iHealthScreen, maker of AI-enabled software for retinal imaging, received FDA 510(k) clearance for its iPredict Eye Screening System that leverages AI to help providers determine if a patient over 50 has age-related macular degeneration. 

The iPredict System screens for AMD by using AI to analyze high-resolution images of a patient’s eyes taken with a color fundus camera. The test can be done in five minutes, and results are available within 60 seconds.  

The company is currently fundraising for a pre-Series A round of $5 million. 

“This is a major milestone for iHealthScreen. iPredictTM eye disease diagnostic tools can help prevent blindness for millions of people and save insurers countless millions of dollars in avoidable healthcare cost,” Dr. Alauddin Bhuiyan, founder and CEO of iHealthScreen said in a statement. 

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THE LARGER TREND

In 2019, 19.8 million individuals in the U.S. lived with some form of age-related macular degeneration, an increase of more than 2.75 times previous estimates, according to a study in JAMA Ophthalmology. 

In 2021, iHealthScreen received CE certification for its iPredict System for the early diagnosis of diabetic retinopathy, glaucoma and age-related macular degeneration. A year later, the U.S.-based company announced it gained approval from Australian Health’s Therapeutic Goods Administration. 

Another company utilizing AI to detect AMD is Optain, launched earlier this month by Aegis Ventures and Northwell Holdings, the investment arm of the New York-based health system. Optain uses AI-backed retinal imaging to catch early signs of the disease utilizing technology from the Australian company Eyetelligence. The partners provided Optain with an initial seed investment of $12 million. 

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The money will be used to double its workforce and open an office in Fort Lauderdale, Florida. The company is poised to ramp up sales in the US, where it’s estimated there are around 110 million eye tests annually, after receiving Food and Drug Administration (FDA) listing in March. The company is also looking to tap into the eyecare market of the 448 million citizens across the European Union. IbisVision is already in discussions with a significant number of well-known eyecare brands to develop partnerships for its breakthrough platform.

IbisVision’s refractive technology means optometrists can run standard eye tests over the Internet and enable entire optical prescriptions to be conducted remotely. Remote technology is one of the fastest-growing health sectors as people look to fit appointments into busy schedules and attend appointments with specialists who may not necessarily be nearby. The Covid pandemic has also made patients comfortable with undergoing consultations and tests over visual links.

The funding round is led by keynote investor, Miami-based Compiler VC, led by Adam Wolman. Compiler is one of the US’s leading optical sector experts, having developed and sold the For Eyes retail optician business, which has 150 locations across the US. IbisVision will be the centrepiece of a new investment fund that Compiler is establishing. The investment in IbisVision is also supported by growth capital specialists Deepbridge and by Scottish Enterprise, through Scottish Growth Investments. All three investors are existing financial supporters of IbisVision.

Reacting to the news CEO Mark Roger said “The commitment of our investor base shows they believe strongly in our story — that eyecare will be at the vanguard of remote healthcare, and IbisVision has the technology to make this a reality. Our mission is simple – to make eyecare readily available for anyone on the planet and that distance and time will never be an impediment to getting to an eye appointment.”

Adam Wolman commented: “Not only are we delighted to build on our investment relationship with IbisVision, we’re also very excited about their plans to expand and set up base in our home market in the US. We know the potential that this technology can bring to optometrists around the country and our expertise in the eyecare industry means that we can help IbisVision with its growth plans. But our ambitions for IbisVision extend well beyond the US and we believe the company’s technology could become the global standard for remote eyecare examinations.

Ben Carter, head of Life Sciences at Deepbridge said: “The continued progress of IbisVision shows the UK HealthTech industry can compete at the highest level. We are pleased to continue supporting this pioneering business whose technology has the potential to benefit patients globally.”

