Cardiovascular AI imaging dev Bay Labs raises $6m in Series A


Bay Labs

Cardiovascular artificial intelligence medtech firm Bay Labs said today it raised $5.5 million in a Series A round to support clinical validation and further development of its cardiovascular imaging tech.

The round was led by existing investor Khosla Ventures and joined by newly invested Data Collective, Greenbox Venture Partners, Minneapolis Heart Institute Ventures and Georges Harik. As part of the funding round, Khosla Ventures general partner Ben Ling and DCVC operating partner Armen Vidian will join the San Francisco-based company’s board of directors.

“Bay Labs’ unique application of AI with ultrasound has the potential to enable medical professionals to provide faster and better care to patients. We are excited to increase our investment in Bay Labs to revolutionize ultrasound,” Khosla Ventures general partner Ben Ling said in a prepared statement.

“We are impressed with the strength of the Bay Labs AI engine to bring consistently high-quality ultrasound images and key data to physicians when they need it most – at the point of care, and we are especially excited to see such early enthusiasm from some of the world’s leading physicians. We see tremendous potential for this intelligent, data-rich technology to impact how and when physicians direct patient care to dramatically improve outcomes,” DCVC operating partner Armen Vidian said in prepared remarks.

Bay Labs AI-assisted cardiovascular imaging tech is being designed to help diagnose and manage heart disease. The system uses deep learning technology to help perform and interpret echocardiograms with the goal of improving treatment of heart disease.

The company said it has partnered with the Minneapolis Heart Institute and Allina Health, Northwestern Medicine, Duke University School of Medicine and Stanford University cardiologists to develop the deep learning algorithms for its system.

“We’re gratified by the continued support from our existing investor Khosla Ventures and we welcome our new investors — all of whom share our vision about how deep learning technology can address two key problems in diagnostic cardiology: acquisition and interpretation of echocardiograms. We welcome Ben Ling and Armen Vidian as board members and look forward to their strategic contributions to our efforts to enable providers in achieving high-quality cardiac imaging results to improve patient care,” Bay Labs co-founder & CEO Charles Cadieu said in a press release.

CytoSorbents wins German gov’t funding for CytoSorb endocarditis trial



CytoSorbents (OTC:CTSO) said this week it won funding from the German Federal Ministry of Education and Research for a randomized controlled trial exploring the use of its CytoSorb blood purification technology for treating infective endocarditis.

The newly funded randomized, controlled, multi-center Remove trial aims to enroll 250 patients to explore the safety and efficacy of intraoperative CytoSorb in patients with dangerous bacterial heart valve infections during valve replacement surgeries and cardiopulmonary bypass procedures, the Monmouth, N.J.-based company said.

The study’s goal is to demonstrate improved hemodynamic stability and reduced organ injury, primarily measured by change in the sequential organ failure assessment score, with secondary endpoints of 30-day mortality, need for supportive care therapies and length of intensive care and in-hospital stays.

“We are very grateful to the German government for their commitment to fund the Remove trial in its entirety, and to Prof. Dr. med. Frank Brunkhorst, the Center for Clinical Studies Jena, and Jena University Hospital for sponsoring the study.  Infective endocarditis, or infection of a heart valve, can destroy the valve in hours to days, and can rapidly lead to emergency open heart valve replacement surgery in very sick patients that suffer from both sepsis and heart failure.  Patients are often unstable before, during, and after the surgery, and are prone to a high risk of complications and death, as well as a costly and lengthy hospital stay.  This is a rapidly growing problem, driven by the aging population and the opioid crisis, where the use of dirty needles by intravenous drug abusers can lead to seeding of bacteria in the bloodstream and heart valve infection,” CEO Dr. Phillip Chan said in a prepared statement.

CytoSorbents expects the trial to begin early next year, in collaboration with Thermo Fisher Scientific’s B.R.A.H.M.S and the Fraunhofer Institute for Interfacial Engineering and Biotechnology.

