Researchers Announced A New Implantable Energy Storage System Powered By The Patient’s Body

UCLA announced that scientists from UCLA and University of Connecticut designed a new form of energy storage for powering implantable medical devices that do not require a battery.  According to the announcement, this design makes it possible for implantable medical devices to be powered by a patient’s own body.

The announcement notes that many powered implantable medical devices, such as pacemakers, contain traditional batteries, which limit the lifespan of a device to the lifespan of the battery.  According to the Mayo Clinic, the battery of a pacemaker typically lasts five to 15 years, and needs to be replaced by surgery when it runs out. According an editorial in the BMJ (formerly the British Medical Journal), “[o]ver half of all patients with pacemakers require a replacement procedure because the batteries have reached their expected life. Some 11-16% need multiple replacements.”  Moreover, the article notes that batteries make the implantable device bulky and contain toxic chemicals, which can be harmful to the patient if they leak.

According to UCLA, the new energy storage system is called a biological supercapacitator, which operates on electrolytes in the patient’s body, for example, in blood and urine, and eliminates the need for a traditional battery in an implantable medical device.  The researchers state that the biological supercapacitator can be combined with “an energy harvester” to also convert heat and motion of the patient into electricity to be captured by the supercapacitator.

Although the announcement states that supercapacitators are currently not widely used in implantable device technology, Maher El-Kady, a UCLA postdoctoral researcher and a co-author of the study, commented:

In order to be effective, battery-free pacemakers must have supercapacitors that can capture, store and transport energy, and commercial supercapacitors are too slow to make it work.  Our research focused on custom-designing our supercapacitor to capture energy effectively, and finding a way to make it compatible with the human body.

More details of the research team’s design can be found in a paper recently published in Advanced Energy Material.

Philips Buys RespirTech for Undisclosed Amount

Dutch conglomerate Philips recently announced that it will purchase Respiratory Technologies Inc. (RespirTech). According to its website, RespirTech describes itself as a St. Paul, Minnesota-based provider of inCourage vests, which help fight respiratory disease. According to a news release, the terms of the deal were not disclosed.

RespirTech’s website states that the inCourage vest uses high-frequency chest compression to help loosen and move mucus through the lungs. According to RespirTech’s website, the inCourage technology was developed by Pediatric Pulmonologist Warren Warwick, M.D., and Leland Hansen, MPH, in the early 1990’s to provide more effective secretion clearance for University of Minnesota cystic fibrosis patients.

According to Philips’ website, the conglomerate has primary divisions in the areas of healthcare, lighting, and home electronics. Philips’ 2016 annual report states that sales in its HealthTech portfolio increased 4% and topped $19 billion. In contrast, news sources state that RespirTech was founded in 2004 and reportedly had nearly $37 million in revenue in 2015.

Regarding the acquisition, John Frank, Philips’ business leader for sleep and respiratory care, said in a news release:

With this transaction, we will broaden our portfolio with a proven therapy to enable patients with chronic respiratory disorders manage their condition and receive the care they need in the home.

According to Philips’ CEO, Franz van Houten, Philips has transformed itself over the last five years into a differentiated global health tech leader. Mr. van Houten stated that the markets Philips’ serve have attractive growth and attractive profitability. According to news sources, GE Healthcare, Siemens Healthineers, and Toshiba Medical Systems are other conglomerate divisions competing with Philips in the healthcare space.

As one analyst notes, the Twin Cities have produced a number of competing companies that make vests for treating lung conditions, including New Prauge-based ElectroMed Inc., and St. Paul-based Hill-Rom.

Former Lutonix VP Pleads Guilty to Trade Secret Theft

On May 9, 2017, according to court records, Christopher Barry, former Vice President of R&D at Lutonix Inc., pled guilty to stealing Lutonix’s trade secrets in the form of several confidential electronic files.  According to the Plea Agreement, the allegedly stolen files relate to Lutonix’s proprietary design and manufacture of drug coated balloons, in particular the Lutonix 035 DCB.  The Plea Agreement stated that sales for the Lutonix 035 DCB, depicted below, exceeded $50 million in 2015.

