Vivos Therapeutics Received FDA 510(k) Clearance for its Flagship DNA Oral Appliance for the Treatment of Obstructive Sleep Apnea
On January 4, 2023, Vivos Therapeutics, Inc., a medical technology company focused on developing innovative treatments for patients suffering from dentofacial abnormalities and/or mild-to-moderate obstructive sleep apnea (OSA) and snoring in adults, announced a brand new clearance from the U.S. Food and Drug Administration (FDA) for its proprietary DNA appliance (daytime-night-time appliance).
An entirely new treatment plan for mild-to-moderate OSA has been made possible by the FDA 510(k) clearance of the DNA appliance as a Class II device. This development is made even more significant by the fact that the DNA device for palatal expansion is Vivos’ oldest appliance and is used the most frequently by dentists who have received training from the company. Vivos anticipates that this will make it simpler for people to adopt the DNA for treating OSA.
Current modalities for the treatment of OSA include:
- Continuous positive airway pressure (CPAP). Approximately 50% of patients discontinue the use of CPAP because it is uncomfortable to wear and cumbersome to transport, not to speak of the loud noise that disrupts your partner.
- Mandibular advancement devices (MAD). Some people have issues using appliances that move the jaw forward, causing temporomandibular joint pain and discomfort
- Surgical intervention, including hypoglossal nerve stimulation therapy. Many people simply do not want to undergo anaesthesia or the cost of a surgical procedure.
The DNA appliance has received the most recent FDA clearance, and it now offers a new treatment plan (when used in conjunction with related protocols that are a part of The Vivos Method) that opens the airway by expanding the palate, teaches the tongue to rest in the right position, and switches patients to nasal breathing as opposed to oral breathing. The Vivos Method differs from previous treatments in that it treats the underlying cause of snoring and/or OSA in many people. While the device works well on its own, it can also be combined with other forms of therapy like CPAP or myofunctional therapy.
The clinical data submitted to the FDA as part of the clearance process for the DNA included pre- and post-treatment Apnea Hypopnea Index (AHI) scores obtained with no appliance in the mouth, demonstrating that:
- 28% of patients had their OSA resolved
- 63% of patients improved by one AHI classification (i.e., severe to moderate, moderate to mild, or mild to no OSA)
- 86% of patients improved their airway size
- 97% of patients increased the width of their palate, which allows the tongue to rest in the proper position, thus avoiding a potential airway obstruction
In a study of patient satisfaction with DNA treatment, 97% of patients achieved the desired outcome, while 98% of patients were highly satisfied or very satisfied and likely to recommend the treatment to a friend.
The fact that this new therapy’s effects often endure long after it is finished and may even lead to permanent improvement is another advantage. Vivos DNA efficacy measures were obtained without the device in the mouth, unlike treatments with CPAP or MAD, where the AHI measurements must be taken during active usage of the device to show improvement. Other non-surgical OSA treatments, like CPAP and conventional oral appliances, need to be used every night for life to remain effective.
“This clearance is the culmination of years of pioneering clinical work,” said Kirk Huntsman, Vivos’ Chairman and Chief Executive Officer. Kirk added, “For the first time, the FDA has formally recognized the benefits of our proprietary core technology in our DNA appliance (without mandibular advancement) as an effective treatment for mild-to-moderate OSA in adults. The FDA now joins other international regulatory bodies in recognizing the efficacy of our patented technology in the reduction and resolution of many of the symptoms of OSA that result from a lack of development of the jaws and oral cavity. We believe the DNA treatment can be life changing for many OSA patients, and we look forward to continued market adoption of our expanded menu of treatments for this debilitating condition.”
According to DelveInsight’s “Sleep Apnea Diagnostic Devices Market” report, the global sleep apnea diagnostic devices market was valued at USD 4.89 Billion in 2021, growing at a CAGR of 6.92% during the forecast period from 2022 to 2027 to reach USD 7.30 Billion by 2027. The increase in demand for sleep apnea diagnostic devices is primarily attributed to the rising prevalence of sleep apnea diseases worldwide due to unhealthy lifestyles and excess body weight. Moreover, the increasing number of geriatric population and the increasing prevalence of comorbidities such as hypertension, diabetes, obesity, and cardiovascular diseases will propel the market growth of the device. Additionally, the increasing awareness about the symptoms of sleep apnea across the world is anticipated to bolster the market, thereby contributing to the growth of the sleep apnea diagnostic devices market during the forecast period from 2022-2027.
