Wright Medical acquires surgery planning software dev IMASCAP SAS for $89m

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Wright Medical, IMASCAP SAS

Wright Medical (NSDQ:WMGI) said today it inked a deal to acquire shoulder replacement surgery preoperative planning software dev IMASCAP SAS in a deal worth $88.8 million (EU €75.1 million)

Through the deal, Wright picked up 100% of IMASCAP’s outstanding equity on a fully diluted basis for a total of $88.8 million, consisting of $46.9 million (EU €39.7 million) in cash and $15.6 million (EU €13.2 million) of Wright shares, payable at closing, and $26.3 million (EU €22.2 million) in potential milestone or earn out payments.

“Wright, and previously Tornier, has been involved with IMASCAP for many years with our Blueprint case planning software, and we have seen first-hand the innovation, creativity and differentiated solutions that the IMASCAP team has developed.  Software-enhanced solutions are the future, and with the acquisition of IMASCAP, we have the opportunity to take a significant lead in this area.  We are thrilled that we had an opportunity to acquire IMASCAP, which is the company that has developed the technology behind our Blueprint case planning software for our shoulder portfolio.  This is a highly differentiated, enabling technology for the shoulder and has a number of potential applications to enhance our Prophecy planning for ankles as well. While our Blueprint planning software is a significant differentiator today, IMASCAP has a rich pipeline of potential breakthrough technologies under development and patent-pending.  We believe the future of orthopaedic implant surgery will include advanced elements of artificial intelligence and augmented reality.  When fully developed, we believe such software enabled surgery will leapfrog the current mechanical approaches some orthopaedic companies have developed primarily for hip and knee replacement surgery,” Wright Medical prez & CEO Robert Palmisano said in a prepared statement.

IMASCAP’s Glenosys technology is used in Wright’s Blueprint 3D planning software, the company said. The software allows surgeons to simulate the position of a shoulder prosthesis using CT image data and visualize the shoulder in 3D, rotating through the complete range of motion in any direction.

IMASCAP has no reported revenues, Wright said, and therefore will have no impact on the company’s previously provided full-year 2017 annual net sales guidance of between $740 and $745 million, with minimal incremental expenses in 2017.

“IMASCAP is led by its founder and CEO, Jean Chaoui.  Jean has an impressive background, with degrees in Biomedical Engineering from Damascus University and Telecom Brittany (Masters & PhD) with a focus in Biomedical Imaging.  Jean has received 11 patents and has written more than 30 scientific publications in the field of computer assisted surgery, and he has completed multiple projects in the areas of image and bio-signal processing, artificial intelligence and brain/computer interface.  He is a recent recipient of the MIT Technology Review – Top 10 French Innovators under 35 and a Fellow in the Young Transatlantic Innovative Leaders Initiative, representing France.  We are delighted that Jean and the entire IMASCAP team are joining Wright,” Palmisano said in prepared remarks.

Wright Medical said it will provide more information on the impact of the acquisition and 2018 guidance on its fourth quarter 2017 earnings call, scheduled for February 27.

“We are delighted to have found an excellent strategic buyer in Wright, a company that shares IMASCAP’s commitment to technological leadership and who is deeply committed to the success of our technology.  We believe that Wright, with its global leadership position in the extremities market and expertise in medical education and product development, is the ideal partner to realize the full potential of IMASCAP’s technology and product pipeline and will continue to provide the focus and investment to enable it to reach its full potential.  Also, very importantly, this will provide our employees with enhanced opportunities for career growth and development.  We look forward to an exciting future as part of Wright Medical,” IMASCAP prez & CEO Jean Chaoui said in a press release.

Singapore vascular access dev Advent Access raises $2m in pre-Series A

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Advent AccessSingapore-based vascular access dev Advent Access has raised $1.9 million (SGD $2.6 million) in a pre-Series A financing round to support its av-Guardian technology designed to create vascular access for dialysis patients.

The funding round was led by Accuron MedTech, which the company touted as the largest medical device company in southeast Asia. The investment went through Singapore’s Spring Seeds Capital-assigned accelerator the Med Tech Alliance, Advent Access said.

“We are excited to lead the pre-Series A investment in Advent Access given the company’s strong progress and potential to transform and optimize how care is provided to patients in the S$100 billion global dialysis market. As Southeast Asia’s largest medical device company, this investment reflects our continued belief in Asia’s vibrancy as a hub for disruptive healthcare technologies to develop and thrive. Our investment in Advent Access is Accuron MedTech’s tenth transaction in building a strong portfolio of the most promising innovations which can make a significant difference to healthcare outcomes in Asia and around the world,” Accuron MedTech group chief exec Abel Ang said in prepared remarks.

“We are excited to have Temasek-backed Accuron MedTech onboard. Abel and the Accuron team bring deep experience in growing technologies from Asia, breadth in accessing international markets and financial depth in nurturing startups that will set us apart regionally and internationally. Advent Access is now well equipped to accelerate the development of av-Guardian and tackle some of the most pressing needs in end stage renal disease. Working closely with Accuron, we look forward to unlocking the future of independent dialysis,” Advent Access CEO Peh Ruey Feng said in a press release.

