GenScript USA Announced the Distribution Agreement with EUROIMMUN US for cPass SARS-CoV-2 Neutralizing Antibody Detection Kit

On May 26, 2022, GenScript USA Inc., a subsidiary of GenScript Biotech Corporation and a world-leading biotechnology company, agreed with EUROIMMUN US Inc., a PerkinElmer Company, for the distribution of the GenScript cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit in the United States and Canada.

The test kit is used to measure the relative concentration of neutralizing antibodies (NAbs) in patients recovering from COVID-19. The company announced that the test kit had already received the US FDA Emergency Use Authorization (EUA) as a serology test for neutralizing antibodies to identify an adaptive immune response in individuals with recent and prior SARS-CoV-2 infections. In addition, it is also CE marked (Europe) and has received HSA provisional approval (Singapore), ANVISA in Brazil, and ANMAT in Argentina.

“We are excited to team up with EUROIMMUN to distribute GenScript’s cPass SARS-CoV-2 Neutralization Antibody Detection Kit. We believe this collaboration can further enhance the significant contribution cPass has provided to the fight against COVID-19 and will continue to play an important role as we move towards normalcy,” said Dr. Michael Lau, senior director of corporate development for GenScript USA. 

Greg Stock, general manager of EUROIMMUN US said, “With the addition of the cPass SARS CoV-2 Neutralization Antibody Detection Kit to our SARS-CoV-2 portfolio, EUROIMMUN is well-positioned to assist our customers and their patients in assessing their adaptive immune response. She also added, “As diagnostic testing, clinical recommendations, and the virus itself all continue to evolve, we remain 100 percent committed to empowering clinicians and laboratories with high-quality diagnostic tests and automation that aid in the fight against COVID-19.”

Additionally, According to DelveInsight’s “In-vitro Diagnostics Market” report, the global In-vitro Diagnostics Market was valued at USD 71.01 billion in 2021, growing at a CAGR of 4.71% during the forecast period from 2022 to 2027 to reach USD 93.60 billion by 2027. The rise in demand for in-vitro diagnostics is predominantly attributed due to the increasing prevalence of various infectious diseases, such as COVID-19, growing prevalence of cancers, increasing cases of hematological diseases, and increasing product development activities with respect to in vitro diagnostics among others. As per the Delveinsight analysis, Asia-Pacific is expected to have the fastest growth in revenue in the overall in-vitro diagnostics market during the forecast period. This is due to the factors such as the increasing prevalence of lifestyle disorders like diabetes, and hypertension, the increasing prevalence of cancers, and the growing geriatric population related to hematological disorders such as anemia are expected to aid in the growth of the Asia-Pacific in-vitro diagnostics market.

SELUTION SLR™ Drug-Eluting Balloon (DEB) of MedAlliance Received FDA Investigational Device Exemption (IDE) Approval, Making it the First Limus DEB to be Available to US Patients

On May 26, 2022, MedAlliance, a privately-owned medical technology company announced the FDA Investigational Device Exemption (IDE) approval for SELUTION SLR™ drug-eluting balloon (DEB). The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). It was granted a Breakthrough Device Designation by the FDA on March 4, 2019. The device was also awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020. 

The technology involves unique MicroReservoirs which are made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These polymers are responsible for providing controlled and Sustained Limus Release (SLR) of the drug. Moreover, MedAlliance’s proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.

The company also reported that it will begin enrolment in the Below-the-knee (BTK) IDE Randomized Clinical Trial (RCT) SELUTION4BTK immediately outside of the US (OUS) and early this summer in US centers. 

“This is a major milestone for MedAlliance. We have been able to successfully complete the bench and pre-clinical testing required by the FDA and are ready to begin enrolling US patients in a clinical study to support submission for FDA PMA approval.  We are delighted that US patients may also benefit from this Breakthrough Technology”, commented Jeffrey B. Jump, MedAlliance Chairman, and CEO. 

