Enovis completed the acquisition of Novastep

On June 29, 2023, Enovis, one of the largest orthopedic device companies in the world, announced that the company had completed the purchase of Novastep and its foot and ankle minimally invasive surgical (MIS) platform, which was first announced in April 2023. 

The acquisition of Novastep has allowed Enovis to strengthen its position in the growing bunion segment with its MIS bunion system, Pecaplasty, which accelerates US growth. 

In addition, Novastep’s portfolio of CE-marked forefoot and midfoot implants and outside-the-US channels further the company’s international strategy.

The financial terms of the deal were undisclosed. 

“We are excited to welcome Novastep’s talented team to Enovis, where we will work together to develop the next generation of foot and ankle solutions that improve patient outcomes,” commented Enovis CEO Matt Trerotola. 

As per DelveInsight’s Foot and Ankle Devices Market” report, the global foot and ankle devices market was valued at USD 5.94 billion in 2022, growing at a CAGR of 7.69% during the forecast period from 2023 to 2028 to reach USD 9.26 billion by 2028. Factors such as the rising demand for the prevalence of bone-related disorders, rising number of diabetes-related complications, increasing geriatric population, rising number of accident and trauma cases, the rising number of sports-related injuries, and the increasing focus on developing technologically advanced devices are expected to drive the foot and ankle devices market.

Rockwell Medical Announced 3-Year Co-Promotional Collaboration with B. Braun Medical

On June 29, 2023, Rockwell Medical, Inc., a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, entered into a three-year co-promotion services agreement with B. Braun Medical Inc., a leader in renal therapies including innovative, high-quality products for hemodialysis.

Under the agreement, B. Braun has been designated as an independent, non-exclusive representative to promote the hemodialysis concentrates products of Rockwell Medical to dialysis providers in the United States, concertedly on the west coast. 

Rockwell Medical has set up the terms of the sale of any of its products, including price, delivery schedule, and terms and conditions, at the Company’s sole discretion. All orders will be directed to and processed by Rockwell Medical. B. Braun will receive a fee for any sales generated by its promotional efforts.

“This co-marketing and sales arrangement with B. Braun represents a significant commercial opportunity for Rockwell Medical that immediately connects us to a new customer base we wouldn’t be able to reach otherwise,” commented Tim Chole, Senior Vice President, Sales and Marketing at Rockwell Medical. Tim added, “We are excited to collaborate with B. Braun to augment our commercial efforts. B. Braun’s national sales organization will enable us to generate new business leads and integrate our hemodialysis concentrates products into B. Braun’s robust portfolio of renal care products. Now, B. Braun’s sales team will be able to introduce Rockwell Medical’s complementary products to new customers as part of a complete portfolio, ultimately providing a positive impact on the lives of more hemodialysis patients.”

Jonathan Stapley, Senior Director of Marketing, Active Devices at B. Braun, said, “We are pleased to align with Rockwell Medical to promote their hemodialysis concentrate products.” Jonathan further mentioned, “This ensures we can supply our providers and the patients they serve with a broader range of high-quality hemodialysis products.”

 According to DelveInsight’s Haemodialysis Machines Market” report, the global hemodialysis machines market was valued at USD 13.53 billion in 2022, growing at a CAGR of 4.71% during the forecast period from 2023 to 2028 to reach USD 17.78 billion by 2028. The increase in demand for haemodialysis machines is primarily attributed to the increasing prevalence of kidney disorders such as end-stage kidney disorder, kidney failure, and others. In addition, constantly increasing old population, high blood pressure, and high diabetes prevalence is also driving factor for haemodialysis machines, as old age and diabetic people are more likely to develop kidney disorders. Moreover, technological advancement in the haemodialysis machines product pipeline and an increase in product approvals are among the other factors responsible for the growth of the global haemodialysis machines market during the forecast period from 2023 to 2028.