The factual background provided in the Plea Agreement reports that, following his departure from Lutonix, Barry took a position as CEO of Urotronic, a medical device startup developing its own drug-coated balloon.  According to the Plea Agreement, Barry disclosed the contents of the purportedly stolen files to others at Urotronic.  However, according to news articles, following entry of Barry’s guilty plea, Urotronic denied that Barry had any involvement in the development of the Urotronic technology.

FDA Approves “First-of-its-kind” Infant Medical Device

The U.S. Food and Drug Administration (FDA) recently authorized the use of what it described as a “first-of-its-kind” medical device to treat infants for a birth defect called esophageal atresia, in which the upper esophagus is disconnected from the lower esophagus and the stomach. According to the FDA, babies with this condition require a feeding tube until surgery can be performed to connect the esophagus to the stomach.

According to Cook Medical, its pediatric esophageal atresia anastomosis device, called Flourish™, uses magnets to pull the upper and lower esophagus together, closing the gap and allowing food to enter the stomach. Dr. Mario Zaritzky, a pediatric radiologist at the University of Chicago Medical Center and one of the joint inventors listed on the patent on this technology (U.S. Patent No. 9,168,041), states:

“The idea was to create a minimally invasive procedure that could possibly be an alternative to surgery in selective pediatric cases. Any procedure that can potentially replace major thoracic surgery with a less invasive method should be considered before deciding to go to the operating room.”

Cook Medical’s press release notes that each of the 16 infant patients treated using this device had a successful joining of their esophagus with no remaining gap, within 3‑10 days after receiving the device.

According to the Cook Group, Cook Medical is a company that engages in “medical research and product development in minimally invasive medical device technology for diagnostic and therapeutic procedures.”

Intellectual Property Cases Dominate 2016 Verdict Awards

According to the annual Top 100 Verdicts report by ALM’s VerdictSearch, five jury verdicts for Intellectual Property cases cracked the top 10 with a sixth breaking into the top 25 verdicts of 2016. While the amounts do not account for judicial reductions, offsets or appeals, the report indicates that the more than $4.67 billion in total jury awards from the top 6 IP verdicts alone show that intellectual property cases dominated the Top 100 in terms of total dollars awarded.

The publication ranked Idenix‘s $2.54 billion royalty share of Gilead Sciences‘ profits from two blockbuster hepatitis C drugs as the #1 IP verdict and #3 overall on its list of “Top 100 Verdicts of 2016.” According to the report, Idenix successfully asserted that Gilead willfully infringed Idenix’s patents relating to an antiviral compound used in the treatment of hepatitis C, resulting what commentators have stated is the largest patent infringement verdict in U.S. history.

The second highest IP verdict in VerdictSearch’s 2016 list, $940 million (including $700 million in punitive damages), went to medical software company Epic Systems in what commentators have said is one of the largest trade-secrets verdicts on record. According to the report, Epic successfully asserted that Tata misappropriated information related to Epic’s health care software.

The #3 and #4 IP verdicts of 2016 according to VerdictSearch, $625 million and $302 million, respectively, went to technology patent-holder VirnetX for infringement of four of VirnetX’s internet security patents infringement by several Apple products, including iPhones and iPads.

Merck won the 5th largest IP verdict of the year according to VerdictSearch, a $200 million award against Gilead. The report noted that Gilead Sciences v. Merck & Co. involved infringement of different patents relating to the same drug compound as the Idenix case. The case was filed by Gilead as a declaratory judgment action, but Merck & Co. won on its counterclaim.

CardiAQ‘s $70 million win in CardiAQ Valve Technologies, Inc. v. Neovasc Inc. was listed in VerdictSearch as the #6 IP verdict and tied for #21 overall. As noted in a previous post here, according to the report, the jury found that Neovasc breached the non-disclosure agreement between the parties, misappropriated CardiAQ’s trade secrets, and breached its duty of honest performance to CardiAQ.

According to the report, the 11 IP verdicts in the top 100 totaled approximately $4.8 billion, more than a threefold increase from 2015, when the total was $1.43 billion.

 

Confirm Rx: Abbott Receives CE Mark for Smartphone Compatible ICM

Abbott recently announced the CE Mark and first use of what it claims is “the world’s first smartphone compatible” insertable cardiac monitor (ICM), as reported by a press release dated May 8, 2017.