The company’s av-Guardian is a device-guided needling platform featuring the company’s “guardian guide-door” technology for accessing arteriovenous fistulas, which it claims can reduce wear and tear on the dialysis patient’s veins.

Funds from the round will go towards the filing of CE Mark registration in the European Union, which the company said it hopes to submit within the next 18 months.

Advent Access said that a recent clinical trial of the device showed that it was safe and achieved appropriate clinical performance. The company said it plans to publish full results from the study early next year, with a second clinical study already underway.

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

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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.

Cybersecurity: Email is largest source of healthcare data breaches for 2017

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Emails are the top source for data breaches so far this year according to the US Department of Health and Human Services, Modern Healthcare reports.

A total of 73 breaches were reported between January 1 and November 30, affecting information related to 573,698 individuals, according to the report.

The threat of email breaches is not unknown among hospital staff, who see it as the most likely source for such an intrusion, according to Modern Healthcare.

A total of four out of five US physicians have experienced such email-based cyberattacks, according to an Accenture survey quoted in the report. A separate survey, performed by Mimecast, suggests that 78% of physicians had reported either a malware or ransomware attack over the last 12 months.

“This study confirms that no healthcare provider is immune to the growing threat of email-related cyberattacks,” HIMSS Analytics senior director Bryan Fiekers said, according to Modern Healthcare.

Other data from the Mimecast survey indicated that nearly 25% of surveyed individuals said they’d had 16 or more malware or ransomware attacks over a year, and that nearly 75% of the individuals surveyed saw their email as “mission critical,” according to the report.

“It’s really a business issue to keep it up and running,” Mimecast cyber-resilience strategist David Hood said, according to Modern Healthcare.

Healthcare practices are taking steps to reduce such intrusions, according to data from the Mimecast survey. Results indicated that nearly 75% of those surveyed sad their organizations were taking steps to secure their emails, and 91% said they are training employees on secure practices to prevent and reduce malware and ransomware attacks.

Large organizations were putting in the most effort to prevent such attacks, according to the report.

“But you also have to recognize that no matter how much training you do, you can’t solve for every problem with human beings in the chain and being involved in the decision to open the email and click on something,” Hood said, according to Modern Healthcare.

In November, the US House Energy and Commerce committee said it was looking to the Department of Health and Human Services to shore up medical device cybersecurity.

Corindus touts 1st Corpath GRX system installation outside the US

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  • NanoVibronix inks UK UroShield distro deal with IMS Ultrasound

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    NanoVibronix

    NanoVibronix (NSDQ:NAOV) said today it inked a deal with the U.K.’s IMS Ultrasound to make it the exclusive U.K. distributor of its UroShield device, designed to prevent catheter-acquired urinary tract infections.

    The UroShield device from the Elmsford, N.Y.-based company is designed to decrease pain and discomfort associated with urinary catheter use while also preventing bacterial colonization and biofilm on indwelling catheters to reduce UTIs.

    “CAUTI is a major health concern in the UK and around the world, leading to extended hospital stays, increased costs, as well as increased patient mortality. We are excited to partner with NanoVibronix in order to bring UroShield to market in the UK, which we believe has enormous potential and could help save many lives. Given the strong supporting clinical data to date, we look forward to conducting an additional clinical trial in the UK with the support of NHS, which we believe will help garner even greater support from payors,” IMS Ultrasound managing director Andrew Wakeling said in a prepared statement.

    As part of the deal, NanoVibronix said that IMS Ultrasound will also be funding a clinical study in association with the U.K.’s National Health Service.

    “We are excited to report the addition of a significant European distributor partnership for UroShield following our recently announced preliminary clinical results, which demonstrate a material reduction in the rate of CAUTI. UroShield already has European marketing clearance, and this latest data is now helping us to attract the leading distributors across Europe. The fact IMS Ultrasound is willing to fully fund the planned clinical trial in the UK is strong validation of their interest and commitment to our UroShield product,” NanoVibronix CEO Brian Murphy said in a press release.

    Last month, NanoVibronix released interim results from a trial of its UroShield ultrasound device designed to prevent bacteria and biofilms from forming on urinary catheters, touting a low rate of CAUTIs.

    European investment group LSP closes $330m healthcare fund

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    LSP

    European life sciences investment group LSP said yesterday it closed its new $330 million (EU €280 million) medical technology fund.

    The new Health Economics Fund 2 was oversubscribed and exceeded its target size and original hard cap, LSP said. The investment group touted the fund as the largest in Europe to be dedicated to medical technology.

    “With this new and sizable fund, we have now firmly established our health economics and medical technology strategy. Together with our other fund strategies, LSP 1-5 investing mainly in drug development and LSP Public investing in public health care companies, we now cover the entire life sciences landscape as one of Europe’s largest investors in the sector,” LSP managing partner Dr René Kuijten said in a prepared statement.