Dexcom G7 Received Health Canada Approval for Next-Generation Continuous Glucose Monitoring System with Unmatched Accuracy Coming to Canadians

On July 4, 2023, Dexcom, Inc., a global leader in real-time continuous glucose monitoring (rtCGM) for people with diabetes, announced that Health Canada had approved the next-generation Dexcom G7 Continuous Glucose Monitoring System for people with all types of diabetes, ages two years and older. 

Dexcom G7 delivers a strong yet simple method for people to get greater control of their diabetes and manage it more confidently. Its low-profile, all-in-one sensor and transmitter warm up twice as quickly as any other CGM on the market, allowing users to view real-time glucose readings relayed automatically to their compatible smart device or receiver, eliminating the need to scan or prick their finger regularly. 

Dexcom G7 comes with a suite of customizable alarms that may warn of high or low glucose levels with a predictive urgent low alert to assist in avoiding potentially dangerous hypoglycemia situations and can help users spend more time in range. Users can also share data with family, loved ones, and care teams from any location through industry-leading remote monitoring and reporting capabilities.

The Dexcom G7 has the following features and enhancements: 

  • The smallest Dexcom sensor ever with multiple approved wear locations for more comfortable and discreet wear
  • An all-in-one sensor and transmitter, simplifying the entire CGM system and experience
  • 30-minute sensor warm up, two times faster warmup than any other CGM for a quick, simple start 
  • A 12-hour grace period to replace finished sensors for a more seamless transition between sessions, offering more convenience and flexibility to users
  • Improved alert customization to meet individual user needs and preferences
  • Redesigned and simplified mobile app with Dexcom Clarity integration

The company is also actively working with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems.

The Dexcom G7 will be available to Canadians living with diabetes by the end of 2023.

André Côté, Vice President and General Manager of Dexcom Canada, said, “For more than two decades, Dexcom has had a singular focus on sensor technology, consistently working to evolve our CGM systems by listening to the needs of people with diabetes and their caregivers, making diabetes management easier for people around the world.” André added, “With our latest advancements in sensor technology and software integrations, we’re entering a new era of diabetes care with continuous glucose monitoring at the center. Dexcom G7 builds on the innovation that our previous CGM systems have brought to the lives of Canadians. With greater accuracy, a simplified user experience, proven results, and extensive digital connectivity, our next-generation Dexcom G7 will support greater quality of life and improved outcomes for people with diabetes, and we couldn’t be more excited to bring it to Canada by the end of 2023.”

“Real-time continuous glucose monitoring (rtCGM) has become the standard of care for many people living with diabetes, with clinical evidence supporting its effectiveness for reducing A1C, increasing time spent in the target glucose range, reducing the number of low glucose events and reducing the time spent with dangerous low glucose,” said Alice Cheng, Endocrinologist at Trillium Health Partners, Credit Valley Hospital and St. Michael’s Hospital (Unity Health Toronto). Alice commented, “With approval of Dexcom G7, the newest glucose sensor to come to Canada, patients will have a new, simple to start and easy to use tool in their diabetes management toolbox to effectively manage their diabetes and make important health decisions backed by health data and proven results.”

According to DelveInsight’s Blood Glucose Monitoring Systems Market” report, the global blood glucose monitoring systems market was valued at USD 13.06 billion in 2022, growing at a CAGR of 7.72% during the forecast period from 2023 to 2028, to reach USD 20.40 billion by 2028. The escalating demand for blood glucose monitoring systems is predominantly attributed to the increasing prevalence of diabetes among the population across the globe and the growing burden of the geriatric population who are susceptible to developing hyperglycemia. In addition, the spike in technologically advanced blood glucose monitoring devices, product launches, and government initiatives to raise awareness regarding proper diabetes management, among others, are the factors likely to spur the global blood glucose monitoring systems market.

Abbott Received the US FDA Approval for World’s First Dual Chamber Leadless Pacemaker

On July 5, 2023, Abbott announced that the US Food and Drug Administration (FDA) has approved the company’s AVEIR™ dual chamber (DR) leadless pacemaker system, which is the world’s first dual chamber leadless pacing system that treats people with abnormal or slow heart rhythms.

