Sydnexis Announces FDA Acceptance of New Drug Application and PDUFA date for SYD-101, for the Treatment of Progression of Pediatric Myopia.

Sydnexis Announces FDA Acceptance of New Drug Application for SYD-101 for the Treatment of Progression of Pediatric Myopia

• FDA assigns a PDUFA target action date of October 23, 2025
• If approved, SYD-101 would be the first and only pharmaceutical treatment option proven
to slow the progression of pediatric myopia

DEL MAR, Calif. - March 11, 2025 – Sydnexis, Inc., (www.sydnexis.com) a pre-commercial stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for SYD-101 and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would be the first and only pharmaceutical option for the treatment of progression of pediatric myopia in the United States.

“The FDA acceptance of our NDA filing for SYD-101 marks a critical step forward for Sydnexis in bringing an innovative treatment option to the millions of pediatric patients with progressive myopia,” said Perry Sternberg, Chief Executive Officer of Sydnexis. “I’m incredibly proud of our talented team for reaching this milestone and look forward to collaborating with the FDA to bring a once-daily, safe and effective eye drop to pediatric myopia patients, their families, and clinicians.”

The NDA application is based on three-year primary and secondary endpoints from the STAR Study, Sydnexis’ pivotal Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow the progression of pediatric myopia and the risk of associated co-morbidities.

“SYD-101’s novel, proprietary formulation was uniquely designed to deliver superior drug activity, maximum stability, and optimal comfort,” said Patrick Johnson, Ph.D., President at Sydnexis. “We knew we wanted to evaluate SYD-101 in a very robust study. Our landmark STAR Study is the largest clinical study ever completed for the treatment of progression of pediatric myopia, enrolling more than 850 patients across a broad patient population of 3- to 14-year-olds.”

“Having the ability to offer a safe and effective FDA-approved treatment for my pediatric myopic patients would be a welcomed and critical step forward in addressing this global epidemic as so few options are available,” said Dr. Gregory Ostrow, M.D., Director of Pediatric Ophthalmology and Adult Strabismus at Scripps Clinic in San Diego, CA.

Myopia is the most common eye disease in children, impacting approximately 28 million children in the U.S. alone with prevalence and severity expected to continue climbing due to lifestyle and environmental factors. Once considered a benign refractive condition, even at low levels, myopia is now associated with many serious irreversible sight-threatening co-morbidities later in life.

“We are excited about SYD-101 as a potential treatment option for our pediatric population. Having a first FDA-approved product that we can offer early in our patients’ myopia progression is needed,” said Dr. Paul Karpecki, OD, FAAO, Director of Cornea and Advanced Ocular Surface Disease at Kentucky Eye Institute in Lexington, KY.

Shared by Tyler Stowater, board member of Sydnexis, Inc.

VIC's MIRA Surgical System in the News!

Hoag Becomes First Hospital in the Western U.S. to Offer World’s First Miniaturized Robotic-Assisted Surgery Device

Hoag's participation in the MIRA First Access Program highlights the hospital's continued commitment to innovation, excellence, and improving the health and well-being of patients.

NEWPORT BEACH, Calif. (Feb. 26, 2025) - Hoag announced that it has expanded its robotic-assisted surgery (RAS) offerings for minimally invasive colectomy procedures with the MIRA™ Surgical System (MIRA), the world's first miniaturized robotic-assisted surgery (miniRAS) device. Hoag is the first in the Western U.S. to offer this cutting-edge technology that enhances minimally invasive surgery by providing greater precision and control.

"At Hoag, our dedication to patient care drives us to continually integrate the most advanced, minimally invasive technologies into our practice," said Elizabeth Raskin, M.D., Surgical Director for the Margolis Family Inflammatory Bowel Disease Program, part of the Hoag Digestive Health Institute. "With the addition of the MIRA Surgical System, we're not just enhancing our surgical capabilities - we're expanding access to the life-changing benefits of minimally invasive surgery, ensuring more patients can experience improved outcomes and a higher quality of life."

Hoag is a national leader in robotic assisted surgery, with more than 30,000 surgeries completed using the technology to date. It offers numerous benefits compared to open surgery, including shorter hospital stays, reduced pain and discomfort, faster recovery times, and smaller incisions.

