Medical Industry Week - 17 JUL

July 13 2023
Issue: 1154
ISSN: 1462-8716
Contents
Medical Industry Week Agreement News..............................3
Corporate News ................................4
Roche Emerging As A Key Player In Cerebrospinal Fluid And Blood- Product News ....................................5
Based Tests For Alzheimer's Disease R&D .................................................... 12
Conference Highlights................. 12
Key View
• Roche continues to emerge as a dominant player in cerebrospinal fluid and blood- Highlights
based diagnostic tests for Alzheimer’s disease.
Thermo Fisher Scientific Agrees To Acquire
• We expect to see more cerebrospinal fluid and blood-based biomarker tests for CorEvitas From Audax
Alzheimer’s disease come to market as current diagnostic methods are unlikely to Page 3
cope with the rapidly rising burden of the disease. Following Approval, Leqembi’s Sales Growth
• With treatments for early Alzheimer’s disease coming to market, demand for new May Be Lower Than Expected As Boxed
Warning Given
diagnostic tools for the disease will increase. Page 5
Roche continues to emerge as a dominant player in cerebrospinal fluid (CSF) and

blood-based diagnostic tests for Alzheimer’s disease (AD). In June 2023, Roche
received FDA clearance of its Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys
Total-Tau CSF assays (tTau) to help clinicians spot early signs of AD. The Elecsys AD CSF
Abeta42 and tTau assays can detect two biomarkers of AD pathology, beta-amyloid and
tau proteins, in adults ages 55 and older being evaluated for the disease. The company
has announced the tTau/Abeta42 assay will be available in the US at the beginning of
Q423. This is a second AD diagnostic test from Roche to gain FDA approval in less than
a year. In December 2022, the company secured FDA approval of the Elecsys AD CSF
Abeta42 and pTau181 assays also indicated for early diagnosis of AD. Moreover, in July
2022, Roche received an FDA breakthrough designation for its Elecsys Amyloid Plasma
Panel (EAPP), an innovative and minimally invasive test that enables the measurement
of AD biomarkers from a blood sample. In March 2023, Roche announced a partnership Amy Walker
with Eli Lilly to accelerate R&D activities for the EAPP. Manager, Pharmaceutical & Healthcare
Aumeya Goswami
According to Roche, the findings of its CSF tests are similar to amyloid PET scan
Healthcare Analyst
imaging, but these tests should be used in tandem with other clinical evaluations to
diagnose AD. As Roche grows its portfolio of CSF and blood-based tests for the disease, Megan Cordwell
the company will become a key player in the AD diagnostic market, competing with Healthcare Analyst
other players, namely Fujirebio Diagnostics, Quanterix, Sysmex, C₂N

Diagnostics and Diadem. This will support long-term growth prospects for Roche’s AD
segment, offsetting headwinds from its experimental AD drug, gantenerumab, which
failed in clinical trials in November 2022.
We expect more CSF and blood-based biomarker tests for AD to come to market Head Office
as current diagnostic methods are unlikely to cope with the rapidly rising burden 30 North Colonnade, Canary Wharf, London
E14 5GN, UK
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Medical Industry Week | July 13 2023
of the disease. The WHO estimates that there are currently 55mn people living with AD or other dementias across the globe,
which could rise to 139mn by 2050. This will increase diagnostic demand as more people experience symptoms and require
confirmation of diagnosis. Brain imaging techniques including MRI, CT and PET scans are the commonly used diagnostic
methods for AD. However, these tests are expensive, time consuming and expose patients to radiations, therefore limiting
their use and accessibility. With cases of AD rising, driven by factors such as ageing populations, widespread sedentary
lifestyles and poor diets, it is unlikely that brain imaging techniques will cope with this upward trending demand.
We believe CSF and blood-based assays represent a paradigm shift in the AD diagnostic market as they have the potential to
provide more affordable, accessible and safe routine options to detect AD in early stages of the disease. These tests will be
instrumental in enabling large scale implementation of screening, diagnosis and monitoring programmes for AD. Given their
less invasive features compared to CSF-based tests, we expect increased R&D investment in blood-based biomarkers over the
coming years. There are currently several blood-based biomarker tests for AD in development, as shown in the table below. It
is our view that Roche and Eli Lilly’s EAPP and Quanterix’Simoa test will be first to receive FDA approval given that they have
both received FDA Breakthrough Device Designation. Sysmex’s HISCL β-Amyloid 1-42 and 1-40 assay kits are also likely to
receive FDA approval if shown to be reliable and safe in Japan. We believe adoption of each test will depend on cost, safety and
reliability due to the need for widespread screening programmes for the disease.
LIST OF CSF AND BLOOD-BASED BIOMARKER TESTS FOR AD

