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 The patient swallows the capsule, which swabs the target area for a sample of cells as it is withdrawn, the company said.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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Teleflex’s NeoTract wins AUA support for UroLift system as standard-of-care

Teleflex (NYSE:TFX) subsidiary NeoTract said today that the American Urological Association now recommends the use of NeoTract’s UroLift system as a standard of care treatment for lower urinary tract symptoms due to benign prostatic hyperplasia.

The company’s UroLift system uses tiny devices inserted into the urethra in a minimally invasive procedure to reopen the lower urinary tract by pushing aside tissue from the enlarged prostate, the Pleasanton, Calif.-based company said.

In a set of newly released clinical guidelines, the AUA recommends that the UroLift prostatic urethral lift procedure “should be considered for the management of men’s lower urinary tract symptoms attributed to BPH.” The guidelines were developed by a panel of experts, NeoTract said, and were last revised in 2010.

The AUA warned that, due to the “strong observed relationship between erectile dysfunction and BPH,” patients should be counseled about possible side effects of surgical interventions and outcomes of surgical treatment related to sexual function.

“The AUA is strongly committed to doing what is best for patients. With the inclusion of the UroLift system in these new guidelines, the AUA provides support of the UroLift system as a treatment in the best interest of patients. Following treatment with the UroLift system, thousands of men have avoided invasive surgery, are no longer needing medications, and are back to living their lives, without giving up normal sexual function. We are hopeful that this recommendation from AUA will mean that many more men will choose the UroLift system,” NeoTract interventional urology biz prez Dave Amerson said in a press release.

In February, Neotract said that it won expanded indications from the FDA for its UroLift prostate treatment.

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VA signs $10B EHR contract with Cerner

The Department of Veteran’s Affairs said yesterday it approved a $10 billion, 10-year contract with Cerner Corp. (NSDQ:CERN) to implement an electronic health record system, which Acting VA Secretary Robert Wilkie called one of the largest IT contracts in the federal government.

With the deal, the VA will switch from its internally developed VistA system to off-the-shelf Cerner solutions with the goal of making veteran’s medical history available through a single EHR system.

“We’re honored to have the opportunity to improve the health care experience for our nation’s veterans. The VA has a long history of pioneering health care technology innovation, and we look forward to helping deliver high-quality outcomes across the continuum of care. My thanks to the administration for selecting Cerner to collaborate in creating seamless care as service members transition from active duty to VA medical centers and community providers. We expect this program to be a positive catalyst for interoperability across the public and private health care sectors, and we look forward to moving quickly with organizations across the industry to deliver on the promise of this mission,” Cerner prez Zane Burke said in a press release.

The agreement comes after months of delays, with the VA originally announcing plans to transition last year. Interoperability concerns and alleged interference from President Trump and his unofficial advisors had previously held up the deal, according to a Modern Healthcare report.

The contract will give the VA the same EHR platform that has already been adopted by the US Department of Defense, according to a release posted by Acting VA Secretary Wilkie.

“In sum, signing this contract today is an enormous win for our nation’s Veterans.  It puts in place a modern IT system that will support the best possible health care for decades to come.  That’s exactly what our nation’s heroes deserve,” Wilkie wrote in a note posted by the Office of Public and Intergovernmental Affairs.

In January, Cerner said it named Brent Shafer to serve as chairman & CEO effective Feb. 1.

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Access Vascular raises $2m

Access Vascular has raised $1.9 million in a new round of equity financing, according to an SEC filing posted this week.

Money in the round came from seven unnamed sources, with the first sale recorded on May 4, according to the filing.

The company is looking for an additional $2.1 million before it plans to close the round, with a hopeful end goal of $4 million, according to the SEC filing. The Bedford, Mass.-based company has not yet stated how it plans to spend funds in the round.

In February, Access Vascular said that its HydroPICC catheter won 510(k) clearance from the FDA.

The peripherally-inserted central catheter is designed with Access Vascular’s proprietary bulk-hydrophilic material, which the company touted as “the ideal material for long-term implantable vascular access devices.”

