SteadyPIVOT: Relentless Oncology, Perfected

Cancer Doesn't "Let up". Neither Should You.

The Future of Cancer Therapy IV Delivery

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SteadyPIVOT means Steadystate 
Persistent IV, (working) Overtime”.

SteadyPIVOT is 24/7 cancer-selective chemo, administered continuously between conventional bolus chemo administrations and other oncology interventions.  This steadily pivots the patient’s recovery rate into the green for a winning cellular ecosystem to mathematically guarantee full recovery.  We use FCSC identified chemo patents for the working fluid and will include potentiating integrations.

What Makes SteadyPIVOT Different?

Our Strategy: Lead With The Best of the Best

The metronomic approach to chemotherapy has consistently yielded superior efficacy with the least toxicity. SteadyPivot takes that a step further by integrating non-proprietary potentiations where appropriate to hedge success at negligible cost and test them upfront, out of the gate. This will save healthcare development costs, hedge for success, and provide faster to market results for the ideal therapy.

Duration vs Dose: Duration wins

Most chemotherapeutics work by downregulating a critical cancer metabolic process, essentially starving cancer of that process. The key parameter in starvation is not dose, but duration, so SteadyPIVOT (which maximizes treatment duration) has greater anti-cancer activity and less toxicity. We bring significant IP to the table to substantially lengthen continuity and improve patient convenience for our 24/7 protocols.

A Big Upgrade for Elastomeric Ambulatory Pumps

Disposable elastomeric ambulatory pumps are unanimously preferred by patients so we have significantly improved them. Patent pending changes result in a 3-4x increase in capacity, over 10X more osmolarity capability, better human factors design, and better flowrate uniformity. Additional IP includes dressing improvements, and a method to increase solute saturation by as much as 3X (and it's not just a suspension) for 3x smaller pumps, or 3x longer-lasting infusions.

Differentiation in the Marketplace

The field of chemotherapeutics is a crowded marketplace, and many of the competing new chemistries are analogues of pre-existing treatments. By starting the testing of a chemotherapeutic substance as a SteadyPIVOT candidate it thereby becomes preferred for this industry revolutionizing treatment mechanism.

Integrations to detoxify toxic chemo

We have identified a number of non-propietary integrations that have demonstrated the ability to improve the selectivity of normally toxic chemotherapies (such as those that target fast growing cells). Having done so these normally less-selective chemo agents become more ideal candidates for the SteadyPIVOT protocol.​

Self-sustaining business model

Medical devices on average have a much faster time to market than pharmaceuticals. The early commercialization of our medical device IP will provide additional funding to help complete the later phase testing and commercialization of the FCSC identified pharmaceuticals. 75% of our income will come from the 10% franchise fee required by certified compounding pharmacies to pre-fill the new pump designs.

Making Care (QOL) Part of the Cure

There are hundreds of science-based IV medicaments that consistently demonstrate improved quality of life, make chemo less toxic, and potentiate results. In short, stronger fighters fight better. The investigation of each chemotherapeutic will include a arm to explore those synergies (only to be pursued in the event of demonstrable superior results).

Background
(what's been done already)

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Metronomic Chemo

SteadyPIVOT is very similar to metronomic chemotherapy (delivery small chemo doses parenterally over the period of multiple days). SteadyPIVOT differs by improving cancer selectivity and QOL factors which are critical to insure a continuous positive rate of recovery. Additional advantages over conventional metronomic chemo include increased fluid volume capacities, longer duration (high osmolarity) fluids, better human factors, and improved flowrate uniformity, all which are the result of a new pump setup (see “Pump IP Gets A Big Upgrade”, above).

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Elastomeric Ambulatory Pumps

With the expiration of a number of key patents in the last few years the cost and proliferation of disposable small silent elastomeric pumps has substantially increased. These pumps have consistently demonstrated preferred status among patients due to their carefree non-electrified and silent nature.

New IP, developed largely by Infusion Scientific over that last year allows more conveniently shaped pumps with larger capacities and a much greater osmolarity range, as well as much improved flowrate uniformity.

Additionally, recently developed super-saturated solutions allow much smaller pump sizes resulting in longer pump durations and fewer medical interventions throughout the entire treatment phase.

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Propitious Integrations

Traditionally, chemo agents have not been integrated with presumably potentiating non-proprietary fluids until after the agents are first proven in the field and FDA approved. We propose doing the integrations upfront will add negligible cost (due to their non-proprietary nature) and result in a much greater success rate (and better cost effectiveness) can be realized, not to mention a shorter time-to-market for the optimal combination of the patented chemo agent plus potentiating integrations. There are a number of non-proprietary fluids which have consistently demonstrated significant benefits when recommended protocols are followed profoundly supported in over 100 different articles in peer reviewed literature. We break new testing ground by integrating these advantages up-front in the initial pre-clinical and clinical testing process.

Our Team

David Austin - Team Lead

With 15 years as an entrepreneur and 25 years as an engineer (BSME) specialized in material science, David has led various global product development teams for Fortune 500 companies like York and Outerwall (Redbox). He’s currently CEO of Infusion Scientific, a Boise Idaho company with key IP in medical devices.

Greg Hayes - Product Development

Greg has led product design for multiple startups, and was one of the original members of IDEO, where he worked for 10 years. He’s brought to market medical products for Medtronic, Affusion Medical, and Cothera United Orthopedic. Greg has previous experience designing and testing medical pumps, specifically engineering the same kinds of silicones as those used in our pumps.

Debra Ennis - Clinical Research Administrator

Debra Ennis is an active independent contract study manager and monitor since September 2012 and has worked for many pharmaceutical companies. She has over 25 years experience in pharmaceuticals, is a Registered Nurse, and is a Certified Clinical Research Associate (CCRA®).

Dr. Ron Hunninghake, MD - Advisor

Dr. Hunninghake is the Chief Science Officer of the Riordan Clinic (RiordanClinic.org) where he started in 1989 as its Medical Director, but he is first and foremost a dedicated patient-centered healer. Riordan Clinic is a non-profit clinic that has won numerous awards and honors for leadership in medicine and scholarship in medical research.

Dr. Mary Migliori, MD

Dr. Mary Migliori, MD, has practiced medicine in Boise, Idaho for 34 years and attends 4-6 conferences each year to maintain her knowledge of the most recent advances in medicine. She has an active practice where she currently administers some of the same science-based IV chemistries to be used with SteadyPIVOT technology.

Jeremy Lundevall, CPhT

Jeremy has been in the pharmacy industry for nearly 30 years, doing and teaching hands-on the compounding of sterile and non sterile drugs, and is experienced in assisting and forwarding the objectives of medical startups. Currently he is a partner in, and works as, the COO for number of Boise compounding pharmacy locations.

Michael Retsky, PhD

Dr. Retsky beat cancer 20 years ago as a pioneer in metronomic chemotherapy (which is much improved by SteadyPIVOT), and he has been instrumental in the adoption of a number of key oncological advancements. Dr. Retsky is well connected in the metronomic industry and is assisting in expanding the uitilization of this technology.

Business Strategy Advisor

Our Business Strategy Advisor has worked with C-level people in the b2b and b2c markets in the health industry for the last 10 years. He's led many new product roll-outs and has key understanding and knowledge of the sales/marketing/distribution in that space.

David McKinney - Intellectual Property Counsel

Mr. McKinney's medical patent work includes catheters, guidewires, stents, vascular occlusion devices, drug delivery systems, ventricular assist devices, pacemakers, neural stimulators, and more. He is a registered patent attorney with 20+ years practicing Patent Law in the U.S. and internationally, currently in Boise Idaho.