Company Test Test Method Approved?
Roche Elecsys AD CSF Abeta42 and tTau/Abeta42 ratio in CSF FDA approval in June 2023
tTau
Roche Elecsys AD CSF Abeta42 and pTau181/Abeta42 ratio CSF FDA approval in December 2022
pTau181
Fujirebio Diagnostics Lumipulse β-Amyloid (1-42/1-140) ratio in FDA approval in May 2022
CSF
Quanterix Simoa test Measures tau in the Received FDA Breakthrough

bloodstream Device Designation in April 2022
Roche/Eli Lilly Elecsys Amyloid Plasma panel Measures tau and Received FDA Breakthrough
apolipoprotein E4 Device Designation in July 2022
Sysmex HISCL β-Amyloid 1-42 and 1-40 Measures two beta amyloid Received marketing approval in
assay kits proteins present in the Japan in December 2022
bloodstream
C₂N Diagnostics PrecivityAD2 test Measures tau and amyloid beta Expected launch in 2023
Diadem Alzosure test Measures U-p53AZ biomarker Expected launch in 2023
Note: This is not a conclusive list of all CSF and blood-based biomarker tests approved and in development. Source: Company sources, BMI
With treatments for early AD coming to market, demand for new diagnostic tools for the disease will increase. In our
Central Nervous System Drug Key Themes For 2023, we highlighted that we expect to see new beta-amyloid directed AD
drugs enter the market in 2023 supported by positive trial results and key regulatory decisions. We have already started to see
this view play out such as the FDA accelerated approval granted to Biogen and Eisai’s monoclonal antibody beta-amyloid
drug, Leqembi (lecanemab-irmb), for the treatment of early AD in January 2023. In May 2023, Eli Lilly also announced positive
Phase III trial results for its AD candidate donanemab in patients with early symptomatic AD. The company has stated that it is
expecting a regulatory decision from the FDA towards the end of 2023 or early 2023. These developments in AD drugs
reinforce the need for and importance of reliable, safe and easy AD diagnostic tests. Collaboration among AD drug and
diagnostics makers will be essential to bridge possible gaps in market availability of therapeutic and diagnostic tests for the
disease.
This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in
FitchSolutions.com/bmi the report are solely derived from BMI and independent sources. Fitch Ratings analysts do not share data or information with BMI. Page 2
Agreement News
Thermo Fisher Scientific Agrees To Acquire CorEvitas From Audax
Thermo Fisher Scientific has signed a definitive agreement to acquire CorEvitas from Audax Private Equity for
USD912.5mn in cash.
CorEvitas is leading provider of regulatory-grade, real-world evidence solutions to pharmaceutical and biotechnology
companies to improve patient care and clinical outcomes. It manages 12 registries, including nine autoimmune and
inflammatory syndicated registries. The acquisition of CorEvitas will support Thermo Fisher to further advance its capabilities
to better serve its pharma and biotech customers and strengthen the value proposition.
The transaction is subject to customary closing conditions and expected to be completed by the end of 2023. After the
completion, CorEvitas will become a part of Thermo Fisher's Laboratory Products and Biopharma Services segment.
Microba Signs Agreement With Sonic Healthcare For Distribution Of MetaPanel Test In Australia
Microba Life Sciences has signed a commercial agreement with Sonic Healthcare's wholly owned subsidiary, Douglass
Hanly Moir Pathology, to distribute its advanced infectious disease testing technology, MetaPanel, in Australia. This is the
first executed agreement between Microba and Sonic Healthcare since Sonic Healthcare acquired a 19.99% equity holding in
Microba.
The MetaPanel test is an advanced in-vitro diagnostic designed for testing of causal agents of gastrointestinal infectious
disease. The test uses Microba's metagenomics technology to diagnose infectious pathogens such as bacteria, fungi,
parasites and DNA viruses, and evaluates virulence factors and antimicrobial resistance genes to support precise treatment
decisions. The new metagenomic diagnostic test helps clinicians to avoid multiple, low-coverage, and sequential diagnostic
tests that can impact treatment outcomes for vulnerable patients.
Usono, Clarius Sign International Agreement To Launch Wireless And Wearable Ultrasound
Imaging For Researchers
Clarius Mobile Health and Usono have signed an agreement to bring an innovative wireless and wearable ultrasound
imaging solution for researchers studying the anatomy of people in motion. The imaging solution will be launched at the
European College of Sport Science congress in 2023.
The new wearable ultrasound solution combines a Clarius HD3 high-definition wireless ultrasound scanner for research with
Usono's ProbeFix Dynamic to allow hands-free, stable and reproducible ultrasound imaging during exercise. It is the first
wireless dynamic ultrasound imaging solution for researchers working in the areas of sports medicine, rehabilitation and
other related areas. Clarius's ultrasound tools for research allow access to raw data collected internally, gyroscope collection, a
programmable interface and custom software for real-time analysis.
Per the terms of the international agreement, Usono has become a global distributor of Clarius's wireless ultrasound scanners
combined with research software and its own probe holders. The agreement includes co-marketing efforts to promote the
combination of the two companies' technologies to researchers and clinicians.
ARCH Medical Solutions Completes Acquisition Of gSource
ARCH Medical Solutions has acquired US-based gSource LLC, which specialises in manufacturing an extensive line of
surgical instruments and performs custom contract manufacturing for medical original equipment manufacturers. gSource is
a reputed medical equipment manufacturer known for making instruments primarily for orthopaedic and spinal surgical
procedures.
The acquisition of gSource supports ARCH Medical to strengthen its position as a leading, diversified supplier in the medical
device contract manufacturing market. It will bring growth opportunities for employees and customers. The Emerson facility
will continue working as gSource.
Tempus And TScan Partner For Development Of CDx Test
Tempus has signed a new partnership with TScan Therapeutics to develop a companion diagnostic (CDx) test for the
treatment of cancer patients. The CDx test will be used to prospectively assess HLA loss in patients' tumours and to guide
appropriate treatment selection in TScan's solid tumour clinical trial.
The partnership supports TScan's screening protocol for its Phase I solid tumour trial in which customised mixtures of T cell
receptor (TCR)-engineered T cell therapies (TCR-T) will be administered to patients based on tumour antigen positivity and
intact HLA expression.
Under the collaboration, TScan plans to enrol patients with solid tumours, including non-small cell lung cancer, melanoma,
head and neck cancer, ovarian cancer, and cervical cancer. TScan will use Tempus' 648-gene panel, named the xT assay, to