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About IbisVision

IbisVision’s purpose is to offer innovative eye technology that revolutionizes the customer journey, increases efficiency, and makes eye care more widely accessible. Providing multiple tests on a single cloud-based platform gives universal accessibility with a software as a service (SaaS) delivery model dramatically reducing capital expenditure. The IbisVision platform allows optical professionals to remotely examine eyes using a variety of tests including online refraction, visual acuity, visual fields and colour. This allows for eye care professionals to interact with and support their patients while they assess vision remotely all without any need for direct contact between the professional and patient. The company has worked with eyecare companies both at home and around the world. Its technology is used in healthcare kiosks across India, while the company has worked closely with the NHS to make eye appointments and aftercare more efficient and with the SBRI to help those who’ve suffered strokes.

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“I was devastated and could not believe this was happening to me,” Choi told TechCrunch. “There were no [initial] symptoms for me to recognize. If this had been diagnosed and treated early, I could have saved my vision.”

This ordeal motivated Choi to start a company to help people detect health risks early, even before symptoms appear. Following his treatment, Choi and his doctor Tyler Rim, a vitreoretinal surgeon, founded Mediwhale in 2016. The Seoul-headquartered healthcare startup has built an AI-powered non-invasive retina scan to diagnose cardiac and kidney disorders and more diseases through its patients’ retinal photographs.

Mediwhale’s first product is Reti-CVD, an AI-powered retinal diagnostic solution that assesses the risk of cardiovascular disease (CVD) in patients. Choi told TechCrunch that early detection and assessment of CVD risks would let users start statin therapy early for CVD intermediate and high-risk groups. Mediwhale’s tech offers results in under a minute, according to Choi.

Medical professionals typically use computerized cardiac tomography (CT) scans to predict CVD risk. Despite its accuracy, high-dose radiation exposure, a relatively high price and long wait times for final results are the drawbacks of a cardiac CT scan. Mediwhale claims its Reti-CVD precision matched cardiac CT scanning in predicting potential CVD risks, while avoiding radiation exposure entirely, and being accessible in primary care settings rather than in dedicated testing facilities.

The startup’s primary targets are those who currently do not currently have cardiovascular disease but have the potential to develop CVD in the future, like diabetes and metabolic disease patients, Choi said. Mediwhale focuses on South Korea as a testbed before launching its service in the U.S.

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Just last week, Mediwhale’s Reti-CVD received a temporary reimbursement code for two years from the Korean national insurance government, Choi told TechCrunch. The latest approval comes roughly eight months after it earned medical device approval in August. In other words, health insurance covers Reti-CVD as doctors in primary care and hospitals officially use it to treat patients in South Korea for the next two years; afterward, Mediwhale must submit additional clinical data to get a permanent code. It expects to sell its product this summer in South Korea.

Mediwhale recently closed $9 million in Series A funding, which brings its total to $12 million since inception. SBI Investment led the latest financing with new investor Woori Venture Partners and previous backers BNK Venture Capital, Innopolis Partners and IPS Ventures participating.

Its Series A will enable Mediwhale to accelerate the commercialization of Reti-CVD, Choi said, adding that it aims to obtain U.S. FDA clearance and implement U.S. insurance coverage with a goal of final FDA approval by 2024.

Mediwhale isn’t the only company doing work using AI in the medical diagnostics space. Alphabet’s Verily raised $ 1 billion to expand its data-driven healthcare products in 2022. Digital Diagnostics, formerly known as IDx, an AI-powered diagnostics company, secured $75 million in Series B financing led by KKR last year.

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Bioelectronics company Pixium Vision has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Prima System, a sub-retinal miniature photovoltaic wireless implant, which is in the clinical testing phase.

A photovoltaic substitute for photoreceptors, the Prima System is being developed to partially restore the vision of human patients living with atrophic dry age-related macular degeneration (AMD) condition.

The system enables the simultaneous use of the central prosthetic and peripheral natural vision implanted in patients.

Pixium Vision CEO Lloyd Diamond said: “To receive this breakthrough device designation and have the FDA recognise the therapeutic potential of our Prima System is a significant achievement for Pixium Vision, especially as only a small proportion of devices awarded the designation are intended to treat ophthalmologic conditions.

