Smithfield BioScience and BioCircuit to Develop New Nerve Tape Device

On March 16, 2022, BioCircuit Technologies, a National Institutes of Health (NIH)-funded medical device company primarily focused on developing and commercializing tissue repair and neural interfacing products, and Smithfield BioScience, a unit of Smithfield Foods delivering life-saving medical solutions from porcine-derived bioproducts, declared that the companies would produce Nerve Tape®, a medical device enabling suture-less nerve repair following traumatic injuries. 

The Nerve tape is an implantable device made of decellularized porcine small intestinal submucosa (SIS) embedded with microscale hooks for tissue attachment and can be quickly and easily wrapped around two ends of a severed nerve to form a strong, reliable connection with distributed tension to promote regeneration.

The technology will allow surgeons to operate faster and achieve precise, reliable rejoining of injured nerves, simplifying the surgical process and improving patient outcomes.

Courtney Stanton, President of Smithfield BioScience, said, “Our work with BioCircuit demonstrates our expanding portfolio and the value we are creating in a variety of markets through Smithfield’s vertically integrated supply chain and manufacturing expertise. By harvesting porcine bioproducts for medical applications – such as organs, mucosa, and tissues – we have the ability to improve lives through the development of innovative pharmaceuticals and medical devices like this one.”

“We look forward to working with Smithfield BioScience to bring this promising medical device solution to life. BioCircuit is committed to developing medical technologies, such as Nerve Tape®, to repair, monitor, and control peripheral nerves precisely and reliably. We’re excited to tap into Smithfield’s exceptional level of traceability and product safety in our work to empower surgeons with powerful, practical clinical tools that improve the treatment of injuries.” said Michelle Jarrard, CEO of BioCircuit Technologies.

According to DelveInsight’s Nerve Repair and Regeneration Market Forecast and Competitive Landscape reportthe global nerve repair and regeneration market was valued at USD 7,774.24 million in 2020 and is anticipated to grow at a CAGR of 9.24% during the forecast period from 2021 to 2026, to reach USD 13,004.44 million by 2026. The increase in demand for nerve repair and regeneration products is predominantly attributed to the increasing incidence of nerve injuries and the rising prevalence of lifestyle disorders such as diabetes and hypertension. Moreover, technological advancements in the nerve repair product portfolio and high product approvals in recent times, among others, are also some of the factors contributing to the global market growth for nerve repair and regeneration. Also, as per the DelveInsight analysis, the biomaterials segment, which is further sub-categorized into nerve conduits, nerve protectors, nerve wraps, nerve connectors, holds the largest market share with 55% of the total market.

Cynosure Entered into Partnership Agreement with Jeisys Medical Japan

On March 18, 2022, Cynosure KK (a subsidiary of Cynosure LLC) has entered into a distribution agreement with Jeisys Medical KK (a subsidiary of Jeisys Medical Inc.) in Japan. Under the terms of the agreement, Jeisys Medical will have exclusive distribution rights for key premier products within Cynosure’s energy-based laser portfolio in Japan.

The partnership expands the footprint between the two companies as Cynosure is currently the exclusive global distributor of Jeisys’ Potenza Radio Frequency Micro-Needling System.

Todd Tillemans, Chief Executive Officer of Cynosure, said, “We are pleased to partner with Jeisys Medical in Japan as they are a world-class company and the Asia Pacific region is a key strategic market. With the combined strengths of Jeisys and Cynosure, we are poised to accelerate our growth and leverage our collective innovation in energy-based aesthetic devices and superior regimens of care. By bringing Jeisys Medical on board, supported by the global resources and reach of Cynosure, we will drive a locally relevant focus, offering customers and patients an exceptional level of innovative solutions in Japan.”

“We are excited to be able to broaden our portfolio in Japan to include the innovative product lines from Cynosure, a global leader in aesthetic medical devices. We look forward to driving growth with this partnership, powered by our local strengths and Cynosure’s global expertise,” commented Ryo Tanaka, President, and Director of Jeisys Medical Japan KK.

