QuantuMDx and Menarini Announced an Agreement for the Distribution of the Q-POCTM Platform

On November 2, 2022, QuantuMDx Group Limited, a UK-based developer of transformational Point-of-Need molecular diagnostics, and A.Menarini Diagnostics S.r.I. (Menarini), announced an exclusive distribution agreement for QuantuMDx’s Q-POC™ platform in UK and France.

As per the terms of the contract, QuantuMDx’s SARS-CoV-2 assay, Q-POCTM, and its new SARS-CoV-2, Flu A/B, and RSV Respiratory Panel test, which the Company launched earlier this year, will all be marketed, sold, and serviced by Menarini. Initial distribution to the UK and France will be covered by the five-year contract, with the option to include additional markets. 

Chief Executive Officer of QuantuMDx, Jonathan O’Halloran,  said “This agreement with Menarini is a significant commercial step for QuantuMDx. Not only does Menarini have a vast global network, but their specific in-country knowledge and presence across Europe, and beyond, means they are an excellent partner for us. The agreement will allow us to further accelerate commercial sales of Q- POC™, bringing our Point-of-Need multiplex molecular diagnostics platform to clinical and non-clinical settings in a host of new markets. I look forward to working closely with Menarini on what I am confident will be a very successful partnership.”

Fabio Piazzalunga, the Global Head of Menarini Diagnostics S.r.I., also said, “The recent pandemic has highlighted the importance of being able to accurately and rapidly, diagnose infectious diseases. QuantuMDx’s Q-POC™ platform, which can provide results in approximately 30 minutes, will allow healthcare professionals to make informed treatment decisions and slow the risk of transmission. Menarini is a pioneer in decentralizing diagnostics routines and developed core competencies and technologies in doing so. We are extremely happy to be able to start providing such an innovative platform to laboratories in the UK and France.”

As per DelveInsight’s Molecular Diagnostics Marketreport, the global molecular diagnostics market was valued at USD 16.94 billion in 2021, growing at a CAGR of 9.16% during the forecast period from 2022 to 2027 to reach USD 28.44 billion by 2027. The rise in the demand for molecular diagnostics is primarily due to the rising prevalence of infectious diseases, such as the sudden outbreak of Covid-19 and the rising burden of cancers across the globe. Moreover, rapid technological advancement in the molecular diagnostics product arena and the increasing demand for point-of-care diagnostics, along with rising consumer awareness regarding quick diagnostics, among others, are some of the key factors responsible for the molecular diagnostic market growth during the forecasted period from 2022-2027.

TriVerse™ Primary Knee Replacement System by Exactech Receives FDA 510(k) Clearance

On November 4, 2022, Exactech, a producer of cutting-edge implants, instruments, and smart technologies for joint replacement surgery, announced today that the TriVerseTM primary knee system had received 510(k) clearance from the U.S. Food and Drug Administration.

The TriVerse primary knee system offers cruciate retaining, anterior stabilized, and posterior stabilized constructs to accommodate surgical efficiency in both hospitals and surgery centers. Additionally, only highly crosslinked, vitamin E-stabilized polyethylene will be used for TriVerse insert bearings.

TriVerse will debut with a small set of movable mechanical instruments, with ExactechGPS®, the company’s flagship product, to be compatible in the future.

In addition to the company’s balanced knee system, award-winning primary and revision implants and instruments, and fully integrated GPS platform, the new system will round out its offering of knee solutions.

Exactech’s Chief Marketing Officer and Senior Vice President of Large Joints, Adam Hayden, said, “The TriVerse primary knee system is positioned to be a powerful addition to Exactech’s portfolio that leverages proven design principles and data from hundreds of thousands of total knee replacement patients.” He further added that “TriVerse will offer orthopedic surgeons an impactful solution that is developed using proven implant design features, intraoperative flexibility, and a straightforward approach.”

According to DelveInsight’s Knee Reconstruction/Replacement Devices Marketreport, the global Knee Reconstruction/Replacement Devices market was valued at USD 7.87 billion in 2021, growing at a CAGR of 4.52% during the forecast period from 2022 to 2027, in order to reach USD 10.27 billion by 2027. The Knee Reconstruction/Replacement Devices market is estimated to rise owing to the burgeoning old-age population, the growing prevalence of various knee-associated musculoskeletal disorders such as osteoarthritis, rheumatoid arthritis, psoriatic arthritis, and others, the growing demand for minimally invasive surgeries and technological advancement to improve the efficiency of devices are expected to bolster the demand for knee reconstruction/replacement devices.