    The newly formed LSP HEF 2 fund will look to invest in private companies with innovative medical devices, diagnostics and digital health, LSP said. The first HEF fund previously made 10 investments in the same field, with notable investments in Neuravi and Rotation Medical.

    The LSP HEF 2 will focus on Europe and the US and aims to invest in approximately 15 private companies across the areas of medical devices, diagnostics and digital health.

    “The success of this fundraising is a strong validation of our strategy – investing in medical innovation to benefit both patients, and investors. As with the first LSP Health Economics Fund, we plan to invest in companies with products that can improve quality of care and lower healthcare spending. Our portfolio companies not only contribute to the sustainability of today’s healthcare systems, they also tend to be highly successful in the market, leading to fast adoption and making them attractive acquisition targets. Success stories like Neuravi and Rotation Medical from the first LSP Health Economics Fund are great examples of how our strategy can combine the best patient care with superior returns to our investors. We look forward to continuing this investment strategy with LSP HEF 2,” LSP HEF 2 managing partner Dr Rudy Dekeyser said in a press release.

    Exactech touts 1st Vantage total ankle mobile bearing procedure

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    ExactechExactech (NSDQ:EXAC) said this week its Vantage total ankle mobile bearing system was used in its first commercial surgery.

    The procedure to implant the Vantage total ankle system was performed by Swiss Ortho Center Basel chair and device design member Dr. Victor Valderrabano in Switzerland, the Gainesville, Fla.-based company said.

    The case included both an ankle replacement and the correction of an ankle deformity through fibular lengthening and calcaneal osteotomies.

    “It was a momentous occasion to have performed the first Vantage Ankle mobile bearing surgery, and we were pleased with the implants’ streamlined technique, practical instrumentation and thoughtfully designed implants. This case had an added layer of complexity since the patient was in valgus, but after the deformity correction, we were able to move forward with the replacement,” Valderrabano said in a prepared statement.

    The Vantage ankle was a collaborative effort between Valderrabano and a design team from Duke University, Exactech said. The system has received CE Mark approval in the European Union and the company is hopeful for full market availability in the region in 2018.

    “This year has been an incredible one of exciting milestones and increasing momentum for our total ankle initiative. This first mobile bearing total ankle surgery is the latest success and represents an important expansion of our Vantage Ankle brand. Dr. Valderrabano’s successful surgery also represents the first time our total ankle products have helped a patient outside the U.S., which is impactful on multiple fronts to our mission. We appreciate Dr. Valderrabano and his meaningful contributions to the team and this implant, in particular,” Exactech extremities marketing VP Darin Johnson said in a press release.

    Earlier this month, Exactech said that TPG Capital raised its go-private bid for the orthopedics company by some $108 million, or more than 17%.

    CytoSorbents wins German gov’t funding for CytoSorb endocarditis trial

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    Cytosorbents

    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.

    Elekta taps Brainlab as US stereotactic neurosurgery distro partner

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    Elekta, Brainlab

    Elekta (STO:EKTA B) said today it inked an exclusive deal with Brainlab to make it the authorized distributor of Elekta’s stereotactic neurosurgery solutions.

    Through the deal, Brainlab will be the authorized distributor of Elekta’s Leksell Vantage stereotactic system which won CE Mark approval in the European Union this year. The system also has FDA 510(k) clearance and is commercially available in the US.

    Stereotactic neurosurgery is a minimally invasive approach to brain surgery designed to treat specific regions of the brain and spare surrounding healthy tissue, and is often used to implant deep brain stimulation leads or to perform lesioning of small brain targets for treating functional disorders.

    “Early adopters of the Vantage system are experiencing clinical and patient benefits from its multiple design innovations. These include stereotactic magnetic resonance imaging with fewer restrictions, easier target coordinate setting during surgery as well as improved anesthetic capabilities,” Elekta neuro portfolio VP Jesper Söderqvist said in a prepared statement.

    “We strive to make medical technology more impactful and accessible to physicians and their patients. By partnering with Elekta, we are increasing our reach and providing clinicians with advanced and innovative technology on the stereotactic neurosurgery market,” Brainlab functional & stereotactic neurosurgery VP Paolo Jelmoni said in a prepared release.

    The deal expands on an earlier distro deal the two companies signed in June that covered distribution in the European Union.

    “Brainlab shares our vision for improving care and outcomes for patients undergoing neurosurgical procedures. The expanded partnership with Brainlab, with a large and specialized sales and service team, to distribute Vantage in the United States gives us a strong position from which to realize the potential of the system to advance the care of patients undergoing stereotactic neurosurgery procedures,” Elekta NA exec VP Peter Gaccione said in a press release.

    In November, Elekta said it delayed the rollout of its Unity device, designed to combine magnetic resonance imaging with a linear accelerator for radiation therapy, saying it needed more time to finalize and validate the linac control system.