PavMed subsidiary Lucid Dx inks licensing deal with Case Western Univ.

Pavmed (NSDQ:PAVM) subsidiary Lucid Diagnostics said today it finalized a licensing agreement with Case Western Reserve University to commercialize its EsoCheck non-invasive cell sampling device and DNA biomarker test.

The New York-based company said that the EsoCheck device has been shown to effectively and accurately detect Barrett’s Esophagus, which is a precursor to the most common and lethal forms of esophageal cancer caused by Gastroesophageal Reflux Disease.

The EsoCheck test is composed of a pill-sized capsule with a small inflatable balloon attached to a thin catheter. The patient swallows the capsule, which swabs the target area for a sample of cells as it is withdrawn, the company said.

Collected samples are then tested for biomarkers that have been shown to be accurate for detecting Barrett’s Esophagus.

As part of the licensing agreement, PavMed’s Lucid Diagnostics will own the exclusive worldwide right to develop both the device and biomarker test and the associated intellectual property.

“EsoCheck is a revolutionary technology that we believe will save many lives through the early detection of pre-cancerous conditions of the esophagus including Barrett’s Esophagus. We are proud to have been selected to be the exclusive commercial partner of Case Western Reserve University in this important endeavor. Based on the dramatic results of the recently published multicenter clinical study, we believe widespread EsoCheck screening has the potential to have as great an impact on esophageal cancer as widespread Pap screening has had in preventing cervical cancer, targeting an estimated immediately addressable domestic market of several billion dollars,” PavMed chair & CEO Dr. Lishan Aklog said in a press release.

PavMed said that it has launched a multicenter National Institutes of Health study of the EsoCheck, and that it is enrolling patients at Case Western Reserve University Hospital and other healthcare facilities.

“Our multicenter NIH study aims to establish the clinical evidence for EsoCheck’s widespread use as a screening test to detect Barrett’s Esophagus, eventually targeting the estimated 50 million Americans with and without heartburn who are at risk. The EsoCheck device is already being manufactured for human use in clinical trials and the EsoCheck DNA biomarker test is already being performed at a reference laboratory, which expects to receive CLIA certification later this year. As such, we will be able to aggressively pursue EsoCheck commercialization by seeking U.S. Food and Drug Administration (FDA) 510(k) clearance of the cell sampling device and a Laboratory Developed Test designation of the DNA biomarker test. We are targeting the first quarter of 2019 for the launch of the first commercial product in the U.S.,” principal investigator and EsoCheck co-inventor Dr. Amitabh Chak of the Case Western University School of Medicine said in a prepared statement.

Earlier this month, PavMed said that it filed a preliminary prospectus with the SEC for an offering of the rights to buy a new unit in exchange for each share of outstanding common stock.

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Siemens Healthineers and Hill-Rom team up to provide diabetes tools to primary care providers

Siemens Healthineers (NYSE:SI) and Hill-Rom (NYSE:HRC) inked a co-marketing agreement to provide an array of point-of-care diagnostic instruments for diabetes to primary healthcare providers in the U.S.

The offering is slated to include Siemens’ DCA Vantage Analyzer for HbA1c testing, the Clinitek Status+ Urine Chemistry Analyzer for kidney testing and Hill-Rom’s Welch Allyn RetinaVue Network and imaging tech for teleretinal exams.

Get the full story at our sister site, Drug Delivery Business News.

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Quest Diagnostics posts mixed Q1

Shares in Quest Diagnostics (NYSE:DGX) held steady today after the company met earnings expectations on Wall Street but missed analysts’ sales estimates with its first-quarter results.

The Secaucus, N.J.-based company posted profits of $177 million, or $1.27 per share, on sales of $1.88 million for the 3 months ended March 31, for bottom-line growth of 7.9% on sales growth of 3.7% compared with the same period last year.

Get the full story at our sister site, Drug Delivery Business News.

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UroViu wins FDA nod for disposable diagnostic cytoscope

UroViu said yesterday it won FDA 510(k) clearance for its Uro-V single-use diagnostic cytoscopic system designed to visually assess the urethra and urinary bladder in instances of suspected pathology or dysfunction.

