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

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Pixium Vision announcesimplantation of first patient in Germany inPrima 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 initiatethe patient treatmentin 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 demonstratedimproved vison function and could potentially make a significant impacttopatients’ 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 PRIMASystem 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: http://www.pixium-vision.com/fr

Follow us on @PixiumVision; www.facebook.com/pixiumvision

www.linkedin.com/company/pixium-vision

Contacts

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


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Source: https://www.biospace.com/article/releases/pixium-vision-announces-implantation-of-first-patient-in-germany-in-prima-system-european-pivotal-trial-primavera/?s=93

Medical Devices

Apollo Endosurgery Announces Positive MERIT-Trial Outcomes

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Trial Results Demonstrate ESG Procedure Offers Significant and Durable Weight Loss, with Improvements in Obesity-Related Health Conditions

  • MERIT-Trial met its primary endpoints for safety and efficacy, with patients undergoing the Endoscopic Sleeve Gastroplasty (ESG) procedure achieving excess body weight loss of 49.2% at 12 months and a serious adverse event rate of 2%
  • Patients undergoing ESG also had clinically significant reductions in diabetes, hypertension and metabolic syndrome at 12 months

AUSTIN, TX / ACCESSWIRE / October 22, 2021 / Apollo Endosurgery, Inc.  (“Apollo”) (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, today announced that study investigators of the Multi-Center ESG Randomized Interventional Trial (MERIT) presented positive outcomes.

Dr. Barham Abu Dayyeh, Professor of Medicine and Director of Advanced Endoscopy at the Mayo Clinic, presented the data at the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) during the “Top 10 Papers at IFSO” session.

Key highlights include:

  • Study Methods: The trial enrolled 208 patients across nine US centers. Patients were randomized between ESG and moderate lifestyle modification controls. Average BMI at enrollment was 35.7 ±2.6 kg/m2. The primary efficacy endpoint was Percent Excess Weight Loss (%EWL) and responders were defined as those achieving at least 25% EWL at 12 months. The study targeted a serious adverse event rate of <5%, which was the primary safety endpoint. Patients were followed for 24 months, with control subjects given the option to cross over at 12 months.
  • Efficacy: Patients undergoing Endoscopic Sleeve Gastroplasty (ESG) demonstrated an excess body weight loss (EWL) of 49.2% (+32%) at 12 months, which was a 45% difference in %EWL compared to patients undergoing moderate intensity lifestyle modification. Furthermore, 77% of subjects undergoing ESG achieved at least 25% EWL, and percent total body weight loss (%TBWL) for this responder group was 16.3% (+7%).
  • Impact on Co-Morbidities: Patients undergoing ESG demonstrated improvements in diabetes, hypertension, and metabolic syndrome compared to controls, as well as improvement in, and no onset of, gastroesophageal reflux disease (GERD).
  • Safety: ESG met the primary safety endpoint with a rate of serious adverse events of 2.0% (3/150), all of which resolved and did not require intensive care or surgical intervention[i].
  • Durability: Despite the Global Pandemic during year-two, cross-over patients achieved similar results to the initial treatment group and those that had undergone treatment maintained the vast majority of their weight loss at 24 months.

“The MERIT outcomes are compelling, and the medical community is eager to embrace new treatment options to address the global obesity problem,” said Dr. Abu Dayyeh. “Endoscopic Sleeve Gastroplasty offers a scalable, safe, effective, organ-sparing solution that can be performed in an outpatient facility by either a gastroenterologist or a bariatric surgeon. In addition, the ESG procedure can be combined with other therapeutic options to further enhance patient outcomes.”

ESG is a minimally-invasive (nonsurgical) weight loss procedure that uses the OverStitch™ Endoscopic Suturing System to reduce the volume of a person’s stomach. The MERIT data adds to a larger body of evidence for ESG of more than 200 publications and abstracts reporting positive outcomes in over 6,500 patients[ii].

Worldwide obesity has nearly tripled since 1975, with more than 650 million people now considered obese[iii]. In the U.S., more than 100 million adults are obese, greater than 40 percent of the adult population[iv]. Obesity related conditions including heart disease, stroke, type 2 diabetes, and certain types of cancer are among the leading causes of preventable, premature death. Obesity costs the U.S. health care system more than $170 billion a year[v]. Yet, less than one percent of obese patients are treated with bariatric surgical weight loss procedures each year.

