Metavention Media Fact Sheet

Metavention media fact sheet|Version 8, September 2016

New Zealand Patients First in World to Receive New Diabetes Treatment

Media Fact Sheet

Summary

· Patients in Auckland, Wellington, Christchurch and Dunedin have been the first in the world to be treated with a novel treatment intended to treat type 2 diabetes

· The COMPLEMENT trial is an ongoing first-in-human study of Metabolic Neuromodulation Therapy and is being conducted exclusively in New Zealand

· 28 patients have been treated to date with increasing doses

· Metabolic Neuromodulation Therapy for type 2 diabetes involves changing nerve signals to the liver and other organs in an effort to improve blood sugars to more normal levels

· Nearly half of patients with type 2 diabetes are unable to adequately control their blood sugars, despite multiple medication options, and are thus at risk of significant and costly complications

· New treatments for type 2 diabetes are critically necessary given that type 2 diabetes has reached near-epidemic proportions here in New Zealand, and globally

Background Information

Metabolic Neuromodulation Therapy – What is it?

This one-time procedure involves passing a catheter through the femoral artery in the right groin into the artery that leads to your liver. This basic catheterisation procedure is very common for physicians to deliver a number of cardiovascular treatments. Radiofrequency energy is then passed through the end of the catheter into the wall of one of the liver arteries to disrupt the nerves that lead to the liver and other metabolic organs. Previous research has shown that disrupting these nerves may lead to a lowering of blood sugar levels, which may help to achieve better diabetic control (Am J Physiol Endocrinol Metab 290 E19 2006).

Why are the liver nerves important in type 2 diabetes?

The nerves in the liver arteries play an important role in the regulation of blood sugar levels. Previous research has shown that disrupting the nerves in the liver arteries may return the liver and other organs of the metabolic system to a more normal state and help take more sugar out of the blood when the blood sugar level is high (Am J Physiol Endocrinol Metab 290 E19 2006). As a result, diabetes may be better controlled after having this procedure.

What are the risks?
The main risks of the procedure are believed to be similar to the risks of other common procedures requiring catheterisation of your arteries. Possible risks of the catheterisation procedure include injury to the arteries, kidney damage, clotting in the arteries, or bleeding.

There are additional risks that could possibly be associated with the Metabolic Neuromodulation Therapy procedure or response to the treatment. There may be side effects that the researchers do not expect or do not know about and that may be serious.

What is the COMPLEMENT Trial?

The COMPLEMENT Study is a First In Human study that is being undertaken exclusively in New Zealand. It aims to collect information about a new possible treatment for type 2 diabetes using a medical device called the Metabolic Neuromodulation System. Treatment with the device is intended to help regulate blood sugar levels in patients whose diabetes is not well controlled, despite treatment with oral medications.

The trial aims to enroll 30 total patients by the end of 2016. The COMPLEMENT trial has been approved by the New Zealand Ethics Committee, HDEC reference 14/NTA/102.

What Patients are Eligible?

Patients aged 18-70 who have blood sugar (A1C) between 58 mmol/mol and 86 mmol/mol, and are on an oral antidiabetic medicine called metformin are potential candidates for trial participation. Interested patients should contact one of the study coordinators at the centers listed below.

What centers and physicians are involved?

The COMPLEMENT Study is being led by expert endocrinologists and cardiologists: Dr Rinki Murphy and Professor Mark Webster at Auckland City Hospital, Dr Brandon Orr-Walker and Dr Wil Harrison at Middlemore Hospital, Assoc Professor Jeremy Krebs and Dr Scott Harding at Wellington Hospital, Professor Russell Scott and Dr James Blake at Christchurch Hospital, and Professor Patrick Manning and Professor Gerry Wilkins at Dunedin Hospital.

Study coordinators are available to answer common questions about how to take part: Jan Burd at Auckland City Hospital, Diane Caveney at Middlemore Hospital, Cecilia Ross at Wellington Hospital, Julie Cook and Jinny Willis at Christchurch Hospital, and Mary Blok and Marguerite McLelland at Dunedin Hospital.

What is Metavention?

Metavention is an American medical device company, based in Minneapolis, Minnesota and Newport Beach, California. Metavention was founded in 2012 with the purpose of developing novel therapies for the treatment of diabetes and other metabolic conditions. The Metavention team is comprised of physicians, engineers and scientists with deep experience in the medical device field and is supported by venture capital investors and life sciences industry companies.

Contacts

Metavention, Inc

· Kevin Hykes, Chief Executive Officer –

· Bobby Azamian MD, DPhil, Founder, President & Chief Medical Officer –

Auckland City Hospital

· A/Prof Mark Webster MBChB, FRACP – Cardiology –

· Rinki Murphy MBChB, FRACP, PhD – Endocrinology -

· Jan Burd RN – Study Coordinator -

Middlemore Hospital

· Wil Harrison MBChB, MMedSc, FRACP – Cardiology –

· Brandon Orr-Walker MBChB, FRACP – Endocrinology –

· Diane Caveney RN – Study Coordinator -

Dunedin Hospital

· A/ Prof Gerard Wilkins MBChB, FRACP – Cardiology -

· A/Prof Patrick Manning BHB, MBChB, MMedSc, FRACP – Endocrinology -

· Mary Blok RN – Study Coordinator -

Wellington Hospital

· Scott Harding Wilkins MBChB, FRACP – Cardiology -

· A/Prof Jeremy Krebs Manning MBChB, FRACP – Endocrinology -

· Cecilia Ross RN – Study Coordinator -