BINGHAMTON — The national statistics are stark. On average, Americans sit 11 hours per day. For people 35 and older, 20 percent of deaths are attributed to a lack of physical activity. Less than 20 percent of the U.S. workforce holds physically active positions. Sedentary lifestyles are estimated to cost the country $24 billion in direct-medical spending.

The typical remedy involves turning off the TV or computer, getting your derrière off the sofa, and exercising to stimulate cardio activity. Enter Heart Partner, a product developed by Binghamton–based Sonostics, Inc. to eliminate common symptoms associated with prolonged sitting, such as lower-limb edema, cold hands and feet, fatigue, varicose veins, leg cramps, restless-leg syndrome, dizziness, fibromyalgia, osteoporosis, achy muscles and joints, blurry vision, memory lapses, and difficulty concentrating. Heart Partner doesn’t ask you to exercise; rather, its remedy is counter-intuitive: Remain seated and simply place the balls of your feet on a machine that vibrates at a specific frequency and pattern. Voila, an easy cure for secondary-heart insufficiency.

“The reference to a second heart confuses most people,” says Kenneth J. McLeod, an entrepreneur-in-residence at Binghamton University and the director of the Clinical Science & Engineering Research Center at the university. McLeod is also president & CEO of Sonostics. “The symptoms [noted above] are common in people who sit for long periods. All of them can arise as a result of blood pooling in the lower extremities of the body. A low fluid return to the heart reduces blood circulation in both the upper and lower body. The lack of proper fluid return is generally the result of insufficient soleus-muscle activity. (The soleus muscle is located in the calf of the lower leg and serves as the major body pump for returning blood to the heart.) We developed Heart Partner specifically to retrain the soleus muscles to reduce or eliminate a host of symptoms.”

The Heart Partner provides a 50-micron displacement to the sole of the foot at 45 hertz, a setting designed to optimally stimulate mechanoreceptors on plantar surfaces. The machine vibrates at this setting for one minute and turns off for two minutes, a pattern that mimics the soleus muscle’s natural contraction cycle. “The plantar surface contains a specific type of mechanoreceptor called Meissner’s Corpuscles, which are specialized nerve-endings in the skin,” continues McLeod. “These serve to activate the soleus muscle through a reflex arc, which pumps the fluid in the lymphatics and the deep veins back to the heart and, in turn, reduces venous-tissue pressure and increases cardiac output.”

Sonostics is a for-profit company established to commercialize innovative biotech research at Binghamton University. Founded in 2008 by McLeod and Chuck Schwerin, who remains a company board member and also is a small-business adviser to the Small Business Development Center in Binghamton, Sonostics originally focused on diagnostics for early identification of muscle imbalance. In 2010, the company released a trademark product called MyoWave, a device for the non-invasive assessment of muscle performance and the detection of muscle imbalance, and entered into a sales agreement with BioPac Systems. The next focus was on adults engaged in sports. 

“In the summer of 2013,” notes McLeod, “we totally restructured the operation and converted to a hardware company, which included replacing the original board with new directors. Heart Partner is our first product, designed to help 20 percent of the population with a non-invasive solution to inadequate venous and lymphatic return (rate of fluid flow back to the heart). After two years of testing and market validation, we released the first generation of Heart Partner on Oct. 1, 2015.” 

“At this stage,” says Schwerin, “Sonostics is a wellness company. That means that Heart Partner is classified as an exercise device, not subject to FDA (Food and Drug Administration) oversight. While we sell [Heart Partner] units to individuals who contact us, we are not working the consumer market. Our primary focus is on reaching public and private companies and governmental entities with more than 300 employees which self-insure [under ERISA], and [thus] see a direct cost savings and added productivity from healthy employees. Our sales channels include selling directly to the companies and also promoting the product to TPAs (third-party administrators), which administer the companies’ programs.” 

Growth plans
Sonostics currently employs five people and contracts with a manufacturer in Singapore to produce the units. Annual projections forecast sales of 100 to 200 units per month, totaling 2,100 in calendar-year 2016 and escalating beginning in 2017. The retail price is $595 for the basic unit. The company projects gross revenues this year at about $800,000. The university owns the patented technology and has licensed its use to Sonostics, which pays a royalty to the university. To date, 20 investors hold stock in the C-corporation. McLeod says the company is only months away from the break-even point. 

The co-founders have aggressive plans for growing the company. “While we see a large market as a wellness company, converting to a health-care company opens up a much larger market for us,” McLeod says. “We are working on advanced designs of our Heart Partner and already designing a new generation of products that will be inserts into an individual’s shoes. In the short term, we are focusing on areas such as improving the healing of venous ulcers and reducing obesity. We are also running trials on cognitive aging to slow or reverse the effects of Alzheimer’s and dementia. The plan is to take our studies to the FDA for confirmation and approval in order to release our products for sale to the medical community. In 2016, our target markets are obesity and cognitive aging, in 2017 enhanced wound healing.” 

