The MYNX CONTROL™ VENOUS VCD adds to Cordis’ range of easy-to-use vascular closure devices. It uses GRIP TECHNOLOGY™ with a hydrophilic, bioinert PEG sealant that absorbs three times faster than collagen sealants and provides the fastest hemostasis of any venous closure device. In a clinical trial comparing it to manual compression during cardiac ablation procedures, MYNX CONTROL™ VCD achieved 100% success. The trial showed it significantly reduced time to hemostasis (2.1 vs. 11.4 minutes), time to ambulation (2.6 vs. 5.14 hours), and time to discharge eligibility (3.1 vs. 5.5 hours), improving hospital workflow.
“MYNX CONTROL™ VENOUS VCD demonstrates Cordis’ commitment to innovation and will offer immediate value to physicians and patients” said Chris Bingham, Vice President, Global Marketing & Strategy at Cordis.“Cordis is building a robust portfolio of products across the coronary, peripheral and closure markets. We look forward to bringing transformative innovation to market, benefitting both patients and physicians.”
As per DelveInsight’s “Vascular Closure Device Market Report,” the global vascular closure device market was valued at USD 1.11 billion in 2023, growing at a CAGR of 6.18% during the forecast period from 2024 to 2030 to reach USD 1.59 billion by 2030. Factors such as the growing prevalence of cardiovascular disorders such as heart strokes, the rising prevalence of risk factors associated with cardiovascular diseases such as obesity and hypertension, the increasing geriatric population, and the surge in the popularity of minimally invasive procedures, are expected to drive the vascular closure devices market.
FDA Cleared Forma Medical’s Optimal Plating System, Enhancing MIS Forefoot Portfolio Growth
On July 9, 2024, Forma Medical Inc., a top innovator in medical devices, announced FDA 510(k) clearance for its new OptimalMTP® Plating System. This approval is a major advancement in minimally invasive surgery, bringing more precision and efficiency to foot and ankle surgeries, a rapidly growing area in the medical device field.
“The FDA clearance of our Optimal Plating System marks a pivotal moment for Forma Medical and the orthopedic community at large,” remarked Chris Cole, VP of Sales at Forma Medical. “We are excited to introduce a transformative platform that not only enhances surgical outcomes but also elevates the standard of care for patients undergoing orthopedic foot and ankle procedures.”
Forma Medical specializes in bunion-related procedures, and with the approval of the OptimalMTP® Plating System, it is well-equipped to meet the changing needs of both surgeons and patients. The company strives to set new standards in minimally invasive surgery by offering customized solutions that improve the efficiency and effectiveness of foot and ankle surgeries.
The Optimal Plating System launch is headlined by OptimalMTP®, the first system for less invasive MTP Fusion of the first ray. This flagship product, along with OptimalHT® and OptimalAkin, demonstrates Forma Medical’s commitment to innovation and patient care. These solutions help surgeons address complex orthopedic problems more efficiently and with less invasiveness compared to standard treatments.
As per DelveInsight’s “Minimally Invasive Surgical (MIS) Devices Market Report, the global MIS devices market was valued at USD 28,873.25 million in 2023, growing at a CAGR of 7.38% during the forecast period from 2024 to 2030, in order to reach USD 42,499 million by 2030. The MIS devices market is witnessing a positive market growth owing to the factors such as rising prevalence of various cancers such as lung cancer which accounted for the highest number of cancer-related deaths and highest cancer incidence in 2023, and other indications such as cardiovascular diseases, and neurodegenerative diseases among others. Furthermore, the presence of factors such as growth in aging population wherein age plays a key role in the development of various indications is another factor driving the growth of the MIS devices market. Moreover, the technological advancements in product development such as the development of surgical robots is further driving the MIS devices market as new products are gaining regulatory approvals and are entering the market.
Virpax Reported Positive Outcomes from Swine Model Pilot Study for Probudur™
On July 10, 2024, Virpax® Pharmaceuticals, Inc., which focuses on non-addictive products for pain, post-traumatic stress disorder, central nervous system disorders, and antiviral barriers, announced the results of a Swine Model pilot study for Probudur. Probudur is a long-lasting liposomal bupivacaine injection for wound sites that provides both immediate and extended pain relief.
“Our study results to date for Probudur, as expected, have consistently been positive and support our belief that Probudur has the potential to provide both immediate relief as well as sustained relief at the wound site,” stated Gerald Bruce, CEO of Virpax Pharmaceuticals. “With our agreement to negotiate additional funding from our new institutional investor, and remaining necessary studies underway, we continue to target the end of the year for filing our Investigational New Drug Application (IND) for Probudur.”