Based on the person’s clinical requirements, AVEIR DR devices provide synchronized or coordinated cardiac pacing between two leadless pacemakers using Abbott’s own proprietary i2i™ communication technology. 

The i2i technology uses high-frequency pulses to transmit information between each leadless pacemaker using naturally conductive characteristics of the body’s blood. Each implant converses beat-to-beat with a paired, co-implanted device to allow dual-chamber therapy. Because it consumes significantly less battery power than inductive, radio-frequency, or Bluetooth® communication, which are other alternatives used in implantable medical devices or traditional pacemakers, conductive communication is crucial. 

The AVEIR DR leadless pacing system, which is about one-tenth the size of a conventional pacemaker, consists of two devices: the right atrium-pacing AVEIR AR single chamber device, which has just received approval, and the previously approved AVEIR VR single chamber device, which paces the right ventricle. 

Leadless pacemakers do not require cardiac leads because they are placed into the heart directly through a minimally invasive procedure. Leadless pacemakers, therefore, offer a less constricting and quicker healing period following implantation, and they lessen people’s exposure to potential lead and infection-related issues. 

Following recent late-breaking clinical results that showed that the AVEIR DR system satisfied its three prespecified primary objectives for safety and efficacy and was published in The New England Journal of Medicine, the FDA has approved the AVEIR DR dual chamber leadless pacemaker system. According to data from the AVEIR DR i2i Investigational Device Exemption (IDE) study, three months after implant, 98.3% of patients had successful atrioventricular synchrony, meaning that the upper and lower chambers were beating normally despite various types of underlying slow heart rhythms. 

Each AVEIR pacemaker is installed via a minimally invasive method and is shorter, smaller, and slimmer than an AAA battery. When the necessity for therapy changes or the device needs to be replaced in the future, the device can be removed from the internal surface of the heart using a screw-in mechanism called a helix. The AVEIR DR system is also made to offer real-time pacing analysis, allowing doctors to check the device’s positioning both during the surgery and before implanting it inside the heart chamber.

“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual chamber leadless pacing to that list of achievements,” said Vivek Y. Reddy, M.D., director of cardiac arrhythmia services for the Mount Sinai Hospital and the Mount Sinai Health System. Vivek added, “In delivering a true dual-chamber leadless pacemaker system, Abbott is expanding access to the benefits of leadless pacing to far more people than ever before and providing additional options to improve our ability to treat people with slow or abnormal heart rhythms.”

According to DelveInsight’s “Pacemakers Market” report, the global pacemakers market was valued at USD 4.88 billion in 2022, growing at a CAGR of 5.85% during the forecast period from 2023 to 2028, to reach USD 6.84 billion by 2028. The demand for pacemakers is primarily motivated due to the rise in cardiovascular diseases (CVDs), superior treatment outcomes of sudden cardiac arrests, and growing technological advancements, among others during the forecast period.

Elios Vision Completed Enrollment in Pivotal Trial of ELIOS® procedure for Glaucoma

On June 28, 2023, Elios Vision Inc., an ophthalmic device company focused on preserving vision by increasing micro-invasive glaucoma surgery (MIGS) adoption, announced the completion of enrollment for its pivotal trial involving 300 patients with mild to moderate glaucoma treated with the ELIOS® procedure in combination with cataract surgery. 

Instead of using an implant ELIOS is based upon the utilization of next-generation excimer laser technology for the treatment of glaucoma. 

The company has already built significant traction in Europe, where the technology has a CE mark and is indicated for the treatment of glaucoma with or without cataract surgery. 

S. Arieh Zak, Elios Vision Senior VP, Regulatory/Clinical/Quality, said, “This is a key milestone in our clinical plans as we bring the ELIOS procedure one step closer to patients suffering from glaucoma, a leading cause of blindness.” Arieh added, “We are grateful to our clinical investigators and the internal team’s combined dedication and diligence, and we look forward to our FDA marketing submission in the U.S.”