"As leaders in the field of digestive health, we recognize the importance of continuously pushing the boundaries of what's possible in patient care," said Kenneth J. Chang, M.D., James & Pamela Muzzy Executive Medical Director Endowed Chair in GI Cancer, Digestive Health Institute. "The adoption of the MIRA Surgical System is yet another example of our commitment to delivering innovative solutions that improve patient outcomes and advance the standard of care."

As a designated Center of Excellence in Robotic Surgery (COERS), Hoag has demonstrated expertise in robotic-assisted surgeries, meeting high standards in patient care, surgical outcomes, and safety protocols. The addition of MIRA underscores Hoag's commitment to advancing RAS practices with innovative technology and techniques. The compact and portable nature of the MIRA system is designed for easier integration into surgical settings, significantly improving access to robotic-assisted surgery for patients who may have previously faced barriers.

"Dr. Raskin and Hoag were selected to be part of the MIRA First Access Program because of their unwavering commitment to excellence in surgical care," said Piet Hinoul M.D., Ph.D., chief medical officer of Virtual Incision. "Dr. Raskin is a pioneer in laparoscopy and robotic-assisted surgery and has consistently been at the forefront of minimally invasive techniques. Hoag has a reputation for being a progressive institution and a leader in bringing new technologies to their patients in a thoughtful and safe fashion, and we are thrilled to have them join us in the journey of expanded access to robotic-assisted surgery through miniaturization."

The MIRA Surgical System was partially funded by Hoag Innovators, a group of community leaders dedicated to catalyzing innovation at Hoag through the power of collective giving. Their support plays a crucial role in advancing surgical capabilities and improving patient care.

To learn more about Hoag Digestive Health Institute, visit hoag.org/digestive.

VIC Mentioned in Forbes Story on JP Morgan Event

We think you will enjoy reading this story where Virtual Incision is mentioned by Karl Freund, on January 13, 2025, titled AI Enables Major Healthcare Advances At JP Morgan Event, on the Barrons website. Click here to read the story or to see a PDF archive copy, click here.

Shared by Tyler Stowater, board member of Virtual Incision Corporation.

U.S.-Based Remote Robotic-Assisted Surgery Demonstration Successfully Completed Through Collaborations with Virtual Incision, Sovato, City of Hope, and University of Illinois Chicago

Wet lab demonstration showcases the safe enablement, reproducibility, and scale of remote robotic-assisted surgeries across twenty procedures and four specialties

LINCOLN, Nebraska – November 25, 2024 – Virtual Incision Corporation, the developer of the MIRA Surgical System (MIRA), the world’s first miniaturized robotic-assisted surgery (RAS) device and Sovato Health, the world’s only comprehensive solution designed to enable remote surgery and procedure programs, today announced the successful completion of a preclinical demonstration of nearly 40,000-miles combined distance. Four surgeons performed a total of 20 procedures on porcine models as part of the remote capabilities test, representing approximately 2,000 miles for each procedure.

Francesco Maria Bianco, M.D. from the University of Illinois Chicago, and Yanghee Woo, M.D., Yasmin Zerhouni, M.D., and Clayton Lau, M.D., from City of Hope National Medical Center, which is ranked among the nation’s top 5 cancer centers by U.S. News & World Report, leveraged the combined technology of Virtual Incision and Sovato to complete the remote cholecystectomy, colectomy, gastric mobilization / gastrostomy / primary closure, and nephrectomy procedures on porcine models. Yuman Fong, M.D., chair and professor of City of Hope’s Department of Surgery and president-elect of Clinical Robotic Surgery Association (CRSA), oversaw the design and completion of the wet lab demonstrations.

You can read the rest of the press release in the Virtual Incision Newsroom or a PDF version of the story by clicking here.

Shared by Tyler Stowater, board member of Virtual Incision Corporation.

