Investment Summary

The future is looking brighter for 100M Americans living with neurological conditions and musculoskeletal disorders (e.g., Parkinson’s, stroke, urinary incontinence). These conditions significantly reduce patients’ quality of life and cost the healthcare system an estimated $800B annually.  Scientists and clinicians are working with very fine electrodes (smaller diameters than a human hair in some cases) that can be inserted into the brain or other tissue targets to mitigate neurological conditions with gentle electric fields. The market to treat neurological conditions with brain computer monitoring and computer interface (BCI) is estimated to be greater than $10B.

 

However, the force required to insert these tiny electrodes raises several challenges including 1) buckling or breaking the electrode, 2) causing brain tissue dimpling and electrode deflection, limiting precision placement, and 3) causing tissue damage which provokes the immune system to react, walling off the electrode and reducing the electrode’s working life.

 

Actuated Medical, Inc. (Actuated) is revolutionizing how neural devices are inserted. Our expertise in inserting needles into tissue has been explored to improve epidural, spinal, and bone biopsy procedures. In 2017, Defense Advanced Research Projects Agency (DARPA) scientists asked if our oscillated insertion technology could be used to insert electrodes into the brain with greater precision and less tissue damage. We took the Challenge! DARPA funded us $1.3M to develop, then commercialize, the NeuralGlider inserter (www.neuralglider.com). The first NeuralGlider sales were to Stanford University and University of North Carolina (UNC). After DARPA, the National Institutes of Health/National Institute Neurological Disorders and Stroke (NIH-NINDS) awarded us $3M to continue our work. Recently, NIH awarded us several grants totalling $3.5M to evaluate our technology for peripheral tissue, deep brain stimulation and extending the electrode working life.

 

NeuralGlider has growing preclinical sales to world-leading brain research labs. The goal now is to transition the preclinical safety and efficacy data to clinical research and patients. We have already begun interacting with the FDA to determine what safety data is necessary for first-in-human studies. Our know-how in inserting sharps into tissue, combined with mechanical, electrical, and acoustic engineering, is enabling superior neural device technologies.

 

Our Strategic Plan drives toward an Actuated acquisition by 2029. To achieve our Plan, we need capital. Others in this market are raising millions of dollars via venture capital and private equity. Actuated’s strategy is different. We are raising a $2.5M seed round to support an Executive Sales & Marketing team to focus on selling off our other IP and products (e.g., GripTract-GI, TubeClear, BabyGentleStick). A portion of the product exit profits may be reinvested to support Actuated’s Strategic Plan. The remaining exit profits may be dispersed as shareholder dividends. Our Strategic Plan reduces the risk of needing future fund raises and corresponding shareholder dilution.

 

Actuated is currently valued at $40M. The $2.5M seed round will take equity in a Special Purpose Vehicle (SPV), ActMed Investco, LLC (ActMed). The sole asset of ActMed will be 6,761 shares of the common stock of Actuated, which will constitute 5.88% of the currently issued and outstanding common stock of Actuated on a post-acquisition basis and 4.36% of the fully diluted common stock of Actuated on a post-acquisition basis. As per the Strategic Plan, it is possible that ActMed investors receive a 18x return.

 

 

 

 

Actuated Medical is excited to be featured in the Women in Engineering Issue of Medical Design & Outsourcing, October 2022. Our CEO, Maureen Mulvihill, was featured in “10 women-led medtech startups you should know” on pages 38-41.

The Medical Design & Outsourcing editorial team drew on its resources to create this list of womenled startups. These companies are less than 10 years old or are still working toward commercialization of products and were founded by women and/or are led by women.

Nearly 16 years ago, Actuated Medical co-founder, President and CEO Maureen Mulvihill was working for a company making actuators that were the size of a grain of rice. While the company was focused on components, she wanted to help patients more.

“I was actually sitting in a doctor’s office and I was showing him the little actuators. He’s like, ‘Maureen, I don’t need that. I need the whole system FDA approved,’” she told Medical Design & Outsourcing.

Mulvihill understood that sentiment and went on to start Actuated Medical with the idea of putting motion into medicine.

I lead a small company that created a mechanical system to clear clogs in medical tubes, the TubeClear system. The first patient ever to use the product was a 27-year-old soldier in intensive care at Walter Reed hospital. The seed funding for my device development came from federal programs that some influential members of Congress could now limit or shut down. That would be a colossal mistake. 

Congress created the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs to encourage innovations from U.S. high technology startups like mine to meet government and industry needs. Participating agencies include the National Institutes of Health to support small companies to develop technologies to improve the health of U.S. patients. 

Burn victims at the University of California, Davis. Critical care patients at Harborview Medical Center, Seattle. Critical care surgical patients at Ohio State University Wexner Medical Center. Veterans in Omaha. A device called the TubeClear system unclogs medical tubes in all those settings. The first patient ever to use the technology was a 27-year-old soldier in intensive care at Walter Reed hospital in Washington, D.C. TubeClear would not have been possible without earning highly competitive grant funding from the federal Small Business Innovation Research (SBIR) program, said Maureen L. Mulvihill, PhD, president, chief executive officer, and co-founder of maker Actuated Medical. The central Pennsylvania firm applies electronically controlled motion to medical devices to improve patient outcomes. With 22 employees, the federally certified women-owned business is a member of AdvaMed Accel for start-up companies.

An article published by Bloomberg in July focused on the accelerating reshoring trend in manufacturing and noted that companies aren’t just talking about reshoring — they’re taking action.

Chip shortage may continue to be a manufacturing challenge

Mulvihill noted that “even with the significant government support, it will take many years for these chip manufacturers to begin producing products that industry needs today. We will still have supply chain issues while companies scale up production in the United States.”

Life Sciences PA 2020 CEO of the Year Award

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