Showing all posts written by John Sadlik
NeuroTronik, a North Carolina based subsidiary of NeuroTronik LTD of Dublin, announced that it recently closed a $23.1 million Series B funding round. The press release noted that the round was led by contributions from Boston Scientific, Synergy Life Science Partners, and several venture capital firms. NeuroTronik was quoted in the release as aiming to improve patient outcomes, shorten hospital stays, and reduce hospital recidivism rates.
According to NeuroTronik, the therapy, known as CANS Therapy, utilizes a neuromodulation device designed to stimulate the cardiac autonomic nerve via a catheter. NeuroTronik describes the device as less invasive than currently used implantable defibrillators, providing an alternative to drug-based treatments. According to the company, NeuroCatheterTM is temporarily placed in a vein just above the heart and is controlled via an external NeuroModulatorTM that can be positioned bedside.
“Physicians need better therapy tools to treat Acute Heart Failure in the hospital. With the achievement of our Series A milestones and through subsequent work, our team has demonstrated that NeuroTronik CANS Therapy™ holds considerable promise to be a unique and valuable tool for physicians for use in this clinical setting,” said Fred McCoy, CEO and Director, NeuroTronik LTD in a prepared statement.
NeuroTronik stated that it plans to use the Series B funding to obtain regulatory approval to market its CANS Therapy device in Europe. After obtaining European approval, NeuroTronik plans to bring the treatment to the United States.
Previous news sources state that NeuroTronik closed a $13.1 million Series A round in May of 2013, and was spun out of a medical technology incubator called Synecor in 2012.
The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says a new report issued by the NEST Planning Board. The Planning Board was convened by the FDA and the Duke-Margolis Center for Health Policy in order to outline the initial priorities for NEST.
The FDA plans for NEST to be the national evaluation system for medical devices and is aiming to evaluate evidence from the entire life-cycle of medical device products in order to more effectively monitor medical device safety and efficacy.
In July, FDA Commissioner Dr. Robert Califf and Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health (CDRH) stated that this system for evaluating health technology:
could quickly identify problematic devices, accurately and transparently characterize and disseminate information about device performance in clinical practice, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices.
The Planning Board’s report explains that new standards for sharing medical data between multiple entities will be the focus of a planned NEST Coordinating Center. The proposed Coordinating Center will work to develop a network of experts which will aid NEST in collecting and evaluation clinical data, as well as data received directly from patients. According to the report, the Coordinating Center will foster the development of a NEST clearinghouse of analytical tools, methods, and standards for using linked real-world data collected through clinical and administrative workflows as well as from patients themselves to evaluate devices.
In a per curiam decision the Federal Circuit upheld the U.S. District Court for the District of Massachusetts’ holding that certain claims of Exergen Corporation’s U.S. Patent No. 7,787,938 was invalid as being directed to an abstract idea, and thus not infringed by Thermomedics, Inc.
Exergen’s original lawsuit alleged that Thermomedic’s Caregiver non-contact thermometers infringed certain claims of the ‘938 patent, entitled “TEMPORAL ARTERY TEMPERATURE DETECTOR”. Exergen also markets a variety of temporal artery thermometers.
Claim 51, one of the claims asserted in the suit, recites:
A method of detecting human body temperature comprising: measuring temperature of a region of skin of the forehead; and processing the measured temperature to provide a body temperature approximation based on heat flow from an internal body temperature to ambient temperature.
Figure 1 from the ‘938 patent is reproduced below:
The Federal Circuit upheld the district court’s grant of Thermomedic’s motion for summary judgment of invalidity. The district court found that the asserted claims of Exergen’s ‘938 patent was not eligible for patent protection because it merely identified a discoverable relationship between a patient’s skin temperature and the patient’s core temperature. The court elaborated that the asserted claims of the ‘938 patent did not add an “inventive concept” to this “natural relationship”, and was invalid and thus not infringed by Thermomedics. The court acknowledged that although the discovery may have been extremely valuable to the medical community, the asserted claims of the ‘938 patent did not “add enough to qualify as a patent-eligible process applying” the discovery.
(March 11, 2016) The U.S. Senate Health, Education, Labor & Pensions committee approved a bill to expand an expedited review program for FDA approval of certain medical devices. The bill, S. 1077 “A bill to provide for expedited development of and priority review for breakthrough devices,” is aimed at expediting the approval process for ‘breakthrough’ medical devices, and builds on the FDA’s Expedited Access Pathway, which was implemented in 2015.
According to the bill, ‘Breakthrough’ medical devices treat or diagnose life-threatening or irreversible diseases for which no approved alternatives exist, or offer significant advantages over existing technologies. The streamlined review process for these devices would require shorter and smaller clinical trials to show a device’s success, and would implement quicker compliance time-frames. Expedited review would be available to all classes of medical device; currently only class III, or high risk, devices are able to receive expedited review. A similar program is available for FDA approval of drugs designated as “breakthrough therapies.
Some advocacy groups have expressed concerns that patients may be put at risk if the FDA is not thorough enough during the quickened approval process. Proponents of the bill counter that an expedited review process will allow patients more timely access to potentially life-saving devices.
The bill is part of a larger effort by the National Institutes of Health to increase medical research. The NIH hopes that streamlining the review process for revolutionary medical devices will lead to increased private sector investment in medical device research.
Alameda, California-based medical device company Penumbra, Inc. registered with the Securities and Exchange Commission (SEC) last Friday for an initial public offering (IPO) to raise up to $115 million. The company will be traded under the symbol PEN on the New York Stock Exchange (NYSE).
