STENTiT | April 25, 2022
STENTiT, a medical device company bringing a novel class of regenerative endovascular implants for the treatment of cardiovascular diseases, has closed a €1.8 million seed investment round. The funding facilitates further pre-clinical development and batch production of a regenerative stent (see video) for peripheral indications. The investment was made by Dutch investors NextGen Ventures, Brabant Development Agency and the Ten Cate Investment Company.
STENTiT is an emerging player in the field of regenerative medical devices, offering a breakthrough solution for cardiovascular interventions by developing first-of-its-kind endovascular implants with regenerative capacity. Using a catheter-based approach, these devices provide the ability to restore arteries without the need for an invasive surgical intervention. The aim is to ultimately restore the affected blood vessel from the inside out to provide a lifelong solution.
As a first target indication, the company wants to improve the treatment of critical limb ischemia. This progressive form of peripheral artery disease affects almost 5 million people in the EU and the US in which the blood flow to the foot is severely being compromised. Unfortunately, current treatment options are ineffective, resulting in amputation within 6 months in 40% of these patients.
With the regenerative stent, blood flow to the foot will be maintained by securing vascular patency using temporary mechanical support and improving long-term efficacy by inducing vascular repair, thereby preventing thousands of amputations each year.
"We are excited to receive the support of these esteemed Dutch early-stage investors. This financing round validates our vision to bring a novel class of implants that can rebuild the affected blood vessels. We are looking forward taking the next steps getting our regenerative stents ready for clinical trials. With our first product, we aim to treat millions of patients suffering from peripheral artery diseases, and save their limbs from amputation."
Bart Sanders, CEO of STENTiT
STENTiT is a medical device spin-off company from the Dutch Eindhoven University of Technology, focusing on the development of regenerative endovascular implants. These bioresorbable devices trigger a natural healing response by the circulating blood cells, in which the implant is being replaced by new vascular tissue to restore the artery from the inside-out.
Since the establishment of the company, STENTiT has received broad international recognition and awards for its high-potential approach, covering world leading stages. As the company is currently going through the next translational phases, STENTiT is on its way to fulfill its ambition to become the new standard in endovascular treatment, providing a life-changing solution for millions of cardiovascular patients around the world.
Komodo Health | May 12, 2022
Komodo Health announced the launch of Komodo Publications Planning, introducing the next generation of publications planning and management applications for Life Sciences. The automated and highly customizable end-to-end software is designed to make it easier to maximize the impact and outcome of scientific publications and medical communications in an accurate, efficient, and compliant manner. With today’s news, Komodo extends the power of its real-world data and technology for Medical Affairs professionals, offering a comprehensive suite of applications to manage all aspects of publications planning, including a more data-driven approach to engaging with healthcare providers.
In order to establish scientific integrity aligned to strategic medical objectives, global Medical Affairs teams are responsible for managing complex publication plans within Life Sciences companies, which can include both pipeline and commercial products or therapeutics with overlapping timelines. Multiple stakeholders need to seamlessly collaborate, provide feedback, and share updates with one another throughout the process, from publication concept through planning, and ultimately, publishing.
With out-of-the-box connectors to Altmetric, Office 365, Unpaywall, and the ability to seamlessly integrate and optimize existing technology workflows, Komodo Publications Planning provides the tools to address every aspect of planning, execution, and analysis in a consolidated view to bring speed and ease for Medical Affairs teams. The integrated, user-friendly workflow enhances productivity by helping customers reduce time spent managing tasks to allow more time to focus on producing high-quality publications.
For example, Pfizer was seeking a way to evolve and digitize how its publications were managed. The company developed a customized tool with Komodo Publications Planning as its foundation, which allowed Pfizer to roll out one cohesive publications management system that could be leveraged by a variety of stakeholders around the globe, creating a more efficient path for collaborating with authors and third-party agencies. With a consolidated view into its medical and scientific publication plans, Pfizer’s global team can automate the planning process, quickly tracking publication milestones and monitoring study progression using real-time alerts.
