Suneva Medical Inc. inked a merger agreement with Viveon Health
On January 12, 2022, Suneva Medical Inc., a leading regenerative aesthetics company, and Viveon Health Acquisition Corp., a particular purpose acquisition company, entered into a definitive merger agreement to establish a new regenerative aesthetics company. The pro forma equity valuation of the combined company is anticipated to be about $511 million. Under the agreement, 25 million shares will be issued to Suneva’s current security holders by Viveon Health. Also, in the five years following the completion of the transaction, the Suneva security holders may receive up to 12 million earn-out shares. In addition, the proposed business combination is expected to be completed in the first half of 2022.
Pat Altavilla, Chief Executive Officer of Suneva, said that they are excited to partner with Viveon Health as they step into the next growth phase as a leader in the regenerative aesthetics sector, bolstering the requirements of physicians and patients looking for proven and validated innovations. Their journey to this point has been paved with product innovation and clinical education led by an experienced team, which brings a proven track record of sales growth and market development.
Jagi Gill, Chief Executive Officer and Chairman of Viveon Health, said that as an operator-run SPAC, Viveon was zeroed in on recognizing best-in-class management, which possessed the skills and execution plan to offer robust revenue growth. The merger with Suneva shows their confidence in their category-leading product portfolio and experienced management team to deliver on the next wave of growth in regenerative aesthetics. Their sales channel development and operational background offer natural synergies with the Suneva team as they collectively grow the business and need shareholder value.
According to DelveInsight’s ‘Energy-Based Aesthetic Devices Market & Competitive Landscape”, the global Energy-Based Aesthetic Devices market was worth USD 3.09 billion in 2020, increasing at a CAGR of 8.31% during the study period from 2021 to 2026, touching USD 4.96 billion by 2026. The need for energy-based aesthetic devices is due to the growing number of aesthetically conscious patients in the country, technological advancement in the product line, improved accessibility to the aesthetic procedure, increase in geriatric population, and rise in obese people globally. Moreover, as per the DelveInsight analyst, laser-based aesthetic devices are anticipated to hold a significant market share because of their wide cosmetic applications such as skin tightening, hair reduction, fat destruction, and tattoo removal, among others.
Promising results from Abiomed’s preCARDIA technology in early proof of concept study
On January 12, 2022, Abiomed declared successful and promising results from the first-in-human use of the preCARDIA system in early proof of concept study. The system is intended to improve decongestion through intermittent occlusion of the superior vena cava in patients suffering from acute congestive heart failure (ADHF). The study results were published in the Journal Circulation: Heart Failure. The use of preCARDIA is limited to research purposes by US federal law as it is an investigational device.
Navin Kapur, MD, lead author of the study and executive director of the CardioVascular Center for Research and Innovation at Tufts Medical Center, commented that the study met safety and feasibility endpoints and showed the preCARDIA potential for the first time to quickly decrease cardiac filling pressure and rise urinary output through intermittent superior vena cava occlusion in acute congestive heart failure patients.
The VENUS-HF multi-center, prospective, single-arm early proof of concept study assessed 30 patients with acute congestive heart failure treated with preCARDIA for 12 or 24 hours. The primary endpoint results were as follows:
- No device- or procedure-related serious adverse events in 100% of patients (n=30/30)
- Successful placement, activation, and removal of preCARDIA in 97% of patients (n=29/30)
- 34% reduction in right atrial pressure from baseline (p<0.001)
- 27% reduction in pulmonary capillary wedge pressure (PCWP) from baseline (p<0.001)
- 130% increase in urine output over pre-treatment values (p<0.01)
- 156% increase in net fluid elimination over pre-treatment values (p<0.01)
According to DelveInsight’s ‘Congestive Heart Failure Market”, the total Diagnosed Prevalent Cases of Heart Failure in the 7MM was found to be 12,602,028 in 2020, which is anticipated to increase during the study period (2018-2030). Moreover, as per the DelveInsight analyst, the age-specific diagnosed prevalent cases are seen maximum in the age group of 75–84 (1,607,918) and lowest in <44 (155,410) in 2020, this is because of the progressive aging of the population and enhanced and better survival after cardiac insults, such as myocardial infarction, especially in developed countries.
