Pixium Vision announces implantation of first patient in Germany in Prima System European pivotal trial PRIMAvera – Yahoo Finance

Pixium Vision announces implantation of first patient in Germany in Prima System
European pivotal trial PRIMAvera
Successful first implantation of a patient in the PRIMAvera study in Germany
PRIMAvera clinical sites opening in five locations in Germany
Additional clinical sites to open in additional European countries

Paris, France, September 23, 2021 – 07.00 CET– Pixium Vision SA (Euronext Growth Paris – FR0011950641), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independent lives, announces the successful first implantation of a patient in Germany in the PRIMAvera pivotal trial.
This follows approval of the PRIMAvera study by Germany’s Federal Institute for Drugs and Medical Devices, which aims to confirm the safety and the benefits provided by the Prima System and is the last clinical step before seeking market approval in Europe. PRIMAvera clinical sites have now opened in Bonn, Sulzbach, Hamburg, Munich and Ludwigshafen with one more in Tuebingen to follow. The PRIMAvera study was initiated in Q4 2020 and the first patient was implanted in March 2021.
We are pleased to initiate the patient treatment in Germany as part of the PRIMAvera pivotal trial, which is continuing to make good progress,said Prof. Frank Holz, the lead investigator for Germany and scientific coordinator of the study. "The bionic vision Prima System has demonstrated improved vison function and could potentially make a significant impact to patients’ quality of life. We are looking forward to studying the Prima System further in the PRIMAvera trial and bringing it to more patients in need."
I have followed the development of the PRIMA System for some time and am very proud to implant the first PRIMA device in Germany. I consider the Prima System to bring true innovation to patients and me and my team are keen to see the results of this pivotal trial” said Prof. Peter Szurman, Chief Physician at the Augenklinik in Sulzbach, Germany.
The PRIMAvera study design is based on the positive data generated in a French feasibility study, showing the ability of patients with dry AMD to improve in visual acuity with the Prima System.
A total of 38 patients will be enrolled in PRIMAvera, an open label, baseline-controlled, nonrandomized, multi-center, prospective, single-arm confirmatory trial. The primary efficacy endpoint is the proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 12 month and the primary safety endpoint is the number and severity of device and procedure related serious adverse events at 12 months follow-up. The study will include three years of follow-up, with assessment of the primary endpoints at 12 months after implantation.
About Pixium Vision
Pixium Vision is creating a world of bionic vision for those who have lost their sight, enabling them to regain visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period. Prima System sub-retinal miniature photovoltaic wireless implant is in clinical testing for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD). Pixium Vision collaborates closely with academic and research partners, including some of the most prestigious vision research institutions in the world, such as: Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, University hospital in Bonn, and UPMC in Pittsburgh, PA. The company is EN ISO 13485 certified and qualifies as “Entreprise Innovante” by Bpifrance.
For more information:
Follow us on
Pixium Vision
Offer Nonhoff
Chief Financial Officer
[email protected]
+33 1 76 21 47 68
Media Relations

LifeSci Advisors
Sophie Baumont
[email protected]
+33 6 27 74 74 49
Investor Relations
LifeSci Advisors
Guillaume van Renterghem
[email protected]
+41 76 735 01 31