According to DelveInsight’s Energy-Based Aesthetic Devices Market” report, the global Energy-Based Aesthetic Devices Market was valued at USD 3.09 billion in 2020 and anticipated to grow at a CAGR of 8.31% during the forecast period from 2021 to 2026, to reach USD 4.96 billion by 2026. The demand for energy-based aesthetic devices is primarily motivated by the increasing number of aesthetically conscious patients in the country, technological advancement in the product line, enhanced accessibility to the aesthetic procedure, rise in geriatric population, and increase in obese population across the globe. Additionally, as per the DelveInsight analysis, in the Energy-Based Aesthetic Devices technology segment, laser-based aesthetic devices are expected to hold the largest market share. This is due to its wide cosmetic applications such as skin tightening, hair reduction, fat destruction, tattoo removal, etc.

bioMérieux Received FDA Approval for its VITEK® MS PRIME new MALDI-TOF Mass Spectrometry Identification System

On March 18, 2022, bioMérieux, a global leader in the field of in-vitro diagnostics, received 510(k) clearance from the US FDA for its VITEK® MS PRIME, a new MALDI-TOF1 mass spectrometry identification system. It is a compact benchtop system designed to maximize laboratory productivity for a more significant impact on patient care. Moreover, it enables routine microbial identification in minutes, delivering faster identification results.

According to the company, after receiving the CE-marking in April 2021, the commercial launch of VITEK® MS PRIME is well underway as planned in many European, Asian, and Latin American countries, extending now to the US and the rest of the world throughout 2022.

Brian Armstrong, Senior Vice President, Clinical Operations, North America, said, “With VITEK® MS PRIME, we provide our U.S. customers with an innovative system that brings greater lab workflow efficiency. Extensive lab input was incorporated into the development of VITEK® MS PRIME so we know the unique and differentiating features like prioritization of urgent samples and continuous “load and go” will be valued.”

Pierre Boulud, Chief Operating Officer, Clinical Operations, said, “We are really pleased to bring this unique system to labs during the Covid-19 pandemic when their need for optimal workflow and efficiency are greater than ever. In just 6 months the adoption rate of customers in Europe has been astounding. Extending access to the U.S. means even more labs can benefit from providing critical information more rapidly to clinicians so more effective antimicrobial therapy is prescribed sooner. Our goal is to empower labs to further improve patient management and play a key role in the fight against antimicrobial resistance.”

According to DelveInsight’s In Vitro Diagnostics Market Forecast and Competitive Landscape report, the global in-vitro diagnostics market was valued at USD 67.82 billion in 2020, growing at a CAGR of 4.17% during the forecast period from 2021 to 2026, to reach USD 86.35 billion by 2026. The in-vitro diagnostics market is estimated to register positive revenue growth owing to the factors such as the rising prevalence of various infectious diseases such as COVID-19, growing prevalence of various cancers, increasing cases of hematological diseases, and increasing product development activities with respect to in vitro diagnostics among others. Furthermore, as per the DelveInsight analysis, the impact of the COVID-19 pandemic resulted in the surge in revenue for the in vitro diagnostics market due to the growing demand for COVID-19-specific tests as well as various self-monitoring and testing kits and products.

FDA Cleared Solus Gold™ Embolization Device Developed by Artio Medical

On March 22, 2022, Artio Medical, Inc., a medical device company focused on developing innovative products for the peripheral vascular, neurovascular, and cardiology markets, received the US Food and Drug Administration (FDA) clearance for its Solus Gold Embolization Device, a next-generation product for peripheral vascular occlusion. 

The device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The delivery system balances flexibility and pushability, enabling physicians to navigate tortuous vasculature. Moreover, the device offers a controlled expansion and simple mechanical detachment and also resists migration and recanalization, providing physicians with a “one-and-done” solution for peripheral vascular occlusion. 

F. Nicholas Franano, MD, President and CEO of Artio Medical, said, “We would like to thank the FDA for providing helpful input to the Artio team through the Q-Submission process, and for the careful and thoughtful review of our 510(k) application. I would also like to thank the talented and dedicated Solus Gold product development team at Artio, our many partners in the industry, and our supportive investors for helping Artio reach this important milestone. When I first learned to embolize vessels using small metal coils more than 20 years ago, I thought surely someone will come up with a better device for doing that. As we prepare for the market release of the Solus Gold device later this year, I am excited to have the opportunity to provide physicians and patients with an improved peripheral vascular embolization experience.

According to DelveInsight’s Peripheral Vascular Devices Market Insights and Competitive Landscape report, the global Peripheral Vascular Devices Market was valued at USD 8.96 billion in 2020, growing at a CAGR of 7.85% during the forecast period from 2021 to 2026, to reach USD 13.42 billion by 2026. The demand for peripheral vascular devices is primarily being boosted by the rapid growth in the prevalence of cardiovascular diseases and peripheral vascular diseases, the approval of new and advanced products, and the rising incidence of lifestyle disorders such as diabetes and hypertension. Furthermore, the increase in the geriatric population is also likely to contribute to the peripheral vascular devices market growth. Also, as per the DelveInsight analyst, among all the regions, North America is expected to amass the largest share in the peripheral vascular devices market. The growing prevalence of cardiovascular diseases, access to better healthcare infrastructure coupled with the presence of major market players in the region are predicted to be the major influencing factors in driving the overall growth of the market over the forecast period.

