2022 Year End Newsletter

I’d like to welcome you to NovaSight’s 2022 year-end newsletter.

2022 will be a year set in stone in NovaSight’s books.

In the last few months, we accomplished a few exciting milestones that brought us even closer to our mission – prevent pediatric vision loss by shifting accurate diagnostics and efficient treatment of early childhood vision impairments into the digital age.

The most noteworthy milestone this year was the award winning, CureSight™ amblyopia treatment device being FDA cleared, followed by the US commercialization starting these days .

The FDA clearance was based on CureSight’s pivotal study results which were recently published in an article in the prestigious Ophthalmology journal. Not only did we prove for the very first time in a large pivotal study, that a digital device could be non-inferior to the gold standard patching treatment, but actually, the results at the primary endpoint also showed that the visual acuity improvement of the CureSight group was higher than of the patching group.

As part of the CureSight US commercialization, we have also welcomed a new team member – Drew Hopper – as NovaSight’s VP Sales & Marketing for North America.

Alongside the US launch, CureSight and the EyeSwift®^PRO were also launched in Italy as part of the company’s entry to the European market.

Last but not least, we have recently raised $7 million in the form of a SAFE (Simple Agreement for Future Equity) round bringing the total amount raised by the company to $26 million. Managing to successfully complete this bridge round during challenging times in the financial markets is a token of confidence in the company by our investors.

With eyes on CureSight’s US commercialization and the progress of the clinical validation of the TrackSight™’s myopia prevention program, we have initiated our B round and are welcoming investors from across the board to join our journey.

Wishing you a wonderful holiday season and a happy new year.

Ran Yam
CEO

On September 29^th, CureSight, our eye tracking based digital amblyopia treatment system – has been FDA cleared!

The 510(K) FDA clearance was granted based on a multicenter, randomized, controlled trial in which 103 participants aged 4 to <9 were randomized to CureSight or patching—the current gold-standard-of-care treatment. This was the first-ever pivotal study in which a digital device was shown to be noninferior to patching for amblyopia treatment in children.

“Availability of a dichoptic digital treatment of amblyopia that matches the effectiveness of eye patching will help our patients have an alternative that also helps them deal with social and compliance challenges often associated with occlusion therapy. This will help foster a more positive feeling about amblyopia treatment,” said Michael Repka, MD, MBA, a professor of ophthalmology at Johns Hopkins University.

CureSight’s FDA clearance together with its 3 unique CPT codes becoming effective earlier this year will allow better access to life changing care for patients whose future vision condition is very much depending on the treatment that they receive in their early years.

For the full announcement click HERE

These days we are launching CureSight in the US through selected clinics within the CureSight’s early adopters’ program.

The clinics in the CureSight early adopters’ program were carefully chosen in order to support the company’s efforts towards achieving coverage through the top payors in the US. Clinics that have signed up for CureSight’s referral program will be able to refer their patients to CureSight by the upcoming April as the company prepares for the official full scale launch.

CureSight’s early adopters will be referring CureSight to their amblyopic patients while a dedicated Monitoring Center is already in place and prepared for providing comprehensive, end-to-end physician and patient education, engagement, and support.

Welcoming Drew Hopper - NovaSight’s North America VP Sales & Marketing

It is our pleasure to welcome Drew Hopper NovaSight’s VP Sales & Marketing North America to the NovaSight Family.

Drew Hopper is a Global Commercial Executive who has worked in market leading companies such as Alcon and Stryker to grow brands from acquisition to market leader position. During Drew’s tenure at Sight Sciences, he was a member of the executive team behind the IPO of the company in NASDAQ. At Alcon, Drew led the Surgical Glaucoma Division to a record-breaking year in which he earned the Master’s Club award.

Drew holds a Bachelor of Arts from Capital University and an MBA in Marketing and Strategic Leadership from Southern Methodist University.

CureSight’s Pivotal Trial’s Results Published in AAO’s Ophthalmology Journal

Results of CureSight™’s pivotal trial against the gold standard patching for amblyopia treatment in children were published in the American Academy of Ophthalmology’s journal, the prestigious Ophthalmology magazine.

This is the first ever pivotal trial proving that a digital device is non-inferior to eye patching for the treatment of amblyopia in children. It found that Best Corrected Visual Acuity (BCVA) improvement at week 16 (the primary endpoint) was larger in the CureSight treatment group (0.28 logMAR [±0.13, p<0.0001]) compared to the patching control group (0.23 logMAR [±0.14, p<0.0001]). The study also found that the percentage of subjects with a 2-line or more improvement in the CureSight group was 79% versus only 61% in the patching group.

In addition, no serious adverse events were observed in either treatment arms – CureSight or patching and all non-serious adverse events were transient and self-limiting

The article concluded that “Binocular treatment was well tolerated, non-inferior to patching in amblyopic children aged 4 to ≤9 years. High adherence may provide an alternative treatment option for amblyopia.”

Read the full study HERE

Earlier this year, we have officially partnered with SIR Oftalmica s.r.l to be NovaSight’s official distributer in Italy.

SIR Oftalmica was established in 1989 and among others, focuses on distribution of medical devices in pediatric ophthalmology. SIR Oftalmica will be the official distributor for Italy of CureSight – our eye tracking based amblyopia treatment device and the EyeSwift^PRO – our eye tracking based vision diagnostics device upon its official release.

Mr. Alberto Molteni, General Manager of SIR Oftalmica stated that “SIR Oftalmica is thrilled about the partnership with NovaSight and to bring the future of amblyopia treatment and vision diagnostic based on state-of-the-art eye tracking technology to the Italian market”.

We also had the opportunity to debut our partnership at the annual national congress of the Italian Society of Pediatric Ophthalmology (S.I.O.P.) in Genova where we showcased our technology and vision care solutions.

Global Events

American Academy of Optometry (AAO) 2022 annual meeting

We were happy to exhibit and make our debut with the US Optometry industry at the annual meeting of the American Academy of Optometry’s in San Diego. During the meeting we showcased NovaSight’s advanced eye-tracking based vision care solutions.

The meeting was a great success as the booth received a great deal of attention, and many attendees were interested in NovaSight’s technology.

Awards and Competitions

Health Tech Challengers Competition 2022

We are honored to share that NovaSight won the Health Tech Challengers Competition 2022 held during the HLTH event in Las Vegas!

Out of hundreds of challengers, 80 semi-finalists were chosen to participate in the Health Tech Forward event in October. 8 winners in 8 different tracks with NovaSight being the winner of the neurology track, were invited to pitch at the Super Finals event in Las Vegas.

During the finals, the judges made their decision and chose NovaSight as the Ultimate Health Tech Challenger of 2022!

This award joins the multiple awards that NovaSight won during 2022 for design (The Red Dot Award, IRON A’ Design Award) and the Digital Health Awards.