Medtronic declared promising results for using DTM™ Spinal Cord Stimulation endurance therapy in meaningful pain relief
On January 14, 2022, Medtronic plc, a leading healthcare technology company, declared three-month results from an on-label, prospective, multi-center study which showed meaningful pain relief in patients suffering from chronic overall, back or leg pain by using DTM™ SCS endurance therapy, a modified, lower-energy variation of the company’s Differential Target Multiplexed™ (DTM) Spinal Cord Stimulation (SCS) therapy. The therapy reported meaningful pain relief as measured by a 3.9 cm reduction in overall pain on the 10 cm Visual Analog Scale (VAS). In addition, there was an average 4.3 cm and 5.0 cm decrease in back pain and leg pain, respectively.
Dr. Kasra Amirdelfan, director of Clinical Research at IPM Medical Group, Inc. and principal investigator on the DTM-LE Trial, commented that these 3-month results are highly encouraging, as they show that the DTM SCS endurance therapy may be able to offer effective pain relief while dosing at lower energy than other SCS waveforms. This may enhance device longevity and proffers therapy validation for the patients who would need it.
Charlie Covert, vice president, and general manager, Pain Therapies within the Neuromodulation business, part of the Neuroscience Portfolio at Medtronic, said that every chronic pain patient has their own unique needs, and Medtronic is committed to proffering solutions that personalize care for their patients. For many, especially those who require or prefer a recharge-free SCS solution, their new DTM SCS endurance therapy delivers meaningful clinical benefits by decreasing pain, enhancing the quality of life, and providing significant device longevity.
According to DelveInsight’s Spinal Cord Stimulators Market & Competitive Landscape, the global Spinal Cord Stimulators market was worth USD 2.08 billion in 2020, increasing at a CAGR of 8.69% during the study period from 2021 to 2026 to touch USD 3.42 billion by 2026. Spinal Cord Stimulators are needed due to the increasing number of chronic pain patients and neuropathic pain in the shoulder, legs, and knee. The technologically advanced devices, which are non-invasive, remove targeted pains, cause a decrease in patient discomfort, with no side effects, are likely responsible for a boost in the Global Spinal Cord Stimulators Market growth. In addition to that, favorable government regulations for commercialization and launching products in the market and rising geriatric population are some of the factors responsible for propelling the Spinal Cord Stimulators Market growth.
Endo Tools Therapeutics receives FDA clearance for Endomina® System use by Gastroenterologists
On January 18, 2020, Endo Tools Therapeutics (ETT), focused on developing advanced, minimally invasive medical devices for use by gastroenterologists along with standard endoscopes, received the US Food and Drug Administration (FDA) 510(k) clearance for its endomina® system, developed for placing sutures through endoscopes and approximation of soft tissue in the gastrointestinal tract on the adult population. The company planned a limited market release of the endomina system in the US during the first half of 2022, followed by a more significant market release later in the year.
Dr. Ivo Boškoski from Policlinico Gemelli, Rome, Italy, said this technology is a meaningful addition to their armamentarium for performing effective procedures. The endomina system represents a tremendous advancement in interventional gastroenterology that could expand treatment options for patients.
Alexandre Chau, chief executive officer, Endo Tools Therapeutics, said they are happy to bring this innovative and disruptive technology to the U.S. market. The endomina system was designed and developed with physician needs in mind to let physicians perform endoscopic suturing similar to laparoscopic procedures but without an incision.
The endomina system comprises a universal triangulation platform and an instrument for tissue piercing and approximation (TAPES). The system can be affixed to various tested standard endoscopes and can move independently. The bendable therapeutic channel enables the gastroenterologist to perform endoscopic suturing similar to laparoscopy interventions but using only a natural orifice (mouth), thus providing an incision-less procedure. The system is CE marked and commercially available outside the US. Moreover, the system is in European clinical studies for a wide range of procedures in the digestive tract, such as bariatric interventions, Gastroesophageal Reflux Disease (GERD), or Endoscopic Full Thickness Resection (EFTR).
