Nexus is a next-generation integrated ultrasonic surgical platform that combines all the features of Misonix’s existing solutions, including BoneScalpel, SonicOne and Sonastar, into a single fully integrated platform that will also serve to power future solutions. The Nexus platform is driven by a new proprietary digital algorithm that results in more power, efficiency and control. Nexus uniquely incorporates RF capabilities, allowing for use in general surgery procedures. The device also incorporates Smart Technology that allows for easier setup and use.
Physicians will be able to utilize Nexus’ increased power to improve tissue resection rates, in concert with its proprietary digital algorithm to perform more efficient bone removal procedures. In addition, Nexus’ ease of use will enable physicians to fully leverage Nexus’ impressive capabilities via its digital touchscreen display and smart system setup.
Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, commented, “We are very pleased to have achieved this critical approval, marking a significant milestone for Misonix and the culmination of years of hard work.” Nexus is a powerful, highly integrated and easy-to-use system that will benefit both healthcare providers and patients by incorporating the latest advances in ultrasonic technology allowing for increased efficiency and efficacy, and thus improved outcomes. It is truly a transformational product.
“The overwhelmingly positive feedback we have received from the surgeon community since first unveiling Nexus reinforces our confidence in its potential to serve as a significant growth engine for Misonix. Nexus is a key component of our strategy to increase our presence in the neuro, spine, ortho, wound and general surgery markets. Nexus provides us with a unique opportunity to leverage our robust consignment business model, further drive the sale of consumables competitively, and extend our ability to cross-sell into multiple physician specialties. The commercialization of Nexus will expand the utilization of ultrasonic surgical applications as we continue to strategically invest in our products to become the standard of care in operating rooms and hospital outpatient departments.”
The ADEXUSDx® Analyzer is a portable handheld analyzer that performs blood analysis at the point-of-care for use with the ADEXUSDx® test cassettes, used by healthcare professionals trained and certified to use the ADEXUSDx® System.
Arguably, the most complex project that Omnica has undertaken is the Plex-ID universal pathogen detector. As is common with many projects, the science and core technology was provided by the client. Together, the two teams developed the Product Definition and developed the final product meeting the goal of providing sample reports every 30 seconds.
All of the design, engineering, software, prototyping, and documentation were done in house by Omnica team members except for the GUI and pathogen I.I. database, which were provided by the client (note: since that effort ending in 2009, GUI design has become a specialty at Omnica).
The IBIS/Abbott Molecular PLEX-ID system won the 2009 Wall Street Journal gold innovation award and was also recognized as the year’s 2nd most exciting development from the panel of judges at “The Scientist” magazine.
Omnica had the honor of developing the last pH meter product family before Dr. Beckman passed away in 2004. We worked with the client’s Industrial Design to produce a family eighteen meter variations based on a single PCB.
The handheld versions passed the requirement of IPX7 (water ingress protection at a submersion level one meter, even though it floats).
SSO2 THERAPY FOR AMI
Current standard of care for the most severe heart attacks involves mechanically opening the blocked artery using percutaneous coronary intervention (PCI), otherwise known as angioplasty and stenting. While PCI has reduced early mortality post-heart attack over the past 25 years, significant myocardial tissue (heart muscle) death and sizable scarring may be present even after the left anterior descending (LAD) artery has been stented. This myocardial damage is linked to increased risk of heart failure and long-term mortality2.
SSO2Therapy is a novel treatment that complements PCI and is designed to minimize myocardial damage caused by acute myocardial infarction in qualifying patients suffering a LAD ST-elevation myocardial infarction (STEMI) event who are treated with primary PCI within 6 hours of symptom onset. SSO2 Therapy delivers superoxygenated arterial blood directly to at-risk myocardial tissue and is performed in the cardiac catheterization laboratory immediately after PCI is completed.
Part of ‘Phase 3: Production Engineering’ often includes the design and fabrication of assembly and testing fixtures. Omnica has built hundreds of these using in-house engineering and fabrication resources.