Kardium Announced the Successful First-in-Human Clinical Study of the New Globe® Pulsed Field System

On November 8, 2022, Kardium Inc. announced the accomplishment of its next-generation Globe® Pulsed Field System’s successful first-in-human study to treat atrial fibrillation (AF) with pulsed-field ablation (PFA) therapy. A team of doctors all worked together to successfully treat several patients by using the Globe Pulsed Field System to isolate all of their pulmonary veins.

The ground-breaking Globe Catheter, equipped with 122 gold electrodes, is the centerpiece of the Globe Pulsed Field (PF) System. It can map the patient’s cardiac anatomy and electrical activity and treat atrial fibrillation by delivering PFA energy to the heart. For the purpose of ensuring that therapy is effectively administered to the heart, the Globe Catheter uses contact sensing to identify which electrodes are in contact with cardiac tissue.

In this study, pulmonary vein isolation (PVI) therapy was administered to patients with paroxysmal AF in as little as 16 minutes. The Globe PF System was used to create a high-definition map of the entire atrium using real-time 3-D mapping capabilities after PVI treatment was administered to patients with persistent AF. Using the same Globe Catheter, all of the patients with persistent AF received additional posterior wall ablation using these maps, and several patients also received a mitral isthmus line.

Kevin Chaplin, CEO of Kardium, said, “The Globe PF System is designed to be a safe, effective and rapid treatment for AF. He further added that, “We are extremely excited by these procedures, which demonstrate the flexibility and ease of use of the Globe PF System. Previous clinical cases with the Globe PF System have achieved 100% durable PV isolation three months after the procedure. 

“PVI with the Globe PF System was very easy. I could quickly position the catheter in each pulmonary vein, ensure that the electrodes were in good contact, and then deliver pulsed field energy to isolate each vein safely and rapidly from one position. I also really liked the system’s flexibility in more complex cases. I could map the atrium and then deliver additional pulsed field lesions to isolate the posterior wall quickly and then create a mitral isthmus line.” said Dr. Vivek Reddy* from Mount Sinai Hospital (New York, USA).

According to DelveInsight’s Central Venous Catheters Marketreport, the global central venous catheters market was valued at USD 2.73 billion in 2021, growing at a CAGR of 6.85% during the forecast period from 2022 to 2027, to reach USD 4.04 billion by 2027. The central venous catheters market is slated to witness prosperity owing to the factors such as an increase in the prevalence of chronic diseases such as cancer, cardiovascular, and kidney diseases, among others, increasing sedentary lifestyle,rising number of blood transfusions and the rising number of technological advancements with respect to the products are further expected to result in the appreciable revenue growth in the global central venous catheters market during the forthcoming years.

TruClear System Launched by India Medtronic for the Treatment of Intra-uterine Abnormalities

On November 2, 2022, Medtronic India, a part of Medtronic plc. family, announced the introduction of the TruClearTM system, a mechanical system for removing hysteroscopic tissue used for the safe and efficient treatment of intrauterine abnormalities (IUA). IUA is frequently associated with fibroids, polyps, retained fetal products, adhesions, malignancies, or hyperplasia.

Abnormal Uterine Bleeding is said to be present at a prevalence of 17.9% in India. Abnormal Uterine Bleeding is frequently treated with watchful waiting and a hysterectomy, which involves removing the uterus. Hysteroscopy, a minimally invasive procedure that is the gold standard for enabling surgeons to see inside the uterus and ascertain whether Abnormal Uterine Bleeding is related to fibroids, polyps, retained products of conception, or intrauterine adhesions, lies in between these two extremes. It gives patients a quicker recovery time and does not involve electric shocks or incisions.

In order to carry out a hysteroscopy as quickly as possible, the TruClearTM device offers practitioners a clear operative field and patients gentle mechanical resection during the procedure. The TruClearTM system removes intrauterine tissue mechanically rather than using a high-frequency electric current like other intrauterine abnormality treatment options. Because the uterine lining is not damaged by thermal or electrical energy, there is a greater chance of keeping the uterus for future use.

“TruClear system is a new addition to our GYN and women’s health portfolio and by introducing innovations like these we’re bringing choice, control and confidence to women’s healthcare in India. The system is built to facilitate a less invasive and effective way of treating intra uterine pathologies, giving patients the choice to retain the organ and go back to routine faster. Its precision and enhanced visibility provides gynecologists much needed comfort and helps avoid complications, yielding better patient outcomes,” said Abhishek Bhargava, director of Surgical, Patient Monitoring, Respiratory Interventions & ENT, Medtronic India.

According to DelveInsight’s Intra-uterine Devices Market” report, the global Intra-uterine Devices market was valued at USD 4.85 billion in 2021, growing at a CAGR of 5.81% during the forecast period from 2022 to 2027 to reach USD 6.77 million by 2027. The growing demand for intrauterine devices is primarily associated with the increasing awareness of family planning, high rates of unintended pregnancies, paving the way for planned or delayed pregnancies, and various healthcare initiatives by the government around contraception, is therefore expected to propel the market growth of Intra-uterine Devices during the forecast period.   

