Neuveo

vs.

Admetsys

Describe your device and how it will benefit healthcare.

Our company is focused on accelerating cancer treatment and drug discovery (breast, solid organ, prostate), with a novel use of at-home ultrasound to detect if treatment is working sooner, rather than expensive, long durations of chemotherapy, polypharmacy, and imaging (CT/PET). The compelling value proposition is that it is possible to detect key changes in a tumor's response to therapeutic agents within 2-3 weeks compared to months using conventional diagnostic imaging. This technology may also aid in drug development as well as potentially superiority claims vs. traditional non-inferiority-based drug investigations. Human studies for breast cancer have already been published in the United States and Canada by leading cancer centers. Through serialized, patient-directed imaging "sessions" as prescribed by one's oncologist, the tumor microenvironment can be assessed quickly and inexpensively, without the need of costly imaging and radiation exposure. Microenvironmental identifiers such as pH, oxygen, temperature, flow, and tissue stiffness can all be measured through the capabilities of quantitative ultrasound and microsensor based fiducials.  At each session, data is collected real time and transmitted (HIPAA secured/Bluetooth) to clinicians as well as aggregated in the cloud for a larger research and critical pathway service model. Our pipeline includes an exclusive license working with UCal Berkeley with an implantable sensor about the size of a grain of rice for extended tumor sensing capabilities. Currently, 20-25% of Medicare pharmaceutical expenditure is on chemotherapeutic agents. With no two cancer patients responding to the same drug equally, we feel we can reduce overall healthcare cost burden and mitigate patient exposure to adverse side effects as well as the cost to treat the damage from unneeded chemotherapeutic agents.

The device may also be used separately in a nonimaging format in the same form, using ultrasound noninvasively for stimulation.  Approximately 30% of chemotherapy patients experience chemotherapy induced peripheral neuropathy. With the current epidemic of opioids used for pain management, we feel the body of literature supports neurostimulation for mild to moderate pain and a nondrug option for the healthcare system and patients to use in a home setting. This would still be a Class II device, thus providing an earlier entry to market over conventional implanted Class III offerings.

In the last three decades, diabetes incidence has more than tripled. Meanwhile, techniques for controlling glucose levels in hospitalized patients have remained unchanged, relying on a nurse to a perform a repeating cycle of imprecise, labor-intensive, error-prone tasks. High glucose levels prevent healing, increase complications, and lengthen hospital stays, driving up care costs. Low glucose levels risk seizures, coma, and even death. Precision is necessary for high-quality outcomes. Repeatability at scale is needed for cost control.

Admetsys has developed the first artificial pancreas system specifically for the needs of hospital and surgical care. The system attaches to a patient's intravenous line, and automatically measures blood glucose concentration in real time and with no blood loss. From this, it creates an adaptive, computational model of each patient's metabolism, evolving as patient condition does, and delivers precisely-optimized, treatment - insulin to reduce high glycemic levels and glucose to raise and support falling levels.

How does your product differ from the competition?

Currently, there is nothing on the market that is like this.

Admetsys' system is the first fully- automated glucose control device designed for hospital care; no competitive closed-loop systems presently exist. Moreover, it is the only technology that provides an active safeguard against hypoglycemia in hospital patients.

Do you have customers yet?

Product is not commercial. We are working on building a prototype. Leading cancer centers such as Mayo Clinic (Rochester-Main campus) as well as MD Anderson Cancer Center in Houston Tx are working closely with us on various projects.

Admetsys has conducted three FDA approved clinical trials using fully-engineered prototype devices, demonstrating 97% target glucose control (80-125 mg/dL) and 100% prevention of hypoglycemia (<70 mg/dL). Pivotal trials to support market clearance will begin in 2017.

How much money have you raised?

Currently all self funded and has submitted for various grants.

Admetsys has raised a $1.5M convertible debt round led by Blue Cross & Blue Shield and Baptist Health System to accelerate its production engineering and support its European clinical trials. A subsequent series A raise of $12 million will be required to achieve market clearance both in the Europe and the United States, with commercial launch in select European markets. These objectives would position the company strongly to raise future growth capital, as well as make the company highly attractive to potential acquirers.

Who are your investors?

We are currently finalizing investors.

Blue Cross & Blue Shield, Baptist Health System, Dreamit Ventures, University of Michigan Zell Early-Stage Fund

What is the next milestone for your device?

Complete prototype build. As the product will be a Class II vs. Class III device, a clinical trial will be completed; however, short in duration given the classification and the duration of chemotherapy needed to assess efficacy.

ISO 13485 and CE certification to support a market launch in the European Union is expected in Q4 2017.