Orasis Pharmaceuticals Announces Licensing Agreement with Optus Pharmaceuticals for Commercialization of Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4% in Korea

Exclusive Agreement Includes $18 Million in Milestone Payments to Orasis, Together with a Double-Digit Royalty on Sales in the Korean Market

Ponte Vedra, FL, October 16, 2024 – Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced the signing of an exclusive licensing agreement with Optus Pharmaceuticals, a Korean-based pharmaceutical company specializing in total eye care solutions. Under the agreement, Orasis grants Optus Pharmaceuticals the rights to commercialize, import and sell Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, a novel corrective eye drop for the treatment of presbyopia in adults, in Korea.

“Our licensing agreement with Optus Pharmaceuticals marks an important step in our goal of offering patients around the world a safe, effective and innovative solution to manage their presbyopia,” said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. “Building on the momentum of our recent Series D financing to support our first market launch in the U.S., this partnership represents our commitment to bring Qlosi to more patients globally and define what’s next in vision care.”

Additional terms include an upfront payment and payments for key milestones, totaling $18 million, in addition to double-digit royalties on sales in the Korean market. Optus Pharmaceuticals plans to be the first to launch a new presbyopia treatment drug in the Korean market, and plans to launch Qlosi in Korea by 2026, after receiving domestic regulatory approval and sales approval.

For more information about Qlosi and Full Prescribing Information, visit www.Qlosi.com.

Shared by Tyler Stowater, board member of Orasis Pharmaceuticals.

Orasis Pharmaceuticals Completes $78 Million Financing to Support Commercial Launch of Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%

$68 Million Series D Financing Co-led by Arboretum Ventures and Johnson & Johnson Innovation – JJDC, Inc. 

Ponte Vedra, FL, October 8, 2024 – Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced the completion of a $78 million financing to support the commercial launch of Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, a novel corrective eye drop for the treatment of presbyopia in adults. The Series D financing included a $68 million equity component, co-led by Arboretum Ventures and Johnson & Johnson Innovation – JJDC, Inc., along with participation from Catalio Capital Management, Freepoint Capital Group, and returning investors—Visionary Ventures, Bluestem Capital, SBI (Japan) Innovation Fund, Sequoia Capital, and Maverick Ventures, as well as other individuals. Concurrent with its equity raise, Orasis has secured $15 million in structured capital from Catalio Capital Management, of which $10 million will be drawn at closing.

“We are proud to collaborate with leading, high-quality investors who share our dedication to reshaping vision possibilities for presbyopes seeking a break from reading glasses,” said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. “This significant funding will allow us to successfully launch Qlosi, providing the eye care community a near-vision solution with a balance of efficacy and tolerability, using the lowest effective concentration of pilocarpine approved.”1,2

“We are pleased to co-lead this financing and to join an experienced syndicate of investors whose collective support is further validation of the market potential for Qlosi,” said Paul McCreadie, Partner at Arboretum Ventures. “We have high confidence in the Orasis team to successfully launch Qlosi and generate a positive impact on patients’ near vision."

For more information about Qlosi and Full Prescribing Information, visit www.Qlosi.com.

Shared by Tyler Stowater, board member of Orasis Pharmaceuticals.

Sydnexis welcomes Perry J. Sternberg as Chief Executive Officer

July 16th, 2024 – Sydnexis, Inc., (www.sydnexis.com) a pre-commercial stage biopharmaceutical company focused on the treatment of progression of pediatric myopia, is excited to announce the appointment of Perry J. Sternberg as Chief Executive Officer and as a member of the Board of Directors. An accomplished pharma/biotech executive with over 30 years in the industry and 15 years in eye care, Perry will provide invaluable leadership experience to help guide Sydnexis’ strategic direction and next phase of growth.

 “Perry’s appointment comes at a pivotal time for Sydnexis as we continue to advance our lead asset, SYD-101, to slow the progression of pediatric myopia and the risk of associated co-morbidities,” said Jeffry Weinhuff, Managing Partner at Visionary Venture Fund and Lead Board Director at Sydnexis. “Perry has deep expertise in commercialization of new therapies across diverse markets and extensive experience leading organizational growth and transformation. He will be a tremendous asset to Sydnexis.”

Click here to read the remainder of the press release.

Shared by Tyler Stowater, board member of Sydnexis, Inc.