Chindex Medical Acquired 10 ViewRay MRIdian Systems for Advanced Cancer Treatment
On January 5, 2023, ViewRay, Inc. announced that Chindex Medical Limited (Chindex), through its subsidiary, has ordered 10 MRIdian MR-Guided Therapy Systems. Chindex, a subsidiary of Shanghai Fosun Pharmaceutical Co., Ltd., has been ViewRay’s distribution partner since 2019.
MRIdian received regulatory approval in September 2022 from the National Medical Products Administration (NMPA), allowing for its sale and utilization throughout China. This approval expands MRIdian’s global reach and offers cancer patients a new radiation therapy option, MRIdian Stereotactic MRI-Guided Adaptive Radiotherapy (SMART).
With the patient on the table, the MRIdian system gives doctors exceptional anatomical visualization through diagnostic-quality MR images and the capacity to modify a radiation therapy plan for the targeted cancer. This combination enables the delivery of ablative radiation doses in five or less treatment sessions without relying on implanted markers, allowing doctors to establish tight treatment boundaries to prevent needless radiation exposure of fragile organs-at-risk and healthy tissue.
MRIdian permits automatic radiation beam gating if the target wanders outside the user-defined margins by providing continuous real-time tracking of the target and organs in danger. This reduces toxicities generally associated with conventional radiation therapy by enabling the administration of the specified dose to the target while protecting nearby healthy tissue and important structures.
“The integration of a ground-breaking radiation therapy system that’s guided by MRI is key to remaining at the forefront of personalized cancer care,” said Marie Li, CEO of Chindex. Marie Li also said, “MRIdian will allow physicians to offer a leading-edge, state-of-the-art technology to address the increasing burden of cancer prevalence in China.”
“We are excited to deepen our Fosun Pharma relations by announcing this level of commitment from our partners at Chindex,” said Scott Drake, the president and CEO of ViewRay. Drake added, “Chindex is focused on driving innovation and challenging the status quo of radiation oncology in China, bringing MRIdian’s advanced technology to a deserving patient population.”
According to DelveInsight’s “Radiotherapy/Radiation Oncology Devices Market” report, the global radiotherapy/radiation oncology devices market is projected to grow at a 7.78% CAGR during the forecast period (2022-2027). The radiotherapy/radiation oncology devices market is witnessing a positive growth owing to the factors such as the rising cases of various cancers, rapid technological developmental activities, strong R&D initiatives from key players, rising adoption of radiotherapy procedures in cancer treatment, growing demand for minimally invasive procedures, thereby contributing to the growth of the radiotherapy/radiation oncology devices market during the forecast period from 2022-2027.
Zimmer Biomet to Acquire Embody, Inc.
On January 5, 2023, Zimmer Biomet Holdings, Inc., a global medical technology leader, announced that it has reached a definitive agreement to acquire Embody, Inc., a privately-held medical device company focused on soft tissue healing, for $155 million at closing and up to an additional $120 million subject to achieving future regulatory and commercial milestones over a three-year period. The acquisition is expected to be accretive to overall revenue growth and slightly dilutive to adjusted earnings per share in 2023.
The acquisition includes Embody’s entire line of collagen-based bio-integrative solutions, including one of the first arthroscopic implant systems for rotator cuff repair, TAPESTRY RC, and the bio-integrative implant TAPESTRY for tendon healing. These solutions support healing in even the most difficult orthopaedic soft tissue injuries.
The transaction is subject to customary closing conditions and is expected to be completed in February 2023.
Bryan Hanson, Chairman, President and CEO of Zimmer Biomet, said, “Embody’s differentiated products and innovative pipeline in the area of sports medicine support our continued focus on and investment in high-growth markets and underscores our commitment to bringing meaningful new advances to patients and surgeons.” Bryan further said, “The planned acquisition of Embody is an important step in the ongoing transformation of ZB and the execution of our strategic priority to increase long-term growth and drive value creation.”
“We are excited for the potential to create value for patients and customers in new ways and believe the combination of Embody’s innovative products and Zimmer Biomet’s established portfolio will bring new solutions to the market that could redefine the standard of care,” said Jeff Conroy, Chief Executive Officer of Embody.
According to DelveInsight’s “Orthopedic Devices Market” report, the global orthopedic devices market was valued at USD 44.09 billion in 2021, growing at a CAGR of 4.78% during the forecast period from 2022 to 2027 to reach USD 57.79 billion by 2027. The orthopedic devices market is slated to witness increasing revenue owing to factors such as a growing population of people above the age of 65, rising cases of bone disorders such as osteoarthritis and osteoporosis, among others, increasing cases of occupational and non-occupational injuries along with the latest technological developments in healthcare technology is further expected to result in the appreciable revenue growth in the orthopedic devices market during the forecast period (2022-2027).