ProciseDx Announces the FDA Clearance for C Reactive Protein (CRP) Assay and ProciseDx Instrument

On November 5, 2022, ProciseDx Inc. announced the FDA clearance of its ProciseDx instrument and C reactive Protein (CRP) test. In less than 5 minutes, Procise CRP provides a quantitative assessment of the CRP levels in the patient serum. In 2023, ProciseDx anticipates receiving FDA approval for additional tests.

An initial FDA clearance is a crucial confirmation of ProciseDx’s innovative technology. In Europe, ProciseDx offers a selection of 5-minute gastroenterology and Therapeutic Drug Monitoring (TDM) tests. In Europe, ProciseDx has introduced four gastroenterology (GI) tests after obtaining CE Marks. A total of 50 sites are working toward implementation, and 30 ProciseDx instruments have already been installed and are supporting patient care. ProciseDx has submitted De Novo applications to the FDA for two TDM tests intended for the US market. 

“Accurate quantitative diagnostic results have typically required big lab instruments and taken several hours or day. The ProciseDx platform can change that, with a simple workflow producing a reliable quantitative measurement in 5 minutes or less.” said Larry Mimms, President & Chief Scientific Officer.

Peter Westlake, ProciseDx CEO, said, “ProciseDx technology is a real step forward because it can deliver reliable quantitative results from a drop of blood in 5 minutes or less. We’re preparing to bring these additional ProciseDx 5-minute tests to doctors and patients in the US.”

DelveInsight’s “Clinical Diagnostics Market” report provides an overview of Clinical Diagnostics, its applications, advantages, and limitations. The global pacemakers market was valued at USD 70.11 billion in 2021, growing at a CAGR of 7.02% during the forecast period from 2022 to 2027. The demand for clinical diagnostics is motivated due to the rise in chronic diseases such as blood disorders, liver disorders, and cancers, among others. In addition, an increase in the adoption of point-of-care diagnostic tests, the establishment of new clinical diagnostic labs worldwide, and technological advancements in the product portfolio, among others, are expected to propel the market growth of Clinical Diagnostics during the forecast period. 

Enrollment of LFR-260 Phoropter in U.S. FDA Clinical Study completed by Evolution Optiks Limited

On November 8, 2022, Evolution Optiks Limited, a global leader in light field technology applications, announced today the completion of enrollment of the pivotal U.S. Food and Drug Administration (FDA) clinical study to evaluate the safety and efficacy of its subjective light field LFR-260 tele-phoropter (investigational device). Results from the study will be used in the submission to the FDA to support clearance that the company currently anticipates receiving in the middle of 2023.

Within the newly established Optokare division, which focuses on eye care medical devices, the LFR-260, a world-first subjective phoropter (investigational device) with a proprietary light field engine at its core, tele-operability, and special features like QuadViewTM, is Evolution Optiks’ flagship product. By offering up to four views at once, each with a slightly different prescription, it aims to replace the memory-based back-and-forth guessing that patients encounter when getting their prescriptions. Additionally, its tele-operability is made to enable eye care professionals to reach patients in distant locations.

Dr. Anne Reuter, the principal investigator of the study, said, “This study was a multi-center, open-label 2×2 cross-over designed to investigate the effectiveness of the LFR-260 phoropter device compared to traditional phoropters. With the study concluded, we look forward to the final analysis and the subsequent opportunity to present the clinical and patient experience to the ophthalmic communit.” 

“We are delighted with how the study was conducted and would like to thank the patients, investigators and research teams who are participating in the LFR-260 study. Their hard work and dedication have resulted in a timely enrollment amid challenging circumstances presented by the COVID-19 pandemic. This speaks volumes about the interest to investigate the potential clinical benefits of our device.” said Raul Mihali, President and Chief Executive Officer of Evolution Optiks.

“The regulatory clearance of the LFR-260 to be used as a tele-operable phoropter would add a very attractive solution to a rather stagnant market and unlock a significant addressable market expansion opportunity. With the completion of the enrollment phase, we look forward to shifting to the analysis phase of the study in anticipation of submitting the clinical data to the FDA,” said Andreas Kusay, Chairman of Evolution Optiks.

DelveInsight’s “Phoropters Market” report, the global Phoropters market is expected to grow substantially owing to the rising prevalence of eye refractive disorders such as astigmatism, myopia, and hyperopia, increase in the geriatric population with vision impairments, technological advancements in ophthalmology during the given forecast period from 2022-2027.