The Bellevue, Wash.-based company’s newly cleared Uro-V device is a self-contained single-use diagnostic cytoscope designed for female diagnostic cytoscopy. The system is designed to be light-weight, portable and battery powered with a disposable cannula and a reusable handle, video processor, LCD display and touchscreen display.

“Today’s growing and aging population faces a severe problem of an increasing shortage of urologists. The Uro-V Cystoscope has great potential to make the standard urological care more accessible and convenient for the patients while greatly reducing the burden of the urologists and staff,” Dr. Marshall Stoller of the University of California San Francisco said in prepared remarks.

UroViu said it has completed a prospective, observational open-label usability study of 64 subjects who were candidates for office diagnostic cytoscopy at 2 centers in the US and Europe. Results from the study were completed without incident or adverse reactions, the company said.

“Our group of 12 providers made the decision to change to disposable sheaths after critical review of single-use versus reusable scopes, finding significant advantages clinically and economically: safer for patient, ease of use for staff, decreased preparation time, overall decreased cost to provider, with higher safety margin—faster turnover of procedure room, equipment, improved patient time efficiency, increased revenue—lower overall cost, increased number of cystoscopy procedures per day and I think that Uro-V will further improve the single-use model—better visualization digital vs analog, less risk of scope malfunction, improved prep time even compared to single-use sheath (which still requires cleansing scope prior to overlaying scope), ability to show in real time to patient operative findings,” trial principal investigator Dr. Vijay Goli of the University of Nevada School of Medicine said in a prepared release.

“The device was easy to use; my staff preferred it due to easy set up and off-the-shelf availability, and patients were satisfied due to less discomfort than they experienced with standard scopes,” trial principal investigator Dr. Jed Kaminetsky of Manhattan Medical Research said in a press release.

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Drug delivering contact lenses win MIT’s top healthcare innovation prize

[Image from MIT]

Contact lenses that deliver medications directly to the eye over a period of days or weeks was the recent grand prize winner of Massachusetts Institute of Technology’s Sloan Healthcare Innovation Prize.

The MIT Sloan Healthcare Innovation Prize competition had 8 finalists who pitched their healthcare innovations to judges from Optum and other local venture firms, as well as an audience in MIT’s Wong Auditorium.

Harvard Medical School affiliate Theraoptix won a $25,000 grand prize in the competition. Strand Therapeutics took home the second place prize of $2,000 for developing mRNA-based cancer-fighting drugs. Healthcare Hospitality Systems received a $500 audience choice prize for developing directional sound systems for hospital rooms.

Get the full story on our sister site, Medical Design & Outsourcing.

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ACC ’18 Roundup: Abbott releases long-term HeartMate 3 data

Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure.

Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session.

More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years.

The two-year cohort met its primary endpoint, achieving 77.9% event-free survival – topping the 56.4% rate seen in patients treated with the HeartMate II LVAD.

Patients treated with the HeartMate 3 device had a survival rate of 82.8% after two years, compared to 76.2% for the HeartMate II group. Abbott also reported that low pump thrombosis rates remained low at 1.2% for the HeartMate 3 group, with no reoperations or pump replacements needed at two years.

Finally, the stroke rate in the HeartMate 2 group was 19% compared to just 10% for the patients treated with HeartMate 3.

“The long-term data for the pivotal Momentum 3 trial demonstrate overall survival of 83% at 2-years and marked improvement in clinical outcomes for our patients suffering with advanced heart failure,” Dr. Mandeep Mehra, medical director of Brigham and Women’s Hospital Heart and Vascular Center, said in prepared remarks. “We have seen greater pump durability—mostly driven by an absence of confirmed pump thrombosis—as well as a significantly lowered stroke rate without an increase in other adverse events.”

“As the leader in LVAD therapy, our goal is to provide patients with life-changing health technology that minimizes risk and offers them an enhanced quality of life. Data from the Momentum 3 study show Abbott’s significant progress in LVAD innovation and how it’s improving patient health outcomes,” Dr. John O’Connell, medical director for Abbott’s mechanical circulatory support business, added.

