04 SEPTEMBER 2020
Infosys to acquire Kaleidoscope Innovation to expand presence in Us
Infosys has signed a definitive agreement to acquire product design and development company Kaleidoscope Innovation, which specialises in medical, consumer and industrial markets.
Kaleidoscope has a deep understanding of clinical environments and strong product development capabilities across various domains.
The company designs microsurgical instruments used in minimally invasive surgery, drug delivery devices for ophthalmic therapies and user-centric wearables. It also provides usability testing for regulatory submissions, including the delivery mechanism for aortic stents.
The move will enable the India-based IT consulting company to strengthen its presence in the medical device, consumer and industrial markets across the US.
The company expects the acquisition to enable it to bring together cutting-edge technologies and experience to transform patient care, treatment, diagnostics and consumer health globally.
Infosys president Ravi Kumar said: “This acquisition further strengthens our digital offerings at the intersection of new software technologies and medical devices – a sector that is expected to witness significant investments and consumerisation in the post-Covid-19 era.
“Our clients will benefit from the combination of Kaleidoscope’s strong upstream offerings of product innovation and design, and Infosys’ stack of product engineering, validation and commercialisation services at a global scale.”
According to reports, in a regulatory filing, Infosys said that the cost of acquisition is up to $42m, including earn-out and management incentives.
Kaleidoscope Innovation CEO and co-founder Matt Kornau said: “We are enthusiastic about our exciting new partnership with Infosys. It allows us to scale quickly and bring expanded offerings in AI, analytics and digital infrastructure to our clients.
“Kaleidoscope has always valued the ability to enhance people’s lives and their outcomes through innovation. We feel Infosys shares these same values and will open new avenues for our client partners and our staff to pursue larger opportunities together.”
The acquisition is expected to close during the second quarter of the fiscal year 2021, subject to customary closing conditions.
04 SEPTEMBER 2020
Abbott begins clinical trial of new drug-eluting resorbable scaffold
Abbott has started LIFE-BTK clinical trial to assess the safety and effectiveness of its new Esprit BTK Everolimus Eluting Resorbable Scaffold System.
The company’s Esprit BTK System is a semi-crystalline bioresorbable polymer developed to prevent vessel recoil and offer a platform for drug delivery.
It consists of a thin strutted scaffold, which measures 99 microns made from poly-L-lactide (PLLA), uniformly coated with poly-D, L-lactide (PDLLA) and the cytostatic drug, everolimus.
The LIFE-BTK trial is the first Investigational Device Exemption trial in the US to assess a fully dissolvable device for the treatment of critical limb ischemia in patients with advanced stages of peripheral artery disease (PAD).
Abbott vascular business chief medical officer and Medical Affairs divisional vice-president Nick West said: “Far too many people are impacted by peripheral artery disease, and this new drug-eluting resorbable scaffold is needed to offer meaningful improvements in how this disease is treated.
“Patients treated with balloon angioplasty often require repeat procedures on treated arteries, and therefore, a drug-eluting resorbable device is ideally suited to provide mechanical support for the vessel, reduce the chance of vessel re-narrowing and then gradually disappear over time.”
Unlike traditional metal stents, Abbott’s Esprit BTK System is not a permanent implant.
It is designed to offer support to an artery, following balloon angioplasty, and prevents the vessel from reclosing. The scaffold, once implanted, delivers a drug over a few months to keep the artery open and help its healing.
Over time, it is naturally resorbed into the body, leaving only a healed artery behind.
The Esprit BTK was granted breakthrough device designation by the US Food and Drug Administration (FDA) to streamline its review and pre-market approval timelines.
The first patient to LIFE-BTK trial was enrolled at New York-Presbyterian / Columbia University Irving Medical Center.
Abbott plans to enrol 225 patients at multiple centres around the world. To date, the trial has sites in Australia, Japan, New Zealand, Singapore and the US.
The LIFE-BTK trial builds on the previous studies of the company, examining resorbable technology in treating diseased vessels and blocked arteries.