“Our Prima System is making great progress in the clinic with a read-out on the primary endpoints due toward the end of this year.

“This designation not only helps us to expedite the development of the Prima System but also affords us the opportunity of working closely with the FDA in refining the Prima System for its US regulatory submission.”

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Last December, the company concluded the implantation of the Prima System in patients participating in the European pivotal study, named PRIMAvera.

The company plans to report the trial’s primary endpoints at the end of the year, ahead of the planned regulatory submission in Europe in the first half of next year.

PRIMAvera’s primary efficacy endpoint is the proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline after one year. Meanwhile, the primary safety endpoint is defined as the number and severity of device and procedure-related serious adverse events during a 12-month follow-up.

The study will have a three-year follow-up period, with an evaluation of the primary endpoints planned to be conducted 12 months after implantation.

The design of the study is based on the positive data captured from a French feasibility study, which demonstrated the Prima System’s ability to enhance visual acuity in patients with dry AMD.

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The funding round was led by London VC Nesta Impact Investments (that closed £50M and invested in solar tech startup Naked Energy) and joined by KHP Ventures, APY Ventures and Vestel Ventures. They were joined by angel investors which included the public via a Crowdcube raise and the Manchester City captain and German international footballer İlkay Gündoğan.

Growth plans

With this funding, WeWALK is planning to push the capabilities of their tools even further. The company plans to develop their products and expand across new global markets.

WeWALK Co-founder & CEO Gökhan Meriçliler commented, “WeWALK’s products are already transforming the lives of visually impaired people across the world by improving their mobility, but there’s so much more to be done. We want to scale our business to reach a wider global audience and advance our technology to offer better, more meaningful information to visually impaired people, older people, and anyone that faces mobility challenges. This VC-backed round will enable us to unlock that next phase of development and transform mobility for millions.”

Tolly Humphreys, Investment Manager at Nesta Impact Investments, the social impact investors who led the round, commented, “One of our core missions at Nesta is to help people live longer, healthier lives – and together with Innovate UK, we are able to put both grant and equity investment into some of the most exciting companies tackling health in later life. We’re huge admirers of the WeWALK team and really excited about the potential of the product to enrich the lives of those with visual impairments. We’re looking forward to working with them to bring their products to a much wider audience.”

KHP Ventures Co-Managing Partner, Daniel Dickens, added, “We’re excited to back WeWalk’s impressive founding team in their mission to help everyone in the visually impaired community to experience better mobility. As a joint venture from one of the largest healthcare systems in the UK, we look forward to supporting WeWALK to accelerate their traction and evidence base as they continue to grow in the coming years.”

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Smart cane for the visually impaired!

There are 253 million visually impaired people globally who rely on the white cane, which provides ground-level obstacle detection. The company is on a mission to enhance the mobility of visually impaired people.

By equipping the white cane with modern technology and providing a fully accessible, custom-built navigation app, WeWALK improves the safety and independence of visually impaired people.

WeWALK was founded by Gokhan Mericliler and Kürşat Ceylan in 2017 in London. The team of 14 comprises 12 Turkish, one Lebanese, and one Filipino national. Also, there are a couple of women in the team. WeWALK has partnered with a number of high-profile R&D with the likes of Microsoft, Imperial College London and RNIB.

Transforms mobility with advanced tech

WeWALK’s smart cane uses advanced mobility tools and facial recognition. The smart cane can detect obstacles and vibrate to help the user avoid them, provide navigation prompts, and update users with key details like bus and train timings or which restaurants are nearby; radically changing how people with visual impairments can move around public spaces.

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The fully automatic retinal camera is intended to provide reliable, sharp-quality imaging with improved capability.

It provides innovative slit scan illumination and a rolling shutter mechanism that helps to capture sharp-quality fundus images for clear review and analysis.