The study of Probudur in the Swine Model focused on its effects and safety. The drug was injected under the skin of four young pigs at a dose of 30 mg/kg. It was well-tolerated by all pigs, showing a slow, long-lasting release. Histopathology at the injection site also confirmed the drug’s safety.
Probudur is being created to reduce or eliminate the use of opioids after surgery in approved cases. It acts as a local anesthetic by blocking pain signals from reaching the brain through sodium channels. In tests before clinical trials, Probudur has effectively controlled pain for at least 96 hours. Studies using a rat model of incisional pain showed pain relief for up to five days, and laboratory studies indicated a gradual release of bupivacaine that lasted up to six days.
According to DelveInsight’s “Pain Management Devices Market Report”, the global pain management devices market was valued at USD 4.86 billion in 2023, growing at a CAGR of 7.90% during the forecast period from 2024 to 2030, to reach USD 7.67 billion by 2030. The demand for pain management devices is primarily motivated by the rise in the prevalence of chronic pain, the high prevalence of musculoskeletal disorders, the surge in the geriatric population, the surge in awareness among people toward pain management devices, improved R&D investment to develop innovative products, and increasing cost of healthcare expenditure.
SetPoint Medical Reported Positive Topline Results from Pioneering RESET-RA Study on Neuroimmune Modulation for Rheumatoid Arthritis
On July 10, 2024, SetPoint Medical, a company focused on treating chronic autoimmune diseases, announced positive results from the RESET-RA study. This study tested the SetPoint System as a new neuroimmune treatment for adults with moderate-to-severe rheumatoid arthritis who don’t respond well to or can’t tolerate traditional disease-modifying anti-rheumatic drugs.
“Despite multiple treatment options, including biologic therapies and oral Janus kinase (JAK) inhibitors, there continue to be challenges and unmet medical needs in managing rheumatoid arthritis,” said David Chernoff, M.D., Chief Medical Officer of SetPoint Medical. “A significant proportion of patients either do not adequately respond to or are intolerant to currently approved treatment options. Approved therapies can also have serious immunosuppressive risks leading to safety concerns, poor patient satisfaction, and low treatment adherence.”
The study achieved its main goal, with significantly more participants in the treatment group reaching an ACR20 response compared to the control group at 12 weeks (p=0.0209). An ACR20 response is a measure of RA treatment effectiveness by the American College of Rheumatology. No safety issues were observed during the first 12 weeks or in long-term follow-up. Adverse event rates were low for both the implant procedure and stimulation therapy. Overall, the treatment was effective and well-tolerated.
RESET-RA is a pivotal trial conducted in two stages, involving multiple centers, and is randomized, sham-controlled, and double-blind. It enrolled 242 patients at 41 sites across the U.S. After reaching the primary endpoint at 12 weeks, the study is now continuing to assess the long-term safety and effectiveness of the device in an open-label extension.
The SetPoint System features an implantable, rechargeable neurostimulation device that stimulates the vagus nerve once a day. This activation of anti-inflammatory and immune-restorative pathways offers a way to treat autoimmune conditions like RA without the risks of immunosuppression that come with drug therapies. After a simple outpatient procedure to place the device, it is programmed to automatically deliver therapy on a set schedule, ensuring better compliance and persistence with treatment.
“We are thrilled with the results from the RESET-RA study as they highlight the potential of the SetPoint System for providing rheumatologists and their patients with a safe and effective treatment alternative to current rheumatoid arthritis therapies,” said Murthy V. Simhambhatla, Ph.D., Chief Executive Officer of SetPoint Medical. “As next steps, we look forward to submitting the data for presentation at upcoming rheumatology and neurosurgical medical meetings, and completing our premarket approval submission to the FDA.”
According to DelveInsight’s “Neurostimulation Devices Market Report”, the global neurostimulation devices market was valued at USD 5.82 billion in 2023, growing at a CAGR of 11.77% during the forecast period from 2024 to 2030, to reach USD 11.34 billion by 2030. The demand for neurostimulation devices is primarily motivated by the increasing incidence of chronic neurological diseases, such as migraine and epilepsy, escalating product demand as add-on therapy, the prevalence of lifestyle diseases such as depression and chronic pain, the adoption of technologically advanced products, and rising geriatric population among others during the forecast period.
