ONWARD, a medtech company developing therapies to aid recovery from spinal cord injuries, plans to raise an additional USD 50m-USD 100m over the next 24-36 months, CEO Dave Marver told Mergermarket.
ONWARD, a medtech company developing therapies to aid recovery from spinal cord injuries, plans to raise an additional USD 50m-USD 100m over the next 24-36 months, CEO Dave Marver told Mergermarket.
Today, the company closed a EUR 27m (USD 32m) financing round, led by Dutch impact investor Invest-NL and Olympic Investments, the private investment arm of the Onassis Foundation, it said in a press release.
The funding round announced today provides ONWARD an approximately 18-month runway, he said, declining to disclose valuation or cash burn rate. The proceeds will be used to complete its R&D initiatives, fund a currently running pivotal trial, and complete preliminary studies for its next pivotal trial, he added.
ONWARD will need to raise the additional funds for further pivotal trials of its platforms over the next three to five years, Marver said. After that point, the company expects to be cash-flow positive, and not dependent on external capital, he said.
For its subsequent funding needs, it will focus on growth equity and crossover investors, he said. It will look at options in both the private and public markets, seeking financial partners who share its objectives and also allow it to raise capital in an efficient way, he explained.
Marver declined to comment on whether ONWARD will appoint a financial advisor for its future fundraising.
ONWARD was formed in 2014 by researchers at the Swiss Federal Institute of Technology (EPFL). Its proprietary ARC Therapy delivers targeted stimulation of the spinal cord to restore movement and other functions in in people with spinal cord injury. It has two platforms, an external and non-invasive one called ARC-EX, and an implantable platform called ARC-IM, which have both received breakthrough device designations from the US FDA.
It started FDA pivotal trials of the external system in January. ONWARD enrolled 65 subjects across 15 centers in the US, Canada, UK and the Netherlands. The trial, called Up-LIFT, studies the use of the system for improving upper extremity strength and function in people with spinal cord injuries.
Its platform technology can be leveraged across multiple indications, and as a result the company is planning multiple pivotal trials, Marver said. Other potential indications are in regaining walking ability after spinal injury, and restoring normal blood pressure, since low blood pressure is often a chronic problem for those who have spinal injuries.
The company expects US FDA approval for ARC-EX in early 2023 and for ARC-IM in 2024, Marver said. It plans to commercialize ARC-EX in 2023 for the upper extremity strength and function indication, he said. In 2024, it plans to commercialize ARC-IM for use in restoring normal blood pressure in people who have had spinal cord injuries, and later for aid in regaining the ability to walk, he added.
To date, the company has raised a total of EUR 63m, which includes today’s funding round, he said. Its previous investors, who also participated in the round announced today, include LSP, INKEF Capital, Gimv, and Wellington Partners.
The company is headquartered in Eindhoven, the Netherlands, and in Lausanne, Switzerland. It also has a team based in Boston, Massachusetts.