Mikra Announces Partnership with Virun NutraBiosciences Inc. and Releases CELLF 2.0

Mikra partners with global leader in NutraBiosciences® to release CELLF 2.0 featuring improved flavor and consistency thanks to Virun’s patented technology

ORONTO, May 09, 2024 (GLOBE NEWSWIRE) -- Lifeist Wellness Inc. (“Lifeist” or the “Company”) (TSXV: LFST) (FRANKFURT: M5B) (OTCMKTS: LFSWF), a health-tech company that leverages advancements in science and technology to build breakthrough ventures that transform human wellness, is pleased to announce that its U.S. biosciences subsidiary Mikra Cellular Sciences Inc. (“Mikra”) has partnered with Virun NutraBiosciences Inc. (“Virun”), the global leader in NutraBiosciences®1, to offer CELLF 2.0, an enhanced nutraceutical gel for improving cellular health. CELLF 2.0 is available for sale now and can be ordered directly at http://wearemikra.com/products/cellf.

“We are so excited to partner exclusively with Mikra and their CELLF brand containing Glutathione, PQQ and CoQ10. Our patents and patents-pending technologies are a perfect fit for Mikra. The anti-aging, mitochondrial biogenesis benefits of CELLF 2.0 are unrivaled,” said Philip Bromley, CEO of Virun NutraBiosciences Inc.

Read the rest of the story here or a PDF version here. To read the news published by Virun on their blog, click here.

Shared by Steve Kirby, board member of Virun, Inc.  

Virtual Incision to Showcase Miniaturized Robotic-Assisted Surgery at SAGES 2024

-MIRA, the world’s first miniaturized robotic-assisted surgery device, will make its debut at the national conference for gastrointestinal and endoscopic surgeons 

 – Scientific program includes four presentations that highlight Virtual Incision’s technology, including one-year follow-up of the cancer patient cohort from the U.S. Investigational Device Exemption clinical study 

Click here to view the Key Note video prepared for this event that tells the story of VIC.

LINCOLN, Neb. – April 10, 2024 – Virtual Incision Corporation, the developer of the MIRA Surgical System (MIRA), today announced its participation at the 2024 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conference taking place April 17–20 in Cleveland.

You can read the remainder of the press release here on Virtual Incision’s website or view a PDF file of the story by clicking here.

CNN's Julia Chatterley Shares the VIC Story

Virtual Incision Corporation continues to be featured in the news. Enjoy this video interview of CEO John Murphy, posted by Julia Chatterley of CNN. Click here to view on X, formerly Twitter.

Shared by Tyler Stowater, board member of Virtual Incision Corporation.

DeviceTalks Interviews Dr. Shane Farritor and Dr. Piet Hinoul

We're excited to present the DeviceTalks podcast, "Extending a Surgeon's Reach into Space with Virtual Incision's Miniaturization and Remote Tech.” Host Tom Salemi sits down with Dr. Shane Farritor and Dr. Piet Hinoul from Virtual Incision Corporation (VIC) to discuss the launch of MIRA into space. This is the description of the podcast:

On Feb. 16, six surgeons successfully directed Virtual Incision’s spaceMira robotic surgery to perform “surgery” on the International Space Station. Instead of human tissue, the robotic arms cut rubber bands and other tissue like substitutes over 200 miles away from the surgeons. The exercise demonstrated the potential for remote-controlled robotic surgery. 

In this talk we’ll learn how the two-pound surgical robotic system was built and what this achievement could mean for future designs.

Note, the site does require registration to access the 59 minute podcast.

Shared by Tyler Stowater, board member of Virtual Incision Corporation.

Virtual Incision’s MIRA Surgical System to be Featured Among Elite AI-Enabled Innovations at NVIDIA GTC

Company To Showcase What is On Horizon For Miniaturized Robotic-Assisted Surgery and AI

LINCOLN, Neb. — March 18, 2024 — Virtual Incision Corporation, the developer of the MIRA Surgical System (MIRA), today announced the company will showcase MIRA at NVIDIA GTC. The global AI conference is focused on exploring what’s next in AI, computer graphics, data science, machine learning, and autonomous machines across industries. Virtual Incision will be featured in booth 1332 at the Healthcare Pavilion located inside the Expo Hall. The event will take place March 18–21, 2024 in San Jose, Calif.