According to DelveInsight’s “Drug-Eluting Stents Market” report, the global drug-eluting stents market was valued at USD 2.57 billion in 2021, growing at a CAGR of 8.09% during the forecast period from 2022 to 2027 to reach USD 4.08 billion by 2027. The drug-eluting market is slated to witness prosperity owing to factors such as the growing prevalence of cardiovascular diseases which can be further attributed to the increase in the geriatric population wherein aging is considered to have a deleterious effect on blood vessels, growing prevalence of lifestyle disorders such as hypertension, diabetes, and obesity. Further, as per the Delveinsight analysis, among all regions, North America is estimated to hold the highest share in the global drug-eluting stents market due to a large patient pool of cardiovascular disease in the region. 

RevoLix™ HTL Hybrid Thulium Laser of OmniGuide Holdings Received FDA Clearance for the Treatment of BPH and Stones

On May 26, 2022, OmniGuide Holdings (OGH), a safety-focused medical technology innovator received the US Food and Drug Administration clearance for RevoLix™ HTL a family of pulsed and continuous-wave Thulium YAG lasers used for urology patients undergoing BPH and Stone Management procedures.

RevoLix Thulium laser shows outstanding tissue ablation rate, hemostasis, and economics for the application in urology. It is a universal laser used in urology for lithotripsy, BPH, endoscopic, laparoscopic, and open surgery. 

“The FDA’s clearance reflects our confidence in our unique RevoLix™ HTL therapy and our efforts into surgical laser innovation, setting new standards in patients’ safety,” said Dr. Samir Lamrini Global Director of R&D LISA Institute for Digital Surgery. The doctor also commented, “We believe strongly in our patient-first innovation mindset, setting a path forward for urology patients to receive therapy for both BPH and Stone Management.”

Giorgio Brusa Executive Vice President of Global Marketing OmniGuide Holdings said, “RevoLix™ HTL innovative Thulium YAG Continuous Wave and Pulse modes allow complete surgical customization of the Therapy parameters providing the surgeon with full control and confidence to address any Urological clinical procedure,” Giorgio Brusa also added, “Virtually no stone retropulsion and superior stone dusting compared to the gold standard Holmium YAG decrease OR time and may lead to improved patient outcomes. At the same time, patent-pending HTL technology allows for stone clearance without overheating stone and urine medium.”

“With over 600 peer-reviewed clinical articles and 31 years of surgical Thulium laser research and development experience, RevoLix™ and OmniGuide look forward to serving patients and their Urologists here in the United States,” said Carlos Acosta Global Director of RA QA OmniGuide Holdings.

According to DelveInsight’s Analysis, the Urology Lasers Market is expected to experience significant growth in the forecast period of 2022 – 2027. This is owing to the high prevalence of urologic conditions worldwide. As per the data provided by the World Health Organization in their decade of Healthy Aging (2020-2030) report, it was estimated that the number of people aged 60 years and older will be 34% higher, increasing from one billion in 2019 to 1.4 billion in 2030. Aging is considered to cause numerous urological disorders. The increasing prevalence of geriatric patients will increase the prevalence of urological conditions leading to an increase in the demand for urology lasers used in the diagnosis and treatment of the disorders, thereby propelling the overall market growth of the urology lasers. Also, the rising adoption of minimally invasive surgical procedures in holmium systems and thulium laser treatment systems is one of the major factors propelling the market for urology lasers. These systems offer several benefits, such as greater efficiency, safety, and rapid recovery, resulting in increased demand for thulium and holmium systems. All the above factors are anticipated to bolster the overall market growth of the urology lasers in the year 2022 – 2027. 

Biomerics Announced its Expansion with a New Facility in Galway in Ireland

On May 31, 2022, Biomerics, a leading vertically integrated medical device contract manufacturer serving the interventional device market announced the opening of a 2,000 sq. ft. Balloons & Balloon Catheters Centre of Excellence in Galway and the creation of approximately 40 jobs over the next five years. 

