Naviswiss secures FDA 510k clearance for Naviplan, an advanced planning solution for hip replacement surgery 

On October 21, 2021, Naviswiss, a Swiss-based medical technology company, received approval from the FDA to commercialise Naviplan in the United States. Naviplan is a digital pre-operative planning application allowing orthopaedic surgeons to conduct navigated CT-based total hip replacement surgery. It has the prospective to improve accuracy, predictability and provide seamless documentation of the outcome.

Jan Stifter, Naviswiss CEO, said that Naviplan and CT-based Navigation are a vital addition to the Naviswiss portfolio and complete their proffering for navigated hip replacement. They now have two patient-specific options where the surgeon determines the best application for the procedure. CT-based Navigation may be required in complex deformity cases, while kinematic registration may be preferred in more traditional surgeries. The surgeon can depend on highly precise guidance in placing the acetabular components.

According to DelveInsight’s ‘Hip Reconstruction/Replacement Devices Market Analysis’, it will help boost the Hip Reconstruction/Replacement Devices Market growth as there will be a gradual shift from traditional CT-based navigation surgeries. The company plans to launch the CT-based Navigation and Naviplan to orthopaedic care centres in the United States over the fourth quarter of 2021. 

US FDA approved the first nasally-administered pharmaceutical treatment for Dry Eye Disease 

On October 25, 2021, the US Food and Drug Administration (FDA) approved AptarGroup, Inc., a global leader in drug delivery products, for its patented Cartridge Pump System (CPS), Oyster Point Pharma’s TYRVAYA™ (varenicline solution) Nasal Spray 0.03 mg, designed for the multidose delivery of preserved and non-preserved drug formulations. 

TYRVAYA™, a highly selective cholinergic agonist, is the first nasally-administered pharmaceutical therapy to treat dry eye disease symptoms approved by the US FDA.

According to DelveInsight’s ‘Dry Eye Disease Market Assessment’, this is first-of-its-kind treatment and makes Aptar’s Cartridge Pump System an essential component of the first and only US FDA-approved pharmaceutical therapy to offer treatment for the symptoms of dry eye disease, an ophthalmic condition, via the nasal route and re-confirms Aptar’s expertise for developing innovative drug delivery solutions.

According to DelveInsight’s ‘Aerosol Delivery Devices Market & Competitive Landscape Report’, It will also affect the aerosol delivery devices market as more than 38 million adults in the United States are estimated to suffer from dry eye disease and will drive the demand for the Aptar product.

New publication backs clinical effectiveness of Centinel Spine’s STALIF® Integrated Interbody™ System 

On October 26, 2021, Centinel Spine®, LLC, a leading global medical device company, announced the latest publication of a research study on its STALIF C-Ti® product in the Journal of Surgery & Anesthesia Research: “Preliminary 12-Month Safety and Efficacy Outcomes for the Treatment of Cervical Radiculopathy and Myelopathy with the Stalif-C Integrated Interbody Fusion Device.” The prospective multi-centre study backs that patients receiving STALIF C-Ti implants showed significant improvements in clinical outcome scores with minimal overall complication rate.

Co-investigator on the study Jad G. Khalil, MD of Michigan Orthopaedic Surgeons, said they believe it to be a vital multi-centre study on stand-alone devices. Very little data on stand-alone devices is available. And, while reference is frequently made comparing cervical fusions, most of those references are comparing plated fusions. This study was undertaken to evaluate an advantage to an Integrated Interbody device over traditional plated fusion. The study was conducted at eleven centres across the country—a mix of private practice and university-based programs, with all data garnered and entered into a validated database. 

Centinel Spine’s CEO, Steve Murray, added that they are committed to offering clinical evidence to support their portfolio of devices. This study is one of the few multi-centre prospective clinical evaluations of this type of technology.

According to DelveInsight’s Spinal Fusion Market report, the STALIF C-Ti implant technology has been one of the significant contributors to the interbody fusion devices market growth as these offer thorough fixation at the fusion site, pulling the vertebral bodies onto the implant and graft material to enhance opportunities for fusion in line with Wolff’s Law of Bone Healing.

Smith+Nephew’s IODOSORB™ range shown more than twice as likely to heal wounds than standard care 

On October 26, 2021, Smith+Nephew, the global medical technology business leader, announced the results of a systematic review and meta-analysis of comparative trials to determine the efficacy of its IODOSORB 0.9% Cadexomer Iodine Range on chronic wounds versus standard care specific to the wound type.

It was found that IODOSORB Range healed wounds twice than with standard care, and considerably more significant reductions in wound area were seen after eight weeks of treatment versus usual care.

Dr Kevin Woo, PhD, RN, Associate Professor, Queen’s School of Nursing, University of Toronto, Canada, said that with the cost of chronic hard to heal wounds is an estimated USD 3.9 billion in Canada, they can be a significant burden on patient quality of life, healthcare resources, and budgets. The data show consistent positive outcomes [IODOSORB] has on chronic stalled wounds by removing barriers that impede wound healing.

According to DelveInsight’s Advanced Wound Care Market & Competitive Landscape Report, Smith+Nephew is a significant market player as it offers superior products from standard care treatment. 

AlloSource launches Allomend Extra-large Acellular Dermal Matrix 

On October 27, 2021, AlloSource®, the largest allograft provider in the US developing innovative cellular and tissue products to aid surgeons heal their patients, declared the launch of AlloMend® Extra-Large (XL) Acellular Dermal Matrix (ADM), the newest addition to the AlloMend product line.  

This is the company’s largest dermal graft and comes in meshed and non-meshed varieties with a footprint of 320cm² (16cm x 20cm) for use in demanding soft tissue applications. The flexible and pliable material delivers desired handling characteristics allowing precision placement.

Dr Ross Wilkins, AlloSource Senior Medical Director, said that based on AlloSource’s 27 years of manufacturing skin grafts, they have observed surgeons switch to new reconstruction techniques that need larger dermal grafts for single piece coverage. AlloMend XL was developed with the purpose to benefit surgeons offering better results options for their patients.

SpinaFX and StarFish medical enter into a strategic commercialisation contract manufacturing agreement 

On October 26, 2021, SpinaFX Medical Inc. (SpinaFX), a start-up working in minimally invasive image-guided therapy, entered into a commercialisation contract manufacturing agreement with StarFish Product Engineering Inc. (“StarFish Medical”), Canada’s most significant medical device design, development, and manufacturing services organisation.

John Soloninka, SpinaFX’s Chief Operating Officer, said that SpinaFX is delighted to welcome StarFish to the SpinaFX team. They ran a rigorous process comparing four of the top, highly-recommended medical device design, commercialisation, and contract manufacturing organisations from across the US and Canada.   StarFish Medical’s great skills and experience, facilities, customer reviews, and willingness to intimately customise and integrate their services with the operations won the day. The strategic alignment between the companies is impressive. 

Scott Philips, CEO of StarFish, said that they measure their success through the value they help their clients generate for patients, providers, payers, and their shareholders.  They select clients they believe will contribute to their “100×100” objective: 100 clients with over USD 100 Million in market capitalisation. SpinaFX’s minimally-invasive image-guided procedure promises to decrease the time, cost, and complexity of spine surgery for patients with low back pain, one of the most extensive and most costly cohorts of patients worldwide. This is a highly vital goal, and StarFish is committed to helping SpinaFX travel as far and efficiently on their trajectory as possible.