NW500 features a 12-megapixel image sensor and rotating monitor that allows operators to optimise the distance from patients.

It offers a broad range of connectivity options, including direct DICOM, EZ Capture/ IMAGEnet 6, Shared Folder and Direct Storage.

Topcon Healthcare stated that NW500 helps to streamline workflows and improve the patient experience by providing the ability to capture retinal images in lighted settings without the need to dilate patients.

It provides better quality colour fundus images across the traditional nine fixation positions for peripheral photography as well as the disc, centre and macula fixation points.

Topcon Healthcare Product Management senior director Tobias Kurzke said: “The NW500 reflects Topcon’s commitment to continuous innovation in pursuit of technology that helps to improve the quality-of-care patients receive and make care more efficient and accessible.

“Combined, the innovative slit scan technology and 12-megapixel camera offer clinicians fast, sharp quality imaging with less failure and retakes, making the process of acquiring fundus images faster and more reliable than before.

“The added benefit of enhancing the patient experience through faster screening times and the absence of the need for dilation will give clinicians and large volume wellness screening settings a competitive advantage.”

The touch-screen operation of NW500 enables images to be captured quickly and simply with a single touch.

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The completely automated operation provides flexibility for clinicians, allowing them to delegate screening to non-clinical staff.

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“A safer treatment that does not disrupt the epithelium could enable treatment upon diagnosis and vision preservation for a broader group of patients. The EpiSmart trial will enroll patients upon diagnosis with tomographic imaging, which can detect keratoconus at its earliest stages”

“EpiSmart has the potential to be a game-changer for the treatment for keratoconus. With a true epithelium-preserving (Epi-On) approach, CXLO is striving to deliver safer and more accessible care globally to the millions of patients at risk of vision loss. This funding announcement is an important step in achieving this goal,” said Michael D. Webb, President and Chief Executive Officer of CXL Ophthalmics.

EpiSmart is CXLO’s transformative cross-linking system targeting keratoconus, a common type of corneal ectasia. EpiSmart is designed to be highly effective and minimally invasive with reduced discomfort, plus a decreased recovery time versus the current standard of care. CXLO’s approach will elevate the standard of care for keratoconus by enabling the treatment of both eyes simultaneously and eliminating the need for further deterioration.

“A safer treatment that does not disrupt the epithelium could enable treatment upon diagnosis and vision preservation for a broader group of patients. The EpiSmart trial will enroll patients upon diagnosis with tomographic imaging, which can detect keratoconus at its earliest stages,” said Michael W. Belin, CXLO’s Chief Medical Officer.

Curt LaBelle, MD, MBA, Head of Healthcare Private Equity at AXA IM Alts, said, “Keratoconus is undertreated globally. The current standard of care, Epi-Off cross-linking, can be painful and require months of recovery, limiting its utilization. CXLO’s Epi-On approach has the potential to safely deliver vision-preserving treatment to millions of patients globally, including resource-limited areas where Epi-Off treatment would be untenable due to the risk of infection and inadequate access to follow up care.”

Results of CXLO’s recent Phase 2 trial, the largest study to-date of corneal cross-linking as a treatment for keratoconus, indicate improvements in visual acuity after EpiSmart treatment at levels similar to currently available treatments, but with a substantial enhancement in safety and comfort compared to the current standard of care.

Piper Sandler acted as exclusive financial advisor to CXLO in connection with this capital raise.

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About EpiSmart

The patented EpiSmart system, including Ribostat, is designed to optimize cross-linking therapy for keratoconus, allowing minimally-invasive treatment via simultaneous bilateral application of UV light without the need for surgical disruption of the corneal epithelium. The safety and efficacy of EpiSmart was investigated in a recently concluded 2,258-subject Phase 2 trial, and CXL Ophthalmics is preparing to initiate Phase 3 clinical trials for the treatment of keratoconus with EpiSmart.