Long-term clinical data from a meta-analysis of randomised Absorb trials suggested that bioresorbable scaffolds might be an acceptable alternative to metallic DES for many patients with coronary artery disease, the company noted.
Last month, Abbott began participant enrolment into the TactiFlex PAF IDE clinical study of its new catheter device for the treatment of paroxysmal atrial fibrillation.
03 SEPTEMBER 2020
UK commits £500m for quick-result Covid-19 test trials
03 SEPTEMBER 2020
Miracor Medical raises €24m to support PiCSO clinical trial
Miracor Medical has raised €24m in a Series E financing round to fund the PiCSO clinical trial, which will recruit and randomise approximately 750 patients in three studies across Europe and the US.
Interventional cardiologists deliver PiCSO therapy during the primary percutaneous coronary intervention (PCI) procedure in patients, experiencing anterior ST-elevated myocardial infarction (STEMI).
The company’s PiCSO Impulse System is designed to reduce the infarct size by intermittently occluding the coronary sinus outflow. It supports the redistribution of blood to deprived myocardium and potentially improves microvascular function.
Infarct size reduction is considered to be strongly correlated to improvement in heart failure hospitalisations and reduced mortality.
The PiCSO Impulse System obtained breakthrough designation from the Food and Drug Administration (FDA) last year and the CE-Mark in June.
Miracor also plans to use the proceeds to advance the commercialisation of the system in Europe.
The latest financing round was led by a new corporate strategic investor and joined by co-investor Yonghua.
It was also joined by the company’s current investors Earlybird, Noshaq, Quest for Growth, SFPI-FPIM, SRIW and another corporate strategic investor.
Miracor Medical CEO Olivier Delporte said: “We are very happy to welcome strong new investors and to receive the continued endorsement and belief in Miracor from our existing shareholders.
“Following the recent CE Mark, we have hired a very experienced commercial leader, James Hallums, who will build the strategy to prepare the controlled commercial launch planned for H2 2021. We look forward to this exciting next phase of the company.”
The company is currently enrolling patients in its European randomised controlled trial called PiCSO-AMI-I.
The trial will demonstrate the benefits of PiCSO therapy for the treatment of anterior STEMI patients compared with conventional PCI.
In another major development in the field of cardiology, Cardiac Dimensions received the Australian Therapeutic Goods Administration’s approval for its Carillon System.
Carillon System is a right heart transcatheter mitral valve repair (TMVr) device designed to treat functional mitral regurgitation (FMR) in patients with 2+, 3+ and 4+ grade mitral regurgitations.
Cardiac Dimensions CEO and president Rick Wypych said: “This is a significant milestone as Australian patients with heart failure can now be treated earlier in their disease state with a minimally invasive treatment for mitral regurgitation.”
Approximately 26 million people are estimated to be affected by heart failure worldwide, while nearly 70% of these patients suffer from FMR.
02 SEPTEMBER 2020
FDA approves Roche’s HIV-1/HIV-2 test for use in cobas Systems
Roche has received US Food and Drug Administration (FDA) approval for its cobas HIV-1/HIV-2 Qualitative test for use on fully automated cobas 6800/8800 Systems in the US.
The test is an in vitro nucleic acid amplification assay for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma.
It enables healthcare professionals to diagnose HIV with a single result. It also differentiates HIV-1 and HIV-2, offering appropriate treatment options for patients.
Roche Diagnostics CEO Thomas Schinecker said: “Roche is committed to improving diagnostic technologies in the fight against HIV/AIDS.
“Being able to reliably determine a person’s HIV status and accurately diagnose, which HIV type they may have, is crucial for patients and healthcare providers in preventing further community transmission and selecting an individual’s best treatment options.”
Studies have found that 50% of new HIV infections are transmitted during the acute period, between three days and three weeks from the time of infection.
Roche’s test uses PCR technology, which reduces the time-to-detection period by one week or more.
Existing serology-based testing methods for HIV/AIDS depends on the ability to detect an antibody or antigen response. The tests often fail to identify an infection if the person is tested before having a detectable antibody or antigen response.
