Despite Interruption, Pixium Vision Aims to Keep Moving Toward Commercializing Prima System

Despite a potential business arrangement with a fellow retinal prosthesis innovator falling apart in recent weeks, Paris-based Pixium Vision is working to stay on course with its goal of pivoting from being a research-oriented company to a commercialization-focused entity to take its sight-restoring technology to the next level.

Days after its agreement to acquire Second Sight Medical Products fell apart, Pixium initiated the clinical trial of its lead technology, received recognition for its innovative technology, and then firmed up its financial position.

Terminated Business Arrangement
Paris-based Pixium and Los Angeles-based Second Sight announced the business arrangement in January. Two months later, Pixium disclosed that the agreement had been terminated.

Second Sight has developed the Argus II, a retinal prosthesis the Food and Drug Administration and European Union had approved for use in people with late-stage retinitis pigmentosa, a hereditary, degenerative retinal disease, and is developing Orion, a cortical stimulation device that bypasses the diseased eye.

Pixium CEO Lloyd Diamond explained the company is pivoting from a research organization to a commercial one.

Pixium reported the arrangement with Second Sight unraveled when Second Sight raised a $27.9 million private placement, which, Pixium stated, violated the memorandum of understanding (MOU) between the two companies. Pixium said that it extended an offer to Second Sight to renegotiate the MOU, but that Second Sight never responded. Then, Pixium reported, Second Sight notified Pixium it would unilaterally terminate the MOU.

In the intervening weeks, Pixium noted that Second Sight had sought Pixium’s consent, which Pixium had refused.

Second Sight did not respond to e-mails and a phone call for comment.

The stock-based transaction between the two companies would have also included a $25 million capital raise and would have created a combined company that would be listed on Nasdaq.

Apportion of Assets Under Agreement
Under the agreement, Pixium would have become a holding company that owned 60% of the combined company’s assets, which would have included Pixium’s retina neuromodulation assets, and 40% of a subsidiary containing the assets related to Second Sight’s Orion device.

Second Sight shareholders were to receive 40% of the combined company’s assets but retain 60% ownership in the Orion-related subsidiary. The combined company would have had exclusive right of first refusal to commercialize the Orion system.

Pixium had hoped to use the acquisition of Second Sight to aid in the transition from a research to commercial focus. Medical Device and Diagnostic Industry Online reported that if Pixium could have acquired Second Sight, it wouldn’t have had to rely so heavily on the approval of the Prima device to pivot from a research entity to a commercialization one.

“While we are naturally disappointed in the position being taken by Second Sight and that this business combination has not proceeded, Pixium Vision is in a strong position both financially and clinically, with a world-class research-and-development team and core expertise in vision neuromodulation and a solid patent portfolio,” Pixium CEO Diamond said. “We are continuing our transition from a research organization to a commercially oriented company with the recent initiation of our PRIMAvera pivotal trial of the Prima System.”

The acquisition would’ve given Pixium access to an already commercialized product, Second Sight’s Argus II, which received FDA approval in 2013. In March, the FDA issued approval for the Argus 2s retinal prosthesis system, a redesigned set of external hardware – glasses and a video processing unit – to partner with implanted Argus II systems.

Pixium said it received a payment of $1 million (€840,000) from Second Sight, but that it considers this payment insufficient to compensate for the loss it sustained due to the unilateral termination. Pixium has said it intends to bring an action before the Paris Commercial Court to obtain full compensation for its loss.

European Clinical Trial
Just days after the agreement between the two companies was terminated, Pixium announced the first successful implantation in a patient in the PRIMAvera pivotal trial of its bionic Prima System, a miniaturized subretinal implant for atrophic dry age-related macular degeneration (AMD). The study is the last clinical step before the company seeks market approval in Europe.

“This first implantation makes us a step closer to getting our highly innovative and exciting Prima System on the market and to the patients who are in desperate need,” Diamond said.

HealthTech Award 2021
Pixium also recently received the HealthTech Award 2020 for the Prima System in the category Best Product/Deal, at the MedTech Forum 2021. The award “honors European game changers developing breakthrough[s] in technologies for health.”

Said Diamond, “The Prima System has demonstrated its potential to make a significant improvement to the quality of life of patients with dry AMD, and this award recognizes its capacity to improve vision.”

Finances and Activity
Pixium last week issued a new tranche of $1.8 million (€1.5 million), at the request of US-based European Select Growth Opportunities Fund (ESGO) to exercise 150 of 300 bond warrants that were remaining on an initial agreement with ESGO to provide up to $12 million (€10 million) over a 30-month period that began in November 2019. It’s the seventh tranche the company has drawn down, leaving another $1.8 million outstanding if all bond warrants are exercised.

Pixium recently reported that it had $11.72 million (€9.7 million) cash on hand at the end of March compared with $12.8 million (€10.6 million) at the start of the year. Net cash outflow from operating activities in the first three months of 2021 totaled $4.34 million (€3.6 million) compared with $3 million (€2.5 million) a year earlier.

The increased cash outflow was primarily due to the launch of the PRIMAvera trial, and work begun in connection with the proposed business combination with Second Sight. Pixium reported it’s now considering several financing offers it recently received.

Pixium noted that Q1 highlights included the announcement of positive clinical results and continued patient recruitment in the US.