About Keratoconus

Keratoconus is a bilateral, progressive corneal degenerative disease accompanied by corneal distortion and corneal thinning. In later stages, the cornea takes on a bulging, conical shape, leading to irregular astigmatism that is difficult or impossible to correct and results in loss of functional vision. Typical onset of symptoms occurs in late teens to early twenties but can manifest in children younger than 10 years old. Based on global epidemiological research, estimates of prevalence range from 1.2% in Australia to 4-5% in the Middle East to 8% in Africa, with geographic and ethnic variation. The recent Raine study, performed in Australia, showed a prevalence at 1.2%, which implies prevalence in the US of more than 3 million.

About AXA IM Alts

AXA IM Alts is a global leader in alternative investments with c. €188 billion of assets under management^[1] comprising c.€88 billion of primarily private real estate, over €88 billion of private debt and alternative credit, as well as over €11 billion in Infrastructure, private equity and hedge funds. We take a 360° approach to real assets (real estate & infrastructure) investing with over €131 billion of assets under management in direct opportunities, held indirectly through debt and listed equities and via long term private equity investments into operating platforms. ESG is fully integrated into our investment decision making processes with our responsible investment approach anchored by the three key pillars of decarbonisation, resilience and building tomorrow. AXA IM Alts employs over 800 people located in 16 offices around the world and serves the needs of more than 500 clients from Europe, North America, Asia Pacific and Middle East. We are the number one property portfolio and asset manager in Europe^[2], and one of the largest worldwide.

¹ Source: AXA IM – Real Assets data (unaudited) as of 30 June 2022.
² Source: IPE Top 150 Real Estate Investment Managers, November/December 2021. #1 real estate investment manager in Europe based on total European real estate assets under management.

About CXL Ophthalmics

CXLO is developing a minimally-invasive treatment for ectatic corneal disease that can bring early intervention to millions of patients globally. Our EpiSmart approach is a transformative cross-linking system designed to treat keratoconus without disrupting the epithelium, allowing for a rapid return to normal activities.

For more information, please visit www.cxlophthalmics.com.

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Online eyewear and vision care company Visibly announced it had received FDA 510(k) clearance for its at-home vision test.

The Visibly Digital Acuity Product uses a touchscreen mobile device, like a smartphone, paired with a computer to test visual acuity, or how sharp a user’s vision is at a distance. 

The computer screen displays optotypes, or specifically shaped symbols or letters for vision testing, while the mobile device serves as a controller where users can input their responses. The test is designed to be used by adults between the ages of 22 and 40.

Visibly said the test usually takes about six minutes. Results are then sent to eye care professionals who can help users determine how users should proceed. 

“We are thrilled to achieve this milestone. Our performance data, including our prospective, multi-center clinical study that evaluated the safety and effectiveness of VDAP compared to an ETDRS Visual Acuity Lane Test, demonstrated that the safety and effectiveness of VDAP are substantially equivalent to those of its predicate device,” Paul Foley, Visibly’s COO, said in a statement.

“VDAP’s clinical performance will aid eye care professionals in the remote evaluation of visual acuity and connect patients with care in a way that was not available before.”

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THE LARGER TREND

Founded in 2012 as Opternative, the company most recently raised $9 million in funding in 2018. According to Crunchbase, Visibly’s total raise is $18.5 million. 

It launched an online refractive eye exam in 2015, aiming to help users determine their prescription for glasses or contacts. The tests received pushback from the American Optometric Association, which wrote a letter to the FDA arguing the agency should more strictly regulate Opternative. 

The company later received a warning letter from the FDA saying the online eye exam required premarket authorization as a Class 2 medical device. At the time, Opternative told MobiHealthNews it was “working closely” with the agency to resolve the matter. In 2019, the refractive eye exam was recalled.

ON THE RECORD

“After many years working with the FDA, we are excited to receive this clearance,” Visibly CEO Brent Rasmussen said in a statement. “We look forward to fulfilling our mission of bringing affordable, accessible vision care to the masses.”