“Completing enrollment of our U.S. clinical trial marks a significant milestone on our journey to advancing the global standard of care in glaucoma,” commented Elliot Friedman, Elios Vision Chairman and CEO. Elliot further added, “In Europe, we are already seeing that the ELIOS technology has the profile to reach the thousands of glaucoma and cataract surgeons currently performing cataract surgery but not providing MIGs to their glaucoma patients. Our world-class team and KOLs in Europe and the U.S. allow Elios Vision to establish a significant next-generation MIGS treatment that is implant-free, preserves tissue, and has many independent clinical studies demonstrating the powerful efficacy and safety that you would expect from an excimer laser treatment.”

According to DelveInsight’s “Glaucoma Drainage Devices Market” report, the global glaucoma drainage devices market was valued at USD 640.57 million in 2022, growing at a CAGR of 11.95% during the forecast period from 2023 to 2028, to reach USD 1,184.39 million by 2028. The increase in demand for glaucoma drainage devices is primarily due to the rising prevalence of glaucoma across the globe, increasing lifestyle disorders such as diabetes & hypertension, the growing burden of the old age population, and technical innovation in product development are expected to boost the market for glaucoma drainage devices.

First Patient Enrolled in the Synergy Disc® 2-Level IDE Trial

On June 29, 2023, Synergy Spine Solutions Ltd, an innovative orthopedic medical device developer focused on artificial cervical disc replacement, announced that the first patient was enrolled in the company’s IDE 2-Level clinical trial, which aims to evaluate the safety and effectiveness of the Synergy Disc® artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of degenerative disc disease in subjects that are symptomatic at two contiguous vertebral levels from C3 to C7.

The multi-center, prospective, non-randomized, historically controlled trial expects to enroll up to 200 patients at up to 25 sites. 

Every patient in the trial will receive the Synergy Disc, and they will be evaluated preoperatively, at the time of surgery, immediately following surgery, at six weeks, and three, six, 12, and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up. 

Josh Butters, CEO of Synergy Spine Solutions, said, “This is an exciting year for the entire Synergy team and is a direct result of the hard work and incredible support from our employees, consultants, founders, directors, and shareholders. Beginning our 2-Level trial on the heels of completing enrollment in the 1-Level trial is another significant advance in our US market access pathway and puts us further down the path towards realizing our mission of expanding the surgeons and patients that have access to the Synergy Disc technology. I am eager to evaluate the results of our 2-Level trial, as the design of the Synergy Disc was specifically created to address the complexities associated with alignment, stability, and balance in multi-level artificial disc replacement.” 

Dr. David Musante, a neurosurgeon in Raleigh-Durham, North Carolina, commented, “Initiation of the 2-Level clinical trial is an important and essential milestone for the Synergy Cervical Disc. In the real-world setting, I am performing two-level procedures as frequently, if not more frequently, than one-level procedures. Having had the opportunity to participate in the single-level trial, I am looking forward to beginning this natural next step. In a two-level replacement, there is potentially more opportunity to see the benefits of restoring lordosis and maintaining physiologic motion. My hope is the Synergy Disc design, with its lordotic option and unique articulation, will improve these variables and enhance outcomes.” 

“I perform more two-level procedures than one-level procedures and look forward to seeing the benefits of sagittal alignment and balance provided by the unique lordotic core in the Synergy Disc.” commented Dr. Dan Peterson, a neurosurgeon in Austin, Texas, who also participated in the 1-Level trial, has just performed the first 2-Level Synergy Disc case in the US.”

According to DelveInsight’s “Artificial Disc Market” report, the global artificial disc market was valued at USD 1.59 billion in 2022, growing at a CAGR of 11.16% during the forecast period from 2023 to 2028 to reach USD 3.01 billion by 2028. The artificial disc market is slated for positive market growth owing to factors such as the increasing geriatric population, rising prevalence of degenerative disc disorders, growing number of trauma cases & sports-related injuries, and increasing product development activities, among other factors.