Onward Medical Archives - Medical Design Sourcing

Onward raises $22M to support neurostim tech

The Onward ARC-IM implantable pulse generator and lead. [Image from the Onward website]Onward Medical announced today that it successfully raised $21.8 million (€20 million) in gross proceeds through a private placement.

The company offered more than 4.4 million new ordinary shares at an issue price of $4.89 (€4.50) per share. It completed the offering with participation from institutional investors, certain founders and management and members of the board.

Onward plans to use 45% of the net proceeds to fund R&D activities. That includes the development and regulatory process for its investigational ARC-EX system. ARC-EX nerve stimulation technology aims to restore hand and arm function. Additionally, the company plans to put funds toward its investigational ARC-IM system for improved blood pressure regulation after spinal cord injury.

The company also has the ARC-BCI system that won FDA breakthrough device designation last month. Onward didn’t li…

FDA accepts Onward BCI into advisory program

The Onward ARC-IM neurostimulation device. [Image courtesy of Onward]Onward Medical announced today that the FDA accepted it into its new Total Product Lifecycle Advisory Program (TAP) — a move that could boost the development of Onward’s BCI technology.

Acceptance into the TAP program comes on the heels of FDA breakthrough device designation for the ARC-BCI system last month. Breakthrough device designation is a requirement for TAP consideration, according to a news release. Onward says that this nod made its BCI only the second such system accepted into the program.

TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Onward can benefit from more timely premarket interactions, earlier identification and mitigation of device development risk and a more efficient premarket review for its ARC-BCI system.

ARC-BCI uses brain-computer i…

Onward wins FDA breakthrough nod for use of neurostim with brain-computer interface

The Onward ARC-IM neurostimulation device. [Image courtesy of Onward]Onward Medical announced today that the FDA granted breakthrough device designation for its ARC-BCI system that uses brain-computer interface (BCI) technology.

ARC-BCI uses BCI technology in conjunction with ARC-IM neurostimulation. It aims to restore thought-drive lower limb mobility after spinal cord injury (SCI). The BCI system uses AI to decode brain signals and translate them into specific instructions for the neurostimulation system. This converts the instructions into precise spinal cord stimulation.

The company describes the result as a “digital bridge” that restores communication between the brain and the body. It can enable thought-driven movement after paralysis.

Onward used clinical data from two feasibility studies to support the breakthrough nod. The company also announced the first implant of this technology in a study evaluating upper extremity function restorat…

Onward begins neurostim study to address post-spinal cord injury hemodynamic instability

The Onward ARC-IM implantable pulse generator and lead. [Image from the Onward website]Onward Medical announced today that it began the HemON NL clinical feasibility study to evaluate its ARC-IM neurostimulation therapy.

Onward said that, in late 2023, a study participant received the investigational ARC-IM neurostimulator and lead implant. This study aims to assess the safety and effectiveness of the therapy to address hemodynamic instability after spinal cord injury (SCI).

The Eindhoven, the Netherlands-based company is conducting its study at Sint Maartenskliniek in Nijmegen, the Netherlands. Dr. Erkan Kurt of Radboud University Medical Center performed the surgery. Dr. Ilse van Nes of Sint Maartenskliniek serves as the principal investigator of HemOn NL.

Onward said that HemON NL builds on its Swiss HemON clinical feasibility study. It also prepares the company for the expected initiation of the Empower BP global pivotal trial. The company designed Empo…

5 more brain-computer interface companies you need to know

BCI technology from Cognixion, Precision Neuroscience, InBrain Neuroelectronics and Kandu Health.

The brain-computer interface (BCI) space continues to rise in notoriety, and a number of players are throwing their hats in the ring.

Such technologies could enable users to control a computer with their brain, or even go beyond that. Countless immobile people someday could control a mouse cursor, keyboard, mobile device/tablet, wheelchair or prosthetic device by only thinking.

Big names have already established their presence in the space. Elon Musk’s Neuralink continues to make headway, while Bill Gates- and Jeff Bezos-backed Synchron has an innovative catheter-delivered implant. Blackrock Neurotech, which has a next-generation BCI, has been implanting its Utah Array in patients since 2004.

Those companies and more were covered in last year’s roundup of brain-computer interface companies you need to know. But there are several more companies ou…

Onward spinal cord stimulation demonstrates improved mobility in study

The Onward ARC-IM neurostimulation device. [Image courtesy of Onward]Onward Medical announced a new publication demonstrating the impact of its ARC therapy to address gait challenges related to Parkinson’s disease.

Eindhoven, the Netherlands-based Onward designed its ARC-IM stimulation system to deliver targeted, programmed therapy to the spinal cord. It aims to restore movement and other functions after spinal cord injury.

The study, published in Nature Medicine, evaluated a patient living with Parkinson’s for nearly three decades. The subject has a severe gait disorder that failed to respond to conventional therapies.

In a press release issued by Switzerland’s Lausanne University Hospital (CHUV), the subject said: “I could hardly walk without frequent falls, several times a day. In certain situations, like getting into an elevator, I would stomp, freeze as they say.”

