After a running start of the fiscal year, July 1, 2016 - June 30, 2017, it’s high time for a status update from the company. The status can be briefly summarized as everything runs according to plan in terms of development and research. The good news is that sales also exceeded expectations.
Launch of new Foot Device
The company's new foot instrument will be ready in 2017, with the required CE approval. Estimated sales start is set to the fourths quarter of 2017, but it is too early to estimate what this means in terms of sales.
Currently, we are working to develop a detailed launch plan but the main features are already in place. The launch is divided into several stages and the first, which has already started, is called pre-launch.
In this context it is important to point out that a successful launch of a new medical device requires that you can prove that it will provide a clinical added value. The medical health care today is extremely strained why it is not enough to develop new technologies that provide only a marginal improvement.
This basic idea has been the main guideline for the launch plan of the foot instrument. As a consequence we will initially focus on selling the foot device to researchers and to research institutions. We believe that this business is large enough to generate good income to the company, since our product aims at diagnosis within diabetes which is the world's most widespread disease.
However, this is only our first milestone. Once we have received, what we call an "academic consensus" from leading diabetes scientists, the plan is to go ahead. We will then change our target and focus on reimbursement systems, diabetes centres and patient organizations. The last step is the "Roll Out" phase, where the real volume growth to shall occur.
Pre-Launch of new Foot Device
The Pre-launch is the first step where the goal is to communicate our existence and to find interesting research groups that are interested in the new device. The pre-launch is a preparation for the planned sales start, in Q4 2017, and it will continue running until then.
The annual EASD congress, this year held in Munich, was the start of our pre-launch. The purpose of our participation was to get in touch with researchers who are interested in doing research with our instruments.
Physician Eero Lindholm's oral presentation, where he presented his research findings obtained with our prototype foot device gave us a great boost. We were fully occupied most days with presenting our technology for diabetes researchers, without usual dips between seminars.
A number of contacts were made, some more valuable than others, and my judgment is that this may result in interesting research studies. We also received a lot of interest from doctors and professors from Russia and China.
This autumn and winter, we will continue our pre-launch. VibroSense will participate on the "French-Swedish Life Science Day 2016" in Paris on 20 October. Moreover, VibroSense will participate as an exhibitor at the Medica fair in In Dusseldorf in November 2016. Medica is the world's largest trade fair in medical technology.
VibroSense has also engaged an international public relations company, who in a very short time has managed to generate five articles, three of which in the international media and two in the Swedish media
Development of the foot device
The development runs on unabated. The design concept is set and the mechanical design has come far. The detailed design of the electronics is completed and all parts to the Alpha-prototype will be manufactured soon. This shall be a working prototype that includes both new mechanics and new electronics.
The Alfa prototype will be used for tests of both functionality and pre- CE marking. The Alpha prototype will be showcased at Medica fair, but only as a visual model since we do not want to reveal critical functionality in advance to not limit our ability to get a strong IP protection.
During autumn and winter we will carefully evaluate and select a contract manufacturer that will manufacture the new foot device. We will also select and contract a global Type Approval provider who shall handle the required approval process of the foot device, including the CE marking.
The Type Approval supplier must be a so-called "Notified Body", since this significantly facilitates the process of obtaining type approvals in most countries outside the EU.
On-going Research Studies
The activity has increased gradually during September after a pause during the summer vacation. Shortly, we will replace the existing foot-prototypes with new devices having much greater dynamics than current prototypes. The new prototype supports significant larger frequency range, i.e. from 4-250 Hz.
At the moment we have collected reference data from about 500 healthy people. The plan is that the data collection shall be completed during the first quarter of 2017, rendering reference data from 400 women and 400 men, equally distributed between 20 to 70 years of age.
Dr. Lindholm is very hopeful with the upgraded foot prototype (4-250 Hz) as it may reveal further new knowledge about diabetes-related impaired sensitivity at the sole of the feet.
About VibroSense Dynamics AB (public)
VibroSense Dynamics AB (public) develops and markets efficient systems for early detection and diagnosis of peripheral sensory neuropathy, i.e. disease of large nerve fibres and nerve trunks in the legs and arms.
The Company, founded in 2005, is listed on the Small Cap list AktieTorget since May 2015. The product portfolio includes a CE-marked medical device, the VibroSense Meter, for diagnostics of impaired sensitivity in the hands.