“Working in partnership with Komodo on designing and building a new publications management system has been an exciting and courageous journey. We were able to realize some of the innovative solutions we wanted to incorporate into our system to advance our publications practice,”
Catherine Skobe, MPH, Sr. Director, Publications Innovative Solutions Lead at Pfizer
“Legacy publications management applications often require long build cycles and offer limited control; Komodo Publications Planning is helping our customers eliminate the need for multiple, disjointed systems, which often cause timely and costly delays for publishing critical clinical advancements,” said Prasad Kanumury (PK), Mavens founder and General Manager at Komodo Health. “The ability to integrate into existing IT infrastructure is helping Medical Affairs teams to more effectively achieve their scientific objectives and produce timely, journal-accepted publications within a single, customizable solution.”
Stemming from the 2021 acquisition, Mavens' integration into Komodo has resulted in a number of new opportunities for enterprise impact. The release of Komodo Publications Planning marks the first new application within Komodo’s Medical Affairs Suite. The Medical Affairs Suite offers end-to-end workflow support on everything from optimizing publications, impact reporting, and clinical education to enabling HCPs with disease burden intelligence and advanced analytic solutions to build comprehensive, measurable, and evidence-based strategies. The suite also allows for strategic engagement opportunities through key expert identification within Komodo’s Aperture application, now with Medical Information Cloud integration, to encourage even more timely, compliant, and trackable clinical interactions.
The launch of Komodo Publications Planning coincides with the 18th Annual ISMPP Meeting, where experts from Komodo Health and Pfizer presented about the future evolution of the medical publications ecosystem in a session on May 9th. For more information, visit Komodo Health onsite at booth #14.
About Komodo Health
Komodo Health is a technology platform company creating the new standard for real-world data and analytics by pairing the industry’s most complete view of patient encounters with enterprise software and machine learning that connects the dots between individual patient journeys and large-scale health outcomes. Across Life Sciences, payer, provider, and developers, we help our customers unearth patient-centric insights at scale — marrying clinical data with advanced algorithms and AI-powered software solutions to inform decision making, close gaps in care, address disease burden, and help the enterprise create a more cost-effective, value-driven healthcare system.
Alcon | March 07, 2022
Alcon the global leader in eye care dedicated to helping people see brilliantly, announced the launch of the Clareon®family of intraocular lenses (IOLs) in the U.S. Utilizing Alcon’s most advanced IOL material, Clareon can deliver consistent visual outcomes and exceptional clarity that lasts.°,1-7The Clareon clarity is born out of a glistening-free§IOL material that has among the lowest levels of haze and subsurface nanoglistenings compared to leading competitor IOLs.†,*,1-3
“We are proud to offer our latest IOL technology in the U.S. and other countries across the globe. At Alcon, we are consistently pushing the boundaries to deliver transformational innovation to cataract surgeons and their patients. Clareon is the result of robust R&D efforts at every level—inventive material science, advanced manufacturing techniques and novel delivery systems—to deliver exceptional, long-lasting clarity.”
Ian Bell, President, Global Business & Innovation, Alcon
The Clareon portfolio leverages many of the same design characteristics and optics as Alcon’s leading IOLs to help deliver the outcomes surgeons expect.8,9Clareon offers sharp, crisp vision with a proprietary edge designed to help reduce glare and posterior capsular opacification.7The lens’ unique and proven STABLEFORCE®Haptics provide superior axial and rotational stability.*,β,8-14Clareon has been extensively researched, with inclusion in 30 published studies worldwide. Clareon Monofocal and Clareon Toric IOLs have already been implanted in more than one million eyes across more than 70 countries.15
Clareon IOLs are inserted using the next-generation, reusable Clareon Monarch®IVDelivery System, which provides precise and controlled implantation and that was designed specifically for the new Clareon material.15,16Clareon Monofocal is also available in the next-generation automated, single-use delivery system, AutonoMe™.
“As one of the investigators for the Clareon pivotal trial, I was immediately impressed with the clarity of the new IOL material, delivery system and the consistent refractive outcomes,” said Dr. Samuel H. Lee, MD, Ophthalmologist, Sacramento, CA.** “Today, the clarity of Clareon persists four years later in my trial patients, with the optic performance that I expect from Alcon IOLs, as well as continued high patient satisfaction.”
Clareon Monofocal, Clareon PanOptix®, Clareon PanOptix Toric, Clareon Vivity®and Clareon Vivity Toric IOLs are now available in the U.S. Clareon PanOptix offers patients the possibility of 20/20 vision at distance (far), intermediate (at arm’s length) and near (up close), with continuous vision of 20/25 or better.¥,14,17Clareon Vivity is a non-diffractive extended depth of focus lens with wavefront-shaping X-WAVE™ technology, delivering monofocal-quality distance with excellent intermediate and functional near vision and with a monofocal visual disturbance profile.13,18
Clareon Toric will be available in the U.S. later this year. Alcon will be rolling out the Clareon family of IOLs in international markets throughout 2022 and 2023.