Glaukos Announced Positive Results for iDose TR Exchange Trial, Highlighting Favorable Safety and Tolerability
On January 10, 2023, Glaukos Corporation, an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, announced positive results for a prospective, multi-center clinical trial designed to evaluate the safety of the surgical exchange procedure for iDose TR (travoprost intraocular implant) in subjects who had previously been administered an iDose TR in the Phase 2b clinical trial, referred to as the exchange trial.
The iDose TR contains a unique formulation of travoprost, a prostaglandin analog used to reduce intraocular pressure, and is administered via a micro-invasive technique. The iDose TR is intended to be withdrawn once all the travoprost has been released and replaced with a new iDose TR, potentially providing a drop less alternative to daily eye drop therapy.
The exchange trial’s findings showed that removing the original iDose TR implant and administering a second dose of iDose TR were both safe and well-tolerated, with the second dose of iDose TR showing a good safety profile during a 12-month evaluation period.
Furthermore, no individual in the exchange study demonstrated a loss of endothelial cells higher than 30% over the lengthy evaluation period of, on average, more than five years. The positive exchange trial data set will be included in Glaukos’ next New Drug Application (NDA) filing to the U.S. Food and Drug Administration (FDA), which is planned for the first quarter of 2023.
Based on an agreement with the FDA, the exchange trial was created to assess the viability and safety of a surgical exchange procedure for iDose TR in patients who had previously received the medication as part of the Phase 2b clinical trial. In the trial 33 participants in total were enrolled, and 32 of them (97.0%) finished the experiment. The exchange operation for the second implant in the exchange trial took place on average 4.2 years after the administration of the first implant in the Phase 2b experiment. Following the second implantation cycle, the exchange trial participants were then monitored for an additional year, for a total prolonged evaluation time that averaged 5.2 years.
The initial implant from the first implantation cycle was gripped and removed by the surgeon during the exchange operation using the pre-loaded injector. The fresh implant was then implanted and secured into the sclera at least one clock hour distant.
“We are pleased to clinically confirm the iDoseTR exchange procedure is safe and facile. We look forward to including these positive data in our upcoming NDA submission to further support the safety and tolerability of redosing iDose TR patients over time,” said Thomas Burns, Glaukos chairman and chief executive officer. Thomas also said, “We continue to believe iDose TR can be a transformative novel technology able to fundamentally improve the treatment paradigm for patients with glaucoma.”
As per DelveInsight’s “Glaucoma Drainage Devices Market” report, the global glaucoma drainage devices market was valued at USD 640.57 million in 2021, growing at a CAGR of 11.95% during the forecast period from 2022 to 2027, to reach USD 1,184.39 million by 2027. 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 during the forecast period from 2022 – 2027.
Arthrex Received FDA Clearance for TightRope Implant as First, Only Device Cleared for Pediatric ACL Surgery
On January 10, 2023, Arthrex, a global leader in minimally invasive surgical technology, announced its ACL TightRope implant has received clearance from the U.S. Food and Drug Administration (FDA) for pediatric indications.
The TightRope implant is used in the surgical treatment of orthopaedic injuries and is the first and only fixation device for anterior cruciate ligament (ACL) injuries cleared for pediatric use. The Arthrex ACL TightRope portfolio of fixation devices includes the ACL TightRope II implant, the TightRope attachable button system (ABS) and implant, the FiberTag® TightRope implant and the ACL Repair TightRope implant with FiberRing™ sutures.
When repairing or reconstructing the ACL, the Arthrex all-epiphyseal approach avoided the pediatric growth plates and was created for patients with skeletal immaturity. In order to reduce the possibility of growth disruption, surgeons drill sockets for the new, rebuilt ACL while avoiding the growth plate using pediatric-specific equipment guidance.
Surgeons will drill across the growth plates in older adolescent patients who are nearing skeletal maturation in order to repair the ACL using an all-soft-tissue autograft. In comparison to hamstring autografts, quadriceps autografts have been proven to produce better results in this young athlete population, with lower revision rates and higher rates of return to sport.
“For more than a decade, Arthrex has worked closely with leading orthopaedic surgeons from HSS to develop minimally invasive solutions for pediatric and young adolescent ACL surgery,” said Arthrex President and Founder Reinhold Schmieding. Reinhold added, “We are proud to partner with surgeons from the Hospital for Special Surgery to design treatment options specifically for ACL injuries in younger patients. This is a significant achievement in orthopaedic surgery and another testament to Arthrex’s dedication to its mission of Helping Surgeons Treat Their Patients Better™, starting from an early age.”