HELiOS® Personal Oxygen System for Nellcore-Puritan-Bennett®– The portable oxygen conserver is designed for the ambulatory patient in a home care environment. It is the smallest and lightest portable liquid oxygen system on the market that lasts up to 10 hours. The result was an ultra-compact package that initiated industry-wide growth in the use of liquid oxygen-based delivery devices. The award winning device is now marketed by Caire® Inc. under the names HELiOS Plus & Marathon®. We were hired to perform competitive benchmarking studies, and develop a product that incorporated their best features. Our technical input consisted of industrial design, mechanical engineering, human factors, ergonomics, and design for manufacture.
Thermastar™ for Volcano Therapeutics – Intravascular thermography device for research. This system measures minute interior artery temperature changes and identifies areas where arterial plaque may form. We proved feasibility of the client’s proprietary arterial catheter, and based on that technology we developed a complete diagnostic system which could be used in a clinical setting. We designed a custom keyboard, the PC cart housing, a handheld controller, and the video-based GUI for the operating software. Our in-house team managed the manufacture of the rotomolded parts, controller and keyboards. We prototyped and assembled 10 fully operational units.
When we first met the Inogen group, they were already familiar with our work on the HELiOs Personal Oxygen System the conserver we had developed for Nellcor Puritan-Bennett three years before. Inogen wanted us to duplicate this success for them in the oxygen concentrator market. An oxygen concentrator is a device that cleans nitrogen from ambient air and supplies a continuous flow of pure (about 95%) oxygen to the user by way of an air tube called a nasal cannula.
The conserver market has boomed, largely due to the success of the HELiOs™ system.
The main issue with these types of devices is that they require refilling from a large liquid oxygen tank every few hours. Concentrators don’t need refilling, but for other reasons, business has not fared so well. Inogen’s idea was to re-think the technology and re-define the category.
The concentrator market had been in decline for many years. For COPD patients on the go, concentrators added a degree of mobility, but the units were big and noisy, and needed to be connected to a wall socket. It was also difficult to sell a product that was industrial looking and heavy to lug about. Inogen planned to develop a lightweight, efficient, and quiet portable oxygen concentrator that could run on batteries.
Start-up company needed help developing a funtional prototype.
The start-up company presented us with a very preliminary prototype that worked, but had only limited functionality. They had already completed a portion of the initial development and had identified some proprietary components they wanted to incorporate into the final design. Their plan was to use off-the-shelf parts, hire us for the I.D., and make a real product out of what they had. But like most of the devices we develop, almost all of the components eventually had to be custom designed.
Over the period of about a year, their group completed the electronics and software development. Concurrently, Omnica performed the industrial design, mechanical layout, the internal and external packaging, battery case, chargers, carts, the satellite conserver valve, the manifold design, and the extrusion and chassis assembly. Omnica worked with other vendors to successfully miniaturize the pneumatics and valving for use in the lightweight design. We even built the production test equipment, the manifold leak testers, and later approved the first articles.
We fabricated 18 pre-production prototypes of the Inogen One OxygenConcentrator System™.
Our client used them to introduce the product in a trade show. Reaction to the new device was overwhelming, and on that basis, the company made projections of how many units to manufacture as a first run of the product. Six months later, when the concentrator actually became available to the market, they had to dramatically revamp production forecasts to keep up with rapidly rising demand.
The concentrator runs on batteries and is approved for use on most airlines.
The Inogen One Oxygen Concentrator System fulfilled the promise of independence for highly active home oxygen patients. It weighs 10 pounds, and runs for 2 to 3 hours on rechargeable batteries (indefinitely on A/C). It is very quiet and features a breath detection system four times as efficient as other concentrators. The Inogen One is the only oxygen concentrator which meets 100% of FAA requirements for use upon aircraft. It has won three awards including the prestigious MDEA design excellence award.
R&D requires low-volume, functional prototypes and fixtures. This project’s goal was to detect and quantify particulate passing through the carotid artery during coronary surgery. The results were rather stunning and enabled our client to better understand vital program issues.