Funding Sonostics has been challenging. “Initially, Chuck and I made personal investments; pitched friends, family, and angel investors; and pursued a variety of grants and loans,” notes McLeod. “We received a federal grant for $225,000 from a collaboration between the NIH and IRS, which was offered to companies conducting medical-device research. New York State also helped to fund our research and development by allowing us to develop a prototype at Stony Brook; issuing a grant to leverage graduate-student research; and rewarding our research through a state tax- and finance-administered program designed to boost technology transfer in small, startup companies by accepting tax benefits as grants.” 

He continues, “The BCIDA (Broome Country Industrial Development Agency) loaned us $100,000 and offered incubator space in the Innovation Center, and Tioga State Bank supported us with a loan for operations and for buying equipment. Now we want to speed up our product development with a $5 million fundraising effort that will support our clinical trials; engineering and tooling of our second-generation products; development of the third-generation, electromagnetic inserts that require no vibration; and marketing and sales. We have plenty of interest from not only domestic markets but also from foreign markets. Our goal for the third-generation products is to be first to market by 2018.” 

The co-founders agree that this is not the time to bootstrap the company’s growth. “We have chosen to utilize the federal EB-5 program,” says McLeod. “EB-5 targets foreign direct investment for the purpose of stimulating U.S. economic growth. To be eligible, an investor must commit a minimum of $500,000, prove the funds were obtained lawfully, and create at least 10 full-time, U.S. jobs. We think this is the fastest and easiest way to reach our $5 million goal by this August.” 

The EB-5 Visa–Immigrant Investor program was launched in 1990. Figures from 2010-2013 reflect a $9.2 billion contribution to the country’s GDP, $2 billion in tax revenue, and an average annual job creation of 41,000 in years 2012 and 2013, all at zero cost to taxpayers. The immigrant investor receives a green card and has the option to set up and manage a U.S. business, live in any state, conduct any activity of his choice, or just retire. 

Background of the principals
In 1977, McLeod earned a bachelor’s degree in electrical engineering from Kettering University in Flint, Michigan. He next earned his master’s degree in electrical engineering in 1981 and his Ph.D. in electrical engineering and bioengineering in 1985 from MIT. McLeod was a professor at Stony Brook University from 1987 until 2002, where he taught in the department of orthopaedics. He joined the Binghamton University faculty in 2002 and served as a professor and chair of the bioengineering department until 2010. He assumed the title of director of the Clinical Science and Engineering Research Center in 2007 and continues to guide the center’s health care-product development and clinical testing. In 2014, McLeod was named the entrepreneur-in-residence in the university’s office of Entrepreneurship and Innovative Partnerships, where he nurtures students with entrepreneurial interests and assists newly launched alumni ventures. He specializes in electromagnetic interactions with living tissue and second-heart physiology and function. 

Schwerin earned a bachelor’s degree in geography from Clark University and his master’s degree in environmental policy and planning from Tufts University. He began his career in 1990, where he founded and served as president of Environmental Data Systems, which produced electronic-medical packages and compliance software for medical practices and software products for the waste-management field. In 1999, he moved to MapInfo as a senior product manager, garnering three patents for geo-coding engine design. Schwerin joined Sonostics in 2008 as the CEO and currently serves as a small-business adviser at the Small Business Development Center (SBDC) administered by Binghamton University and funded by the U.S. Small Business Administration. The SBDC, with regional headquarters in Binghamton, serves seven Southern Tier counties offering one-on-one business counseling and training to assist startup and existing companies. 

“Outside of the traditional startup sweet spots of Silicon Valley, Research Triangle, and Route 128 outside Boston, there historically has been neither the institutional knowledge nor the raw materials for nurturing an environment for innovative, high-tech startups like Sonostics,” says Schwerin. “Starting most businesses is akin to salmon swimming upstream, hoping to spawn the next generation. The key is for entrepreneurs to partner with research institutions and their faculties to convert pure research into a commercially viable product underwritten with sufficient investment and community support. With the vast SUNY system and its research network, we have the capacity to foster an environment where small businesses like ours can thrive.”

The co-founders of Sonostics have a much larger goal than being a thriving company that successfully transfers pure research into products for the health-care marketplace. “Our ultimate vision,” stresses McLeod, “is to delay and eventually prevent every Baby Boomer from suffering the debilitating effects of Alzheimer’s and Parkinson’s disease. We want to accomplish this in the next five to 10 years.”        

Contact Poltenson at npoltenson@cnybj.com