During the conference, attendees will have the opportunity to perform a series of simulated surgical tasks with MIRA, the world’s first miniaturized robotic-assisted surgery (miniRAS) platform. The system utilizes the NVIDIA Jetson platform to collect, convert, and enhance visual data from MIRA’s integrated articulating camera. In addition, Virtual Incision will show examples of how Jetson can be used in future iterations of MIRA to enable capabilities such as low-latency remote surgery, intra-procedure AI-enhanced visualization, and post-procedure data analysis.

Read the rest of the press release on VIC’s website or view a PDF archive copy of the story here.

Shared by Tyler Stowater, board member of Virtual Incision Corporation.

Virtual Incision Receives FDA Authorization for the MIRA Surgical System as the First Miniaturized Robotic-Assisted Surgery Device

-New category challenges industry standards in soft tissue robotic-assisted surgery and has the potential to expand access to minimally invasive care

-De Novo premarket review pathway establishes initial indication for adults undergoing colectomy procedures and lays the foundation for expansion into other abdominal procedures

LINCOLN, Neb. — February 24, 2024 — Virtual Incision Corporation announced the U.S. Food and Drug Administration (FDA) has granted marketing authorization of the MIRA™ Surgical System (MIRA), the world’s first miniaturized robotic-assisted surgery (miniRAS) device, for use in adults undergoing colectomy procedures. The device was submitted via the FDA’s De Novo Classification process, a rigorous pathway designed to classify novel medical devices with no current legally marketed predicate. FDA authorization was based in part on findings from the company’s U.S. Investigational Device Exemption (IDE) clinical study. The announcement was made by Virtual Incision’s president and chief executive officer, John Murphy, at the SAGES 5th Annual Next Big Thing Innovation Weekend in Houston.

“Today marks a turning point in surgical robotics as we have hit a significant milestone in making miniaturized robotic surgery a reality,” said John Murphy. “For more than a decade, our team has been dedicated to our core mission of making every operating room robot-ready. I’m incredibly proud to see our efforts come to fruition. We extend our gratitude to the FDA for its thoughtful review of MIRA’s technology and our clinical evidence. Whether as a complement to the existing mainframes or as a stand-alone platform, miniaturization has the potential to accelerate the adoption of robotic-assisted surgery.”

You can read the remainder of the press release on Virtual Incision’s website by clicking here, or view a PDF copy of the press release.

Shared by Tyler Stowater, board member of Virtual Incision Corporation

Virtual Incision’s Miniaturized Surgical Robot En Route to the International Space Station for Testing of Long-Range Remote Capabilities

We are excited to share with you items related to the successful rocket launch (newest to oldest - updated as of 2/14/2024):

CNN - February 13, 2024 - Video shows surgeons remotely controlling robot to perform simulated surgery in space and interview with Dr. Mike Jobst and Dr. Shane Farritor.

CNN - February 13, 2024 - Surgery in space: Tiny remotely operated robot completes first simulated procedure at the space station, by By Taylor Nicioli and Kristin Fisher

NPR - February 10, 2024 - A tiny robot on the space station will simulate remote-controlled surgery up there, by Juliana Kim

MIRA in the news - February 2, 2024 - Small Surgical robot with a South Dakota Connection

VIC Press Release - January 30, 2024 - Space MIRA becomes the first surgical robot on the Space Station through partnership with the University of Nebraska and NASA

Cygnus cargo ship launch video (40 minutes)

Space.com - January 26, 2024 - A robot surgeon is headed to the ISS to dissect simulated astronaut tissue, by Monisha Ravisetti

NASA Overview - January 25, 2024 - Overview for NASA’s Northrop Grumman 20th Commercial Resupply Mission

Virtual Incision’s Original Announcement - August 2, 2022 - MIRA will go into space for simulated surgical testing aboard the ISS thanks to a NASA grant

Zerigo Health Appoints Eric Zerneke as New Chief Growth Officer to Expand Commercialization Efforts

Amazon Health Services alum brings 25 years of experience to fast-growing digital health company

SAN DIEGO — FEB 6, 2024 - Zerigo Health, a digital health platform for the home treatment of chronic skin conditions, including psoriasis and eczema, today announced the appointment of Eric Zerneke as the company’s Chief Growth Officer.