identify patients with HLA loss in the tumour to select TCR-Ts that recognise HLA genes still intact in the patient's tumour.
KUKA Enters Expanded Partnership With Siemens Healthineers To Supply Robots For ARTIS
Pheno System
KUKA has expanded its long-term partnership with Siemens Healthineers to supply 300 KUKA KR QUANTEC robots for the
latter's ARTIS pheno angiography system.
The KUKA KR QUANTEC robot is the robotic heart of ARTIS pheno, a state-of-the-art, X-ray-based imaging system designed for
interventional, cardiological and surgical disciplines. The device is used for various medical treatments such as examinations
of vascular diseases, repairs of heart valves or even complex orthopaedic operations of the spine or pelvis. The robot helps to
move the C-arm with X-ray source and image converter around the patient, providing the surgeon with optimal access to the
surgical field during medical intervention. The robotic system can navigate as per the physician's desired positions using a
joystick. It enables the positioning of patients differently on the operating table during surgical procedures, leading to easier
breathing or stabilisation of blood pressure.
KUKA has decided to launch KR QUANTEC HC, an innovative robot for use in the medical sector, with new, comprehensive
safety functions in the future.
Corporate News
Liberate Medical Closes USD6.2mn In Series B Financing Round To Strengthen Its Position In
Respiratory And Critical Care
Liberate Medical has closed USD6.2mn in a Series B financing round co-led by a large strategic investor and Scientific
Health Development.
The proceeds from the financing will be used by the firm to support the clinical trial of the VentFree respiratory muscle
stimulator, known as the PREVENT trial, for FDA clearance and full commercial launch of the device. The PREVENT trial is
designed to demonstrate that VentFree reduces the duration of invasive mechanical ventilation in patients that are at risk of
being difficult to wean.
The VentFree respiratory muscle stimulator is the only non-invasive, breath-synchronised, neuromuscular electrical stimulator
which is designed to prevent expiratory muscle atrophy in mechanically ventilated patients. The device has gained FDA
breakthrough device designation, FDA emergency use authorisation and CE marking in the EU.
Methodist Le Bonheur Healthcare Opens New Breast Cancer Centre In The US
Methodist Le Bonheur Healthcare has opened a new Methodist Comprehensive Breast Centre and Diagnostic Centre in
Memphis, US, to provide a variety of breast health services, including screening, ultrasounds, diagnostic mammograms and
biopsies.
The Memphis-based healthcare system features new exam and consult rooms and a special clinical area for breast surgeons
to provide comprehensive care experience to patients at one location. The data obtained from Methodist Le Bonheur
Healthcare's latest Community Needs Health Assessment graded cancer as the second-leading cause of death in DeSoto
County, and Shelby County in the US.
The company has a comprehensive healthcare system with 13,000 associates supporting six hospitals, ambulatory surgery
centres, outpatient facilities, a hospice residence and physician and specialty practices serving communities across the Mid-
South of the US.
Product News
Following Approval, Leqembi’s Sales Growth May Be Lower Than Expected As Boxed Warning
Given
Key View
• FDA approval and Medicare coverage of Leqembi will support treatment access for Alzheimer’s disease patients in the US,
as the first approved treatment which slows disease progression.
• The boxed warning and need for MRI scans to monitor side effects will constrain sales growth.
• Approval of amyloid plaque diagnostic tests will support future sales growth of Leqembi, as it would remove the need for
MRI scans to monitor side effects.
• The use of Leqembi for subcutaneous injection would also support future sales growth if approved later this year.
FDA approval and Medicare coverage of Leqembi will support treatment access for Alzheimer’s disease patients in
the US, as the first approved treatment which slows disease progression. In line with our view, Eisai and Biogen’s
Leqembi (lecanemab-irmb) received full FDA approval on July 6 2023 as the first treatment shown to reduce the rate of disease
progression and slow cognitive and functional decline in adults with Alzheimer’s disease. Clinical trial data showed the
treatment slows progression of the disease by 27% over 18 months for patients in the earliest stages of the disease. Leqembi
works by removing amyloid plaque, a biomarker of Alzheimer’s disease, and is administered by injection infusion every two
weeks. The Centers for Medicare and Medicaid Services also announced on July 6 that it will provide broader coverage for the
drug, supporting more individuals with Alzheimer’s disease in early stages to slow progress of the disease, improving quality of
life and potentially life span. Under the coverage policy, patients will have to pay for 20% of Leqembi’s approved pricing, with
Medicare coverage including the remaining 80% with the list price for Leqembi in the US at USD26,500 per year.
Side effects and the need for frequent MRI scans will constrain sales growth. Despite approval of Leqembi, Eisai and
Biogen’s stock fell following the announcement, as investors did not anticipate that the drug would carry a boxed warning due
to side effects. We expect this will constrain sales growth, which Eisai forecasts will be USD7.3bn by 2030. This is because
some doctors may advise against using the drug as the side effects may outweigh the benefits for some, given disease
progression is only slowed by 27% over 18 months. Trials found Leqembi can increase risk of brain hemorrhages, particularly
for those on blood thinners, with two copies of gene APOE4 and those with cerebral amyloid angiopathy, which is a common
but often undiagnosed Alzheimer’s-related condition. Those taking the drug will also have to undergo frequent MRI scans to
ensure that they are not experiencing amyloid-related imaging abnormalities (ARIA), which can result in bleeding or swelling
in the brain.
Biogen And Eisai Stock Fell Following Approval Due To Unexpected Leqembi Boxed Warning
Biogen (LHS) – Close Stock, USD & Eisai (RHS) – Close Stock, JPY
Source: New York Stock Exchange, Japan Exchange Group, BMI
Approval of amyloid plaque diagnostic tests will support future sales growth of Leqembi eqembi, as it would remove the need
for MRI scans to monitor side effects. Those taking Leqembi will require MRI scans for baseline and on their fifth, seventh
and 14th infusions to check for ARIA. We expect that this will hinder sales growth, given how expensive and time-consuming
MRI scans are. We expect the approval of a blood-based amyloid biomarker test would support uptake of Leqembi, as it will
speed up and reduce costs involved with monitoring side effects of the drug. Aside from MRI scans, the only FDA approved
tests for monitoring amyloid plaque are cerebrospinal fluid tests are approved to monitor amyloid plaque, which can be