“This is a significant milestone for Apollo in our mission to dramatically impact chronic obesity and obesity-related health conditions that continue unabated around the world,” said Chas McKhann, president and CEO of Apollo Endosurgery. “The results of MERIT support that the ESG procedure offers a compelling value proposition of clinically significant weight loss from a safe, convenient, outpatient procedure. We look forward to our continued work with the FDA, following our recent De Novo 510(k) submission, as we seek regulatory clearance to recognize ESG as a potential treatment option for those living with obesity.”

About the MERIT Study

The MERIT study (NCT03406975, FDA IDE G190189) is a multi-center, prospective randomized clinical trial evaluating the safety and effectiveness of the ESG procedure, a minimally invasive, endoscopic weight loss procedure performed with Apollo Endosurgery’s OverStitch® Endoscopic Suturing System compared to a medically monitored regimen of diet and healthy lifestyle. The co-principal investigators are Dr. Erik Wilson, University of Texas at Houston (Houston, TX), and Dr. Barham Abu Dayyeh, Mayo Clinic, (Rochester, MN) under a collaborative research agreement sponsored by Apollo Endosurgery. The study’s primary efficacy endpoint is to achieve at least 25% excess body weight loss (%EBWL) at 12 months and at least 15% EWL vs. control at 12 months, and the primary safety endpoint is a serious adverse event rate of less than 5%. Serious adverse events were those that scored a ‘3′ or more using the Clavien-Dindo classification. Additionally, patients undergoing ESG are being evaluated for improvement in hypertension and type 2 diabetes at 24 months.

About Apollo Endosurgery, Inc.

Apollo Endosurgery, Inc. is a medical technology company focused on development of next-generation, minimally invasive devices to advance therapeutic endoscopy designed to treat a variety of gastrointestinal conditions including closure of gastrointestinal defects, managing gastrointestinal complications, and the treatment of obesity. Apollo’s device-based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo’s products are offered in over 75 countries today and include the X-Tack® Endoscopic HeliX Tacking System, the OverStitch® Endoscopic Suturing System, the OverStitch Sx® Endoscopic Suturing System, and the ORBERA® Intragastric Balloon.

Legal Notice Regarding Forward-Looking Statements

Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations, including Apollo’s expectations regarding the final publication of the MERIT-Trial data supporting the presentation and Apollo’s utilization of the MERIT-Trial results in a submission to the FDA to potentially add a new indication for ESG. Important factors that could cause actual results to differ materially include: further analysis and full publication of the MERIT-Trial data may result in additional information, conclusions or characterization of the achievement of trial objective and endpoints; the impact of the ongoing COVID-19 pandemic and the effect it may have on Apollo’s operations, the demand for the Apollo’s products, Apollo’s liquidity position, global supply chains and economic activity in general; reports of adverse events related to our products, outcomes of clinical studies related to our products; development of competitive products or procedures; regulatory approvals and extensive regulatory oversight by the FDA or other regulatory authorities; unfavorable media coverage related to our products or related procedures; coverage and reimbursement decisions by private or government payors; Apollo’s ability to support the adoption of its products and broaden its product portfolio; the potential size of Apollo’s addressable markets; the execution of our gross margin improvement projects; the availability of cash for Apollo’s future operations as well as other factors detailed in Apollo’s periodic reports filed with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2020 and its Form 10-Q for the period ending June 30, 2021. Copies of reports filed with the SEC are posted on Apollo’s website and are available from Apollo without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

[i] There were three serious adverse events (2%): a peri-gastric abscess, bleeding, and malnutrition. All were treated successfully by endoscopy without need for intensive care or formal surgery. In addition, while most patients received the ESG as an outpatient procedure, six patients (4%) were briefly hospitalized for non-serious adverse events to manage their difficulties with accommodation of reduced gastric volume.

[ii] Apollo Endosurgery internal meta-analysis of published ESG studies

[iii] World Health Organization (June 2021)

[iv] Centers for Disease Control and Prevention (February 2020)

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Medical Devices

Pixium Vision announces its cash position at 30 September 2021 and provides an update on its activities and financial outlook until the end of 2022

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Pixium Vision announces its cash position at 30September 2021 and provides an update on its activities and financial outlook until the end of 2022.

Paris, 22October 2021 – 7:00 a.m. CEST – Pixium Vision (Euronext Growth Paris – FR0011950641 – ALPIX), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independently, announces a cash position of €16.9 million at 30 September 2021 and reports on its key developments.

