser beam.
Speaking about the exclusive license, Eric Major, K2M President and CEO, stated:
We are excited to have obtained the exclusive rights to this intellectual property portfolio and look forward to integrating our 3D printing technology with new expandable spinal devices as part of our effort to build a comprehensive portfolio of industry-leading, 3D-printed solutions to address the full range of spinal pathologies.
K2M recently expanded its portfolio of 3D-printed spinal solutions in June 2017 after receiving FDA clearance of MOJAVE™ PL 3D Expandable Interbody System, which is a fusion device designed to allow for independent adjustment of the anterior and posterior height in the lumbar spine. K2M also introduced its SAHARA™ AL Expandable Stabilization System in June, which is the only expandable, lordotic interbody device currently available that uses an integrated screw fixation to help achieve spinal balance.
Globus Medical announced early today that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017.
Globus Medical, which describes itself as a musculoskeletal implant manufacturer, acquired the robotics developer Excelsius Surgical and its robotic guidance device Excelsius GPSTM three years ago according to press releases. The Excelsius GPSTM platform is said to function as a robot-assisted surgery guidance system “designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement,” according to the press release. Globus Medical further describes the platform as being compatible for use with pre-operative CT, intra-operative CT, and fluoroscopic imaging modalities.
The FDA’s decision is stated to allow the platform for use within minimally invasive and open orthopedic and neurosurgical procedures, including screw placement applications in spine and orthopedic surgery. This announcement also follows Globus Medical’s earlier news release announcing that the Excelsius GBSTM system received CE mark approval in the European Union.
Norbert Johnson, Vice President of Robotics, Imaging, & Navigation at Globus Medical, views these results as an example of Globus Medical’s developmental capabilities:
We believe the Excelsius GPS™ System will advance patient care and provide tangible benefits for surgeons and hospitals in terms of time, accuracy and reduced radiation exposure through the application of robotic and navigation technology in spine and orthopedic surgery.
The Excelsius GPSTM received FDA 510(k) clearance after Globus Medical re-filed its 510(k) bid following an FDA decision that Globus Medical’s initial bid had not “sufficiently addressed the FDA’s questions,” according to Mass Device.
The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017. This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA. Previously, companies had to submit a report within 30 days of a problem. Under the current version of the Reauthorization Act, companies will be able to submit reports once every three months instead. Additionally, these reports will be able to “summarize previously reported product malfunctions, rather than filing detailed reports on each case” as reported by the StarTribune. However, this does not affect the 30-day reporting requirement for medical device companies to report “adverse events” or anything that result in actual injury to consumers.
This measure is part of a piece of legislation that must be renewed every five years and which sets the fees that device makers pay the FDA to review their products. The goal of the agreement from the device maker’s perspective is to reduce the time it takes for the FDA to review products and get them to market. According to the New York Times, this bill “compels the F.D.A. to speed medical devices onto the market — and into patients — faster than ever.” But this may not be in patients’ best interest, because medical device malfunctions are already “vastly underreported” as acknowledged by the FDA.
StarTribune reports that proponents of the change say that it would “simplify the needlessly repetitive process of reporting known product problems.” Minneapolis-based med-tech regulatory attorney Mark DuVal said that “A lot of MDRs (Medical Device Reports) are really boilerplate and repetitive,” and that “[i]t would be nice to be able bundle them.” According to the StarTribune, DuVal thinks that the current system of reporting MDR’s creates a lot of work for companies while doing little to inform doctors about issues that are known. Janet Trunzo, a senior executive vice president with the lobbying group AdvaMed, said in a statement that the reporting provision “will allow the agency to better focus its resources on more serious reportable events.” According to Trunzo, the quarterly summary reporting only applies to well-understood and familiar malfunction incidents. Medical device companies would still be required to file an individual report on any malfunction incident that had not been previously reported.
According to the New York Times, critics of the change do not think relaxing the rules is proper when so much already goes unreported. Jack Mitchell, director of health policy for the National Center for Health Research, said that “[p]ost-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices.” Mitchell thinks that loosening up the reporting rules will “exacerbate the tendency to underreport.” Ms. Tomes, who is now the chief executive of Device Events, which mines FDA’s device data to find signals of problems, also does not think this loosening of the reporting rules is in the public’s best interest. Ms. Tomes pointed out that last year, many reports about battery depletion of cardiac defibrillators were reported as “malfunctions.”
The bill still needs to be passed in the Senate before being signed into law by President Trump. The Regulatory Affairs Professionals Society reports that this bill is “must-pass” legislation because there will be massive layoffs at the FDA if the fee agreements are not reauthorized before the current ones expire on Oct. 1, 2017.
The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone with pending 510(k) submissions for devices that are now exempt “should withdraw their submissions.”
According to the Notice, the exemptions from the 510(k) requirements do not apply to other statutory or regulatory requirements. Further, the Notice indicates there are limitations on some of the exemptions. Table 1 in the Notice lists exempt devices that are subject to general limitations of certain sections of the Code of Federal Regulations (CFR). Table 2 lists exempt devices subject to those general limitations and that must comply with partial exemption limitations as indicated in the table. Table 3 lists exempt devices classified as “radioallergosorbent (RAST) immunological test systems” but which are only a subset of all devices in that classification.
The FDA claims the exemptions “will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.” Further, the Notice states, “regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.”
The Notice was published in accordance with procedures established by the 21st Century Cures Act, which was signed into law December 13, 2016. According to the Notice, the 21st Century Cures Act requires the FDA to publish a list of each type of exempt class II device within 90 days after enactment of the Act and at least once every 5 years thereafter. The Notice reflects the FDA’s final determination regarding a proposed list of devices for exemption issued earlier this year. The relevant codified language for each listed device will be amended by the FDA in a “future action.”