“The expansion of Arthrex’s knee ligament portfolio to include pediatric- and young-adolescent-specific instrumentation and implants, along with the new indications cleared by the FDA, represents a substantial improvement on existing treatment options in this high-risk population of athletes,” said Dr. Cordasco.
“These pediatric and young adolescent-specific guides help surgeons address the young athlete’s unique anatomy, greatly enhancing surgical options for reconstruction and epiphyseal fixation for ligamentous reconstruction or avulsion injury repair,” said Dr. Green.
According to DelveInsight’s “Orthopedic Digit Implants Market” report, the global orthopaedic digit implants market was valued at USD 92.34 million in 2021, growing at a CAGR of 6.50% during the forecast period from 2022 to 2027 to reach USD 134.53 million by 2027. The increase in demand for orthopaedic digit implants is primarily attributed to the increasing geriatric population worldwide and the rising prevalence of rheumatoid arthritis. Additionally, the increasing number of orthopaedic conditions will propel the market growth of orthopaedic digit implants. Further, the rising demand for minimally invasive operations across the world are anticipated to bolster the market, thereby contributing to the growth of the orthopaedic digit implants market during the forecast period from 2022-2027.
GE HealthCare to Buy France’s IMACTIS in First Acquisition as Independent Firm
On January 9, 2023, GE HealthCare announced it had entered into an agreement to acquire IMACTIS, an innovator in the rapidly growing field of computed tomography (CT) interventional guidance across an array of care areas. IMACTIS is a France-based company that was founded in 2009 by Stephane Lavallee and Lionel Carrat, who created CT-Navigation, an ergonomic universal solution that provides stereotactic needle guidance, enabling intuitive pre-planning and continuous control throughout a wide range of procedures, from diagnosis to treatment.
The IMACTIS purchase gives GE HealthCare access to this expanding market for CT interventional guidance in the worldwide interventional radiology market. While the current emphasis of this breakthrough is CT, GE HealthCare intends to use it to advance its image guided therapy (IGT) business. The demand for interventional guidance is also rising as a result of the expanding requirement in a variety of medical specialties, including oncology, cardiology, urology, nephrology, and gastrointestinal.
The IMACTIS CT-Navigation, which comprises an integrated workstation, guidance software, and a disposable procedure kit, has FDA authorization for usage in the United States and is currently approved under the Medical Devices Regulation (MDR) of the European Union. Since GE HealthCare is a market leader in CT and has a sizable installed base around the world, there are numerous prospects for the IMACTIS CT-Navigation system at current client locations.
The completion of the deal is subject to the usual closing requirements, including approval by the relevant French government agencies. The transaction’s financial information has not been made available to the public. This transaction will be paid for with cash on hand, according to GE HealthCare.
“We’re thrilled to take this step in strengthening our interventional guidance offering for patients and customers,” said Jan Makela, President and CEO of Imaging, GE HealthCare. Jan Makela further said, “The IMACTIS CT-Navigation system is designed to improve workflow for interventional radiologists and hospitals by increasing procedural accuracy, while helping to reduce procedure time and radiation dose for patients and physicians. It is an innovative navigation solution for image-guided percutaneous procedures that aims for better patient outcomes, by reducing variability for simple and complex procedures and improving reproducibility.”
Pierre Olivier, President and CEO of IMACTIS, said, “The timing to join GE HealthCare is perfect.” Olivier added, “Our solution, which is already deployed in leading healthcare systems in Europe and the U.S., is ready to scale and become a standard of care, thanks to GE HealthCare’s market access. Our product development team also sees significant opportunities to integrate our hardware and software into GE HealthCare solutions and make the workflow of the interventional radiologists and oncologists even simpler and faster.”
According to DelveInsight’s “Computed Tomography (CT) Devices Market” report, the global computed tomography (CT) devices market was valued at USD 6.13 billion in 2021, growing at a CAGR of 6.36% during the forecast period from 2022 to 2027 to reach USD 8.87 billion by 2027. The computed tomography (CT) devices market is witnessing positive growth owing to the rising incidence of severe chronic diseases such as cardiovascular, oncology, and others. Further rapid technological developmental activities, growing awareness for early detection, and the increasing incidences of the aging population, thereby contributing to the growth of the computed tomography (CT) devices market during the forecast period from 2022-2027.