Statement of cash flows summary
In thousands of euros (YTD)   30/09/2021 30/09/2020
Opening cash and cash equivalents   10,566.0 6,791.5
(Decrease)/Increase in cash position   6,310.7 6,515.3
O/W net cash flows from operating activities   (6,500.1) (4,213.2)
O/W net cash flows from investment activities   (99.5) 222.5
O/W net cash flows from financing activities   12,909.0 10,506.0
Impact of changes in exchange rates   1.3 0
Closing cash and cash equivalents   16,876.7 13,306.8

Net cash outflow from operating activities in the first nine months of 2021 totalled €6.5 million, compared to €4.2 million the previous year. The increased cash outflow was primarily due to the launch of the PRIMAvera clinical trial in Europe, the continuation of the Europe and US feasibility studies, as well as spendings associated with the preparation of the business combination with Second Sight Medical Products, Inc.

Until 30.9.2021, investments in fixed and intangible assets remain low leading to a net cash outflow from investment activities of €0.1 million.

At 30 September 2021, net cash provided by financing activities totalled €12.9 million, primarily following the drawdown of a 5 ORNAN tranches for a total of €6.25 million (in gross proceeds) of the financing set up with ESGO and a capital increase for a gross amount of €8.0 million from US institutional investors.

In total, at 30 September 2021, Pixium Vision’s cash position amounted to €16.9 million, compared to €10.6 million on 1 January 2021. Given its current cash position, the Company believes that it is able to finance its operations until the end of 2022.

In addition, Pixium Vision is continuing to explore various avenues that will enable the Company to secure its cash flow necessary to pursue its strategic ambitions. In particular, the Company is considering several financing proposals it recently received, is evaluating further sources of financing and, at the appropriate time, will disclose to the market the main terms of any financing it accepts and will submit for the relevant approval of the shareholders, if needed.

Key developments in the thirdquarter of 2021

In the third quarter of 2021 Pixium Vision continued its positive momentum of the PRIMAvera study, its partnership with Stanford and the successful fundraising leading to a capital increase of approximately €8m in a private placement primarily from US institutional investors.

On 23 September 2021, Pixium Vision announced the enrolment of 5 clinical sites (Bonn, Sulzbach, Hamburg, Munich and Ludwigshafen) to the PRIMAvera study in Germany as well as the successful implantation of the first patient in Germany, with one further clinical sites expected to follow.

The PRIMAvera study further expanded to the United Kingdom by initiating Moorfields Eye Hospital as a clinical site as reported on 13 August 2021.

On 8 September 2021, Pixium Vision announced the successful expansion of its collaboration with Stanford University on the next generation implants leveraging the existing PRIMA design, mainly targeting an improved implant resolution.

Subsequent to the closing as of 30 September 2021, continued success of the feasibility study that Pixium is conducting in France were announced. In the frame of the event the Eye and The Chip held virtually 3-5 October 2021 the positive long-term follow-up scientific data on PRIMA implant from Prima System French feasibility study were presented, mainly stating a positive safety profile 36 months after implantation, stability with no lifetime deteriorations and reiteration that PRIMA is able to provide meaningful visual acuity.

Contacts

Pixium Vision

Offer Nonhoff
Chief Financial Officer [email protected]

Media Relations

LifeSci Advisors
Sophie Baumont
[email protected]

+33 6 27 74 74 49

Investor Relations
LifeSci Advisors
Guillaume van Renterghem
[email protected].com

+41 76 735 01 31

ABOUT PIXIUM VISION

Pixium Vision’s mission is to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period.

Pixium Vision is conducting clinical feasibility studies of its Prima system, its miniaturised wireless sub-retinal implant, in patients who have lost their sight due to retinal degeneration associated with the dry form of Age-Related Macular Degeneration (AMD). Pixium Vision works closely with world-renown academic partners, such as Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, and UPMC in Pittsburgh, USA. The company is EN ISO 13485 certified. Pixium Vision has been qualified as an “Innovative Company” by Bpifrance.

For more information: http://www.pixium-vision.com/fr

Follow us on @PixiumVision; www.facebook.com/pixiumvision

www.linkedin.com/company/pixium-vision

Disclaimer

This press release, implicitly or expressly, contains certain forward-looking statements concerning Pixium Vision and its business. Such statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, financial conditions, performance or achievements of Pixium Vision to be materially different from the results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Pixium Vision issues this press release as at this date and does not undertake to update any forward-looking statements contained herein, whether in response to new information, future events or otherwise. For a description of the risks and uncertainties that could cause the actual results, financial conditions, performance or achievements of Pixium Vision to differ from those contained in the forward-looking statements, please refer to section 3 “Risk Factors” of the Company’s reference document, which was filed with the Autorité des Marchés Financiers under number D.20-0350 on 24 April 2020, and which can be viewed on the websites of the Autorité des Marchés Financiers – “AMF” (www.amf-france.org) and Pixium Vision (www.pixium-vision.com).

