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NIA Small Business Showcase: Healthy Design

NIA SBIR Web BannerOlder patients who are mechanically ventilated are often immobilized with wrist restraints and sedated to prevent self-extubation and reduce agitation. This leads to complications, including delirium and muscle weakness, reduced physical functioning, and increased risk of mortality. The incidence and duration of delirium in the intensive care unit (ICU) are strongly and independently associated with long-term cognitive impairment that is similar to Alzheimer’s disease and related dementias.

Two animated people arched over the words "Healthy Design"Healthy Design is developing the novel Exersides™ as a restraint alternative that allows arm mobility by helping patients move without snagging endotracheal and feeding tubes or intravenous lines, cords, and other medical equipment. Because it precludes forced immobilization by permitting safe mobility, Exersides™ reduces agitation and the need for sedatives and increases mobilization, which can then lead to faster healing and fewer complications.

The estimated market for Exersides™ is expected to be $600 million. The current market includes confused or intubated adult and pediatric medical, surgical, postoperative, mentally challenged, and neurologic patients, as well as patients in long-term acute care and rehabilitation hospitals. Also included are government contracts for Veterans Administration hospitals with post-traumatic stress disorder concerns and military medevacs. Based on expressed interest, new markets involving non-ICU ward patients, who are currently over-sedated, as well as hospice, nursing home, and ambulance patients, will add a 10-fold increase in potential new users.

As institutions follow guidelines on sedation minimization, delirium prevention, and early mobilization, demand for this device will increase to maintain patient safety and improve outcomes as an avenue for cost savings. This is especially poignant during the COVID-19 pandemic sedation shortage and our current limited ability to mobilize patients and tend to delirium prevention policies. A testament to market need is the existence of organizations that function solely to assist hospitals in addressing complications the Exersides™ Refraint™ System targets.

Exersides™ prevents unwanted removal of vital tubes and lines without chemical or physical restraints and provides multiple levels of Refraint™ and restraint. Exersides™ allows patients to move while keeping them from disconnecting vital equipment. There is no need to remove competitor products, so product bundling and existing contracts are not obstacles to market entry. The Refraint™ System addresses the tidal wave of patient-centric care initiatives underway by payors, key opinion leaders (KOLs), and international medical societies.

Healthy Design enjoys a last mover advantage with a new technology in a mature market and is also developing additional products for the same market. International KOLs are conducting Healthy Design’s NIH STTR Fast Track multisite clinical trial, and company founders are participating in international medical societies, task forces, public forums, and thought leadership forums. The company is also a woman-owned small business and HUBZone-qualified.

Company Milestones

Scientific

  • 2017: Pilot study showing decreased agitation scores, decreased sedation usage, increased mobility, increased interaction, and improved satisfaction by patients, families, and staff. Based on patient feedback, more features added to the device.
  • 2018–2019: Single-center clinical trial at The University of Vermont Medical Center showing safety and feasibility, as well as family, staff, and patient satisfaction. More features added to the device following staff feedback.
  • 2020: Multisite clinical trial measuring delirium, agitation scores, sedation usage, and mobility being conducted by international KOLs at Johns Hopkins University, the University of California San Diego, and The University of Vermont Medical Center.
  • 2021: Research and development of a dedicated pediatric Exersides™ Refraint™ System, scheduled to be completed by the end of 2020.
  • 2021: Acceleration of ongoing development of the next-generation model of Exersides™, to include its sensor. Initial research has been completed to create a new dictionary of patient behavior that will be used in the development of three new device capabilities by the end of 2021.
  • 2021: Acceleration of ongoing development of other devices for the same patient population, to be introduced between 2021 and 2022.

Business

  • 2016: Company founded with an NIH award of $25,000 from Incubator. Extensive customer discovery.
  • 2017: Device development, including focus groups and healthy subjects. Pilot study.
  • 2018: Received an NIH award of $1.86 million for clinical trialing and device development.
  • 2018–2020: Conference exhibitions with collection of more than 1,000 interested subscribers.
  • 2019: Creation of a robust medical device quality management system./li>
  • 2020: Received an NIH supplemental award of $375,000 to accelerate manufacture and commercialization in a timely manner to assist with the COVID-19 pandemic.
  • 2020: Hiring of a medical device innovation-to-market expert to spearhead the company’s launch strategy and build infrastructure for post-market analysis.
  • 2020: Quarter 3 launch with combination in-house manufacturing and contract manufacturing of the company’s first run of 1,000 devices.
  • 2020: Organic growth, including manufacturing and sales hires as well as partnerships, including licensing, co-marketing, wholesale, distribution, and acquisition.

Financial Overview

Healthy Design has raised $2.3 million in NIH funding from 2015 through 2021. The company anticipates active interaction with investors from 2020 to 2022, raising $3 million to $8 million to fully launch and then penetrate markets, as well as for complete development of next-generation devices. In 2021, Healthy Design will apply for up to $3 million in additional NIH funding for a next-generation model and pediatric device.

Intellectual Property

  • Trademarks: Exersides™, Refraint™, TheraPete™
  • 2020: U.S. Patent No. 10646369: Medical Protective and Exercise Restraint Systems and Methods
  • 2020: China patent issued for Medical Protective and Exercise Restraint Systems and Methods

Additional international patent applications for the current device and patent applications for developing products have been submitted.

Product Development and Regulatory Strategy

The Exersides™ Refraint™ is a Class I 510(k) exempt device and one of only five such devices required to maintain design controls. A quality management system is in place, maintained by the company’s quality officer and overseen by its regulatory and quality consultant. U.S. Food and Drug Administration allowance for market entry was granted in October 2019.

Commercialization Strategy

Healthy Design is preparing for imminent launch. The company is pursuing several promising leads while training and new marketing materials are set in place before product availability is widely announced. At that time, Healthy Design will contact the more than 1,000 leads procured from two years of exhibiting at international conferences, and sales will begin in earnest. Healthy Design has acquired a successful medical device commercialization expert, and company systems are being established for a well-prepared and sturdy launch.

Company Details

Healthy Design website

35 Mountain Spring Road
Chittenden, VT 05737-9843

Industry: Therapeutic Device

Management Team:

  • President and CEO: Marie Pavini, M.D., FCCM, FCCP
  • Medical Device Expert-in-Residence: Stephen Flint, with 25 years in successful senior leadership and as a chief technology officer delivering therapeutic innovation, patient safety, and improved outcomes to the market and beyond
  • Chief Quality Officer: Evan McKenzie, B.M.E.
  • Lead Design Engineer: Jacob Lind

Point of Contact:
Marie Pavini, M.D., FCCM, FCCP
Email Marie Pavini
(800) 821-1002

Conference Selected for Showcase: Digital RESI (June 2020)