painful for patients. We highlight Roche and Eli Lilly’s Elecsys Amyloid Plasma panel as a diagnostic test which will be
particularly significant for Leqembi if it receives full FDA approval, as it is currently the only blood-based test which measures
amyloid plaque and received FDA breakthrough device designation in mid-2022.
The use of Leqembi for subcutaneous injection would also support future sales growth if approved in 2024. We expect
the approval of Leqembi for subcutaneous injection would drive sales growth, as it would mean patients receiving the
treatment could access this from home without needing to visit a treatment centre every two weeks. Eisai stated in June 2023
that Leqembi is currently being trialled for dosing using an autoinjector and will be submitted to the FDA at the end of 2023.
LumiraDx Submits First 510(k) Application With US FDA For Covid Ultra Test
LumiraDx has submitted its first 510(k) application with the FDA for the clearance of its innovative 5-minute Covid Ultra Test.
The firm has also filed a traditional 510(k) dual submission for LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver for the
commercial distribution at point of care of the LumiraDx Platform, including the LumiraDx Instrument, with the LumiraDx SARS-
CoV-2 Antigen (Ag) Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit. The firm had previously received
various Emergency Use Authorisations for its SARS-CoV-2 Ag tests in the US.
The LumiraDx SARS-CoV-2 Ag Ultra Test is a state-of-the-art diagnostic test that uses the firm's technology to detect the
presence of SARS-CoV-2. The test has shown exceptional accuracy and reliability and is available in Europe and various
international markets.
LAMH Gains NMPA Approval For cfDNA Liver Cancer Detection Test In Mainland China
Helio Genomics' sister company, Laboratory for Advanced Medicine & Health Group (LAMH), has gained the National
Medical Products Administration (NMPA) approval for its novel cfDNA liver cancer detection test. The product is the first liver
cancer liquid biopsy test approved by the NMPA in Mainland China.
The cfDNA liver cancer detection test is a variation of the HelioLiver test, developed by the same core scientific team and
using the intellectual property portfolio of Helio Genomics. It uses state-of-the-art genomic technology that helps to cater
specifically to the genetic variations prevalent in the Asia-Pacific region. The company is planning to work with leading
medical institutions, healthcare providers and key stakeholders in Mainland China to enhance access to its new product.
Health Canada Grants Approval To Next-Generation Dexcom G7 CGM System
Dexcom has secured Health Canada's approval for the next-generation Dexcom G7 Continuous Glucose Monitoring (CGM)
System for the management of all types of diabetes in patient ages two years and older. The device is expected to be
launched by the end of 2023.
Dexcom G7 is the most accurate CGM system which is clinically proven to lower A1C, reduce hypoglycaemia and improve time
in range. The device features an all-in-one sensor and transmitter that help to simplify the entire CGM system and experience.
Its 30-minute sensor warms up two times faster than any other CGM and enables users to see real-time glucose readings sent
automatically to their compatible smart device or receiver, without the need to routinely scan or prick their finger. It includes
a suite of customisable alerts to help avoid potentially dangerous hypoglycaemic events and allows users to share
information with family, loved ones and care teams.
The company is actively engaged with its insulin pump partners to integrate Dexcom G7 into current and future automated
insulin delivery systems.
Avatar Medical Receives US FDA 510(k) Clearance For Its VR Platform
Avatar Medical has received FDA 510(k) clearance for its virtual reality (VR) platform that collects data from computerised
tomography and MRI scans to generate a 3D representation of the imaged body region.
The software creates a patient avatar that helps surgeons in pre-operative planning and reference during surgeries, such as
breast surgery, vascular surgery, orthopaedic surgery and surgical oncology. The company expects to receive European
medical device certification for the software in 2024.
Abbott Receives FDA Approval For World's First Dual Chamber Leadless Pacemaker
Abbott has gained FDA approval for the world's first dual chamber (DR) leadless pacemaker system AVEIR for the treatment of
people with abnormal or slow heart rhythms.
AVEIR DR devices use Abbott's proprietary i2i communication technology to provide synchronised or coordinated cardiac
pacing between two leadless pacemakers, based on the person's clinical needs. The i2i technology uses high-frequency
pulses to send messages via the naturally conductive blood in the body between the two leadless pacemakers. The system
features two devices, the previously-approved AVEIR VR single chamber device, which paces the right ventricle, and the AVEIR
AR single chamber device, which paces the right atrium. It is attached to the heart's interior surface with a screw-in helix
mechanism. The dual system enables physicians to assess proper placement of the device during the procedure and before
implanting the device inside the heart chamber.
FDA approval for the system was based on clinical trial data demonstrating that the AVEIR DR system is safe and effective at
treating abnormal heart rhythms. Data from the AVEIR DR i2i Investigational Device Exemption study through three months
post-implant showed a 98.3% implant success rate for physicians.
Guardant Health Reports Reimbursement Approval Of Guardant360 Cdx Liquid Biopsy Test From
MHLW In Japan
Guardant Health has received national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare
(MHLW) for its Guardant360 CDx liquid biopsy test for comprehensive genomic profiling (CGP) in patients with advanced or
metastatic solid tumour cancers, which will be effective from July 24 2023. The declaration follows the regulatory approval of
the Guardant360 CDx test by the MHLW.
The Guardant360 CDx test analyses circulating tumour DNA to provide comprehensive genomic profiling, or tumour mutation
profiling, for all solid tumour cancers. It enables healthcare professionals to detect actionable biomarkers in a patient's blood
that may help inform their therapy selection. The device is currently approved in Japan as a companion diagnostic to identify
patients with microsatellite instability-high solid tumours who may benefit from Keytruda (pembrolizumab) and patients with
MSI-High advanced colorectal cancer who may benefit from Opdivo (nivolumab). The test has also received MHLW approval as
a companion diagnostic for identifying patients with metastatic non-small cell lung cancer who may benefit from treatment
with LUMAKRAS (sotorasib). It has gained FDA approval and a CE mark for comprehensive genomic profiling across all solid
tumuor cancers.
First Implantation Procedure Successfully Performed Using Salvia's Neuromodulation Solution