Axsome Therapeutics (NASDAQ: AXSM) is close to earning approval for a new depression drug that could generate billions in annual revenues. Unfortunately, the proposed action date for the Food and Drug Administration (FDA) to grant approval already came and went. Consensus price targets suggest Axsome Therapeutics' stock price could rise 197% if most investors begin seeing the company in the same light as the investment-bank analysts who follow it closely.
The past month has been fraught with debate over who should be allowed to get boosters, and the messaging changed with each new step causing confusion among experts.
Shares of Cassava Sciences (NASDAQ: SAVA) — the biotech company responsible for Alzheimer's drug candidate simufilam — are up 15% as of Thursday's market close after the company released interim data from a study funded by the National Institutes of Health. According to management, data from the first 50 patients to receive treatment, who had mild to moderate Alzheimer's, showed improved cognition scores after 12 months. The fireworks started after law firm Labaton Sucharow filed a citizen petition with the Food and Drug Administration.
Oral antiviral treatments for Covid-19 could give a public health boost and generate blockbuster sales for the drug industry.
The CDC overruled its own panel Friday, endorsing booster shots for elderly and otherwise vulnerable adults. But some vaccine stocks dipped.
It was a constant refrain from federal health officials after the coronavirus vaccines were authorized: These shots are all equally effective. That has turned out not to be true. Roughly 221 million doses of the Pfizer-BioNTech vaccine have been dispensed thus far in the United States, compared with about 150 million doses of Moderna’s vaccine. In a half-dozen studies published over the past few weeks, Moderna’s vaccine appeared to be more protective than the Pfizer-BioNTech vaccine in the month
Lilly's experimental Alzheimer's therapy, donanemab, still has a “transformational growth opportunity,” despite Biogen's embattled rollout of Aduhelm, says J.P. Morgan Christ Schott.
The supermodel said she’s "permanently deformed" from the fat freezing procedure, and has filed a lawsuit against CoolSculpting's parent company
Brittany Gould became emotional recounting the Theranos test that falsely said she had miscarried.
Biogen stock jumped Thursday on a fresh buy rating even as the controversy surrounding Alzheimer's drug Aduhelm deepened.
AstraZeneca Plc on Thursday struck a deal with the firm behind Imperial College London's experimental COVID-19 vaccine to develop and sell drugs based on its self-amplifying RNA technology platform in other disease areas. Under the deal, VaxEquity, a startup founded by Imperial vaccinologist Robin Shattock, could receive up to $195 million if certain milestones are met, in addition to royalties on approved drugs and equity investment from AstraZeneca and life sciences investor Morningside Ventures. AstraZeneca already produces an adenoviral vector COVID-19 vaccine, and emphasised the potential of the self-amplifying RNA (saRNA) technology in novel therapeutic programmes beyond the coronavirus pandemic.
Vaccine stocks popped Thursday after the FDA authorized Pfizer and BioNTech's Covid booster shot for at-risk groups.
AstraZeneca has taken a sizeable stake in an Imperial College spinout that develops drugs based on the RNA technology used in Covid vaccines made by two major rivals.
Cassava said Wednesday that patients who received its experimental Alzheimer's drug showed improved cognition at a year. But SAVA stock dipped.
Forceful words don't always result in strong action. AP Photo/Damian DovarganesAre workplace vaccine mandates prompting some employees to quit rather than get a shot? A hospital in Lowville, New York, for example, had to shut down its maternity ward when dozens of staffers left their jobs rather than get vaccinated. At least 125 employees at Indiana University Health resigned after refusing to take the vaccine. And several surveys have shown that as many as half of unvaccinated workers insist th
The increasing number of at-home testing kits for COVID-19 makes it convenient to test for COVID-19, plus considerably safer than risking exposure by going for testing at a public location. However, a group of infectious disease researchers have discovered that for someone who actually wants a positive COVID-19 test result, getting it may be as easy as stopping by a convenience store's beverage cooler.A group of scientists studying tropical medicine at Germany's Tübingen University recently publ
The coronavirus is not stopping, as deaths rack up at the rate of an average of 2,000 daily in America alone. This is why Dr. Anthony Fauci, the chief medical advisor to the President and the director of the National Institute of Allergy and Infectious Diseases, is sounding an alarm. He spoke on CNN, and with The Washington Post and Boston Globe issuing advice about how to stay safe given the "more transmissible" Delta variant. Read on for five life-saving pieces of advice—and to ensure your hea
You already know that food affects your brain in the short term – just think about how much easier it is to concentrate after an afternoon snack, or how much tougher it gets after an entire packet of biscuits – but it’s easy to forget, amid the chaos of everyday life, that what you eat impacts your grey matter over the long term.
We've just passed a grim coronavirus milestone: COVID-19 has now killed about as many Americans as the 1918-19 Flu. And it's nowhere near over. How can you stay safe, so you and your family don't become the next headline? Dr. Anthony Fauci, the chief medical advisor to the President and the director of the National Institute of Allergy and Infectious Diseases, spoke with Major Garrett on CBS's The Takeout to discuss just that. Read on for 8 essential points that can save your life—and to ensure
The FDA has approved Baxter International Inc's (NYSE: BAX) premix norepinephrine bitartrate in 5% dextrose injection. Norepinephrine is indicated to raise blood pressure in adult patients with severe, acute hypotension (low blood pressure). According to a news release, the company's formulation of norepinephrine is the first and only manufacturer-prepared, ready-to-use formulation. The Company offers the formulation in 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/mL) strengths. Baxter's form