According to DelveInsight’s ‘Surgical Sutures Market & Competitive Landscape”, the global surgical sutures market was worth USD 3.34 billion in 2020, increasing at a CAGR of 6.64% during the study period from 2021 to 2026, to touch USD 4.90 billion by 2026. The growing demand for surgical sutures is attributed to the increase in surgeries worldwide. Also, a rise in various diseases such as arthritis, spinal deformities, cancers, among others that require surgery for their management, a rise in non-fatal injuries, increasing approval of products, and launches of various advanced surgical sutures are expected to support the need for these sutures hence leading to a rise in the global surgical sutures market during the forecasted period.
Diadem’s AlzoSure® predict prognostic blood test receives FDA Breakthrough Device Designation for the early prediction of Alzheimer’s Disease
On January 18, 2022, Diadem U.S., Inc., which is a subsidiary of Diadem Srl and is focused on developing a blood-based test for early prediction of Alzheimer’s disease (AD), was granted the US Food and Drug Administration (FDA) Breakthrough Device Designation for its AlzoSure® Predict, a blood-based biomarker assay, designed to identify Alzheimer’s disease in individuals over the age of 50 with signs of cognitive impairment before definitive symptoms are apparent.
Paul Kinnon, CEO of Diadem, said that securing the FDA Breakthrough Device designation reinforces their view that AlzoSure® Predict is a potential game-changer for the early identification and management of Alzheimer’s disease afflicting millions and their families globally. They see the Breakthrough Device designation as a vital step in bolstering the future commercialization of AlzoSure® Predict in the U.S and worldwide. They look forward to working closely with the FDA to finish their clinical studies and accelerate the regulatory review process.
The application of Diadem’s AlzoSure® Predict was supported by positive data from a 482-patient longitudinal study which has shown that the test can identify whether there will be progression to full-fledged AD up to six years before the illness is apparent. The study results were published in a MedRxiv preprint and have been submitted to a peer-reviewed journal. The second phase of this study is due for completion, which includes biobank data on more than 1,000 additional patients from the U.S. and Europe.
According to DelveInsight’s “Alzheimer’s Disease Epidemiology Forecast,” Alzheimer’s disease is the most common type of dementia and involves parts of the brain that control thought, memory, and language. Moreover, according to the data published by the CDC in the year 2020, approximately 5.8 million Americans were living with Alzheimer’s disease in the US in the same year.
Smith+Nephew acquires novel cementless Partial Knee System
On January 19, 2022, Smith+Nephew, a leading medical technology company, took over Engage Surgical, manufacturer of the only cementless unicompartmental (partial) knee system commercially available in the US. This acquisition bolsters Smith+Nephew’s strategy for market expansion and business transformation. Currently, Smith+Nephew is the only medical device company in the US delivering both cemented and cementless partial knee implants. The acquisition will further boost the company’s Robotics and Real Intelligence strategy as the Engage Surgical partial knee system is optimized for robotics and will have an application with CORI™ Surgical System of Smith+Nephew in the future.
Dan Justin, Chief Executive Officer, Engage Surgical, said that the Engage Surgical Team is excited about joining Smith+Nephew to help expand the impact of the Engage Surgical Partial Knee System and integrate it with the CORI Surgical System. Smith+Nephew is well-suited and well-prepared to continue its mission of offering better outcomes for knee arthroplasty patients.
Randy Kilburn, Executive Vice President & General Manager, Reconstruction, Robotics and Digital, said Smith+Nephew is now the only medical device company proffering both cemented and cementless partial knee implants in the US, as well as robotics-assistance through the CORI™ Surgical System, which is well-suited for the precise alignment needed. Their Sports Medicine franchise has an established, strong position in ASCs where the vast majority of partial knees in the US are performed. Their VISIONAIRE™ business, the high performance and small footprint of CORI, plus their partial knee portfolio, is a uniquely compelling offering for customers.
According to Partial Knee Arthroplasty Market & Competitive Landscape, B. Braun Melsungen AG, Smith & Nephew, DePuy Synthes, Arthrex, Inc., Stryker, Zimmer Biomet, among others, are the key players operating in the partial knee arthroplasty market.