For Severe Migraine And Cluster Headaches
The first implantation procedure has been successfully performed in a 29-year-old woman with debilitating headaches using
Salvia BioElectronics' neuromodulation solution. The novel neuromodulation solution is used for treatment of severe
migraine and cluster headaches.
The company develops flexible bioelectronic foils that can uniquely conform to the anatomy of the head, providing a
promising neuromodulation solution. It aims to restore the balance of the nervous system by delivering gentle electrical
pulses via the thin bioelectronic foil to reduce migraine and cluster headache attacks.
Biotronik Receives US FDA Approval For Amvia Edge Pacemakers
Biotronik has received FDA approval for its portfolio of Amvia Edge pacemakers and cardiac resynchronisation therapy
pacemaker (CRT-P) in the US.
The Amvia Edge pacemakers are the smallest single-chamber MR conditional pacemaker that offer a set of patient-centric
solutions coupled with automated workflow efficiency. The devices featuring Biotronik's proprietary MRI Guard 24/7
technology uses always-on, dedicated sensors to automatically recognise a patient's entrance into an MRI field. The devices
are then converted into mode by the MRI Guard and returned to its permanent programming after the scan completes.
The Amvia Edge devices also feature Atrial ATP which provides multiple automatic therapies in response to detected stable
atrial arrhythmias. These include new tools that automate key tasks like pre-discharge checks. The company's EarlyCheck
feature automatically sends a device report and Intracardiac electrograms to the Home Monitoring Service Centre two hours
post-implant, removing the need for in-person device interrogation.
Stryker Introduces Ortho Q Fully Autonomous Guidance System
Stryker has introduced its Ortho Q autonomous guidance system which combines new optical tracking options through a
redesigned, state-of-the-art camera.
The Ortho Q guidance system comprises sophisticated algorithms as part of the new software that helps to deliver additional
surgical planning and guidance capabilities. The system is used as a planning intraoperative guidance system for the Express
Knee, Precision Knee and Versatile Hip offerings to enhance procedural speed and efficiency. The device also features a
robotics-ready platform with dual PCs and a quick-refresh camera. It is integrated with implant-agnostic software that offers
surgeons with options on implants to address the needs of the entire service line in one platform. It can be used in the
operating room and ambulatory surgery centre settings.
Bausch + Lomb Acquires Blink Product Line Of Eye And Contact Lens Solutions From Johnson &
Johnson
Bausch + Lomb has acquired the Blink product line of eye and contact lens drops from Johnson & Johnson Vision through
one of its affiliates. The acquisition supports the company's commitment to increase over-the-counter consumer
convenience in eye care. As per the deal terms, Bausch + Lomb agreed to acquire the Blink product line for USD106.5mn in
cash.
The Blink portfolio of eye drops consists of a variety of eye drops and contact lens rewetting drops that offer immediate and
long-lasting symptom relief. The products that are included in the acquisition are the following: Blink Tears Lubricating Eye
Drops, Blink Tears Preservative Free Lubricating Eye Drops, Blink GelTears Lubricating Eye Drops, Blink Triple Care Lubricating
Eye Drops, Blink Contacts Lubricating Eye Drops and Blink-N-Clean Lens Drops.
Getinge Gains US FDA 510(k) Clearance For Servo-Air Lite Ventilator
Getinge has gained FDA clearance for Servo-airLite, a wall gas independent non-invasive mechanical ventilator in the US.
Servo-air Lite is a turbine-driven ventilator which is designed for non-invasive ventilation. It provides ICU-quality ventilation like
all Servo ventilators and is used to help patients who need extra breathing support. It features a powerful turbine and long-
lasting battery backup power with embedded workflows, support for high flow therapy, carbon dioxide monitoring and tools
to support escalation of therapy if required. It can be operated independently of wall gas and is suitable for intrahospital
transports. It is expected to be launched for customers in the US in September 2023.
Inovedis Secures US FDA Clearance For SINEFIX Implant System For Rotator Cuff Repair
Inovedis has gained FDA clearance for a new implant system, SINEFIX, designed for the repair of rotator cuff tears, a common
cause of shoulder pain and disability.
The SINEFIX implant system is designed to enable refixation of the rotator cuff tendon to bone with a simplified surgical
technique that helps to reduce time and cost of the procedure and is easy and quick to learn for the surgeon. The system
provides effective mechanical reinforcement of the fixed tendon and stimulates the patient's intrinsic healing potential. It is a
simple staple implant, which creates a flat and even contact of tendon and bone and distributes the shear stress uniformly,
without causing punctual pressure peaks. It also helps to maintain blood circulation and reduces the risk of complications due
to surgical errors.
The company expects to launch SINEFIX at the upcoming American Orthopaedic Society for Sports Medicine annual
meeting the US. It will also launch the product in selected clinical sites in 2023.
Quanterix Introduces LucentAD Biomarker Blood Test For AD Diagnosis
Quanterix Corporation has introduced the LucentAD biomarker blood test that helps in the diagnosis of patients
experiencing cognitive symptoms consistent with the early signs of Alzheimer's disease (AD).
The LucentAD test is designed to measure an isoform of phosphorylated tau protein in plasma, which is correlated with the
presence of amyloid pathology in the brain, which is a hallmark of AD. The test uses the Simoa p-Tau 181 assay that has been
extensively studied in large longitudinal and cross-sectional cohorts, and its high specificity for amyloid pathology for AD has