“This announcement of funding and collaboration follows our previous press release on October 19, 2017 highlighting the largest published endocarditis case series to date, where the intraoperative use of CytoSorb during emergent and urgent valve replacement surgery helped to improve hemodynamic stability, reduce the need for vasopressors, and was associated with a reduction of in-hospital mortality compared to a historical control.  We believe that similar results could be seen in the Remove trial.  Interestingly, the Remove study will parallel our Refresh 2 pivotal, registration trial in the U.S., designed to support FDA regulatory approval.  The Refresh 2 trial will also focus on the intraoperative use of CytoSorb during valve replacement surgery – but specifically excludes infective endocarditis – to reduce the incidence or severity of post-operative organ dysfunction. If successful, the two trials could rapidly lead to the use of CytoSorb as standard of care in most, if not all, open heart valve replacement surgeries, which accounts for hundreds of thousands of procedures worldwide,” CEO Dr. Chan said in a press release.

In May, CytoSorbents presented results from the Refresh trial of its CytoSorb blood purification tech, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.

Lexington Biosciences moves forward with its affordable heart diagnostic device

Lexington Biosciences HeartSentry

[Image courtesy of Lexington Biosciences]

Lexington Biosciences (Vancouver, British Columbia) said today that it has brought on reimbursement experts as it seeks FDA clearance for its HeartSentry device.

The strategic business relationship with a San Francisco arm of Chicago-based Navigant Consulting, is meant to help Lexington(CSE: LNB) (OTCQB: LXGTF) better work with relevant authorities to develop a coverage policy to support the commercial rollout of HeartSentry, an endothelial function measurement product that holds the promise of better pinpointing of people at risk of heart attacks.  The San Francisco arm was previously Quorum Consulting, which Navigant recently acquired.

Lexington Bioscience is moving ahead quickly to start its HeartSentry pilot clinical research to support FDA clearance, according toLexington’s President Eric Willis.

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

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Edwards Lifesciences acquires mitral repair dev Harpoon Medical for $100 million


Edwards Lifesciences, Harpoon Medical

Edwards Lifesciences (NYSE:EW) said today it acquired mitral valve repair developer Harpoon Medical for $100 million in cash, with the potential for an additional $150 million in milestone payments over 10 years.

Harpoon is developing a system designed to enable echo-guided repair of mitral valve regurgitation through the stabilization of prolapse leaflets to restore coaptation and valve function.

The device is currently investigational, though Harpoon is hopeful it will receive CE Mark approval in the European Union in the near future.

“We believe the addition of Harpoon Medical’s technology and talented team will enable even more opportunities to help patients with degenerative mitral regurgitation. The unique beating-heart repair procedure for mitral valve patients complements Edwards’ comprehensive portfolio of treatments for structural heart disease, and reinforces our commitment to innovation in cardiac surgery,” Edwards surgical heart valve therapy VP Bernard Zovighian said in a prepared statement.

The deal comes two years after Edwards made a structured investment in Harpoon and gained an exclusive option to acquire the company.

“There are a significant number of patients currently undergoing mitral valve surgery that we believe can benefit from Harpoon’s therapy during a minimally invasive, beating-heart procedure. This therapy offers the potential for earlier treatment of degenerative mitral valve disease with faster recovery and less morbidity, while also providing the opportunity for more consistent procedures and outcomes for patients,” Harpoon scientific advisory board chair and device inventor Dr. James Gammie of the University of Maryland School of Medicine said in a prepared release.

The new acquisition and its mitral valve repair technology, which is designed to reduce the amount of time required for mitral valve surgery from 3 to 6 hours down to 60 minutes, will join mitral valve replacement tech being developed by previously acquired CardiAQ Valve Technologies.

Medtronic wins FDA nod for Azure remote monitoring equipped pacers


Medtronic logoMedtronic (NYSE:MDT) said today it won FDA approval for its portfolio of Azure pacemakers with BlueSync patient monitoring technology.