Researchers from the Swiss Federal Institute of Technology…

How Onward is combining spinal cord stimulation with BCI to restore movement

The Onward ARC-IM neurostimulation device. [Image courtesy of Onward] The brain-computer interface space has taken medtech by storm. This novel approach from Onward has the potential to bring it to another level.

Several companies are developing brain-computer interfaces (BCIs), many of which offer people with paralysis a chance to control external devices with their mind. Onward, a Dutch medtech company, develops technology that could utilize BCIs to go even further.

Onward’s ARC-IM stimulation system delivers targeted, programmed therapy to the spinal cord. It aims to restore movement and other functions after spinal cord injury. Combined with BCI technology, the company believes it could restore thought-driven movement.

The BCI works in tandem with ARC-IM to capture the intention of a paralyzed individual to move their upper extremities. It uses artificial intelligence (AI) to decode those thoughts and convert the information into ARC-IM therapy. Precise sti…

Onward announces first-in-human implant of stimulator with BCI

The Onward ARC-IM neurostimulation device. [Image courtesy of Onward]Onward Medical announced today that it completed the first-in-human implant of its ARC-IM stimulator for restoring upper extremity function.

Eindhoven, The Netherlands-based Onward designed the stimulator to restore function after spinal cord injury (SCI). The patient also received a wireless brain-computer interface (BCI) for initiating thought-driven movement when paired with ARC-IM.

Onward’s ARC-IM delivers targeted, programmed therapy to the spinal cord to restore movement and other functions after SCI. Multiple feasibility studies demonstrated restored mobility and stabilized blood pressure with the device.

Last month, Dr. Jocelyne Bloch performed two procedures at Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland. The ARC-IM implant took place on Aug. 14 and Bloch implanted the WImagine BCI from CEA-Clinatec nine days later.

The BCI works …

Brain-spine ‘digital bridge’ allows spinal cord injury patient to walk — and enjoy a beer

“This simple pleasure represents a significant change in my life,” Gert-Jan Oksam said of his regained ability to stand at a bar with friends thanks to an experimental “digital bridge” between his brain and spine. [Photo courtesy of NeuroRestore]

A wireless “digital bridge” between a paralyzed patient’s brain and spinal cord has allowed him to walk naturally, researchers say.

The experimental technology uses electronic implants on the brain and spinal cord to relay leg movement control signals, allowing 40-year-old Gert-Jan Oksam to walk again 12 years after a bicycle accident.

Neuroscientists and neurosurgeons from Ecole Polytechnique Fédérale de Lausanne (EPFL), Lausanne University Hospital (CHUV) and University of Lausanne (UNIL) published their research in Nature last week.

“We have implanted Wimagine devices above the region of the brain that is…

Research supports brain-computer interface tech from Onward

The Onward ARC-IM implantable pulse generator and lead. [Image from the Onward website]Onward Medical announced today that published data demonstrates the ability of its wireless brain-computer interface (BCI).

The data, published in Nature, demonstrates how the BCI uses thought to modulate ARC therapy. Researchers say that, when paired with ARC therapy, an implanted BCI allowed an individual to gain augmented control over when and how he moved his paralyzed legs.

Onward designed its ARC-IM lead to restore movement, function and independence in people with spinal cord injury (SCI). The Eindhoven, the Netherlands-based company developed ARC-IM to deliver targeted electrical pulses to the spinal cord. It represents a key component of the Onward ARC-IM system engineered to deliver ARC therapy to address multiple indications. The company completed first-in-human use for its movement-restoring lead earlier this month.

“This publication shows the remarkable poten…

Onward completes first-in-human use of movement-restoring lead

The Onward ARC-IM implantable pulse generator and lead. [Image from the Onward website]Onward Medical announced today that it successfully completed the first-in-human use of its investigational ARC-IM lead.

Eindhoven, the Netherlands-based Onward designed the lead to restore movement, function and independence in people with spinal cord injury (SCI).

The company developed ARC-IM to deliver targeted electrical pulses to the spinal cord. It represents a key component of the Onward ARC-IM system engineered to deliver ARC therapy to address multiple indications. The lead works in combination with the ARC-IM neurostimulator (IPG). Onward purpose-built it for placement along the spinal cod to stimulate the dorsal roots with specific parameters outlined for each anatomical location.

According to a news release, Onward has a portfolio of these leads in many shapes, sizes and electrode arrays under development. Future indications the company may explore include blo…

Paralyzed patients walk, swim and cycle with spinal cord neuromodulation implant

The spinal cord stimulating electrodes are implanted directly on the spinal cord, below the vertebrae. [Image courtesy of the Swiss Federal Institute of Technology in Lausanne]

The latest iteration of a spinal cord stimulation implant has allowed three paralyzed patients to take steps independently on a treadmill within a day of their device’s activation, and to stand, walk, swim and even pedal a bicycle after five months of rehab.

In 2018, the technology helped a patient get out of his wheelchair and walk after being paralyzed by a partial spinal cord injury, but the latest results helped three men with complete spinal cord injuries walk again beyond the walls of the lab.

“Our stimulation algorithms are still based on imitating nature,” system co-developer Grégoire Courtine, a professor at the Swiss Federal Institute of Technology in Lausanne, said today in a news release. “And our new, soft impla…