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Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the iStent infinite^® Trabecular Micro-Bypass System indicated for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma uncontrolled by prior medical and surgical therapy.

“This FDA clearance for iStent infinite represents a significant milestone for Glaukos and the MIGS market as the first FDA-cleared micro-invasive implantable device indicated for use as a standalone treatment option for glaucoma patients not undergoing concomitant cataract surgery”

The iStent infinite includes three heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents across a span of up to approximately six clock hours around Schlemm’s canal, the eye’s primary drainage channel. Once in place, the stents are designed to lower IOP by restoring the natural, physiological outflow of aqueous humor. The iStent infinite has a similar mechanism of action to the company’s two-stent iStent inject^® W Trabecular Micro-Bypass System, which is approved by the FDA for the reduction of IOP in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery.

“This FDA clearance for iStent infinite represents a significant milestone for Glaukos and the MIGS market as the first FDA-cleared micro-invasive implantable device indicated for use as a standalone treatment option for glaucoma patients not undergoing concomitant cataract surgery,” said Thomas Burns, chairman and chief executive officer. “Supported by strong pivotal data highlighting favorable safety and effectiveness, we believe iStent infinite provides ophthalmic surgeons a compelling new interventional glaucoma alternative designed to provide foundational, 24/7 IOP control for their patients in need. We are grateful to the clinical investigators and patients who participated in the clinical trial for their instrumental roles in helping us reach this pioneering achievement and bring iStent infinite to the U.S.”

The company intends to commence initial commercial launch activities for iStent infinite later this year.

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About Glaukos

Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and has since developed a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.

Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the timing and extent to which we obtain regulatory approval for investigational products, our ability to successfully commercialize such products, the ability to obtain and maintain adequate financial coverage and reimbursement for our products, and the continued efficacy and safety profile of our products. These and other risks, uncertainties and factors related to Glaukos, and our business are described in detail under the caption “Risk Factors” and elsewhere in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on May 5, 2022. Our filings with the SEC are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

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AcuFocus, Inc., a privately held ophthalmic medical device company, announced U.S. Food and Drug Administration (FDA) approval for its breakthrough IC-8^® Apthera™ intraocular lens (IOL) for the treatment of cataracts. The Apthera IOL is the first and only non-toric extended depth of focus IOL approved for the 82% of cataract patients who have as much as 1.5 diopters (D) of corneal astigmatism.²

“As one of the clinical investigators for the Apthera IOL, I saw firsthand how the unique optics work, and I can’t wait to add it to my practice”

“We are delighted to receive FDA approval for our first-of-its-kind Apthera IOL,” said Al Waterhouse, president and chief executive officer for AcuFocus. “The Apthera IOL represents several firsts for surgeons and patients: the first small aperture IOL to receive FDA approval, the first lens indicated for implantation with a monofocal or monofocal toric IOL in the fellow eye, the first extended depth of focus lens indicated for monovision, and the first non-toric IOL indicated for cataract patients with low amounts of corneal astigmatism.”

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Cataracts are a common condition affecting an estimated 24 million people in the United States. Cataracts can only be treated with surgery in which the cloudy natural lens is removed and an artificial lens, or IOL, is implanted.¹ Most patients receive a monofocal IOL at the time of cataract surgery. While monofocal lenses provide excellent distance vision, objects up close remain blurry. Other available presbyopia-correcting lens designs have complex optics that split, shift, or stretch light to provide clear vision at more than one discrete focal point. In contrast, the Apthera IOL, with its proprietary small aperture technology, seamlessly provides excellent distance vision as well as clear intermediate and near vision, effectively mitigating the effects of presbyopia.

“The Apthera IOL is the first lens design, with its embedded FilterRing™ component, to mitigate the effects of presbyopia by simply filtering out peripheral defocused and aberrated light that degrades image quality. This allows central focused light to be delivered to the retina,” said Vance Thompson, MD of Vance Thompson Vision, Sioux Falls, South Dakota. “This novel mechanism of action provides patients with continuous range of vision from far through intermediate and near, even if they have as much as 1.5 D of corneal astigmatism.”