According to its S-1 filing, Penumbra develops, manufactures, and markets medical devices focused on interventional therapies. Founded in 2004, the company’s primary focus has been on neurovascular devices, although it recently entered the peripheral vascular market, and focuses on thrombectomy and embolization technology. According to press releases, Penumbra’s Ace64 aspiration thrombectomy device, reportedly the largest-lumen thrombectomy device on the market, won 510(k) clearance from the FDA last May.
The S-1 disclosed that Penumbra reported sales of $125.5 million in 2014, an increase of 41.3% from 2013, and also that Penumbra maintains a portfolio of 18 global patents, of which seven are U.S. patents. The S-1 also stated that Penumbra owns 31 pending worldwide patent applications.
Acelity has reportedly tasked J.P. Morgan Chase & Co., Goldman Sachs, and Bank of America Merrill Lynch with underwriting the deal. The Wall Street Journal noted that proceeds from the IPO may be used to pay down some of the company’s long term debt.
According to news sources, Acelity, formerly known as Kinetic Concepts, Inc., was founded in 1976 and specializes in developing and commercializing wound-care and regenerative medicine products. Apax Partners and two Canadian pension funds acquired Acelity in a $6.1 billion leveraged buyout in November, 2011. Acelity has since made several acquisitions, the most notable being the nearly $500 million purchase of Systagenix, a wound care company spun out of Johnson & Johnson, in October 2013.
According to filings with the Securities and Exchange Commission (SEC), Acelity maintains a patent portfolio of over 2,000 patents and over 1,000 pending patent applications in the areas of wound-care and regenerative medicine, among others.
In 2011, DePuy-Synthes, a subsidiary of Johnson & Johnson Inc. sued Globus Medical, Inc. in the United States District Court for the District of Delaware. In that suit, Synthes alleged that Globus had infringed three Synthes patents (U.S. Patent Nos. 7,846,207; 7,862,616; and 7,875,076) all directed to intervertebral implants.
The jury found that Synthes’ patents were valid and that three of Globus’ intervertebral implant products infringed those patents. The jury awarded Synthes $16 million in damages, representing a 15% royalty on Globus’ sales of infringing products.
In December 2014, Synthes learned that its damages expert, Richard Gering, did not have a Ph.D., as he had testified under oath. Synthes notified the court and Globus the following day.
Globus argued in a brief, filed April 24th, 2015, that it should be granted a new trial because it is impossible to quantify how much the discredited expert’s testimony influenced the jury’s decision. Synthes responded that because Globus did not offer evidence that the expert’s testimony itself was factually incorrect, it could not establish that a new trial is warranted. Mr. Gering testified only on damages, and not on validity or infringement. Therefore, Synthes argued that there is no reason to grant a new trial.
The U.S. Food and Drug Administration (FDA) recently announced its tougher new requirements for testing reusable medical devices. According to the FDA’s News Release, the new rules are “aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.” The guidance document (Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling) also includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices.
The new rules and recommendations are based on draft proposals that the FDA released in 2011 for public comment. The rules’ issuance follows the news of the deaths of two patients from “superbug” infections that have been linked to reusable medical scopes. Olympus, the manufacturer of the implicated scopes, is being sued for failing to issue updated cleaning instructions after a recent redesign, and for selling a “defective scope,” among other allegations.
The FDA’s new rules will only apply to new devices receiving FDA approval, not to devices that are currently on the market. The New York Times reported that “Officials acknowledged that they could only recommend — not require — that products on the market use the more rigorous testing.”
The FDA has said that that the new rules incorporate new testing requirements intended to make reprocessing reusable medical devices more effective. For example, manufacturers will be required to submit data to show that their reusable medical devices, such as duodenoscopes, endoscopes, and bronchoscopes, can be properly disinfected. Manufacturers had previously been required to collect this data, but were not required to submit it to the FDA.
According to the FDA’s press release, the guidance document further “recommends that manufacturers consider reprocessing challenges early in device design.”
(January 20, 2015) KFx Medical Corp.’s $35 million patent infringement award against Arthrex, Inc. was upheld by the Federal Circuit. KFx’s lawsuit alleged that Arthrex’s SutureBridge and SpeedBridge devices infringed U.S. Patent No.7,585,311, 8,109,969, and 8,100,942, each entitled “System and method for attaching soft tissue to bone.” Figure 1 from the ‘311 patent is reproduced below:
The Federal Circuit upheld the Southern District of California court’s dismissal of Arthrex’s motion for a new trial after a jury found that Arthrex had infringed the KFx patents, and awarded KFx $29 million in damages. The district court judge later awarded additional damages and pre-judgment interest. The Federal Circuit’s decision is available here, and a press release from KFx is available here.
Federal Circuit Vacates $176 Million Damages Award to Covidien relating to Ethicon Harmonic Ultrasonic Cutters
The United States Court of Appeals for the Federal Circuit vacated a $176 million district court damages award to Covidien, formerly known as Tyco Healthcare Group LP, in a patent infringement suit against Ethicon Endo-Surgery, Inc., a subsidiary of Johnson & Johnson. Covidien’s lawsuit alleged that Ethicon’s Harmonic ultrasound cutting devices infringed U.S. Patent Nos. 6,682,544; 6,063,050; and 6,468,286. According to the Federal Circuit, “the asserted patents generally disclose a surgical device… that employs ultrasonic energy to cut and coagulate tissue in surgery.” Figure 12 from U.S. Patent No. 6,063,050 is illustrated below:
The Federal Circuit held that the claims Covidien asserted against Ethicon were invalid as obvious. The opinion stated that “the district court improperly held that the Ethicon Prototype could not be considered prior art under 35 U.S.C. § 103, and erred in finding that the… claims would not have been obvious.”