Signature Orthopaedics Partnered with THINK Surgical for Robotic Total Knee Arthroplasty
On July 9, 2024, THINK Surgical, Inc., a leading innovator in orthopedic surgical robots, announced a collaboration with Signature Orthopaedics (SignatureOrtho™), an Australian company specializing in orthopedic device design. Through this partnership, THINK Surgical will integrate SignatureOrtho’s advanced knee design into its proprietary ID-HUB™ data bank of implant modules, to be used with the TMINI® Miniature Robotic System.
“We are thrilled to collaborate with THINK Surgical to offer a robotic solution to our customers” said Declan Brazil, Chief Executive Officer of Signature Orthopaedics. “This partnership highlights our dedication to innovation and our responsiveness to customer feedback. Together, we aim to enhance surgical precision and improve patient outcomes through this innovative effort.”
“THINK Surgical is committed to maximizing our implant agnostic platform and we are excited about this new collaboration with SignatureOrtho that will enable even more choice for customers using TMINI,” said Stuart Simpson, President and Chief Executive Officer of THINK Surgical.
THINK Surgical is committed to providing open-platform orthopedic surgical robots that support implants from multiple manufacturers. The addition of the SignatureOrtho knee system to THINK Surgical’s ID-HUB database will allow SignatureOrtho customers access to robotic-assisted technology for total knee replacement. The development of the implant module for use with the TMINI System is in progress.
According to DelveInsight’s “Total Knee Arthroplasty Market Report”, the global knee replacement market size is estimated at USD 11.74 billion in 2023 and is expected to reach USD 14.80 billion by 2024, growing at a CAGR of 4.73% during the forecast period from 2024 to 2030. The demand for total knee arthroplasty is primarily motivated by the increasing incidence of road accidents leading to amputations, increasing prevalence of osteoarthritis & rise in the number of knee injury cases, and technological advancement across the globe during the forecasted period.
Nusano and PharmaLogic Formed Strategic Supply Agreement to Boost Radiopharmaceuticals
On July 10, 2024, Nusano Inc., a company revolutionizing medical radioisotope production, and PharmaLogic Holdings Corp., a top radiopharmaceutical CDMO, announced a supply agreement. This deal ensured a more efficient and reliable supply of essential radioisotopes. Nusano will provide on-demand radioisotopes for pharmaceutical products made in PharmaLogic’s facilities.
“Partnering with innovative companies like Nusano enhances our capabilities to meet the unique needs of our customers,” said James Beatty, vice president of development and commercialization for PharmaLogic. “PharmaLogic is excited to collaborate with Nusano in our shared commitment to quality and advancement in radiopharmaceutical diagnostics and therapies.”
As part of the agreement, Nusano will work with PharmaLogic to establish a radionuclide production schedule before the initial orders are placed, ensuring it meets the needs of PharmaLogic and its customers. The priority radioisotopes include lutetium-177, actinium-225, copper-67, and astatine-211. The companies will review and adjust the supply agreement each year to keep up with the changing demands of the radiopharmaceutical industry.
“Nusano is bringing unparalleled production capacity and flexibility to the market,” said Chris Lowe, CEO of Nusano. “Our proprietary production platform will be capable of making a full menu of radioisotopes of interest to healthcare and up to 12 different isotopes simultaneously. We look forward to working with PharmaLogic and its collaborators to alleviate supply chain pressures so they can focus on advancing new therapies for cancer patients.”
According to DelveInsight’s “Nuclear Medicine/Radiopharmaceuticals Market Report”, the global nuclear medicine/radiopharmaceuticals market was valued at USD 7,203.62 million in 2023 and is estimated to grow at a CAGR of 9.67% during the forecast period from 2024 to 2030 to reach USD 12,495 million by 2030. The nuclear medicine/radiopharmaceuticals market is observing substantial market growth due to the growing prevalence of cancer, cardiovascular, and other chronic diseases owing to the inactive routine. Further, the increasing number of the geriatric population prone to chronic diseases, increasing demand for image-guided procedures and diagnostics across the world, and presence of robust products in the pipeline will propel the demand for nuclear medicine during the forecast period. Additionally, favorable government initiatives to improve access to nuclear medicine and research collaborations and partnerships will also aid in driving the market of nuclear medicine. Likewise, the increasing research & developmental activities along with the surging nuclear medicine approvals and radiopharmaceutical diagnosis device launches, the presence of key players in the market, and other factors will create a requisite for the nuclear medicine/radiopharmaceuticals in the market. Therefore, the market for nuclear medicine/radiopharmaceuticals is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.