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Source: https://www.biospace.com/article/releases/pixium-vision-announces-its-cash-position-at-30-september-2021-and-provides-an-update-on-its-activities-and-financial-outlook-until-the-end-of-2022/?s=93

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Medical Devices

Align Technology to Host Investor Day on October 29, 2021

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TEMPE, Ariz., Oct. 22, 2021 (GLOBE NEWSWIRE) — Align Technology, Inc.  (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, announced today that the Company will host a hybrid Investor Day on Friday, October 29, 2021, beginning at 4:00 p.m. Eastern Time.

Meeting Schedule: The hybrid meeting will take place between 4:00 p.m. – 8:30 p.m. Eastern Time. Participants attending virtually are advised to register in advance here.

Location: The event will be broadcast live using the same registration link on Align’s dedicated website here, under Events. The webcast console will be available to registered attendees 15 minutes prior to the scheduled event start time.

A replay of the webcast will be available after the meeting on Align’s website and will remain on the website for approximately three months following the event.

If you have any questions, please contact Courtney Clemons at [email protected] or call 408-591-0379.

About Align Technology, Inc.
Align Technology designs, manufactures and offers the Invisalign® system, the most advanced clear aligner system in the world, iTero® intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 200 thousand doctor customers, and is key to accessing Align’s 500 million consumer market opportunity worldwide. Align has helped doctors treat approximately 10.9 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero systems and services, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Align Technology Zeno Group 
Madelyn Valente Sarah Johnson
(408) 470-1180 (828) 551-4201
[email protected] [email protected]


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Source: https://www.biospace.com/article/releases/align-technology-to-host-investor-day-on-october-29-2021/?s=93

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Medical Devices

Treace Announces Grant of Additional U.S. Patent on Instrumented Bunion Correction

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PONTE VEDRA, Fla., Oct. 21, 2021 (GLOBE NEWSWIRE) — Treace Medical Concepts, Inc. (“Treace” or the “Company”) (Nasdaq: TMCI), a commercial-stage orthopaedic medical device company driving a paradigm shift in the surgical treatment of hallux valgus (commonly known as bunions) through its Lapiplasty® 3D Bunion Correction™ procedure, announced that the United States Patent and Trademark Office granted to the Company U.S. Patent No. 11,147,590, titled “Bone Positioning and Cutting System and Method.” This patent is directed generally to methods of performing a bunion surgery to correct a first metatarsal alignment.

The patent, granted October 19, 2021, strategically enhances Treace’s comprehensive patent coverage on instrumented bunion correction techniques. The patent is an expansion of a portfolio filed during Treace’s pathbreaking development work in the field with early priority dating back to 2014. The new patent complements coverage obtained through a related asset, U.S. Patent No. 10,945,764, also entitled “Bone Positioning and Cutting System and Method” granted in March 2021.   

The new patent is the Company’s 30th granted US patent (Treace also holds 6 patents granted outside the U.S.). Treace’s research and development team continues to innovate and bring to market new products designed to address patient needs. Treace actively protects those innovations through patenting and is gratified that the United States Patent and Trademark Office and patent agencies worldwide continue to recognize the novelty of Treace’s contributions to the field. The Company has a global portfolio of over 60 pending patent applications, including over 30 pending US patent applications. Additional details on Treace’s patent coverage can be found at www.treace.com/patents.    

About Treace Medical Concepts
Treace Medical Concepts, Inc. is a commercial-stage orthopaedic medical device company with the goal of advancing the standard of care for the surgical management of bunion deformities and related midfoot correction. Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot. Treace has pioneered and patented the Lapiplasty® 3D Bunion Correction™ system – a combination of instruments, implants, and surgical methods designed to correct all 3 planes of the bunion deformity and secure the unstable joint, addressing the root cause of the bunion and helping patients get back to their active lifestyles. Treace recently expanded its offering with the Adductoplasty™ Midfoot Correction System, designed for reproducible correction of the midfoot which could provide further support to hallux valgus patients. For more information, please visit www.treace.com.

Contacts:
Treace Medical Concepts
Mark L. Hair
Chief Financial Officer
[email protected]t
(904) 373-5940

Investors:
Gilmartin Group
Lynn Lewis or Vivian Cervantes
[email protected]


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Source: https://www.biospace.com/article/releases/treace-announces-grant-of-additional-u-s-patent-on-instrumented-bunion-correction/?s=93

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