This expansion is Biomerics’ first facility in Europe and the second facility outside the United States after Costa Rica. The expansion will be used for the development and manufacturing of balloons and balloon catheters and act as an extension to the operations in Athens, TX. This expansion is supported by The Irish Government through IDA Ireland. The new office will be located at 2 Liosban Business Park in Galway. 

Jhovanny Ortega, Commercial Director said, “I look forward to leading a group of individuals and creating cohesive teams that ultimately support the Biomerics vision”.

“Biomerics strongly believes in fielding teams with excellent skillsets. We think it is essential to use an exploratory approach to designing and developing balloon components for a variety of critical medical device applications,” says CEO Travis Sessions.  He also added, “Jhovanny and his team will be the key to success for this facility, and we have every belief that he will thrive. We are always looking for new ways to innovate as it is the lifeblood of any company and adding a location here in Ireland helps us magnify our efforts and strengthen our vision.”

According to DelveInsight’s “Medical Device Contract Manufacturing Market” report, the global medical device contract manufacturing market is expected to grow at a 10.82% CAGR during the forecast period (2022-2027). The increase in medical device contract manufacturing is predominantly owing to the increasing demand for complex medical devices at an affordable price. Furthermore, the rising prevalence of various chronic disorders, rapidly advancing healthcare infrastructure in developing nations, and rising demand for several medical devices for effective treatment are some of the factors contributing to the growth of the market. Additionally, as per DelveInsight analysis, in the product type segment, in-vitro diagnostic devices (IVD) are expected to hold a considerable market share in the year 2021. This is due to various factors such as a wide application of IVD devices in clinical diagnostics, the sudden outbreak of COVID-19 infection, and an increase in key players’ initiatives to hold the market position in the IVD market, among others.

Positive Results Reported from A First-In-Human Study for the Filterlex Medical’s CAPTIS® Full-Body Embolic Protection Device

On May 31, 2022, Filterlex Medical Ltd., a cardiovascular medical device startup, announced the results of its CAPTIS device. CAPTIS is a next-generation, full-body embolic protection device that reduces the risk of stroke and other complications during left-heart procedures when embolic particles are released into the bloodstream.

The results were presented at EuroPCR 2022 conference by Prof. Ran Kornowski, Director of the Cardiology Center at Rabin Medical Center in Israel. The first-in-human (FIH) study of the device demonstrated its safety, feasibility, and its performance. 

The study trial was a prospective, single-arm study involving 20 patients. The participants underwent a successful Transcatheter Aortic Valve Replacement (TAVR) procedure while using the CAPTIS embolic protection device. 

The key outcomes of the study are: 

  • 100% technical device performance success. The CAPTIS device was successfully deployed and retrieved in all patients, and the TAVR procedure was performed with no interference.
  • There were no device-related complications.
  • No patients experienced cerebrovascular events (objectively examined by an independent neurologist).

Prof. Haim Danenberg, Head of Interventional Cardiology at Wolfson Medical Center and the study principal investigator said, “Safe and effective brain protection in percutaneous heart procedures is a true unmet need – I am very impressed with the promising CAPTIS technology. Filterlex has developed an innovative solution that protects TAVR patients’ brain and kidneys.”

Sigal Eli, Filterlex Medical Co-founder, and CEO added: “We are extremely encouraged by the study and will continue to build robust clinical evidence around the CAPTIS embolic protection device to support its use in TAVR.”

According to the DelveInsight analysis, “Embolic Protection Devices Market” is anticipated to grow at a significant rate during the forecast period (2022-2027). This is owing to an increase in the prevalence of cardiovascular and neurovascular disorders. For instance, as per the 2022 statistics published by the Brain Aneurysm Foundation, an estimated 6.5 million people in the United States have an unruptured brain aneurysm. The annual rate of rupture is approximately 8 – 10 per 100,000 people. Furthermore, rising demand for minimally invasive procedures and increasing technological advancements in the product arena are also projected to boost the market growth. 