The clearances cover both the Azure XT MRI and Azure S MRI pacers including single chamber and dual chamber models, the Fridley, Minn.-based company said. The newly cleared pacers have estimated lifespans of 13.7 years for dual chamber pacers, which Medtronic estimates is 27% longer than the earlier-gen devices.

The Azure portfolio of pacers feature the company’s BlueSynch technology which allows for automatic remote monitoring through the company’s CareLink network, and its Azure XT device features the Reactive ATP algorithm intended to slow the progression of atrial fibrillation.

“With the approval of Azure, clinicians managing patients with bradycardia now have pacemakers with improved longevity, and better ability to detect and reduce atrial fibrillation. BlueSync technology with Azure also enables secure and automatic wireless data transmission to clinicians. Remote monitoring with automatic data transmissions can result in earlier clinical decisions and improved patient monitoring compliance,” cardiac rhythm & heart failure division prez Dr. John Liddicoat said in a press release.

Medtronic said that in connection with the approval, its Percepta line of cardiac resynchronization therapy pacers now include BlueSync tech for remote monitoring through the CareLink network.

Earlier this month, Medtronic released its preliminary second quarter earnings, estimating the impact of Hurricane Maria at approximately $55 to $65 million, or 3¢ on its second quarter non-GAAP earnings per share.

Medtronic, Boston Scientific, St. Jude Medical escape catheter patent suit


gavelA trio of medical device companies yesterday escaped a patent infringement lawsuit filed by the inventor of a catheter after a federal judge in Wisconsin ruled that the case was filed in the wrong jurisdiction.

Imran Niazi in April sued Medtronic (NYSE:MDT), Boston Scientific (NYSE:BSX) and Abbott (NYSE:ABT) subsidiary St. Jude Medical in the U.S. District Court for Western Wisconsin, alleging infringement of U.S patent 6,638,268 covering a coronary sinus catheter.

The companies moved to dismiss the case, arguing that it lacked jurisdiction in light of the U.S. Supreme Court decision in TC Heartland v. Kraft Foods Group Brands, which limited the ability of patent holders to sue in other states.

Yesterday Judge James Peterson found for the defendants based on the Heartland ruling, according to court documents.

“In these cases, it is undisputed that none of the defendants are incorporated in Wisconsin, so none of them ‘reside’ here. As to the second option for establishing proper venue, some of the defendants admit that they sell accused products in this district and some deny that they do, but all of the defendants deny that they have ‘a regular and established place of business’ in the district, so the court will focus on that issue,” Peterson wrote. “In light of the absence of any evidence or even allegations from Niazi that any of the defendants have a regular and established place of business in this district, the court concludes that Niazi has failed to show that venue is proper here.”

Peterson also ruled against allowing Niazi to proceed with discovery to prove residence in the western Wisconsin district, according to the documents.

“In these cases, Niazi has not identified any basis for believing that discovery will show that any of the defendants have a place of business in this district. Even if the court assumes as Niazi suggests that some of the sales people might keep some inventory at their homes, that type of de minimis evidence would not be sufficient to show that a defendant engaged in business from the employees’ homes,” he wrote. “To avoid questions about jurisdiction after a transfer, the court will dismiss the cases so that Niazi and the assignee can refile after determining the proper parties.”

Mercator MedSystems to study its Bullfrog micro-infusion device in below-the-knee critical limb ischemia


Mercator MedSystemsMercator MedSystems announced last week that it finished enrollment for a six-month trial of its Bullfrog micro-infusion device in patients with below-the-knee critical limb ischemia.

The Emeryville, Calif.-based company’s 120-patient trial was designed to evaluate if Mercator’s Bullfrog device can improve blood flow and reduce the occurrence of restenosis following atherectomy-based revascularization.