been well established through comparison to amyloid positron emission tomography. p-Tau 181 is a low-abundance protein
in blood, requiring high analytical sensitivity for its reliable measurement.
The test has been shown to correlate with a reduction in amyloid load in the brains of amyloid patients on anti-amyloid drug
therapy, as demonstrated in the Leqembi (lecanemab) Clarity AD drug trial. It will be available to healthcare providers as an aid
in combination with other diagnostic tools, enabling clinicians to quickly assess the likelihood of a patient having amyloid
pathology consistent with AD. It is run by Quanterix's CLIA laboratory.
Shimadzu Medical Systems Rolls Out V Series Glass-Free Flat Panel Detectors For General
Radiography Systems
Shimadzu Medical Systems USA, a subsidiary of Shimadzu Corporation, has rolled out a new V series Glass-Free Flat Panel
Detector (FPD) for its general radiography systems.
The system provides a comprehensive V series lineup to support the demands of versatile solutions. The device features a
99-micron small pixel pitch that helps in detection of finely detailed X-ray images. It has a lightweight design which helps to
reduce the physical burden on radiology technologists, while increasing robustness to withstand accidental drops. The V
series Glass-Free FPDs are available in three sizes: 17"x17", 14"x17" and 10"x12".
MedRhythms' InTandem Listed As A Class II Medical Device By US FDA
MedRhythms has reported that its neurorehabilitation system, MR-001, which is designed to improve walking and
ambulation in adults with chronic stroke walking deficits, has been listed as a Class II medical device with the FDA. The
company has also launched the brand name, InTandem for MR-001. The name shows the synchronisation inherent in the
device's mechanism of action and the partnership formed between patient and device.
MR-001 delivers an intervention based on the principle of Rhythmic Auditory Stimulation using the mechanism of auditory-
motor entrainment, through which the motor and auditory systems in the brain subconsciously synchronise to an external
cue, such as music. It can be used independently by a patient in a home setting. It previously received Breakthrough Device
Designation from the FDA in 2020.
KORU Medical Submits 510(K) Premarket Notification With US FDA For Using Freedom60
Infusion System With Hizentra Prefilled Syringes
KORU Medical Systems has submitted a 510(k) premarket notification with the FDA for using its FREEDOM60 Infusion
System with Hizentra 50mL prefilled syringes in the US. Hizentra is the most prescribed subcutaneous immunoglobulin
available in prefilled syringes.
The clinical studies data showed up to an 80% reduction in drug preparation tasks for patients using prefilled syringes with the
FREEDOM Infusion System as compared to vials. The clearance will support the firm to further enhance the patient experience
and potentially become an additional growth driver for home subcutaneous therapy.
The FREEDOM Infusion System currently includes the FREEDOM60 and FreedomEdge Syringe Infusion Drivers, Precision Flow
Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets, which are used for infusions in the home and alternate care
settings.
Motive Knee Pain Relief Therapy Now Available In US
Motive Health has launched the only FDA-cleared muscle stimulation device, Motive Knee, for management of knee pain in
the US.
Motive Knee is used to relieve knee pain and enhance mobility by strengthening the quadriceps muscles, using
neuromuscular stimulation technology. The device is currently available without a prescription on Motive Health's website,
with prices starting at USD399 for a complete therapy system. The device treats knee pain with a precise electrical pulse to
stimulate muscle movement. It enables the consumers to control the therapy in the comfort of their own home, with a
recommended use of 30 minutes per day.
The device is coupled with the MyMotive App to allow users to personalise therapy levels, monitor progress and achieve
mobility goals. It is available with reusable Therapy Pads, Knee Wrap, Conductive Gel and Charging Cable.
Canon Medical Launches Next Generation Compact Ultrasound Systems
Canon Medical has launched its two latest premium compact ultrasound systems, Aplio flex and Aplio go, to address the
challenges of modern healthcare. The products are compact, lightweight and manoeuverable ultrasound systems which
enable high quality imaging for fast throughput in routine, screening and interventional procedures.
Aplio go is an agile system designed to support a wide range of imaging tasks with outstanding reliability, balanced workflow
and robust image quality. Aplio flex is a mobile, highly efficient ultrasound system which is integrated with features like pristine
imaging, automated functions and intelligent workflows for a wide range of imaging needs. Both the devices are integrated
with artificial intelligence-enabled functions, such as Auto IMT or Auto EF, to help users to improve their workflow and increase
the reproducibility of their diagnoses. The devices are ideal for stationary routine operation and for mobile use. These can be
equipped with an innovative technology, ApliGate, that enables image sharing remotely and connecting with Canon experts
directly from the ultrasound console.
Shineco Subsidiary Biowin Secures Marketing Approval For Its Cardiac Five-Minute Test In
Mainland China
Shineco's subsidiary, Changzhou Biowin Pharmaceutical, has secured marketing and distribution approval from the Jiangsu
Bureau of National Medical Products Administration (NMPA) for its Cardiac Five-Minute Test in Mainland China. The product
registration with the NMPA will be valid for five years through June 20 2028.
The Cardiac Five-Minute Test is a combination test of three major cardiac markers that is designed to detect cardiac troponin
I, myoglobin and heart fatty acid binding proteins for the clinical diagnosis of acute myocardial infarction (AMI) in one test.