The FDA approval of the Apthera IOL is based on data from the U.S. Investigational Device Exemption study that evaluated the safety and effectiveness of the Apthera IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye. A total of 453 subjects were enrolled and followed for 12 months. Outcomes for the Apthera IOL group (n=343) were compared to a control group (n=110) receiving a monofocal or monofocal toric IOL in both eyes. Apthera IOL treated eyes maintained 2 D of extended depth of focus and demonstrated 0.91 D of additional range of vision benefit over monofocal IOL eyes at 0.2 logMAR threshold, exceeding the 0.50 D ANSI criterion for extended depth of focus IOLs. Apthera IOL subjects achieved equivalent uncorrected distance vision and statistically superior intermediate and near vision compared to control subjects. Apthera IOL subjects also achieved comparable binocular contrast sensitivity to control subjects in both photopic and mesopic conditions, a first reported for an extended depth of focus lens.

“As one of the clinical investigators for the Apthera IOL, I saw firsthand how the unique optics work, and I can’t wait to add it to my practice,” said Elizabeth Yeu, MD of Virginia Eye Consultants, Norfolk, Virginia. “The Apthera IOL is unlike any lens we have had before. I believe it will fill a significant gap in our IOL armamentarium allowing every cataract surgeon to meaningfully expand their treatment options for patients.”

The company plans to begin with a limited commercial release of the Apthera IOL in the U.S. in the fall of 2022.

ABOUT ASTIGMATISM

Astigmatism is a common eye condition that causes blurry far and/or near vision.³ In a normal eye, the cornea (clear front part of the eye) has a round shape and allows the light rays coming into the eye to focus on a single point on the back of the eye (retina) to form a clear image. With astigmatism, the cornea has an oval shape and, as a result, the light rays do not focus at the same point on the retina. This may cause some parts of a viewed object to be unclear and may also lead to eye discomfort and headaches.

ABOUT THE IC-8^® APTHERA™ IOL

The IC-8 Apthera IOL is a wavefront-filtering intraocular lens for unilateral implantation in patients who have as much as 1.5 D of corneal astigmatism in the implanted eye. This IOL, compared to a monofocal or monofocal toric IOL, provides an extended range of vision from distance through near. The Apthera IOL is the first extended depth of focus lens indicated for monovision.

As with any cataract surgery, risks of complications exist whether or not the IOL is implanted. The complications of IOL implantation surgery range from minor side effects (usually temporary) to serious complications. Patients with a history of previous illnesses or disorders of the eye may have a higher risk of complications. Patients with a history of retinal disease or those predisposed to retinal disease must not be implanted with the IOL. As with other extended depth of focus IOLs, further surgical treatment (such as IOL replacement for a different lens) may be needed after implantation of the IOL.

A full list of benefits and risks associated with the IC-8 Apthera IOL will be available in the Directions For Use and the Patient Information Brochure.

ABOUT ACUFOCUS

AcuFocus, Inc., is a privately held ophthalmic medical device company that delivers breakthrough small-aperture intraocular products to address diverse unmet needs in eye care and help patients achieve their best personal vision. The IC-8^® Apthera™ IOL (known as the IC-8 IOL in global markets) is approved in the United States for the treatment of cataract patients. The lens received CE mark in 2015 and is available in Australia, New Zealand, Singapore and select markets across Europe. AcuFocus is based in Irvine, California. For more information about AcuFocus, visit www.acufocus.com and follow @AcuFocus on LinkedIn, Facebook, and Instagram and @AcuFocusInc on Twitter.

The post <strong>AcuFocus Announces FDA Approval for the IC-8^® Apthera™</strong> <strong>Intraocular Lens, the First and Only Small Aperture Lens for Cataract Surgery</strong> appeared first on Medical Device News by Guided Solutions.