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Varian inks Brazilian training, education deal

Varian Medical (NYSE:VAR) said today it inked a software technology training and education cooperation agreement with the Brazil Ministry of Health and seven universities and science and tech institutes in the country.

The Palo Alto, Calif.-based medical device maker said the agreement is part of its strategy of partnering with the Ministry of Health to increase quality and access to radiotherapy treatments in Brazil and across Latin America.

Varian said that the list of participating institutions includes the Universidade Federal de São Paulo, Universidade Federal de Pernambuco, Instituto Nacional de Telecomunicações, Universidade Federal de Itajubá, Universidade Estadual da Paraíba, Universidade Estadual de Campinas and Instituto de Pesquisas Eldorado.

“We look forward to partnering with the ICTs in Brazil to expand their knowledge of radiation therapy technology and software. Together we have the opportunity to expand access to advanced cancer care in Brazil,” Varian’s Brazilian managing director Humberto Izidoro said in a press release.

Earlier this month, Varian said it acquired Taiwanese radiotherapy equipment distributor Cooperative CL Enterprises for an undisclosed amount.

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NeuroVasc Tech raises $6m in Series B

NeuroVasc Technologies said yesterday it closed a $6.3 million Series B preferred stock round.

The round was joined by multiple investors, and led by ShangBay Capital, the Laguna Hills, Calif.-based company said.

NeuroVasc Tech is developing treatments for neurovascular conditions with a focus on treating ischemic stroke, and currently has CE Mark approval in the European Union for its Versi mechanical thrombectomy system used to remove clots form the brain during acute ischemic stroke.

The device does not yet have FDA clearance for use in the US, the company said.

“NeuroVasc’s technologies may significantly improve treatment outcome of stroke patients and the quality of patients’ lives. We are very excited to be part of this effort,” ShangBay Capital founding partner William Dai said in a press release.

“Helping patients is our passion. We have been seeing good early clinical results, and we plan to expand on this clinical work with the current financing,” co-founder & CEO Jim Ma said in a preapred statement.

In December 2016, the then-stealthy company said it raised a $1 million funding round, taking its total raise since 2015 to nearly $2.5 million.

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Teleflex launches TrapLiner cath in the EU

Teleflex (NYSE:TFX) said yesterday it launched the TrapLiner catheter, designed for use in vascular procedures, in Europe.

The Wayne, Penn.-based company said that its TrapLiner cath is similar in design to its GuideLiner V3 cath but also features an integrated balloon for trapping standard 0.014″ guidewires within a guide catheter.

The newly launched TrapLiner catheter is designed to operate as an alternative method to the trapping technique which requires the use of a PTCA balloon to exchange an existing over-the-wire catheter while maintaining guidewire position, Teleflex said.

The catheter is intended for use alongside guide catheters to access regions of the coronary or peripheral vasculature and to aid in placing interventional devices and for the exchange of interventional devices while maintaining the guidewire position, according to a press release.

Earlier this month, Teleflex posted first quarter earnings that beat the consensus on Wall Street and announced a manufacturing consolidation plan it hops will save $25 million to $30 million annually.

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FDA clears MC10’s BioStamp nPoint wearable sensor

Wearable sensor developer MC10 said yesterday it won FDA 510(k) clearance for its BioStamp nPoint wireless biometric data collection platform.

The newly cleared system is designed for the continuous collection of physiological data in either home or traditional healthcare settings, the Lexington, Mass.-based company said. The system succeeds the company’s previous BioStampRC sensor.

MC10 said that the BioStamp nPoint system features improvements over its predecessor, including being rechargeable, reusable and the ability to to collect data for 24 hours. The system can be used to measure, record and display general activity, postural classifications, vital signs and sleep metrics, MC10 claims.

“We need objective, sensitive measures of health that can be assessed by anyone, anytime, anywhere. MC10’s new sensor brings us one step closer to a reality that can improve health and accelerate the development of new therapies,” Dr. Ray Dorsey of the University of Rochester said in a prepared statement.

The BioStamp nPoint sensors are connectible through smartphones and include an app to guide patients through sensor application and other prescribed activities. MC10 plans to launch the system in June.