There are more than 28 million cataract surgeries performed each year in the world. With the aging population and increased life expectancies, these surgeries are expected to increase 3-4% per year for the next 30 years, leading to an estimated 60 million global cataract surgeries annually by 2045.19
A cataract is a cloudy area in the natural lens of the eye that affects vision. As a cataract develops, the eye's lens gradually becomes hard and cloudy, allowing less light to pass through, which makes it more difficult to see. The vast majority of cataracts result from normal aging, but radiation exposure, taking steroids, diabetes and eye trauma can accelerate their development. Cataracts are the most common age-related eye condition and the leading cause of preventable blindness.20Cataracts are treated by removing the eye's cloudy natural lens and surgically replacing it with an IOL. More than 92% of cataract surgeries are considered successful, and patients typically can return to their normal routines within 24 hours.21
About Clareon IOLs and Delivery Systems
The family of Clareon intraocular lenses (IOLs) includes the Clareon Aspheric Hydrophobic Acrylic and Clareon Aspheric Toric IOLs, the Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Toric, Clareon Vivity Extended Vision Hydrophobic Posterior Chamber IOL and Clareon Vivity Toric IOLs. Each of these IOLs is indicated for visual correction of aphakia in adult patients following cataract surgery. In addition, the Clareon Toric IOLs are indicated to correct pre-existing corneal astigmatism at the time of cataract surgery. The Clareon PanOptix lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL. The Clareon Vivity lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity while maintaining comparable distance visual acuity. All of these IOLs are intended for placement in the capsular bag. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting any IOL in a patient with any of the conditions described in the Directions for Use that accompany each IOL. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon, informing them of possible risks and benefits associated with these IOLs. Reference the Directions for Use labelling for each IOL for a complete listing of indications, warnings and precautions.
Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 24,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care.
Medtronic | January 11, 2022
Medtronic plc, a global leader in healthcare technology,today announced it has received approval fromJapan'sMinistry of Health, Labor and Welfare for the sale and reimbursement of the Micra™ AV Transcatheter Pacing System (TPS), and the company will launch the product this month.
This approval expands the number of patients inJapan– one of the largest markets in the world – who are eligible to receive the Micra TPS, the world's smallest pacemaker. The Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired. The Micra TPS is the first-ever leadless pacemaker; its first version (the Micra VR) was approved inJapanin 2017 for patients who only require single-chamber pacing.
"Pacemakers have made significant progress over their approximately 60-year history, including miniaturization, improvements in pacing technology, MRI compatibility, and remote monitoring," explainedKyoko Soejima, professor of cardiovascular internal medicine at Kyorin University Hospital and a member of the Micra TPS Global Clinical Trial steering committee. "The first Micra system transformed the concept of pacemakers by eliminating surgical pockets and leads, and Micra AV promises to deliver the benefits of leadless pacing to a larger number of patients because ventricular pacing can be performed synchronously with the atrium."
Historically, patients with AV block have been treated with traditional dual-chamber pacemakers which are implanted in the upper chest, under the skin below the collar bone, and connected to the heart using thin wires called "leads." Identical in size and shape to the original Micra TPS, Micra AV has several additional algorithms which detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, providing "AV synchronous" pacing therapy to patients with AV block.
The Micra AV approval is based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. The study evaluated the ability of the Micra's internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony.
"Since introducing the first battery-powered external pacemaker in 1957 to the innovative Micra leadless pacemaker portfolio, Medtronic continues to pioneer pacing innovations for physicians and their patients."
Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiac Rhythm Management business at Medtronic
About the Micra Transcatheter Pacing Systems (TPS)
The Micra TPS received CE Mark inApril 2015and U.S. FDA approval in 2016. Comparable in size to a large vitamin, Micra is less than one-tenth the size of traditional pacemakers yet delivers advanced pacing technology to patients via a minimally invasive approach. During the implant procedure, the device is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.
Unlike traditional pacemakers, Micra does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to leads and pockets are reduced, and there is no visible sign of the device.
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered inDublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.