The test completes the detection of AMI within five minutes, enabling additional time for sample collection and maintaining
the total diagnostic time within 10 minutes. It meets the detection requirements for AMI within 10 minutes and provides
effective tools for managing AMI that improve the prognosis for cardiac patients.
Anbio Launches ADL i1910 CLIA Analyser For Comprehensive Clinical Testing
Anbio has introduced a fully automated, compact and affordable CLIA analyser, Anbio ADL i1910, to perform comprehensive
clinical testing.
The ADL i1910 provides a comprehensive range of qualitative and quantitative testing options for analytes present in human
serum, plasma, whole blood and urine samples. The device uses a direct chemiluminescence method based on acridinium
ester to deliver accurate and reliable results across a wide array of applications.
The device has a range of 49 developed assays that allow both qualitative and quantitative testing of analytes. It has a
throughput of up to 120 tests per hour which enhances laboratory productivity. It is designed to occupy minimal space,
making it suitable for laboratories of all sizes and has an intuitive graphic user interface with a large colour touch screen which
helps in simplifying operation and minimising the learning curve.
R&D
Clarity To Commence CLARIFY Phase III PC Trial For 64Cu SAR-bisPSMA PET To Diagnose
Prostate Cancer
Clarity Pharmaceuticals will start its pivotal CLARIFY Phase III trial evaluating the diagnostic performance of 64Cu SAR-
bisPSMA PET to detect prostate cancer (PC) within the pelvic lymph nodes after receiving a positive recommendation from
the FDA.
The CLARIFY study is likely to start patient recruitment in late 2023. The prospective Phase III trial of 64Cu SAR-bisPSMA PET
will enrol 383 subjects with untreated, histopathology-confirmed PC, with high-risk features, who are proceeding to radical
prostatectomy with pelvic lymph node dissection. The final study results will be submitted to the FDA as part of the approval
for 64Cu SAR-bisPSMA as a new diagnostic imaging agent in PC. Two imaging timepoints will be evaluated: day one (day of
administration) and day two (approximately 24 hours post administration).
The rationale for the CLARIFY trial is supported by preclinical and clinical trial data, including positive results from its
completed PROPELLER trial that showed that 64Cu SAR-bisPSMA is safe, and its uptake in PSMA-expressing cancer lesions
was significantly higher compared to the approved standard-of-care PSMA imaging agent for PC in Australia and the US.
MIRROR RCT Trial Shows KRYSTEXXA Plus Methotrexate Combination Demonstrates Improved
Patient Response
Horizon Therapeutics has unveiled 12-month data from the MIRROR randomised controlled clinical (RCT) trial
demonstrating a sustained patient response rate and similar safety profile of the KRYSTEXXA (pegloticase) injection in
combination with a commonly used immunomodulator, methotrexate, at the six-month findings. These data were published
in ACR Open Rheumatology.
The MIRROR RCT trial enrolled a total of 152 participants who were randomised 2:1 to a four-week run-in and treatment
period with oral methotrexate (15mg/week) or placebo, followed by bi-weekly infusions of KRYSTEXXA (8mg) with either
methotrexate or placebo for 52 weeks. The published data showed that the patient response rate remained nearly 30
percentage points higher with methotrexate co-therapy during month 12 (p<0.001). A 23 percentage point increase in the
complete resolution of at least one tophus at month 12 (p=0.048) was reported. Pharmacokinetic and immunogenicity
findings through month 12 were found consistent with month six. All health assessment questionnaire measures
progressively decreased during the treatment in a clinically meaningful way.
KRYSTEXXA is used for the treatment of chronic gout in adult patients who have failed to normalise serum uric acid and whose
signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose
or for whom these drugs are contraindicated.
Conference Highlights
Histologics Launches Novel Debridement And Wound Biopsy Fabric-Curettage Devices At
WOCNext 2023 In The US
Histologics has launched its novel debridement and wound biopsy fabric-curettage devices, including the innovative
SoftBiopsy+D device and Kylon fabric-tipped device, at WOCNext in Las Vegas, the US.
Kylon fabric tipped brushes are designed to gently remove and trap tissue for biopsy for histology or microbiology. They can
be used to obtain true tangential biopsy samples from the debrided wound base for lab testing. The SoftBiopsy product is
exclusively used for biopsy, which is then sent to a laboratory. The device is versatile and durable and can help clinicians to
sustain longer procedure time for wound debridement and biopsy.
BrainTale Showcases Preliminary Results On Its Digital Biomarker Platform At EAN And World
Parkinson Congress
BrainTale, a spin-off of the Paris Region Greater Hospitals, has showcased preliminary results demonstrating the ability of its
digital biomarker platform for the early and differential diagnosis of Parkinson’s disease (PD). The results were shown at the
European Academy of Neurology (EAN) and the World Parkinson congress. These results were presented under a poster
entitled, 'Evaluation of a clinically validated digital platform to provide Diffusion MRI biomarkers in Parkinsonian syndrome'.
A total of 81 subjects were enrolled in the study, out of which 46 had PD, 18 suffered from tauopathy, 10 had ⍺-
synucleinopathy and seven had multiple system atrophy with phenotypes. The preliminary data validated the relevance and
sensitivity of BrainTale's white matter biomarkers to Parkinsonian syndromes, including early stages of PD. The positive data
enables the possibility of using these white matter biomarkers for a reliable, non-invasive and early differential diagnosis of
Parkinson's syndromes, and can help accelerate the development of new therapies.
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July 13 2023