Orthofix Medical Inc. Presented IDE Study Data of M6-C Artificial Cervical Disc at ISASS Annual Meeting

On May 31, 2022, Orthofix Medical Inc., a global medical device company with a spine and orthopedics focus, announced they the company has a five-year data from the M6-C™ artificial cervical disc single-level IDE study. The disc offers an innovative non-fusion solution for treating degeneration of the cervical disc. The M6-C device is an artificial cervical disc that can mimic the structure and movement of a natural disc.

U.S. IDE study results at five years indicate:

  • At five years, patients receiving the M6-C disc experienced a mean NDI improvement from the baseline of 47.5 points compared to 33.4 for the ACDF cohort, significantly better for the M6-C disc group.
  • Statistically significant favorable results were observed in shoulder/arm pain VAS scores at five years, with a mean of 0.5 for M6-C disc study patients and 2.1 for ACDF participants. There was a mean improvement from baseline of 6.8 for M6-C disc patients compared to 5.2 for the ACDF cohort.
  • At the five-year endpoint, the M6-C artificial cervical disc continues to demonstrate one of the lowest Subsequent Surgical Interventions (SSI) rates at 3.1 percent when compared to other FDA-approved artificial cervical discs, suggesting that these rates are consistent with data reported for other FDA approved devices.
  • Through five years post-operative, five M6-C study patients experienced SSIs at the index level. Of the removals, two were performed due to persistent neck and arm pain (with one being replaced by a new M6-C disc,) and one was performed due to bone loss associated with a confirmed infection. In the ACDF cohort, 11 patients underwent SSIs during the five-year postoperative period.

The company announced that the results will be presented on June 3 during the International Society for the Advancement of Spine Surgery (ISASS) annual meeting at The Atlantis Hotel in Nassau, Bahamas. 

Dr. Frank Phillips, Professor of Orthopaedic Surgery at Rush University Medical Center and an investigator in the study said, “We are pleased to see that at five years postoperative, participants in the study who received the M6-C artificial cervical disc continue to show significant benefits in Neck Disability Index (NDI) scores and neck and shoulder/arm pain Visual Analog Scale (VAS) scores compared to patients who received anterior cervical discectomy and fusion (ACDF),.” He even commented: “Additionally, M6-C patients in the study had a low rate of revision surgery compared to the ACDF cohort. Patients in the study will be monitored out to 10 years post-op as we continue to compile the data supporting the efficacy and benefits of cervical disc arthroplasty with the M6-C disc.”

Dr. Avinash Patwardhan, Director of the Musculoskeletal Biomechanics Laboratory at Edward Hines Jr. VA Hospital, added, “Mobility and stability are two essential requirements which allow a spinal segment to function in harmony with its neighboring segments. The M6-C disc, with its inherent progressive resistance to motion provided by the nucleus-annulus design, yielded the highest proportion (103/131 or 79 percent) of implanted segments in the physiological motion range compared to the cohort average of 65 percent. These results support the functional goals of CDA which include restoring segmental range of motion and reducing the risk of accelerated adjacent segment degeneration.”

According to DelveInsight’s ‘Artificial Disc Market” report, the global artificial disc market was valued at USD 1.59 billion in 2021, growing at a CAGR of 11.16% during the forecast period from 2022 to 2027, to reach USD 3.01 billion by 2027. The demand for the artificial disc market is primarily motivated by the increasing number of geriatric patients, rising prevalence of degenerative dis disorders, growing trauma cases, and leg injury. As per the Delveinsight analysis, in the product type segment of the artificial disc market, the lumbar artificial discs account for the highest contributor to the artificial disc market, due to the higher prevalence of lumbar disc degeneration. The rising prevalence of degenerative disc disease and the rising prevalence of obesity accounts for the rising demand for the lumbar artificial disc, thereby propelling the overall market growth of artificial disc in the forecast period (2022 – 2027).