Abbott’s HeartMate 3 LVAD has CE Mark clearance in the E.U. and is approved by the FDA in the U.S. for short-term use. The company plans to use data from its Momentum 3 trial to support an regulatory bid for a long-term indication for HeartMate 3 in the U.S.

NEXT: Philips touts NEJM study on iFR v. FFR

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Banyan Biomarkers wins 1st FDA nod for concussion blood test


Banyan Biomarkers this week won FDA clearance for its Banyan Brain Trauma Indicator blood test designed to evaluate concussions in adults, making it the first such test of its kind to get a pass from the federal watchdog.

Approval for the device came through the the FDA’s breakthrough devices program and took only six months to review, according to a release from the agency.

Patients with suspected mild traumatic brain injuries are normally examined using a neurological scale followed by a computed tomography scan to detect brain tissue damage or intracranial lesions that could require treatment, but often do not have detectable intracranial lesions after the CT scan.

The FDA said that the blood test will help healthcare professionals in determining the need for CT scans and prevent unnecessary neuroimaging and radiation exposure to patients.

“Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority. Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging—an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose. 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,” FDA Commissioner Dr. Scott Gottlieb said in a press release.

The newly cleared Brain Trauma Indicator works by measuring levels of the proteins UCH-L1 and GFAP which are released from the brain into the blood within 12 hours of head injury. Those proteins can help prediction patients with intracranial lesions that will be visible to CT scans, the FDA said.

Approval came based data from a clinical study of 1,947 blood samples from adults with suspected concussions, with the indicator successfully predicting the presence of intracranial lesions 97.5% of the time, and identifying those without such lesions 99.6% of the time.

“A blood test to aid in concussion evaluation is an important tool for the American public and for our Service Members abroad who need access to quick and accurate tests. The FDA’s review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of mTBI that can be used both in the continental U.S. as well as foreign U.S. laboratories that service the American military,” FDA’s Center for Devices and Radiological Health director Dr. Jeffrey Shuren said in a prepared statement.

Masimo wins CE Mark for Eve newborn CCHD screening app


Masimo (NSDQ:MASI) said today it won CE Mark approval in the European Union for its Eve critical congenital heart disease newborn screening application which runs on the company’s Rad-97 and Radical-7 pulse co-oximeters.

The Eve application is designed to streamline CCHD screenings by providing visual instructions, animations and automatic synchronization algorithms with a detailed display of screening results, the Irvine, Calif.-based company said.

Eve also enables the incorporation of perfusion index measurements into screening, which Masimo said has been shown to increase sensitivity to the detection of CCHD in infants with pathologically low perfusion rates.

“Multiple studies have shown that Masimo SET pulse oximetry can help improve CCHD screening, helping to save many newborns’ lives while reducing the cost of care. Eve builds on the powerful benefits of SET by transforming pulse oximeters into intuitive screening tools which can help clinicians perform the crucial work of screening newborns in an easy-to-follow and intuitive application,” CEO Joe Kiani said in press release.

Last month Masimo released results from a study of its Oxygen Reserve Index’s ability to function as an early warning of impending arterial hemoglobin desaturation in obese patients, touting its ability to provide advanced warning in the high risk patient population.

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    Intelligent medical device developer M3dicine yesterday announced the launch of its Stethee AI-enabled stethoscope system designed to amplify, filter, record and analyze heart and lung sound.

    The newly launched, FDA-cleared Stethee Pro features technology to capture and analyze heart and lung sounds and data via Bluetooth, operating around smartphone applications for both Apple iOS and Google Android devices, the Brisbane, Australia-based company said.

    “The Stethee system has the potential to transform healthcare. We are on the forefront of a new era in healthcare driven by artificial intelligence and its ability to significantly improve our ability to care for patients. This innovative technology can significantly help drive efficiency and productivity and empower healthcare providers worldwide by providing real time data and clinical interpretation,” Dr. John Sperling of the Mayo Clinic said in a press release.

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    M3dicine said it has inked an exclusive agreement with Korea Telecom for the distribution of its Stethee Pro in a number of developing countries.

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