News / Synopsis: 2008 – 2010

Acuity Medical Systems is pleased to announce its new relationship with the University of Minnesota School of Medicine.

A paper co-authored by George D. O’Clock, PhD (Acuity Medical Systems co-founder and consultant to the University of Minnesota Medical School, Department of Pediatrics) and John B. Jarding OD, FAAO (Acuity Medical Systems co-founder and Chief Medical Officer) has been published in the Proceedings of the 31st Annual International Conference of the IEEE Engineering in Medicine and Biology Society. The title of the paper is Electrotherapeutic Device/Protocol Design Considerations for Visual Disease Applications. Dr. O’Clock presented the paper on September 3, 2009. This peer-reviewed published paper explains part of the science and design philosophy behind the TheraMac® device. It also provides the results achieved with the Acuity Medical Systems FDA guided open label studies and the FDA supervised double-blind Phase I clinical trials. The papers from this conference are indexed on MEDLINE. Dr O’Clock was the co-author of two papers in the conference and was appointed Chairman for the Muscle and Nerve Stimulation session.

Acuity Medical, Inc. announced it has completed requirements for the CE Mark in Europe and Canada

John Jarding the spokesperson for Acuity Medical announced today that the company after 9 years of development has successfully completed two FDA trials and product development. It has also received the CE Mark, allowing it to begin sales in Europe and Canada.

Acuity Medical Enhances Patents and Intellectual Property

John Jarding announced today that the company has increased its patent and intellectual property protection.  Additional patent expansions have been approved and the company is working on the enhancement of global patents and on product upgrades to protect its position when the Acuity Macular Degeneration (MD) therapy medical devices rollout globally.

Acuity Medical Announces Name Change

Acuity Medical, Inc.  has elected to change its name to Acuity Medical Systems, Inc. (DBA) to better reflect its broader scope of products and services related to Macular Degeneration.  The name change will become effective immediately.

Acuity Medical Systems, Inc. Announces New Chairman and Vice Chairman

In an announcement by the company, Peter C. Lytle, Managing Partner of BDG Partners, a strategic planning and investment banking firm, who has a background in the medical and science research products field, has been named Chairman of Acuity Medical Systems, Inc. Lytle has successfully taken companies from one million in sales to over $600 million in sales in less than two years. John Jarding, OD, a co-founder of Acuity and key researcher for Acuity has been named Vice-Chairman.

Acuity Medical Systems, Inc. Announces New Executive Team

Blair Mowery of the M&A Group and a former CEO of a public medical company has been named President and CEO, Marshall Masko a former senior executive with a micro stimulation medical device company has been named Executive Vice President of Sales and Marketing. Both individuals have strong backgrounds in the area of medical products, working with startup ventures, raising money and building teams to drive growth.

Acuity Medical Systems, Inc. Announces the Launch of its Clinical Therapeutic System and Change in Design for the TheraMac Home Therapy System

In an announcement by the company, Acuity Medical Systems, Inc. is designing a new feature added model for its home therapy system, code-named the TheraMac Vision II® and a second professional clinical unit, code named TheraMac® Pro

Acuity Medical Systems, Inc. Announces Introduction of the TheraMac Vision II® System into Europe

The TheraMac® System designed to aid in the management of Dry Macular Degeneration will be introduced into Europe in the Summer of 2010, according to Blair Mowery, the company CEO.  The System received CE mark approval after successful completion of clinical trials for the treatment of Dry Macular Degeneration.  This is the first MD device to demonstrate in clinical trials significant improvement in vision for individuals with Dry Macular Degeneration.

Acuity Medical Systems, Inc. Announces the Planned Introduction of the TheraMac Vision II® System into Canada this year (2010)

Blair Mowery announced that Acuity Medical Systems will introduce the TheraMac Vision II® System into Canada this year.  The medical device has been granted a CE mark following clinical trials, allowing sales in Canada, where it is awaiting final approval, which is expected by summer. The medical procedure is provided in a doctor’s office and some patients will have the ability to take a specialized medical device home for continued therapy.  This is not an OTC device, it is prescribed. Patients will go to a referral center where a visual test will take place to determine if they are a candidate for the treatment, then they will go through a four or five day, 40 minute treatment session.  The sessions are pain free, economical and generally show improved vision for the patient by the end of the first week.

Acuity Medical Systems, Inc. Relocates to Minnesota

Acuity Medical Systems, Inc. of South Dakota and Michigan announced today that it has consolidated and relocated its corporate and development offices to Wayzata, Minnesota, a suburb of Minneapolis.  According to Peter Lytle, Chairman of Acuity, this move has been done to attract more talent to the company.  Minneapolis has a variety of companies like Medtronic that are focused on micro stimulation and a large talent pool from the University of Minnesota Medical Research Centers doing research in this area which the company can draw on as it grows.

Acuity Medical Systems, Inc. Announced That it Will Raise $3 Million to Enhance Its Financial Position for Development and Growth

Peter Lytle, Chairman of Acuity Medical Systems, Inc. announced that the company would raise an additional $3 million to manage growth of the company and for use with additional product development. The MD market is considered to be in the $56 billion range. Until the introduction of the TheraMac System, Dry Macular Degeneration suffers have had no FDA tested devices to rely upon for managing the disease, which is considered the leading cause of blindness in the developed world.

Acuity Medical Systems, Inc Announces New CFO and Supporting Rolls for Lytle and Jarding

Blair Mowery CEO of Acuity announced that Peter Barsness, a CPA, well-recognized financial consultant and experienced CFO with several brand name companies has been named CFO of Acuity Medical Systems, Inc.  Peter Lytle and John Jarding will be providing additional support in operations and product development as the company explores new device enhancement opportunities and additional FDA trials.

Sandhill® Scientific and Acuity Medical Strategic Partnership Announced

Peter Lytle, Chairman of Acuity Medical Systems, Inc. announced that Acuity and Sandhill Scientific, a leader in medical device development and manufacturing, have begun a strategic partnership for the production of the line of TheraMac and MacPro medical systems.  In addition Sandhill Scientific will be providing additional support in customer service, clinical education and compliance for Acuity Medical Systems.

Acuity Medical Systems to start process for next FDA trial on new generation of MD medical devices for the US population of Dry Macular Degeneration suffers

Blair Mowery, CEO of Acuity Medical Systems announced that the company is in the planning stages for a final FDA trial with its TheraMac medical devices.  Upon successfully completing the trials they anticipate a rollout of the new generation of TheraMac Vision II products to the US markets. Mowery would not speculate on the timing of the trial.

Acuity Medical Systems, Inc Launches New Website

Acuity Medical Systems has dropped it old logo, created a new one and launched a simpler and easier to use website.  The site is designed to become a future repository for all research information on Macular Degeneration.  It is expected that Acuity Medical will spend several years categorizing this information.  The purpose is to aid MD patients with a single stop to see all clinical information about MD and provide a social networking location for groups to discuss MD and related retinal issues.