Heartpoint Global’s Implant System Proves Safety and Efficacy

On March 22, 2022, HeartPoint Global, a medical device company dedicated to improving lives globally by providing disruptive, safer, cost-effective, accessible, and minimally invasive treatments for numerous cardiovascular indications declared another major milestone in the ongoing pre-clinical trials of the HeartPoint Global Implant System (HPGS), a first-of-its-kind patented, adjustable system which focuses on treating devastating left heart diseases, congestive heart failure, and structural pulmonary hypertension. 

The findings from a successful pre-clinical study recently completed in conjunction with Hadassah University Hospital at Lahav CRO, Israel, included:

  • Long-term data proving that the HeartPoint Implant System (HPIS) caused a significant restriction to blood flow and effectively maintained the reduced pressure gradient over the five months of the study.
  • Data proving that even a significant reduction in the pressure gradient did not result in thrombus, blockages, or negative biological responses.
  • The observation of positive structural alterations to the hearts in echo and gross pathology. Maintaining the resulting gradient from the HeartPoint Global Implant System demonstrated septum shift and right ventricle enlargement. This significant pronounced structural change to the heart suggests the ability to target a lower gradient, boosting safety margins for human patients. 
  • The trial also proved that the HPGS could navigate the most torturous curves in vivo, deliver successful deployments, and accomplish stent recapture. Previous successful pre-clinical tests of the implant system studied the direct placement of the device in the main pulmonary artery and the arterial branches and allowed for the adjustment of blood flow in the heart-lung system.

Seth Bogner, Chairman & CEO of HeartPoint Global, said, Providing a treatment for cardiovascular diseases that is both minimally invasive, adjustable at any time, and affordable is of paramount importance. Throughout the pre-clinical testing process, our groundbreaking technology has demonstrated the ability to significantly improve the structure of the heart and the function of the heart-lung system. We are encouraged by the positive results we have seen thus far and look forward to starting our clinical trials imminently.”

As per DelveInsight’s analysis, the Congestive Heart Failure Treatment Devices Market will propel during the forecast period owing to the rising burden of Cardiovascular Diseases (CVDs). Moreover, the increasing geriatric population is also leading to an upsurge in the cases of CVDs and the adoption of sedentary lifestyles, which further increase the chance of CVDs could increase the Congestive Heart Failure Treatment Devices market in the upcoming years.

ObvioHealth Completed First Fully Virtual Urogynecology Clinical Trial

On March 17, 2022, ObvioHealth, a leading global Virtual Research Organization (VRO) delivering end-to-end decentralized clinical trial solutions, announced it has completed the first fully virtual urogynecology study in partnership with the trial sponsor, Renovia, Inc. (Renovia). The trial validated the efficacy of Renovia’s leva® Pelvic Health System on women’s incontinence, a health concern that affects 62% of U.S. adult women.

The study included 350 women, randomized into control and treatment arms, who participated entirely from the comfort of their homes without being required to visit a site. Patients used ObvioHealth’s app to capture real-time data on bladder leaks, reducing recall bias while increasing data accuracy. ObvioHealth’s Virtual Site team helped maintain patient retention by monitoring compliance and engaging with participants to troubleshoot tech issues, answer questions and encourage patients along the journey. The trial had a 93.5% ePRO compliance rate.

Robin Sutherland, Vice President of Human Resources and Clinical Operations at Renovia, commented, “We knew we needed to make the study easy for our patients. Women are commonly a difficult cohort to recruit due to their busy lifestyles, and we had the added stress of launching this trial at the height of the pandemic. This encouraged us to investigate a virtual design. ObvioHealth’s virtual site delivered the support we needed for our patients, and their clinical science team provided expertise without the rigidity of a large CRO.”

Ivan Jarry, CEO of ObvioHealth, said, “This research from Renovia has the potential to help millions of women. Women’s health issues are under-represented in the industry and that simply should not be the case. We have now successfully completed several decentralized trials in women’s health and have carved out an important area of expertise that we are dedicated to serving. We’ve developed best practices for digitization that we’re able to replicate in other women-focused trials, which separates ObvioHealth from other CROs in the market.”

According to the analysis done by DelveInsight, the Urinary Incontinence Devices Market will surge due to the rising prevalence of urinary incontinence cases, the growing aging population prone to urological conditions like urinary tract infections, weakening of pelvic floor, and the development of innovative devices. Moreover, physical problems caused due to conditions including pregnancy, diabetes, menopause, and Parkinson’s disease could also propel the market during the forecasted period.