Mercator’s micro-infusion device delivers drugs directly through blood vessel walls and into adventital tissues. The Bullfrog device is tipped with a microneedle that is protected by a balloon as it is guided through the vasculature. When the device reaches its intended injection site, the balloon inflates and slides the microneedle through the vessel wall.

“This technology is so hyper-efficient,” CEO Trent Reutiman told Drug Delivery Business News. “It delivers the drug very locally and precisely to the tissue surrounding a blood vessel or an airway.”

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

Japan clears Abbott’s Mitraclip


Abbott's Mitraclip

Abbott (NYSE:ABT) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its MitraClip transcatheter mitral valve repair device, cleared for indications of treating people with mitral regurgitation.

Currently, standard of care treatment for mitral regurgitation in Japan is limited to open-heart surgery and medication, Abbott said. Clearance of the catheter-based MitraClip system adds a minimally-invasive treatment option not previously available in the region, the company added.

The MitraClip is designed to be delivered to the heart through a blood vessel in the leg, securing portions of the leaflets of the mitral valve with a clip to allow the heart to pump blood more efficiently through the body.

“It is our mission to help people suffering from structural heart disease return to better health and quality-of-life by providing technologies and therapies that advance how people are treated. With the approval of our revolutionary MitraClip device in Japan, we can help more people live better by reducing the severity of their extremely life-altering illness in a safe and predictable way,” structural heart biz VP Michael Dale said in a press release.

Approval in Japan came based on data from the AVJ-514 clinical trial in the region, which reported an 86.7% rate of 2+ or less mitral regurgitation and classified 96.7% of patients as NYHA class I or II with no major adverse events at 30 days.

“MitraClip provides a new treatment option for many people with severe mitral regurgitation who cannot undergo the mitral valve surgery. The introduction of MitraClip therapy in Japan will help more people who previously had limited options return to better health faster, with dramatically reduced symptoms,” trial principal investigator Dr. Kentaro Hayashida of Tokyo’s Keio University said in a press release.

Last week, Abbott said it won’t introduce its next-generation drug-eluting stent, the Xience Sierra, to the Indian market due to price caps there.

Price caps to keep Abbott’s Xience Sierra off the Indian market

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  • Study: PCI procedures ineffective at treating chest pain


    heart - generic

    Cardiovascular stents intended to relieve chest may not be effective at all for a good number of patients they’re implanted in, according to a new study reported yesterday by the New York Times.

    The study, published in the Lancet, examined the use of stents to open blocked arteries to treat chest pain, often experienced during exercise, according to the report.

    Results from the study stood in stark contrast to existing medical evidence and call into question the use of stents for treating chest pain, the Times reports.

    In the blinded, randomized, study, researchers compared percutaneous coronary interventions against a placebo procedure for the symptomatic relief in stable angina.

    A total of 105 patients received PCI treatments, while 95 were assigned to the placebo cohort, receiving a sham procedure that closely mirrored the PCI.

    All patients in the trial were treated for six weeks to reduce heart attack risk, as well as with other medications to reduce chest pain by either slowing the heart or opening blood vessels, according to the Times.

    According to the results, there was no significant difference in the primary endpoint of exercise time increment between the two groups. Both groups reported improved outcomes and lowered pain after the sham and PCI procedures, according to the report.

    “In patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure. The efficacy of invasive procedures can be assessed with a placebo control, as is standard for pharmacotherapy,” study authors wrote.

    Currently, guidelines recommend the use of stenting for treating patients with blocked arteries and chest pain who’ve already tried other treatment methodologies, according to the report. But those guidelines were mostly based off of patient reports.

    “All cardiology guidelines should be revised,” Dr. David Brown of Washington University School of Medicine and Dr. Rita Redberg of the University of California, San Francisco wrote in an editorial, according to the Times.

    Another study is underway looking to determine whether medications can be as effective as stunting and coronary bypasses in preventing heart attacks, according to the report.