According to the press release, Abbott produces the Confirm RxTM ICM, which is marketed as the slimmest ICM available. Pictured on the right, Abbott states that the Confirm RxTM is designed to continuously monitor a patient’s heart rhythm and proactively transmit information via the myMerlinTM mobile app, thereby allowing physicians to follow their patients remotely and ICMaccurately diagnose arrhythmias.  As noted on the Confirm RxTM webpage, the ICM is placed by a physician under local anesthesia by making a small incision in the pectoral region, inserting the ICM under the skin using an insertion tool, and then closing the incision. “Patients can record symptoms directly on their smartphone without the need for a bedside transmitter or separate activator,” said Georg Nölker, M.D. in prepared remarks.  Dr. Nölker was one of the first physicians to implant the Confirm Rx ICM after it received CE Mark approval.

According to Abbott, the myMerlinTM mobile app makes it easy for patients to stay connected to their physicians.  A listing of the product features from the Confirm RxTM product website includes:

  • Transmit nightly data reports automatically simply by being in range of the smartphone;
  • Manually record patient symptoms on their own smartphone and specify events such as fainting or if they experience a fast heart rate;
  • Confirm patient data was transmitted to their physician;
  • Automatic alerts when they have missed a scheduled transmission;
  • Offers secure transmission of patient data.

Mark D. Carlson, M.D., chief medical officer of Abbott’s cardiac arrhythmias and neuromodulation businesses, views these results as a step forward in ICM technology, stating:

Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance…The Confirm Rx ICM addresses a broad range of indications, such as syncope, palpitations and atrial fibrillation. The technology has been designed with robust data privacy and security measures to ensure peace of mind for both patients and providers.

Dr. Christopher Piorkowski, said to be one of the first physicians to implant the Confirm RxTM ICM, stated:

The Confirm Rx ICM will be particularly useful in monitoring for atrial fibrillation in my patients with paroxysmal AF, following AF ablation and with stroke of an unknown cause. It allows an objective way to quantify AF events to guide treatment decisions. The smartphone compatibility engages patients and allows better compliance to remote monitoring through a simple and intuitive user interface. This allows clinic staff to reduce follow-up burden and focus on reviewing transmitted data for AF.

As reported by the press release, the Confirm RxTM ICM is available in select European countries, with full European release expected during the second quarter of 2017.  It further states that the device is currently under review by the U.S. Food and Drug Administration.

WannaCry Malware and Medical Device Security

The WannaCry virus has infected and frozen computers in many industries around the world.  According to a news source report, the virus has extorted doctors and hospital administrators for the keys to unlock and regain access to their systems in order to treat patients.  The Telegraph reports that in the United Kingdom alone, up to 40 hospital trusts were hit by the WannaCry ransomware virus, which resulted in a wave of cancelled appointments and a general state of disarray.  Recently, the BBC has stated that at least 16 of these hospitals are still facing issues.  With the widespread damage associated with the WannaCry virus, many experts have advocated that the medical device industry should be on alert, now more than ever, regarding the cyber security of their medical devices.

Although the issues associated with medical device security have recently been discussed, some industry professionals believe there does not seem to be an adequate solution to the problem of device security.  Tressa Springman, the CIO of LifeBridge Health, explains:

“There’s a lot of talk in healthcare about device security. Discussions about what we’re comfortable pushing as endpoint security and what we’re unable to do – because certainly, we don’t want to create any harm to patients.  Many of these devices and the vendors who manage them, it’s very hard to go direct on patching and adding security.”

While medical devices are generally tested extensively for safety, some cybersecurity experts have observed the same cannot necessarily be said for security.  Brian NeSmith, co-founder and CEO of cyber security company Arctic Wolf Networks, has stated:

“Medical devices, similar to many other IoT devices, were not designed with rigorous security in mind and are more vulnerable to being hacked. They also do not fall under normal security operations procedures since they are used as needed by the medical practitioners and not deployed and maintained by the IT department.”

Security experts are emphasizing the importance of security patches.  Optimistically, Richard Staynings, the principal cybersecurity healthcare leader at Cisco’s Security unit, believes:

“This is going to cause a paradigm shift, at least for patching.”