Click here to read the rest of the press release on Zerigo’s site, or click here to view it as a PDF.

Shared by Drew Doshier, board observer of Zerigo Health. 

Sydnexis Welcomes Erin Horn as Vice President, Head of Market Access

January 19,2023 – Sydnexis, Inc. (www.sydnexis.com), a clinical stage biopharmaceutical company focused on the treatment of progressive myopia in children and minimizing the risk of associated co-morbidities, is excited to announce the appointment of Erin Horn as its Vice President, Head of Market Access.  With a strong and diverse track record of commercial success in traditional and specialty ophthalmic pharmaceuticals, Erin will provide her market access, launch expertise, and commercial leadership to Sydnexis’ ongoing expansion and growth.

Erin will lead Sydnexis’ market access, pricing, contracting, and go-to-market strategies.  With 25 years of industry experience, Erin brings a wealth of knowledge in leading ophthalmic product launches and building successful brands and teams.

“We are thrilled that Erin has joined Sydnexis in pursuit of our mission. Erin brings a wealth of knowledge, expertise, and direct experience with market access customers and organizations that is unsurpassed in Ophthalmology. She is adynamic addition to the Sydnexis leadership team and we are extremely excited for her future success,” said Nick Ruth, Chief Commercial Officer at Sydnexis.

Read the rest of the press release here on Sydnexis’ site or a PDF copy of the story by clicking here.

SoundHound AI to Acquire SYNQ3 to Expand Its AI Customer Service Solutions and Create the Largest Voice AI Provider for Restaurants

Merger will create a new AI market leader with over 10,000 restaurant locations and best-in-class voice AI solutions

SANTA CLARA, Calif., December 07, 2023 – SoundHound AI, Inc. (Nasdaq: SOUN), a global leader in voice artificial intelligence, today announced a definitive merger agreement to acquire SYNQ3 Restaurant Solutions, a leading provider of voice AI and other technology solutions to the restaurant industry.

The deal will make SoundHound the preeminent U.S. provider of voice AI for restaurants, significantly extending its market reach by an order of magnitude to over 10,000 signed locations and accelerating the deployment of leading-edge generative AI capabilities to the industry. SYNQ3 will add large brands spanning drive thru, fast casual, casual segments, and convenience stores to SoundHound’s fast growing customer base – bringing the total to more than 25 national and multinational chains.

The highly complementary businesses will match nearly two decades of SoundHound AI innovation with decades of SYNQ3 industry expertise and established relationships. The SYNQ3 team brings deep restaurant sales, product, and customer service experience with an increasing focus on AI. Seasoned executive talent like CEO and Co-Founder Steve Bigari, a former McDonald’s operator, will strengthen SoundHound AI’s leadership as the company moves to rapidly roll out its best-in-class proprietary AI solutions to restaurants across the U.S. and beyond.

Click here to read the rest of the release posted by SoundHound AI or click here to see a PDF of the press release.

Shared by Tyler Stowater, board member of SYNQ3 Restaurant Solutions.

ORASIS PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF QLOSI™ (PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION) 0.4% FOR THE TREATMENT OF PRESBYOPIA

QLOSI™ is a preservative-free, low-dose eye drop for presbyopia, which consistently demonstrated efficacy, safety, and tolerability in two pivotal Phase 3 trials

Ponte Vedra, FL, October 18, 2023 – Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced that the U.S. Food and Drug Administration (FDA) has approved QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. QLOSI is expected to be commercially available in the U.S. in the first half of 2024.

“The FDA approval of QLOSI marks a tremendous milestone for Orasis as we continue our mission to provide a flexible treatment option for the millions of people in the U.S. living with presbyopia, or blurry near vision,” said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. “I am grateful to the Orasis team, our strategic partners, clinical investigators, and patients who participated in our clinical trials, all of whom made this achievement possible.”

QLOSI (pronounced CLOH-see) is a prescription eye drop that can be used daily, or as needed, up to twice per day. QLOSI demonstrated efficacy 20 minutes after administration and can last up to 8 hours, as measured on day 15, to improve near vision without impacting distance or night vision. QLOSI is a preservative-free formulation of pilocarpine, an established eye care therapeutic, designed to achieve an optimal balance between efficacy, safety, and comfort.

