Clinton Pinto posted an article
New View Surgical, Inc. Announces FDA Clearance of its VisionPort™ System for Minimally Invasive SurgeryNew View Surgical, Inc., received clearance from the U.S. FDA for its VisionPort™ System see more
The VisionPort™ is the first surgeon-controlled, multi-camera laparoscopic visualization system.
BOSTON, MA - June 22, 2021 New View Surgical, Inc., a medical device company developing proprietary imaging and access technologies for minimally invasive surgery (MIS), announced today that it received 510(k) clearance from the U.S. Food and Drug Administration for its VisionPort™ System. The VisionPort™ imaging and access system simplifies laparoscopic procedures for hospitals and provides surgeon-controlled visualization. Its dual-camera design offers multiple, simultaneous views of the anatomy and surgical instrumentation – unavailable with conventional laparoscopic systems. The VisionPort puts the most advanced visualization technology more readily in the hands of customers and is intended to be used in a broad range of diagnostic and therapeutic procedures within the thoracic and abdominal cavities. It is adaptable to a wide variety of surgical environments, representing a significant market opportunity.
“The VisionPort System allows the surgeon to control the scope and keeps the tip of the instruments within the field of view at all times. This has significant potential to make the operation easier for the surgeon and reduce risk to the patient,” commented David Earle, MD, FACS, Director of the New England Hernia Center and Associate Professor of Surgery at Tufts University School of Medicine in Boston, MA. “Additionally, the VisionPort provides multiple, simultaneous views of the operative field. Previously, changing the viewing angle was only possible by removing the laparoscope and moving it to another port, frequently wasting time and causing frustration. Furthermore, the VisionPort eliminates a separate incision and the need for a surgical assistant to hold the scope. The elimination of the camera port and assistant means surgeons and hospitals can expand access to the operating room without increasing staffing requirements. This increased efficiency is good for the surgeon, the facility, and most importantly, the patient.”
Added Dr. Earle, “It’s been exciting to collaborate with the New View Surgical team during the development of the VisionPort. Not only will this technology allow more patients to access minimally invasive surgical techniques, but it will also make many high volume procedures easier for surgeons to perform.”
“FDA clearance of the VisionPort is a significant milestone for New View Surgical. We’re excited to bring revolutionary technology to market that supports our overall mission to improve the outcomes and efficiency of laparoscopic surgical procedures, all while increasing patient access to minimally invasive surgical techniques worldwide,” said Bryce Klontz, President & CEO. “The FDA clearance process for the VisionPort was completed in less than 90 days. We are incredibly pleased with the timeline as we can now move ahead with the next stages of company development and commercialize this exciting technology.”
Clinton Pinto posted an article
LumiThera Announces Valeda Treatments Improve Vision and Retinal Function in Top Line Data from the ELECTROLIGHT Pilot Study in Dry AMD patientsLumiThera Inc., announced the final topline data from the ELECTROLIGHT pilot study. see more
SEATTLE, July 21, 2021 /PRNewswire/ -- LumiThera Inc., a commercial stage medical device company offering a photobiomodulation (PBM) treatment for ocular damage and disease, today announced the final topline data from the ELECTROLIGHT pilot study in intermediate dry AMD patients.
A total of 23 eyes from 15 subjects with Dry AMD were enrolled into the prospective clinical study and treated with PBM using the Valeda® Light Delivery System (3 times per week for 3 weeks). Eight Caucasian males and seven females were enrolled with a mean age of 75.1 years (65-93 years). The mean time since AMD diagnosis was 5.0 years (0-14 years). Subjects were tested for safety and functional vision improvements using the Diopsys electroretinogram (ERG) device. ERG is a diagnostic test that measures the electrical activity of the retina of the eye in response to a light stimulus. All subjects were tested at weekly intervals for ERG function prior to the start of the next week of PBM treatments. The study followed the patients out to 6 months. The study was conducted by Dan Montzka, M.D. and Larry Perich, D.O. at the Perich Eye Center (New Port Richey, Florida).
Multi-luminance Electroretinogram (ERG) Magnitude AUC improved by 14.4% from baseline after completion of the Month 1 treatment and showed a 9% improvement at 6 months in the ITT population. A positive correlation between multi-luminance ERG and best corrected visual acuity (BCVA) was seen (p < 0.05) following initial PBM treatment. Positive correlations between multi-luminance ERG and fixed luminance (R = 0.870) and chromatic ERG outcomes (R = 0.676) were also reported in the Month 1 interim analysis.
Subjects showed approximately 12.8 ± 0.98 letter improvement in BCVA at Month 6 compared to BL scores. Mars Contrast Sensitivity (CS) also showed improvement from BL to Month 6 at 40 cm (0.202 log + 0.02), 80 cm (0.197 log + 0.02) and 120 cm (0.28 log + 0.03).
"Valeda provided statistically significant and sustained improvements in BCVA, CS and multi-luminance ERG function from baseline out to Month 6 time point following 9 PBM treatments," stated Dan Montzka, M.D. "Diopsys multi-luminance ERG is an early, sensitive and quantitative measure of visual dysfunction in dry AMD patients."
"The study further confirms previous LIGHTSITE I and II studies that the Valeda Light Delivery System improves visual function," stated Larry Perich, D.O. "The subjects were very pleased with the results of their treatments and no safety issues were seen."
Diopsys ERG testing is a powerful and quantitative diagnostic that can be coupled with LumiThera's PBM treatments to characterize early patient benefits on visual function," indicated Joe Fontanetta, CEO, Diopsys. "These results of this work will allow physicians to diagnose, treat and monitor patients and provides physicians a solution for a disease with limited treatment options."
"We are strong supporters of treating degenerative disease early to slow the progression of vision-threatening disease." stated Clark E. Tedford, Ph.D., President and CEO, LumiThera, Inc. "The key in chronic ocular disease is early diagnosis, treatment and monitoring and we hope studies such as this pilot pave the way to a more preventative approach. The patients in the ELECTROLIGHT study are similar in demographics as the LIGHTSITE III US study in terms of time from dry AMD diagnosis, AREDs use and age. Previously, we reported the US LIGHTSITE III dry AMD trial fully enrolled 100 subjects in 1Q of 2021 and is continuing to move forward with the 13-month efficacy timepoint for all patients in 1Q of 2022."
AMD is a leading cause of vision loss for people age 65 and older. Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase 7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).
Diopsys, Inc. is a leader in modern visual electrophysiology medical devices that help eye care professionals analyze the entire visual pathway for visual and neuro-visual disorders. The company provides both Visual Evoked Potential (VEP) and Electroretinography (ERG) vision testing technology. It is this technology that powers Diopsys, Inc.'s medical devices – the Diopsys® NOVA™, Diopsys® ARGOS™, and Diopsys® RETINA PLUS™ ERG and VEP Vision Testing System product series and the Enfant® Pediatric VEP Vision Testing System.
About LumiThera Inc.
LumiThera is a commercial-stage medical device company focused on treating people affected by ocular damage and disease including dry age-related macular degeneration, a leading cause of blindness in adults over 65. The company is a leader in the use of PBM for treatment of visual disorders. The company is commercializing the office based Valeda Light Delivery System to be used by eye care specialists as medical treatments.
The Valeda Light Delivery System has been granted authorization to use the CE Mark by an EU Notified Body as required for commercial use in the European Union only. Valeda is not approved for use by the Food & Drug Administration (FDA) in the USA.