“The nature, location, and endpoints of clinical trials for new drug development are all evolving rapidly. The BioStamp nPoint system was designed and clinically validated to meet this rapidly growing and expanding unmet need. BioStamp nPoint produces clinical quality, medical grade physiological data from research subjects in their own homes, available to investigators from virtually anywhere,” chief medical officer Dr. Arthur Combs said in a press release.

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Report: Amazon-Berkshire Hathaway-JPMorgan Chase health play struggles to find CEO

The joint healthcare venture between Amazon (NSDQ:AMZN), Berkshire Hathaway and J.P. Morgan Chase that looks to lower costs and improve health insurance is struggling to find the right individual to fill the corner office, according to a CNBC report.

The joint venture began searching for a CEO after announcing its launch in January, according to the report, meeting potential candidates by phone and in person in Omaha, Nebraska, where Berkshire Hathaway resides, and in New York, where J.P. Morgan is based.

The group considered health insurance and policy experts, including ex-Aetna exec Gary Loveman and former CMS chief Andy Slavitt, CNBC reports, but none were selected.

Interest has shifted to individuals with an entrepreneurial background in tech and health who are removed from involvement in health insurance and drug supply, according to the report. A recent top choice for the group is Grand Rounds Health CEO Owen Tripp, who runs a medical second-opinion service start-up, though Tripp is reportedly committed to his current position.

Warren Buffet, Berkshire CEO and major player in the combined group, said during an investor meeting for the JV that they hoped to have a chief exec “within a couple of months,” according to CNBC.

Whoever is chosen will have a significant task ahead of them, managing a combined 1.2 million employees across the three companies in a multitrillion-dollar industry, according to the report.

The group announced the venture in January, and sent shares in major health insurers UnitedHealth and Anthem down in response.

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Sivantos, Widex merge to form 3rd largest hearing aid maker

Hearing aid maker Sivantos, formerly Siemens (NYSE:SI) audiology biz now owned by PE firm EQT, announced plans this week to merge with Danish hearing aid maker Widex in a deal that could make the merged group the third largest player in the hearing aid market, according to a Reuters report.

The merged company is expected to have combined revenues of approximately $1.9 billion (EU €1.6 billion), EQT said in a press release, and will allow for expanded investment into future technology and software for treating hearing loss.

The newly merged group has not yet decided on a new name or announced which of the combined entity’s monikers it will operate under.

“Sivantos has developed immensely during EQT funds’ ownership and now the idea is to create a game changer for the future of hearing. Combining these two innovative companies will change the hearing experience for people with hearing loss across the world. In Widex, we have found an equally strong partner to Sivantos, sharing a passion for enriching the quality of life for people with hearing deficiencies. The combined company presents a unique opportunity for EQT to extend the investment horizon in Sivantos and take part of the next phase of transforming the hearing aid industry. With nearly 170 years of combined experience, Sivantos and Widex will take the lead in developing hearing aid technology for future generations,” EQT Partners partner & EQT funds investment advisor Marcus Brennecke said in a prepared statement.

The combined company will employ more than 10,000 individuals and will be valued at more than $8.3 billion (EU €7 billion) with $3.5 billion (EU €3 billion) in debt, according to Reuters.

Funds of PE firm EQT will own a majority of the merged group, according to Reuters, while Widex-owners will retain the largest stakes and make up the largest shareholder group in the combined company.

“We and Sivantos share a common vision of giving people unlimited access to a world of sound by providing unparalleled hearing aids and customer services. I am confident that our employees, partners and customers will benefit from this merger as it will allow us to accelerate our efforts to pioneer innovation, quality, manufacturing and customer satisfaction. Further we will expand our geographical footprint and provide exciting career opportunities for our employees across countries and functions. The merger fits with the families’ values and long-term goals for Widex and that’s why we have decided to substantially invest to become long-term owners,” Widex chair Jan Tøpholm said in a press release.

The merger may also push back EQT plans to list Sivantos, though plans for an IPO are still “very, very likely,” according to Reuters, referencing an interview with Brennecke.

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