INC Research Merges with inVentiv Health Creating a $7.4B Combined Entity

According to press releases, INC Research Holdings, Inc. has agreed to merge with inVentiv Health, creating a combined company having an enterprise value of approximately $7.4 billion. The press release further notes that the combined company will be the second largest biopharmaceutical outsourcing provider, one of the top 3 contract research organizations and the largest contract commercial organization by net revenue.

In other news, INC Research was recently recognized for its cybersecurity awareness training at the 5th annual CSO50 Conference + Awards event held on May 1–3.  The CSO50  recognizes 50 organizations for security projects that demonstrate “outstanding business value and thought leadership” and are selected through a nomination and review process each year by a team of security experts and academics.  CSO is an online publisher focusing on information security, physical security, business continuity, identity and access management, and loss prevention.

According to its website, INC Research is a contract research organization that provides clinical development services to the pharmaceutical, biotechnology, and medical device industries.  With more than 6,000 employees across 110 countries, over 100 client audits a year, and access to sensitive medical information by most employees, INC Research was tasked with providing adequate and efficient cybersecurity training—in addition to many other internal training programs.

The award-winning program it developed was said to save over 3,500 hours of disruptive training time.  According to news sources, INC Research’s security program focused on frequency of training communications, as opposed to a single one-hour yearly session.  Its program used two 15-minutes trainings per year, quarterly two-minute training videos and regular contacts with employees using the company’s intranet and email systems to reinforce cybersecurity principles.

Other honorees included AstraZeneca, Beebe Healthcare, Celgene Corporation, the FDA, and Health Management Systems.

Becton Dickinson to Acquire C. R. Bard for $24 Billion

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.”

Johnson & Johnson’s Codman Neuro Announces Acquisition of Neuravi

Codman Neuro, part of Johnson & Johnson’s DePuy Synthes business unit, recently announced its acquisition of Neuravi Ltd., a privately-held Irish medical device company, for an undisclosed amount.  The Irish Times reported that the acquisition is the largest price paid for a European venture-backed medtech company since Medtronic’s $700 million buyout of CoreValve in 2009.  According to its website, Neuravi focuses on neurointervention therapies for acute stroke treatment.

Neuravi’s sale to Codman Neuro comes after several rounds of fundraising, in which Neuravi secured tens of millions of dollars for the development and commercializing of its EmboTrap Revascularization Device.  Neuravi explains that the EmboTrap Revascularization Device is a thrombectomy system designed to restore blood flow to the brain by capturing and removing blood clots.  EmboTrapIn a 2016 press release, Neuravi CEO Eamon Brady quoted the most recent investment of $16.7 million as important for building a commercial presence in the U.S. and cited the “opportunity due to the under-developed stroke treatment ‘toolbox’ available to stroke clinicians today.”  The EmboTrap devices are now commercially available in Europe and are currently undergoing clinical trials in the U.S.  Speaking to the Irish Times regarding Neuravi’s acquisition, Justin Lynch, a partner of one of Neuravi’s early institutional investors, said:

This is a company that has knocked the ball out of the park. They have beaten every milestone, earlier and with less money that budgeted, which is almost unheard of in this business.

Neuravi’s revascularization devices appear to have successfully caught the attention of Codman Neuro.  Shlomi Nachman, Company Group Chairman of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions recently stated:

Rapid restoration of flow is of utmost importance when treating stroke patients . . . .  The EmboTrap platform was designed to address this critical need and we are excited to combine Neuravi’s expertise in clot research with Codman Neuro’s global resources to accelerate innovation in acute ischemic stroke treatment.

Codman Neuro describes its portfolio as including medical devices for hydrocephalus management, neuro intensive care and cranial surgery, and endovascular treatment of cerebral aneurysms and stroke, including aneurysm coils and vascular reconstruction devices.

Shortly before Codman Neuro’s acquisition of Neuravi, Integra Lifesciences announced that it plans to purchase Codman from Johnson & Johnson for $1.05 billion.  Integra explained that it intends the acquisition to expand Integra’s international presence.  Integra markets products in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery, including wound repair.  According to Integra’s press release,  Codman Neuros’ neurosurgery business generated $370 million in 2016 from the sale of neuro-critical care and electrosurgery devices.  Johnson & Johnson reported to Reuters that the deal with Integra excludes its neurovascular and drug delivery businesses.

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