Roche continues to emerge as a dominant player in cerebrospinal fluid (CSF) and

other players, namely Fujirebio Diagnostics, Quanterix, Sysmex, C₂N

LIST OF CSF AND BLOOD-BASED BIOMARKER TESTS FOR AD

Quanterix Simoa test Measures tau in the Received FDA Breakthrough

Diadem Alzosure test Measures U-p53AZ biomarker Expected launch in 2023

ARCH Medical Solutions Completes Acquisition Of gSource

Tempus And TScan Partner For Development Of CDx Test

Methodist Le Bonheur Healthcare Opens New Breast Cancer Centre In The US

Source: New York Stock Exchange, Japan Exchange Group, BMI

Health Canada Grants Approval To Next-Generation Dexcom G7 CGM System

Avatar Medical Receives US FDA 510(k) Clearance For Its VR Platform

First Implantation Procedure Successfully Performed Using Salvia's Neuromodulation Solution

Biotronik Receives US FDA Approval For Amvia Edge Pacemakers

Stryker Introduces Ortho Q Fully Autonomous Guidance System

Getinge Gains US FDA 510(k) Clearance For Servo-Air Lite Ventilator

Quanterix Introduces LucentAD Biomarker Blood Test For AD Diagnosis

MedRhythms' InTandem Listed As A Class II Medical Device By US FDA

Motive Knee Pain Relief Therapy Now Available In US

Canon Medical Launches Next Generation Compact Ultrasound Systems

helps in simplifying operation and minimising the learning curve.

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