“Patients experiencing age-related, blurry near vision are in need of flexible treatment options to manage their presbyopia in ways that work for them with fewer tradeoffs,” said Paul Karpecki, O.D., FAAO, Director, Cornea and External Disease, Kentucky Eye Institute, and Associate Professor, University of Pikeville, Kentucky College of Optometry. “In clinical trials, QLOSI demonstrated the optimal balance of efficacy, safety, and tolerability, and the FDA approval marks an exciting next step in being able to provide a new treatment for patients looking for a break from reading glasses or contact lenses.”

You can read the remainder of the press release here in the news page the Orasis website.

Shared by Tyler Stowater, board member of Orasis Pharmaceuticals.

Lentechs Announces Successful $6 Million Fundraise to Further Key Development Objectives

COLUMBUS, OH, Oct 17, 2023 – Lentechs, a clinical-stage ophthalmic medical device company developing a new generation of soft, suspended contact lens, designed to transform the treatment paradigm for presbyopia, today announced the closing of a successful fundraise to further key development objectives for its investigational contact lens for patients with presbyopia. The round was led by Vision Vestments LLC, with additional significant investments from JobsOhio Growth Capital Fund, Ohio Innovation Fund, Bluestem Capital, and Rev1 Ventures.

“This milestone signifies the strength and confidence in Lentechs and our APIOC®, a first-of-its-kind line of soft, suspended contact lens designed to deliver exceptional, glasses-like vision at all distances with the freedom of a contact lens. Proceeds will be utilized to finalize industry-leading manufacturing methods and additional randomized clinical trials that will test molded APIOC vs the leading multifocal contact lenses from each of the Big-4 contact lens manufacturers,” stated Mr. Robin G. Sears, CEO of Lentechs. “Thank you to all our Board of Directors members and the investors in our company for their continued support to improve visual outcomes for millions of people worldwide.”

Read the remainder of the press release by clicking here.

Shared by Tyler Stowater, board member of Lentechs.

Virtual Incision Extends Series C Round with Additional $30M Funding

Investment will accelerate advancements of the MIRA Surgical System

LINCOLN, Neb. – September 19, 2023 – Virtual Incision Corporation, the developer of the world’s first miniaturized robotic-assisted surgery (RAS) system, today announced a $30 million extension to its previous $46 million Series C financing. The round was led by current investors Bluestem Capital, Endeavour Vision, Baird Capital, cultivate(MD) Capital Funds, and PrairieGold Venture Partners, as well as new health-tech investors Arboretum Ventures and InVivium Capital.

Concurrent with the extension, Virtual Incision has appointed Tom Shehab, MD, managing partner from Arboretum Ventures, as a member of its board of directors, and Amy Kobe, general partner from InVivium Capital, as a board observer.

“We’re grateful for our investors – both existing and new – and are excited to build an even stronger medtech syndicate with the additions of Arboretum and InVivium,” said John Murphy, president and chief executive officer of Virtual Incision. “This financing, particularly in the current fundraising environment, is a significant affirmation of the promise Virtual Incision offers to both patients and shareholders.”

The $30 million funding extension will support the company’s operations well into 2025 as it seeks to disrupt the industry with miniaturized RAS (miniRAS). miniRAS aims to deliver the capabilities of traditional RAS systems through a form factor small enough to fit in a surgical tray. The compact, capable, and convenient design is uniquely positioned to expand RAS to the millions of patients who do not have access to the technology today.1

This funding comes on the heels of a series of significant milestones toward commercial readiness of the MIRA Surgical System. Earlier this year, Virtual Incision completed an Investigational Device Exemption (IDE) clinical study for MIRA’s use in bowel resection and announced that its De Novo request is under substantive review by the U.S. Food and Drug Administration (FDA). If granted marketing authorization, the company plans to initiate a limited launch of MIRA across select U.S. centers.

Read the rest of the press release on VIC’s site by clicking here. An archived PDF is available for download here.

Shared by Tyler Stowater, board member of Virtual Incision Corporation.