The cobas HIV-1/HIV-2 Qualitative test can be used as an additional test to validate the presence of HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens.
It may also be used as an aid in the diagnosis of infection with HIV-1 and / or HIV-2 in paediatric subjects and pregnant women, the company noted.
02 SEPTEMBER 2020
MedGyn completes Thomas Medical acquisition from Biomerics
US-based medical device supplier and women’s healthcare products developer MedGyn has completed the acquisition of Thomas Medical from Biomerics through one of its subsidiaries.
The financial terms of the deal were not disclosed.
Based in Indianapolis, US, Thomas Medical develops and manufactures single-use medical devices and accessories, including HS catheters and procedure trays, uterine manipulators (UMI), injectors, endometrial samplers, IUI catheters and LEEP/LLETZ electrodes.
These products are Food and Drug Administration (FDA)-cleared and CE-marked.
MedGyn CEO and chairman Lakshman Agadi said: “This acquisition underscores MedGyn’s strong commitment to both patients and healthcare professionals by continuing to provide trusted products and services in women’s healthcare.
“While we focus on domestic manufacturing, the breadth of our distribution network is global and includes over 140 countries. We look forward to providing our customers with reliable access to Thomas Medical’s high-quality portfolio of products.”
Following the acquisition, Thomas Medical will operate as an independent division of MedGyn. It will retain its brand name and continue to manufacture all products in the US without any disruption.
In a separate development, diagnostic and therapeutic medical technology company Laborie Medical Technologies (LABORIE) has signed an agreement to acquire GI Supply in partnership with growth equity company Signet Healthcare Partners.
GI Supply provides endoscopy and paracentesis products for gastroenterologists, colorectal surgeons and interventional radiologists.
GI Supply, which will continue to operate independently, will be led by its current CEO Kristi Dahlke and its existing leadership team.
LABORIE president and CEO Michael Frazzette said: “At LABORIE, we are committed to helping improve lives by enabling our clinical customers and their patients with relevant solutions for their needs. We do this organically, as well as through strategic acquisitions.
“With the acquisition of GI Supply, we immediately enhance LABORIE’s gastroenterology product offering and sales channel in the US and internationally. This is an important step in the evolution of our GI business.”
01 SEPTEMBER 2020
Enigma Biomedical to evaluate Janssen’s neuroimaging biomarkers
01 SEPTEMBER 2020
FDA approves Medtronic’s insulin delivery and monitoring system
The US Food and Drug Administration (FDA) has approved Medtronic’s MiniMed 770G System for use by paediatric patients aged between two and six years with type 1 diabetes.
The system is a hybrid closed-loop diabetes management device, which automatically monitors glucose and enables appropriate basal insulin doses with little or no input from the users or their caregivers.
It is designed to measure the glucose levels in the body every five minutes and automatically adjust insulin delivery by either administering or withholding insulin.
It is a Bluetooth-enabled version of the company’s previously approved MiniMed 670G System.
FDA Commissioner Stephen Hahn said: “Advancements in science, technology and manufacturing have helped make great strides in the treatment and successful management of type 1 diabetes, a life-threatening chronic condition.
“The FDA is dedicated to promoting policies that support the development of new technologies based on these advances and remains committed to helping ensure that development and expansion of products that can improve the quality of life for those with this condition, which can particularly impact children, is safe and effective.”
The approval was based on the outcomes from a clinical trial that included 46 pediatric type 1 diabetes patients.
The FDA also noted that Medtronic MiniMed 770G System is a first-of-a-kind device to be cleared for use in patients in the age category.
It is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for this patient population, said the agency.
Patients with type 1 diabetes condition require constant monitoring of glucose levels throughout the day. Usually, to maintain adequate glucose levels in order to avoid becoming hyperglycemic or hypoglycaemic, insulin is injected with a syringe, pen or pump.
In June, Medtronic secured CE Mark certification for its MiniMed 780G system for the treatment of type 1 diabetics between the ages of seven and 80 years.