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.
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.
Minimed Paradigm® for MiniMed (now Medtronic) – This percutaneous insulin infusion pump is the basis for a family of wearable and water-resistant insulin pumps. It supports three basal programs and a bolus delivery option. We developed a custom, non Luer lock connector to allow for the water-resistant design. It uses a proprietary stepper motor with a captive lead screw and is powered by an easily replaceable AAA battery. We performed project management and coordination with the client’s engineering team, industrial design, graphic interface, enclosure design, electronics packaging and others. We also fabricated test fixtures for life testing motors and force sensors, and designed the occlusion sensor and thin film force sensor transducer design. We coordinated tooling, drop, immersion, and acoustic testing, and documentation transfer to production.
A novel platform of magnetically adjustable implant systems based on its MAGnetic External Control technology. Ellipse’s novel and proprietary implants are adjustable at the time of implantation and are distracted non−invasively over the course of treatment to accommodate the changing clinical needs of patients as they heal, grow or age. Ellipse’s technology enables physicians to customize therapy for patients in a non-invasive manner, reducing the need for further repeat surgical procedures, and providing meaningful improvements in patient clinical outcomes and quality of life while generating cost savings to the healthcare system.
Omnica was part of a multiple discipline team that developed an LVAD related system for animal testing. We were responsible for the packaging, Industrial Design, fluid and electrical inter-connectivity, power supply, user interface, and prototype fabrication. The system was comprised of an “Acute Controller/Console”, a “Chronic Controller Assembly” and “Telemetry-linked Clinical Console”.
The NeuroThera System, De Taboada said, consists of a fiber optic cable, a handpiece, a cap that guides the laser energy to treatment locations on the scalp, accessories and a cart for portability.
When the system establishes contact with the patient’s completely shaved head, detectors in the handpiece trigger it to emit a specific wavelength of near-IR energy. “A total treatment regimen consists of treating 20 locations on the head for two minutes at each location for a total of 40 minutes of nominal treatment time,” De Taboada said.
The mitochondrial photoreceptor cytochrome C oxidase absorbs near-IR and drives adenosine triphosphate (ATP) formation by oxidative phosphorylation, he explained. The hypothesis goes that improved energy metabolism leads to mitigation of cell death in the stroke-affected tissue and to the enhancement of neuro-recovery mechanisms.
The improved neurometabolism could be beneficial not only in stroke treatment, but also in treating traumatic brain injury, and Parkinson’s and Alzheimer’s diseases, he said.
The EMulate Therapeutics Voyager® ulRFE® system is a non-invasive medical device. It is the first of many product expressions of the company’s underlying ulRFE platform technology. Showing promise in pre-clinical and clinical trials, the EMulate Therapeutics Voyager® has potential treatment applications in a wide range of diseases, including cancer, chronic pain, inflammatory, among others. The EMulate Therapeutics Voyager device is being evaluated for the treatment of glioblastoma multiforme (GBM) brain tumors in human clinical trials and is currently limited by Federal United States law to investigational use only.